According to a research report “Clinical Trials Marketboasts a total value of $38.7 billion in 2021 and is projected to register a growth rate of 6.1% to reach a value of $52.0 billion by 2026.
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Driver: Increase in number of clinical trials
This significant growth in the number of clinical trials across the globe is expected to drive the demand for clinical trial services and, in turn, propel market growth. According to the clinical trials registry of the WHO, as of June 2021, North America and Europe accounted for the largest number of clinical trials. US registered more than 30% of the clinical trials by February 2023. Additionally, the frequency of decentralised clinical trials has increased by more than 25% in 2022. Decentralisation of clinical trial elements have offered significant momentum to the number of clinical trials conducted each year.
Challenge: Requirement of unique analytical testing approaches for innovative drug molecules
Over the years, competition in the pharmaceutical and biopharmaceutical market to develop cutting-edge therapies and gain patent exclusivity through quick drug development has increased significantly. In all phases of pharmaceutical and biopharmaceutical development, bioanalytical testing plays a major role and is the most outsourced process among all the chemistry, manufacturing, and control (CMC) activities. CMC data is also pivotal to meet regulatory expectations and acquire Investigational New Drug (IND) approval. The diversity of CMC requirements for biopharmaceutical IND and the development of novel drug delivery systems pose a variety of challenges and require a myriad of analytical methods for testing new drug molecules.
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Phase III segment accounted for the largest share of clinical trials market
Based on phase, the clinical trials market is segmented into phases I, II, III, and IV. Phase III dominated the market in 2020. Services that incur high expenses and large patient/population size are the key factors attributing to the high share of the Phase III segment.
Laboratory services segment accounted for the largest share of the clinical trials market
Based on service type, the clinical trials market is segmented into protocol designing, site identification, patient recruitment, laboratory services, bioanalytical testing, analytical testing, clinical trial supply & logistic services, decentralized clinical services, clinical trial data management services, medical device testing services, and other services. Laboratory services is the leading segment of clinical trial services market, this can be attributed to the increasing preference of clinical research professionals to outsource such services. Among all the aspects of conducting clinical trials (such as protocol designing, site identification, and patient recruitment, among others), laboratory services have witnessed comparatively high outsourcing rates in the past few years, thus contributing to the growth of this segment.
Oncology segment accounted for the largest share of the clinical trials market
Based on the therapy area, the clinical trials market is segmented into oncology, infectious diseases, cardiology, neurology, womens health, genetic diseases, immunology, and other therapeutic areas. The large share of oncology segment is primarily attributed to the increasing number of drug discovery activities for oncology and the rising prevalence of cancer worldwide.
Small molecules segment accounted for the largest share of clinical trials market
The clinical trials market is segmented into small molecules, vaccines, cell & gene therapy, and others based on application. Small molecules is the key driver of the clinical trials application market, regardless of the synthetic method and materials used, small molecules are able to retain their chemical identity as opposed to sensitive biologics candidates, which has contributed to the robust demand for small molecule drug candidates. The majority of the patented drugs marketed in the past five years have been small molecules and generics of these patented drugs.
North America accounted for the largest share of the clinical trials market
The clinical trials market is segmented into North America, Europe, the Asia Pacific (APAC), Latin America (LATAM), and the Middle East and Africa (MEA). In 2020, North America accounted for the largest share of the clinical trials market, followed by Europe. The large share of the North American regional segment can be attributed to presence of a well-established base of pharmaceutical & biopharmaceutical companies, and high investments in the biosimilars & biologics market space.
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The prominent players operating in the clinical trials market are IQVIA (US), LabCorp (US), Charles River Laboratories (US), WuXi AppTec (China), Syneos Health (US), PPD (US), and ICON Plc (US).
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