Immuno-Oncology – Focus on Developments and Opportunities in Immune Checkpoint Modulators

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Immuno-oncology (IO) is the study and development of specialized treatments or immunotherapies for cancer to overcome the immune evasion mechanisms and to stimulate and enhance the immune system’s combat against cancer cells.
This report focuses on immune checkpoint modulators and provides an overview of the current and emerging key products and players within the 8MM (France, Germany, Italy, Spain, UK, US, Japan, China), main unmet needs; R&D challenges, strategies and opportunities; and clinical development trends. The report also includes competitive analysis of marketed products and a tabular analysis of key checkpoint targets and indications investigated in clinical trials. In addition, the report also provides an overview and critical assessment of the future landscape including bispecific antibodies, predictive/prognostic biomarkers and microbiome.
Key Questions Answered
What are the main types of immune checkpoint modulators?
What are the key marketed products and agents in development in the 8MM?
What are the key checkpoint targets and indications that are being investigated?
What are the main unmet needs in immune checkpoint inhibitors (ICIs)?
What are the main R&D challenges and strategies in ICIs?
What development trends exist or are anticipated in ICI-based therapies?
What are the opportunities in biomarker development and microbiome studies?

Scope

Quotes from 10 US-, 5EU-, and Japan-based key opinion leaders

Robust analysis of high-prescriber survey conducted with 94 oncologists

Summary of main types of immune checkpoint modulators

Competitive Analysis of key marketed/pipeline products in 8MM

Overview and critical analysis of main unmet needs, R&D challenges and strategies.

Overview and analysis of development opportunities in current and emerging clinical targets, and novel combinations across key indications.

Overview of biomarker technologies and microbiome

Call-outs of key information and details

Insight from GlobalData’s specialist oncology analysts

Key Highlights

Although ICIs work in some tumors such as lung cancer and melanoma, the majority of cancers fail to respond to ICIs, mainly due to various tumor- and immune-related factors.

These tumor types are refractory, benefitting the least from available therapies. Remission rates in all tumors are high, which can result in secondary resistance to ICIs.

The understanding of endogenous resistance mechanisms is poor and ICI monotherapy has not been able to overcome issues related to secondary resistance.

None of the current biomarkers used in development and in clinical practice are sensitive or accurate enough.

Without robust predictive/prognostic biomarkers, it is difficult to execute effective patient segmentation in clinical trials, match the best drugs for combination therapies, or predict and proactively manage side effects that might arise due to a treatment.

Lack of robust, predictive biomarkers creates a bottleneck for companies to develop safer and effective therapies for both small subsets of patients as well as for common tumors.

Current research in novel checkpoint targets provides possible rationale for addressing primary and secondary resistance in some tumor types.

In addition to immunotherapy combinations, companies are investigating targeted therapies as possible additions to ICI-based combinations to increase response rates in tumors with known mutations and genetic aberrations.

In the future, with emerging pharmacological and immune biomarkers, GlobalData expects numerous doublet and triplet combination therapies to appear in all lines of treatment.

Reasons to Buy

The report will enable you to:

Develop business strategies by understanding the trends shaping and driving ICI-based therapies in the 8MM.

Drive revenues by understanding the key trends, innovative combination strategies and indications likely to impact the utility of immune checkpoint modulators 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 immune checkpoint modulators in preclinical studies and clinical trials.

Organize your sales and marketing efforts by understanding ICI-based combination approaches across indications that present maximum opportunities for consolidations, investments, and strategic partnerships.

Develop strategies by understanding expert perceptions of unmet needs in key indications in oncology, and the potential for immune checkpoint modulators to meet those needs.

Agenus
AkesoBio
AstraZeneca
Beigene
Bristol-Myers Squibb
F. Hoffmann-La Roche
GlaxoSmithKline
Innate Pharma
Innovent
Jiangsu Hengrui Medicine
Jounce Therapeutics
Merck & Co.
Merck KGaA
Novartis AG
Pfizer
Regeneron Pharmaceuticals
Sanofi
Shanghai Junshi Biotech

Table of Contents

1 Table of Contents (PowerPoint Deck)

1. Preface

1.1 Related Reports

1.2 Upcoming Reports

1.3 Abbreviations

2. Executive Summary

2.1 Key Findings from GlobalData’s Research and Analysis of the ICI Field

2.2 KOL Insights: Unmet Needs and Opportunities Across Indications

2.3 KOL Insights: Biomarker Strategies and Microbiome

3. Immuno-oncology Definition and Overview

3.1 Introduction: Essentials of Immuno-oncology

3.2 IO: Different than Other Pillars of Cancer Treatment

3.3 IO Milestones Timeline for Immunotherapies: Rapid Breakthrough Achieved Following the Introduction of Immune Checkpoint Inhibitors

