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Gene Therapy Market (3rd Edition), 2019-2030

  • ID: 4845182
  • Report
  • 550 Pages
  • Roots Analysis
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FEATURED COMPANIES

  • 4D Molecular Therapeutics
  • Boehringer Ingelheim
  • Foresite Capital
  • Kolon TissueGene
  • Orchard Therapeutics
  • SillaJen
  • MORE

Since the approval of the first therapy, Genedicine® in 2003, the gene therapy domain has evolved significantly. Specifically, in 2019, three gene therapies, namely Zolgensma® (US), Zynteglo™ (Europe) and Beperminogene Perplasmid (Japan), have received approval / conditional approval, leading to a marked upward surge in the interest in this field. In fact, the growing popularity can be correlated to the substantial increase (more than 90%) in the number of patents that have been filed/granted in the last three years. Moreover, in the same time period, more than USD 12.5 billion in the capital has been invested by various private and public investors to fund research activities. Presently, there are more than 10 approved gene therapies in the market, while many others are being investigated across various phases of clinical research.

Over time, the efforts of industry stakeholders and clinical researchers have led to the discovery of novel molecular targets, thereby, strengthening the research pipelines of companies involved in the development of gene therapies. Further, several technology developers have designed innovative ways to improve the efficacy and safety of gene therapies and introduced advanced therapy development and vector engineering platforms. It is also worth mentioning that, in the last 4-5 years, there has been a marked rise in the M&A activity in this domain, including the involvement of several big pharma players as well. The capability of such therapies to target diverse disease indications is considered to be amongst the most prominent growth drivers of this market. Backed by promising clinical results and several therapy candidates in late phases of development, we believe that the overall market is expected to witness tremendous growth in the coming decade.

Scope of the Report

The “Gene Therapy Market (3rd Edition), 2019-2030” report features an extensive study of the current market landscape of gene therapies, primarily focusing on gene augmentation-based therapies, oncolytic viral therapies, and genome editing therapies. The study also features an elaborate discussion on the future potential of this evolving market. Amongst other elements, the report features:

  • A detailed review of the overall landscape of gene therapies and genome editing therapies, including information on various drug / therapy developer companies, phase of development (marketed, clinical, and preclinical / discovery stage) of pipeline candidates, key therapeutic areas (cardiovascular disorders, muscular disorders, neurological disorders, ocular disorders, oncology and others) and target disease indication(s), information on gene type, type of vector used, type of therapy (ex vivo and in vivo), mechanism of action, type of gene modification (gene augmentation, oncolytic viral therapy and others) and special drug designation (if any).
  • A discussion on the various types of viral and non-viral vectors, along with information on design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vectors.
  • A world map representation, depicting the most active geographies, in terms of the presence of companies engaged in developing gene therapies, and a bull’s eye analysis, highlighting the distribution of clinical-stage pipeline candidates by a phase of development, type of vector and type of therapy (ex vivo and in vivo).
  • A discussion on the regulatory landscape related to gene therapies across various geographies, namely North America (the US and Canada), Europe and Asia-Pacific (Australia, China, Japan, and South Korea), providing details related to the various challenges associated with obtaining reimbursements for gene therapies.
  • Detailed profiles of marketed and phase II/III and gene therapies, including a brief history of development, information on current development status, mechanism of action, affiliated technology, strength of patent portfolio, dosage and manufacturing details, along with information on the developer company.
  • An elaborate discussion on the various commercialization strategies that can be adopted by drug developers for use across different stages of therapy development, namely prior to drug launch, at/during drug launch and post-marketing.
  • A review of various emerging technologies and therapy development platforms that are being used to design and manufacture gene therapies, featuring detailed profiles of technologies that were/are being used for the development of four or more products/product candidates.
  • An in-depth analysis of the various patents that have been filed/granted related to gene therapies and genome editing therapies, since 2016. The analysis also highlights the key parameters associated with the patents, including information on patent type (granted patents, patent applications and others), publication year, regional applicability, CPC classification, emerging focus areas, leading industry / non-industry players (in terms of the number of patents filed / granted), and patent valuation.
  • An analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019. The analysis also provides information on the key value drivers and deal multiples related to the mergers and acquisitions that we came across.
  • An analysis of the investments made at various stages of development in companies that are focused in this area, between 2014-2019, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants, and other offerings.
  • An analysis of the big biopharma players engaged in this domain, featuring a heat map based on parameters, such as the number of gene therapies under development, funding information, partnership activity and strength of the patent portfolio.
  • A case study on the prevalent and emerging trends related to vector manufacturing, with information on companies offering contract services for manufacturing vectors. The study also includes a detailed discussion of the manufacturing processes associated with various types of vectors.
  • A discussion on the various operating models adopted by gene therapy developers for supply chain management, highlighting the stakeholders involved, factors affecting the supply of therapeutic products and challenges encountered by developers across the different stages of the gene therapy supply chain.
  • An analysis of the various factors that are likely to influence the pricing of gene-based therapies, featuring different models/approaches that may be adopted by manufacturers to decide the prices of these therapies.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for gene therapies, for the next decade. Based on multiple parameters, such as target patient population, likely adoption rates, and expected pricing, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (cardiovascular disorders, muscular disorders, neurological disorders, ocular disorders, oncology and others), [B] various types of vectors used for therapy development (adeno associated virus, adenovirus, lentivirus, plasmid DNA, retrovirus and others), [C] type of therapy (ex vivo and in vivo), [D] type of gene modification (gene augmentation, oncolytic viral therapy and others) and [E] key geographical regions (US, EU5 and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order):

  • Adam Rogers (CEO, Hemera Biosciences)
  • Al Hawkins (CEO, Milo Biotechnology)
  • Buel Dan Rodgers (Founder & CEO, AAVogen)
  • Cedric Szpirer (Executive & Scientific Director, Delphi Genetics)
  • Christopher Reinhard (CEO and Chairman, Cardium Therapeutics)
  • Jeffrey Hung (CCO, Vigene Biosciences)
  • Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory)
  • Michael Triplett (CEO, Myonexus Therapeutics)
  • Robert Jan Lamers (CEO, Arthrogen)
  • Ryo Kubota (Chairman, President, and Chief Executive Officer, Acucela)
  • Tom Wilton (Chief Business Officer, LogicBio Therapeutics)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD unless otherwise specified.

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

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  • Boehringer Ingelheim
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  • Kolon TissueGene
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  • SillaJen
  • MORE

1 Preface
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2 Executive Summary

3 Introduction
3.1. Context and Background
3.2. Evolution of Gene Therapies
3.3. Classification of Gene Therapies
3.3.1. Somatic and Germline Gene Therapy
3.3.2. Ex Vivo and In Vivo Gene Therapy
3.4. Routes of Administration
3.5. Mechanism of Action of Gene Therapies
3.6. Concept of Gene Editing
3.7. Advantages and Disadvantages of Gene Therapies
3.8. Ethical and Social Concerns Related to Gene Therapies
3.9. Future Constraints and Challenges Related to Gene Therapies
3.9.1. Concerns Related to Manufacturing
3.9.2. Concerns Related to Commercial Viability

4 Gene Delivery Vectors
4.1. Chapter Overview
4.2. Viral Vectors
4.2.1 Types of Viral Vectors
4.2.1.1. Adeno-associated Viral Vectors
4.2.1.1.1. Overview
4.2.1.1.2. Design
4.2.1.1.3. Advantages
4.2.1.1.4. Limitations
4.2.1.2. Adenoviral Vectors
4.2.1.2.1. Overview
4.2.1.2.2. Design
4.2.1.2.3. Advantages
4.2.1.2.4. Limitations
4.2.1.3. Lentiviral Vectors
4.2.1.3.1. Overview
4.2.1.3.2. Design
4.2.1.3.3. Advantages
4.2.1.3.4. Limitations
4.2.1.4. Retroviral Vectors
4.2.1.4.1. Overview
4.2.1.4.2. Design
4.2.1.4.3. Advantages
4.2.1.4.4. Limitations
4.2.1.5. Other Viral Vectors
4.2.1.5.1. Alphavirus
4.2.1.5.2. Herpes Simplex Virus
4.2.1.5.3. Simian Virus
4.2.1.5.4. Vaccinia Virus
4.3. Non-Viral Vectors
4.3.1. Types of Non-Viral Vectors
4.3.1.1. Plasmid DNA
4.3.1.2. Liposomes, Lipoplexes and Polyplexes
4.3.1.3. Oligonucleotides
4.4. Methods of Transfection
4.4.1. Biolistic Method
4.4.2. Electroporation
4.4.3. Receptor Mediated Gene Delivery
4.4.4. Gene Activated Matrix (GAM)

5 Regulatory Landscape And Reimbursement Scenario
5.1. Chapter Overview
5.2. Regulatory Guidelines in North America
5.2.1. The US Scenario
5.2.2. The Canadian Scenario
5.3. Regulatory Guidelines in Europe
5.4. Regulatory Guidelines in Asia Pacific
5.4.1. Chinese Scenario
5.4.2. Japanese Scenario
5.4.3. South Korean Scenario
5.4.4. Australian Scenario
5.5. Reimbursement Scenario
5.5.1. Challenges Related to Reimbursement
5.6. Payment Models for Gene Therapies

6 Competitive Landscape
6.1. Chapter Overview
6.2. Gene Therapy Market: Clinical Pipeline
6.2.1. Analysis by Phase of Development
6.2.2. Analysis by Therapeutic Area
6.2.3. Analysis by Type of Vector Used
6.2.4. Analysis by Type of Gene
6.2.5. Analysis by Type of Modification
6.2.6. Analysis by Type of Gene Therapy
6.2.7. Analysis by Route of Administration
6.3. Gene Therapy Market: Early Stage Pipeline
6.3.1. Analysis by Stage of Development
6.3.2. Analysis by Therapeutic Area
6.3.3. Analysis by Type of Vector Used
6.3.4. Analysis by Type of Gene
6.3.5. Analysis by Type of Modification
6.3.6. Analysis by Type of Gene Therapy
6.4. Key Players
6.5. Developer Landscape
6.6. Regional Landscape

