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Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs - Thematic Research

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  • 146 Pages
  • March 2021
  • Region: Global
  • GlobalData
  • ID: 5306829
Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs - Thematic Research


Immuno-oncology (IO) describes the treatment of various cancers with the use of bispecific-antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses. These classes of IO therapies achieved sales of ~$30B in 2019, which is projected to reach ~$95B by 2026. Of these, checkpoint modulators is the most valuable segment, forecast to achieve $66B in sales by 2026.

The field of (IO) is consolidating its presence in most major types of cancer, as there are now 22 marketed agents in the 7MM (United States, France, Germany, Italy, Spain, United Kingdom, and Japan), the majority being cancer vaccines, followed by 8 checkpoint modulators and 4 cell therapies.

IO agents are part of the standard of care in major cancer types, such as Melanoma, Lung, and Head & Neck Cancer. The clinical activity in the field is among the highest in oncology, with 4,822 clinical trials in the 7MM as of December 2020 and 422 drugs in clinical development.

The report “Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs” assesses physician perceptions on use of immuno-oncology drugs in clinical practice in the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan. It also provides the landscape of marketed and pipeline immuno-oncology drugs across the five major classes (bispecific antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses), opportunities, challenges, and unmet needs.

There is also a market analysis section with forecasts, as well as information on regulation and market access. The report combines information obtained from secondary sources and primary research with specialists and physicians from different disease areas within oncology who utilize immuno-oncology drug approaches during treatment.

Components of the report include primary and secondary research -
  • Quotes from key opinion leaders and payers
  • Summary of immuno-oncology definitions and classifications
  • Overview of key marketed and pipeline immuno-oncology drugs, including bispecific antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses
  • Trends in the immuno-oncology drug market
  • Call-outs of key information and details
  • Insight from the publisher’s specialist healthcare analysts

Key Questions Answered -
  • What impact will late-stage pipeline agents have on the market? Which class of IO drugs will have the highest peak sales, and why?
  • What are the current unmet needs in IO, which pipeline agents or strategies are positioned to counter these unmet needs? What are the opportunities for R&D?
  • How is the field of checkpoint modulation going to move forward? Which technologies are the most promising for combinations?
  • What is the regulatory landscape for IO agents in the US, the 5EU and Japan?
  • What is the current and future outlook of IO according to high prescribers?

Key findings from the report include -
  • The field of immuno-oncology (IO) is consolidating its presence in most major types of cancer: There are currently 22 marketed IO products in the 7MM. Prophylactic and therapeutic cancer vaccines lead the category with 9 products, followed by checkpoint modulators with 8 approved drugs and cell therapies with 4 approved drugs. As of December 2020, there are 4,822 clinical trials investigating IO across the 7MM with 422 drugs in development.
  • Checkpoint modulation is the most valuable IO sector: The checkpoint modulation market was valued at $24B in 2019 globally and is forecast to reach $66.5B by 2026, with Merck’s Keytruda (pembrolizumab) leading the market. Key patent expiries for checkpoint modulators in the decade 2020–2030 will start eroding market value away from branded agents and into biosimilars.
  • Existing programs facilitate the approval and development of IO: Special new designations for certain components of IO can be assigned such as RMAT in the US and ATMP in the EU. Countries in the 7MM have set programs to expedite IO therapy approvals, especially when they address an unmet need or are targeting orphan indications.
  • High cost of therapy and need for personalized treatment using biomarkers remain as unmet needs: Despite new competitors entering the market, IO agents have retained or increased their very high prices, causing concern for their future use in most markets The need for better biomarkers to guide treatment decisions is well-documented and new efforts in the industry may move the needle in the next five years.

  • Overview of immuno-oncology including classification of therapy and technologies, regulatory and market access details, product & company profiles.
  • Quotes from US- and 5EU-based key opinion leaders and payers.
  • Key topics covered for IO in the 7MM include trends, value chain, market analysis, opportunities, challenges and unmet needs and high-value deals.
  • Pipeline analysis: Comprehensive data split across different phases and indications, emerging novel trends under development, and analysis of the most promising late-stage pipeline drugs for each class of IO (Phase II - III).
  • Analysis of the key dynamics of the IO market. Insightful review of the key industry drivers and challenges. Deals and R&D strategies covered in detail to highlight business opportunities.
  • Robust analysis of high-prescriber survey conducted with 80 oncologists.

