Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026

  • ID: 3944788
  • Report
  • Region: Global
  • 260 Pages
  • Roots Analysis
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The Growing Number of Gene Therapy Candidates Coupled with their Rapid Progression Through the Various Phases of Clinical Development Continues to Create an Increasing Demand for Vectors

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Gene therapy has emerged as a promising treatment option for various diseases (primarily the ones that currently have no cure) including cancers, inherited disorders and some viral infections. Gene therapies and genetically modified therapies involve the introduction of therapeutic DNA (gene of interest) into the patient’s body. There have been a number of successful trials in several systems showing the efficient transfer and expression of a variety of human genes into target cells. This process of gene delivery into cells is accomplished by the use of vectors.

Over the last few decades, various viral and non-viral vectors have been optimized and standardized for this purpose. Currently, the most popular viral vectors used for gene therapies are those based on adenovirus, retrovirus, AAV and lentivirus vectors (these respectively form 20%, 16%, 8% and 8% of the active gene therapy clinical trials). Similarly, among non-viral gene delivery tools, plasmid DNA has emerged as the most commonly used vector. It is also used in the development and production of viral vectors and DNA vaccines.

Eight gene therapies have been approved so far; these are (in the order of their approval) Gendicine®, Oncorine®, Rexin-G®, Glybera®, Neovasculagen®, Imlygic®, Strimvelis™ and Zalmoxis®. Strimvelis™, one of the most recently approved gene therapy, received a market authorization from the European Commission in May 2016. In addition, over 500 gene therapy candidates are in different stages of clinical development; for these, approximately 1,700 clinical studies are currently being conducted in various regions across the globe.

The growing number of gene therapy candidates coupled with their rapid progression through the various phases of clinical development continues to create an increasing demand for vectors. The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industrial players as well as academic institutes are significantly contributing to the production of GMP and non-GMP grade vectors. In the recent past, these players have signed multiple partnerships/collaborations with an aim to optimize and scale-up the production processes and expand their capabilities of vector production.

Looking at the evolutionary trends, we believe that the market will continue to be steadily driven in the mid to long term by expansions of existing and establishment of new dedicated manufacturing facilities. Technological advancements to mitigate challenges posed by conventional methods of vector production will act as a key enabler to this growth.

The "Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026" report provides an extensive study of the rapidly growing market of gene therapy vectors, with a special focus on lentivirus, AAV, adenovirus, retrovirus and plasmid DNA. Gene therapies require a viral or non-viral vector to efficiently transfer the therapeutic gene into targets cells. It is well known that the gene therapy market is characterized by a robust pipeline of drugs targeting several therapeutic indications. The pipeline is witnessing continuous progression that has further led to an upward surge in demand for gene delivery tools, including both viral and non-viral vectors.

Several players, including pharmaceutical companies, research institutes, contract manufacturing organizations and non-profit organizations, are playing a critical role in the development and production of these vectors. Led by technological advancements, these organizations have developed and introduced proprietary platforms to overcome the challenges posed by conventional production technologies and have also made heavy investments in the expansion of their existing capabilities for vector production.
 
During the course of our study, we identified over 140 organizations that are actively involved in the production of viral vectors and plasmid DNA. In addition to other elements, the study provides information on:

  • The current status of the market with respect to key players along with information on the location of their manufacturing facilities, scale of production, type of vectors manufactured, purpose of production (fulfilling in-house requirement/as a contract service provider) and the type of organization (industry/academia).
  • Most active regions in terms of vector manufacturing; the report contains schematic representations of world maps that clearly indicate the locations of global vector manufacturing hubs.
  • Elaborate profiles of key players that have commercial scale production capabilities for viral vector/plasmid DNA; each profile covers an overview of the company, its financial performance, information on its manufacturing facilities, vector manufacturing technology, recent investments, expansions and collaborations.
  • A discussion on the key enablers of the market and challenges associated with the vector production process.
  • Potential future growth of the vector manufacturing market segmented by the type of vector and phase of development. For the purposes of our analysis, we took into consideration several parameters that are likely to impact the growth of this market over the next decade; these include the likely increase in the number of clinical studies, increase in the patient population, existing price variations among different vector types, estimated dosage frequency and the anticipated success of commercial gene therapy products.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth.Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain.

The report features detailed transcripts of interviews held with Alain Lamproye (President of Biopharma Business Unit, Novasep), Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital), Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing), Joost van den Berg (Director, Amsterdam BioTherapeutics Unit), Nicole Faust (Chief Scientific Officer, Cevec) and Semyon Rubinchik (Scientific Director, ACGT).
 
