United States Clinical Trials Market Research Report Information By Phase (Phase 1, Phase 2, Phase 3, and Phase 4), By Study Design (Observational, Interventional, and Expanded Access), By Application (Vaccine, Cell & Gene Therapy, Small Molecules, and Other Applications), 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 Diseas

US Clinical Trials Market Overview

United States Clinical Trials Market Size was valued at USD 23.8 Billion in 2022. The clinical trials market industry is projected to grow from USD 25.03 Billion in 2023 to USD 37.559 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.20% during the forecast period (2024 - 2032). Rapid technological advancement, an increase in the frequency of chronic illnesses, the globalization of clinical trials, the penetration of customized medicine, and the growing need for CROs to carry out research are some of the key market drivers predicted to have a positive effect on the market's growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Clinical Trials Market Trends

• Growing Clinical Trial Adoption and Outsourcing to Boost the Market Growth

The purpose of clinical trials is to evaluate the safety, efficacy, and effectiveness of novel medications, preventative measures, and medical equipment. The trials are generally conducted while new drugs are being developed. The National Library of Medicine (NLM) supplied data that showed that in 2020, there were about 52,000 new studies registered with NLM (ClinicalTrials.gov), and by 2023 there were about 58,000. The NLM announced in January 2023 that there were 38,837 ongoing clinical trials in the US and 105,172 ongoing trials globally. The growing prevalence of chronic diseases worldwide is driving an increasing number of clinical trials for the development of various effective medicines, which is driving the growth of the United States clinical trials market. Moreover, clinical studies are quite intricate procedures. Research-based organizations can overlook or improperly carry out these procedures. Research-based firms contract with clinical research organizations (CROs) to conduct clinical trials, which they use to their advantage because CROs have deep subject matter expertise and top-notch facilities. This helps prevent errors coming from incorrect execution. Consequently, the factors influencing the size of the clinical trial market include the creation of affordable solutions and a reduction in CRO errors during the drug development process.

It is anticipated that rising disease incidence and prevalence will further propel the clinical trial industry. The disease profile of the global population varies, with rising nations having the most diversified disease profiles. It is anticipated that this will help clinical trials for novel or uncommon diseases, which might not have found sponsors otherwise. A greater number of patients with a certain disease might encourage biopharmaceutical companies to increase their investment in clinical studies related to that disease. A diverse population would facilitate patient recruitment and expedite the clinical trial process. In the United States, rare diseases are classified as "Orphan diseases," and biopharmaceutical companies that fund clinical studies for orphan medications receive financial rewards for the endeavor. This pattern is probably going to benefit clinical studies for uncommon diseases, which will boost the market for clinical trials in the United States. Thus, driving the clinical trials market revenue.

Clinical Trials Market Segment Insights

Clinical Trials Phase Insights

The United States Clinical Trials market segmentation, based on phase, includes Phase 1, Phase 2, Phase 3, and Phase 4. The Phase 3 segment dominated the market mostly. This market has grown as a result of a number of factors, including the use of advanced services to evaluate the safety and efficacy of the drug candidates and a larger patient population for clinical research than for other stages. Furthermore, phase 3 clinical studies are regarded as sophisticated clinical trials that call for dependable clinical resources in addition to strong technology in order to successfully recruit patients, establish locations swiftly, and offer cost-effective study management.

Clinical Trials Study Design Insights

The United States Clinical Trials market segmentation, based on study design, includes Observational, Interventional, and Expanded Access. The interventional category generated the most income. The effectiveness of new intermediation can be measured more accurately and with comparatively more evidence when using interventional studies. This is why a lot of biologics and medications are the subject of them. Another benefit of an interventional study is the reduced recall bias, which occurs when exposure information is obtained before the onset of the disease.

Figure 1: United States Clinical Trials Market, by Study Design, 2023 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Clinical Trials Application Insights

The United States Clinical Trials market segmentation, based on application, includes Vaccine, Cell & Gene Therapy, Small Molecules, and Other Applications. The cell & gene therapy category generated the most income, propelled by improvements in investment, biotechnology, and the potential to treat a vast range of illnesses. This expansion is driven by the possibility that new therapies may offer individualized care and possibly even cures for illnesses that were incurable before. Furthermore, regulatory bodies are becoming more helpful, hastening the approval process for novel treatments.

Clinical Trials Indication Insights

The United States Clinical Trials market segmentation, based on indication, includes 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, and Others. The oncology category generated the most income. The growing number of older people and the rising incidence of cancer are factors driving the growth of the market in the oncology sector. The US is expected to see 609,820 cancer fatalities and 1,958,310 new instances of cancer in 2023, according to estimates from the American Cancer Society. There is a large unmet medical need for treatments for primary malignancies (e.g., prostate, lung, breast, and colon cancer) despite the tremendous advancements in cancer diagnosis, prevention, and treatment methods. This is probably going to lead to more activity in cancer research and development.

Clinical Trials Sponsor Insights

The United States Clinical Trials market segmentation, based on sponsor, includes Pharmaceutical & Biopharmaceutical Companies, Medical Device Companies, and Others. The pharmaceutical & biopharmaceutical companies category generated the most income. The pharmaceutical and biopharmaceutical companies segment contributed the most and is expected to continue leading the way throughout the forecast period. This is attributed to the expansion of these companies and the efforts made by public and private entities to advance the pharmaceutical industry.

