Clinical Trials Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 50.66 Billion |
| Market Size (2029) | USD 67.5 Billion |
| CAGR (2024 - 2029) | 5.91 % |
| Fastest Growing Market | North America |
| Largest Market | Asia Pacific |
| Market Concentration | Low |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Clinical Trials Market Analysis
The Clinical Trials Market size is estimated at USD 50.66 billion in 2024, and is expected to reach USD 67.5 billion by 2029, at a CAGR of 5.91% during the forecast period (2024-2029).
The major factors propelling the market growth include the high demand for clinical trials in emerging markets, increasing research and development (R&D) spending by pharmaceutical and biopharmaceutical companies, increasing prevalence of diseases, robust investigational pipeline, and growing outsourcing by companies.
The increasing R&D spending by pharmaceutical and biopharmaceutical companies is expected to propel research efforts, thereby supporting clinical trials. For instance, Bayer AG invested USD 16,211 million in R&D in FY 2022, compared to USD 15,310 million in FY 2021. Similarly, Pfizer Inc. invested USD 11,428 in R&D in FY 2022, compared to USD 10,360 million in FY 2021. The increasing research and development expenses by the major players are expected to accelerate drug development activities, boosting the market growth during the forecast period.
The growing burden of diseases needs more advanced and effective medicines for treatment, which is projected to contribute to market growth. For instance, as per the Australian Institute of Health and Welfare estimates, the country recorded 165,000 cancer cases in 2023, compared to 162,163 cancer cases in 2022. Moreover, as per June 2023 data from the Institute for Health Metrics and Evaluation, diabetes cases are projected to soar from 529 million in 2023 to 1.3 billion by 2050. The alarming increase in the burden of diseases demands novel treatment options, supporting market growth.
The initiatives taken by the government in different regions are further projected to contribute to the growth of the market. For instance, in January 2022, the European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) launched an initiative to transform the way clinical trials are conducted under the Accelerating Clinical Trials in the EU (ACT EU) act. ACT EU aims to develop Europe as a focal point for clinical research, promote the development of high-quality, safe, and effective therapeutics, and better integrate clinical research into the European healthcare system. Such initiatives by governments globally are projected to contribute to market growth.
The increasing trend of clinical trial outsourcing by pharmaceutical companies to focus on their core competencies is another factor expected to propel market growth. For instance, in February 2024, Divergent CRO established its new contract research organization in the United States. This CRO aims to transform the R&D process by providing tailored clinical services for pharma and biotechnology companies. Similarly, in October 2023, PQE Group launched an internal contract research organization (CRO) based on a revolutionary model. Thus, such growing CROs that offer clinical trial services for pharma companies are expected to hinder market expansion over the coming years.
Therefore, with the increased research and development (R&D) spending by pharmaceutical and biopharmaceutical companies, increasing prevalence of diseases, robust investigational pipeline, and growing outsourcing trends by companies, the market is anticipated to grow over the forecast period. However, the lack of a skilled workforce in clinical research and stringent regulations for patient enrolment are factors that are expected to hinder the market growth during the forecast period.
Clinical Trials Market Trends
Phase III is Expected to Register Healthy Growth Over the Forecast Period
Phase III clinical trials evaluate the comparative effect of the new medication over the previous medications available or confirm and expand on safety and effectiveness results from Phase 1 and 2 trials. This phase of clinical trial usually involves up to 3,000 participants with the condition that the new medication is meant to treat and may last for many years. Also, the number of volunteers in Phase III clinical trials is comparatively higher than in Phase II and Phase I trials, owing to their greater complexity and need for a larger patient pool. Factors such as increasing research activities, the growing burden of diseases, and many investigational drug candidates in Phase III are projected to propel the segment’s growth over the coming years.
The high number of drugs in Phase III of a clinical trial is projected to drive the growth of the segment. For instance, according to the data from clinicaltrials.gov, as of January 2024, around 3,055 studies were in Phase III, and among them, most were for cancer, autoimmune diseases, and other chronic conditions like rare diseases and cardiovascular conditions. Thus, such a high number of clinical trials in Phase III of clinical trials is expected to contribute to the segment's growth.
The supportive regulatory framework for Phase III trials to bring innovative therapeutics into the market as soon as possible is further expected to contribute to segment expansion. For instance, in October 2023, the US Food and Drugs Administration granted clearance to Transcenta to proceed with a Phase III trial of Osemitamab for the first-line treatment of gastric cancer. Similarly, in September 2023, the National Institute of Cholera & Enteric Disease (NICED) announced its plans to be a part of the Phase III clinical trial of India’s first dengue vaccine. Thus, such a supportive regulatory framework for Phase III clinical trials is projected to spur segment expansion over the forecast period.
