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HER2 Targeting Therapies Market by Target Disease Indication, Type of Molecule, Type of Therapy and Route of Administration, Key Geographical Regions: Industry Trends and Global Forecasts, 2021-2030

  • ID: 5441011
  • Report
  • July 2021
  • Region: Global
  • 250 Pages
  • Roots Analysis

FEATURED COMPANIES

  • Abbott
  • Biocon
  • Duke University
  • Jiangsu Hengrui Medicine
  • NBE Therapeutics
  • Silverback Therapeutics
  • MORE

Overview

Human epidermal growth factor receptor 2 (HER2), a member of human epidermal growth factor receptor family, plays an important role in the development and progression of various types of cancers, especially breast cancer. Over time, it has been found to be an important target for the drug therapies intended for treating various types of breast cancer. HER2 targeting therapies have shown to be a promising treatment option, capable of preventing tumor cells from evading immune surveillance. In 1998, the FDA approved the first HER2 targeting monoclonal antibody, called Herceptin® (trastuzumab) for the treatment of metastatic breast cancer. Later, in 2006, the drug got approved for HER2 positive early breast cancer. Following its success in treating breast cancer, significant efforts were made to evaluate its potential in other conditions involving HER2 alterations, such as overexpression, amplifications and other mutations. Eventually in 2010, the drug got FDA approval for HER2 positive metastatic stomach cancer as well.  In addition to Herceptin, more than five drugs have been approved and about 70 candidates are under development for breast cancer, HER2-positive biliary tract, colorectal, non-small-cell lung and gastric cancers. Further, combinatorial studies of HER2 targeting therapeutics along with immune checkpoint inhibitors have also shown positive results across various disease indications.

Presently, several companies, including well-established players and new entrants, are actively engaged in developing the HER2 targeting therapies for a wide variety of disease indications. Innovation in this field is mostly focused on improving the therapeutic efficacy and safety, and overall survival rate. The research activity has gained significant attention from private and public investors, which have extended their financial support to capable developer companies. The market has also witnessed substantial partnership activity over the last few years. Driven by the success of the currently available drugs / therapy products and the encouraging clinical trial results, the market is poised to witness healthy growth as multiple late stage drugs get approved and marketed over the next decade.

Scope of the Report

The “HER2 Targeting Therapies Market, 2021-2031” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapies over the next decade. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. 

In addition to other elements, the study includes:

  • A detailed review of the current market landscape of HER2 targeting therapies, including analyses based on several parameters, such as current status of development (marketed, clinical, pre-clinical and discovery), phase of development (phase III, phase II/III, phase II, phase I/II and phase I) of lead candidates, type of molecule (biologic and small molecule), type of biologic (antibody drug conjugates, bispecific antibodies, CAR-T cell therapies, monoclonal antibodies, vaccines and others), type of therapy (monotherapy, combination therapy and both), target disease indication, target therapeutic area and route of administration (intravenous, intradermal, oral and others).
  • A detailed analysis of completed, ongoing and planned clinical trials of HER2 targeting therapies, highlighting prevalent trends across various relevant parameters, such as trial registration year, trial phase, trial recruitment status, enrolled patient population, study design, leading industry sponsors / collaborators (in terms of number of trials conducted), trial focus, target therapeutic area, popular indications and regional distribution of trials.
  • Elaborate profiles of the companies developing HER2 targeting therapies. Each profile features a brief overview of the company, details on its product portfolio, and recent developments and an informed future outlook.
  • An in-depth analysis of grants awarded to various research institutes for projects related to HER2 targeting therapies, in the period between 2018 and 2021 (till March), on the basis of several parameters, such as year of award, amount awarded, funding institute center, support period, type of grant application, purpose of grant award, activity code, focus area, responsible study section, popular NIH departments, prominent program officers and type of recipient organizations. In addition, it highlights the geographical distribution of recipient organizations.
  • An analysis of the partnerships established between various stakeholders in this domain, during the period 2017-2021, covering R&D agreements, licensing agreements (specific to affiliated technology platforms and product candidates), product development and commercialization agreements, clinical trial agreements, manufacturing agreements, mergers and acquisitions, manufacturing agreements and other relevant types of deals. 
  • A case study on HER2 targeting biosimilars, including a review of the current market landscape of HER2 targeting biosimilar molecules, and a detailed analysis based on several parameters, such as parent drug, phase of development and target disease indications. The chapter also provides information on the companies involved in the development of these HER2 targeting biosimilars.
  • A case study on companion diagnostic tests developed/being developed for various HER2 targeting drug candidates, including a detailed analysis based on commercial availability, assay technique used, corresponding drug candidate and target disease indication. In addition, the chapter provides information on the companies engaged in the development of companion diagnostics for HER2 targeting drug candidates.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for HER2 targeting therapies, over the next decade. Based on multiple parameters, such as disease prevalence, anticipated adoption rates and likely selling price of HER2 targeting therapies, we have provided informed estimates on the evolution of the market for the period 2021-2031. The report also features the likely distribution of the current and forecasted opportunity across [A] different target indications (breast cancer, gastric cancer head and neck cancer and lung cancer) [B] type of molecule (small molecule and biologic), [C] type of therapy (monotherapy, combination therapy and both), [D] route of administration (intravenous and oral) and [E] key geographical regions (US, Europe, Asia-Pacific, Middle East and North Africa and Latin America). To account for the 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.  

