Clinical Trials Market

The global clinical trials market, valued at $48.2 billion in 2023 and projected to grow to $73.2 billion by 2028, reflects significant growth driven by increasing pharmaceutical R&D investments and a burgeoning pipeline of drug candidates. Key trends include outsourcing of R&D functions to Contract Research Organizations (CROs), particularly for biologics and biosimilars, which require specialized testing services. However, challenges such as a shortage of skilled professionals in clinical trials may hinder market expansion. Major players like IQVIA, Syneos Health, and WuXi AppTec dominate the industry, focusing on innovation and strategic partnerships to enhance clinical trial efficiency and outcomes.

Attractive Opportunities in the Clinical Trials Market

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Global Clinical Trials Market Dynamics

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.

OPPORTUNITY: Favorable outlook for biologics and biosimilars

The field of pharmaceuticals and biotechnology has experienced rapid expansion in recent times. Notable investments have been seen in R&D activities aimed at creating innovative medications and biological substances for tackling a range of illnesses. Many new drugs and biologics are currently in the clinical trial stages of development. s. With the continuous influx of novel pharmaceutical products in the pipeline, the demand for clinical trial services is expected to witness substantial growth. Despite an overall reduction in approvals by the US FDA in 2022 due to the COVID-19 impact, the biologics sector remained unaffected, recording the approval for 15 new molecules and maintaining momentum from prior years. As in previous years, cancer continued to be the condition most addressed by monoclonal antibodies, which also continued to be the medicine class with the most approvals.

CHALLENGE: Shortage of Skilled Professionals in Clinical Trials

Clinical research organizations (CROs) are facing a tough time finding and keeping skilled people. They're competing with drug companies, biotech firms, medical device makers, and academic research institutes for qualified and experienced scientists. To compete effectively, these companies have to offer better pay and perks. But this can affect their financials and results, especially for small-scale clinical trials service providers. This shortage of skilled professionals may hamper the adoption of new technologies and methodologies and inhibit the growth of the market in the coming years.

According to the Global Workforce Intelligence (GWI) Project, by 2025, there will be a staggering demand-supply gap of 2.1 million healthcare workers, with one in three roles remaining unfilled. Per CareerBuilder, only 5.7 million people were available for recruitment in the US in September 2022, despite the 6.6 million clinical research positions offered. Additionally, seven positions are listed for every CRC searching for employment.

Even though small-molecule drugs dominate the global pharmaceutical market, the share of biologics, biosimilars, and large-molecule drugs is growing, led by the launch of new biologic-based drugs and increased revenues from existing biologics. Biologics and biosimilars require more specialty testing services such as biomarker testing and virology testing at each stage than small molecules. The increasing need for outsourcing these services to CROs is expected to stimulate the growth of the market in the coming years.

Clinical Trials Market Ecosystem

The global clinical trials market ecosystem includes raw material suppliers, clinical trials service providers, and end users such as pharmaceutical & biotechnology companies, medical device companies, and academic institutes. Raw material suppliers and service providers offer supplies and services for Phase I to Phase IV clinical trials and other studies. This includes consumables, assays, kits, accessories, and other products required throughout drug development.

Clinical research entities partner with their clients (such as pharmaceutical and biotechnology companies) to design strategies, implement them, and manage services. This long-term relationship enables the partners to conduct trials successfully and bring new products to market. Also, as the partners work together for a long time, the contracted work volume can expand, depending on how comfortable they are in taking their partnership forward.

The laboratory services segment dominated the clinical trials industry by service type.

The laboratory services segment held the largest share of the global clinical trials market in 2022. The increasing importance of laboratory services to establish regulatory compliance is expected to boost the growth of the segment during the forecast period. Laboratory services play a crucial role across every phase of drug development, encompassing clinical advancement. These services act as a basis for pharmaceutical, biopharmaceutical, and medical device enterprises, supporting them in adhering to regulatory benchmarks and ensuring the production of high-quality products. Furthermore, the increasing number of CROs providing a comprehensive range of laboratory services is expected to drive the segment growth.

The phase III segment accounted for the largest share of the clinical trials industry in 2022 by Phase.