Example Highlights

  • Overall, we came across over 90 manufacturers producing viral vectors and over 30 manufacturers producing plasmid DNA. In addition, we observed that there are 14 manufacturers that have the capabilities to produce both viral vectors and plasmid DNA.
  • Several established organizations have been involved in the production of vectors since the inception of this domain. However, the growing demand for these programs have spurred the establishment of many start-ups as well. Examples include (indicative list, in alphabetical order) Batavia Biosciences, Brammer Bio, GenIBET Biopharmaceuticals, Immune Technology, Lentigen Technology, Luminous Biosciences, Oxford Genetics, SignaGen Laboratories, Vectalys and Virovek. It is also worth highlighting that over 50 academic institutes/non-profit organizations are currently involved in the production of vectors for use in gene therapies.
  • As most of the gene therapy candidates are in development stage, the demand for research and clinical grade vectors is more as compared to the demand for commercial grade vectors. However, some players (as per our research, 24) have developed/are developing commercial scale capacity for vector production. Examples include (in alphabetical order) Aldevron, BioReliance/SAFC, Cobra Biologics, Eurogentec, FUJIFILM Diosynth Biotechnologies, Lonza, MassBiologics and WuXi AppTec.
  • Although the current market landscape is dominated by contract manufacturers, some drug developers have established in-house capabilities to produce vectors for internal programs. Example include (in alphabetical order) Amsterdam BioTherapeutics Unit (AmBTU), bluebird bio, BioVex (Amgen subsidiary), Epeius Biotechnologies, GeneCure Biotechnologies, MolMed and uniQure. Some of these are well established players and have approved gene therapies in their pipeline whereas some are being supported by large pharmaceutical companies, venture capital firms or non-profit organizations.
  • Despite the fact that the first three gene therapy candidates (Gendicine®, Oncorine® and Rexin-G®) were approved in Asian countries, the US and Europe have emerged as vector manufacturing hubs over the last few years. This is a result of the high volume of ongoing clinical studies in these developed regions. Approximately 68% of the total worldwide active clinical studies for gene therapies are underway in North America. The second major market is Europe where around 21% of the trials are ongoing.
  • The heightened competition has resulted in the emergence of innovative technologies that mitigate the challenges of safety, stability, purification and scale up posed by conventional methods of vector production. There is a growing focus on the cultivation of suspension cell cultures in serum free media using large scale bioreactors, adoption of more efficient downstream processes based on chromatographic techniques and use of baculovirus based cultures systems. Some organizations have also developed proprietary platform processes to optimize and scale-up the vector production process. Examples include Herpes-Assisted Vector Expansion (AGTC), LentiVector® platform (Oxford BioMedica), CAP®-GT (Cevec) and NAV® technology (REGENXBIO). In addition, Aldevron and Plasmid Factory have introduced a new technology based on minicircle DNA that has so far demonstrated superior results as compared to the conventional plasmid production process.
  • The growing interest in vector manufacturing domain is further highlighted by the increasing number of collaborations/partnerships among the organizations involved in this field. The motives behind the partnerships vary; collaborations have been signed for purposes such as out/in licensing of vector manufacturing technology, production of vector promoters and acquisition/development of manufacturing facilities.
  • The short-term demand for viral and non-viral vectors will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage molecules (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for viral vectors and plasmid DNA manufacturing to grow at an annualized growth rate of ~17% and be worth over USD 1 billion over the course of next ten years.
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FEATURED COMPANIES

  • 4D Molecular Therapeutics
  • Blue Sky BioServices
  • Fondazione Telethon
  • Massachusetts Eye and Ear
  • Puresyn
  • T. Rowe Price Associates
  • MORE

1. Preface
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
 
2. Executive Summary
 
3. Introduction
3.1. Chapter Overview
3.2. Viral Vectors
3.3. Types of Viral Vectors
3.3.1. Retroviral Vectors
3.3.1.1. Introduction
3.3.1.2. Design and Manufacturing
3.3.1.3. Advantages
3.3.1.4. Limitations
 
3.3.2. Lentiviral Vectors
3.3.2.1. Introduction
3.3.2.2. Design and Manufacturing
3.3.2.3. Advantages
3.3.2.4. Limitations
 
3.3.3. Adenoviral Vectors
3.3.3.1. Introduction
3.3.3.2. Design and Manufacturing
3.3.3.3. Advantages
3.3.3.4. Limitations
 
3.3.4. Adeno-associated Viral Vectors
3.3.4.1. Introduction
3.3.4.2. Design and Manufacturing
3.3.4.3. Advantages
3.3.4.4. Limitations
 
3.3.5. Other Viral Vectors
3.3.5.1. Herpes Simplex Virus
3.3.5.2. Alphavirus
3.3.5.3. Vaccinia Virus
3.3.5.4. Simian Virus
 
3.4. Non-Viral Vectors
3.4.1. Plasmid DNA
3.4.2. Liposomes, Lipoplexes and Polyplexes
3.4.3. Oligonucleotides
3.4.4. Non-Viral Vectors: Methods of Transfection
3.4.4.1. Biolistic Methods: Gene Gun
3.4.4.2. Electroporation
3.4.4.3. Receptor Mediated Gene Delivery Methods
3.4.4.4. Gene Activated Matrix (GAM)
 
3.5. Applications of Viral and Non-Viral Vectors
3.5.1. Gene Therapy
3.5.2. Vaccinology
 
3.6. Current State of Gene Therapy Market
3.6.1. Manufacturing of Gene Therapies
 
4. Market Overview
4.1. Chapter Overview
4.2. Viral Vectors and Plasmid DNA Manufacturers: Overall Market Landscape
4.2.1. Distribution by Location of Manufacturing Facility
4.2.2. Distribution by Type of Organization
 
4.3. Viral Vector Manufacturing
4.3.1. Distribution by Type of Vector
4.3.2. Distribution by Scale of Production
4.3.3. Distribution by Location of Manufacturing Facility, Type of Organization and Purpose of Production
 