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in the report are in USD, unless otherwise specified.

Key Questions Answered

  • What are the key therapeutic indications for which HER2 targeting therapies have been/are being developed?
  • Who are the leading industry and non-industry players in this domain?
  • Which geographies are the most active in conducting clinical trials on HER2 targeting therapies?
  • Which are the leading funding organizations for providing grants in this domain?
  • Which partnership models are commonly adopted by industry stakeholders? 
  • Which players are involved in developing companion diagnostics for HER2 targeting therapies?
  • How is the current and future market opportunity likely to be distributed across key market segments?
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Abbott
  • Biocon
  • Duke University
  • Jiangsu Hengrui Medicine
  • NBE Therapeutics
  • Silverback Therapeutics
  • MORE

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Introduction to Cancer Immunotherapy
3.3. Fundamentals of Cancer Immunotherapy
3.4. HER2 Mutations
3.5. Overview of HER2 Targeting Therapies
3.5.1 Biologics Targeting HER2
3.5.1.1 Types of Products
3.5.2 Small Molecules Targeting HER2
3.5.2.1 Types of Products
3.6. Existing Challenges and Future Perspectives

4. CURRENT MARKET LANDSCAPE: MARKETED PRODUCTS AND DEVELOPMENT PIPELINE
4.1. Chapter Overview
4.2. HER2 Targeting Therapies: Marketed Products and Development Pipeline
4.3. HER2 Targeting Therapies: Pipeline Analysis
4.3.1. Analysis by Current Status
4.3.2. Analysis by Phase of Development
4.3.3. Analysis by Type of Molecule
4.3.4. Analysis by Type of Biologic
4.3.5. Analysis by Type of Therapy
4.3.6. Analysis by Target Disease Indication
4.3.7. Analysis by Route of Administration
4.3.8. Analysis by Phase of Development and Type of Molecule
4.3.9. Analysis by Phase of Development and Route of Administration
4.4. HER2 Targeting Therapies: Developer Landscape
4.4.1. Analysis by Type of Developer
4.4.2. Analysis by Year of Establishment
4.4.3. Analysis by Company Size
4.4.4. Analysis by Geographical Location
4.4.5. Analysis by Company Size and Geographical Location
4.4.6. Leading Industry Players: Analysis by Number of Therapies
4.4.7. Leading Non-Industry Players: Analysis by Number of Therapies

