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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

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

  • June 2021
  • 250 pages
  • ID: 6154598
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
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, lung cancer, head and neck cancer and ovarian 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?

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary 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 will evolve across different regions and technology segments. Where 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 key insights captured in our research. It offers a high-level view on the current state of the HER2 targeting therapies market and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to various aspects of cancer immunotherapy. The chapter lays emphasis on the role of targeting therapies in cancer treatment, including details on the HER2 mutations, mechanism of action of HER2 targeting therapies and the type of molecules that are developed / being developed. Further, it includes a discussion on the various challenges associated with the use of HER2 targeting therapies and highlights certain future perspectives.

Chapter 4 provides an overview of more than 200 molecules that are currently under development for the treatment of various cancer indications, along with a detailed analysis of these molecules, based on phase of development (marketed, clinical, preclinical and discovery stage) 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(s), therapeutic area(s) and route of administration (intradermal, intravenous, oral, and others). In addition, the chapter provides information on drug developer(s), highlighting their year of establishment, company size and geographical location of headquarters.

Chapter 5 includes detailed profiles of the key players (shortlisted based on number of pipeline products) engaged in the development of HER2 targeting therapies. Each profile includes a brief overview of the company, details on its product portfolio, and recent developments and an informed future outlook.

Chapter 6 provides a detailed analysis of more than 1,500 completed, ongoing and planned clinical studies of HER2 targeting therapies, based on the parameters, such as current trial status, trial registration year, phase of development, study design, leading industry sponsors (in terms of number of trials conducted), study focus, target indication(s), focus areas, target therapeutic area(s), enrolled patient population and regional distribution of trials.

Chapter 7 provides an analysis of more than 1,300 grants awarded to research institutes engaged in the projects related to HER2 targeting therapies, in the period between 2018 and 2021 (till March) based on important parameters, such as year of grant award, amount awarded, funding institute center, support period, type of grant application, purpose of grant award, grant mechanism, responsible study section, focus area, prominent program officers, and recipient organizations.

Chapter 8 features a detailed analysis of the various partnerships and collaborations that have been established amongst the stakeholders in this domain, since 2017. It includes a brief description of various types of partnership models (namely acquisitions, licensing agreements, product development and commercialization agreements, research agreements, and other agreements) adopted by stakeholders. It also includes analysis of the key companies that have established maximum number of partnerships, highlighting most popular type of molecule, and target disease indications.

Chapter 9 includes an insightful market forecast analysis, presenting the likely growth of HER2 targeting therapies market till the year 2031. In addition, we have provided inputs on the likely distribution of the market opportunity based on different target indications (breast cancer, gastric cancer, head and neck cancer, lung cancer and ovarian cancer), type of molecule (small molecule and biologic), type of therapy (monotherapy, combination therapy and both), route of administration (intravenous and oral) and key geographical regions (US, Europe, Asia-Pacific, Middle East and North Africa and Latin America). 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.

Chapter 10 presents a case study on HER2 targeting biosimilars, highlighting market landscape of various biosimilars molecules that are developed / being developed. These molecules are further analyzed on the basis of several parameters, such as parent drug, phase of development and target disease indications. This chapter also provide insights on developer landscape, including information on year of establishment and geographical location of headquarters of the companies.

Chapter 11 features a case study on companion diagnostic tests for that are developed / being developed corresponding to various HER2 targeting drug candidates, and their analysis on the basis of their commercial availability, assay technique used, corresponding drug candidate and target disease indication. This chapter also provide insights on developer landscape, including information on year of establishment and geographical location of headquarters of the companies.

Chapter 12 is a summary of the overall report, which presents the insights on the contemporary market trends and the likely evolution of the HER2 targeting therapies market.

Chapter 13 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 14 is an appendix, which contains the list of companies and organizations mentioned in the report.

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