Immuno-Oncology Clinical Trials Market By Therapy Type (Checkpoint Inhibitors, Cancer Vaccines, Adoptive Cell Therapy (ACT), Monoclonal Antibodies, Oncolytic Virus Therapy, Cytokine-Based Therapy, Others), By Trial Phase (Phase I, Phase II, Phase III, Phase IV), By Cancer Type (Hematologic Malignancies {Leukemia, Lymphoma, Multiple Myeloma}, Solid Tumors {Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer, Melanoma, Ovarian Cancer, Pancreatic Cancer, Head & Neck Cancer, Others}), By Design Type (Interventional Trials, Observational Studies, Expanded Access Studies), By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutions, Contract Research Organizations (CROs), Government & Non-Profit Organizations), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles and Market Forecast, 2025 – 2035

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Industry Outlook

The Immuno-Oncology Clinical Trials Market accounted for USD 9.26 Billion in 2024 and is expected to reach USD 33.19 Billion by 2035, growing at a CAGR of around 12.3% between 2025 and 2035.

The Immuno-Oncology Clinical Trials Market dedicates itself to developing innovative tumor-fighting cancer treatments that activate the immune system. The market leads clinical research for immune checkpoint inhibitors as well as CAR-T cell therapies cancer vaccines and monoclonal antibodies. The market prospers from four main growth factors which comprise cancer's higher incidence alongside innovative medicine development together with deepening research and development spending and government backing of next-generation treatments. The primary customer bases of our business model include pharmaceutical and biotechnology companies and Contract Research Organizations (CROs), academic research institutions, and healthcare providers as well.

Report Scope:

Market Dynamics

The increasing global cancer burden is driving demand for new and more effective immuno-oncology therapies.

The growth of worldwide cancer cases serves as a main market driver for Immuno-Oncology (I-O) Clinical Trials because cancer stands as one of the major contributors to mortality and disease worldwide. The urgent requirement for better treatment solutions has intensified due to the rising diagnostics of multiple cancers associated with population aging together with lifestyle adaptations and environmental causes. The body's immune system receives targeted cancer therapy through two I-O treatment types - immune checkpoint inhibitors and CAR-T cell therapies.

The pharmaceutical industry and research sector conduct rapid clinical research to create promising innovative treatments and combination therapies because of the expanding demand for these therapies. The improved survival data from immunotherapy success has motivated regulatory agencies to speed up their approval procedures thereby bolstering the number of clinical trials. Research funding and investment into I-O studies foster innovation which expands the clinical development program. Multiple influential factors create rapid market growth within the I-O Clinical Trials sector.

The growing prevalence of cancers like lung, breast, and colorectal cancer fuels trial activity

An increase in the burden of cancers-such as lung, breast, and colorectal cancer-has become one of the leading causes responsible for the growth of the Immuno-Oncology (I-O) Clinical Trials market, as these cancers form a significant disease burden globally, calling for novel therapeutic approaches. In these malignancies, immunotherapies, such as immune checkpoint inhibitors and CAR-T therapies, have shown great promise and have therefore attracted investment into more research.

Regulatory agencies are encouraging fast-track approval for these new immunotherapies targeting prevalent cancers. Successful patient selection through biomarkers further enhances success in trials, drawing even more sponsors and investment. Survival outcomes seem to always be improving with immunotherapy, making pharmaceutical companies increasingly interested in trialing combinations, thus boosting trial activity. In all, the growing burden of cancer continues to sustain a pipeline of I-O clinical trials aiming at changing the landscape of cancer treatment.

Conducting immuno-oncology trials is expensive due to long study durations, and complex trial designs.

The major part cost above any immuno-oncology (I-O) trial is for the prolonged duration and complex nature of the study designs; hence, it is a major restraint in the market. Follow-ups are long in the case of I-O therapies because the long-term efficacy and durability of the immune response are determined over time. The above trials seek to employ biomarker-driven patient selection and adaptive protocols, which call for sophisticated technologies and expertise, thereby increasing costs.