5. COMPANY PROFILES
5.1. Chapter Overview
5.2. AstraZeneca
5.2.1. Company Overview
5.2.2. Financial Information
5.2.3. HER2 Targeting Therapies Portfolio
5.2.4. Recent Developments and Future Outlook
5.3. Boehringer Ingelheim
5.3.1. Company Overview
5.3.2. Financial Information
5.3.3. HER2 Targeting Therapies Portfolio
5.3.4. Recent Developments and Future Outlook
5.4. GlaxoSmithKline
5.4.1. Company Overview
5.4.2. Financial Information
5.4.3. HER2 Targeting Therapies Portfolio
5.4.4. Recent Developments and Future Outlook
5.5. MacroGenics
5.5.1. Company Overview
5.5.2. Financial Information
5.5.3. HER2 Targeting Therapies Portfolio
5.5.4. Recent Developments and Future Outlook
5.6. Pfizer
5.6.1. Company Overview
5.6.2. Financial Information
5.6.3. HER2 Targeting Therapies Portfolio
5.6.4. Recent Developments and Future Outlook
5.7. Puma Biotechnology
5.7.1. Company Overview
5.7.2. Financial Information
5.7.3. HER2 Targeting Therapies Portfolio
5.7.4. Recent Developments and Future Outlook
5.8. Roche
5.8.1. Company Overview
5.8.2. Financial Information
5.8.3. HER2 Targeting Therapies Portfolio
5.8.4. Recent Developments and Future Outlook
5.9. Seagen (previously Seattle Genetics)
5.9.1. Company Overview
5.9.2. Financial Information
5.9.3. HER2 Targeting Therapies Portfolio
5.9.4. Recent Developments and Future Outlook
5.10. Triumvira Immunologics
5.10.1. Company Overview
5.10.2. Financial Information
5.10.3. HER2 Targeting Therapies Portfolio
5.10.4. Recent Developments and Future Outlook
5.11. Zymeworks
5.11.1. Company Overview
5.11.2. Financial Information
5.11.3. HER2 Targeting Therapies Portfolio
5.11.4. Recent Developments and Future Outlook

6. CLINICAL TRIAL ANALYSIS 
6.1. Chapter Overview
6.2. Scope and Methodology
6.3. HER2 Targeting Therapies: Clinical Trial Analysis
6.3.1. Analysis by Trial Registration Year
6.3.2. Analysis by Trial Phase and Enrolled Patient Population
6.3.3. Analysis by Trial Registration Year and Enrolled Patient Population
6.3.4. Analysis by Study Design
6.3.5. Analysis by Sponsor / Collaborator
6.3.6. Most Active Industry Players: Analysis by Number of Registered Trials
6.3.7. Most Active Non-Industry Players: Analysis by Number of Registered Trials
6.3.8. Analysis by Trial Focus
6.3.9. Analysis by Target Disease Indication
6.3.10. Analysis by Target Therapeutic Area 
6.3.11. Geographical Analysis by Number of Registered Trials 
6.3.12. Geographical Analysis by Enrolled Patient Population 

7. ACADEMIC GRANTS ANALYSIS
7.1. Chapter Overview
7.2. ` Scope and Methodology
7.3. HER2 Targeting Therapies: Analysis of Awarded Grants
7.3.1. Analysis by Year of Grant Award
7.3.2. Analysis by Amount Awarded
7.3.3. Analysis by Funding Institute Center
7.3.4. Analysis by Support Period
7.3.5. Analysis by Funding Institute Center and Support Period
7.3.6. Analysis by Type of Grant Application
7.3.7. Analysis by Purpose of Grant Award
7.3.8. Analysis by Activity Code
7.3.9. Word Cloud Analysis: Emerging Focus Areas
7.3.10. Analysis by Study Section Involved
7.3.11. Popular NIH Departments: Analysis by Number of Grants Awarded
7.3.12. Prominent Program Officers: Analysis by Number of Grants Awarded
7.3.13. Analysis by Type of Recipient Organization
7.3.14. Popular Recipient Organizations: Analysis by Number of Grants Awarded
7.3.15. Regional Distribution of Recipient Organizations

