Clinical Trials Market Size, Share & Industry Analysis, By Phase (Phase I, Phase II, Phase III, and Phase IV), By Application (Oncology, CNS Disorder, Cardiology, Infectious Disease, Metabolic Disorder, Renal/Nephrology, and Others), and Regional Forecast, 2024-2032

The global clinical trials market size was valued at USD 57.76 billion in 2023 and is projected to grow from USD 61.58 billion in 2024 to USD 106.78 billion by 2032, exhibiting a CAGR of 7.1% during the forecast period (2024-2032). Clinical trials are an important process in developing new therapeutics or medical devices. These studies are performed to analyze novel pharmaceuticals, medical devices, or any other therapeutics. These studies provide a scientific foundation for guiding and treating patients and evaluating novel medications and equipment. Increasing R&D by pharmaceutical and biotechnological companies globally has fueled the number of clinical trials being conducted globally.

Furthermore, increased companies' focus on the development of novel treatments for chronic diseases and rising demand for outsourcing R&D activities have also been fueling the market’s growth. For instance, in July 2021, the Beijing Illness Challenge Foundation (ICF) in China formed a strategic relationship with Parexel. This ground-breaking collaboration aimed to obtain direct feedback from individuals with rare diseases to improve their access to and participation in these studies.

The impact of COVID-19 pandemic resulted in the slow growth of the market during the pandemic. Many clinical studies were put on hold after the sudden outbreak of COVID-19 due to lockdown restrictions and the low presence of resources.

However, many pharmaceutical and biotechnological companies increased their focus on the development of drugs, test kits, and vaccines against the SARS-CoV-2 virus. These companies increased their focus on collaboration and partnership with CRO service providers for R&D and clinical studies. 

• In January 2021, ICON plc, BioNTech, and Pfizer announced their partnership to develop an experimental COVID-19 vaccine program to provide clinical trial services.

However, the market experienced a significant recovery in 2021 compared to the prior year, due to the release of lockdown restrictions, mass vaccination, and increased demand for clinical trials to develop novel treatments.

Clinical Trials Market Trends

Pharmaceutical and Biotechnological Companies Increased their Investments in R&D

Many medical device, pharmaceutical, and biopharmaceutical companies continue to put significant resources into the development of technologies and new medications. The pharmaceutical sector, in particular, has been majorly making investments in R&D initiatives for the development of novel therapeutics. Pharmaceutical and biotechnology companies have increased their focus on expanding their R&D efficiencies by investing in R&D.

• For instance, according to the research article published by NCBI, in 2021, overall pharmaceutical expenditures in the U.S. increased by 7.7% as compared to 2020, for a total of USD 576.90 billion.

Moreover, over the past two decades, both R&D spending and the launch of new drugs have witnessed notable increases. This is due to the rapidly growing demand for innovative medicines to treat a wide range of diseases.

• For instance, as per the data published by the Congressional Budget Office in April 2021, the pharmaceutical industry’s research and development expenditure reached USD 83.00 billion in 2019, marking a tenfold increase compared to its yearly spending in the 1980s when adjusted for inflation.

Furthermore, these companies also initiated outsourcing of their R&D activities to CRO companies for time efficient and smooth conduction of these trials.

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Clinical Trials Market Growth Factors

Increasing Prevalence of Chronic Diseases to Increase the Demand for the Development of Efficient Therapeutics

The burden of chronic diseases, such as diabetes, several types of cancers, neurological disorders, and arthritis, has been increasing at a significant pace globally. This is expected to fuel the demand for the development of more effective therapeutics.

• For instance, as per the data provided by the University of Washington (UW) education, in June 2023, the global population of individuals living with diabetes currently exceeds half a billion, and projections indicate it will surpass 1.30 billion within the next three decades. This growth is anticipated across all countries, marking a significant global increase.


• Similarly, according to the data published by Globocan in 2020, Europe accounted for 22.8% of all cancer cases and 19.6% of cancer deaths, representing 9.7% of the global population.

People worldwide are affected by chronic diseases. Compared to developing countries, emerging countries are more prone to chronic disease-related public health problems. According to the World Health Organization (WHO), in five out of six regions, chronic disease is the major reason for mortality. Infectious diseases, such as malaria, TB, HIV/AIDS, and other conditions, are still predominant in Sub-Saharan Africa and are expected to prevail in the coming years.