Phase III trials conducted by market players and positive results from the trial are projected to contribute to segmental growth. For instance, in January 2024, Merck initiated the Phase III clinical trial of novel therapeutics for hematologic and oncologic malignancies. With this, the company bolstered its efforts to develop and commercialize advanced therapeutic options for cancers. Similarly, in November 2023, Pharvaris initiated the Phase III trial of PHVS416, a candidate being investigated for the treatment of hereditary angioedema (HAE).
In addition, in August 2022, Wockhardt Ltd initiated a global Phase III clinical study of its new antibiotic candidate, WCK 5222. It is an entirely new class of antibiotics known as "β-lactam ENHANCER' and is targeted for the treatment of hospitalized adults with complicated urinary tract infections, including acute pyelonephritis. Such a high number of studies in Phase III is expected to boost the growth of the segment. Thus, such efforts undertaken by market participants to conduct Phase III trials and their expected launch during the study period are projected to augment segment expansion over the coming years.
The high number of investigational candidates under Phase III of the pipeline, supportive regulatory frameworks, and increasing company activities to conduct Phase III trials are anticipated to bolster segment expansion over the forecast period.
North America is Expected to Witness Significant Market Growth Opportunities Over the Forecast Period
North America is expected to witness significant market growth during the forecast period owing to factors such as high R&D investments by the pharmaceutical industries, the presence of well-established players, the adoption of new technologies for clinical trials, and the significant burden of chronic diseases in the region.
The growing burden of chronic diseases in the region is expected to contribute to the demand for advanced treatment options, boosting market growth. For instance, according to the American Cancer Society's 2023 update, around 1.93 million new cancer cases were diagnosed in 2023, compared to 1.9 million cases in 2022 in the United States. In addition, as per the Centers for Disease Control's National Diabetes Statistics Report for 2022, the prevalence of diabetes in the United States rose to 37.3 million in 2022. The high burden of chronic diseases in the region is expected to contribute to market expansion over the forecast period.
The adoption of new technologies in clinical trials to facilitate clinical trial procedures is further expected to support regional market growth. For instance, in January 2024, Medable, a United States-based clinical trial technology provider, launched an automation technology to reduce the time needed to set up clinical trial procedures. In addition, in October 2023, Advarra launched a new technology to align sites, patients, and sponsors in clinical trials. This technology molded the overall clinical trial procedures, enabling easy data integration across sites and sponsors associated with the clinical trials.
The major market players in the region are active in the innovation of new drugs and devices, which is another factor expected to contribute to market growth in the region. For instance, in October 2023, BioAge Labs planned to launch a Phase II clinical trial of azelaprag (BGE-105) with tirzepatide for the treatment of obesity. The company’s trial was expected to commence in mid-2024. Thus, such initiatives are projected to support regional market growth.
Therefore, high R&D investments by pharmaceutical companies, the presence of well-established players, the adoption of new technologies for clinical trials, and the significant burden of chronic diseases in the region are expected to drive regional market growth over the coming years.
Clinical Trials Industry Overview
The clinical trial sector is highly competitive, and the leading players and industry stakeholders are involved in undertaking several strategic initiatives such as product launches, portfolio expansion, collaborations, mergers & acquisitions, and regional expansion to bolster their business avenues in the market. Some of the key players operating in the clinical trial market are Caidya, Lilly, Laboratory Corporation of America, ICON PLC, and IQVIA Inc.
Clinical Trials Market Leaders
-
Laboratory Corporation of America
-
Caidya
-
ICON plc
-
Lilly
-
IQVIA Inc
*Disclaimer: Major Players sorted in no particular order
Clinical Trials Market News
- August 2024: Pfizer Inc: Pfizer and BioNTech announced top-line results from their Phase 3 clinical trial evaluating a combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals aged 18-64. The combination vaccine met one of its two primary immunogenicity objectives.
- August 2024: Eli Lilly and Company: In August 2024, Eli Lilly announced positive topline results from the SURMOUNT-1 three-year study evaluating the efficacy and safety of tirzepatide for long-term weight management and delay in progression to diabetes in adults with pre-diabetes and obesity or overweight. Tirzepatide significantly reduced the risk of progression to type 2 diabetes by 94% among adults with pre-diabetes and obesity or overweight compared to placebo.
- September 2024: Parexel International (MA) Corporation: In September 2024, Parexel announced the strengthening of its Real World Research (RWR) offering by integrating its Scientific Data Organization and Real World Evidence capabilities. This initiative aims to better meet growing customer needs and enhance the company's ability to provide valuable insights using real-world evidence for clients worldwide.
- July 2024: Thermo Fisher Scientific Inc.: In July 2024, Thermo Fisher Scientific announced a partnership with the National Cancer Institute (NCI) to advance the myeloMATCH precision medicine clinical trial. This collaboration utilizes Thermo Fisher's next-generation sequencing technology to rapidly match patients with appropriate clinical trials for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), aiming to accelerate research into new treatments for these conditions.
- July 2024: ICON plc: In July 2024, ICON plc expanded its decentralized clinical trial capabilities by integrating advanced digital health technologies to enhance patient engagement and data collection.
