Immuno-oncology Clinical Trials Market Size to Hit US$ 25.1 Billion by 2030

According to Vision Research Reports, the Immuno-oncology Clinical Trials market size is expected to hit around US$ 25.1 billion by 2030 from valued at US$ 10.3 billion in 2020 and growing at a CAGR of 23.6% from 2021 to 2030.

Growth Factors

The rapidly growing field of Immuno-oncology has emerged as a novel therapeutic area within the oncology ecosystem, transforming the treatment of cancer. The growth can be attributed to recent developments in immuno-oncology, changes in lifestyle brought on by urbanization predisposing populations to the rise of cancer, and the growing acceptability of targeted therapy.

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The number of new immuno-oncology studies increased from 280 to almost 620, with double-digit growth rates each year as drug classes diversified. Biomarker and checkpoint inhibitor studies were primarily responsible for this rapid growth. 

Report Coverage


Market Size

US$ 25.1 billion by 2030

Growth Rate

CAGR of 23.6% From 2021 to 2030

Base year


Historic Data

2017 to 2020

Forecast Period

2021 to 2030

Segments Covered

Phase, Design, Indication

Regional Scope

North America, Europe, Asia Pacific, Latin America, Middle East & Africa (MEA)

Companies Mentioned

ICON Plc; IQVIA Holdings; Covance; BioNTech; IO Biotech Medical; Medpace; Novartis; Exscientia; Syneous Health; AstraZeneca


Phase Insights

The phase III segment dominated the market with 53.1% of revenue share in 2020. This is largely attributed that Phase III is roughly USD 59,500. Oncology trials also have a lower average number of trials are the most expensive ones and involve huge subjects. According to the FDA, the average cost of single-Phase III trial participants, so any fixed expenses are spread out among a smaller number of people. It has the most trials (2,560, or nearly 40% of all industry-sponsored studies) and the most trial participants (215,176, or almost 19 percent of all trial participants).

The Phase II trial segment is anticipated to witness the fastest growth rate of 19.8% over the forecast period. It's also the most expensive stage, placing second after Phase III. This study is split into two parts. The first step involves looking at a variety of dosages as well as efficacy trials, and the second half involves deciding on a dose. Phase II is crucially significant, especially in oncology trials.

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Design Insights

The interventional trials dominated the market and accounted for the largest revenue share of 78.6 % in 2020. There are around 3,042 interventional active clinical trials evaluating the clinical-stage immune therapies with a target of enrolling 5, 77, 076 patients. Interventional oncology trials are designed to demonstrate that some treatments are as effective as the present standard of care, but with far less morbidity and better results for cancer patients.

Single-arm studies reporting technical success or clinical efficacy dominate the evidence for interventional oncology success. These studies have led to the creation of new techniques, but they are insufficient to transform clinical practice throughout healthcare systems in a uniform manner. Interventional oncology trials are designed to demonstrate that some treatments are as effective as the present standard of care, but with far less morbidity and better results for cancer patients.

Indication Insights

Based on indication, the solid tumor segment led the immuno-oncology clinical trials market and accounted for more than 56.0% of the global revenue share in 2020. The segment is also projected to witness the fastest CAGR of 13.6% during the forecast period. Solid tumors can develop in a variety of tissues, including muscle, bone, and organs. Unmet demand for cancer therapy and increased expenditure on cancer drug research and development are two key factors driving growth. However, the solid tumor treatment market is being held back by issues such as the increasing quantity of generic therapeutic goods, the high cost of cancer therapy, and the growing medication patent cliff.

Advancements in cancer therapy, such as nanomedicines for cancer treatment, are projected to assist industry players in providing effective patient care in the treatment of solid tumors. However, the solid tumor therapy market is projected to be hampered by stringent regulatory standards for manufacturing medications. Solid tumors have advanced more slowly than hematopoietic malignancies in terms of comprehending genetic alterations, owing to problems in inducing the neoplastic cells of many tumors to divide in vitro.

Furthermore, when karyotypes are obtained, they are frequently discovered to be of poor quality. Solid tumors account for only 21% of the 14,000 neoplasms already in the cytogenetic database, despite the fact that they are the most common cancers in humans. Although solid tumor cytogenetics is still in its early stages, a number of areas of current and potential clinical use are emerging.

Regional Insights

North America dominated the market and accounted for the largest revenue share of 51.0% in 2020. This growth is attributed to the growing demand for personalized medicine-based novel treatments. In addition, increasing financial support from the government is also propelling the growth of the market in the region. 

Asia Pacific is anticipated to register the fastest growth rate of 14.7% throughout the forecast period. An increasing number of biotechnology companies are going to Asia and Australia to conduct immune-oncology clinical studies. Melanoma, lung cancer, bladder cancer, stomach cancer, and esophageal cancer are known to be more responsive to immune-oncology trials. Over 600 locations throughout the Asia Pacific have been involved in the clinical development of IO drugs, and hundreds more have gained valuable knowledge and skill managing clinical trials with immunotherapies, both monotherapy and combination medicines. These trials are mostly held in countries like China, Australia, and South Korea.

India is on pace to become a significant hub for immuno-oncology clinical trials and should be routinely considered by foreign sponsors for the use of immuno-oncology (IO) medicines such as immune checkpoint inhibitors in clinical care and solid tumor clinical trials. The most prevalent types of cancer recorded in India include breast, oral, cervical, lung, stomach, and colorectal cancers. Various government-funded and private cancer hospitals and research institutes with cutting-edge infrastructure that can handle multi-center immune-oncology clinical trials can be located throughout the country. These factors make the country highly cost-effective. With precise standards, the Indian regulatory authority is speeding up the discovery of new drugs and making immune-oncology clinical trials more accessible.

Key Players 

  • Medpace
  • Novartis
  • Exscientia
  • Syneous Health
  • AstraZeneca

Market Segmentation

  • Phase Outlook 
    • Phase I
    • Phase II
    • Phase III
    • Phase IV
  • Design Outlook 
    • Interventional trials
    • Observational trials
    • Expanded access trials
  • Indication Outlook
    • Solid tumors
    • Hematological cancer
  • Regional Outlook 
    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East & Africa

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