Immuno-oncology Clinical Trials Market Size Analysis:

The Immuno-oncology Clinical Trials Market size was valued at USD 8.30 billion in 2023 and is expected to reach USD 23.63 billion by 2032, growing at a CAGR of 12.37% from 2024-2032.

The Immuno-oncology Clinical Trials Market report offers a comprehensive analysis of the drug pipeline and approval success rates, providing insights into trial development and commercialization trends. It emphasizes the regional distribution of immuno-oncology trials, highlighting leading and emerging markets. The report outlines R&D investments, focusing on funding trends from pharma, biotech, and government sources. It also discusses biomarker utilization in clinical trials, fueling precision medicine strategies. Moreover, it compares the regulatory framework and approval processes, detailing speeded-up approvals, breakthrough classifications, and the effect on clinical trial completion and market launch.

The U.S. Immuno-oncology Clinical Trials Market size was USD 3.08 billion in 2023 and is expected to reach USD 8.61 billion by 2032, growing at a CAGR of 12.15% over the forecast period of 2024-2032.

The market is witnessing significant growth due to the rising prevalence of cancer and increasing investments in immunotherapy research. The development of checkpoint inhibitors, CAR-T cell therapies, and cancer vaccines has fueled the demand for clinical trials in this space. Advances in biomarker-based patient selection and precision medicine are further enhancing trial success rates. Additionally, regulatory support and collaborations between pharmaceutical companies and research institutions are expected to drive market expansion, offering promising treatment options for cancer patients.

Immuno-oncology Clinical Trials Market Dynamics

Drivers

• Rising Prevalence of Cancer Driving Immuno-oncology Trials is propelling the market growth.

The rising global cancer burden is a key driver for the Immuno-oncology Clinical Trials Market, with pharmaceutical firms and research centers emphasizing novel therapies. The World Health Organization (WHO) states that cancer caused almost 10 million deaths in 2023, with lung, breast, and colorectal cancers being the most common. This increasing incidence of the disease has driven the demand for new immunotherapies like checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines. Recent developments include Merck's current trials for Keytruda in combination therapies and BeiGene's Phase 3 trial success with tislelizumab in gastric cancer (April 2023). Furthermore, the FDA's Accelerated Approval Program is fast-tracking the development of promising immuno-oncology therapies, prompting drug giants to make massive investments in clinical trials to cater to rising patient demand.

• Increasing R&D Investments and Strategic Collaborations are accelerating the market growth.

Increased patient demand is leading to more research and development (R&D) spending by pharmaceutical and biotech firms, which is driving the Immuno-oncology Clinical Trials Market significantly. Top companies are making huge investments to create next-generation immunotherapies, with special emphasis on combination therapies and personalized medicine. In February 2025, Merck KGaA revealed that it was considering acquiring SpringWorks Therapeutics to bolster its immuno-oncology pipeline. Also, Anbogen's September 2024 collaboration with BeiGene to initiate a global Phase II trial combining an HDAC inhibitor (ABT-301) with tislelizumab shows the increasing trend of strategic alliances. Governments and private entities are also stepping up funding, such as the U.S. National Cancer Institute (NCI) heavily investing in immunotherapy research. These initiatives are speeding up the identification, testing, and certification of innovative immuno-oncology drugs globally.       

Restraint

• The High Cost and Complexity of immuno-oncology clinical trials are restraining the market from growing.

The Immuno-oncology Clinical Trials Market is challenged by the high cost and complexity of carrying out trials for new cancer immunotherapies. It takes a lot of research, long trial periods, and high operating expenses to develop checkpoint inhibitors, CAR-T cell therapies, and personalized cancer vaccines, which in many cases run over $1 billion per drug. Stringent regulatory demands and biomarker-based patient selection further compound the challenge. Production of innovative biologics, including cell and gene therapies, involves unique infrastructure and logistics that increase costs further. Current reports place the average Phase III oncology trial cost at around $59 million, which deters smaller biotech companies from competing. Pharmaceutical firms' high costs and restricted patient recruitment to drive complex trial designs slow market growth, postponing the commercialization of milestone immuno-oncology therapeutics.

Opportunities

• Expansion of personalized immunotherapy and biomarker-driven trials presents a significant opportunity to the market.