Reasons to Buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential.
  • Develop business strategies by understanding the trends shaping and driving the global immuno-oncology therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global immuno-oncology market in the future.
  • Design your development strategy through a review of potential novel targets or combinations across indications.
  • Understand the challenges and strategies impacting the development of immuno-oncology agents in preclinical studies and clinical trials.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the classes of IO and indications that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1. Preface
1.1. Table of Contents
1.2. Abbreviations
1.3. Related Reports
2. Executive Summary
2.1. Key Findings
3. Immuno-oncology Overview
3.1. What is Immuno-oncology?
3.2. Most Important Milestones of Immuno-oncology Development Globally
3.3. Key Twitter Chat
4. Trends
4.1. Industry Trends – Bispecific Antibodies
4.2. Industry Trends – Cancer Vaccines
4.3. Industry Trends – Cell Therapies
4.4. Industry Trends – Checkpoint Modulators
4.5. Industry Trends – Oncolytic Viruses
4.6. Regulatory Trends
5. Value Chain
5.1. Immuno-oncology Value Chain
5.2. Bispecific Antibodies
5.3. Cancer Vaccines
5.4. Cell Therapies
5.5. Checkpoint Modulators
5.6. Oncolytic Viruses
5.7. Immuno-oncology in Clinical Trials
6. Marketed Products
6.1. Marketed Immuno-oncology Products in the 7MM
6.2. Total Market Size for Immuno-oncology Agents
6.3. Ten Highest-grossing Immuno-oncology Treatments in 2019
6.4. Leading Checkpoint Modulators in The 7MM
6.5. Leading Cancer Vaccines, Bispecific Antibodies and Oncolytic Viruses in The 7MM
6.6. Leading Cell Therapies in The 7MM
7. Pipeline Products
7.1. Immuno-oncology Pipeline Products in the 7MM
7.2. Pipeline Products by Type and Phase
7.3. Future Outlook of Immuno-oncology Agents According to High-Prescribing Physicians
7.4. Consensus Forecast Sales for the Top Products per Class of Immuno-oncology
7.5. Late Stage Bispecific Antibody Products
7.6. Late Stage Cancer Vaccine Products
7.7. Late Stage Cell Therapy Products
7.8. Late Stage Checkpoint Modulator Products
7.9. Late Stage Oncolytic Virus Products
8. Market Analysis and Deals
8.1. Immuno-oncology Market Analysis and Forecast by Class of Therapy
8.2. Top 10 Transaction Deals by Size during 2011-2020 in the Immuno-oncology Space
8.3. Latest Transaction Deals in the Immuno-oncology Space
8.4. Mergers and Acquisitions That Include Immuno-oncology Assets: 2019 – 2020
8.5. Mergers and Acquisitions That Include Immuno-oncology Assets: 2014 - 2018
9. Regulatory and Market Access
9.1. Immuno-oncology in Clinical Trials
9.2. Differences in Immuno-oncology Clinical Trials – KOLs Perspective
9.3. Challenges in Immuno-oncology Clinical Trials – KOLs Perspective
9.4. Regulatory and Market Access – US
9.5. Regulatory and Market Access – Europe
9.6. Regulatory and Market Access – Japan
9.7. Comparison of Early Access Schemes in the US, EU, and Japan
9.8. Barriers to Access According to High Prescribers
10. Opportunities, Challenges, and Unmet Needs
10.1. Bispecific Antibodies – Opportunities & Challenges
10.2. Cancer Vaccines – Opportunities & Challenges
10.3. Cell Therapies- Opportunities & Challenges
10.4. Checkpoint Modulators – Opportunities & Challenges
10.5. Oncolytic Viruses – Opportunities & Challenges
10.6. Clinical Unmet Needs in Immuno-oncology - Gap Analysis
10.7. Commercial Unmet Needs in Immuno-oncology - Gap Analysis
10.8. Unmet Needs – KOLs Perspective
10.9. Unmet Needs According to High Prescribers
10.10. R&D Strategies
10.11. Opportunities According to KOLs and Closing Remarks
11. Companies
11.1. Drug Development Scorecard
11.1.1. Current Major Players
11.1.2. Novartis
11.1.3. Merck & Co
11.1.4. Gilead
11.1.5. Roche
11.1.6. Bristol-Myers Squibb
11.1.7. AstraZeneca
11.1.8. Sanofi
11.1.9. Amgen
11.1.10. Regeneron
11.2. Future Players Based on Pipeline Strength
11.2.1. Genmab
11.2.2. Bluebird Bio
11.2.3. GlaxoSmithKline
11.2.4. Iovance Biotherapeutics
11.2.5. Macrogenics
11.2.6. Hookipa
11.2.7. SELLAS Life Sciences
11.2.8. IMV
11.2.9. Replimune
11.2.10. Oncolytics
12. Appendix
12.1. Sources
12.2. Scope & Miscellaneous KOL Quotes
12.3. Primary Research
12.4. Key Themes Impacting the Pharmaceutical Industry
12.5. Thematic Research Methodology
12.6. About the Authors
12.7. Contact the Publisher
12.8. Disclaimer

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Amgen
  • AstraZeneca
  • Bluebird Bio
  • Bristol Myers Squibb
  • Genmab
  • Gilead
  • GlaxoSmithKline
  • Hookipa
  • IMV
  • Iovance Biotherapeutics
  • Novartis
  • Macrogenics
  • Merck & Co
  • Oncolytics
  • Regeneron
  • Replimune
  • Roche
  • Sanofi
  • SELLAS Life Sciences