The global market is anticipated to grow significantly due to the high prevalence of chronic diseases during the forecast period.

Rising Number of Clinical Trials Globally has been Fueling the Market Growth

Registration of trials has been growing at a significant rate annually to meet the increasing demand to treat chronic diseases.

• For instance, as per the data published by WHO in 2022, the total number of these trials conducted in 2021 experienced an increase of 11.7% from the prior year.

These study trials conducted in the U.S. are comparatively fewer than in other countries worldwide. Due to its cost-effectiveness and easy process, many of the trials are conducted outside of the U.S. and the European Union. Clinical trial success rates are majorly dependent on the stage of the study and the treatments or items being developed.

In recent years, the number of registered trials has increased significantly.

• For instance, as per the International Clinical Trials Registry Platform (ICTRP), the annual number of these registered trials by high-income countries increased from 21,028 in 2010 to 29,538 in 2020.

In addition, clinical trials have addressed chronic diseases, emerging infectious diseases, and other global health problems through research and development of novel medicines. Clinical trial research has recognized several necessary interventions for various diseases. Therefore, increase in development of new drugs & medical devices is expected to drive the clinical trials market growth during the forecast period.

RESTRAINING FACTORS

Limited Availability of Skilled Workforce and High Costs of Study Trials Limit the Market Growth

Increasing globalization has been fueling the adoption of advanced technology. New opportunities are emerging in terms of occupation. Furthermore, rising industrialization and the requirement for new amenities have fueled the need for new skills. This factor has also enhanced competency in job opportunities.

Contract Research Organization (CRO) services face issues in drawing and maintaining vastly proficient experts as they require qualified as well as experienced scientists from the field of pharmaceutical, biotechnology, academic & research institutes, and medical device businesses. Companies must give high rewards and other such recognitions to compete efficiently, impacting other players’ capitals and operational outcomes, majorly small-scale analytical testing providers. This limited availability of experienced specialists could limit the adoption of advanced technologies and processes, limiting the market’s growth in the coming years.

Furthermore, adherence to regulatory requirements significantly impacts clinical trial costs. From research to the final drug approval, the drug development process is quite costly. According to the Tufts Center for the Study of Drug Development, on average, the complete drug development process costs USD 2.60 billion to develop a new medicine, including the cost of failures. Moreover, only 12.0% of new drug candidates that enter study trials get the U.S. FDA approval.

An additional important factor affecting the costs of a trial is the complexity of the study design and protocol. Apart from financial costs, there are several obstructions to conducting clinical trials, including difficulties in recruitment, lengthy time frames, retention of participants, insufficiencies in the clinical research workforce, and drug sponsor-imposed barriers.

These factors are expected to restrict the market growth during the forecast period.

Clinical Trials Market Segmentation Analysis

By Phase Analysis

Increased Registration of Clinical Trials along with the Emergence of CRO Services has been Fueling the Segment’s Growth

Based on phase, the market is segregated into phase I, phase II, phase III, and phase IV.

Phase III segment generated the highest revenue in 2023. The market players’ increased initiative to outsource their R&D activities is responsible for the segment’s dominance in the market.

Furthermore, the phase II segment is expected to grow at the fastest CAGR over the forecast period. The segment's growth is attributed to the increasing prevalence of chronic diseases and increasing investment by pharmaceutical companies in the R&D of novel treatments.

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By Application Analysis

Limited Presence for Effective Treatment of Cancer has been Fueling the Segment’s Growth

Based on application, the market is segmented into renal/nephrology, cardiology, metabolic disorder, infectious disease, CNS disorder, oncology, and others.

The oncology segment dominated the market by generating the highest revenue in 2023. The segment's growth is due to the growing demand for effective cancer treatment therapies and the rising number of drug approvals for cancer treatment.

• For instance, in 2020, Pralsetinib (Gavreto) received FDA approval. It is indicated for adult and pediatric patients aged 12 or older suffering from advanced or metastatic RET-mutant medullary thyroid cancer, which requires systemic therapy or RET fusion.  

Furthermore, CNS disorder is expected to grow at a significant CAGR during the forecast period. The increase in the prevalence of CNS disorders is expected to accelerate the segment's growth. For instance, in 2019, neurological conditions accounted for 47.39 per 100,000 among the American population.

