According to a research report "Clinical Trials Market is projected to reach USD 73.2 billion by 2028 from an estimated USD 48.2 million in 2023, at a CAGR of 8.7% during the forecast period. The major factors driving the growth of this clinical trials market include increasing drugs in the pipeline, growing investment in pharmaceutical R&D, increasing number of clinical trials, high cost required for in-house drug development, and rising prevalence of orphan and rare diseases. Additionally, the favorable outlook for biologics and biosimilars, rising demand for specialized testing services and need for novel clinical trial designs for complex cell and gene therapies offer growth opportunities for clinical trial service providers operating in the market.

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Key Market Players:

  • IQVIA (US),
  • LabCorp (US),
  • Charles River Laboratories (US),
  • WuXi AppTec (China),
  • Syneos Health (US),
  • PPD (US), &
  • ICON Plc (US).

Driver: Increase in number of clinical trials The increase in the number of clinical trials globally is a significant driver of market growth. The demand for clinical trial services is expected to rise as more trials are conducted, leading to increased market opportunities. The WHO clinical trials registry data highlights the dominance of North America and Europe in terms of the number of registered clinical trials. In particular, the United States has been a major contributor, registering more than 30% of clinical trials by February 2023. Furthermore, the frequency of decentralized clinical trials has witnessed a substantial increase of over 25% in 2022. The adoption of decentralized elements in clinical trials has contributed to the growth in the number of trials conducted each year.

Challenge: Requirement of unique analytical testing approaches for innovative drug molecules The pharmaceutical and biopharmaceutical market has become highly competitive, driving the need for rapid drug development and gaining patent exclusivity. In this context, bioanalytical testing plays a crucial role throughout the phases of drug development. It is the most outsourced process among the chemistry, manufacturing, and control (CMC) activities. Bioanalytical testing is pivotal in generating data to meet regulatory expectations and obtain Investigational New Drug (IND) approval. However, the diverse CMC requirements for biopharmaceuticals and the development of novel drug delivery systems present challenges that require various analytical methods for testing new drug molecules.

The need for unique analytical testing approaches arises from the complexity and specificity of innovative drug molecules. These molecules may have distinct characteristics, such as large size, high potency, complex structures, or unique mechanisms of action. Consequently, specialized analytical methods are required to accurately assess their safety, efficacy, and quality. The development and validation of these analytical methods pose challenges, including the need for robust and sensitive techniques, appropriate sample preparation, and the availability of reference standards.

Addressing these challenges is crucial to ensure the successful development and commercialization of innovative drug molecules. Collaboration between pharmaceutical companies, contract research organizations (CROs), and regulatory agencies plays a vital role in establishing standardized approaches for analytical testing and overcoming these challenges. Continuous advancements in analytical technologies, such as mass spectrometry, chromatography, and immunoassays, also contribute to overcoming these challenges and meeting the unique requirements of innovative drug molecules.

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The laboratory services segment accounted for the largest share by service type in the clinical trials market in 2022.

By service type, the clinical trials market has been further categorized as patient recruitment, protocol designing, site identification, analytical testing, laboratory services, bioanalytical testing, decentralized clinical services, clinical trial supply & logistic services, medical device testing services, clinical trial data management services, and other clinical trial services. The laboratory services segment held the largest share of the global clinical trials market in 2022, owing to the increasing preference of clinical research experts to outsource laboratory testing services. The outsourcing rate for laboratory services has been significantly high in recent years compared to other services.

The oncology segment accounted for the largest share of the therapeutic area segment in the clinical trials market in 2022.

Based on therapeutic areas, the global clinical trials market has been segmented into infectious diseases, oncology, neurology, metabolic disorders, immunology, cardiology, genetic diseases, women's health, and other therapeutic areas. The oncology segment held the largest market share in 2022. The large share of this segment can be attributed to the rising prevalence of cancer worldwide and the high number of oncology clinical trials conducted globally.

The Small molecules segment accounted for the largest share of the application segment in the clinical trials market in 2022. 

The clinical trials market is segmented into small molecules, monoclonal antibodies, vaccines, cell & gene therapy, and other applications based on application. Small molecules are the largest application segment of the clinical trials market due to increasing demand for early-phase development outsourcing services as well as clinical & laboratory testing services for small molecules, the presence of a large number of service providers operating in this segment, and 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.

The North American region catered for the largest share of the clinical trials market in 2022.

The clinical trials market is segmented into North America, Europe, the Asia Pacific (APAC), Latin America (LATAM), and the Middle East and Africa (MEA). North American region held a substantial share of the clinical trials market owing to the strong presence of the pharmaceutical industry, the ongoing development of clinical trial investigations, increased research and development (R&D) spending, the expansion of biosimilars and generics markets, and the increasing trend of outsourcing preclinical, clinical, and laboratory testing services by pharmaceutical and biopharmaceutical companies within the region.

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Recent Developments:

  • In March 2023, Syneos Health entered into a multiyear agreement with Microsoft to create a platform that uses machine learning to elevate biopharma companies’ commercial performance and speed up clinical trial analysis, planning, and operation.
  • In September 2022, Parexel International established a new clinical trial supplies and logistics facility in Suzhou, China. This facility provides both local and international biopharmaceutical clients with quick access to clinical trial materials and medications for sites and patients, thus expediting the progress of clinical trials in the region.
  • In April 2021, CRL and Valence Discovery entered an alliance to provide AI-enabled drug design capabilities. The partnership will grant access to Valence’s ML platform.

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