Clinical Trials Market Size to Increase USD 153.59 Billion by 2033

According to Nova One Advisor, the global clinical trials market size was estimated at USD 81.90 billion in 2023 and it is projected to increase USD 153.59 billion by 2033 with a CAGR of 6.49% from 2024 to 2033.

A graph of growth in the market

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The market growth spiked in 2020 owing to the COVID-19 pandemic. This growth pattern was witnessed by both virtual clinical trials and traditional ones. Several companies invested heavily in novel drug development to minimize COVID-19 patient burden. One such example being, in 2020, Synairgen plc and Parexel collaborated on a Phase III study of Interferon-beta (IFN-beta) treatment for COVID-19. Furthermore, rapid technological evolution, rising prevalence of chronic diseases, globalization of clinical trials, penetration of personalized medicine and a rise in demand for CROs for conducting research activities is expected to positively impact the market growth.

In addition, the COVID-19 pandemic led to changing the ways of conducting upcoming or ongoing clinical trials. Regulatory agencies including the U.S. FDA, the European Medicines Agency (EMA), the National Institutes of Health (NIH), and China’s National Medical Products Administration among several others issued various guidelines for conducting trials during the pandemic to support the implementation of decentralized clinical trials and virtual services. The current scenario for research and development activities across the globe and the need for several new treatment options have also led to the adoption of fast-track clinical trials. Thus, aforementioned factors are estimated to offer new avenues to the clinical trials market growth.

Favorable government support and initiatives is another aspect boosting the market growth potential. For instance, the WHO launched Solidarity, an international clinical trial to determine effective treatment against COVID-19. [PS2]  It includes comparing four treatment options against the standard of care to evaluate their effectiveness against the coronavirus. In May 2020, the WHO also announced an international alliance for simultaneously developing multiple candidate vaccines to prevent the spread of the coronavirus disease, calling this effort the Solidarity trial for vaccines.

Furthermore, the use of CRO services helps manufacturers/sponsors pay complete attention to the production capacity and enhance their in-house processes. The availability of the vast array of services from drug discovery to post marketing surveillance has further simplified processes for mid-size & small-scale pharmaceutical and biotechnological organizations by providing them the option to outsource research and development activities to reduce infrastructure investment. For instance, in November 2023, Syneos Health signed an agreement with GoBroad Healthcare Group. This collaborative initiative extended the company’s clinical trial capabilities into a more extensive array of therapeutic areas in China.

Key Takeaways:

  • North America accounted for 50% of the global market in 2023
  • Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period
  • Phase III segment led the market and accounted for 53.13% of the total revenue share in 2023.  
  • Phase II segment is expected to witness considerable growth over the analysis period.
  • The interventional studies segment dominated the market in 2023.
  • The expanded access trials segment also referred to as compassionate use trials, is anticipated to register notable CAGR during the forecast period.
  • The interventional trials market for autoimmune/inflammation accounted for the largest revenue share in 2023.
  • Oncology segment accounted for the largest revenue share in 2023.
  • Pharmaceutical & biopharmaceutical companies accounted for the largest revenue share in 2023.
  • Patient recruitment and retention segment garnered a significant share in 2023.
  • Data management segment held a significant share in 2023 and is anticipated to show a similar trend over the forecasted period.

Clinical Trials Market Trends

  1. Virtual Trials and Decentralized Trials: The adoption of virtual and decentralized clinical trials is increasing, driven by advancements in digital health technologies, remote monitoring tools, and patient-centric approaches. These trials offer greater flexibility, convenience, and inclusivity for participants while reducing costs and accelerating trial timelines.
  2. Real-world Evidence (RWE) Integration: There is a growing emphasis on incorporating real-world evidence, derived from electronic health records, wearables, and other sources, into clinical trial design and decision-making processes. This trend enhances the understanding of treatment outcomes, patient populations, and safety profiles.
  3. Adaptive Trial Designs: Adaptive trial designs, which allow for modifications to study protocols based on interim data analysis, are gaining popularity. These designs enable more efficient allocation of resources, faster decision-making, and increased flexibility in responding to emerging insights during the trial.
  4. Patient-Centricity: Patient-centric approaches are becoming central to clinical trial design and execution. This includes initiatives to enhance patient engagement, improve recruitment and retention rates, and incorporate patient-reported outcomes into trial endpoints. Such efforts aim to ensure that clinical trials are more relevant, accessible, and meaningful to participants.
  5. Artificial Intelligence and Data Analytics: The integration of artificial intelligence (AI) and advanced data analytics is transforming various aspects of clinical trial conduct, including patient recruitment, site selection, protocol optimization, and safety monitoring. AI-driven insights improve decision-making, streamline processes, and enhance trial efficiency.
  6. Regulatory Flexibility and Innovation: Regulatory agencies are increasingly embracing flexible approaches to streamline clinical trial processes, such as expedited review pathways for breakthrough therapies, adaptive licensing frameworks, and harmonized global regulatory standards. This facilitates innovation and accelerates the development of novel treatments.
  7. Diversity and Inclusion: Efforts to improve diversity and inclusion in clinical trials are gaining traction, driven by recognition of the importance of representative study populations and equitable access to experimental therapies. Initiatives aim to address barriers to participation among underrepresented groups and ensure that clinical trial data accurately reflect the broader patient population.
  8. Globalization and Outsourcing: Clinical trial outsourcing to contract research organizations (CROs) and clinical research sites in emerging markets is increasing, driven by cost considerations, access to diverse patient populations, and regulatory harmonization efforts. Globalization enables sponsors to leverage expertise and infrastructure worldwide while navigating complex regulatory landscapes.
  9. Biomarker-driven Trials: Biomarker-driven trials, which utilize molecular biomarkers to stratify patient populations and inform treatment decisions, are becoming more prevalent. This personalized medicine approach enables targeted therapies, improves patient outcomes, and enhances trial efficiency by identifying responsive subgroups.
  10. Remote Monitoring and Siteless Trials: Remote monitoring technologies and siteless trial models are transforming the traditional clinical trial paradigm by enabling remote data collection, telemedicine visits, and direct-to-patient drug delivery. These approaches enhance patient convenience, reduce site burden, and mitigate logistical challenges associated with traditional site-based trials.

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Rise in R&D Activities in Biotechnology and Pharmaceuticals Industries Boosts Market Growth

  • Clinical research organizations, diagnostic laboratories, and biotechnology players are engaged in the development of newer diagnostic tests to address the unmet needs in the healthcare industry. The life science industry’s R&D spending is driven primarily by the mass and research intensity of the biopharmaceutical sector, which accounts for nearly 85% of all expenditure.
  • Additionally, laboratories strive to improve equipment cost and performance. UHPLC and ultra-fast mass spectrometers are more reliable, faster, and more sensitive as a result of research initiatives by major players.
  • Acceleration in biopharmaceutical R&D innovation, buoyed by several contributing factors such as precision medicine getting into gear in rare diseases, cancer, and autoimmune diseases; immunotherapy, expansion of therapeutic modalities exploiting natural and synthetic biology innovation, and expedited regulatory pathways boost the growth of the clinical trials market

Segments Insights:

Phase Insights

Phase III segment led the market and accounted for 53.13% of the total revenue share in 2023.  clinical trial statistics indicate market growth due to rising phase III trials, involving a large number of subjects. The median cost for a single-phase III trial is over USD 19.0 million.  Also, phase III requires a higher number of patients and often a longer treatment period. According to a clinical trial logistics survey by Nice Insights, 35.0% of phase III clinical trials are outsourced and the number is likely to increase owing to the growing number of investigational drugs advancing to the next phase.

Phase II segment is expected to witness considerable growth over the analysis period. Phase II is the second most expensive stage after phase III studies. This study is performed in two parts; the first part includes exploring a range of doses along with efficacy studies and the second part includes finalizing the dose. Phase II plays a crucial role, especially in oncology-related studies. The FDA estimated that around 33.0% of the investigational drugs are usually under phase II trial. Furthermore, there are numerous therapeutics and vaccines currently in phase II that are indicated for the treatment of oncology thereby boosting the growth. The growing number of industry-sponsored and non-industry-sponsored clinical trials in phase II, complexity associated with phase II clinical trials, and globalization of clinical trials are factors expected to drive the growth of the clinical trials market.

Study Design Insights

The interventional studies segment dominated the market in 2023. It is one of the most prominent methods used in clinical trials. Interventional studies comprised over 75.0% of the total registered studies in 2022,ut of which most were for drug or biologics, followed by clinical procedure, behavioral, and device interventional studies.  These studies contribute to 94.0% of the total studies that posted results, out of which drug or biologics contribute the most, followed by behavioral, devices, and Clinical procedure intervention studies.

The expanded access trials segment also referred to as compassionate use trials, is anticipated to register notable CAGR during the forecast period. It is a potential pathway for patients with serious disease conditions where lack of satisfactory therapies to undergo treatment outside the trial. Increasing innovation in clinical trial methods will drive the expanded access trials segment. Numerous oncology drugs are regularly administered to patients before their approval by the U.S. FDA and are considered part of the expanded access trial, thereby accelerating segmental revenue growth. 

Indication by Study Design Insights

The interventional trials market for autoimmune/inflammation accounted for the largest revenue share in 2023. This can be attributed to large number of interventional studies on autoimmune/inflammation worldwide. Numerous advantages of interventional studies, such as minimization of confounding effects, avoidance of bias in allocation to exposure groups, and efficient detection of small to moderate clinically important effects. There are over 8,900 interventional studies listed on Clinicaltrails.gov related to autoimmune/inflammation.

Indication Insights

Oncology segment accounted for the largest revenue share in 2023.  As per the U.S. FDA and various other sources, more than USD 38.0 billion is currently being spent by the pharmaceutical industry on the pre-clinical and clinical development of oncology therapy products. The cardiovascular condition segment is also anticipated to witness lucrative growth over the forecast period. The growing prevalence and increased demand for cost-effective medications worldwide have led to significant investment in R&D in this segment with more than 190 drugs in the pipeline. The majority of the drugs in the pipeline are indicated for heart failure, lipid disorders, vascular diseases, and stroke. Growing demand for cost-effective medicines in low- and middle-income countries is expected to boost the R&D investment by the government, thereby strengthening the industry growth.

Sponsors Insights

Pharmaceutical & biopharmaceutical companies accounted for the largest revenue share in 2023. This can be attributed to the greater interest of the pharmaceutical industry in the research field. In addition, there has been an increase in the number of clinical trials funded by pharmaceutical & biopharmaceutical companies. The pharmaceutical industry plays a vital role in financing the research for the development of new drugs.

Although grants from the National Institutes of Health (NIH) fund most of the basic research in academic laboratories, it is largely the industry that bears the cost of identifying new molecular entities and testing them on animal models and human subjects. Clinical studies account for the major portion of the estimated cost, ranging from USD 266 million to USD 802 million for bringing each new drug to the market. Currently, in the U.S., around 75% of all funding for Clinical studies is received from corporate sponsors.

Patient recruitment and retention segment garnered a significant share in 2023. The growing number of clinical studies globally is one of the key reasons supporting the demand for clinical trial patient recruitment services. Moreover, there is a growing amount of funding for clinical research, and the wide adoption of digital technologies in clinical research further supports the growth. The market is further fueled by major investments in R&D and government support for clinical trials. The presence of leading Contract Research Organizations (CROs) that offer comprehensive support services, including patient recruitment, along with the active participation of multinational pharmaceutical & biopharmaceutical companies, has contributed to the market expansion.

Data management segment held a significant share in 2023 and is anticipated to show a similar trend over the forecasted period. The segment growth is owing to increasing adoption of data management services coupled with a growing trend towards decentralized trials. Moreover, integration of advanced technologies as Artificial Integration (AI) and Machine Learning (ML) for data entry and analysis and quality control. Thus, abovementioned factors are expected to drive segmental demand.

Regional Insights

North America accounted for 50% of the global market in 2023 and is expected to continue its dominance over the forecast period. This can be attributed to an increase in R&D investments and a rise in the adoption of new technologies in clinical trials in this region. For instance, the implementation of virtual services in various stages of clinical trials by market players, such as IQVIA and PRA Health Sciences, is anticipated to further propel the North American market growth.

Moreover, favorable government support in the U.S. clinical trials market is anticipated to boost the demand. For instance, in March 2020, the FDA launched a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to accelerate the development of treatment for global diseases caused by the coronavirus. The program employs every available way to provide novel treatment to patients as rapidly as possible, simultaneously finding out whether they are harmful or helpful.

Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period owing to the availability of a large patient pool allowing easy recruitment. The global COVID-19 pandemic is one of the major factors driving the market. Asia Pacific’s largest, expertized biotech CRO “Novotech”, has reported an increase in demand from biotechnology sponsors for studies due to good quality and quick turnaround. An increasing number of biotechnology firms prefer the APAC region for conducting COVID-19 trials to leverage a large patient pool and fast-track procedures.