7 Marketed Gene Therapies
7.1. Chapter Overview
7.2. Gendicine® (Shenzhen Sibiono GeneTech)
7.2.1. Company Overview
7.2.2. Development Timeline
7.2.3. Mechanism of Action and Vectors Used
7.2.4. Target Indication(s)
7.2.5. Current Status of Development
7.2.6. Manufacturing, Dosage and Sales
7.3. Oncorine® (Shanghai Sunway Biotech)
7.3.1. Company Overview
7.3.2. Development Timeline
7.3.3. Mechanism of Action and Vectors Used
7.3.4. Target Indication(s)
7.3.5. Current Status of Development
7.3.6. Dosage and Sales
7.4. Rexin-G® (Epeius Biotechnologies)
7.4.1. Company Overview
7.4.2. Development Timeline
7.4.3. Mechanism of Action and Vector Used
7.4.4. Target Indication(s)
7.4.5. Current Status of Development
7.4.6. Manufacturing, Dosage and Sales
7.5. Neovasculgen® (Human Stem Cells Institute)
7.5.1. Company Overview
7.5.2. Development Timeline
7.5.3. Mechanism of Action and Vectors Used
7.5.4. Target Indication(s)
7.5.5. Current Status of Development
7.5.6. Manufacturing, Dosage and Sales
7.6. Imlygic® (Amgen)
7.6.1. Company Overview
7.6.2. Development Timeline
7.6.3. Mechanism of Action and Vectors Used
7.6.4. Target Indication(s)
7.6.5. Current Status of Development
7.6.6. Manufacturing, Dosage and Sales
7.7. Strimvelis® (Orchard Therapeutics)
7.7.1. Company Overview
7.7.2. Development Timeline
7.7.3. Mechanism of Action and Vectors Used
7.7.4. Target Indication(s)
7.7.5. Current Status of Development
7.7.6. Manufacturing, Dosage and Sales
7.8. Invossa™ (TissueGene)
7.8.1. Company Overview
7.8.2. Development Timeline
7.8.3. Mechanism of Action and Vectors Used
7.8.4. Target Indication(s)
7.8.5. Current Status of Development
7.8.6. Manufacturing, Dosage and Sales
7.9. Luxturna™ (Spark Therapeutics)
7.9.1. Company Overview
7.9.2. Development Timeline
7.9.3. Mechanism of Action and Vector Used
7.9.4. Target Indication(s)
7.9.5. Current Status of Development
7.9.6. Manufacturing, Dosage and Sales
7.10. Zolgensma™ (AveXis / Novartis)
7.10.1. Company Overview
7.10.2. Development Timeline
7.10.3. Mechanism of Action and Vector Used
7.10.4. Target Indication(s)
7.10.5. Current Status of Development
7.10.6. Manufacturing, Dosage and Sales
7.11. Collategene® / Beperminogene Perplasmid (AnGes)
7.11.1. Company Overview
7.11.2. Development Timeline
7.11.3. Mechanism of Action and Vector Used
7.11.4. Target Indication(s)
7.11.5. Current Status of Development
7.11.6. Manufacturing, Dosage and Sales
7.12. Zyntelgo™ (bluebird bio)
7.12.1. Company Overview
7.12.2. Development Timeline
7.12.3. Mechanism of Action and Vector Used
7.12.4. Target Indication(s)
7.12.5. Current Status of Development
7.12.6. Manufacturing, Dosage and Sales
 
8 Key Commercialization Strategies
8.1. Chapter Overview
8.2. Successful Drug Launch Strategy: ROOTS Framework
8.3. Successful Drug Launch Strategy: Product Differentiation
8.4. Commonly Adopted Commercialization Strategies based on Development Stage of the Product
8.5. Approved Gene Therapies
8.6. Key Commercialization Strategies Adopted by Companies Focused on Gene Therapy
8.6.1. Strategies Adopted Before Therapy Approval
8.6.2. Strategies Adopted During / Post Therapy Approval
8.7. Concluding Remarks

9 Late Stage (Phase Ii/Iii And Above) Gene Therapies
9.1. Chapter Overview
9.2. Axalimogene Filolisbac: Overview of Therapy, Current Development Status and Clinical Results
9.3. AMT-061: Overview of Therapy, Current Development Status and Clinical Results
9.4. BIIB111: Overview of Therapy, Current Development Status and Clinical Results
9.5. BIIB112: Overview of Therapy, Current Development Status and Clinical Results
9.6. Donaperminogene Seltoplasmid (VM202): Overview of Therapy, Current Development Status and Clinical Results
9.7. E10A: Overview of Therapy, Current Development Status and Clinical Results
9.8. Fidanacogene Elaparvovec (PF-06838435): Overview of Therapy, Current Development Status and Clinical Results
9.9. FLT180a: Overview of Therapy, Current Development Status and Clinical Results
9.10. GS010: Overview of Therapy, Current Development Status and Clinical Results
9.11. Instiladrin®: Overview of Therapy, Current Development Status and Clinical Results
9.12. Lenti-D™: Overview of Therapy, Current Development Status and Clinical Results
9.13. LYS-SAF302: Overview of Therapy, Current Development Status and Clinical Results
9.14. Ofranergene Obadenovec (VB-111): Overview of Therapy, Current Development Status and Clinical Results
9.15. OTL-101: Overview of Therapy, Current Development Status and Clinical Results
9.16. OTL-103: Overview of Therapy, Current Development Status and Clinical Results
9.17. OTL-200: Overview of Therapy, Current Development Status and Clinical Results
9.18. Pexastimogene Devacirepvec (PEXA-VEC): Overview of Therapy, Current Development Status and Clinical Results
9.19. ProstAtak®: Overview of Therapy, Current Development Status and Clinical Results
9.20. SPK-8011: Overview of Therapy, Current Development Status and Clinical Results
9.21. Unnamed Therapy: Overview of Therapy, Current Development Status and Clinical Results
9.22. Valoctocogene Roxaparvovec (BMN 270): Overview of Therapy, Current Development Status and Clinical Results
9.23. Vigil®: Overview of Therapy, Current Development Status and Clinical Results
9.24. VGX-3100: Overview of Therapy, Current Development Status and Clinical Results
9.25. Vocimagene Amiretrorepvec (Toca-511): Overview of Therapy, Current Development Status and Clinical Results

10 Emerging Technologies
10.1. Chapter Overview
10.2. Gene Editing Technologies
10.2.1. Overview
10.2.2. Applications
10.3. Emerging Gene Editing Platforms
10.3.1. CRISPR / Cas9 System
10.3.2. TALENs
10.3.3. megaTAL
10.3.4. Zinc Finger Nuclease
10.4. Gene Expression Regulation Technologies
10.5. Technology Platforms for Developing / Delivering Gene Therapies

11 Promising Therapeutics Areas
11.1. Chapter Overview
11.2 Analysis by Special Designations Awarded
11.3. Cardiovascular Disorders
11.3.1. Analysis by Target Indication
11.3.2. Analysis by Type of Vector Used
11.4. Hematological Disorders
11.4.1. Analysis by Target Indication
11.4.2. Analysis by Type of Vector Used
11.5. Inflammatory & Infectious (I&I) Diseases
11.5.1. Analysis by Target Indication
11.5.2. Analysis by Type of Vector Used
11.6. Metabolic Disorders
11.6.1. Analysis by Target Indication
11.6.2. Analysis by Type of Vector Used
11.7. Muscular Disorders
11.7.1. Analysis by Target Indication
11.7.2. Analysis by Type of Vector Used
11.8. Neurological Disorders
11.8.1. Analysis by Target Indication
11.8.2. Analysis by Type of Vector Used
11.9. Ophthalmic Disorders
11.9.1. Analysis by Target Indication
11.9.2. Analysis by Type of Vector Used
11.10. Oncology
11.10.1. Analysis by Target Indication
11.10.2. Analysis by Type of Vector Used

12 Patent Analysis
12.1. Chapter Overview
12.2. Gene Therapy-related Patents
12.2.1. Scope and Methodology
12.2.1.1. Analysis by Publication Year
12.2.1.2. Analysis by Geographical Location
12.2.1.3. Analysis by CPC Classification
12.2.1.4. Emerging Focus Areas
12.2.1.5. Leading Players: Analysis by Number of Patents
12.2.1.6. Patent Benchmark Analysis
12.2.1.7. Patent Valuation Analysis
12.2. Gene Editing-related Patents
12.2.1. Scope and Methodology
12.2.1.1. Analysis by Publication Year
12.2.1.2. Analysis by Geographical Location
12.2.1.3. Analysis by CPC Classification
12.2.1.4. Emerging Focus Areas
12.2.1.5. Leading Players: Analysis by Number of Patents
12.2.1.6. Patent Benchmark Analysis
12.2.1.7. Patent Valuation Analysis
12.3. Overall Intellectual Property Portfolio: Analysis by Type of Organization

13 Mergers And Acquisitions
13.1. Chapter Overview
13.2. Merger and Acquisition Models
13.3. Gene Therapy: Mergers and Acquisitions
13.3.1. Analysis by Year of Mergers and Acquisitions
13.3.2. Analysis by Type of Mergers and Acquisitions
13.3.3. Regional Analysis
13.3.3.1. Continent-wise Distribution
13.3.3.2. Intercontinental and Intracontinental Deals
13.3.3.3. Country-wise Distribution
13.3.4. Analysis by Key Value Drivers
13.3.4.1. Analysis by Key Value Drivers and Year of Acquisition
13.3.5. Analysis by Phase of Development of the Acquired Company’s Product
13.3.6. Analysis by Therapeutic Area

14 Funding And Investment Analysis
14.1. Chapter Overview
14.2. Types of Funding
14.3. Funding and Investment Analysis
14.3.1. Analysis by Number of Funding Instances
14.3.2. Analysis by Amount Invested
14.3.3. Analysis by Type of Funding
14.3.4. Analysis by Amount Invested across Different Types of Therapies
14.3.5. Regional Analysis by Amount Invested
14.3.6. Most Active Players
14.3.7. Key Investors
14.3.8. Analysis by Stage of Development
14.4. Concluding Remarks

15 Cost Price Analysis
13.1. Chapter Overview
13.2. Gene Therapy Market: Factors Contributing to the Price of Gene Therapies
13.3. Gene Therapy Market: Pricing Models
13.3.1. On the Basis of Associated Product / Component Costs
13.3.2. On the Basis of Competition
13.3.3. On the Basis of Patient Segment
13.3.4. On the Basis of Opinions of Industry Experts

16 Big Pharma Players: Analysis Of Gene Therapy Related Initiatives
16.1. Chapter Overview
16.2. Top Pharmaceutical Companies
16.2.1. Analysis by Therapeutic Area
16.2.2. Analysis by Type of Vector Used
16.2.3. Analysis by Type of Modification
16.2.4. Analysis by Type of Gene Therapy
16.3. Other Big Pharma Players

