CLINICAL TRIALS SUPPORT SERVICES MARKET ANALYSIS

The global clinical trials support services market was valued at US$ 20.84 Bn in 2022 and is forecast to reach a value of US$ 37.13 Bn by 2030 at a CAGR of 7.5% between 2023 and 2030. The global clinical trials support services market is experiencing strong growth owing to the increasing demand for clinical trials support services and rise in burden of chronic and infectious disease. Furthermore, increasing number of clinical trials and increase in drug discovery and drug development is expected to boost the market growth. However, factors such as stringent regulatory framework and poor healthcare infrastructure are expected to hamper the market growth.

Global Clinical Trials Support Services Market: Regional Insights

Based on geography, the global clinical trials support services market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

Among regions, North America is expected to gain highest share in the market during the forecast period owing to the increasing prevalence of orphan and rare disease, increasing demand for safe and effective treatment, high cost of in-house drug development, and increasing number of clinical trials in the region. For instance, according to the National Clinical Trials Registry (NCT), as of September 2022, there were more than 3,300 active clinical trials under phase III development for various disease in the United States. Moreover, more than 1,478 active phase III clinical trials were being investigated in Canada, driving the market growth.

Europe and Asia Pacific are also expected to witness significant growth in the global clinical trials support services market owing to the increasing number of clinical trials, rise in burden of orphan and rare disease, growing trend of outsourcing, and increasing demand for safe/effective treatment in these regions. For instance, according to the European Medicine Agency, around 4,000 clinical trials are authorised each year in the European Union (EU) or the European Economic Area (EEA). More than 60% of clinical trials are sponsored by the pharmaceutical industry and around 40% by non-commercial sponsors, mainly academia.

Figure 1. Global Clinical Trials Support Services Market Share (%), by Region, 2023

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Global Clinical Trials Support Services Market Drivers:

Increasing demand for support services to propel market growth

One of the key factors expected to augment the growth of the global clinical trials support services market during the forecast period is the increasing demand for clinical trials support services. With the increasing number of clinical trials worldwide, the demand or the use of clinical trials support services is also increasing with a rapid pace. In December 2022, RQM+ announced the launch of the Clinical Trial Services Division. RQM+ now offers comprehensive laboratory testing, product development, reimbursement strategy, and clinical trial services to support entire product lifecycle for medical devices, digital therapeutics, and diagnostics.

Rise in burden of chronic/infectious disease to drive market growth

Another factor which is driving the growth of the global clinical trials support services market is the increasing prevalence of chronic and infectious diseases. For instance, with the rise in burden if chronic and infectious disease, the demand for safe/effective treatment is also increasing rapidly, leading to an increase in the number of clinical trials. In November 2022, Amgen presented end-of-treatment data from its Phase II OCEAN(a)-DOSE study of investigational olpasiran (formerly AMG 890) in adults. It was found that Olpasiran reduced lipoprotein(a) levels by more than 95% in patients with established atherosclerotic cardiovascular disease (ASCVD).

Global Clinical Trials Support Services Market Opportunities:

Increasing number of clinical trials worldwide is expected to offer significant growth opportunities for players in the global clinical trials support services market. For instance, with the rising number of clinical trials around the world, the demand for clinical trials support services is also increasing rapidly. According to the World Health Organization (WHO), there was a steady rise in the number of newly recruiting trials registered on the International Clinical Trials Registry Platform (ICTRP) for most WHO regions. The U.S. had a highest total number of trials registered during 1999-2022 (168,520), followed by China (94,193) and Japan (63,499).

Increase in drug discovery and drug development across the globe is expected to offer significant growth opportunities for players in the global clinical trials support services market. For instance, in January 2022, Catalent launched new Xpress Pharmaceutics Service, designed to accelerate the oral development drugs through Phase 1 clinical studies. By integrating formulation development, on-demand clinical manufacturing, regulatory support and clinical testing, the approach can reduce the cost and time taken to complete first-in-human trials. The approach provides a faster alternative to the traditional clinical development model.

Global Clinical Trials Support Services Market Trends:

Rise in adoption of AI/ML-based tools is a recent trend

Advanced technologies, such as Artificial Intelligences (AI) and Machine Learning (ML) in a drug discovery process has significantly increased the success rate of early stages of drug development. The U.S. FDA has recognized the increasing use of AI/ML across the drug development life cycle and a range of therapeutic areas. AI and ML play an important role in drug development, and FDA is planing to develop and adopt a flexible risk-based regulatory framework to promote innovation and protect patient safety. This trend is expected to continue over the forecast period.

