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The clinical trials market size is projected to reach US$ 73.33 billion by 2031 from US$ 43.37 billion in 2023. The market is expected to register a CAGR of 6.8% during 2023–2031. AI-driven clinical trials is likely to act as a future trend in the market in the coming years.
Clinical Trials Market Analysis
The clinical trial market is mainly driven by continuous efforts made by pharmaceutical, biotechnology, and medical device companies for product innovations. Other factors contributing to the market progress include the globalization of clinical trials, rapid advancements in associated technologies, and an increase in demand for CROs for conducting clinical trials. Further, conferences such as "Global Clinical Trials Connect 2022" offer companies in this marketplace a platform to get acquainted with advancements in clinical trials and clinical research.
Clinical Trials Market Overview
Increasing strategic initiatives by companies such as product launches, mergers and acquisitions, partnerships, and geographic expansions benefit the clinical trials market. In September 2023, ICON plc released its next-generation Clinical Trial Tokenisation solution. Combining its proprietary tokenization engine, access to real-world data, and advanced clinical analytics expertise, ICON now delivers a cohesive and seamless operational model, providing valuable, long-term insights on drug safety and efficacy throughout the product development lifecycle. In February 2023, Labcorp announced its plans to form a new company—Fortrea—following the planned spin-off of its Clinical Development business. Upon completion of the spin-off from Labcorp, Fortrea will operate as an independent, publicly traded global CRO to offer comprehensive drug and medical device development services.
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Clinical Trials Market: Strategic Insights
Market Size Value in US$ 55,051.94 million in 2022 Market Size Value by US$ 76,023.44 million by 2028 Growth rate CAGR of 5.5% from 2023 to 2028 Forecast Period 2023-2028 Base Year 2023
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Clinical Trials Market: Strategic Insights
| Market Size Value in | US$ 55,051.94 million in 2022 |
| Market Size Value by | US$ 76,023.44 million by 2028 |
| Growth rate | CAGR of 5.5% from 2023 to 2028 |
| Forecast Period | 2023-2028 |
| Base Year | 2023 |
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Clinical Trials Market Drivers and Opportunities
Practice of Outsourcing Clinical Studies with Massive Rise in Number of Trials Fuels Market
Clinical trials are conducted to determine if a new form of medical product, i.e., a drug, diet, or medical device, is safe and effective. The trials are mainly a part of the overall drug development process. According to the National Library of Medicine (NLM), ~52,000 new studies were registered with NLM (ClinicalTrials.gov) in 2020, and the number increased to ~58,000 in 2023. In January 2023, the NLM reported 38,837 active clinical trials in the US and 105,172 active trials worldwide. According to the European Medicine Agency, in the European Union (EU), ~4,000 clinical trials are authorized annually, of which about 60% of studies are associated with the pharmaceutical industry. An upsurge in the number of clinical trials can be attributed to the rising prevalence of chronic diseases worldwide, which creates an immense demand for more effective treatments.
The increasing complexity of clinical trials adds to the cruciality of the proper execution and overseeing of operations carried out in research-based organizations. To avoid errors due to improper execution, many research-based organizations outsource clinical trials to clinical research organizations (CROs). CROs assist in successfully implementing clinical trials through the services they offer from their high-quality facilities and deep subject matter expertise. They have gradually become a backbone of the clinical trial industry through their efficient and cost-effective operations that benefit trial sponsors. According to a blog published by Thermo Fisher Scientific, in 2022, CROs executed ~3 out of 4 clinical trials to reassure the clinical programs of drug developers, provide a wealth of expertise, drive time and cost efficiencies, and deliver customized, high-quality data. Thus, the increasing number of clinical trials, and the practice of outsourcing trials to CROs to boost cost-effectiveness and reduce errors are the major factors driving the clinical trials market growth.
Adoption of Decentralized Clinical Trials and Hybrid Clinical Trials to Offer Opportunities for Market
Subjects enrolled in decentralized clinical trials (DCT) do not need to access hospital-based trial sites frequently. In DCTs, digital technologies are used to enable remote data collection and monitoring, along with streamlined communications between investigators and participants. A hybrid clinical trial approach combines home-based and on-site activities, bringing the best patient experience and meeting complex protocol regimes, gaining traction across various therapeutic areas and trial phase journeys. Challenges such as patient privacy, data security, regulatory barriers, and complex protocol regimes hindered the adoption of DCTs in the past. However, the COVID-19 pandemic compelled the sponsors of clinical trials to adopt decentralized and hybrid clinical techniques for developing drugs, as in-person studies were not feasible amid the health crisis. With restrictions imposed on commute, the only way to gather data and keep trials going was to work remotely and make optimal use of technologies to accelerate processes. According to the data provided by McKinsey, ~70% of the potential participants for clinical trials reside away from trial sites. Therefore, decentralization broadens trial access to reach a more significant number of subjects, consisting of potentially a more diverse pool of patients. Hybrid clinical trials allow sponsors to strategically incorporate DCT elements into study designs. These trial models offer unprecedented flexibility; thus, more companies are showing interest in hybrid trials, which is redefining the industry landscape. According to ObvioHealth, the FDA had plans to unveil protocols to support the use of DCT methods in 2023 to enhance the credibility of future clinical research. Thus, the increasing focus on using decentralized and hybrid clinical trials over traditional clinical trial methods is expected to provide lucrative opportunities for the clinical trials market during the forecast period.
