The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is poised to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033, growing at a CAGR of 4.88% in the forecast period 2024-2033, the oncology segment accounted for the maximum revenue share of 27% in 2023.
The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is poised to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033, growing at a CAGR of 4.88% in the forecast period 2024-2033, the oncology segment accounted for the maximum revenue share of 27% in 2023.
The clinical trials market in the United States is experiencing significant growth due to the increasing emphasis on comparing new products or therapies with existing ones to determine their efficacy and safety.
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U.S. Clinical Trials Market Overview
The U.S. clinical trials market is experiencing rapid growth, by its indispensable role in advancing medical knowledge and treatments. At the core of clinical research, clinical trials explore novel approaches to disease prevention, detection, and treatment. They encompass a wide array of interventions, including new drugs, surgical techniques, medical devices, and behavioral modifications aimed at improving health outcomes. The overarching goal of these trials is to ascertain the safety and efficacy of these approaches. Participation in clinical trials is driven by diverse motivations, with healthy volunteers often citing altruism and a desire to contribute to scientific progress.
Rigorously regulated by the Food and Drug Administration (FDA), clinical trials adhere to stringent protocols to ensure patient safety and data integrity. New interventions, such as vaccines, drugs, and devices, these studies play a critical role in shaping healthcare practices. As the demand for innovative healthcare solutions continues to rise, the U.S. clinical trials market is poised for sustained expansion, driven by ongoing research efforts and the imperative to enhance patient care.
- In April 2024, Alvotech and Teva announced the FDA approval of SELARSDI, a biosimilar to Stelara.
- In December 2023, Exelixis and Arcus Biosciences collaborated on a clinical trial to evaluate Zanzalintinib in combination with AB521 for patients with advanced renal cell carcinoma.
Key Takeaways:
- The phase III segment held the lion’s share of 55% in 2023.
- Phase I studies are anticipated to register the fastest CAGR growth of 7.2% during the forecast period.
- The interventional study design segment accounted for the largest market share of 48.9% in 2023. The segment is also anticipated to register the second-fastest growth during the forecast period.
- The expanded access trials segment is projected to grow at a CAGR of 5.7% during the forecasted period in the U.S. clinical trials market.
- The oncology segment accounted for the maximum revenue share of 27% in 2023 & is also anticipated to register the fastest CAGR over the forecast period.
- The autoimmune segment of the U.S. clinical trials market is expected to be the second most lucrative segment with a CAGR of 5.6%
Market Dynamics
Driver
- Pharmaceutical Companies’ Clinical Trials in the U.S. Market
Clinical trials act as important drivers in the pharmaceutical industry, with the primary objective of demonstrating safety and efficacy for FDA approval. FDA guidance shapes trial parameters, ensuring acceptable standards and outcomes. Enhancing the drug development process through improved and expedited trials fosters innovation in medical product development. The substantial investments by the United States in clinical research aim to enhance national health and well-being, significantly contributing to disease treatment, prevention, and life extension. These investments propel growth in the U.S. clinical trials market, strengthening its important role in advancing healthcare innovation.
Restraint
- Challenges in the U.S. Clinical Trials Market
Several factors impede the growth of the U.S. clinical trials market, including high financial costs, lengthy time frames, and challenges in participant recruitment and retention. Insufficiencies in the clinical research workforce, along with barriers imposed by drug sponsors and regulatory complexities, further hinder market expansion. Additionally, there exists a disconnect between clinical research and medical care, compounded by globalization-related barriers. Addressing these challenges is imperative to unlock the full potential of the U.S. clinical trials market and drive sustained growth in the healthcare innovation landscape.
Opportunity
- Integration of AI in U.S. Clinical Trials Market
The application of AI tools presents a significant opportunity to advance clinical development processes, enhancing the likelihood of trial success and regulatory approval. By leveraging adaptive protocols, AI facilitates the generation of diverse datasets while alleviating the trial burden on both patients and sites. This transformative technology holds immense potential to advance healthcare, accelerate medical research, and bolster the health and well-being of Americans. The National Institutes of Health (NIH) is at the forefront of exploring AI applications to propel biomedical research forward, leveraging extensive datasets from initiatives like the NIH Human Microbiome Project and the All of Us Research Program. Harnessing AI capabilities creates unprecedented opportunities within the U.S. clinical trials market, driving innovation and optimizing healthcare outcomes.
- In November 2023, AstraZeneca launched Evinova, a health-tech business aimed at accelerating innovation across the life sciences sector and improving clinical trial delivery and health outcomes.
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By Phase Insights
In the U.S. clinical trials market, the phase III segment commanded the largest share, underscoring its pivotal role in evaluating the safety and efficacy of new treatments against established standards. These trials involve random allocation of participants to either the standard treatment or the new intervention, often employing double-blind methodologies to minimize bias. 00Normally enrolling a substantial number of patients, usually several hundred, Phase III trials are conducted across multiple sites nationally or globally, including local community hospitals and doctor’s offices. Their extended duration distinguishes them from earlier-phase trials, allowing for comprehensive assessment of treatment outcomes. While placebos may be incorporated into Phase III studies, they are never utilized as standalone interventions if an effective treatment is available. Patients assigned to placebos are often provided access to the standard treatment at some point during the study, ensuring ethical considerations are met. As a crucial phase in the development and validation of new treatments, Phase III clinical trials provide invaluable insights into their comparative effectiveness, guiding healthcare decision-making and fostering innovation in the medical field.
In the U.S. clinical trials market, Phase I studies are poised to exhibit the most rapid growth during the forecast period, reflecting their critical role as the initial step in human testing for new drugs. These studies mark the pivotal transition from laboratory and animal testing to human subjects, aiming to determine the optimal dosage that can be administered safely, mitigating severe side effects. While prior preclinical research provides foundational insights, Phase I trials are essential for assessing how the human body responds to the treatment and understanding its pharmacokinetics. Safety remains paramount throughout these studies, with research teams closely monitoring participants for any adverse reactions. Given the limited number of participants in Phase I trials, rare side effects may only manifest in later trial phases, underscoring the importance of continued vigilance. Although Phase I trials primarily focus on safety endpoints rather than disease response, they provide invaluable insights into the drug’s potential therapeutic profile and inform subsequent trial phases. As the gateway to clinical development, Phase I studies play a pivotal role in advancing medical innovation and shaping the trajectory of new treatments.
By Indication Insights
In the U.S. clinical trials market, the oncology segment has emerged as the largest shareholder and is poised for accelerated growth throughout the forecast period. Clinical trials serve as pivotal platforms for studying new drugs, procedures, and treatments, particularly in the realm of oncology, where the need for innovative therapies is paramount. Cancer immunotherapy clinical trials play a crucial role in expanding treatment options for patients across various cancer types, offering the potential for life-saving interventions. As a beacon of hope for those grappling with cancer, immunotherapy trials represent a promising avenue for delivering novel therapies to a broader patient population.
The rapid evolution of clinical research has led to the increased availability of immunotherapy trials, not only for advanced-stage cancers but also for early-stage malignancies and as first-line treatment options. This progression underscores the integral role of clinical trials in advancing cancer care and improving patient outcomes along the continuum of cancer treatment. With ongoing advancements in oncology research and the growing emphasis on personalized medicine, clinical trials remain indispensable in driving innovation and shaping the future landscape of cancer care.
By Study Design Insights
In U.S. clinical trials market, the interventional study design segment has secured the largest market share, signifying its prominence in evaluating potential interventions, including drugs, medical devices, activities, or procedures, in human subjects. Commonly known as clinical trials, interventional studies often adopt a placebo-controlled approach, wherein participants are randomly assigned to receive either the treatment under investigation or a placebo. This design allows researchers to systematically compare the effectiveness of the intervention against the placebo, enabling rigorous assessment of its efficacy. Participants enrolled in interventional studies receive the specific intervention being studied, whether it be a drug or a procedural intervention.
In the U.S. clinical trials market, the expanded access trials segment is poised for significant growth during the forecasted period. Expanded access, also known as “compassionate use,” entails the utilization of investigational new drugs outside of formal clinical trials for the diagnosis, monitoring, or treatment of severe diseases or conditions. Unlike participants in traditional clinical trials, individuals accessing expanded access are typically patients in need of therapeutic options beyond standard treatments. This pathway offers a means for patients to access investigational drugs, biologics, and medical devices when comparable or satisfactory therapies are unavailable outside of clinical trials.
Related report:
- Clinical Trials Market : The global clinical trials market size was estimated at USD 81.90 billion in 2023 and is projected to hit around USD 153.59 billion by 2033, growing at a CAGR of 6.49% 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.
- Biologics Market : The global biologics market size was estimated at USD 511.04 billion in 2023 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period from 2024 to 2033.
U.S. Clinical Trials Market Top Key Companies:
- Parexel International Corp.
- IQVIA Holdings Inc.
- LabCorp
- Thermo Fisher Scientific (Pharmaceutical Product Development)
- Charles River Laboratory
- ICON plc
- Wuxi AppTec
- Eli Lilly and Company
- SGS SA
- Novo Nordisk A/S
- Clinipace
- Syneos Health Inc.
- Pfizer Inc.
U.S. Clinical Trials Market Report Segmentation
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 U.S. Clinical Trials market.
By Phase
- Phase I
- Phase II
- Phase III
- Phase IV
By Study Design
- Interventional Studies
- Observational Studies
- Expanded Access Studies
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 Conditions
- Epilepsy
- Parkinson’s Disease (PD)
- Huntington’s Disease
- Stroke
- Traumatic Brain Injury (TBI)
- Amyotrophic Lateral Sclerosis (ALS)
- Muscle Regeneration
- Others
- Diabetes
- Obesity
- Cardiovascular
- Others
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