8. PARTNERSHIPS AND COLLABORATIONS
8.1. Chapter Overview
8.2. Partnership Models
8.3. HER2 Targeting Therapies: List of Partnerships and Collaborations
8.3.1. Analysis by Year of Partnership
8.3.2. Analysis by Type of Partnership
8.3.3. Analysis by Year of Partnership and Type of Partner
8.3.4. Analysis by Type of Partnership and Type of Partner
8.3.5. Most Active Players: Analysis by Number of Partnerships
8.4. Regional Analysis
8.4.1. Intercontinental and Intracontinental Agreements

9. MARKET SIZING AND OPPORTUNITY ANALYSIS
9.1. Chapter Overview
9.2. Forecast Methodology and Key Assumptions
9.3. Global HER2 Targeting Therapies Market, 2021-2031
9.4. HER2 Targeting Therapies: Individual Product Sales Forecasts 
9.4.1. BAT8001 (Bio-Thera Solutions)
9.4.1.1. Target Patient Population
9.4.1.2. Sales Forecast
9.4.2. ENHERTU® (AstraZeneca)
9.4.2.1. Target Patient Population
9.4.2.2. Sales Forecast
9.4.3. Gilotrif® (Boehringer Ingelheim)
9.4.3.1. Target Patient Population
9.4.3.2. Sales Forecast
9.4.4. KADCYLA™ (Roche)
9.4.4.1. Target Patient Population
9.4.4.2. Sales Forecast
9.4.5. MARGENZA™ (MacroGenics)
9.4.5.1. Target Patient Population
9.4.5.2. Sales Forecast
9.4.6. RC48 (RemeGen)
9.4.6.1. Target Patient Population
9.4.6.2. Sales Forecast
9.4.7. Nerlynx™ (Puma Biotechnology)
9.4.7.1. Target Patient Population
9.4.7.2. Sales Forecast
9.4.8. Perjeta® (Genentech, a Roche’s company)
9.4.8.1. Target Patient Population
9.4.8.2. Sales Forecast
9.4.9. SYD985 (Byondis)
9.4.9.1. Target Patient Population
9.4.9.2. Sales Forecast
9.4.10. MOBOCERTINIB (Takeda)
9.4.10.1. Target Patient Population
9.4.10.2. Sales Forecast
9.4.11. Tukysa® (Seagen)
9.4.11.1. Target Patient Population
9.4.11.2. Sales Forecast
9.4.12. Tyverb® (Roche)
9.4.12.1. Target Patient Population
9.4.12.2. Sales Forecast
9.4.13. Vizimpro® (Pfizer)
9.4.13.1. Target Patient Population
9.4.13.2. Sales Forecast
9.5. Global HER2 Targeting Therapies Market, 2021-2031: Distribution by Geography
9.5.1. HER2 Targeting Therapies Market in the North America, 2021-2031
9.5.2. HER2 Targeting Therapies Market in Europe, 2021-2031
9.5.3. HER2 Targeting Therapies Market in Asia Pacific, 2021-2031
9.5.4. HER2 Targeting Therapies Market in Middle East and North Africa, 2021-2031
9.5.5. HER2 Targeting Therapies Market in Latin America, 2021-2031
9.6. Global HER2 Targeting Therapies Market: Distribution by Target Disease Indication
9.6.1. Global HER2 Targeting Therapies Market for Breast Cancer, 2021-2031
9.6.2. Global HER2 Targeting Therapies Market for Gastric Cancer, 2021-2031
9.6.3. Global HER2 Targeting Therapies Market for Head and Neck Cancer, 2021-2031
9.6.4. Global HER2 Targeting Therapies Market for Lung Cancer, 2021-2031 
9.7. Global HER2 Targeting Therapies Market: Distribution by Type of Molecule
9.7.1. Global HER2 Targeting Therapies Market for Biologics, 2021-2031
9.7.2. Global HER2 Targeting Therapies Market for Small Molecules, 2021-2031
9.8. Global HER2 Targeting Therapies Market: Distribution by Type of Therapy
9.8.1. Global HER2 Targeting Therapies Market for Monotherapy, 2021-2031
9.8.2. Global HER2 Targeting Therapies Market for Combination Therapy, 2021-2031
9.8.3. Global HER2 Targeting Therapies Market for Both Therapies, 2021-2031
9.9. Global HER2 Targeting Therapies Market: Distribution by Route of Administration
9.9.1. Global HER2 Targeting Therapies Market for Intravenous Therapies, 2021-2031
9.9.2. Global HER2 Targeting Therapies Market for Oral Therapies, 2021-2030

