The global immuno-oncology clinical trials market size was valued at USD 8.30 billion in 2023 and is anticipated to reach around USD 35.37 billion by 2033, growing at a CAGR of 15.6% from 2024 to 2033. North America dominated the market and accounted for the largest revenue share of 54.0% in 2023.
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While traditional cancer treatments like chemotherapy and radiation effectively target cancer cells, they can also harm healthy cells, posing long-term health risks to patients. In response, cancer researchers globally are advancing toward more effective therapies that mitigate these risks. Immunotherapy stands out as a promising, demonstrating remarkable efficacy across various cancer types. These treatments harness the body’s immune system to target and destroy cancer cells specifically, improving outcomes significantly. As a result, immunotherapy has emerged as a cornerstone of modern medicine, driving substantial growth in the immuno-oncology clinical trials market. The rapid expansion of these trials underscores the transformative potential of immunotherapy in reshaping cancer treatment.
The immuno-oncology clinical trials market is experiencing rapid expansion fueled by pioneering advancements in cancer treatment that leverage the body’s own immune system. Immunotherapy represents a powerful tool against cancer by harnessing natural immune defenses to combat the disease. Key therapies include T cell therapy, which utilizes specialized immune cells to target and destroy cancer cells, and immune checkpoint blockade, which enhances immune responses to attack tumors. These therapies offer promising outcomes for patients with metastatic cancer and provide new hope for those who have exhausted conventional treatment options. Cancer immunotherapy encompasses diverse approaches such as targeted antibodies, cancer vaccines, adoptive cell transfer, and viral therapies, among others. This diverse array of biotherapies, including gene therapies that enhance immune cell functions, underscores the transformative potential of immuno-oncology in combination with existing cancer treatments. This integration aims to improve overall treatment effectiveness and patient outcomes in oncology.
· In March 2024, Gilead and Xilio announced an exclusive license agreement for the tumor-activated IL-12 program
· In December 2023, AbelZeta presented data from two clinical studies related to its immuno-oncology drug development at the 65th ASH Annual Meeting
Key Takeaways:
- North America dominated the market and accounted for the largest revenue share of 54.0% in 2023, this is due to the rising adoption of personalized medicine-focused novel treatment methods, as well as the government funding and investments
- Asia Pacific is anticipated to register the fastest growth rate of 14.7% throughout the forecast period.
- The phase III segment dominated the market with 53.1% of revenue share in 2023.
- The Phase II trial segment is anticipated to witness the fastest growth rate of 19.8% over the forecast period.
- The interventional trials dominated the market and accounted for the largest revenue share of 78.6 % in 2023.
- Based on indication, the solid tumor segment led the immuno-oncology clinical trials market and accounted for more than 60.0% of the global revenue share in 2023.
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U.S. Immuno-oncology Clinical Trials Market Size in U.S. 2024 to 2033
The U.S. immuno-oncology clinical trials market size was exhibited at USD 3.14 billion in 2023 and is projected to hit around USD 13.71 billion by 2033, growing at a CAGR of 15.9% during the forecast period 2024 to 2033.
North America dominated the market and accounted for the largest revenue share of 54.0% in 2023, driven by significant advancements in cancer treatment using immunotherapy agents. These therapies have transformed cancer management and prognosis, particularly immune-checkpoint inhibitors now utilized as first- and second-line treatments, enhancing patient outcomes. These advancements, accessibility remains a challenge, impacting treatment availability for some patients. In June 2024, the Marathon of Hope Cancer Centres Network and Canadian Cancer Trials Group announced a partnership on three pan-Canadian projects aimed at optimizing immunotherapy effectiveness for cancer patients. This collaboration underscores ongoing efforts to expand access and improve outcomes through innovative research initiatives across Canada.
Asia Pacific is anticipated to register the fastest growth rate of 14.7% throughout the forecast period. The region’s prominence is underscored by significant developments in oncology clinical development, where it has taken the lead in drug development pipelines. Demographic shifts, coupled with unmet medical needs and promising research pipelines, drive this growth. The Asia-Pacific Vaccine and Immunotherapy Congress (APVIC) serves as a pivotal platform bringing together experts across immunology, clinical trials, gene therapies, and vaccine manufacturing, among others. As the region continues to expand its role in clinical trials, addressing challenges and capitalizing on emerging opportunities will be critical for advancing cancer care and improving patient outcomes.
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Immuno-Oncology (IO) Market : The global Immuno-Oncology (IO) market size was estimated at USD 43.73 billion in 2023 and is projected to hit around USD 284.29 billion by 2033, growing at a CAGR of 23.12% during the forecast period from 2024 to 2033.
Oncology Clinical Trials Market : The global oncology clinical trials market size reached USD 13.19 billion in 2023 and is projected to hit around USD 22.11 billion by 2033, expanding at a CAGR of 5.3% during the forecast period from 2024 to 2033.
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Biotechnology Market: The global biotechnology market size was estimated at USD 1.54 Trillion in 2023 and is projected to hit around USD 5.68 Trillion by 2033, growing at a CAGR of 13.95% during the forecast period from 2024 to 2033.
Clinical Trials Market: The global clinical trials market size was estimated at USD 81.90 billion in 2023 and is projected to hit around USD 153.59 billion by 2033, growing at a CAGR of 6.49% during the forecast period from 2024 to 2033.
Biologics Market : The global biologics market size was estimated at USD 511.04 billion in 2023 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period from 2024 to 2033.
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U.S. Clinical Trials Market : The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of 4.88% over the forecast period of 2024 to 2033.