4.4. Plasmid DNA Manufacturing
4.4.1. Distribution by Scale of Production
4.4.2. Distribution by Location of Manufacturing Facility, Type of Organization and Purpose of Production
 
4.5. Key Insights on the Overall Vector Manufacturing Market
4.5.1. Outsourcing is More Prevalent as Compared to In-house Production
4.5.2. In-house Manufacturing, Though Uncommon, is Gradually Gaining Ground
4.5.3. Efforts are Well-Distributed across Industry and Academia
4.5.4. Several New Companies That Have Recently Emerged are Likely to Benefit From the Growing Demand for Vectors
4.5.5. The US and EU will Continue to Dominate as Manufacturing Hubs
4.5.6. Commercial Scale Capabilities are Currently Limited; However, This is Likely to Change in the Near Future
 
5. Viral Vectors
5.1. Chapter Overview
5.2. BioReliance (A Part of SAFC Commercial)
5.2.1. Company Overview
5.2.2. Financial Performance
5.2.3. Vector Manufacturing Technology
5.2.4. Manufacturing Facilities
5.2.5. Recent Developments (Investments, Expansions and Collaborations)
 
5.3. Biovian
5.3.1. Company Overview
5.3.2. Manufacturing Facility
5.3.3. Manufacturing Experience
5.3.4. Recent Developments (Investments, Expansions and Collaborations)
 
5.4. Brammer Bio
5.4.1. Company Overview
5.4.2. Manufacturing Facilities
5.4.3. Recent Developments (Investments, Expansions and Collaborations)
 
5.5. Cell and Gene Therapy Catapult
5.5.1. Company Overview
5.5.2. Manufacturing Facilities
5.5.3. Recent Developments
5.5.3.1. Investments and Expansions
5.5.3.2. Recent Developments (Investments, Expansions and Collaborations)
 
5.6. Cobra Biologics
5.6.1. Company Overview
5.6.2. Financial Performance
5.6.3. Manufacturing Facility
5.6.4. Vector Manufacturing Technology
5.6.5. Manufacturing Experience
5.6.6. Recent Developments (Investments, Expansions and Collaborations)
 
5.7. FinVector
5.7.1. Company Overview
5.7.2. Manufacturing Facility
5.7.3. Viral Vector Manufacturing Technology
5.7.4. Manufacturing Experience
 
5.8. FUJIFILM Diosynth Biotechnologies
5.8.1. Company Overview
5.8.2. Manufacturing Facilities
5.8.3. Recent Developments (Investments, Expansions and Collaborations)
 
5.9. Lonza
5.9.1. Company Overview
5.9.2. Financial Performance
5.9.3. Vector Manufacturing Technology
5.9.4. Manufacturing Facilities
5.9.5. Manufacturing Experience
5.9.6. Recent Developments (Investments, Expansions and Collaborations)
 
5.10. MassBiologics
5.10.1. Company Overview
5.10.2. Manufacturing Facilities
5.10.3. Recent Developments (Investments, Expansions and Collaborations)
 
5.11. MolMed
5.11.1. Company Overview
5.11.2. Financial Performance
5.11.3. Manufacturing Facilities
5.11.4. Manufacturing Experience
5.11.5. Recent Developments (Investments, Expansions and Collaborations)
 
5.12. Oxford BioMedica
5.12.1. Company Overview
5.12.2. Financial Performance
5.12.3. Manufacturing Facilities
5.12.4. Viral Vector Manufacturing Technology
5.12.5. Manufacturing Experience
5.12.6. Recent Developments (Investments, Expansions and Collaborations)
 
5.13. Sanofi (CEPiA, Sanofi Pasteur, Genzyme)
5.13.1. Company Overview
5.13.2. Manufacturing Facilities
5.13.3. Manufacturing Experience
5.13.4. Recent Developments
5.13.4.1. Investments and Expansions
5.13.4.2. Recent Developments (Investments, Expansions and Collaborations)
 
5.14. Spark Therapeutics
5.14.1. Company Overview
5.14.2. Financial Performance
5.14.3. Manufacturing Facility
5.14.4. Viral Vector Manufacturing Technology
5.14.5. Manufacturing Experience
5.14.6. Recent Developments
5.14.6.1. Investments and Expansions
5.14.6.2 Acquisitions
5.14.6.3 Recent Developments (Investments, Expansions and Collaborations)
 
5.15. uniQure
5.15.1. Company Overview
5.15.2. Financial Performance
5.15.3. Manufacturing Facilities
5.15.4. Viral Vector Manufacturing Technology
5.15.5. Recent Developments (Investments, Expansions and Collaborations)
 
5.16. ViGene Biosciences
5.16.1. Company Overview
5.16.2. Manufacturing Facility
5.16.3. Vector Manufacturing Technology
5.16.4. Manufacturing Experience
 
5.17. Wuxi AppTec
5.17.1. Company Overview
5.17.2. Financial Performance
5.17.3. Manufacturing Facilities
5.17.4. Manufacturing Experience
5.17.5. Recent Developments (Investments, Expansions and Collaborations)
 
5.18. Drivers and Challenges
5.18.1. Adenoviral Vectors
5.18.2. Retroviral Vectors
5.18.3. AAV Vectors
5.18.4. Lentiviral Vectors
 