17 Market Forecast And Opportunity Analysis
17.1. Chapter Overview
17.2. Scope and Limitations
17.3. Key Assumptions and Forecast Methodology
17.4. Overall Gene Therapy Market, 2019-2030
17.4.1. Gene Therapy Market: Analysis by Type of Gene Modification
17.4.2. Gene Therapy Market: Analysis by Type of Therapy
17.4.3. Gene Therapy Market: Analysis by Type of Vector Used
17.4.4. Gene Therapy Market: Analysis by Therapeutic Area
17.4.5. Gene Therapy Market: Analysis by Route of Administration
17.4.6. Gene Therapy Market: Analysis by Geography
17.5. Gene Therapy Market: Value Creation Analysis
17.6. Gene Therapy Market: Product-wise Sales Forecasts
17.6.1. Gendicine®
17.6.1.1. Target Patient Population
17.6.1.2. Sales Forecast
17.6.1.3. Net Present Value
17.6.1.4. Value Creation Analysis
17.6.2. Oncorine®
17.6.2.1. Target Patient Population
17.6.2.2. Sales Forecast
17.6.2.3. Net Present Value
17.6.2.4. Value Creation Analysis
17.6.3. Rexin-G®
17.6.3.1. Target Patient Population
17.6.3.2. Sales Forecast
17.6.3.3. Net Present Value
17.6.3.4. Value Creation Analysis
17.6.4. Neovasculgen®
17.6.4.1. Target Patient Population
17.6.4.2. Sales Forecast
17.6.4.3. Net Present Value
17.6.4.4. Value Creation Analysis
17.6.5. Strimvelis®
17.6.5.1. Target Patient Population
17.6.5.2. Sales Forecast
17.6.5.3. Net Present Value
17.6.5.4. Value Creation Analysis
17.6.6. Imlygic®
17.6.6.1. Target Patient Population
17.6.6.2. Sales Forecast
17.6.6.3. Net Present Value
17.6.6.4. Value Creation Analysis
17.6.7. Invossa™
17.6.7.1. Target Patient Population
17.6.7.2. Sales Forecast
17.6.7.3. Net Present Value
17.6.7.4. Value Creation Analysis
17.6.8. Luxturna™
17.6.8.1. Target Patient Population
17.6.8.2. Sales Forecast
17.6.8.3. Net Present Value
17.6.8.4. Value Creation Analysis
17.6.9. Zolgensma™
17.6.9.1. Target Patient Population
17.6.9.2. Sales Forecast
17.6.9.3. Net Present Value
17.6.9.4. Value Creation Analysis
17.6.10. Collategene® / Beperminogene Perplasmid
17.6.10.1. Target Patient Population
14.6.10.2. Sales Forecast
17.6.10.3. Net Present Value
17.6.10.4. Value Creation Analysis
17.6.11. Zyntelgo™
17.6.11.1. Target Patient Population
17.6.11.2. Sales Forecast
17.6.11.3. Net Present Value
17.6.11.4. Value Creation Analysis
17.6.12. Axalimogene Filolisbac
17.6.12.1. Target Patient Population
17.6.12.2. Sales Forecast
17.6.12.3. Net Present Value
17.6.12.4. Value Creation Analysis
17.6.13. AMT-061
17.6.13.1. Target Patient Population
17.6.13.2. Sales Forecast
17.6.13.3. Net Present Value
17.6.13.4. Value Creation Analysis
17.6.14. BIIB111
17.6.14.1. Target Patient Population
17.6.14.2. Sales Forecast
17.6.14.3. Net Present Value
17.6.14.4. Value Creation Analysis
17.6.15. BIIB112
17.6.15.1. Target Patient Population
17.6.15.2. Sales Forecast
17.6.15.3. Net Present Value
17.6.15.4. Value Creation Analysis
17.6.16. Donaperminogene Seltoplasmid (VM202)
17.6.16.1. Target Patient Population
17.6.16.2. Sales Forecast
17.6.16.3. Net Present Value
17.6.16.4. Value Creation Analysis
17.6.17. E10A
17.6.17.1. Target Patient Population
17.6.17.2. Sales Forecast
17.6.17.3. Net Present Value
17.6.17.4. Value Creation Analysis
17.6.18. Fidanacogene Elaparvovec (PF-06838435)
17.6.18.1. Target Patient Population
17.6.18.2. Sales Forecast
17.6.18.3. Net Present Value
17.6.18.4. Value Creation Analysis
17.6.19. FLT180a
17.6.19.1. Target Patient Population
17.6.19.2. Sales Forecast
17.6.19.3. Net Present Value
17.6.19.4. Value Creation Analysis
17.6.20. GS010
17.6.20.1. Target Patient Population
17.6.20.2. Sales Forecast
17.6.20.3. Net Present Value
17.6.20.4. Value Creation Analysis
17.6.21. Instiladrin®
17.6.21.1. Target Patient Population
17.6.21.2. Sales Forecast
17.6.21.3. Net Present Value
17.6.21.4. Value Creation Analysis
17.6.22. Lenti-D™
17.6.22.1. Target Patient Population
17.6.22.2. Sales Forecast
17.6.22.3. Net Present Value
17.6.22.4. Value Creation Analysis
17.6.23. LYS-SAF302
17.6.23.1. Target Patient Population
17.6.23.2. Sales Forecast
17.6.23.3. Net Present Value
17.6.23.4. Value Creation Analysis
17.6.24. Ofranergene Obadenovec (VB-111)
17.6.24.1. Target Patient Population
17.6.24.2. Sales Forecast
17.6.24.3. Net Present Value
17.6.24.4. Value Creation Analysis
17.6.25. OTL-101
17.6.25.1. Target Patient Population
17.6.25.2. Sales Forecast
17.6.25.3. Net Present Value
17.6.25.4. Value Creation Analysis
17.6.26. OTL-103
17.6.26.1. Target Patient Population
17.6.26.2. Sales Forecast
17.6. 26.3. Net Present Value
17.6.26.4. Value Creation Analysis
17.6.27. OTL-200
17.6.27.1. Target Patient Population
17.6.27.2. Sales Forecast
17.6.27.3. Net Present Value
17.6.27.4. Value Creation Analysis
17.6.28. Pexastimogene Devacirepvec (PEXA-VEC)
17.6.28.1. Target Patient Population
17.6.28.2. Sales Forecast
17.6.28.3. Net Present Value
17.6.28.4. Value Creation Analysis
17.6.29. ProstAtak®
17.6.29.1. Target Patient Population
17.6.29.2. Sales Forecast
17.6.29.3. Net Present Value
17.6.29.4. Value Creation Analysis
17.6.30. SPK-8011
17.6.30.1. Target Patient Population
17.6.30.2. Sales Forecast
17.6.30.3. Net Present Value
17.6.30.4. Value Creation Analysis
17.6.31. Unnamed Therapy
17.6.31.1. Target Patient Population
17.6.31.2. Sales Forecast
17.6.31.3. Net Present Value
17.6.31.4. Value Creation Analysis
17.6.32. Valoctocogene Roxaparvovec (BMN 270)
17.6.32.1. Target Patient Population
17.6.32.2. Sales Forecast
17.6.32.3. Net Present Value
17.6.32.4. Value Creation Analysis
17.6.33. Vigil®
17.6.33.1. Target Patient Population
17.6.33.2. Sales Forecast
17.6.33.3. Net Present Value
17.6.33.4. Value Creation Analysis
17.6.34. VGX-3100
17.6.34.1. Target Patient Population
17.6.34.2. Sales Forecast
17.6.34.3. Net Present Value
17.6.34.4. Value Creation Analysis
17.6.35. Vocimagene Amiretrorepvec (Toca-511)
17.6.35.1. Target Patient Population
17.6.35.2. Sales Forecast
17.6.35.3. Net Present Value
17.6.35.4. Value Creation Analysis

18 Vector Manufacturing
18.1. Chapter Overview
18.2. Overview of Viral Vector Manufacturing
18.3. Viral Vector Manufacturing Processes
18.3.1. Mode of Vector Production
18.3.2. Adherent and Suspension Cultures
18.3.3. Unit Processes and Multiple Parallel Processes
18.3.4. Cell Culture Systems for Production of Viral Vectors
18.3.5. Culture Media Specifications
18.4. Bioprocessing of Viral Vectors
18.4.1. AAV Vector Production
18.4.2. Adenoviral Vector Production
18.4.3. Lentiviral Vector Production
18.4.4. γ -Retroviral Vector Production
18.5. Challenges Associated with Vector Manufacturing
18.6. Companies Offering Contract Services for Viral and Plasmid Vectors

19 Case Study: Gene Therapy Supply Chain
19.1. Chapter Overview
19.2. Overview of the Gene Therapy Supply Chain
19.3. Implementation of Supply Chain Models
19.4. Logistics in Gene Therapy
19.4.1. Logistics Processes for Autologous and Allogeneic Therapies
19.5. Regulatory Supply Chain across the Globe
19.6. Challenges Associated with Gene Therapy Supply Chain
19.7. Optimizing Cell and Advanced Therapies Supply Chain Management
19.8. Recent Developments and Upcoming Trends

20 Conclusion
20.1. Chapter Overview
20.2. Key Takeaways

21 Interview Transcripts
21.1. Chapter Overview
21.2. Adam Rogers, Chief Executive Officer, Hemera Biosciences
21.3. Al Hawkins, Chief Executive Officer, Milo Biotechnology
21.4. Buel Dan Rodgers, Founder & Chief Executive Officer, AAVogen
21.5. Cedric Szpirer, Executive & Scientific Director, Delphi Genetics
21.6. Christopher Reinhard, Chief Executive Officer and Chairman, Gene Therapeutics (previously known as Cardium Therapeutics)
21.7. Jeffrey Hung, Chief Commercial Officer, Vigene Biosciences
21.8. Marco Schmeer, Project Manager and Tatjana Buchholz, Marketing Manager, PlasmidFactory
21.9. Michael Tripletti, Chief Executive Officer, Myonexus Therapeutics
21.10. Robert Jan Lamers, Chief Executive Officer, Arthrogen
21.11. Ryo Kubota, Chairman, President and Chief Executive Officer, Acucela
21.12. Tom Wilton, Chief Business Officer, LogicBio Therapeutics

