Global Clinical Trials Market Size (2024 - 2030)

The global clinical trials market, valued at USD 41.71 billion, is anticipated to reach USD 58.93 billion by 2030. Over the forecast period spanning 2024-2030, the market is forecasted to grow at a CAGR of 5.06%. Factors driving this growth include the increasing prevalence of rare diseases, a rising demand for specialized testing, a surge in outsourcing clinical trials to Contract Research Organizations (CROs), adoption of artificial intelligence-based tools in drug discovery, augmented government funding for clinical trials, and an increase in Research and Development (R&D) expenditure.

Industry Overview:

Clinical trials represent extensive research studies assessing novel tests and treatments to evaluate their impact on human health outcomes. These trials, conducted in four phases, require approval prior to commencement and engage participants across various age groups. The market's growth is propelled by the escalating prevalence of chronic diseases, particularly in developing nations, coupled with an increasing demand for clinical trials. Moreover, the market witnesses traction due to the growing number of biologics and the necessity for CROs to conduct clinical trials. Presently, numerous pharmaceutical and biotechnology companies are initiating clinical trials for infectious and chronic diseases, further stimulating market expansion. Notably, the COVID-19 pandemic accentuated the demand for decentralized clinical trial services. Substantial investments in pharmaceutical R&D have resulted in a significant uptick in clinical trials, further fostering market growth. The market is poised for robust expansion due to ongoing healthcare advancements and the development of patented New Chemical Entities (NCEs) for various health conditions. Government initiatives have also encouraged players of all sizes to venture into drug development.

COVID-19 Pandemic Impact on the Global Clinical Trials Market

The COVID-19 outbreak profoundly disrupted the execution of clinical trials worldwide, particularly concerning vulnerable populations such as the elderly and those with pre-existing conditions. The pandemic expedited the clinical trials for COVID-19 vaccines while causing postponements or suspensions of several other trials due to operational complexities induced by pandemic-related restrictions. Regulatory agencies responded by issuing guidelines supporting the implementation of virtual services during the pandemic, facilitating the fast-track conduct of clinical trials. International collaborations, such as the WHO's "Solidarity" trial, aimed to develop effective treatments for COVID-19. Regulatory bodies, including the U.S. FDA, introduced initiatives like the Coronavirus Treatment Acceleration Program (CTAP) to expedite treatment development. The market also benefited from increased investments in manufacturing capacities for COVID-19 drugs/vaccines, as well as strategic partnerships between pharmaceutical companies and academic institutes. Notably, NIH funding for clinical research surged from USD 15 billion in 2019 to approximately USD 17.6 billion in 2020, indicating a favorable outlook for market growth.

MARKET DRIVERS:

The escalating demand for outsourcing clinical trials to CROs is anticipated to propel market value.

The clinical trials market is expected to witness growth driven by the rising demand for efficient, reliable, and expedited clinical trial programs amid increasing demand for novel medications and advanced medical technologies. Outsourcing clinical trials to Contract Research Organizations (CROs) enables pharmaceutical companies to save significant time and resources, thereby fostering market growth.

The increasing prevalence of rare diseases and the growing demand for specialized testing are fueling market growth.

Pharmaceutical companies' focus on developing drugs for rare diseases, facilitated by technological advancements in genetic identification, is expected to drive market growth. Incentives and initiatives globally toward rare disorder therapeutics contribute positively to this growth trajectory. Notably, the approval rates for orphan drugs have spurred clinical trial service providers to expand their portfolios, further driving market growth.

The adoption of artificial intelligence-based tools and predictive analysis for drug discovery is expected to fuel market growth.

Artificial intelligence (AI) has revolutionized the drug discovery process, enhancing success rates and expediting drug development. AI algorithms facilitate data analysis to identify potential drug candidates more efficiently, while deep learning systems generate candidates with minimal adverse effects, thereby propelling the market growth.

MARKET RESTRAINTS:

The high cost of clinical trials poses a significant challenge to market growth.

Clinical trial services incur substantial costs, including high labor expenses, complicating patenting and contracting processes. These high costs raise operating expenses across the industry, potentially hindering new medicine development and adversely impacting academia, pharmaceutical companies, and consumers alike.

Stringent regulatory frameworks and language barriers may impede market growth.

Conducting clinical trials across different countries entails navigating complex regulatory landscapes, which can stifle market progression. Collaboration among regulatory authorities could streamline these processes; however, the current operating speed remains sluggish. Additionally, language barriers and intricate regulatory structures in various regions could dampen regional growth prospects.

Clinical Trials Market – By Phase

• Phase I
• Phase II
• Phase III
• Phase IV

The Clinical Trials Market is categorized into different phases, including Phase I, Phase II, Phase III, and Phase IV. In 2021, the Phase III segment accounted for the largest revenue share, contributing to 53.4% of the global market. This dominance is attributed to extensive testing and increasing demand for evaluating new treatments alongside existing ones. Phase III trials focus on confirming preliminary evidence gathered in earlier phases regarding the safety and efficacy of drugs, aiming to obtain statistical evidence that expedites the approval process.

Clinical Trials Market – By Indication

• Oncology
• Autoimmune/Inflammation
• Diabetes
• Central Nervous System
• Cardiovascular
• Ophthalmology
• Infectious Disease
• Pain Management
• Others

The Clinical Trials Market, segmented by indication, includes areas such as Oncology, Autoimmune/Inflammation, Diabetes, Central Nervous System, and others. In 2021, the Oncology segment accounted for a substantial revenue share of 23.5%, driven by the increasing incidence of cancer and the consequent need for advanced treatments. Robust funding and a rise in oncology CRO services further fuel market growth.

The Autoimmune/Inflammation segment also witnessed significant revenue share due to numerous interventional studies worldwide, minimizing biases in exposure allocation and enhancing the detection of clinically important effects. Additionally, the Cardiovascular segment is poised for lucrative growth, primarily due to increasing prevalence and demand for cost-effective pharmaceuticals, coupled with significant R&D investments.

Clinical Trials Market – By Application

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

The Clinical Trials Market by application encompasses vaccines, Small Molecules, Cell & Gene Therapy, and Other Applications. The Vaccine segment is expected to experience the highest growth, driven by the COVID-19 pandemic, which spurred a surge in registered clinical trials. The pandemic compelled clinical research service providers with vaccine expertise to diversify their portfolios to address vaccine enrollment challenges.

Clinical Trials Market – By Study Design

• Interventional
• Expanded Access
• Observational

Segmented by Study Design, the Clinical Trials Market includes Interventional, Expanded Access, and Observational studies. The Interventional design segment held the largest revenue share in 2021, accounting for 45.7% of the global market. Interventional studies are predominant in clinical trials, covering various investigations, medicines, biologics, and clinical procedures.

Clinical Trials Market – By Sponsor Outlook

• Pharmaceutical & Biopharmaceutical Companies
• Medical Device Companies
• Others

In terms of Sponsor Outlook, the Clinical Trials Market is divided into Pharmaceutical & Biopharmaceutical Companies, Medical Device Companies, and Others. Pharmaceutical & Biopharmaceutical Companies dominated the market in 2021, with a 70.0% share. This dominance is attributed to the increasing number of clinical trials funded by these companies and their growing interest in research and development.

Clinical Trials Market - By Region:

• North America
• Europe
• Asia-Pacific
• Rest of the World

Geographically, North America led the Clinical Trials Market in 2021, accounting for 50.7% of global revenue. This dominance is fueled by factors such as increased focus on novel drug development, advanced healthcare infrastructure, and substantial R&D investments. The region, particularly the US, serves as a global hub for clinical trials.