6. Plasmid DNA
6.1. Chapter Overview
6.2. Aldevron
6.2.1. Company Overview
6.2.2. Manufacturing Facilities
6.2.3. Manufacturing Experience
6.2.4. Recent Developments (Investments, Expansions and Collaborations)
 
6.3. Eurogentec
6.3.1. Company Overview
6.3.2. Manufacturing Facility
6.3.3. Manufacturing Experience
6.3.4. Recent Developments (Investments, Expansions and Collaborations)
 
6.4. Richter-Helm
6.4.1. Company Overview
6.4.2. Manufacturing Facilities
6.4.3. Manufacturing Experience
6.4.4. Recent Developments (Investments, Expansions and Collaborations)
 
6.5. Drivers and Challenges
 
7. Opportunity Analysis
7.1. Chapter Overview
7.2. Scope of the Forecast
7.3. Forecast Methodology
7.4. Input Data Tables and Assumptions
7.5. Vector Manufacturing Market Outlook, 2016-2026
7.5.1. Distribution by Type of Vector
7.5.1.1. Adenoviral Vector Manufacturing Market Outlook, 2016-2026
7.5.1.2. AAV Vector Manufacturing Market Outlook, 2016-2026
7.5.1.3. Retroviral Vector Manufacturing Market Outlook, 2016-2026
7.5.1.4. Lentiviral Vector Manufacturing Market Outlook, 2016-2026
7.5.1.5. Plasmid DNA Manufacturing Market Outlook, 2016-2026
7.5.1.6. Other Gene Therapy Vectors Manufacturing Market Outlook, 2016-2026
 
7.5.2. Distribution by Phase of Development
 
8. Survey Analysis
8.1. Chapter Overview
8.2. Seniority Level of Respondents
8.3. Type of Vector
8.4. Scale of Production
8.5. Vector Stabilization Technology
8.6. In-house v/s Contract Service Production
 
9. Conclusion
9.1. Accelerated Progression in the Pipeline of Gene Therapy Drugs Will Continue to Act as a Key Driver of the Vector Manufacturing Market
9.2. In Light of Exorbitant Costs Associated with Developing In-house Facilities, Outsourcing has Emerged as a Convenient Alternative
9.3. Both Industry and Academia are Leading the Manufacturing Efforts
9.4. Innovative Technological Platforms have Emerged as Vital Enablers
9.5. Partnerships/Collaborations will Further Contribute to the Rapid Development of This Market
9.6. Anticipated Market Success Backed up by Progressive Pipeline and Rapid Development
 
10. Interview Transcripts
10.1. Chapter Overview
10.2. Alain Lamproye, President of Biopharma Business Unit, Novasep
10.3. Bakhos A Tannous, Director, Massachusetts General Hospital (MGH) Viral Vector Development Facility
10.4. Brian M Dattilo, Business Development Manager, Waisman Biomanufacturing
10.5. Joost van den Berg, Director, Amsterdam BioTherapeutics Unit (AmBTU)
10.6. Nicole Faust, Chief Scientific Officer, Cevec
10.7. Semyon Rubinchik, Scientific Director, ACGT
 