Market Dynamics
Driver
Advances in Genomic
Immunotherapeutic agents, categorized into ‘passive’ and ‘active’ I-O treatments, target cancer cells and modulate interactions within the tumor microenvironment and immune system. These agents encompass antitumor antibodies, adoptive cell therapies, cytokines, immune checkpoint inhibitors (ICIs), co-stimulatory agonists, cell death inducers, and cancer vaccines. The expanding use and affordability of high-throughput technologies like next-generation sequencing enhance understanding of genomic characteristics across cancers. This advancement accelerates the Immuno-oncology clinical trials market by facilitating personalized treatment strategies and advancing precision medicine approaches in oncology.
Restraint
Challenges in Immuno-Oncology
Immuno-oncology faces significant challenges that hinder market growth. Key obstacles include limited effectiveness in diverse patient populations, necessitating improved predictive methods and biomarker discovery. Resistance development, inadequate preclinical models, and immune-related adverse events (irEAs) further complicate treatment strategies. The intricacies of the immune system, equipped with fail-safe mechanisms, pose additional barriers to expanding immuno-oncology clinical trials. Addressing these challenges is critical to unlocking the full potential of immunotherapies and fostering sustainable growth in the field.
Opportunities
Advances in Immunotherapy
Amidst the dynamic landscape of cancer research, immuno-oncology emerges as a promising, offering innovative treatment avenues. Advances in immunotherapy leverage the body’s immune system to target and eliminate cancer cells, marking a transformative shift in cancer treatment paradigms. Clinical trials play a pivotal role in validating the safety and efficacy of these therapies across various cancer types, presenting substantial opportunities for growth in the Immuno-oncology clinical trials market. This evolving field underscores the potential to enhance patient outcomes and redefine standards of care in oncology through tailored immunotherapeutic interventions.
· In November 2023, AbbVie agreed to acquire ImmunoGen, including its flagship cancer therapy ELAHERE (mirvetuximab soravtansine-gynx), expanding its solid tumor portfolio.
Report Highlights
By Phase
The phase III trials segment commands a significant share of the market, driven by its pivotal role in assessing the clinical efficacy and safety of new treatments. These trials are characterized by their intensive time and resource requirements, leading to escalating costs over time. While studies focusing on agents with substantial clinical benefits may be conducted more cost-effectively, those with marginal effects incur higher expenses. Both pharmaceutical sponsors and academic institutions conduct phase III trials, but studies initiated by pharmaceutical sponsors typically prioritize short-term endpoints. Advancements, approximately 50% of phase III oncology trials end unsuccessfully, often due to lack of efficacy in late-stage development. Addressing these challenges remains crucial for optimizing trial outcomes and advancing new treatments in oncology.
The phase I trials segment within the immunotherapy market is poised for rapid growth, driven by its pivotal role in exploring novel combinations to overcome resistance mechanisms in immune-oncology (IO). These trials focus on integrating PD-1/PD-L1 antagonists with chemotherapy, radiotherapy, and other innovative molecules to address both primary and acquired forms of resistance. By informing future study designs, phase I trials not only enhance treatment efficacy but also pave the way for transformative advancements in cancer therapy, underscoring their critical importance in shaping the future of IO treatments.
By Design
The interventional trials segment commands the largest market share, characterized by assigning participants to receive interventions, placebos, or no interventions to assess their impact on biomedical or health-related outcomes. These studies, also known as clinical trials, evaluate potential drugs, medical devices, activities, or procedures in human subjects. Many interventional trials employ placebo controls to rigorously assess the efficacy and safety of interventions. This design framework ensures robust evaluation of new treatments, guiding critical decisions in biomedical research and healthcare innovation.
The observational trials segment is projected to experience the fastest compound annual growth rate (CAGR) during the forecast period. Unlike interventional studies, observational trials do not involve testing potential treatments but instead observe participants on their existing treatment plans. Researchers monitor health outcomes over time through methods like blood draws or questionnaires, making participation less intrusive and quicker than interventional trials. Participants can engage in multiple observational studies simultaneously, as these studies do not alter regular treatment regimens. This design flexibility enhances the efficiency of gathering real-world data, driving advancements in medical research and healthcare insights.
By Indication
The solid tumors segment commands the highest market share, encompassing abnormal masses of tissue that may be benign or malignant. These tumors are composed of various cell types, including cancer cells, cancer stem cells, connective tissue cells, and immune cells, all interacting through specialized junctions like tight and gap junctions. This heterogeneous composition shapes the tumor microenvironment, influencing tumor growth and response to treatment. Understanding and targeting the complexities of solid tumors are critical in developing effective therapies and advancing oncology treatment strategies.
The hematological cancers segment is poised to achieve the fastest growth among indication segments. These malignancies, affecting the blood and lymphatic systems, represent some of the most prevalent cancers. Understanding their incidence, mortality rates, and underlying hematopoietic disruptions is crucial for optimizing prevention strategies, enhancing clinical practices, and allocating research resources effectively. The diverse spectrum of hematological tumors includes myeloid and lymphatic malignancies, highlighting the need for targeted therapies and continuous advancements in hematologic oncology.
Recent Developments
· In November 2023, Boehringer Ingelheim expanded its immuno-oncology portfolio with the acquisition of bacterial cancer therapy specialist T3 Pharma
· In January 2024, Sanofi announced the acquisition of Inhibrx, Inc., adding a potential best-in-class rare disease asset for Alpha-1 Antitrypsin Deficiency to its pipeline.
Some of the prominent players in the Immuno-oncology clinical trials market include:
- Medpace
- Novartis
- Exscientia
- Syneous Health
- AstraZeneca
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the global immuno-oncology clinical trials market.
Phase
- Phase I
- Phase II
- Phase III
- Phase IV
Design
- Interventional trials
- Observational trials
- Expanded access trials
Indication
- Solid tumors
- Hematological cancer
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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