The increasing emphasis on individualized immunotherapy and biomarker-guided clinical trials offers an enormous opportunity in the Immuno-oncology Clinical Trials Market. With advances in genomic sequencing, tumor profiling, and AI-aided biomarker discovery, researchers can develop precision therapies that enhance treatment efficiency and patient outcomes. Regulatory bodies like the FDA and EMA are becoming more favorable towards the application of companion diagnostics and biomarker authentication within clinical trials. The emergence of tumor-infiltrating lymphocyte (TIL) therapies, neoantigen vaccines, and engineered TCR therapies showcases the promise of next-generation immunotherapies. Moreover, partnerships between biotech companies and contract research organizations (CROs) to optimize trial designs through adaptive protocols and decentralized trial models also improve efficiency. This transition towards precision oncology paves the way for quicker approvals, increased success rates, and broader use of new immuno-oncology therapies.

Challenges

• Patient recruitment and retention in immuno-oncology trials are challenging the market growth.

One of the greatest challenges facing the Immuno-oncology Clinical Trials Market is patient recruitment and retention, particularly for trials focused on rare mutations or particular immune reactions. Checkpoint inhibitors, CAR-T cell treatments, and tumor microenvironment-modulating medicines all have eligibility requirements based on certain biomarkers, tumor types, or histories of treatment, which constrict the available patient base. Reports show that close to 80% of clinical trials do not achieve their enrollment targets within the allotted timeframe, which slows down drug development. Also, the high toxicity profiles, irAEs, and long-term follow-ups affect patient willingness to join and stay in trials. Regulatory bodies are promoting RWE integration, decentralized trial designs, and patient-centered approaches to enhance recruitment, but logistical and financial barriers remain, being a major hurdle to trial success.

Immuno-oncology Clinical Trials Market Segmentation Analysis

By Phase

The Phase III segment dominated the Immuno-oncology Clinical Trials Market with 54.06% market share in 2023 due to the huge number of late-stage trials evaluating the safety and efficacy of immunotherapies before regulatory approval. Since the drugs in immuno-oncology are sophisticated, e.g., immune checkpoint inhibitors (PD-1/PD-L1 inhibitors), CAR-T cell therapies, and cancer vaccines, extensive multi-center Phase III studies are necessary to prove clinical benefit. Increased investment from pharma giants such as Merck, Bristol-Myers Squibb, and Roche, and effective drug trials of Keytruda, Opdivo, and Tecentriq, have given way to a high-stakes trend of studies. Government authorities such as the FDA and EMA also demand strong long-term survival data before approvals, thereby spurring the market with Phase III trials.

The Phase I segment is expected to experience the fastest expansion during the forecast period, with the rise in first-stage investigation of new immunotherapies and second-generation immuno-oncology drugs. Development for customized cancer vaccines, TIL therapy, and oncolytic viruses has driven high interest in first-in-human trials. In addition, development in biomarker-driven trial designs is enhancing patient stratification, allowing smaller, faster, and cost-effective Phase I trials. The development of decentralized clinical trials (DCTs) and adaptive trial designs further accelerates the early-phase development of pioneering immune-modulating treatments. Also, greater investment by biotech startups and venture capital groups, combined with prospective collaborations among academia and pharma companies, is fueling tremendous expansion in Phase I immuno-oncology trials.

By Design

The Interventional Trials segment dominated the Immuno-oncology Clinical Trials Market with a 79.40% market share during the year 2023 due to the rigorous testing nature of immuno-oncology drugs. Immunotherapies like immune checkpoint inhibitors (PD-1/PD-L1), CAR-T cell therapies, and cancer vaccines require long randomized controlled trials (RCTs) to ascertain the safety, efficacy, and long-term survival benefits. These trials are essential in the process of gaining regulatory approvals from regulatory bodies like the FDA, EMA, and PMDA. Moreover, major pharma companies like Merck, Bristol-Myers Squibb, and Roche have conducted a large number of late-stage interventional trials for top therapies like Keytruda, Opdivo, and Tecentriq. The incidence of solid tumors and hematologic cancers has also led to the need for controlled interventional studies, thereby making this segment the largest contributor to the market.

The Observational Trials segment is experience to grow the fastest during the forecast period, owing to the increase in demand for real-world evidence (RWE) in immuno-oncology treatments. Healthcare professionals and regulatory authorities are placing greater value on long-term safety data, post-marketing surveillance, and real-world outcomes of patients. With the growing utilization of immunotherapies, observational studies are now being utilized to track treatment efficacy in a broad spectrum of patient populations, even comorbid patient populations that were previously excluded from past clinical trials. Scaling up biomarker-guided patient registries, coupled with increasing decentralized clinical trials (DCTs) and electronic health record (EHR) interoperability, has spurred the creation of observational studies. Additionally, collaborations between academia, government agencies, and drug companies are driving large post-marketing trials to assess long-term immunotherapy advantages.