11. Appendix 1: Tabulated Data
 
12. Appendix 2: List of Companies and Organizations

List of Figures

Figure 3.1 Gene Transfer: Viral and Non-Viral Methods
Figure 3.2 Open Gene Therapy Trials: Distribution by Phase of Development
Figure 4.1 Viral Vectors and Plasmid DNA Manufacturers: Overall Market Landscape
Figure 4.2 Viral Vectors and Plasmid DNA: Location of Manufacturing Facilities
Figure 4.3 Viral Vectors and Plasmid DNA Manufacturers: Distribution by Type of Organization
Figure 4.4 Viral Vector Manufacturers: Distribution by Types of Vector
Figure 4.5 Viral Vector Manufacturers: Distribution by Scale of Production
Figure 4.6 Viral Vector Manufacturers: Distribution by Location of Manufacturing Facility
Figure 4.7 Lentiviral Vector Manufacturers: Distribution by Location of Manufacturing Facility, World Map Representation
Figure 4.8 AAV Vector Manufacturers: Distribution by Location of Manufacturing Facility, World Map Representation
Figure 4.9 Adenoviral Vector Manufacturers: Distribution by Location of Manufacturing Facility, World Map Representation
Figure 4.10 Retroviral Vector Manufacturers: Distribution by Location of Manufacturing Facility, World Map Representation
Figure 4.11 Viral Vector Manufacturers: Distribution by Type of Organization
Figure 4.12 Viral Vector Manufacturers: Distribution by In-house Production v/s Contract Manufacturing Services
Figure 4.13 Plasmid DNA Manufacturers: Distribution by Scale of Production
Figure 4.14 Plasmid DNA Manufacturers: Distribution by Location of Manufacturing Facility
Figure 4.15 Plasmid DNA Manufacturers: Distribution by Location of Manufacturing Facility, World Map Representation
Figure 4.16 Plasmid DNA Manufacturers: Distribution by Type of Organization
Figure 4.17 Plasmid DNA Manufacturers: Distribution by In-house Production v/s Contract Manufacturing Services
Figure 4.18 Active Clinical Studies: Regional Distribution
Figure 5.1 SAFC: Revenues, 2011- Q3 2015 (USD Million)
Figure 5.2 H.A.V.E.: AAV Vector Manufacturing Technology
Figure 5.3 Lonza: Revenues, 2011- H1 2016 (CHF Million)
Figure 5.4 MolMed: Revenues, 2011- H1 2016 (EUR Million)
Figure 5.5 Oxford BioMedica: Revenues, 2011-2015 (GBP Million)
Figure 5.6 Oxford BioMedica: Viral Vector Manufacturing Process
Figure 5.7 uniQure: Revenues, 2013- H1 2016 (EUR Million)
Figure 5.8 Wuxi AppTec: Revenues, 2011- Q3 2015 (USD Million)
Figure 5.9 Adenoviral Vectors: Drivers and Challenges
Figure 5.10 Retroviral Vectors: Drivers and Challenges
Figure 5.11 AAV Vectors: Drivers and Challenges
Figure 5.12 Lentiviral Vectors: Drivers and Challenges
Figure 6.1 Plasmid DNA: Open Gene Therapy Trials
Figure 6.2 Plasmid DNA: Drivers and Challenges
Figure 7.1 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026 (USD Million)
Figure 7.2 Adenoviral Vector Manufacturing Market, 2016-2026 (USD Million)
Figure 7.3 AAV Vector Manufacturing Market, 2016-2026 (USD Million)
Figure 7.4 Retroviral Vector Manufacturing Market, 2016-2026 (USD Million)
Figure 7.5 Lentiviral Vector Manufacturing Market, 2016-2026 (USD Million)
Figure 7.6 Plasmid DNA Manufacturing Market, 2016-2026 (USD Million)
Figure 7.7 Other Vectors Manufacturing Market, 2016-2026 (USD Million)
Figure 7.8 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026 (USD Million): Distribution by Phase of Development
Figure 8.1 Survey Analysis: Distribution by Type of Organization
Figure 8.2 Survey Analysis: Distribution by Location of Organization
Figure 8.3 Survey Analysis: Distribution by Seniority Level of Respondents
Figure 8.4 Survey Analysis: Distribution by Type of Vector
Figure 8.5 Survey Analysis: Distribution by Scale of Production
Figure 8.6 Survey Analysis: Vector Stabilization Technology
Figure 8.7 Survey Analysis: Distribution by In-house Production v/s Contract Manufacturing Services
Figure 9.1 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026 (USD Million): Distribution by Phase of Development
Figure 9.2 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026 (USD Million): Distribution by Type of Vector