22 Appendix 1: Tabulated Data

23 Appendix 2: List Of Companies And Organizations

List of Figures
Figure 3.1 History of Evolution of Gene Therapies
Figure 3.2 Ex Vivo Gene Therapy
Figure 3.3 In Vivo Gene Therapy
Figure 3.4 Mechanism of Action of Gene Therapies
Figure 3.5 Advantages and Disadvantages of Gene Therapies
Figure 4.1 Gene Transfer: Viral and Non-Viral Methods
Figure 5.1 Centralized Regulatory Pathway for Market Approval in the US
Figure 5.2 Centralized Regulatory Pathway for Market Approval in Europe
Figure 5.3 Manufacturing Requirements for Gene Therapy Products in China
Figure 5.4 Key Elements of Quality Control in China
Figure 5.5 Centralized Regulatory Pathway for Market Approval in Japan
Figure 6.1 Gene Therapies, Clinical Pipeline: Distribution by Phase of Development
Figure 6.2 Gene Therapies, Clinical Pipeline: Distribution by Therapeutic Area
Figure 6.3 Gene Therapies, Clinical Pipeline: Distribution by Therapeutic Area and Phase of Development
Figure 6.4 Gene Therapies, Clinical Pipeline: Distribution by Type of Vector Used
Figure 6.5 Gene Therapies, Clinical Pipeline: Distribution by Type of Gene
Figure 6.6 Gene Therapies, Clinical Pipeline: Distribution by Type of Modification
Figure 6.7 Gene Therapies, Clinical Pipeline: Distribution by Type of Modification and Type of Vector Used
Figure 6.8 Gene Therapies, Clinical Pipeline: Distribution by Type of Gene Therapy
Figure 6.9 Gene Therapies, Clinical Pipeline: Distribution by Route of Administration
Figure 6.10 Gene Therapies, Early Stage Pipeline: Distribution by Stage of Development
Figure 6.11 Gene Therapies, Early Stage Pipeline: Distribution by Therapeutic Area
Figure 6.12 Gene Therapies, Early Stage Pipeline: Distribution by Type of Vector Used
Figure 6.13 Gene Therapies, Early Stage Pipeline: Distribution by Type of Gene
Figure 6.14 Gene Therapies, Early Stage Pipeline: Distribution by Type of Modification
Figure 6.15 Gene Therapies, Early Stage Pipeline: Distribution by Type of Modification and Type of Vector Used
Figure 6.16 Gene Therapies, Early Stage Pipeline: Distribution by Type of Gene Therapy
Figure 6.17 Gene Therapies: Key Players
Figure 6.18 Gene Therapy Developers: Distribution by Year of Establishment
Figure 6.19 Gene Therapy Developers: Distribution by Size of Employee Base
Figure 6.20 Gene Therapies Developers: Distribution by Location of Headquarter
Figure 6.21 Gene Therapy Developers: North America
Figure 6.22 Gene Therapy Developers: Europe
Figure 6.23 Gene Therapy Developers: Asia Pacific
Figure 7.1 Gendicine®: Development Timeline
Figure 7.2 Oncorine®: Development Timeline
Figure 7.3 Oncorine®: Mechanism of Action
Figure 7.4 Rexin-G®: Development Timeline
Figure 7.5 Neovasculgen®: Development Timeline
Figure 7.6 Imlygic®: Development Timeline
Figure 7.7 Imlygic®: Mechanism of Action
Figure 7.8 Strimvelis®: Development Timeline
Figure 7.9 Invossa™: Development Timeline
Figure 7.10 Invossa™: Mechanism of Action
Figure 7.11 Luxturna™: Development Timeline
Figure 7.12 Zolgensma™: Development Timeline
Figure 7.13 Collategene®: Development Timeline
Figure 7.14 Zyntelgo™: Development Timeline
Figure 8.1 Successful Drug Launch Strategy: ROOTS Framework
Figure 8.2 Successful Drug Launch Strategy: Product Differentiation
Figure 8.3 Commonly Adopted Commercialization Strategies based on Development Stage of the Product
Figure 8.4 Harvey Ball Analysis: Commercialization Strategies Adopted by Companies Focused on Gene Therapies
Figure 8.5 Approved Gene Therapies: Historical Timeline of Geographical Expansion
Figure 8.6 Approved Gene Therapies: Snapshot of Promotional Activities on Product Websites
Figure 10.1 Gene Editing: Key Application Areas
Figure 10.2 Gene Editing: Emerging Technology Platforms
Figure 11.1 Gene Therapies: Distribution by Therapeutic Area and Special Designations Awarded
Figure 11.2 Gene Therapies for Cardiovascular Disorders: Distribution by Target Indication and Phase of Development
Figure 11.3 Gene Therapies for Cardiovascular Disorders: Distribution by Type of Vector Used
Figure 11.4 Gene Therapies for Hematological Disorders: Distribution by Target Indication and Phase of Development
Figure 11.5 Gene Therapies for Hematological Disorders: Distribution by Type of Vector Used
Figure 11.6 Gene Therapies for I&I Disorders: Distribution by Target Indication and Phase of Development
Figure 11.7 Gene Therapies for I&I Disorders: Distribution by Type of Vector Used
Figure 11.8 Gene Therapies for Metabolic Disorders: Distribution by Target Indication and Phase of Development
Figure 11.9 Gene Therapies for Metabolic Disorders: Distribution by Type of Vector Used
Figure 11.10 Gene Therapies for Muscular Disorders: Distribution by Target Indication and Phase of Development
Figure 11.11 Gene Therapies for Muscular Disorders: Distribution by Type of Vector Used
Figure 11.12 Gene Therapies for Neurological Disorders: Distribution by Target Indication and Phase of Development
Figure 11.13 Gene Therapies for Neurological Disorders: Distribution by Type of Vector Used
Figure 11.14 Gene Therapies for Ophthalmic Disorders: Distribution by Target Indication and Phase of Development
Figure 11.15 Gene Therapies for Ophthalmic Disorders: Distribution by Type of Vector Used
Figure 11.16 Gene Therapies for Oncology: Distribution by Target Indication and Phase of Development
Figure 11.17 Gene Therapies for Oncology: Distribution by Type of Vector Used
Figure 12.1 Gene Therapy Patent Portfolio: Distribution by Type of Patent
Figure 12.2 Gene Therapy Patent Portfolio: Cumulative Distribution by Publication Year, 2016-2019
Figure 12.3 Gene Therapy Patent Portfolio: Distribution by Geographical Location
Figure 12.4 Gene Therapy Patent Portfolio: Distribution by Geographical Location, North America
Figure 12.5 Gene Therapy Patent Portfolio: Distribution by Geographical Location, Europe
Figure 12.6 Gene Therapy Patent Portfolio: Distribution by Geographical Location, Asia-Pacific
Figure 12.7 Gene Therapy Patent Portfolio: Distribution by CPC Classification Symbols
Figure 12.8 Gene Therapy Patent Portfolio: Emerging Focus Areas
Figure 12.9 Gene Therapy Patent Portfolio: Leading Industry Players
Figure 12.10 Gene Therapy Patent Portfolio: Leading Non-Industry Players
Figure 12.11 Gene Therapy Patent Portfolio (Genentech and GSK): Benchmarking by Patent Characteristics
Figure 12.12 Gene Therapy Patent Portfolio, Leading Industry Players: Benchmarking by Patent Characteristics
Figure 12.13 Gene Therapy Patent Portfolio: Distribution of Patents by Age (2016-2019)
Figure 12.14 Gene Therapy Patent Portfolio: Valuation Analysis
Figure 12.15 Gene Editing Patent Portfolio: Distribution by Type of Patent
Figure 12.16 Gene Editing Patent Portfolio: Cumulative Distribution by Publication Year, 2016-2019
Figure 12.17 Gene Editing Patent Portfolio: Distribution by Geographical Location
Figure 12.18 Gene Editing Patent Portfolio: Distribution by Geographical Location, North America
Figure 12.19 Gene Editing Patent Portfolio: Distribution by Geographical Location, Europe
Figure 12.20 Gene Editing Patent Portfolio: Distribution by Geographical Location, Asia-Pacific
Figure 12.21 Gene Editing Patent Portfolio: Distribution by CPC Classification Symbols
Figure 12.22 Gene Editing Patent Portfolio: Emerging Focus Areas
Figure 12.23 Gene Editing Patent Portfolio: Leading Industry Players
Figure 12.24 Gene Editing Patent Portfolio: Leading Non-Industry Players
Figure 12.25 Gene Editing Patent Portfolio (Sangamo Therapeutics and Cellectis): Benchmarking by Patent Characteristics
Figure 12.26 Gene Editing Patent Portfolio (Leading Industry Players): Benchmarking by Patent Characteristics
Figure 12.27 Gene Editing Patent Portfolio: Distribution of Patents by Age (2016- 2019)
Figure 12.28 Gene Editing Patent Portfolio: Valuation Analysis
Figure 12.29 Gene Therapy and Gene Editing Patent Portfolio: Cumulative Distribution by Type of Organization
Figure 13.1 Mergers and Acquisitions: Cumulative Year-Wise Trend, 2014- 2019
Figure 13.2 Mergers and Acquisitions: Distribution by Type of Mergers and Acquisitions, 2014 - 2019
Figure 13.3 Mergers and Acquisitions: Distribution by Year and Type of Merger and Acquisition, 2014 - 2019
Figure 13.4 Mergers and Acquisitions: Continent-wise Distribution
Figure 13.5 Mergers and Acquisitions: Intercontinental and Intracontinental Acquisitions
Figure 13.6 Mergers and Acquisitions: Country-wise Distribution
Figure 13.7 Acquisitions: Distribution by Key Value Drivers
Figure 13.8 Acquisitions: Distribution by Key Value Drivers and Year of Acquisition, 2014-2019
Figure 13.9 Mergers and Acquisitions: Distribution by Phase of Development of the Acquired Company’s Product
Figure 13.10 Mergers and Acquisitions: Distribution by Phase of Development of the Acquired Company’s Product and Year of Acquisition
Figure 13.11 Mergers and Acquisitions: Distribution by Phase of Development of the Acquired Company’s Product and Deal Amount
Figure 13.12 Mergers and Acquisitions: Distribution by Therapeutic Area
Figure 14.1 Funding and Investment Analysis: Distribution by Type of Funding and Year of Establishment, 2014-2019
Figure 14.2 Funding and Investment Analysis: Cumulative Number of Instances by Year, 2014-2019
Figure 14.3 Funding and Investment Analysis: Cumulative Amount Invested, 2014-2019 (USD Million)
Figure 14.4 Funding and Investment Analysis: Distribution by Type of Funding and Year, 2014-2019
Figure 14.5 Funding and Investment Analysis: Distribution of Instances by Type of Funding, 2014-2019
Figure 14.6 Funding and Investment Analysis: Distribution of the Total Amount Invested by Type of Funding, 2014-2019 (USD Million)
Figure 14.7 Funding and Investment Analysis: Summary of Investments, 2014-2019 (USD Million)
Figure 14.8 Funding and Investments: Distribution by Amount Invested across Different Types of Gene Modification
Figure 14.9 Funding and Investment Analysis: Distribution by Geography
Figure 14.10 Funding and Investment Analysis: Regional Distribution of Funding Instances
Figure 14.11 Funding and Investment Analysis: Most Active Players, on the basis of Number of Instances, 2014-2019 (USD Million)
Figure 14.12 Funding and Investment Analysis: Most Active Players, on the basis of Amount Invested, 2014-2019 (USD Million)
Figure 14.13 Funding and Investment Analysis: Distribution by Type of Investors
Figure 14.14 Funding and Investment Analysis: Distribution by Big Pharma Players (Investors)
Figure 14.15 Funding and Investment Analysis: Distribution by Government Institutes (Investors)
Figure 14.16 Funding and Investment Analysis: Leading Investors
Figure 14.17 Funding and Investment Analysis: Distribution of Investments by Stage of Development of the Company’s Product
Figure 14.18 Funding and Investment Analysis: Distribution by Highest Phase of Development of the Company’s Product
Figure 14.19 Funding and Investment Summary, 2014-2019 (USD Million)
Figure 15.1 Gene Therapy: Pricing Model Based on Patient Segment
Figure 16.1 Big Pharma Players: Heat Map Analysis of Top Pharmaceutical Companies
Figure 16.2 Big Pharma Players: Analysis by Therapeutic Area
Figure 16.3 Big Pharma Players: Analysis by Type of Vector Used
Figure 16.4 Big Pharma Players: Analysis by Type of Modification
Figure 16.5 Big Pharma Players: Analysis by Type of Gene Therapy
Figure 16.6 Big Pharma Players: Heat Map Analysis of Other Players
Figure 17.1 Overall Gene Therapy Market, 2018-2030: Base Scenario (USD Million)
Figure 17.2 Gene Therapy Market: Distribution by Type of Gene Modification, 2019, 2025 and 2030
Figure 17.3 Gene Therapy Market: Distribution by Type of Therapy, 2019, 2025 and 2030
Figure 17.4 Gene Therapy Market: Distribution by Type of Vector Used, 2019, 2025 and 2030
Figure 17.5 Gene Therapy Market: Distribution by Therapeutic Area, 2019, 2025 and 2030
Figure 17.6 Gene Therapy Market: Distribution by Route of Administration, 2019, 2025 and 2030
Figure 17.7 Gene Therapy Market: Distribution by Geography, 2019, 2025 and 2030
Figure 17.8 Gene Therapy Market: Country-wise Distribution of Rest of the World Region, 2019, 2025 and 2030
Figure 17.9 Gene Therapy Market: Distribution by Key Players, 2019, 2025 and 2030
Figure 17.10 Gendicine® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.11 Oncorine® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.12 Rexin-G® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.13 Neovasculgen® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.14 Strimvelis® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.15 Imlygic® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.16 Invossa™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.17 Luxturna™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.18 Zolgensma™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.19 Collategene® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.20 Zyntelgo™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.21 Axalimogene Filolisbac Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.22 AMT-061 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.23 BIIB111 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.24 BIIB112 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.25 Donaperminogene Seltoplasmid (VM202) Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.26 E10A Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.27 Fidanacogene Elaparvovec (PF-06838435) Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.28 FLT180a Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.29 GS010 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.30 Instiladrin® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.31 Lenti-D™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.32 LYS-SAF302 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.33 Ofranergene Obadenovec (VB-111) Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.34 OTL-101Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.35 OTL-103 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.36 OTL-200 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.37 Pexastimogene Devacirepvec (PEXA-VEC) Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.38 ProstAtak® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.39 SPK-8011 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.40 Unnamed Therapy Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.41 Valoctocogene Roxaparvovec (BMN 270) Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.42 Vigil® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.43 VGX-3100 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 17.44 Vocimagene Amiretrorepvec (Toca-511) Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 18.1 Viral Vectors: Manufacturing Steps
Figure 19.1 Steps Involved in the Development of Gene Therapies
Figure 19.2 Workflow of Cell-based Gene Therapies
Figure 19.3 Key Responsibilities of Stakeholders Involved in Advanced Therapies Supply Chain
Figure 19.4 Key Steps Involved in the Implementation of a Supply Chain Strategy
Figure 19.5 Keys Steps in the Logistics of Autologous Therapies
Figure 19.6 Comparison of Logistics Processes for Autologous and Allogeneic Therapies
Figure 19.7 Supply Chain Regulatory Authorities Across the Globe
Figure 19.8 Overview of Supply Chain Orchestration Platform
Figure 19.9 Functions of Key Technological Solutions for Cell and Advanced Therapies Supply Chain Management