3.4 Immune Checkpoints as Evasion Mechanisms for Cancer: Main Types of Immune Checkpoint Targets

3.5 Cancer Immunogenicity and More: Factors that Influence Resposne to ICI Therapies

3.6 TMB and T Cell Infiltration: Scale of Immunogenicity for Tumors

3.7 Types of Immune Contexture: A Narrow Therapeutic Window for ICIs

4. Immune Checkpoint Inhibitors: Key Players and Product Profiles, Approvals, and Approved Indications Summary

4.1 Key Players and Market Shares by Geography (8MM)

4.2 Key Marketed Product Profiles

4.3 Approvals Summary for ICIs in the 7MM

4.4 Approvals Summary for ICIs in China

4.5 Approved Indications Summary for ICIs (8MM)

5. Competitive Assessment of Marketed ICIs: Route to Market Success for ICIs in Development

5.1 Historical and Forecast Sales for Immune Checkpoint Inhibitors (Global)

5.2 SWOT Analysis for Marketed ICIs in the 8MM

5.3 Key Development and Approval Information for ICIs (First Indications Approved in the US)

5.4 Clinical and Commercial Factors that Contribute to the Success of ICIs

5.5 Objectives and Strategies to Increase the Impact of ICIs in Cancer Treatment

6. New Immune Checkpoint Modulators in Clinical Trials

6.1 Current and Emerging Co-inhibitory Checkpoint Targets by Clinical Trial Phase

6.2 Current and Emerging Co-inhibitory Checkpoint Targets by Clinical Trial Status

6.3 Co-stimulatory Checkpoint Targets by Clinical Trial Phase

6.4 Co-stimulatory Checkpoint Targets by Clinical Trial Status

6.5 Top Immune Checkpoint Targets in Clincal Trials for Solid Tumors

6.6 Top Immune Targets in Clinical Trials for Blood Cancers

6.7 Combinations of Different Checkponit Targets in Clinical Trials

6.8 Level of Familiarity and Potential for Novel Checkpoint TargetsL High-Prescriber Survey Results

6.9 KOL Insights on Emerging Checkpoint Targets

6.10 Key Analysis for Novel Checkpoint Modulators

7. Major Unmet Needs in Immune Checkpoint Inhibitors

7.1 Major Unmet Needs in ICIs Identified by GlobalData

7.2 Major Unmet Needs by Relaive Importance and Current and Future Level of Attainment

7.3 Level of Significance of Unmet Needs in ICIs According to Key Opinion Leaders

7.4 Level od Significance of Unmet Needs in ICIs According to High-Prescriber Phyisicians

7.5 Lack of Predictive/Prognostic Biomarkers: Objectives, Challenges, and Strategies

7.6 Lack of Therapies to Overcome Drug Resistance: Objectives, Challenges, and Stategies

7.7 Lack of Response in Cold Tumors: Objectives, Challenges, and Strategies

7.8 Lack of Effective Combination Therapies: Objectives, Challenges, and Strategies

7.9 Lack of Therapies in the Earlier Lines of Treatment: Objectives, Challenges, and Strategies

7.10 Access Challenges Due to Rising Costs and Label-Specific Limitations

7.11 Key Analysis for Unmet Needs

8. R&D Strategies: Challenges and Opportunities

8.1 Objectives and Strategies in ICI Drug Development

8.2 Top 10 R&D Challenges in ICI Development Identified by GlobalData

8.3 Top R&D Challenges – KOL Scores for Current Level of Attainment

8.4 Key Analysis for R&D Challenges

8.5 The Perceived Impact of ICI-Based Combinations: High-Prescriber Survey Results

8.6 The Perceived Impact of IO Combinations: High-Prescriber Survey Results

8.7 Perceived Versus Actual Impact of ICI-Based Combinations: KOL Survey Results

8.8 Key Analysis: Combination Therapies to Overcome Treatment Resistance and Immune-Suppressive TME

8.9 Opportunities in Treatment-Resistant and Cold Tumors: High Prescriber Survey Results

8.10 Bringing ICI-Based Combination Therapies to Earlier Disease Treatment Setting: High-Prescriber Survey Results

8.11 Key Analysis and Insights for R&D Strategies

9. New Checkpoint Modulators: Pipeline Analysis and Key Pipeline Product Profiles

9.1 Immune Checkpoint Modulators in Development: Pipeline Products Summary

9.2 Immune Checkpoint Modulators in Development: Key Phase III Pipeline Summary

9.3 Immune Checkpoint Modulators in Development: Key Phase II Pipeline Summary

9.4 Immune Checkpoint Modulators in Development: Key Clinical Trials

9.5 Key Pipeline Products Profiles

9.6 KOL Insights on Pipeline Products

9.7 Key Analysis and Insights for Pipeline Products

10. Future Lanscape in Immuno-oncology: Bispecific Agents, Novel Biomarkers, and Microbiome

10.1 Bispecific Antibodies: Merging Two Therapies into a Single Agent

10.2 Main Types of Bispecific Antibodies

10.3 Critical Assessment of Clinical Attributes of Bispecific Antibodies

10.4 Future Trends and Opportunities: Key Analysis for Bispecific Antibodies

10.5 Biomarkers for ICI Therapies: Progressive Field of Biomarker Research

10.6 Balue of PD-L1 Expression as Predictive/Prognostic Biomarker

10.7 Most Significant Biomarkers by Predictive/Prognostic Value

10.8 Key Analysis for Predictive/Prognostic Biomarkers of ICIs

10.9 Microbiome and Cancer Immunity: Harnessing Response to ICIs

10.10 Key Analysis for Exploiting Microbiome to Enhance Response to ICIs

11. Appendix

11.1 Primary Research High-Prescriber Survey Respondent Demographics

11.2 Primary Research: KOL Information

11.3 Additional KOL Insights

11.4 Approvals Timeline for Immune Checkpoint Inhibitors: US

11.5 Approvals Timeline for Immune Checkpoint Inhibitors: 5EU

11.6 Approvals Timeline for Immune Checkpoint Inhibitors: Japan

11.7 Approvals Timeline for Immune Checkpoint Inhibitors: China

11.8 Key Patent Expiry Dates for Immune Checkpoint Inhibitors (7MM)

11.9 Sources

11.10 About the Authors

11.11 About GlobalData

11.12 Contact Us

11.13 Disclaimer

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