List of Tables

Table 3.1 Viral Vectors: Features
Table 3.2 Manufacturing of Vectors for Marketed and Approved Gene Therapies
Table 4.1 Viral Vectors and Plasmid DNA: List of Manufacturers
Table 4.2 Viral Vector Manufacturers: Types of Viral Vector
Table 4.3 Viral Vector Manufacturers: Scale of Production
Table 4.4 Viral Vector Manufacturers: Location of Manufacturing Facility, Type of Organization and Purpose of Production
Table 4.5 Plasmid DNA Manufacturers: Scale of Production
Table 4.6 Plasmid DNA Manufacturers: Location of Manufacturing Facility, Type of Organization and Purpose of Production
Table 4.7 Vector Manufacturers with In-house Production Capabilities
Table 5.1 Cell and Gene Therapy Catapult Manufacturing Facility: Features
Table 5.2 FinVector Manufacturing Suites: Features
Table 5.3 uniQure: Evolution of BEVS rAAV Production
Table 6.1 Aldevron Plasmid DNA: QC Assays
Table 7.1 Gene Therapy Vectors: Distribution by Active Clinical Studies
Table 7.2 Gene Therapy Vectors: Distribution by Patients Enrolled in the Active Clinical Studies
Table 7.3 Adenoviral Vectors: Prices, Concentration and Volume
Table 7.4 AAV Vectors: Prices, Concentration and Volume
Table 7.5 Retroviral Vectors: Prices, Concentration and Volume
Table 7.6 Lentiviral Vectors: Prices, Concentration and Volume
Table 7.7 Plasmid DNA: Prices and Volume
Table 7.8 Gene Therapy Vectors: Dosage Frequency
Table 7.9 Number of Active Clinical Trials, 2016-2026
Table 7.10 Number of Patients Enrolled in Gene Therapy Clinical Studies, 2016-2026
Table 7.11 Patient Population of the Approved / Late-Stage Gene Therapies, 2020, 2026
Table 8.1 Survey Response: Overview of the Participating Companies / Organizations
Table 8.2 Survey Response: Seniority Level of Respondents
Table 8.3 Survey Response: Type of Vector
Table 8.4 Survey Response: Scale of Production
Table 8.5 Survey Response: Vector Stabilization Technology
Table 8.6 Survey Response: In-house Production v/s Contract Services
Table 11.1 Open Gene Therapy Trials: Distribution by Phase of Development
Table 11.2 Viral Vector and Plasmid DNA Manufacturers: Overall Market Landscape
Table 11.3 Viral Vectors and Plasmid DNA: Location of Manufacturing Facilities
Table 11.4 Viral Vector and Plasmid DNA Manufacturers: Distribution by Type of Organization
Table 11.5 Viral Vector Manufacturers: Distribution by Types of Vector
Table 11.6 Viral Vector Manufacturers: Distribution by Scale of Production
Table 11.7 Viral Vector Manufacturers: Distribution by Location of Manufacturing Facility
Table 11.8 Viral Vector Manufacturers: Distribution by Type of Organization
Table 11.9 Viral Vector Manufacturers: Distribution by In-house Production v/s Contract Manufacturing Services
Table 11.10 Plasmid DNA Manufacturers: Distribution by Scale of Production
Table 11.11 Plasmid DNA Manufacturers: Distribution by Location of Manufacturing Facility
Table 11.12 Plasmid DNA Manufacturers: Distribution by Type of Organization
Table 11.13 Plasmid DNA Manufacturers: Distribution by In-house Production v/s Contract Manufacturing Services
Table 11.14 Active Clinical Studies: Regional Distribution
Table 11.15 SAFC: Revenues, 2011- Q3 2015 (USD Million)
Table 11.16 Lonza: Revenues, 2011- H1 2016 (CHF Million)
Table 11.17 MolMed: Revenues, 2011- H1 2016 (EUR Million)
Table 11.18 Oxford BioMedica: Revenues, 2011-2015 (GBP Million)
Table 11.19 uniQure: Revenues, 2013- H1 2016 (EUR Million)
Table 11.20 Wuxi AppTec: Revenues, 2011- Q3 2015 (USD Million)
Table 11.21 Plasmid DNA: Open Gene Therapy Trials
Table 11.22 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026: Base Scenario (USD Million)
Table 11.23 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026: Conservative Scenario (USD Million)
Table 11.24 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026: Optimistic Scenario (USD Million)
Table 11.25 Adenoviral Vector Manufacturing Market, 2016-2026: Base Scenario (USD Million)
Table 11.26 Adenoviral Vector Manufacturing Market, 2016-2026: Conservative Scenario (USD Million)
Table 11.27 Adenoviral Vector Manufacturing Market, 2016-2026: Optimistic Scenario (USD Million)
Table 11.28 AAV Vector Manufacturing Market, 2016-2026: Base Scenario (USD Million)
Table 11.29 AAV Vector Manufacturing Market, 2016-2026: Conservative Scenario (USD Million)
Table 11.30 AAV Vector Manufacturing Market, 2016-2026: Optimistic Scenario (USD Million)
Table 11.31 Retroviral Vector Manufacturing Market, 2016-2026: Base Scenario (USD Million)
Table 11.32 Retroviral Vector Manufacturing Market, 2016-2026: Conservative Scenario (USD Million)
Table 11.33 Retroviral Vector Manufacturing Market, 2016-2026: Optimistic Scenario (USD Million)
Table 11.34 Lentiviral Vector Manufacturing Market, 2016-2026: Base Scenario (USD Million)
Table 11.35 Lentiviral Vector Manufacturing Market, 2016-2026: Conservative Scenario (USD Million)
Table 11.36 Lentiviral Vector Manufacturing Market, 2016-2026: Optimistic Scenario (USD Million)
Table 11.37 Plasmid DNA Manufacturing Market, 2016-2026: Base Scenario (USD Million)
Table 11.38 Plasmid DNA Manufacturing Market, 2016-2026: Conservative Scenario (USD Million)
Table 11.39 Plasmid DNA Manufacturing Market, 2016-2026: Optimistic Scenario (USD Million)
Table 11.40 Other Vectors Manufacturing Market, 2016-2026: Base Scenario (USD Million)
Table 11.41 Other Vectors Manufacturing Market, 2016-2026: Conservative Scenario (USD Million)
Table 11.42 Other Vectors Manufacturing Market, 2016-2026: Optimistic Scenario (USD Million)
Table 11.43 Viral Vectors and Plasmid DNA Manufacturing Market: Distribution by Phase of Development, 2016-2026 Base Scenario (USD Million)
Table 11.44 Viral Vectors and Plasmid DNA Manufacturing Market: Distribution by Phase of Development, 2016-2026 Conservative Scenario (USD Million)
Table 11.45 Viral Vectors and Plasmid DNA Manufacturing Market: Distribution by Phase of Development, 2016-2026 Optimistic Scenario (USD Million)
Table 11.46 Survey Analysis: Distribution by Type of Organization
Table 11.47 Survey Analysis: Distribution by Location of Organization
Table 11.48 Survey Analysis: Distribution by Seniority Level of Respondents
Table 11.49 Survey Analysis: Distribution by Type of Vector
Table 11.50 Survey Analysis: Distribution by Scale of Production
Table 11.51 Survey Analysis: Vector Stabilization Technology
Table 11.52 Survey Analysis: Distribution by In-house Production v/s Contract Manufacturing Services
Table 11.53 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026 (USD Million): Distribution by Phase of Development
Table 11.54 Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026 (USD Million): Distribution by Type of Vector

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FEATURED COMPANIES

  • 4D Molecular Therapeutics
  • Blue Sky BioServices
  • Fondazione Telethon
  • Massachusetts Eye and Ear
  • Puresyn
  • T. Rowe Price Associates
  • MORE

Research Methodology

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
 
The secondary sources of information include:

  • Annual reports
  • Investor presentations
  • SEC filings
  • Industry databases
  • News releases from company websites
  • Government policy documents
  • Industry analysts’ views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
 
Chapter Outlines

Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of the viral vectors and plasmid DNA manufacturing market over the coming decade.
 
Chapter 3 provides a general introduction to the various types of viral and non-viral vectors. It includes a detailed discussion on the design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vectors. The chapter also provides a brief description of the clinical and approved pipeline of gene therapies.
 