List of Tables
Table 3.1 Comparison of Ex Vivo and In Vivo Techniques
Table 3.2 Vectors used for Targeted Gene Delivery to Tissues / Organs
Table 3.3 Routes of Administration of Gene Therapies: Advantages and Disadvantages
Table 4.1 Viral Vectors: Key Features
Table 5.1 Approved Advanced Therapies Medicinal Products (ATMPs) and their Reimbursement Status in Europe
Table 5.2 Payment Options Available for Gene Therapies
Table 6.1 Gene Therapy Market: Clinical Pipeline
Table 6.2 Gene Therapy Market: Early Stage Pipeline
Table 6.3 Gene Therapy Market: Developer Overview
Table 7.1 Gene Therapies: Marketed and Approved Products
Table 7.2 Company Overview: Shenzhen Sibiono GeneTech
Table 7.3 Gendicine®: Patent Portfolio
Table 7.4 Gendicine®: Status of Development
Table 7.5 Company Overview: Shanghai Sunway Biotech
Table 7.6 Oncorine®: Status of Development
Table 7.7 Company Overview: Epeius Biotechnologies
Table 7.8 Rexin-G®: Status of Development
Table 7.9 Company Overview: Human Stem Cell Institute
Table 7.10 Neovasculgen®: Status of Development
Table 7.11 Company Overview: Amgen
Table 7.12 Imlygic®: Status of Development
Table 7.13 Imlygic®: Recommended Dose and Schedule
Table 7.14 Imlygic®: Determination of Injection Volume based upon Lesion Size
Table 7.15 Company Overview: Orchard Therapeutics
Table 7.16 Strimvelis®: Status of Development
Table 7.17 Company Overview: TissueGene
Table 7.18 Invossa™: Status of Development
Table 7.19 Company Overview: Spark Therapeutics
Table 7.20 Luxturna™: Status of Development
Table 7.21 Company Overview: AveXis (A Novartis Company)
Table 7.22 Zolgensma™: Status of Development
Table 7.23 Company Overview: AnGes
Table 7.24 Collategene®: Status of Development
Table 7.25 Company Overview: bluebird bio
Table 7.26 Zyntelgo™: Status of Development
Table 8.1 Luxturna™: List of Conferences Attended Before Approval
Table 8.2 Zolgensma™: List of Conferences Attended Before Approval
Table 8.3 Luxturna™: List of Conferences Attended Post Approval
Table 8.4 Strimvelis™: List of Conferences Attended Post Approval
Table 8.5 Approved Gene Therapies: Patient Support Services Available on Product Websites (Comparative Analysis)
Table 8.6 Key Commercialization Strategies: Harvey Ball Analysis by Ease of Implementation, Value Addition and Current Adoption
Table 9.1 Gene Therapies: Phase III Drugs
Table 9.2 Drug Profile: Axalimogene filolisbac
Table 9.3 Drug Profile: AMT-061
Table 9.4 Drug Profile: BIIB111
Table 9.5 Drug Profile: BIIB112
Table 9.6 Drug Profile: Donaperminogene Seltoplasmid (VM202)
Table 9.7 Drug Profile: E10A
Table 9.8 Drug Profile: Fidanacogene Elaparvovec (PF-06838435)
Table 9.9 Drug Profile: FLT180a
Table 9.10 Drug Profile: GS010
Table 9.11 Drug Profile: Instiladrin®
Table 9.12 Drug Profile: Lenti-D™
Table 9.13 Drug Profile: LYS-SAF302
Table 9.14 Drug Profile: Ofranergene Obadenovec (VB-111)
Table 9.15 Drug Profile: OTL-101
Table 9.16 Drug Profile: OTL-103
Table 9.17 Drug Profile: OTL-200
Table 9.18 Drug Profile: Pexastimogene Devacirepvec (PEXA-VEC)
Table 9.19 Drug Profile: ProstAtak®
Table 9.20 Drug Profile: SPK-8011
Table 9.21 Drug Profile: Unnamed Therapy
Table 9.22 Drug Profile: Valoctocogene Roxaparvovec (BMN 270)
Table 9.23 Drug Profile: Vigil®
Table 9.24 Drug Profile: VGX-3100
Table 9.25 Drug Profile: Vocimagene Amiretrorepvec (Toca-511)
Table 10.1 Gene Editing Technology Platforms
Table 10.2 CRISPR Therapeutics: Funding Instances
Table 10.3 CRISPR Therapeutics: Collaborations
Table 10.4 Editas Medicine: Funding Instances
Table 10.5 Editas Medicine: Collaborations
Table 10.6 Intellia Therapeutics: Funding Instances
Table 10.7 Intellia Therapeutics: Collaborations
Table 10.8 Cellectis: Funding Instances
Table 10.9 Cellectis: Collaborations
Table 10.10 bluebird bio: Funding Instances
Table 10.11 bluebird bio: Collaborations
Table 10.12 Sangamo Therapeutics: Funding Instances
Table 10.13 Sangamo Therapeutics: Collaborations
Table 10.14 Gene Switch Technology Platforms
Table 10.15 Intrexon: Funding Instances
Table 10.16 Intrexon: Collaborations
Table 10.17 MeiraGTx: Funding Instances
Table 10.18 MeiraGTx: Collaborations
Table 10.19 Gene Therapy: Technology Platforms
Table 11.1 Gene Therapies for Cardiovascular Disorders
Table 11.2 Gene Therapies for Hematological Disorders
Table 11.3 Gene Therapies for I&I Disorders
Table 11.4 Gene Therapies for Metabolic Disorders
Table 11.5 Gene Therapies for Muscular Disorders
Table 11.6 Gene Therapies for Neurological Disorders
Table 11.7 Gene Therapies for Ophthalmic Disorders
Table 11.8 Gene Therapies for Oncology
Table 12.1 Gene Therapy Patent Portfolio: CPC Classification Symbol Definitions
Table 12.2 Gene Therapy Patent Portfolio: Most Popular CPC Classification Symbols
Table 12.3 Gene Therapy Patent Portfolio: List of Top CPC Classifications
Table 12.4 Gene Therapy Patent Portfolio: Summary of Benchmarking Analysis
Table 12.5 Gene Therapy Patent Portfolio: Categorizations based on Weighted Valuation Scores
Table 12.6 Gene Therapy Patent Portfolio: List of Leading Patents (by Highest Relative Valuation)
Table 12.7 Gene Editing Patent Portfolio: CPC Classification Symbol Definitions
Table 12.8 Gene Editing Patent Portfolio: Most Popular CPC Classification Symbols
Table 12.9 Gene Editing Patent Portfolio: List of Top CPC Classifications
Table 12.10 Gene Editing Patent Portfolio: Summary of Benchmarking Analysis
Table 12.11 Gene Editing Patent Portfolio: Categorizations based on Weighted Valuation Scores
Table 12.12 Gene Editing Patent Portfolio: List of Leading Patents (by Highest Relative Valuation)
Table 13.1 Gene Therapy: List of Mergers and Acquisitions, 2014-2019
Table 13.2 Acquisitions: Key Value Drivers
Table 13.3 Mergers and Acquisitions: Therapeutic Areas and Phase of Development of the Acquired Company’s Product
Table 14.1 Gene Therapy Market: Funding and Investments, 2014-2019
Table 14.2 Funding and Investment Analysis: Summary of Investments
Table 14.3 Funding and Investment Analysis: Summary of Venture Capital Funding
Table 15.1 Pricing Model: Price of Marketed Gene / Cell Therapies
Table 15.2 Pricing Model: Price of Marketed Targeted Drugs
Table 15.3 Pricing Model: Opinions of Experts / Other Analysts
Table 17.1 Gene Therapies: Expected Launch Years of Advanced Stage Drug Candidates
Table 17.2 Gendicine®: Target Patient Population
Table 17.3 Gendicine®: Net Present Value (USD Million)
Table 17.4 Gendicine®: Value Creation Analysis (USD Million)
Table 17.5 Oncorine®: Target Patient Population
Table 17.6 Oncorine®: Net Present Value (USD Million)
Table 17.7 Oncorine®: Value Creation Analysis (USD Million)
Table 17.8 Rexin-G®: Target Patient Population
Table 17.9 Rexin-G®: Net Present Value (USD Million)
Table 17.10 Rexin-G®: Value Creation Analysis (USD Million)
Table 17.11 Neovasculgen®: Target Patient Population
Table 17.12 Neovasculgen®: Net Present Value (USD Million)
Table 17.13 Neovasculgen®: Value Creation Analysis (USD Million)
Table 17.14 Strimvelis®: Target Patient Population
Table 17.15 Strimvelis®: Net Present Value (USD Million)
Table 17.16 Strimvelis®: Value Creation Analysis (USD Million)
Table 17.17 Imlygic®: Target Patient Population
Table 17.18 Imlygic®: Net Present Value (USD Million)
Table 17.19 Imlygic®: Value Creation Analysis (USD Million)
Table 17.20 Invossa™: Target Patient Population
Table 17.21 Invossa™: Net Present Value (USD Million)
Table 17.22 Invossa™: Value Creation Analysis (USD Million)
Table 17.23 Luxturna™: Target Patient Population
Table 17.24 Luxturna™: Net Present Value (USD Million)
Table 17.25 Luxturna™: Value Creation Analysis (USD Million)
Table 17.26 Axalimogene Filolisbac: Target Patient Population
Table 17.27 Axalimogene Filolisbac: Net Present Value (USD Million)
Table 17.28 Axalimogene Filolisbac: Value Creation Analysis (USD Million)
Table 17.29 AMT-061: Target Patient Population
Table 17.30 AMT-061: Net Present Value (USD Million)
Table 17.31 AMT-061: Value Creation Analysis (USD Million)
Table 17.32 BIIB111: Target Patient Population
Table 17.33 BIIB111: Net Present Value (USD Million)
Table 17.34 BIIB111: Value Creation Analysis (USD Million)
Table 17.35 BIIB112: Target Patient Population
Table 17.36 BIIB112: Net Present Value (USD Million)
Table 17.37 BIIB112: Value Creation Analysis (USD Million)
Table 17.38 Donaperminogene Seltoplasmid (VM202): Target Patient Population
Table 17.39 Donaperminogene Seltoplasmid (VM202): Net Present Value (USD Million)
Table 17.40 Donaperminogene Seltoplasmid (VM202): Value Creation Analysis (USD Million)
Table 17.41 E10A: Target Patient Population
Table 17.42 E10A: Net Present Value (USD Million)
Table 17.43 E10A: Value Creation Analysis (USD Million)
Table 17.44 Fidanacogene Elaparvovec (PF-06838435): Target Patient Population
Table 17.45 Fidanacogene Elaparvovec (PF-06838435): Net Present Value (USD Million)
Table 17.46 Fidanacogene Elaparvovec (PF-06838435): Value Creation Analysis (USD Million)
Table 17.47 FLT180a: Target Patient Population
Table 17.48 FLT180a: Net Present Value (USD Million)
Table 17.49 FLT180a: Value Creation Analysis (USD Million)
Table 17.50 GS010: Target Patient Population
Table 17.51 GS010: Net Present Value (USD Million)
Table 17.52 GS010: Value Creation Analysis (USD Million)
Table 17.53 Instiladrin®: Target Patient Population
Table 17.54 Instiladrin®: Net Present Value (USD Million)
Table 17.55 Instiladrin®: Value Creation Analysis (USD Million)
Table 17.56 Lenti-D™: Target Patient Population
Table 17.57 Lenti-D™: Net Present Value (USD Million)
Table 17.58 Lenti-D™: Value Creation Analysis (USD Million)
Table 17.59 LYS-SAF302: Target Patient Population
Table 17.60 LYS-SAF302: Net Present Value (USD Million)
Table 17.61 LYS-SAF302: Value Creation Analysis (USD Million)
Table 17.62 Ofranergene Obadenovec (VB-111): Target Patient Population
Table 17.63 Ofranergene Obadenovec (VB-111): Net Present Value (USD Million)
Table 17.64 Ofranergene Obadenovec (VB-111): Value Creation Analysis (USD Million)
Table 17.65 OTL-101: Target Patient Population
Table 17.66 OTL-101: Net Present Value (USD Million)
Table 17.67 OTL-101: Value Creation Analysis (USD Million)
Table 17.68 OTL-103: Target Patient Population
Table 17.69 OTL-103: Net Present Value (USD Million)
Table 17.70 OTL-103: Value Creation Analysis (USD Million)
Table 17.71 OTL-200: Target Patient Population
Table 17.72 OTL-200: Net Present Value (USD Million)
Table 17.73 OTL-200: Value Creation Analysis (USD Million)
Table 17.74 Pexastimogene Devacirepvec (PEXA-VEC): Target Patient Population
Table 17.75 Pexastimogene Devacirepvec (PEXA-VEC): Net Present Value (USD Million)
Table 17.76 Pexastimogene Devacirepvec (PEXA-VEC): Value Creation Analysis (USD Million)
Table 17.77 ProstAtak®: Target Patient Population
Table 17.78 ProstAtak®: Net Present Value (USD Million)
Table 17.79 ProstAtak®: Value Creation Analysis (USD Million)
Table 17.80 SPK-8011: Target Patient Population
Table 17.81 SPK-8011: Net Present Value (USD Million)
Table 17.82 SPK-8011: Value Creation Analysis (USD Million)
Table 17.83 Unnamed Therapy: Target Patient Population
Table 17.84 Unnamed Therapy: Net Present Value (USD Million)
Table 17.85 Unnamed Therapy: Value Creation Analysis (USD Million)
Table 17.86 Valoctocogene Roxaparvovec (BMN 270): Target Patient Population
Table 17.87 Valoctocogene Roxaparvovec (BMN 270): Net Present Value (USD Million)
Table 17.88 Valoctocogene Roxaparvovec (BMN 270): Value Creation Analysis (USD Million)
Table 17.89 Vigil®: Target Patient Population
Table 17.90 Vigil®: Net Present Value (USD Million)
Table 17.91 Vigil®: Value Creation Analysis (USD Million)
Table 17.92 VGX-3100: Target Patient Population
Table 17.93 VGX-3100: Net Present Value (USD Million)
Table 17.94 VGX-3100: Value Creation Analysis (USD Million)
Table 17.95 Vocimagene Amiretrorepvec (Toca-511): Target Patient Population
Table 17.96 Vocimagene Amiretrorepvec (Toca-511): Net Present Value (USD Million)
Table 17.97 Vocimagene Amiretrorepvec (Toca-511): Value Creation Analysis (USD Million)
Table 18.1 Small Scale Cell Culture Systems
Table 18.2 Contract Manufacturing Service Providers for Viral Vectors and Plasmid DNA
Table 20.1 Gene Therapy Market: Key Takeaways