10. CASE STUDY: HER2 TARGETING BIOSIMILARS
10.1. Chapter Overview
10.2. HER2 Targeting Biosimilars: Marketed Products and Development Pipeline
10.3. HER2 Targeting Biosimilars: Pipeline Analysis
10.3.1. Analysis by Parent Drug
10.3.2. Analysis by Phase of Development of Biosimilar
10.3.3. Analysis by Target Disease Indication
10.4. HER2 Targeting Biosimilars: Developer Landscape
10.4.1. Analysis by Year of Establishment
10.4.2. Analysis by Geographical Location
10.4.3. Analysis by Company Size and Geographical Location

11. CASE STUDY: COMPANION DIAGNOSTICS FOR HER2 TARGETING THERAPIES
11.1. Chapter Overview
11.2. Companion Diagnostics for HER2 Targeting Therapies
11.2.1. Analysis by Commercial Availability of the Test
11.2.2. Analysis by Assay Technique Used
11.2.3. Analysis by Corresponding Drug Candidate
11.2.4. Analysis by Target Disease Indication
11.3. Companion Diagnostics for HER2 Targeting Therapies: Developer Overview
11.3.1. Analysis by Year of Establishment
11.3.2. Analysis by Company Size
11.3.3. Analysis by Geographical Location

12. CONCLUDING REMARKS

13. APPENDIX 1: TABULATED DATA

14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Note: Product cover images may vary from those shown
  • Abbott
  • AbbVie
  • Acepodia
  • AdaptVac
  • Advaxis
  • Affimed
  • Agilent Technologies
  • Aleta Biotherapeutics
  • Alphamab Oncology
  • AlphaVax
  • Alpine Immune Sciences
  • Alteogen
  • Ambrx
  • Amgen
  • Amunix
  • Anhui Anke Biotechnology
  • Apotex
  • Artiva Biotherapeutics
  • AryoGen Pharmed
  • AstraZeneca
  • Aurora Biopharma
  • Barbara Ann Karmanos Cancer Institute
  • Bavarian Nordic
  • Bayer
  • Baylor College of Medicine
  • BeiGene
  • Beijing Mabworks Biotech
  • Bellicum Pharmaceuticals
  • BioAtla
  • BIOCAD
  • Biocon
  • Biocytogen
  • BioGenex
  • Bio-Thera Solutions
  • BioXpress Therapeutics
  • Black Diamond Therapeutics
  • Bliss Biopharmaceutical
  • bluebird bio
  • Boehringer Ingelheim
  • Bolt Biotherapeutics
  • BrightPath Biotherapeutics
  • Bristol-Myers Squibb
  • Byondis (formerly Synthon Biopharmaceuticals)
  • CARISMA Therapeutics
  • Case Western Reserve University
  • Catalent
  • Celcuity
  • Celgene
  • Cellid
  • Celltrion Healthcare
  • CEVEC Pharmaceuticals
  • CinnaGen
  • City of Hope National Medical Center
  • Covance
  • CSPC Pharmaceutical
  • Curis
  • Daiichi Sankyo
  • Dana-Farber Cancer Institute
  • Denali Therapeutics
  • Dizal Pharmaceuticals
  • DM Bio
  • DotBio
  • Dr. Reddy's Laboratories
  • Dragonfly Therapeutics
  • Duke University
  • EirGenix
  • Eli Lilly
  • Etubics
  • Evergreen Theragnostics
  • Exelixis
  • ExpreS2ion Biotechnologies
  • F1 Oncology
  • Fochon Pharmaceuticals
  • Fosun Pharmaceutical
  • Foundation Medicine
