Oncology Clinical Trial Market: Introduction

Oncology clinical trials includes the development of new treatments for various cancers. Oncology is somewhat more complicated than other therapeutic areas. Rather than running a clinical trial to test the safety and efficacy of an antibiotic against an infection, an oncology trial also tries to extend and improve the subject's quality of life.

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Key Drivers and Restraints of Global Oncology Clinical Trial Market

Cancer has a major impact on society across the world. It is one of the leading causes of death across the globe and is more prevalent in developed and emerging markets. According to American Cancer Society data, over 1.7 million new cancer cases are expected to be diagnosed in 2019 in the U.S. According to information published in the European Journal of Cancer, an estimated 3.9 million new cases of cancer and 1.9 million deaths due to the disease were reported in Europe in 2018.

Increased R&D spending on cancer also fuels the market. Revenue from cancer drugs after their FDA approval is considerably higher than spending for research & development. Governments are also taking initiatives to invest in research of various oncology drugs along with R&D funding from several companies. Total investment in medical and health research and development (R&D) in the U.S. increased by 6.4% from 2017 to 2018, reaching a value of US$ 194.2 billion.

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Recruitment obstacles in clinical trial process may hamper the market. Several international studies investigating the issues in recruitment have put forth strategies such as piloting the recruitment process, financial and educational incentives for clinicians, newsletter and reminders for patients, open- versus placebo-controlled trials, assistance with patient travel, and networking with various healthcare professionals. Lack of awareness about clinical trials in patients, social and cultural issues related to trial participation, and complexity of study protocol are a few reason behind recruitment obstacles in the clinical trial process.

Phase II Dominated Global Oncology Clinical Trial Market

Based on phase, the global oncology clinical trial market can be divided into Phase I, Phase II, Phase III, and Phase IV

The phase II segment held a prominent share of the global market in 2019. Conventional seamless phase II design with fixed sample size determination (SSD) has gained popularity in oncology drug development due to attractive features such as significantly shortening the development timeline, minimizing sample size as well as early decision making. According to an article published in Haymarket Media, Inc. in September 2020, results from a phase II study of 3 oral targeted agents for chronic lymphocytic leukemia (CLL) showed that patients achieved deep remissions after a limited-time duration treatment. The study was also published in the Journal of Clinical Oncology, which included both treatment-naive patients and those with recurrent/relapsed disease.

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Interventional Segment Witnessed Significant Expansion

Based on study design, the global oncology clinical trial market can be divided into interventional, observational, and expanded access

The interventional segment accounted for a notable share of the global market in 2019. In interventional studies, participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes. It is a highly prominent method used in clinical trials.

However, the expanded access segment is projected to expand at a significant CAGR during the forecast period. An investigational drug product (including biological product) is available through expanded access for patients who do not qualify for enrollment in a clinical trial.

Lung Cancer Segment to Dominate Global Oncology Clinical Trial Market

Based on cancer type, the global oncology clinical trial market can be segregated into lung cancer, breast cancer, thyroid cancer, leukemia, liver cancer, skin cancer, lymphoma, pancreatic cancer, prostate cancer, colon & rectal cancer, urinary system cancer, and other cancer

In terms of revenue, the lung cancer segment held a considerable share of the global market in 2019, followed by the breast cancer segment. Lung and breast cancers were highly common cancers, worldwide, each contributing 12.3% of the total number of new cases diagnosed in 2018. In China, the incidence and mortality of lung cancer has gradually increased over the last 30 years, and this trend is expected to continue. Numerous clinical studies on lung cancer were carried out in 2018. In particular, significant progress has been made in immunotherapy and targeted therapy.

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North America to Dominate Global Oncology Clinical Trial Market

In terms of region, the global oncology clinical trial market can be divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa

In terms of revenue, North America dominated the oncology clinical trial market. Increase in incidence of cancer, rise in number of FDA approvals, and numerous product launches in the U.S. contribute to the leading share held by the region. Surge in investment by companies also fuels the market in North America. According to the American Cancer Society, 1,806,590 new cancer cases and 606,520 cancer deaths are likely to be recorded in the U.S. in 2020.

The oncology clinical trial market in Asia Pacific is anticipated to be driven by countries such as India and China. Rise in the number of target patients, increase in healthcare expenditure, and investments by various companies in research & development fuel the market in the region. In January 2019, CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) recently approved the clinical trial application (CTA) to start a phase I clinical trial in China for BLU-554 (CS3008), an inhibitor of fibroblast growth factor receptor 4 (FGFR4) discovered by the company's partner, Blueprint Medicines.

Key Manufacturers Operating in Market

The global oncology clinical trial market was highly fragmented in 2019. Key manufacturers operating in the global market are:

• PAREXEL International Corporation
• PRA Health Sciences
• Syneos Health
• Medpace
• Novotech
• Pivotal

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