Table 22.1 Gene Therapies, Clinical Pipeline: Distribution by Phase of Development
Table 22.2 Gene Therapies, Clinical Pipeline: Distribution by Therapeutic Area
Table 22.3 Gene Therapies, Clinical Pipeline: Distribution by Therapeutic Area and Phase of Development
Table 22.4 Gene Therapies, Clinical Pipeline: Distribution by Type of Vector Used
Table 22.5 Gene Therapies, Clinical Pipeline: Distribution by Type of Gene
Table 22.6 Gene Therapies, Clinical Pipeline: Distribution by Type of Modification
Table 22.7 Gene Therapies, Clinical Pipeline: Distribution by Type of Modification and Type of Vector Used
Table 22.8 Gene Therapies, Clinical Pipeline: Distribution by Type of Gene Therapy
Table 22.9 Gene Therapies, Clinical Pipeline: Distribution by Route of Administration
Table 22.10 Gene Therapies, Early Stage Pipeline: Distribution by Stage of Development
Table 22.11 Gene Therapies, Early Stage Pipeline: Distribution by Therapeutic Areas
Table 22.12 Gene Therapies, Early Stage Pipeline: Distribution by Type of Vector Used
Table 22.13 Gene Therapies, Early Stage Pipeline: Distribution by Type of Gene
Table 22.14 Gene Therapies, Early Stage Pipeline: Distribution by Type of Modification
Table 22.15 Gene Therapies, Early Stage Pipeline: Distribution by Type of Modification and Type of Vector Used
Table 22.16 Gene Therapies, Early Stage Pipeline: Distribution by Type of Gene Therapy
Table 22.17 Gene Therapies, Early Stage Pipeline: Distribution by Route of Administration
Table 22.18 Gene Therapies: Key Players
Table 22.19 Gene Therapy Developers: Distribution by Year of Establishment
Table 22.20 Gene Therapy Developers : Distribution by Size of Employee Base
Table 22.21 Gene Therapy Developers : Distribution by Location of Headquarter
Table 22.22 Gene Therapies: Distribution by Therapeutic Area and Special Designations Awarded
Table 22.23 Gene Therapies for Cardiovascular Disorders: Distribution by Target Indication and Phase of Development
Table 22.24 Gene Therapies for Cardiovascular Disorders: Distribution by Type of Vector Used
Table 22.25 Gene Therapies for Hematological Disorders: Distribution by Target Indication and Phase of Development
Table 22.26 Gene Therapies for Hematological Disorders: Distribution by Type of Vector Used
Table 22.27 Gene Therapies for I&I Disorders: Distribution by Target Indication and Phase of Development
Table 22.28 Gene Therapies for I&I Disorders: Distribution by Type of Vector Used
Table 22.29 Gene Therapies for Metabolic Disorders: Distribution by Target Indication and Phase of Development
Table 22.30 Gene Therapies for Metabolic Disorders: Distribution by Type of Vector Used
Table 22.31 Gene Therapies for Muscular Disorders: Distribution by Target Indication and Phase of Development
Table 22.32 Gene Therapies for Muscular Disorders: Distribution by Type of Vector Used
Table 22.33 Gene Therapies for Neurological Disorders: Distribution by Target Indication and Phase of Development
Table 22.34 Gene Therapies for Neurological Disorders: Distribution by Type of Vector Used
Table 22.35 Gene Therapies for Ophthalmic Disorders: Distribution by Target Indication and Phase of Development
Table 22.36 Gene Therapies for Ophthalmic Disorders: Distribution by Type of Vector Used
Table 22.37 Gene Therapies for Oncology: Distribution by Target Indication and Phase of Development
Table 22.38 Gene Therapies for Oncology: Distribution by Type of Vector Used
Table 22.39 Gene Therapy Patent Portfolio: Distribution by Type of Patent
Table 22.40 Gene Therapy Patent Portfolio: Cumulative Distribution by Publication Year, 2016-2019
Table 22.41 Gene Therapy Patent Portfolio: Distribution by Geographical Location
Table 22.42 Gene Therapy Patent Portfolio: Distribution by Geographical Location, North America
Table 22.43 Gene Therapy Patent Portfolio: Distribution by Geographical Location, Europe
Table 22.44 Gene Therapy Patent Portfolio: Distribution by Geographical Location, Asia Pacific
Table 22.45 Gene Therapy Patent Portfolio: Distribution by CPC Classification Symbols
Table 22.46 Gene Therapy Patent Portfolio: Emerging Focus Areas
Table 22.47 Gene Therapy Patent Portfolio: Leading Industry Players
Table 22.48 Gene Therapy Patent Portfolio: Leading Non-Industry Players
Table 22.49 Gene Therapy Patent Portfolio (Genentech and GSK): Benchmarking by Patent Characteristics
Table 22.50 Gene Therapy Patent Portfolio, Leading Industry Players: Benchmarking by Patent Characteristics
Table 22.51 Gene Therapy Patent Portfolio: Distribution of Patents by Age (2016-2019)
Table 22.52 Gene Therapy Patent Portfolio: Valuation Analysis
Table 22.53 Gene Editing Patent Portfolio: Distribution by Type of Patent
Table 22.54 Gene Editing Patent Portfolio: Cumulative Distribution by Publication Year, 2016-2019
Table 22.55 Gene Editing Patent Portfolio: Distribution by Geographical Location
Table 22.56 Gene Editing Patent Portfolio: Distribution by Geographical Location, North America
Table 22.57 Gene Editing Patent Portfolio: Distribution by Geographical Location, Europe
Table 22.58 Gene Editing Patent Portfolio: Distribution by Geographical Location, Asia-Pacific
Table 22.59 Gene Editing Patent Portfolio: Distribution by CPC Classification Symbols
Table 22.60 Gene Editing Patent Portfolio: Emerging Focus Areas
Table 22.61 Gene Editing Patent Portfolio: Leading Industry Players
Table 22.62 Gene Editing Patent Portfolio: Leading Non-Industry Players
Table 22.63 Gene Editing Patent Portfolio (Sangamo Therapeutics and Cellectis): Benchmarking by Patent Characteristics
Table 22.64 Gene Editing Patent Portfolio, Leading Industry Players: Benchmarking by Patent Characteristics
Table 22.65 Gene Editing Patent Portfolio: Distribution of Patents by Age (2016- 2019)
Table 22.66 Gene Editing Patent Portfolio: Valuation Analysis
Table 22.67 Gene Therapy and Gene Editing Patent Portfolio: Distribution by Type of Organization
Table 22.68 Mergers and Acquisitions: Cumulative Year-Wise Trend (2014- 2019)
Table 22.69 Mergers and Acquisitions: Distribution by Type of Mergers and Acquisitions (2014 - 2019)
Table 22.70 Mergers and Acquisitions: Distribution by Year and Type of Mergers and Acquisitions (2014 - 2019)
Table 22.71 Mergers and Acquisitions: Continent-wise Distribution
Table 22.72 Mergers and Acquisitions: Intercontinental and Intracontinental Acquisitions
Table 22.73 Mergers and Acquisitions: Country-wise Distribution
Table 22.74 Acquisitions: Distribution by Key Value Drivers
Table 22.75 Acquisitions: Distribution by Key Value Drivers and Year of Acquisition (2014-2019)
Table 22.76 Mergers and Acquisitions: Distribution by Phase of Development of the Acquired Company’s Product
Table 22.77 Mergers and Acquisitions: Distribution by Phase of Development of the Acquired Company’s Product and Year of Acquisition
Table 22.78 Mergers and Acquisitions: Distribution by Phase of Development of the Acquired Company’s Product and Year of Acquisition
Table 22.79 Mergers and Acquisitions: Distribution by Therapeutic Area
Table 22.80 Funding and Investment Analysis: Distribution by Type of Funding and Year of Establishment, 2014-2019
Table 22.81 Funding and Investment Analysis: Cumulative Number of Instances by Year, 2014-2019
Table 22.82 Funding and Investment Analysis: Cumulative Amount Invested, 2014-2019 (USD Million)
Table 22.83 Funding and Investment Analysis: Distribution by Type of Funding and Year, 2014-2019
Table 22.84 Funding and Investment Analysis: Distribution of Instances by Type of Funding, 2014-2019
Table 22.85 Funding and Investment Analysis: Distribution of the Total Amount Invested by Type of Funding, 2014-2019 (USD Million)
Table 22.86 Funding and Investment Analysis: Summary of Investments, 2014-2019 (USD Million)
Table 22.87 Funding and Investments: Distribution by Amount Invested across Different Types of Therapies
Table 22.88 Funding and Investment Analysis: Distribution by Geography
Table 22.89 Funding and Investment Analysis: Regional Distribution of Funding Instances
Table 22.90 Funding and Investment Analysis: Most Active Players, on the basis of Number of Instances, 2014-2019 (USD Million)
Table 22.91 Funding and Investment Analysis: Most Active Players, on the basis of Amount Invested, 2014-2019 (USD Million)
Table 22.92 Funding and Investment Analysis: Distribution by Type of Investors
Table 22.93 Funding and Investment Analysis: Distribution by Big Pharma Players (Investors)
Table 22.94 Funding and Investment Analysis: Distribution by Government Institutes (Investors)
Table 22.95 Funding and Investment Analysis: Leading Investors
Table 22.96 Funding and Investment Analysis: Distribution of Investments by Stages of Development
Table 22.97 Funding and Investment Analysis: Distribution by Highest Phase of Development of the Company’s Product for Funding
Table 22.98 Funding and Investment Summary, 2014-2019 (USD Million)
Table 22.99 Overall Gene Therapy Market, 2018-2030: Base Scenario (USD Million)
Table 22.100 Gene Therapy Market: Distribution by Type of Gene Modification, 2019, 2025 and 2030
Table 22.101 Gene Therapy Market: Distribution by Type of Therapy, 2019, 2025 and 2030
Table 22.102 Gene Therapy Market: Distribution by Type of Vector Used, 2019, 2025 and 2030
Table 22.103 Gene Therapy Market: Distribution by Therapeutic Area, 2019, 2025 and 2030
Table 22.104 Gene Therapy Market: Distribution by Route of Administration, 2019, 2025 and 2030
Table 22.105 Gene Therapy Market: Distribution by Geography, 2019, 2025 and 2030
Table 22.106 Gene Therapy Market: Distribution by Geography (Rest of the World), 2019, 2025 and 2030
Table 22.107 Gene Therapy Market: Key Players, 2019, 2025 and 2030
Table 22.108 Gendicine® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.109 Oncorine® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.110 Rexin-G® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.111 Neovasculgen® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.112 Strimvelis® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.113 Imlygic® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.114 Invossa™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.115 Luxturna™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.116 Zolgensma™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.117 Collategene® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.118 Zyntelgo™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.119 Axalimogene Filolisbac Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.120 AMT-061 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.121 BIIB111 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.122 BIIB112 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.123 Donaperminogene Seltoplasmid (VM202) Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.124 E10A Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.125 Fidanacogene Elaparvovec (PF-06838435) Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.126 FLT180a Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.127 GS010 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.128 Instiladrin® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.129 Lenti-D™ Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.130 LYS-SAF302 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.131 Ofranergene Obadenovec (VB-111) Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.132 OTL-101Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.133 OTL-103 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.134 OTL-200 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.135 Pexastimogene Devacirepvec (PEXA-VEC) Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.136 ProstAtak® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.137 SPK-8011 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.138 Unnamed Therapy Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.139 Valoctocogene Roxaparvovec (BMN 270) Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.140 Vigil® Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.141 VGX-3100 Sales Forecast (Till 2030): Base Scenario (USD Million)
Table 22.142 Vocimagene Amiretrorepvec (Toca-511) Sales Forecast (Till 2030): Base Scenario (USD Million)

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FEATURED COMPANIES

  • 4D Molecular Therapeutics
  • Boehringer Ingelheim
  • Foresite Capital
  • Kolon TissueGene
  • Orchard Therapeutics
  • SillaJen
  • MORE

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the market for gene therapies and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general overview of gene therapies, including a discussion on their historical background. It highlights the different types of gene therapies (namely somatic and germline therapies, and in vivo and ex vivo therapies), potential application areas and the route of administration of such therapeutic interventions. In addition, it includes information on the various steps involved in the transfer of therapeutic gene(s) into the body, along with a discussion on the advantages and disadvantages of this treatment paradigm. Further, the chapter features a brief discussion on the ethical and social concerns related to gene therapies, while highlighting future constraints and challenges related to the manufacturing and commercial viability of such product candidates.

Chapter 4 provides a general introduction to the various types of viral and non-viral gene delivery vectors. It includes a detailed discussion on the design, manufacturing requirements, advantages, limitations and applications of currently available vectors.

Chapter 5 features a detailed discussion on the regulatory landscape related to gene therapies across various geographies, such as the US, Canada, Europe, China, Japan, South Korea and Australia. Further, it highlights an emerging concept of reimbursement which was recently adopted by multiple gene therapy developers, along with a discussion on several issues associated with reimbursement of gene therapies.

Chapter 6 includes information on over 450 gene therapies and genome editing therapies that are currently approved or are in different stages of development. It features a comprehensive analysis of pipeline molecules, highlighting the drug developers, key therapeutic areas and target disease indication(s), phases of development, type of vector used, target gene type, type of therapy (gene augmentation / oncolytic viral therapy / others), type of somatic cell therapy (in vivo / ex vivo), mechanism of action and drug designation (if any). In addition, it features a schematic world map representation, highlighting the key regional hubs where gene therapies are being developed for the treatment of various disorders. Further, we have presented a logo landscape of product developers in North America, Europe and the Asia-Pacific region on the basis of company size.

Chapter 7 provides detailed profiles of marketed gene therapies. Each profile includes an overview of the developer and information on various other parameters, such as history of development, indication, mechanism of action, patent portfolio, current developmental status, target, clinical trial results and information related to manufacturing.

Chapter 8 features an elaborate discussion on the various strategies that can be adopted by the therapy developers across key commercialization stages, namely prior to drug launch, during drug launch and post-launch. In addition, it presents an in-depth analysis on the key strategies adopted by drug developers for the commercialization of their gene therapies that were approved post 2014.

Chapter 9 contains detailed profiles of drugs that are in advanced stages of clinical development (phase II/III and above). Each profile provides information on the mechanism of action, current status of development, route of administration, affiliated technology platform (if applicable), dosage form, clinical studies and key clinical trial results.

Chapter 10 provides a list of technology platforms that are either available in the market or in the process of being designed for the development of gene therapies. In addition, it features brief profiles of some of the key technologies. Each profile contains details on the various pipeline molecules that have been / are being developed using the technology, its advantages and the partnerships that have been established related to the technology platform. Further, the chapter includes detailed discussions on various novel and innovative technologies, along with brief information about key technology providers.

Chapter 11 highlights the potential target indications (segregated by therapeutic areas) that are currently the prime focus of companies developing gene therapies. These include cardiovascular disorders, hematological disorders, metabolic disorders, muscular disorders, neurological disorders, ocular disorders and oncology.

Chapter 12 provides insights from a detailed patent analysis, presenting an overview on the filed / granted patents related to gene therapies and genome editing therapies since 2016. For this analysis, we looked at the patents that have been published by various players till May 2019. It also highlights the important information and trends associated with these patents, including patent type (granted patents, patent applications and others), patent publication year, regional distribution, CPC classification, emerging focus areas and the leading industry / academic players (in terms of the number of patents filed / granted). The chapter also includes a patent benchmarking analysis and a detailed valuation analysis.

Chapter 13 features a detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019, based on parameters such as key value drivers, year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, and financial details of the deal (if available). In addition, the chapter presents a schematic world map representation of the geographical distribution of this activity, highlighting intracontinental and intercontinental deals.

Chapter 14 presents details on various funding instances, investments and grants that have been made within the gene therapy domain. The chapter includes information on various types of investments (such as venture capital financing, debt financing, grants, capital raised from IPO and subsequent offerings) received by the companies between 2014 and 2019, highlighting the growing interest of the venture capital community and other strategic investors in this domain.

Chapter 15 highlights our views on the various factors that may be taken into consideration while pricing gene therapies. It features discussions on different pricing models / approaches, based on the size of the target population, which a pharmaceutical company may choose to adopt to decide the price of its proprietary products.

Chapter 16 highlights top ten big biopharma players in the field of gene therapy. It features tabulated profiles of the companies and each profile includes a brief overview of the company, its financial information (if available), information on its product portfolio and recent developments.

Chapter 17 presents a comprehensive forecast analysis, highlighting the future potential of the market till the year 2030. It also includes future sales projections of gene therapies that are either marketed or in advanced stages of clinical development (phase II/III and above). Sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of products. The chapter also presents a detailed market segmentation on the basis of key therapeutic areas (cardiovascular disorders, muscular disorders, neurological disorders, ocular disorders, oncology and others), type of vector (adeno associated virus, adenovirus, lentivirus, plasmid DNA, retrovirus and others), type of somatic cell therapy (ex vivo and in vivo), type of gene modification (gene augmentation, oncolytic viral therapy and others) and geography (the US, EU5, RoW (Australia, China, Israel Japan and South Korea)).

Chapter 18 provides insights on viral vector manufacturing, highlighting the steps and processes related to manufacturing and bioprocessing of vectors. In addition, it features the challenges that exist in this domain, and highlights some of the recent collaborations and developments related to manufacturing processes of gene therapies. Further, the chapter provides details on various players that offer contract manufacturing services for viral and plasmid vectors.

Chapter 19 provides a general overview on the supply chain of gene therapies. It features the process and steps followed in the supply chain to deliver gene therapies to target patients for the treatment of various rare disorders.

Chapter 20 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the gene therapies industry.

Chapter 21 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Adam Rogers (CEO, Hemera Biosciences), Al Hawkins (CEO, Milo Biotechnology), Buel Dan Rodgers (Founder & CEO, AAVogen), Cedric Szpirer (Executive & Scientific Director, Delphi Genetics), Christopher Reinhard (CEO and Chairman, Cardium Therapeutics), Jeffrey Hung (CCO, Vigene Biosciences), Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory), Michael Triplett (CEO, Myonexus Therapeutics), Robert Jan Lamers (CEO, Arthrogen), Ryo Kubota (Chairman, President and Chief Executive Officer, Acucela) and Tom Wilton (Chief Business Officer, LogicBio Therapeutics). In addition, a brief profile of each company has been provided.

Chapter 22 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 23 is an appendix, which contains a list of companies and organizations mentioned in this report.