By Indication

The Solid Tumors segment dominated the immuno-oncology clinical trials market with a 56.23% market share in 2023 due to the high prevalence of solid tumors, such as lung, breast, colorectal, and melanoma cancers, across the globe. Lung and breast cancer are two of the most prevalent cancers in the world, according to the World Health Organization (WHO), which has prompted increased focus on immuno-oncology therapy for these cancers. Most promising immunotherapies like PD-1/PD-L1 inhibitors (Keytruda, Opdivo, Tecentriq), CAR-T cell therapies, and cancer vaccines have been investigated extensively in solid tumors due to their ability to achieve durable response rates and improved survival outcomes. Moreover, pharma firms and research centers have given strong importance to big Phase II and III trials on solid tumors to get regulatory approvals and obtain expanded treatment indications, further solidifying the segment's leadership in the immuno-oncology space.

Immuno-oncology Clinical Trials Market Regional Insights

North America dominated the immuno-oncology clinical trials market with a 51.26% market share in 2023, with its established clinical research landscape, strong regulatory regime, and extensive presence of major pharmaceutical and biotech firms. The United States stands out in the region with a high volume of active immuno-oncology trials, buttressed by the FDA's fast track, breakthrough, and priority review pathways, high government investments, and strategic partnerships between industry and research organizations. Also, the presence of sophisticated healthcare infrastructure, high patient recruitment rates, and access to innovative immuno-oncology treatments are factors that make the region a leader in clinical trials.

Asia Pacific is experiencing the fastest growth in the Immuno-oncology Clinical Trials Market with 13.05% CAGR throughout the forecast period, being spurred by growing investments in clinical research, rising incidence of cancer, and enhanced participation from pharmaceutical firms. Nations such as China, Japan, and South Korea are expanding their clinical trial capacities at a swift rate, owing to regulatory reforms, government programs, and economic operations of trials. China, specifically, has witnessed growth in immuno-oncology trials because of supportive policies, local biotech growth, and increasing use of checkpoint inhibitors and cell therapies. Moreover, the region's multinational patient pool as well as its lower trial prices make it appealing to international players looking to quicken immuno-oncology drug development.

Immuno-oncology Clinical Trials Market Key Players

• Merck & Co. (Keytruda, Gardasil)

• Genmab (Epkinly, Tivdak)

• Kite Pharma (Yescarta, Tecartus)

• BeiGene (Tevimbra, Brukinsa)

• Nanobiotix (NBTXR3, Hensify)

• Imugene (HER-Vaxx, PD1-Vaxx)

• Novartis (Kymriah, Zykadia)

• AstraZeneca (Imfinzi, Enhertu)

• BioNTech (BNT111, BNT113)

• Gilead Sciences (Trodelvy, Veklury)

• Bristol-Myers Squibb (Opdivo, Yervoy)

• Pfizer (Bavencio, Talzenna)

• Roche (Tecentriq, Avastin)

• Eli Lilly and Company (Cyramza, Verzenio)

• Regeneron Pharmaceuticals (Libtayo, Zaltrap)

• Seagen (Adcetris, Padcev)

• Amgen (Blincyto, Lumakras)

• Johnson & Johnson (Darzalex, Rybrevant)

• Celgene (Revlimid, Pomalyst)

• Takeda Pharmaceutical Company (Ninlaro, Adcetris)

Suppliers (These suppliers provide biopharmaceutical manufacturing services, clinical trial support, contract research, and analytical testing for immuno-oncology therapies.) in Immuno-oncology Clinical Trials Market

• Lonza Group

• WuXi AppTec

• Samsung Biologics

• Catalent Inc.

• Thermo Fisher Scientific

• Charles River Laboratories

• Parexel International

• IQVIA

• Eurofins Scientific

• Merck KGaA (MilliporeSigma)

Recent Development in the Immuno-oncology Clinical Trials Market

• February 2025: Merck KGaA, one of Germany's most prominent healthcare and technology companies, announced that it is in advanced talks to buy U.S.-based biopharmaceutical company SpringWorks Therapeutics. With expertise in cancer and rare disease treatments, the takeover of SpringWorks is expected to bolster Merck's pipeline of oncology medicines with a primary emphasis on advancing immuno-oncology treatments.

• September 2024: Clinical-stage biotech company Anbogen partnered with BeiGene to start a global Phase II trial. The trial will evaluate the effectiveness of a combination of Anbogen's HDAC inhibitor, ABT-301, with BeiGene's anti-PD-1 antibody, tislelizumab, in patients with mismatch repair–proficient or microsatellite stable metastatic colorectal cancer.

• April 2023: BeiGene reported that its global Phase 3 RATIONALE 305 trial met its primary endpoint successfully. The trial results showed that the addition of tislelizumab to chemotherapy resulted in significantly better overall survival in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, regardless of PD-L1 expression levels.