Chapter 4 identifies the contract service providers/in-house manufacturers that are actively involved in the production of viral vectors and plasmid DNA. The chapter provides details on the vector production capabilities of these organizations, specifically focusing on the type of organization, geographic location of their facilities, scale of operation and the purpose of vector production (in-house requirement/third party manufacturing). It contains schematic representations of world maps highlighting the geographical locations of vector manufacturing facilities. Further, it discusses the development trends within the overall vector manufacturing landscape.
 
Chapter 5 contains detailed profiles of viral vector manufacturers having commercial scale production capacities. Each profile provides a brief overview of the company, its financial performance, details on vector manufacturing facilities, vector manufacturing technology, manufacturing experience, recent investments/expansions and the relevant collaborations and partnerships that have been inked over the last few years. In addition, the chapter summarizes the key drivers and challenges associated with the production of these vectors.
 
Chapter 6 contains detailed profiles of plasmid DNA manufacturers having commercial scale production capacities. Each profile provides a brief overview of the company, its financial performance, details on plasmid manufacturing facilities, manufacturing experience, recent investments/expansions and the relevant collaborations and partnerships that have been inked over the last few years. In addition, the chapter summarizes the key drivers and challenges associated with the production of these vectors.
 
Chapter 7 presents a ten year sales forecast to highlight the likely growth of the market of gene therapy vectors. We have segregated the financial opportunity by type of vectors (lentivirus, adenovirus, AAV, retrovirus and plasmid DNA) and the phase of development. All our predictions related to this market’s future are backed by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.
 
Chapter 8 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development of different types of gene therapy vectors. The participants, who were primarily Director/CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.
 
Chapter 9 summarizes the entire report. The chapter presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.
 
Chapter 10 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details on our discussions with Alain LAMPROYE (President of Biopharma Business Unit, Novasep), Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital), Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing), Joost van den Berg (Director, Amsterdam BioTherapeutics Unit (AmBTU), Nicole Faust (Chief Scientific Officer, Cevec), Semyon Rubinchik, (Scientific Director, ACGT).
 
Chapter 11 is an appendix, which provides tabulated data and numbers for all the figures in the report.
 
Chapter 12 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.