High-price biosimilars, like checkpoint inhibitors and CAR-T therapies, discourage penetration into I-O treatment. Another major setback includes recruitment difficulties and strict regulatory parameters; it often results in additional delays or costs. Small biotechs may not help fund such large-scale studies necessary for innovation out there. The high-cost burden denies patients access and slows down their adoption of newer therapies. These challenges will have to be overcome for innovative trial designs and efficiencies driven by AI to occur for market growth.

Growing interest in combining immune checkpoint inhibitors with target therapies, chemotherapy, or novel agents

The immuno-Oncology (I-O) Clinical Trials market has a wide perspective opportunity due to the growing interest in combining immune checkpoint inhibitors (ICIs) with targeted therapies, chemotherapy, or novel agents, mainly to augment treatment efficacy and counter-resistance mechanisms. While the PD-1/PD-L1 inhibitors quite successfully have been applied with variable response rates across various cancer types, combinations can enhance immune activation, broaden patient eligibility, and yield durable responses.

New agents like oncolytic viruses and cancer vaccines synergize well with ICIs for fresh therapeutic avenues. These combinations give rise to new trial opportunities, investments, and regulatory approvals. Biomarker-driven combinations can further enhance patient selection, thereby lowering the likelihood of trial failure. Combination strategies will continue to be a crucial growth driver for the I-O clinical trials market, as various pharma and biotech companies will be racing to develop next-generation immunotherapies.

Expansion of CAR-T and TCR therapies beyond hematologic malignancies into solid tumors

The Immuno-Oncology Clinical Trials Market offers significant potential through the expansion of CAR-T and TCR therapy applications into solid tumor therapy because solid tumors represent large treatment needs in the field. The remarkable success of CAR-T cells within blood cancers encounters obstacles with both the immunosuppressive tumor environment and diverse tumor antigens when researchers attempt their application to solid tumors.

Modern treatment approaches that focus on hitting multiple antigens and developing armored CAR-T cell cells and combination therapy protocols have proven successful at increasing CAR-T cell therapy effectiveness. Successful trials have the potential to establish a multi-billion-dollar market which would increase patient availability to effective immunological treatments. Pharma and biotech companies together with regulatory support continue to speed up research through increasing investments. Solid tumor barriers' successful overcoming would revolutionize cancer therapies, so this represents an exceptionally promising field for commercial and medical research.

Industry Experts Opinion

“Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward,"

• Steven Elmore, vice president, of small molecule therapeutics and platform technologies at AbbVie

“We are extremely proud of the work of T3 Pharma’s team and very excited to continue and accelerate the successful development of our bacterial delivery platform as part of Boehringer Ingelheim. Being integrated with our partners at Boehringer will enable us to realize the full potential of our platform to fight solid cancers,”

• Simon Ittig, CEO of T3 Pharma

Segment Analysis

Based on the Therapy Type, the Immuno-Oncology Clinical Trials Market has been classified into Checkpoint Inhibitors, Cancer Vaccines, Adoptive Cell Therapy (ACT), Monoclonal Antibodies, Oncolytic Virus Therapy, Cytokine-Based Therapy, Others. Checkpoint inhibitors are the largest segment in the Immuno-Oncology Clinical Trials Market due to their broad applicability across multiple cancer types and their proven clinical success. Checkpoint inhibitors pembrolizumab (Keytruda) and nivolumab (Opdivo) transformed cancer treatment which now gains ultimate acceptance from medical practice and receives ongoing clinical trial improvements. High patient interest and pharmaceutical company investments stem from these treatments effectively improving tumor responses by the immune system. Checkpoint inhibitors show extensive investigation as combination treatment agents which drives trial numbers higher. The segment continues to lead clinical investigations together with commercial success.

Based on the Cancer Type, the Immuno-Oncology Clinical Trials Market has been classified into Hematologic Malignancies and Solid Tumors. Hematologic malignancies are the fastest-growing segment in the immuno-oncology market due to advancements in targeted therapies such as CAR-T cell therapy and bispecific antibodies. Researchers are observing remarkable success rates from immunotherapy treatments of these cancers that have triggered more approvals and current medical trials. Blood cancer cases are increasing worldwide and so are the aging population numbers which together strengthen the need for new treatment approaches. The pharmaceutical industry devotes considerable funds to research and development to strengthen the process of creating novel treatment methods. The segment continues to expand rapidly because of speedy regulatory approvals and beneficial approval processes.

