DelveInsight’s “Next Generation Immunotherapies Market Insights, Epidemiology, and Market Forecast-2034” report delivers an in-depth understanding of Next Generation Immunotherapies, historical and forecasted epidemiology, as well as the Next Generation Immunotherapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Next Generation Immunotherapies Market Report

• The leading Next Generation Immunotherapies companies include Bristol-Myers Squibb, Regeneron, Novartis, GlaxoSmithKline, Merck, Roche, AstraZeneca, and others.

• Rising prevalence of cancer and autoimmune diseases globally is accelerating demand for advanced immunotherapies offering durable and targeted treatment outcomes.

• Breakthroughs in CAR-T, TCR therapies, bispecific antibodies, and immune checkpoint modulators are expanding therapeutic applications and improving clinical efficacy.

• The Next Generation Immunotherapies market in the 7MM is expected to witness major change during the study period 2020–2034.

• Key targets currently under development include LAG-3, TIGIT, NKG2A, CD73, TIM-3, B7-H3, A2A receptor, FAK, CD47-SIRPα receptor, and CSF-1, among others.

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Next Generation Immunotherapies Epidemiology Segmentation in the 7MM

• Total Next Generation Immunotherapies Market Size

• Market Size by Therapies

• Market Size by Class

• Next Generation Immunotherapies Treatment Market

Next Generation Immunotherapies Pipeline Analysis

• OPDUALAG (relatlimab/nivolumab): Bristol-Myers Squibb OPDUALAG is a first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion. It is the first LAG-3 inhibitor granted FDA approval in March 2022 for the treatment of adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma.

• Fianlimab (REGN-3767): Regeneron Pharmaceuticals Fianlimab is a fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T cells. In melanoma, LAG-3 expression on cancer cells is associated with therapeutic resistance to PD-1 inhibitors. It is being investigated in combination with Regeneron’s PD-1 inhibitor Libtayo to determine whether concurrent blockade of LAG-3 and PD-1 can help overcome resistance and enhance T-cell activation.

• Cobolimab (GSK-4069889): GlaxoSmithKline Cobolimab is a monoclonal antibody targeting the inhibitory T-cell receptor TIM-3 (T-cell immunoglobulin and mucin domain-containing protein 3), with potential immune checkpoint inhibitory and antineoplastic activities.

• Tiragolumab (RG-6058): Roche Tiragolumab is a novel immune checkpoint inhibitor with an intact Fc region that selectively binds to TIGIT, a novel inhibitory immune checkpoint that suppresses the immune response to cancer.

• Ezabenlimab (BI-754091): Boehringer Ingelheim Ezabenlimab is a monoclonal antibody antagonist of the key myeloid cell checkpoint inhibitor SIRPα, preventing the SIRPα ligand CD47 from binding to SIRPα and thereby preserving the anti-tumorigenic properties of myeloid cells such as macrophages and dendritic cells.

Next Generation Immunotherapies Market Insights

• The current treatment landscape includes checkpoint inhibitors, monoclonal antibody inhibitors, immune system modulators, vaccines, virus therapies, adoptive cell transfer, T-cell therapy, and targeted therapies.

• Cancer immunotherapy is now considered the “fifth pillar” of cancer therapy, joining surgery, cytotoxic chemotherapy, radiation, and targeted therapy.

• The competitive landscape is highly dynamic and innovation-driven, with leading players advancing CAR-T and CAR-NK cell therapies, bispecific and multispecific antibodies, immune checkpoint inhibitors, and cancer vaccines.

• Strategic collaborations, licensing agreements, and mergers are common as companies seek to strengthen pipelines and access novel platforms.

• The expected introduction of emerging therapies with improved efficacy, greater awareness initiatives, and further improvement in diagnosis rates are likely to boost market growth across the 7MM.

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Next Generation Immunotherapies Market Outlook

Cancer immunotherapy harnesses the patient’s own immune system to fight cancer, distinguishing it from conventional therapies that directly target tumor cells. Immune checkpoints are pathways with inhibitory or stimulatory features that maintain self-tolerance and assist with immune response. Well-described checkpoints include CTLA-4, PD-1, and PD-L1. The Next Generation Immunotherapies pipeline is very robust, with many potential therapies under investigation, and the treatment space is expected to experience a significant market impact during the forecast period. Market growth may be offset by therapy failures or discontinuations, unaffordable pricing, market access and reimbursement issues, and a scarcity of healthcare specialists.

