Immuno-oncology Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Design (Interventional Trials, Observational Trials), By Indication, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global immuno-oncology clinical trials market size was estimated at USD 5.3 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 13.6% from 2021 to 2028. 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.

COVID-19 has had a significant impact on cancer and clinical trials, altering therapy and oncology patients in a number of ways. According to the research by Evaluate Vantage, over 170 studies being discontinued as a result of the virus. The pandemic disrupted 920 interventional oncology trials between February and May 2020.

Besides, clinical trial participation has also become challenging due to difficulties such as transportation issues to trial sites or testing locations. IQVIA and the Cancer Research Institute collaborated to conduct a survey among oncology investigators to assess the impact of COVID-19 on ongoing and future clinical studies. Remote tools were highly ranked for the assessments. Also, during the COVID-19 pandemic, several regional authorities provided prompt and detailed support for virtual tools and models, indicating that regulators regard patient-centric technology and approaches as feasible answers to this global issue.

Immuno-oncology trials account for more than a third of all clinical trials in oncology. Small biotech and specialty pharma are poised to play a critical role in the growth. Immunotherapy advances differ from cytotoxic chemotherapy in the way they work, and these distinctions may have an influence on a dose, response evaluation, biomarker validation, combination therapy selection, and adverse event detection. Understanding and overcoming these barriers will be crucial to the success of immuno-oncology clinical trials and, eventually, market approval.

Treatments focusing on two targets - PD-1/PD-L1 and CTLA-4 - which both negatively control T-cell immune function to promote activation of the body's own immune system - have generated the most significant advances in immuno-oncology. Other than PD-1/PD-L1 and CTLA-4 inhibitors, CAR-T (chimeric antigen receptor T-cell) treatment is another popular immuno-oncology treatment option. CAR-T therapies use a patient's own T-cells, which are extracted, changed to attack cancer, and then put back into the patient's body.

Immuno-oncology (IO) continues to play a significant role in oncology deal-making, accounting for 49% of drug licensing deals and 66% of the total disclosed deal value. 15 of the 21 oncology medication licensing deals worth more than $1 billion were for IO assets, with 9 of those for multi-targeted methods such bispecific antibodies and antibody-drug conjugates. In 2020, the AstraZeneca/Daiichi Sankyo pact was the largest drug licensing deal.

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.

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 Companies & Market Share Insights

Key players in the market are undertaking various strategic initiatives such as the signing of the new partnership agreement, collaborations, mergers and acquisitions, geographic expansion, aiming to strengthen their product portfolio, manufacturing capacities, thus providing a competitive advantage.

For example, in May 2021, BioNTech announced its plans to open its first mRNA manufacturing facility in Singapore which will expand its geographical footprint in Southeast Asia. The new mRNA production plant would take advantage of cutting-edge technology and digital infrastructure. Some of the prominent players in the immuno-oncology clinical trials market include:

• Medpace

• Novartis

• Exscientia

• Syneous Health

• AstraZeneca

Immuno-oncology Clinical Trials Market Report Scope

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 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global immuno-oncology clinical trials market report on the basis of phase, design, indication, and region:

• Phase Outlook (Revenue, USD Million, 2016 - 2028)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Design Outlook (Revenue, USD Million, 2016 - 2028)

  • Interventional trials

  • Observational trials

  • Expanded access trials

• Indication Outlook (Revenue, USD Million, 2016 - 2028)

  • Solid tumors

  • Hematological cancer

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Thailand

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE