The total addressable market (TAM) for clinical trials support service was valued at USD 19 billion in 2021. It is estimated to reach USD 35.52 billion by 2030, growing at a CAGR of 7.2% during the forecast period (2022-2030). Clinical trials support services are highly beneficial in the event of a drug, assay design, and clinical testing. It also includes strengthening clinical test sites, securing and storing research medicines, drug dosage calculations, and kit management. Clinical test support services help with the logistics of conducting clinical trials, such as finding and securing a suitable testing site, acquiring and storing study drugs, ensuring the proper blinding of study drugs, recruiting and managing test subjects, and resolving any issues that may arise with the returned medications.
The increasing prevalence of chronic diseases and increased demand for clinical trials in developing countries are among the factors propelling market expansion. The market is also driven by expanding the number of biologics, the growing need for tailored medicines and orphan medications, and increasing demand for innovative technologies. An increase in biologic and biosimilar pharmaceuticals in clinical trials are two of the key drivers expected to propel the market.
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High Research and Development Spending by Pharmacy and Biotech Companies
Pharmaceutical firms are progressively emphasizing R&D efforts to remain competitive and flexible in healthcare knowledge, gradually expanding technology and unstable economic climate. Companies are concentrating on outsourcing jobs, including target validation, hit discovery and lead optimization, assay development safety, genetic engineering, and efficacy evaluations in animal models and human clinical trials. These tasks range from fundamental research to late-stage manufacturing. Spending on R&D and the release of new pharmaceuticals have both surged in the previous two decades.
Drug companies' amount of money to R&D is governed by the revenue they expect to gain from a new drug, laws influencing drug supply and demand, and the expected cost of developing that drug. From 2010-2019, the number of new pharmaceuticals approved for commercialization increased by 60% compared to the previous years, with the top 59 new drugs approved in 2018. Hence, such factors have greatly encouraged the increase in R&D investment in medical device and pharmaceutical businesses, which is also projected to fuel the growth of the clinical trials support services market.
Lack of High-Tech Equipment and Medical Infrastructure
The need for the necessary medical infrastructure to perform clinical research efficiently is one of the main challenges limiting the growth of support services for clinical trials, which is much more visible across emerging markets. Clinical trials present a variety of difficulties for researchers. One of the critical impediments is the lack of supportive clinical research infrastructure, notably financial and administrative support. For instance, according to the Director of the Duke Translational Medicine Institute and Vice Chancellor of Clinical Research, a few of the challenges in participating in clinical trials mentioned by cardiovascular clinical investigators are the overall shortage of cardiovascular specialists, lack of local supportive infrastructure, and inadequate research training.
Increasing Number of CRO providing Services
CROs have experienced considerable expansion owing to rising R&D expenditure and increased attention of pharmaceutical corporations on reducing costs. Biopharmaceutical businesses are increasingly willing to outsource their clinical trials to CROs to save product development time and expense. Collaborations between biopharmaceuticals and CROs are anticipated to favor the global market for clinical trial support services.
Moreover, much of the activity in the CRO field is oriented on regional expansion in new markets for more excellent capabilities, capacity, and services through mergers and acquisitions and technological pacts for electronic data capture. The industry is undergoing a drug development shift, focusing more on safety and quality, cutting drug development costs, and boosting development speed. Some developments responsible for this transition include industry standards, adaptable trial designs, and new all-encompassing EDC solutions.
The global clinical trials support service market is segmented by phase, service, and sponsor.
Based on phase, the global clinical trials support service market is bifurcated into Phase I, Phase II, Phase III, and Phase IV.
The phase III segment is the highest contributor to the market and is estimated to grow at a CAGR of 7.95% during the forecast period. Phase III trials assist in comparing innovative medications to those used routinely. These tests determine which medicine performs better while evaluating the negative consequences of each specific drug. Regulatory authorities usually demand phase III clinical trial results before approving any new medicine. Phase III trials are only reached by one-third of medications tested in clinical trials. Regulatory affairs, site selection and activation, site management, clinical monitoring, data management, and project management are among the phase III services. According to Nice Insights' clinical trial logistics study, 35.0% of phase III clinical trials are outsourced. This percentage is projected to rise as more experimental medications continue to the next development phase.
Sample collection management, early-phase patient screening, data management, assay redesign, and other clinical trial support services are provided for phase I trials. Thus, it is acknowledged that the U.S., Europe, and China, followed by Canada and Australia, are critical locations for registering and carrying out several Phase-I clinical trials. As a result, the countries have a substantial market for clinical trial management services. Despite the propensity for outsourcing, only a small portion of phase I trials are conducted in developing countries.
Based on service, the global clinical trials support service market is bifurcated into clinical trial site management, patient recruitment management, data management, administrative staff, IRB, and others.
