According to a research report "Clinical Trials Market by Phase (Phase I, II, III), Service Type (Laboratory, Analytical Testing, Patient Recruitment, Protocol Designing), Therapeutic Area (Oncology, Cardiology, Neurology), and Application (Vaccine, mAbs, CGT) - Global Forecast to 2028", is projected to reach USD 73.2 billion by 2028 from USD 48.2 billion in 2023, at a CAGR of 8.7% during the forecast period of 2023 to 2028. The global clinical trials market is growing owing to factors such as increased R&D spending, increasing outsourcing of R&D operations, and an increase in clinical trials conducted globally. In addition to this, the growing biosimilars and biologics development and launches, increasing demand for specialized testing services, and emerging Asian markets also offer lucrative growth opportunities for players operating in the market. The market growth could be hampered by a lack of qualified professionals to conduct clinical trials in line with the regulatory guidelines.

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The clinical trials industry is poised to undergo a transformative evolution, marked by unprecedented advancements in technology, streamlined regulatory processes, and a heightened emphasis on patient-centric approaches. Emerging technologies like artificial intelligence, machine learning, and blockchain are set to revolutionize trial design, patient recruitment, and data analysis, vastly improving efficiency and reducing costs. Decentralized trials and virtual monitoring solutions will become commonplace, allowing for greater inclusivity and diversity in participant demographics. Furthermore, precision medicine and biomarker-driven trials will take center stage, enabling more targeted and effective treatments tailored to individual patients' genetic profiles.

Regulatory bodies will adopt agile frameworks, fostering faster approvals and adaptive trial designs, while ensuring robust safety measures. Collaboration between industry stakeholders, including pharmaceutical companies, academic institutions, and patient advocacy groups, will intensify, fostering a more cooperative and innovative ecosystem. Overall, the future of the clinical trials industry promises a paradigm shift towards more efficient, patient-centric, and scientifically rigorous research methodologies, ultimately leading to accelerated advancements in medical science and improved healthcare outcomes for patients worldwide.

Key Market Players:

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

DRIVER: Increasing drugs in the pipeline and rising investments in pharmaceutical R&D

Pharmaceutical, biopharmaceutical, and medical device companies are significant investors in the development of innovative drugs and devices. This industry is highly R&D intensive, with a focus on delivering both high-quality and novel products. Recent trends reveal that leading pharmaceutical companies are enhancing R&D efficiencies by making substantial R&D investments for long-term returns and fostering collaborative research activities. The rising R&D investments within the pharmaceutical and biopharmaceutical sectors are driving a shift towards comprehensive integrated or functionally outsourced services encompassing the entire process of drug discovery and development, starting from early-stage development to late-stage development phase. To enhance profitability, meet stringent drug development timelines, and achieve cost efficiencies, a significant number of pharmaceutical and biopharmaceutical companies now outsource their testing functions during R&D to CROs. This inclination is notably evident in recent partnerships between prominent pharmaceutical firms and Contract Research Organizations (CROs). Furthermore, advancements in biotechnology have resulted in a sharp increase in drug candidates in the pipeline. For instance, the number of drug candidates in the development pipeline has increased from 10,479 in 2013 to 17,737 by 2020. Projections indicate a continuation of this trend, with an estimated count of 21,292 drug candidates anticipated by the end of the year 2023. These trends are expected to drive the market during the forecast period.

Restraint: Need for unique testing approaches for innovative molecules

The pharmaceutical and biopharmaceutical industries have witnessed a considerable rise in competitiveness as they strive to create novel treatments and secure patent exclusivity through accelerated drug development. Bioanalytical testing plays a critical role across all stages of pharmaceutical and biopharmaceutical development and stands as the most frequently outsourced process within the scope of chemistry, manufacturing, and control (CMC) activities. CMC data also holds essential significance in meeting regulatory expectations and attaining approval for Investigational New Drug (IND) applications. The variety of requirements in chemistry, manufacturing, and control (CMC) for seeking approval for biopharmaceutical Investigational New Drug (IND) and developing innovative drug delivery systems presents different challenges. These challenges impose the use of novel and innovative analytical methods to test the new 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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