According to a research report "Clinical Trials Market in terms of revenue was estimated to be worth $38.7 billion in 2021 and is poised to reach $52.0 billion by 2026, growing at a CAGR of 6.1% from 2021 to 2026. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Expanding number of clinical trials along with robust investment in pharmaceutical R&D are some of the key driving factors of the market. Maximum number of pharmaceutical, biopharmaceutical, and medical device companies continue to make large investments to develop novel therapeutics and devices. The R&D-intensive nature of pharmaceutical industry, propels companies to outsource clinical trials for expediating launch of therapeutics to the market.
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Indeed, the clinical trials market is projected to experience robust growth in the coming years. The information you provided highlights several key factors driving this growth:
- Growing Demand for Biosimilars and Biologics: The increasing demand for biosimilars and biologics, which are complex biological products, is driving the need for clinical trials. Biosimilars are highly similar versions of existing biologic drugs, and their development requires extensive clinical testing to demonstrate safety and efficacy. As the market for biosimilars and biologics expands, the demand for clinical trials to support their approval and commercialization will also rise.
- Rising Adoption of Specialized Testing Services: The clinical trials market is witnessing a growing adoption of specialized testing services, such as genomic testing, biomarker analysis, and companion diagnostics. These services play a crucial role in patient stratification, targeted therapy development, and precision medicine approaches. The incorporation of these specialized testing services in clinical trials enhances patient selection, improves treatment outcomes, and contributes to the overall efficiency of the trials.
- Increasing Preference for Outsourcing Clinical Trials from Emerging Asian Markets: Emerging markets, particularly in Asia, are gaining prominence in the clinical trials landscape. These markets offer several advantages, including a large patient pool, diverse demographics, and cost-effective trial conduct. Pharmaceutical and biotechnology companies are increasingly outsourcing their clinical trials to these regions to leverage these benefits. The rising preference for outsourcing clinical trials to emerging Asian markets contributes to the overall growth of the clinical trials market.
Overall, the projected CAGR of 6.1% indicates a positive growth trajectory for the clinical trials market. The market's expansion is driven by factors such as the growing demand for biosimilars and biologics, the adoption of specialized testing services, and the preference for outsourcing clinical trials to emerging Asian markets. These trends offer significant growth opportunities for players 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.
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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Recent Developments:
- In November 2022, Calit Health Services (Israel) collaborated with IQVIA (US) to work on clinical trial delivery.
- In October 2022, PPD (business of Thermo Fisher Scientific) introduced Decentralized Clinical Trials Network to facilitate participation in decentralized clinical trials.
- In September 2021, Syneos Health collaborated with Ride Health to co-develop non-emergency medical transportation (NEMT) for clinical trial participants.
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