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  • 4D Molecular Therapeutics
  • ACGT
  • Advanced BioScience Laboratories
  • Advanced Biotherapeutics Consulting
  • Aldevron
  • Allele Biotechnology
  • Althea Technologies
  • Ampersand Capital Partners
  • AMSBIO
  • Amsterdam BioTherapeutics Unit
  • Applied Biological Materials
  • Applied Genetic Technologies Corporation
  • Applied Viromics
  • ARCO Design/Build
  • Areta International
  • Asklepios BioPharmaceutical
  • Atlantic Bio GMP
  • Avalanche Biotechnologies
  • Batavia Biosciences
  • Beckman Research Institute
  • Benitec Biopharma
  • BioCancell
  • Biogen Idec
  • Biomay
  • Biomiga
  • BioReliance/SAFC
  • Biotec Services International
  • BioTie Therapies
  • BioVex (Amgen subsidiary)
  • Biovian
  • Blue Sky BioServices
  • bluebird bio
  • BMS
  • Boehringer Ingelheim BioXcellence
  • Brammer Bio
  • Brookside Capital
  • Cancer Research UK (Biotherapeutics Development Unit)
  • Carnegie Institution of Washington
  • Cell and Gene Therapy Catapult
  • Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Center
  • Celladon
  • Center for Biomedicine & Genetics, City of Hope
  • Center for Cell & Gene Therapy, Baylor College of Medicine
  • Center for Cell and Gene Processing, Takara Bio
  • Center for Cellular and Molecular Therapeutics, The Children's Hospital of Philadelphia
  • Centre for Process Innovation
  • CEPiA (Industrial Affairs Division of Sanofi )
  • CEVEC Pharmaceuticals
  • Children's GMP/GMP facility St. Jude Children's Research Hospital
  • Cincinnati Children's Hospital Medical Center
  • Clinical Biotechnology Centre, NHS Blood and Transplant
  • Cobra Biologics
  • Core Facility for Therapeutic Vectors, Institute of Medical Science Research Hospital
  • Cranfield University
  • CRB
  • Creative Biogene
  • Creed Commercial Development
  • Crucell
  • CureLab
  • Deerfield Management Company
  • DSM Biologics
  • Epeius Biotechnologies
  • EUFETS (BioNTech)
  • Eurofins Genomics
  • Eurogentec
  • Finnish Bioindustries FIB
  • Finnish Fair Foundation
  • FinVector
  • Fondazione Telethon
  • Fraunhofer Institute for Toxicology and Experimental Medicine
  • Frederik Paulsen Foundation
  • FUJIFILM Diosynth Biotechnologies
  • GEG Tech
  • Genable Technologies
  • Gene and Cell Therapy Lab, Institute of Translational Health Sciences
  • Gene Medicine Japan
  • Gene Transfer Vector Core (Schepens Eye Research Institute and Massachusetts Eye and Ear Infirmary)
  • Gene Transfer, Targeting and Therapeutics Core, Salk Institute for Biological Studies
  • Gene Vector and Virus Core, Stanford Medicine
  • GeneCure Biotechnologies
  • GeneDetect
  • GeneImmune Biotechnology
  • Genethon (Genethon BioProd)
  • GENEWIZ
  • GenIbet Biopharmaceuticals
  • Génopoïétic
  • GenScript
  • GenVec
  • Genzyme
  • GSEx, The Robinson Research Institute, University of Adelaide
  • GSK
  • Guy's and St Thomas' NHS Foundation Trust
  • Hercules Technology Growth Capital
  • Hope Center Viral Vectors Core, Washington University School of Medicine
  • Human Gene and Cell Therapy Center, Akdeniz University
  • Human Stem Cells Institute
  • ID Pharma
  • Immune Design
  • Immune Technology
  • Innovate UK
  • InvivoGen
  • Karolinska University Hospital
  • King's College London, Rayne Cell Therapy Suite
  • Kobe Biomedical Accelerator
  • Lentigen Technology
  • Lonza
  • Luminous BioSciences
  • Massachusetts Eye and Ear
  • Massachusetts Life Science Center
  • MassBiologics
  • Merck
  • Meridian Life Science
  • MGH Vector Core (Massachusetts General Hospital Neuroscience Center)
  • Microbix Biosystems/McMaster University
  • Miltenyi Biotec
  • Mitsubishi Corporation
  • Molecular Diagnostic Services
  • MolMed
  • Nantes Gene Therapy Institute
  • National Institute of Neurodegenerative Disorders and Stroke Center Core
  • Nature Technology Corporation
  • Netherlands Cancer Institute
  • NeuroCure
  • Novartis
  • Novasep
  • Oberland Capital
  • Ocular Gene Therapy Core, National Eye Institute
  • Okairos (GSK subsidiary)
  • Omnia Biologics
  • Ospedale San Raffaele
  • OXB Solutions
  • Oxford BioMedica
  • Oxford Genetics
  • PacificGMP (a part of Abzena Group)
  • Paragon Bioservices
  • Penn Vector Core, University of Pennsylvania
  • Pfizer
  • Pinchal
  • Plasmid Factory
  • Puresyn
  • RecipharmCobra Biologics
  • REGENXBIO
  • Renova Therapeutics
  • Research Center for Hematology of the Russian Ministry of Healthcare
  • Richter-Helm
  • Rimedion
  • Rock Springs Capital
  • SAB Technology
  • San Raffaele Telethon Institute for Gene Therapy
  • Sanofi
  • Sanofi-Pasteur
  • Scancell
  • Shanghai Sunway Biotech
  • Shenzhen SiBiono Gene-Tech
  • SiBionoGeneTech
  • SignaGen Laboratories
  • Sino Biological
  • Sirion Biotech
  • Sofinnova Ventures
  • Southern Research - Bioanalytical Sciences Department
  • Spark Therapeutics
  • Stanford University (Human Gene Therapy)
  • Stevenage Borough Council
  • Synpromics
  • System Biosciences
  • T. Rowe Price Associates
  • Tecrea
  • Telethon Foundation
  • The Goldyne Savad Institute of Gene Therapy, Hadassah Medical Organization
  • The Hong Kong Institute of Biotechnology
  • The Lentiviral Laboratory, USC School of Pharmacy
  • The Vector Core, University of North Carolina
  • The Wellcome Trust/BRC Clinical Research Facility and Cell Therapy Unit, King’s College London
  • THERAVECTYS
  • Thermo Fisher Scientific
  • Touchlight Genetics
  • Transgene
  • UAB Vector Production Facility
  • UK Technology Strategy Board
  • uniQure
  • Unit Biotech & ATMP’s, University Medical Center Groningen
  • University of Iowa Research Foundation
  • University of Massachusetts Medical School
  • University of Minnesota
  • University of North Carolina
  • University of Oxford Clinical BioManufacturing Facility
  • University of Pennsylvania
  • Vaccibody
  • Valneva
  • Vectalys
  • Vector Biolabs
  • Vector Core/GMP Core, Belfer Gene Therapy Core Facility, Cornell University
  • Vector Core/GMP Facility, UC Davis
  • Vector Core Lab/Human Applications Lab, Powell Gene Therapy Center, University of Florida
  • Vector Core of Gene Therapy Laboratory of Nantes
  • Vector Core, Harvard Gene Therapy Initiative
  • Vector Core, Telethon Institute of Genetics and Medicine
  • Vector Core, University of Michigan Medical Center
  • Vector Production Facility, Indiana University
  • Vecura
  • VGXI
  • Vibalogics
  • Vical
  • ViGene Biosciences
  • Viral Gene Transfer Core, MIT
  • Viral Vector Core/Clinical Manufacturing Facility, Nationwide Children's Hospital
  • Viral Vector Core, Duke University
  • Viral Vector Core, Sanford Burnham Prebys Medical Discovery Institute
  • Viral Vector Core, University of Massachusetts Medical School
  • Viral Vector Core,University of Iowa Carver College of Medicine
  • Viral Vector Production Laboratory, Mayo Clinic Cancer Center
  • Virovek
  • VIVEbioTECH
  • Voyager Therapeutics
  • Waisman Biomanufacturing
  • Wellington Management Company
  • WH Partnership
  • Wolfson Gene Therapy Unit, University College of London
  • WuXi AppTec
  • ZambonGroup
  • Zhengyang Gene Technology
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