  • Fudan University
  • Genentech
  • GeneQuantum Healthcare
  • Genor Biopharma
  • GlaxoSmithKline
  • Glenmark Pharmaceuticals
  • Goethe University Frankfurt
  • Guardant Health
  • H. Lee Moffitt Cancer Center and Research Institute
  • Hanmi Pharmaceutical
  • Harbour BioMed
  • Heidelberg Pharma
  • Helixmith
  • Henlius Biotech
  • HLB Life Science
  • ImmuneOnco Biopharmaceuticals
  • Imugene
  • Indiana University
  • InNexus Biotechnology
  • Innovent Biologics
  • Intas Pharmaceuticals
  • Jiangsu Hengrui Medicine
  • Johns Hopkins University
  • Johnson & Johnson
  • Juniper Pharmaceuticals
  • JW Therapeutics
  • Kadmon
  • KLUS Pharma
  • Knight Therapeutics
  • Laboratoires Pierre Fabre
  • LegoChem Biosciences
  • Leica Biosystems
  • LEO Pharma
  • LinXis
  • Lonza
  • Lupin
  • Mabpharm
  • MabSpace Biosciences
  • MacroGenics
  • Marker Therapeutics
  • Mayo Clinic
  • Memorial Sloan Kettering Cancer Center
  • Merck
  • Mersana Therapeutics
  • Merus
  • MilliporeSigma
  • Molecular Partners
  • Molecular Templates
  • Morphotek
  • Mustang Bio
  • National Cancer Institute (NCI)
  • NBE Therapeutics
  • NeuClone
  • Nipro
  • Novartis Pharmaceuticals
  • NYU Langone Health
  • Ohio State University
  • OncoQR
  • ORIC Pharmaceuticals
  • OS Therapies (OST)
  • Palleon Pharmaceuticals
  • Parker Institute for Cancer Immunotherapy
  • Pfizer
  • Phio Pharmaceuticals
  • Pieris Pharmaceuticals
  • Precirix
  • Prescient Therapeutics
  • Prestige BioPharma
  • Puma Biotechnology
  • PX'Therapeutics
  • QIAGEN
  • RemeGen
  • Roche
  • Samsung Bioepis
  • San Antonio Military Medical Center (SAMMC)
  • Sanofi
  • Seattle Genetics
  • Second Affiliated Hospital of Guangzhou Medical University
  • Shanghai Henlius Biotech
  • Shanghai Miracogen
  • Shanghai PerHum Therapeutics
  • Shanghai Pharmaceuticals
  • Shenzhen Geno-immune Medical Institute
  • Shinshu University 
  • Silverback Therapeutics
  • Sinobioway
  • Spectrum Pharmaceuticals
  • Sun Yat-sen University
  • Synaffix
  • Taiho Oncology
  • Takeda
  • Tanvex BioPharma
  • TC BioPharm
  • Technical University of Munich
  • Tessa Therapeutics
  • Tevogen Bio
  • Thermo Fisher Scientific
  • Trinity College London
  • Triumvira Immunologics
  • UBiome
  • United BioPharma
  • University Hospital Brussels
  • University of California
  • University of Minnesota
  • University of North Carolina
  • University of Pennsylvania
  • University of Texas
  • University of Toronto 
  • University of Washington
  • UWELL Biopharma
  • Vineti
  • VIVEbiotech
  • Voronoi 
  • Xyphos Biosciences
  • YZY Biopharma
  • Zion Pharma
  • Zymeworks
Note: Product cover images may vary from those shown

 

 

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