Immuno-Oncology Clinical Trials Market

The global Immuno-Oncology Clinical Trials Market is valued at USD 9.25 Billion in 2024 and is projected to reach a value of USD 33.92 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 12.55% between 2025 and 2035.

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Innovation in oncology is accelerating. An ever-increasing pace of innovation for patients is being seen across the globe. More than 550 active cell- and gene-therapy agents are currently in the clinical development stage, and it is anticipated that immuno-oncology treatments will continue to advance and make advances. There have been many more recent Immuno-Oncology (IO) clinical trials due to recent developments in immuno-oncology (IO) and the regulatory approval of several new drugs. Immuno-oncology, hailed by many as the future of cancer therapy, uses and unleashes the immune system of the body to identify and eradicate cancer cells. Immune checkpoint inhibitors work on pathways that cancers co-opt to evade immune recognition, revolutionizing the treatment of some solid tumors and hematologic malignancies. Cutting-edge treatments push the envelope further, including chimeric antigen receptor T-cells (CAR-T), dendritic cell vaccines, bi-specific T-cell engager (BiTE) antibodies, oncolytic viruses, and even gene transfer and gene editing. These treatments could lessen safety worries, have a higher therapeutic index, and work on various targets, including solid tumors. For instance, allogeneic CAR-T cell therapies can produce therapeutic doses of T cells from just one healthy donor, enough to treat more than 20 adult patients.

This field has advanced significantly due to several effective immuno-oncology clinical trials. The seminal KEYNOTE-024 trial, which demonstrated that Pembrolizumab increased overall survival in non-small cell lung carcinoma patients with high PD-L1 expression, is one of the key examples. Similarly, the CheckMate-067 trial showed that combining Nivolumab and Ipilimumab significantly increased overall survival in patients with advanced melanoma. These studies emphasize the effectiveness of immuno-oncology drugs and their potential as a go-to therapy for various cancers. Additionally, the U.S. Food and Drug Administration has approved several new drugs, treatment plans, combination therapies, and diagnostic tests for this new aspect of cancer treatment as drug development in cancer immunotherapy has accelerated. For example, On May 27, it approved nivolumab plus chemotherapy and nivolumab plus ipilimumab (Yervoy) as first-line treatments for advanced esophageal squamous cell carcinoma.

Key Takeaways

• The Phase III segment of Phase segmentation dominated the market with 54.2% of the revenue share in 2022.
• Interventional Trials dominated the market and accounted for the largest revenue share of 75% in 2022.
• The Solid Tumor segment led the market, accounting for more than 54% of the global revenue share in 2022.
• North America dominated the market and accounted for the largest revenue share of 53.48% in 2022.

Top Market Trends

1. Combination Therapy is Increasingly Being Used in Immuno-Oncology Clinical Trials: Utilising two or more medications that cooperate to improve the immune systems reaction to cancer cells is known as combination therapy. This strategy tries to improve the overall efficacy of cancer treatment by overcoming the drawbacks of monotherapy. Due to their capacity to address tumor heterogeneity and resistance mechanisms that restrict the efficacy of single-agent therapies, combination therapies have become more popular. In addition, numerous clinical trials are investigating innovative combinations of current immunotherapies with other treatments such as radiation therapy, chemotherapy, and targeted therapies. Combination medicines are increasingly being used in immuno-oncology clinical trials because of the demand for more potent cancer treatments that offer durable responses and higher survival rates.
2. Personalized Medicine in Immuno-Oncology Clinical Trials: This strategy involves identifying patients who are most likely to benefit from particular immunotherapies by employing biomarkers such as genetic mutations, protein expression, and immunological profiling. Utilizing treatments as efficiently as possible while also enhancing patient clinical results are the goals of this personalized strategy. Numerous clinical trials are investigating the use of companion diagnostic tests to pinpoint patients who are most likely to respond to particular immunotherapies as part of personalized medicine in immuno-oncology. The field of personalized medicine is increasing quickly due to the introduction of new technologies like single-cell analysis and next-generation sequencing, and it is anticipated to transform the way cancer is treated in the future completely.
3. The use of Cutting-Edge Biomarkers to Guide Treatment Decisions: Biomarkers, like PD-L1 expression or tumor mutational burden, assist in identifying patients who are more likely to benefit from immunotherapy. This makes it possible to enroll and recruit patients for clinical trials in a more focused manner, potentially improving patient outcomes. The discovery of novel biomarkers is also made possible by developments in next-generation sequencing technologies, which support the development of personalized medicine strategies. This development underlines the growing significance of comprehending the particular molecular traits of a patients tumor and adjusting therapies accordingly to maximize overall immuno-oncology treatment efficacy.

Economic Insights

First of all, the expansion of clinical trials has been aided by the rising healthcare costs in both developed and developing nations. For instance, in the United States, expanding clinical trial activities in immuno-oncology has been aided by allocating a sizeable budget for oncology research. Second, the demand for novel treatment options like immuno-oncology has increased as cancer incidence rates rise globally. The demand for clinical trials has increased due to this demand and the economic expansion of emerging markets. Due to economic factors, there has been a significant increase in immuno-oncology clinical trials in nations like China and India, where cancer rates are sharply rising. Due to rising drug development and regulatory requirements, as well as the requirement for larger patient populations for statistically significant results, the cost of conducting clinical trials has steadily risen. It is now harder for pharmaceutical companies to invest in immuno-oncology clinical trials due to reduced funding for research and development and budgetary restrictions.