The clinical trial site management segment owns the highest contributor to the market and is expected to grow at a CAGR of 8.95% during the forecast period. Only about 61% of clinical trial sites and sponsors, according to a Florence survey conducted in January 2020, had already used or intended to use an electronic Investigator Site File (eISF) before the end of the year. In contrast, 89% of sites had an eISF by January 2021 or were on track to do so by the end of the year due to the pandemic. eConsent was present on 47% of websites a year ago; 88% of websites do or will soon have it. According to an industry survey, 83% of sponsors believe that by 2023, most monitoring will be done remotely.
Patient recruitment management offers services for patient registration, retention, and other things (analytics, marketing). The market is expected to rise due to the increasing number of clinical trials for developing new drugs and technical developments, such as management software that may speed up, automate, and improve patient recruitment, screening, and management. Numerous businesses are also emphasizing the use of software for the patient recruiting process. For instance, according to a recent Validic study, 97% of researchers expect to use digital health technologies within the next five years, and 64% have already used them in clinical trials.
Based on the sponsor, the global clinical trials support service market is bifurcated into pharmaceutical and biopharmaceutical companies, medical device companies, and others.
The pharmaceutical and biopharmaceutical company segment is the highest contributor to the market and is estimated to grow at a CAGR of 7.80% during the forecast period. The number of pharmaceuticals in the top 10 innovative drugs list has reduced dramatically and is projected to be replaced by biologics. The majority of clinical trial medications, however, are pharmaceuticals; nevertheless, the increased use of biological agents is anticipated to affect this number. The development of improved pharmaceutical products is anticipated to be fueled by the demand for safe, effective, and affordable medications shortly, driving segment expansion. Investing novel pharmaceuticals in clinical trials would fuel the market for clinical trial support services.
The medical devices firms section is predicted to demonstrate lucrative expansion during the forecast period. Medical device makers have a small clientele in the clinical research market, and clinical research facilities often concentrate on the more lucrative industries of biotechnology, pharmaceuticals, and fundamental science. However, as the FDA focuses more on excellent clinical practices, device companies will engage with this intricate business considerably more regularly. Clinical trials for medical devices comprise preclinical testing followed by long-term observation and reporting of adverse effects before being introduced in the market.
Academic medical centers, nonprofit organizations, and other businesses are featured in part. A few causes promoting the segment's growth include an increasing emphasis on the discovery of novel treatments, an increase in the prevalence of rare diseases, and an increase in clinical trials involving experimental and observational investigations. Moreover, the rise in the number of research institutes and the growing focus on identifying unique techniques to conduct clinical trials, to minimize the employment of animal models are other reasons augmenting the growth of the segment across the clinical trials market.
North America Dominates the Global Market
The global clinical trials support service market is bifurcated into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.
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North America is the highest contributor to the global clinical trials support service market and is expected to grow at a CAGR of 6.90% during the forecast period. Since there are many pharmaceutical and life sciences businesses in the United States, this nation holds the highest proportion of the global market for clinical trial support services. Another factor promoting market expansion in the U.S. is the existence of reputable CROs offering clinical trial support services. In addition, Clinicaltrial.gov predicts that as of March 2022, 34% of all clinical trials conducted worldwide were conducted in the United States alone. There is abundant potential for the market for clinical trials support services due to the significant number of clinical trials conducted in the United States.
Europe is expected to boost at a CAGR of 7.95% during the forecast period. This is due to the presence of reputable biopharmaceutical companies like F. Hoffmann-La Roche. High R&D expenditures and a surge in clinical trials in European nations also foster market expansion. The availability of trained workers and developed infrastructure for clinical trials aid the region's market expansion. Additionally, CROs with facilities in Europe, including the UK, Germany, and France, like Charles River Laboratories and Labcorp, is anticipated to significantly contribute to market expansion in this region.
Asia-Pacific is expected to grow significantly over the forecast period. Asia-Pacific is witnessing the fastest market growth because many developed economies outsource clinical trials to countries like China, India, and South Korea. In addition, due to the enormous and diversified patient pools in these nations, clinical trial recruitment is growing in Asia-Pacific compared to North America and Europe. The expansion of the Asia-Pacific market is also being supported by a well-developed clinical research infrastructure, a strong hospital network, and the availability of qualified medical professionals. The regional presence of multinational pharmaceutical/biopharmaceutical companies and CROs in the region, as well as how much less expensive clinical trials are conducted in the Asia-Pacific region than in the U.S. and other European countries, are presenting opportunities for market expansion.
Large cities are home to 80% of the population in Latin America. A sizable patient pool can be found in Mexico City, Buenos Aires, and So Paulo. Timelines for Latin American regulatory approvals are a drawback, but the time saved in patient recruitment more than makes up for it. Higher clinical trial success rates result from lower costs and the presence of highly qualified investigators, medical staff, and study coordinators who are knowledgeable about GCP compliance. With numerous pharmaceutical companies funding studies, the clinical research market is flourishing in the UAE. For instance, AstraZeneca and G42 Healthcare teamed up in December 2021 to increase research and diagnostics in the United Arab Emirates.
The global clinical trials support service market's major key players are