Europe's Clinical Trials Market is poised for significant growth, driven by high R&D spending and disease prevalence. In the Asia-Pacific region, particularly, countries like China, Australia, and India, are witnessing rapid market growth due to increasing disease prevalence, government support, and cost-effective clinical trial facilities.

On the other hand, Latin America, the Middle East, and Africa are expected to have a minimal share in the global clinical trials market due to factors such as limited technical facilities, poor economies, and fewer clinical trial centers.

The global Clinical Trials Market is highly competitive, with major pharmaceutical companies focusing on substantial R&D investments, especially in emerging nations, to gain market growth. Collaborations between pharmaceutical companies and CROs are expected to influence market dynamics, alongside the rapid adoption of advanced technologies for healthcare improvement.

In recent years, notable events in the Global Clinical Trials Market include acquisitions, collaborations, product launches, and successful completion of clinical trials for various medications, including those for COVID-19. These events underscore the dynamic nature of the market and the continuous efforts towards innovation and advancement in clinical research.

Major Key Players in the Market

1. C.R. Bard
2. Baxter
3. Laboratory Corporation of America Holdings
4. Charles River Laboratories
5. IQVIA
6. Eli Lilly and Company
7. Pharmaceutical Product Development and PRA Health Science
8. PAREXEL International
9. ICON plc
10. Bioclinica
11. Stryker
12. Ethicon (Subsidiary of Johnson & Johnson)
13. Medtronic plc
14. Novo Nordisk
15. Braun Melsungen AG
16. Teleflex Incorporate
17. Pfizer 

The Clinical Trials market is highly competitive, and thus, the prominent pharmaceutical companies are focusing on enormous R&D investments, especially in the emerging nations, to gain market growth in the major regions. The growing partnerships between pharmaceutical companies and CROs are likely to impact the market growth. Also, the quick adoption of advanced technology for improved healthcare is a significant factor affecting the competitive landscape. Major players are involved in new product launches, mergers, and acquisitions to expand the product portfolio.

In December 2021, Pfizer Inc. declared the final results from an analysis of 2,246 adults enrolled in its Phase 2/3 EPIC-HR trial of its novel COVID-19 oral antiviral candidate PAXLOVID.In December 2021, Optimus Pharma announced the successful completion of the Phase 3 Clinical Trial for its frontline COVID-19 medication Molnupiravir on 1,218 subjects covering 29 geographical study sites all over India.

Notable happenings in the Global Clinical Trials Market in the recent past:

• Acquisition- In March 2021, Charles River Laboratories International, Inc. announced the acquisition of Cognate BioServices, Inc. for approximately  USD 875 million, subject to customary closing adjustments.
• Collaboration- In September 2021, IQVIA™ collaborated with HealthCore, Inc., a leading real-world research organization in the US, to advance real-world evidence studies with enhanced quality and efficiency.
• Product Launch-In January 2020, Wuxi AppTec announced a fully integrated adeno-associated virus vector suspension platform to advance the development, manufacture, and launch of cell & gene therapy, to expand its service capabilities.
• Acquisition- In February 2020, Charles River Laboratories International, Inc. agreed to acquire Citoxlab for USD 510 million. Citoxlab is a CRO specialized in medical device testing, regulated safety assessment services, and non-regulated discovery services.
• Acquisition- In February 2020, PAREXEL International announced the acquisition of Model Answers, a consultancy firm. The company is specialized in developing preclinical pharmacokinetic (PK) and pharmacodynamic (PD) models.
• Collaboration In November 2020, Parexel formed a strategic collaboration with Synairgenplc to conduct a Phase III study of an Interferon-beta treatment for COVID-19.
• Acquisition- In October 2019, Icon plc announced the acquisition of Symphony Clinical Research to enhance its offering in customers' hybrid trial solutions and improve the services in the research centers.
• Product Launch-In November 2019, PPD, Inc. launched a site coach where doctors and healthcare centers can receive clinical research at new sites, which provides sufficient training to physicians and other academic institutions for the new clinical researchers.