Market Segmentation

The global Immuno-Oncology Clinical Trials market can be categorized on the following:

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Based on Design

Interventional Trials to Accommodate Maximum Market Share

interventional trials are the market leader in the immuno-oncology clinical trial design segment. Due to their capacity to evaluate the efficacy and safety of cutting-edge immunotherapies. These clinical trials involve the application of a novel medication or therapy in a regulated setting, enabling researchers to compile extensive data on its effects on the immune response in cancer patients. This section is crucial because it details immunotherapies' potential advantages and disadvantages. For instance, the ongoing Phase III CheckMate 227 trial examines the effectiveness of two immune checkpoint inhibitors for treating non-small cell lung cancer. Such interventional studies are crucial for improving our understanding of immunotherapies and for transforming cancer care.

Based on Indication

Solid Tumors Dominate the Immuno-Oncology Clinical Trials market in Terms of Indications due to their High Prevalence and the High Mortality Rates

Solid tumors dominate the Immuno-Oncology Clinical Trials market clinical trials because of their prevalence and difficult-to-treat nature. Solid tumors are distinguished from liquid tumors by a dense microenvironment, which makes it challenging for immune cells to pass through and exert their anti-tumor effects. As a result, scientists are putting more effort into creating immuno-oncology treatments specially made to get around these obstacles and successfully target solid tumors. For instance, novel approaches to improve the immune response against solid tumors, such as immune checkpoint inhibitors, are being tested extensively. The market dominance of solid tumors in clinical trials indicates the urgent need for potent immunotherapies to combat these difficult malignancies.

Based on the Trial Phase

Phase III Trials Express Dominion Because Large Patient Populations are Used

Due to their crucial role in determining the efficacy and safety of potential treatments, phase III trials dominate the phase segment of the Immuno-Oncology Clinical Trials market. Large patient populations are used in these trials, contrasting the novel therapy with the accepted standard of care or a placebo. Phase III trials produce reliable data that regulatory bodies need to give drugs the go-ahead to enter the market. They want to know if the therapy increases the quality of life or extends survival. In patients with advanced melanoma, for instance, the phase III CheckMate-067 trial showed that the combination of nivolumab and ipilimumab increased overall survival and response rates. Phase III trials are significant because they can offer crucial information for better treatment options.

Based on Region

North America’s Rising Cancer Incidence has Increased the Focus on Creating Immuno-Oncology Therapies.

Due to several key factors, North America is undoubtedly the largest region in the Immuno-Oncology Clinical Trials market. Firstly, the region has extensive healthcare infrastructure and expertise, making it an ideal location for clinical trials. The presence of top-tier research institutions, renowned hospitals, and leading pharmaceutical companies significantly contributes to the dominance of North America in this field. Moreover, the region is home to a large patient population, including those diagnosed with various cancers. This diverse patient pool offers ample opportunities for conducting robust and diversified clinical trials, enabling researchers to evaluate the efficiency and safety of novel immunotherapies. North America also benefits from a favorable regulatory environment that encourages the development and testing of innovative treatments. The U.S. Food and Drug Administrations (FDA) expedited approval process for breakthrough therapies has attracted numerous pharmaceutical companies to conduct clinical trials in the region.

Additionally, North America boasts a supportive ecosystem for research and development, with numerous academic collaborations, investment initiatives, and government funding schemes. Such resources enable the region to attract leading experts and drive innovation in immunotherapy. Numerous ongoing trials at renowned institutions like the Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, and MD Anderson Cancer Center exemplify North Americas dominance in immunotherapy clinical trials. These institutions frequently entice top researchers and receive generous funding, which supports the creation of cutting-edge immunotherapeutic strategies. North America is the market leader for immunotherapy clinical trials due to its robust healthcare infrastructure, extensive research capabilities, diverse patient population, and friendly regulatory environment.

Competitive Landscape

Numerous international and regional actors compete fiercely on the global market. Major corporations engage in strategic alliances, mergers & acquisitions, and joint ventures to acquire a market advantage. In addition, manufacturers concentrate on capacity expansions and R&D for new product development to offer consumers products that are on trend. This field has witnessed significant progress in recent years, with multiple companies and institutions vying to develop innovative immunotherapies for various types of cancer. For Instance, on June 16, 2023, the FDA approved TGI-6, a ground-breaking bispecific antibody developed by TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company with a focus on the creation of novel immuno-oncology therapies. TGI-6 simultaneously targets CD3 molecules and distinct tumor-associated antigens (TAA), enabling powerful anti-tumor responses.

The key players in the global Immuno-Oncology Clinical Trials market include - ICON PLC (Ireland) among others.

Recent Market Developments

• On June 19, 2023, Coherus BioSciences and Surface Oncology signed a definitive merger agreement to acquire the immuno-oncology (I-O) company in a deal worth $65 million.
• On June 29, 2023, Immuno-Oncology company Biosyngen opened its newest Good Manufacturing Practice (GMP) facility in Singapore. This facility targets unmet medical needs in treating solid tumors and lymphomas.
• On January 3, 2023, Alligator Bioscience and Orion started the second phase of their license agreement and collaborative immuno-oncology research project. Utilizing the Ruby platform from Alligator, the second program entails the creation of a brand-new bispecific antibody with potential uses in solid tumors.

Segmentation of the Global Immuno-Oncology Clinical Trials Market