Scope of the Next Generation Immunotherapies Market Report

• Coverage: 7MM

• Study Period: 2020–2034

• Forecast Period: 2024–2034

• Next Generation Immunotherapies Companies: Bristol-Myers Squibb, Regeneron, GlaxoSmithKline, Roche, Boehringer Ingelheim, and others

• Next Generation Immunotherapies Therapies: OPDUALAG, Fianlimab, Cobolimab, Tiragolumab, Ezabenlimab, and others

• Next Generation Immunotherapies Market Access & Reimbursements, Unmet Needs and Perspectives

• Next Generation Immunotherapies SWOT Analysis and KOL Views

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Table of Contents

1. Key Insights

2. Report Introduction

3. NGIs Market Overview at a Glance

3.1. Market Share (%) Distribution of NGIs in 2020: By Country

3.2. Market Share (%) Distribution of NGIs in 2034: By Country

3.3. Market Share (%) Distribution of NGIs in 2025: By Indication

3.4. Market Share (%) Distribution of NGIs in 2034: By Indication

4. Key Highlights from Report

5. Executive Summary of NGIs

5.1. Key Events

6. Epidemiology and Market Forecast Flow

7. Background and Overview

7.1. Introduction

7.2. Different types of NGIs

7.3. Applications of NGIs

7.4. Mechanisms of Action of NGIs for Cancer Therapy

7.5. Routes of Administration

7.5.1. Direct intratumoral delivery

7.5.2. IV delivery

7.5.3. Other routes of delivery

7.5.4. Comparing different administration routes

8. Epidemiology and Patient Population

8.1. Key Findings

8.2. Assumptions and Rationale

8.3. Epidemiology Scenario in the 7MM

8.3.1. Total Incident cases of target indications across the 7MM

8.3.2. Target Patient Pool of NGIs across the 7MM

8.3.3. Treated cases by line of therapy across the 7MM

8.4. Epidemiology Scenario in the US

8.4.1. Total Incident cases of target indications across the US

8.4.2. Target Patient Pool of NGIs across the US

8.4.3. Treated cases by line of therapy across the US

8.5. Epidemiology Scenario in EU5

8.5.1. Total Incident cases of target indications across EU5

8.5.2. Target Patient Pool of NGIs across EU5

8.5.3. Treated cases by line of therapy across EU5

8.6. Epidemiology Scenario in Japan

8.6.1. Total Incident cases of target indications across Japan

8.6.2. Indication wise target patient pool across Japan

8.6.3. Treated cases by line of therapy across Japan

9. Key Endpoints in NGIs

10. Marketed therapies

10.1. Key Cross of Marketed Therapies

10.2. OPDUALAG: Bristol Myers Squibb

10.2.1. Product description

10.2.2. Regulatory milestones

10.2.3. Other developmental activities

10.2.4. Pivotal clinical trial

10.2.5. Ongoing pipeline activity

11. Emerging Therapies

11.1. Key Cross Competition

11.2. Fianlimab (REGN-3767) : Regeneron Pharmaceuticals

11.2.1. Product description

11.2.2. Other developmental activities

11.2.3. Clinical development

11.2.4. Safety and efficacy

11.3. Tebotelimab (MGD013) : MacroGenics

11.3.1. Product description

11.3.2. Other developmental activities

11.3.3. Clinical development

11.3.4. Safety and efficacy

11.4. Ezabenlimab (BI-754091): Boehringer Ingelheim

11.4.1. Product description

11.4.2. Other developmental activities

11.4.3. Clinical development

11.4.4. Safety and efficacy

11.5. MGC 018 : MacroGenics

11.5.1. Product description

11.5.2. Other Developmental Activities

11.5.3. Clinical development

11.5.4. Safety and efficacy

11.6. Etigilimab : MereoBiopharma

11.6.1. Product description

11.6.2. Other developmental activities

11.6.3. Clinical development

11.6.4. Safety and efficacy

11.7. HB-0036 : Hubao Biopharm

11.7.1. Product description

11.7.2. Other developmental activities

11.7.3. Clinical development

11.7.4. Safety and efficacy

To be continued in the report…

12. Attribute Analysis

13. Next Generation Immunotherapies: 7 Major Market Analysis

13.1. Key Findings

13.2. Market Outlook

13.3. Market Size of NGIs in the 7MM

13.3.1. Total Market Size of NGIs

13.3.2. Total Market Size of NGIs by Indications in the 7MM

13.3.3. Market Size of NGIs by Therapies

13.4. Market Size of NGIs in the US

13.4.1. Total Market Size of NGIs

13.4.2. Total Market Size of NGIs by Indications

13.4.3. Market Size of NGIs by Therapies in the US

13.5. Market Size of NGIs in EU5

13.5.1. Total Market Size of NGIs

13.5.2. Total Market Size of NGIs by Indications

13.5.3. Market Size of NGIs by Therapies in EU5

13.6. Market Size of NGIs in Japan

13.6.1. Total Market Size of NGIs

13.6.2. Total Market Size of NGIs by Indications

13.6.3. Market Size of NGIs by Therapies in Japan

14. Market Access and Reimbursement

14.1. NICE UK

14.2. IQWiG and GBA Assessment

14.3. Japan

14.4. Patient assistance programs

15. KOL Views

16. SWOT Analysis

17. Unmet Needs

18. Appendix

18.1. Acronyms and Abbreviations

18.2. Bibliography

18.3. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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