Rise in focus on the drug development is another trend

Phase II clinical trials are conducted to determine both the safety and efficacy of the drug within a particular disease or specific patient population. Whereas, Phase III clinical trials are conducted to determine the safety and how well a new treatment works compared to a standard treatment. With the rise in global disease burden, the demand for safe and effective drugs is also increasing, leading to an increase in number of clinical trials. This trend is also expected to continue during the forecast period, driving the clinical trials support services market growth.

Global Clinical Trials Support Services Market Restraints:

Stringent regulatory framework to hamper market growth

One of the key factors expected to hamper the growth of the global clinical trials support services market is the stringent regulatory framework. Complex rules & regulations in clinical trial process from application to approval of new drugs act as major barriers. The framework helps ensure that the rights, safety, and well-being of trial participants are protected and the results of clinical trials are credible. All clinical trials included in applications for marketing authorisation for human drugs in the European Union (EU) must have been carried out in accordance with the requirements set out in Annex 1 of Directive 2001/83/EC.

Poor healthcare infrastructure to hamper market growth

Another factor which is hampering the growth of the global clinical trials support services market is the poor healthcare infrastructure. The clinical trials infrastructure refers to a necessary resources (human capital, financial support, patient participants, information systems, regulatory pathways, and institutional commitment) and the manner in which they are organized and brought together to conduct a clinical trial.  An appropriate and well-established healthcare infrastructure is essential for the smooth conduct of clinical research, but poor healthcare infrastructure acts as major barrier in the growth of the clinical trials support services market.

Figure 2. Global Clinical Trials Support Services Market Share (%), by Phase, 2023

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Global Clinical Trials Support Services Market Segmentation:

The global clinical trials support services market report is segmented into Phase, Service, Sponsor, and Region.

Based on Phase, the market is segmented into Phase I, Phase II, Phase III, and Phase IV. Out of which, Phase II Segment is expected to dominate the clinical trials support services market over the forecast period and this is attributed to the increasing demand for safe and effective medicines (due to rise in global disease burden) across the globe.

Phase III Segment is also expected to witness robust growth in the near future and this is owing to the increasing focus on the safe and effective drug development.

Based on Service, the market is segmented into Clinical Trial Site Management, Patient Recruitment Management, Data Management, Administrative Staff, IRB, and Others. Out of which, Clinical Trial Site Management Segment is expected to dominate the market during the forecast period and this is attributed to the increasing number of clinical trials worldwide.

Patient Recruitment Management Segment is also expected to witness significant growth in the near future and this is owing to rising focus on patient safety.

Based on Sponsor, the market is segmented into Pharmaceutical & Biopharmaceutical Companies, Medical Device Companies, and Others. Out of which, Pharmaceutical & Biopharmaceutical Companies Segment is expected to dominate the market over the forecast period and this is attributed to the increase in drug discovery and drug development.

Medical Device Companies Segment is also expected to witness significant growth in the near future and this is owing to growing trend of outsourcing.

Global Clinical Trials Support Services Market: Key Developments

In June 2022, Walgreens announced the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research.

In November 2021, ICON Plc. announced that its Accellacare Site Network for the clinical trials has expanded in reach and capabilities through new partnerships with six research sites across four countries, i.e., Germany, Spain, Poland, and the U.S.

In July 2021, Charite Research Organisation GmbH conducted a randomized phase II clinical trial to study Polycystic Ovary Syndrome (PCOS) in women by using either licogliflozin or placebo.

In April 2021, Novo Nordisk A/S announced that it is initiating a phase3 trial for the development of oral Semaglutide 50 mg in the treatment of obesity.

In August 2019, IQVIA launched the IQVIA Patient Portal, a web-based solution built on a leading health cloud platform. This tool enables increases in clinical trial patient recruitment, engagement and retention by ensuring transparency and collaboration before, during, and after a clinical study.

Global Clinical Trials Support Services Market: Key Companies Insights

The global clinical trials support services market is highly competitive, and this is attributed to the increasing number of clinical trials across the globe, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global clinical trials support services market are Wuxi AppTec, Inc., IQVIA Holdings, Inc., Syneos Health, Inc., Eurofins Scientific, Laboratory Corporation of America Holdings (Labcorp), Icon PLC, ALCURA, Parexel International Corporation, PPD, Inc. (Pharmaceutical Product Development), and Charles River Laboratories International, Inc.

*Definition: Clinical trial support services are the distinguishing services used by pharmaceutical companies during the clinical trial of new drugs or molecular analysis of generics and biosimilars before their introduction in the market.