Clinical Trials Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Adoption of New Technology In Clinical Research
4.2.2 High R&D Expenditure of the Pharmaceutical Industry
4.2.3 Rising Prevalence of Diseases
4.3 Market Restraints
4.3.1 Lack of Skilled Workforce in Clinical Research
4.3.2 Stringent Regulations for Patient Enrollment
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Phase
5.1.1 Phase I
5.1.2 Phase II
5.1.3 Phase III
5.1.4 Phase IV
5.2 By Design
5.2.1 Treatment Studies
5.2.1.1 Randomized Control Trial
5.2.1.2 Adaptive Clinical Trial
5.2.1.3 Non-randomized Control Trial
5.2.2 Observational Studies
5.2.2.1 Cohort Study
5.2.2.2 Case Control Study
5.2.2.3 Cross Sectional Study
5.2.2.4 Ecological Study
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle East and Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle East and Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Caidya
6.1.2 Laboratory Corporation of America
6.1.3 Lilly
6.1.4 ICON plc
6.1.5 Syneos Health
6.1.6 Parexel International (MA) Corporation
6.1.7 Pfizer Inc.
6.1.8 Thermo Fisher Scientific Inc. (Pharmaceutical Product Development LLC)
6.1.9 Medpace
6.1.10 ACM Global Laboratories
6.1.11 Charles River Laboratories
6.1.12 Frontage Labs
6.1.13 Bioagile
6.1.14 IQVIA Inc
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Clinical Trials Industry Segmentation
As per the scope of the report, clinical trials are experiments that are conducted under clinical research and follow a regulated protocol. These trials are primarily performed to obtain data regarding the safety and efficacy of newly developed drugs. Clinical trial data is mandatory for drug approval and for it to be introduced in the market. This process is expensive and time-consuming and requires expertise at all stages.
The clinical trials sector is segmented by phase, design, and geography. Based on phase, the market is segmented into phase I, phase II, phase III, and phase IV. Based on design, the market is segmented into treatment studies and observational studies. Based on geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report pdf also covers the estimated market size and trends for 17 countries across major regions globally. The market report pdf offers values (USD) for all the above segments.
| By Phase | |
| Phase I | |
| Phase II | |
| Phase III | |
| Phase IV |
| By Design | ||||||
| ||||||
|
| Geography | ||||||||
| ||||||||
| ||||||||
| ||||||||
| ||||||||
|
Clinical Trials Market Research FAQs
How big is the Clinical Trials Market?
The Clinical Trials Market size is expected to reach USD 50.66 billion in 2024 and grow at a CAGR of 5.91% to reach USD 67.5 billion by 2029.
What are the drivers of the clinical trials sector?
This market is driven by growing demand in emerging markets like India and China, high R&D investments by pharmaceutical companies, and the rising prevalence of chronic diseases, which increases the need for new treatments.
What challenges do clinical trials face?
The clinical trials face several challenges, including a shortage of skilled professionals, particularly in emerging markets, stringent and complex regulatory processes hinder patient enrollment, leading to delays in trial timelines.
How do regulations and compliance affect clinical trials?
Regulations and compliance impact clinical trials through strict approval and enrollment guidelines, complicating recruitment, with cross-country differences and ethical standards adding challenges for international studies.
What is the role of contract research organizations (CROs) in clinical trials?
Contract Research Organizations (CROs) support clinical trials by offering trial monitoring, data analysis, and patient recruitment.
Who are the major players in the Clinical Trial Sector?
Laboratory Corporation of America, Caidya, ICON plc, Lilly and IQVIA Inc are the major players in this Sector.
Clinical Trials Industry Report
The Global Clinical Trials Market growth analysis report by Mordor Intelligence provides a comprehensive industry analysis, focusing on the growth rate and market trends within the clinical research industry. The market research report is segmented by phase, design, and geography, offering a detailed market overview of North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The clinical trials industry is instrumental in advancing medical research and treatments, driven by innovation and regulatory changes. This industry report highlights the involvement of key clinical trial companies and examines the market segmentation by services, including Laboratory, Analytical Testing, and Bioanalytical Testing. Additionally, it delves into various therapeutic areas such as Oncology, Neurology, CNS, and Autoimmune/Inflammation, which are crucial due to their high demand and complexity in trials. The market outlook is positive, with significant market growth expected due to the efficiencies introduced by leading clinical trial companies. For stakeholders seeking to understand market value and market data, this report provides an in-depth market analysis and industry information. It includes a market forecast and industry statistics, aiding stakeholders in making informed decisions. The report also features a report pdf for further reference. The clinical trials industry is characterized by its dynamic nature and the continuous efforts of research companies to drive medical advancements. This industry research offers valuable insights into market leaders and their strategies, providing a market review that is essential for understanding the current market predictions and industry trends. For those interested in detailed industry reports and market segmentation, this report serves as a vital resource for comprehending the complexities of the clinical trials sector.