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  • 4D Molecular Therapeutics
  • 5AM Ventures
  • A1ATD Investors
  • AAVogen
  • AbbVie
  • Abby Grace Foundation
  • Abeona Therapeutics
  • Actus Therapeutics
  • Acucela
  • Adage Capital Management
  • Aduro Biotech
  • Advantagene
  • Advaxis
  • Adverum Biotechnologies
  • Agent Capital
  • Agilis Biotherapeutics
  • Aisling Capital
  • AJU IB Investment
  • Akouos
  • Alexandria Venture Investments
  • Allergan
  • Ally Bridge Group
  • Alpha-1 Foundation
  • AlphaVax
  • ALS Investment Fund
  • Altitude Life Science Ventures
  • Ambys Medicines
  • American Gene Technologies
  • Amgen
  • Amicus Therapeutics
  • Anaeropharma Science
  • Anchiano Therapeutics
  • AnGes
  • Angionetics
  • Apic Bio
  • Applied Genetic Technologies (AGTC)
  • ARCH Venture Partners
  • Arix Bioscience
  • ArrowMark Partners
  • Arthrogen
  • Aruvant Sciences
  • AskBio
  • Astellas Pharma
  • Atlas Venture
  • Auburn University
  • Audentes Therapeutics
  • Avalanche Biotechnologies
  • AveXis
  • AVROBIO
  • Axovant Gene Therapies
  • Baillie Gifford
  • Bain Capital Life Sciences
  • Bamboo Therapeutics
  • Baxter
  • Bayer
  • Beam Therapeutics
  • Berkeley Catalyst Fund
  • Biogen
  • BioInvent
  • BioMarin
  • Biomatics Capital
  • Bionic Sight
  • Biotechnology Value Fund
  • Bioverativ
  • Blue Bear Ventures
  • bluebird bio
  • BlueWater Angels
  • Boehringer Ingelheim
  • Boston Children's Hospital
  • Boxer Capital
  • Bpifrance
  • Brace Pharma Capital
  • Breakout Ventures
  • BrightGene Bio-Medical Technology
  • Bristol-Myers Squibb
  • Brookside Capital
  • Butterfly sciences
  • BVF Partners
  • California Institute for Regenerative Medicine (CIRM)
  • Calimmune
  • Cambridge Enterprise
  • Cambridge Innovation Capital
  • Cancer Prevention and Research Institute of Texas (CPRIT)
  • CapDecisif Management
  • Cardiogen Sciences
  • CareNet Group
  • Casdin Capital
  • Castle Creek Pharma
  • Celenex (Nationwide Children’s Hospital Spin Out)
  • Cellectis
  • CellGenTech
  • Celsion
  • Center for Applied Medical Research (CIMA)
  • Chatham Therapeutics
  • Chiba University
  • Children’s Medical Research Foundation
  • Clarus Ventures
  • Clough Capital Partners
  • Cold Genesys
  • Columbus Venture Partners
  • CombiGene
  • Copernicus Therapeutics
  • Cormorant Asset Management
  • Cowen Private Investments
  • CRISPR Therapeutics
  • CSL Behring
  • Cure Sanfilippo Foundation
  • CureDuchenne Ventures
  • Cynvec
  • Cystic Fibrosis Foundation Therapeutics
  • Deerfield Management
  • Defense Advanced Research Projects Agency (DARPA)
  • DEFTA Partners
  • Dimension Therapeutics
  • Discovery Genomics
  • DNAlite Therapeutics
  • DNAtrix
  • Driehaus Capital Management
  • Duke University Medical Center
  • EB Medical Research Foundation (EBMRF)
  • EB Research Partnership
  • EcoR1 Capital
  • EdiGene
  • Editas Medicine
  • Edmond de Rothschild Investment Partners
  • Eight Roads Ventures
  • Endsulin
  • enGene
  • Enochian BioSciences
  • Ensysce Biosciences
  • Epeius Biotechnologies
  • EPS Holdings
  • Errant Gene Therapeutics
  • Esteve
  • Etubics
  • European Investment Bank (EIB)
  • Eventide Asset Management
  • Exonics Therapeutics
  • Expression Therapeutics
  • ExSight Capital
  • Eyevensys
  • F-Prime Capital
  • FF Science
  • Fibrocell
  • Fidelity Management & Research Company
  • FIT Biotech
  • FKD Therapies
  • Flexion Therapeutics
  • Fondation Sanfilippo Suisse
  • Foresite Capital
  • Foundation Sanfilippo B
  • FoxKiser
  • Franklin Templeton Investments
  • Frazier Healthcare Partners
  • Freeline Therapeutics
  • Friedreich’s Ataxia Research Alliance
  • Fund+
  • Gemini Therapeutics
  • Genable Technologies
  • GeneCure Biotechnologies
  • Genelux
  • Genentech
  • GeneOne Life Science
  • GeneQuine Biotherapeutics
  • Generation Bio
  • Genethon
  • Genexine
  • Genprex
  • GenSight Biologics
  • GenVec
  • Ghost Tree Capital Group
  • Global BioTherapeutics (GBT)
  • Go Capital
  • GOG foundation
  • Gradalis
  • Green Cross Holdings
  • Green Pine Capital Partners
  • GSK
  • Guangzhou Double Bioproducts
  • GV (formerly Google Ventures)
  • Gyroscope Therapeutics
  • Harvard College
  • Hatteras Venture Partners
  • HBM Healthcare Investments
  • HealthCap
  • Hemera Biosciences
  • Herantis Pharma
  • Hercules Capital
  • Hiroshima Venture Capital
  • Histogenics
  • Holostem Terapie Avanzate
  • Homology Medicines
  • HORAMA
  • Horizon 2020
  • Horizon Discovery
  • Horizon Technology Finance
  • Huagai Capital
  • Huapont Life Sciences
  • Human Stem Cells Institute (HSCI)
  • Icahn School of Medicine at Mount Sinai
  • Ichor
  • ID Pharma
  • IDG Capital
  • Idinvest Partners
  • Immusoft
  • Imperial Innovations
  • Inception Capital Management
  • Innovation Network Corporation of Japan
  • Inotek Pharmaceuticals
  • Inovio Pharmaceuticals
  • Inserm Transfert
  • Intellia Therapeutics
  • Intrexon
  • Israel Innovation Authority
  • IVERIC bio
  • Janssen Pharmaceuticals
  • Janus Capital Management
  • Janus Henderson Investors
  • Jennerex
  • Jennison Associates
  • Juda Capital
  • JumpStart
  • Juventas Therapeutics
  • Kiwoom Securities
  • Kolon TissueGene
  • Krystal Biotech
  • Kurma Partners
  • Lacerta Therapeutics
  • Leerink Partners
  • Lentigen Technology, a Miltenyi Biotec Company
  • Life Sciences Partners (LSP)
  • Lilly Asia Ventures
  • LIME Asset Management
  • LogicBio Therapeutics
  • Lokon Pharma
  • Longitude Capital
  • Lonza
  • Ludwig Institute for Cancer Research
  • Lundbeckfonden Ventures
  • Lysogene
  • Marsala Biotech
  • Maryland Technology Development Corporation (TEDCO)
  • Maverick Ventures
  • MaxCyte
  • Mayo Clinic
  • MedImmune
  • Medison Ventures
  • MeiraGTx
  • Memorial Sloan Kettering Cancer Center
  • Mercia Technologies
  • Merck
  • Mercury Fund
  • MERITZ Securities
  • Mesa Verde Venture Partners
  • Michigan Economic Development
  • MidCap Financial
  • Midven
  • Milo Biotechnology
  • Mirae Asset
  • Mita Securities
  • Mizuho Capital Partners
  • MOLOGEN
  • Momotaro-Gene
  • Morningside Ventures
  • MultiVir
  • Mustang Bio
  • Myonexus Therapeutics
  • NanoCor Therapeutics
  • Nanogenic Solutions
  • National Institute of Allergy and Infectious Diseases
  • National Institutes of Health (NIH)
  • National MPS Society
  • National Securities
  • Nationwide Children's Hospital
  • Nature Technology
  • Nerveda
  • Neuracle Genetics
  • Neuralgene
  • Neurocrine Biosciences
  • Neurogene
  • Neurotech Pharmaceuticals
  • New Energy and Industrial Technology Development Organization
  • New Enterprise Associates (NEA)
  • New Leaf Venture Partners
  • Nightstar Therapeutics
  • Nissei Capital
  • Nohla Therapeutics
  • Nottingham Technology Grant Fund
  • Novartis
  • Oberland Capital
  • Ocugen
  • Office of Commercialization, Washington State University
  • Omega Funds
  • Omnes Capital
  • Oncolys BioPharma
  • Oncos Therapeutics
  • OncoSec Medical
  • OrbiMed
  • Orbit Biomedical
  • ORCA Therapeutics
  • Orchard Therapeutics
  • ORI Healthcare Fund
  • Osage University Partners
  • Oxford BioMedica
  • Oxford Finance
  • Panmure Gordon
  • Pappas Capital
  • Parker Institute for Cancer Immunotherapy
  • Partner Fund Management
  • Partners Innovation Fund
  • Passage Bio
  • Pattern BioSciences
  • Pavilion Capital
  • Pentwater Capital Management
  • Perceptive Advisors
  • PeriphaGen
  • Perseverance Capital Management
  • Pfizer
  • PlasmaTech Biopharmaceuticals
  • PNP Therapeutics
  • Pontifax Venture Capital
  • Posco Capital Partners
  • Poseida Therapeutics
  • Precision BioSciences
  • Precision Genome Engineering
  • Prevail Therapeutics
  • Promethera Biosciences
  • Prostate Cancer Foundation
  • PsiOxus Therapeutics
  • PTC Therapeutics
  • Quethera
  • QVT Financial
  • RA Capital Management
  • RBV Capital
  • Red Sanfilippo Foundation
  • Redmile Group
  • Regeneron Pharmaceuticals
  • REGENXBIO
  • Renova Therapeutics
  • Renovacor
  • Rentschler Biopharma
  • RetroSense Therapeutics
  • Rev1 Ventures
  • Reyon Pharmaceutical
  • Ridgeback Capital
  • Roche
  • Rock Springs Capital
  • Rocket Pharmaceuticals
  • RTW Investments
  • Ryboquin
  • Sabby Capital
  • Samsara BioCapital
  • Sanfilippo Children’s Foundation
  • Sangamo Therapeutics
  • Sanofi
  • Santhera Pharmaceuticals
  • Sarepta Therapeutics
  • SBI Japan-Israel Innovation Fund
  • Scancell
  • SDL Ventures
  • Sectoral Asset Management
  • Selecta Biosciences
  • Seventure Partners
  • Sham Innovation Santé
  • Shanghai Sunway Biotech
  • Shavit Capital
  • Shenzhen Qianhai Taxus
  • Shinhan Capital
  • Shinsei Corporate Investment
  • Shire
  • Sibiono GeneTech
  • SillaJen
  • SIRION Biotech
  • SMBC Venture Capital
  • Sofinnova Ventures
  • Solid Biosciences
  • SOSV
  • Spark Therapeutics
  • Sphera Global Health Care Fund
  • SR-TIGET
  • St. Jude Children’s Research Hospital
  • Stop Sanfilippo Foundation
  • StrideBio
  • Surveyor Capital (a Citadel company)
  • SV Health Investors
  • SV Life Sciences
  • SVE Capital
  • T. Rowe Price Associates
  • Takeda
  • Target ALS Foundation
  • Targeted Technology Funds
  • Targovax
  • Tasly Biopharmaceuticals
  • Taxus Cardium Pharmaceuticals
  • Tech Coast Angels
  • Technium Partners
  • Temasek
  • Tenaya Therapeutics
  • The Board of Trustees of the Leland Stanford Junior University
  • The Column Group (TCG)
  • The Movember Foundation
  • TheraBiologics
  • THERAVECTYS
  • Third Rock Ventures
  • TNK Therapeutics, subsidiary of Sorrento Therapeutics
  • Tocagen
  • TPG Capital
  • Transgene
  • Transposagen Biopharmaceuticals
  • U.S. Army’s Small Business Innovation Research
  • UB Securities
  • UC Davis Medical Center
  • UK Cystic Fibrosis Gene Therapy Consortium
  • Ultragenyx Pharmaceutical
  • uniQure Biopharma
  • Universitat Autònoma de Barcelona (UAB)
  • University College London
  • University of California
  • University of Massachusetts Medical School
  • University of Oxford
  • University of Pennsylvania
  • Urovant Sciences
  • UT Southwestern Medical Center
  • V-Bio Ventures
  • VBL Therapeutics
  • VCN Biosciences
  • Vector Neurosciences
  • Venrock
  • Versant Ventures
  • Vertex Pharmaceuticals
  • Verve Therapeutics
  • Vessl™
  • Vical
  • Vida Ventures
  • Viking Global Investors
  • Virginia Catalyst
  • ViroMed
  • Virttu Biologics
  • Vivet Therapeutics
  • Vivo Capital
  • Voyager Therapeutics
  • Washington Research Foundation
  • Weill Cornell Medical College
  • Wellcome Trust
  • Wellington Capital Management
  • Wellstat Ophthalmics
  • Whitesun Healthcare Ventures
  • WI Harper Group
  • Woodford Investment Management
  • Wyvern Pharmaceuticals
  • XyloCor Therapeutics
  • Ysios Capital
  • Yuhan Corporation
  • Ziopharm Oncology
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