Regional Analysis

Regionally, North America has been leading the worldwide Immuno-Oncology Clinical Trials Market and is anticipated to continue in the dominant position in the years to come. It is the strongest region regarding Immuno-Oncology (I-O) Clinical Trials, due mainly to its research infrastructure and heavy investments in biotechnology development, along with a favorable regulatory environment. Massive funding as well as government initiatives, such as the Cancer Moonshot program, and expedited regulatory pathways, such as Breakthrough Therapy Designation by the FDA, are among the major driving forces for the region. At the same time, North America has a vast patient pool for clinical trials and advanced healthcare facilities supporting trial execution. Leading I-O drug developers are located within North America, which is consistent with the growing adoption of combination therapies, making this segment more robust in the region's installation.

Asia Pacific is the fastest-growing region in the Immuno-Oncology (I-O) Clinical Trials market due to its expanding healthcare infrastructure, increasing clinical trial activity, and growing investments in biotechnology. The area provides drug developers from around the world with beneficial trial expenses alongside diverse genetic populations and quick enrollment times. The market growth continues to expand at a rapid pace because of the expanding usage of advanced immunotherapies like CAR-T cell therapy and checkpoint inhibitors. I-O research receives acceleration through increased activities by local biotech companies which support accelerated trial expansion. Various elements support the rapid market expansion of I-O clinical trials in Asia Pacific.

Competitive Landscape

Key operating players in the Immuno-Oncology Clinical Trials Market are Merck & Co., Inc., Bristol-Myers Squibb Company, Genentech, Inc., AstraZeneca plc, Pfizer Inc., Novartis AG, Kite Pharma, Inc., Johnson & Johnson, etc. This industry segment features these companies because they excel at research creation alongside extensive clinical trial operations and the development of transformative immunotherapeutic medicines. These companies maintain their dominance in I-O by allocating major research investments alongside strategic partnerships which led to regulatory endorsements that allow their market expansion.

The company firmly controls the market through its worldwide presence and access to extensive patient networks as well as its ability to execute major clinical trials. The pharmaceutical companies maintain their industry dominance by obtaining key medication products such as Keytruda, Opdivo, and Yescarta which promote ongoing field development. The companies build their leadership through strategic alliances with biotech firms and academic institutions together with regulatory agencies to speed up immunotherapy innovations.

Immuno-Oncology Clinical Trials Market, Company Shares Analysis, 2024

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Recent Developments:

• In January 2025, AbbVie announced a collaboration and option-to-license agreement with Neomorph, Inc. to develop novel molecular glue degraders for oncology and immunology.
• In December 2023, AstraZeneca entered into a definitive agreement to acquire Gracell Biotechnologies Inc., enhancing its cell therapy capabilities in oncology and autoimmune diseases.

Report Coverage:

By Therapy Type

• Checkpoint Inhibitors
• Cancer Vaccines
• Adoptive Cell Therapy (ACT)
• Monoclonal Antibodies
• Oncolytic Virus Therapy
• Cytokine-Based Therapy
• Others

By Trial Phase

• Phase I 
• Phase II 
• Phase III 
• Phase IV

By Cancer Type

• Hematologic Malignancies
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
• Solid Tumors
  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Melanoma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Head & Neck Cancer
  • Others

By Design Type

• Interventional Trials
• Observational Studies
• Expanded Access Studies

By End User

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutions
• Contract Research Organizations (CROs)
• Government & Non-Profit Organizations

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Merck & Co., Inc.
• Bristol-Myers Squibb Company
• Genentech, Inc.
• AstraZeneca plc
• Pfizer Inc.
• Novartis AG
• Gilead Sciences, Inc.
• Johnson & Johnson
• Amgen Inc.
• Moderna, Inc.
• Eli Lilly and Company
• Sanofi S.A.
• GlaxoSmithKline plc (GSK)
• Regeneron Pharmaceuticals, Inc.
• BeiGene, Ltd.

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