The phase III segment accounted for the major share of the global clinical trials market in 2022. Additionally, the segment is expected to grow at a higher CAGR during the forecast. Factors such as large patient population for the clinical study as compared to other phases and utilization of sophisticated services to study the safety and efficacy of the drug candidates have contributed to the growth of this segment. Additionally, phase III clinical trials are considered complex clinical trials that require both robust technologies and reliable clinical resources to recruit patients efficiently, initiate sites quickly, and provide cost-effective study management. Most pharmaceutical, biopharmaceutical, and medical device manufacturers outsource services for Phase III clinical trials to CROs; this has contributed to the largest market share of the segment in the global market.

The Cardiology segment of the clinical trials industry is projected to register a higher growth rate during the forecast period by therapeutic area.

The cardiology segment of the clinical trials market is expected to grow at a higher CAGR during the forecast period. The growth of this segment is attributed to the high prevalence of cardiovascular diseases, the rising geriatric population, and the increasing number of partnerships between clinical trial service providers and pharmaceutical & biotechnology companies. Cardiovascular diseases (CVDs) are one of the leading causes of death worldwide. According to a report published by the World Heart Federation, Cardiovascular illnesses continue to impact more than half a billion people worldwide and were responsible for 20.5 million deaths in 2021, or close to a third of all deaths worldwide, and a rise from the anticipated 121 million CVD fatalities. This has created a demand for advanced cardiology drugs, which in turn drive the adoption of clinical trial services for the same.

Asia Pacific region of the clinical trials industry is estimated to register the highest CAGR during the forecast period.

Asia Pacific offers lucrative growth potential for the clinical trials market. This can be attributed to the growing pharmaceutical industry, implementation of favorable government policies, increasing number of newly established manufacturing facilities, and the low cost of clinical trials in the region.

Additionally, The APAC market is also becoming a major drug development and clinical research destination. The expansion of clinical trial operations in the region is mostly attributed to cost benefits, a sizable treatment population, participant retention in clinical trials, and ongoing regulatory procedural improvements. These benefits have caused the majority of pharmaceutical, biopharmaceutical, and medical device businesses to outsource their clinical trial efforts to CROs in this industry. Rapid growth in the outsourcing of preclinical, clinical, and laboratory testing services to Asia Pacific countries is expected to significantly drive market growth during the forecast period.

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Key players in the clinical trials market include IQVIA Inc. (US), Laboratory Corporation of America Holdings (US), Syneos Health (US), WuXi AppTec (China), Charles River Laboratories (US), Parexel International Corporation (US), Thermo Fisher Scientific Inc. (US), ICON plc (Ireland), Medpace (US), ACM Global Laboratories (US), Advanced Clinical (US), SGS (Switzerland), Frontage Labs (US), PSI (Switzerland), Bioagile (India), Fortrea Inc. (US), Clinical Trial Service (Netherlands), Worldwide Clinical Trials (US), Pepgra (UK), CTI Clinical Trial & Consulting (US), Dove Quality Solutions (UK), Firma Clinical Research (US), Celerion (US), Novotech (Australia), and Linical Americas (Japan).

Scope of the Clinical Trials Industry:

This report categorizes the Clinical trials market to forecast revenue and analyze trends in each of the following submarkets:

By Phase

• Phase III
• Phase II
• Phase IV
• Phase

By Service Type

• Laboratory Services
• Bioanalytical Testing Services
  • Cell-Based Assay
  • Virology Testing
  • Serology, Immunogenicity, & Neutralizing Antibodies
  • PK/PD Testing
  • Method Development, Optimization & Validation
  • Biomarker Testing
  • Other Bioanalytical Testing Services
• Decentralized Clinical Trial Services
• Patient Recruitment
• Site Identification
• Analytical Testing Services
• Clinical Trial Supply & Logistic Services
• Protocol Designing
• Clinical Trial Data Management Services
• Medical Device Testing Services
• Other Services

By Therapeutic Area

• Oncology
• Infectious Diseases
• Neurology
• Metabolic Disorders
• Immunology
• Cardiology
• Genetic Diseases
• Women's Health
• Other Therapeutic Areas

By Application

• Small Molecules
• Monoclonal Antibodies
• Vaccine
• Cell & Gene Therapy
• Other Applications

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • Rest of Asia Pacific (RoAPAC)
• Latin America (LATAM)
• Middle East and Africa (MEA)

Recent Developments of Clinical Trials Industry

• 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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