Moreover, the metabolic disorder segment is expected to grow substantially during the forecast period. This is due to the rise in prevalence of chronic diseases, such as diabetes, globally. For instance, according to a published article in 2020 by OECD-iLibrary, in Asia Pacific, around 227 million people are living with type 2 diabetes; half of them are undiagnosed, and thus could develop long-term complications. These factors are propelling CRO services for the metabolic disorder segment.

REGIONAL INSIGHTS

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North America accounted for a major clinical trials market share, generating a revenue of USD 27.65 billion in 2023. Pharmaceutical companies have increased their spending on R&D to improve their drug development. This has been fueling the market growth during the forecast period in the region.

• For instance, as per the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group, in 2021, PhRMA's member companies' Research & Development (R&D) expenditure reached around USD 102.3 billion worldwide.

The market in Europe accounted for a substantial market share in 2021 and is expected to witness stagnant growth during the forecast period. The market growth in the region is attributed to increased R&D expenditure by leading pharmaceutical, biotechnology, and MedTech companies.

• For instance, in 2020, Roche Diagnostics spent around USD 11.30 billion on R&D.

Moreover, the market across the Asia Pacific region is expected to expand at the fastest CAGR during the forecast. The increasing prevalence of infectious and chronic diseases across Asia Pacific is expected to propel the demand for new drugs, thereby increasing the overall market in Asia Pacific.

• For instance, as per the data published in December 2023, around 35.0% of the Indian population is suffering from chronic illnesses, including diabetes and cardiac-related disorders.

List of Key Companies in Clinical Trials Market

Pharmaceutical Companies with a Strong Focus on the Expansion of Product Portfolios to Hold Key Market Share

IQVIA, Laboratory Corporation of America Holdings, and Pfizer, Inc. are among the prominent players in the market and captured a considerable global market share in 2023.

IQVIA and Laboratory Corporation of America Holdings accounted for significant market share in 2023. This is due to their strong emphasis on R&D to introduce solutions and to upskill their offerings.

• For instance, in November 2021, IQVIA announced its data aggregation strategy as a foundation to improve market insights. This helped the company to connect the right data and services to help patients. This increased the efficacy of the company’s services.

Similarly, Pfizer, Inc. held a considerable share of the market in 2023. This was due to the company’s strong brand presence with a strong pipeline of products. Moreover, the company strongly focuses on developing advanced and highly efficient therapeutics for chronic disease treatment.

Other significant players operating in the market, such as Icon PLC, Syneos Health, and Pharmaceutical Product Development, LLC (Thermo Fisher Scientific), emphasize various strategic developments such as service expansion, partnerships, and collaborations.

LIST OF KEY COMPANIES PROFILED:

• IQVIA Inc. (U.S.)


• Laboratory Corporation of America Holdings (U.S.)


• Thermo Fisher Scientific Inc. (U.S.)


• Parexel International Corporation (U.S.)


• Medpace Holdings, Inc. (U.S.)


• Icon plc (Ireland)


• Syneos Health (U.S.)


• WuXi AppTec (China)


• Charles River Laboratories (U.S.)


• Pfizer Inc. (U.S.)


• Lilly (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• December 2023 – Thermo Fisher Scientific Inc. introduced CorEvidence, a cloud-based optimizing pharmacovigilance case processing and safety data management processes.


• December 2021 – Thermo Fisher Scientific Inc. announced the completion of the acquisition of Pharmaceutical Product Development, LLC. This acquisition expanded the key services and offerings provided by the company.


• December 2021 – Laboratory Corporation of America Holdings acquired Toxikon Corporation. This acquisition fueled the company’s strong non-clinical development portfolio.


• November 2021 – Icon plc announced the expansion of its Accellacare Site Network in reach and capabilities through new partnerships with six research sites across four countries.


• October 2021 - Parexel International Corporation and Kyoto University Hospital formed a strategic partnership to expand clinical research opportunities.


• July 2021 – Icon plc announced the acquisition of PRA Health Sciences, creating the world’s most advanced healthcare intelligence and clinical research organization.

REPORT COVERAGE

The research report provides a detailed competitive landscape. It includes the number of clinical trials and key industry developments such as partnerships, mergers, and acquisitions. Additionally, it focuses on key points such as new product launches in the market. Furthermore, the report covers regional analysis of different segments, company profiles of key players, and market trends. The report consists of quantitative and qualitative insights that contribute to the market growth.

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Report Scope & Segmentation