Clinical Trials Service Type Insights

The United States Clinical Trials market segmentation, based on service type, includes Protocol Designing, Patient Recruitment, Laboratory Services, Site Identification, Bioanalytical Testing Services (Cell-based Assays, Virology Testing, Method Development, Optimization, & Validation, Serology, Immunogenicity, & Neutralizing Antibodies, Biomarker Testing Services, PK/PD (Pharmacokinetics/Pharmacodynamics) Testing Services, Other Bioanalytical Testing Services), Analytical Testing Services, Clinical Trial Supply & Logistic Services, Clinical Trial Data Management Services, Decentralized Clinical Services, Medical Device Testing Services, and Others. The laboratory services category generated the most income. It is anticipated that the growing significance of laboratory services in establishing regulatory compliance will spur the segment's expansion during the forecast period. Throughout the whole drug development process, including clinical advancement, laboratory services are essential.

Clinical Trials End-User Insights

The United States Clinical Trials market segmentation, based on end-user, includes Hospital, Laboratories, and Clinics. The laboratories category generated the most income. The growing incidence of chronic diseases necessitating extensive testing, the rise of pharmaceutical and biotechnology companies, and technological advancements are a few of them. Precision medicine is required more frequently. Further driving this market's expansion has been pharmaceutical corporations' outsourcing of laboratory services to specialist contract research organizations (CROs).

Clinical Trials Country Insights

The United States' growth is ascribed to the growing pharmaceutical business, which is expected to boost industry revenue by concentrating on creating new medications to treat a range of chronic ailments. Due to the aging population's increased likelihood of developing a variety of chronic illnesses and age-related disorders, it is also expected that demand for pharmaceuticals, medical equipment, and therapeutic interventions will rise. Statistics on the market will rise as a result. For instance, the United States Census Bureau estimates that there were 54 million persons over 65 in the United States in 2019. That number is expected to rise to approximately 98.2 million by the end of 2060. Businesses are, therefore, generally increasing their R&D expenditures. Furthermore, demand is expected to rise due to the United States government's significant support of clinical research. In March 2020, the FDA launched the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of medications for diseases caused by the coronavirus globally. Using all available resources, the program rapidly offers patients cutting-edge treatments while assessing their potential risks and benefits.

Clinical Trials Key Market Players & Competitive Insights

Leading market players are investing heavily in research and development in order to expand their product lines, which will help the clinical trials market grow even more. Market participants are also undertaking a variety of strategic activities to expand their footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, the clinical trials industry must offer cost-effective items.

Major players in the clinical trials market are attempting to increase market demand by investing in research and development operations, including Parexel, IQVIA, Kendle, Omnicare, Charles River Laboratory, Chiltern, and Pharmaceutical Product Development, LLC.

Key Companies in the clinical trials market include

• Parexel


• IQVIA


• Kendle


• Omnicare


• Charles River Laboratory


• Chiltern


• Pharmaceutical Product Development, LLC

Clinical Trials Industry Developments

March 2023: The clinical research division of Thermo Fisher Scientific, Pharmaceutical Product Development, LLC, has been acknowledged for excellence in the 2023 CRO Leadership Awards. These awards identify leaders in the industry based on a survey of pharmaceutical and biotech professionals for Clinical Leader and Life Science Leader magazines.

July 2022: A strategic partnership between Labcorp and the MD Anderson Cancer Center Foundation Spain, a nonprofit dedicated to eradicating cancer and expanding access to early-phase clinical trials for cancer, was recently revealed. This agreement will give cancer clinical investigations at MD Anderson Cancer Center Foundation Spain priority and oversight by Labcorp Drug Development, providing a novel strategy for upcoming trials.

Clinical Trials Market Segmentation

Clinical Trials Phase Outlook

• Phase 1


• Phase 2


• Phase 3


• Phase 4

Clinical Trials Study Design Outlook

• Observational


• Interventional


• Expanded Access

Clinical Trials Application Outlook

• Vaccine


• Cell & Gene Therapy


• Small Molecules


• Other Applications

Clinical Trials Indication Outlook

• 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

Clinical Trials Sponsor Outlook

• Pharmaceutical & Biopharmaceutical Companies


• Medical Device Companies


• Others

Clinical Trials Service Type Outlook

• Protocol Designing


• Patient Recruitment


• Laboratory Services


• Site Identification


• Bioanalytical Testing Services
  
  
  
  • Cell-based Assays
  
  
  • Virology Testing
  
  
  • Method Development, Optimization, & Validation
  
  
  • Serology, Immunogenicity, & Neutralizing Antibodies
  
  
  • Biomarker Testing Services
  
  
  • PK/PD (Pharmacokinetics/Pharmacodynamics) Testing Services
  
  
  • Other Bioanalytical Testing Services
  
  
  
  


• Analytical Testing Services


• Clinical Trial Supply & Logistic Services


• Clinical Trial Data Management Services


• Decentralized Clinical Services


• Medical Device Testing Services


• Others

Clinical Trials End-User Outlook

• Hospital


• Laboratories


• Clinics