Indian clinical trials market is anticipated to grow at a CAGR of 8.3% over the forecast period. The key factors estimated to drive the market are the globalization of clinical trials, adoption of new technology in clinical research, growing disease variation and prevalence, and increasing research and development promoting outsourcing.

Browse More Insights:

  • Biopharmaceuticals Contract Manufacturing Market : The global biopharmaceuticals contract manufacturing market size was estimated at USD 19.89 billion in 2023 and is projected to hit around USD 33.65 billion by 2033, growing at a CAGR of 5.4% during the forecast period from 2024 to 2033.
  • Biotechnology Market : The global biotechnology market size was estimated at USD 1.54 Trillion in 2023 and is projected to hit around USD 5.68 Trillion by 2033, growing at a CAGR of 13.95% during the forecast period from 2024 to 2033.
  • Oncology Clinical Trials Market: The global oncology clinical trials market size reached USD 13.19 billion in 2023 and is projected to hit around USD 22.11 billion by 2033, expanding at a CAGR of 5.3% during the forecast period from 2024 to 2033.
  • Next Generation Sequencing Market : The global next generation sequencing market size was estimated at USD 9.19 billion in 2023 and is projected to hit around USD 66.04 billion by 2033, growing at a CAGR of 21.8% during the forecast period from 2024 to 2033.

Recent Developments

  • In August 2023, Parexel & Partex entered a strategic partnership aimed at utilizing Artificial Intelligence (AI)-driven solutions to expedite the process of drug discovery and development for biopharmaceutical clients globally. The collaboration aimed to reduce risks associated with the assets in their respective portfolios. 
  • In August 2023, Novo Nordisk announced to acquire Inversago Pharma. This acquisition was part of Novo Nordisk's strategic efforts to develop new therapies targeting individuals with obesity, diabetes, and other significant metabolic diseases
  • In April 2022, Charles River Laboratories International, Inc. disclosed its acquisition of Explora BioLabs Holdings, Inc., a leading provider of contract vivarium research services.

Some of the prominent players in the Clinical Trials Market include:

  • Pharmaceutical Product Development, INC. (Thermo Fisher Scientific, Inc.)
  • ICON plc
  • Charles River Laboratories International, Inc.
  • IQVIA
  • SYNEOS HEALTH
  • SGS SA
  • PAREXEL International Corporation
  • Wuxi AppTec, Inc
  • Chiltern International Ltd (Laboratory Corporation of America)
  • Eli Lilly and Company
  • Novo Nordisk A/S
  • Pfizer
  • Clinipace (Caidya)

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Clinical Trials market.

By Phase 

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

By Study Design 

  • Interventional
  • Observational
  • Expanded Access

By Indication 

  • Autoimmune/Inflammation
    • Rheumatoid arthritis
    • Multiple Sclerosis
    • Osteoarthritis
    • Irritable Bowel Syndrome (IBS)
    • Others
  • Pain Management
    • Chronic Pain
    • Acute Pain
  • Oncology
    • Blood Cancer
    • Solid Tumors
    • Other
  • CNS Condition
    • Epilepsy
    • Parkinson's Disease (PD)
    • Huntington's Disease
    • Stroke
    • Traumatic Brain Injury (TBI)
    • Amyotrophic Lateral Sclerosis (ALS)
    • Muscle Regeneration
    • Others
  • Diabetes
  • Obesity
  • Cardiovascular
  • Others

By Indication by Study Design 

  • Autoimmune/Inflammation
    • Interventional
    • Observational
    • Expanded Access
  • Pain Management
    • Interventional
    • Observational
    • Expanded Access
  • Oncology
    • Interventional
    • Observational
    • Expanded Access
  • CNS Condition
    • Interventional
    • Observational
    • Expanded Access
  • Diabetes
    • Interventional
    • Observational
    • Expanded Access
  • Obesity
    • Interventional
    • Observational
    • Expanded Access
  • Cardiovascular
    • Interventional
    • Observational
    • Expanded Access
  • Others
    • Interventional
    • Observational
    • Expanded Access

By Sponsor 

  • Pharmaceutical & Biopharmaceutical Companies
  • Medical Device Companies
  • Others

By Service Type 

  • Protocol Designing
  • Site Identification
  • Patient Recruitment
  • Laboratory Services
  • Bioanalytical Testing Services
  • Clinical Trial Data Management Services
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

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