Clinical Trials Market Report Segmentation Analysis
Key segments that contributed to the derivation of the clinical trials market analysis are study design, indications, and phase.
- Based on study design, the clinical trials market is bifurcated into interventional trials and expanded access trials. The interventional trials segment held a larger market share in 2023.
- By indication, the market is segmented into cardiovascular diseases, oncological conditions, neurological disorders, autoimmune diseases/inflammation, pain management, diabetes, obesity, metabolic disorders, and others. The oncological conditions segment held the largest market share in 2023.
- Based on phase, the clinical trials market is divided into Phase I, Phase II, and Phase III. The Phase II segment held the largest market share in 2023.
Clinical Trials Market Share Analysis by Geography
The geographic scope of the clinical trials market report is mainly divided into five regions: North America, Asia Pacific, Europe, South & Central America, and the Middle East & Africa. North America dominated the market in 2023. The US is the largest and fastest-growing market for clinical trials. The US is emerging as a leading clinical research destination, and various companies are offering innovative clinical trial services. The US has become a leading clinical research destination. Nearly half of the clinical trials are conducted in the US. Additionally, most pharmaceutical research companies prefer to conduct clinical trials in the country due to established medical infrastructure, rapid approval timelines, a favorable regulatory framework, and accepted clinical trial-generated data globally. A World Health Organization (WHO) report states that the US had the highest number of clinical trials, with 157,618 trials in 2021.
Clinical Trials Market Report Scope
Clinical Trials Market News and Recent Developments
The clinical trials market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the market are listed below:
- Oracle announced new capabilities in Oracle Clinical One Randomization and Trial Supply Management (RTSM). With new enhancements for use, access, and regionalization, Clinical One RTSM users can address dynamic, country-specific regulatory requirements, and gain speed, reliability, and transparency in trials from commencement to closeout. (Source: Oracle Corp, Company Website, May 2024)
- Parexel and Palantir Technologies Inc., a leading builder of artificial intelligence (AI) systems, entered into a multiyear strategic partnership to leverage AI to aid in enhanced, accelerated, safe, and effective clinical trials worldwide. Under this collaboration, Parexel leverages Palantir's Foundry and Artificial Intelligence Platform (AIP) to power its clinical data platform focused on driving clinical trial efficiency while maintaining the highest level of safety and regulatory rigor. (Source: Parexel International Corp, Company Website, April 2024)
Clinical Trials Market Report Coverage and Deliverables
The "Clinical Trials Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering below areas:
- Clinical trials market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Clinical trials market trends, as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST and SWOT analysis
- Clinical trials market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the clinical trials market
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Study Design, Phase, and Indication
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
North America dominated the market in 2023.
The practice of outsourcing clinical studies with a massive rise in the number of trials and the flourishing pharmaceutical industry with a surge in R&D activities are among the most significant factors fueling the market growth.
The market is expected to register a CAGR of 6.8% during 2023–2031.
The clinical trials market value is expected to reach US$ 73.33 billion by 2031.
IQVIA Holdings Inc, Parexel International Corporation, IXICO Plc, Charles River Laboratories Inc, ICON Plc, WuXi AppTec Co Ltd, SGS SA, Syneos Health Inc, SIRO Clinpharm Private Limited, Thermo Fisher Scientific Inc, Laboratory Corp of America Holdings, CliniRx, Caidya, Oracle Corp, and Medpace are among the key players in the market.
AI-driven clinical trials are expected to emerge as a prime trend in the market in the coming years.
The List of Companies - Clinical Trials Market
- IQVIA Holdings Inc
- Parexel International Corp
- IXICO Plc
- Charles River Laboratories International Inc
- ICON Plc
- WuXi AppTec Co Ltd,
- SGS SA
- Syneos Health Inc
- SIRO Clinpharm Pvt Ltd
- Thermo Fisher Scientific Inc
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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