The U.S. clinical trials market size is expected to be worth around USD 75.39 billion by 2034, increasing from USD 43.43 billion in 2025, representing a healthy CAGR of 6.32% from 2025 to 2034.
Clinical trials offer hope for major patients while giving scientists an opportunity to find appropriate treatments that could benefit patients in the future. Well-performed and well-designed clinical trials offer benefits to patients while allowing them to help others by contributing to information related to novel procedures or treatments. It receives regular and careful healthcare attention from a research team that involves doctors and other healthcare professionals and gains access to novel research treatments earlier they are more widely available.
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U.S. Clinical Trials Market Highlights:
• The phase III segment held the lion’s share of 55% in 2024.
• 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 2024. 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 2024 & 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 Overview and Industry Potential
The U.S. clinical trials market is expanding rapidly due to in clinical trials, which compare a novel product or treatment with another that is already present, investigators try to determine whether the novel one is at least as good as the present one. Clinical trials are an especially significant treatment alternative for patients who have severe cancers or advanced cancers that haven't responded to current therapies and treatments. Patients involved in trials are generally followed more closely by their care providers than other patients.
• For instance, In March 2025, GSK plc announced that the US Food and Drug Administration (FDA) had approved Blujepa for the treatment of female adults and paediatric patients with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
Growing regulatory modernization changes clinical trials that are frequent and essential, driven by development in science, ethical standards, and technology. Regulatory-driven clinical research continues to undergo momentous transformation driven by major initiatives and updates from regulatory authorities like the FDA and the International Council for Harmonisation (ICH). It modernizes clinical trial practices, enhances safety of patient safety, and ensures that studies are efficient, inclusive, and associated with the recent scientific and technological advancements.
CDER’s Novel Drugs Approvals for 2024.
|
Drug Name |
Active Ingredient |
FDA-approved Used |
|
Alhemo |
concizumab-mtci |
For routine prophylaxis to prevent bleeding episodes in hemophilia A and B |
|
ALYFTREK |
vanzacaftor/tezacaftor/deutivacaftor |
For the treatment of cystic fibrosis (CF) in patients 6 years of age and older |
|
Alyftrek |
vanzacaftor, tezacaftor, and deutivacaftor |
To treat cystic fibrosis |
|
Bizengri |
zenocutuzumab-zbco |
To treat non-small cell lung cancer and pancreatic adenocarcinoma |
|
Duvyzat |
givinostat |
To treat Duchenne muscular dystrophy in individuals aged 6 years and older |
|
Hympavzi |
marstacimab-hncq |
To prevent or reduce bleeding episodes related to hemophilia A or B |
|
Itovebi |
inavolisib |
To treat locally advanced or metastatic breast cancer |
Latest Trends of the Market • In June 2025, the U.S. Food and Drug
Administration (FDA) announced an immediate review of novel clinical trials
that involve sending American citizens’ living cells to China and other hostile
countries for genetic engineering and subsequent infusion back into U.S.
patients, sometimes without their knowledge or consent. • In January 2025, Massive Bio announced
its inclusion in the White House Office of Science & Technology Policy’s
upcoming Cancer Moonshot Fact Sheet, underscoring the company’s revolutionary
efforts to transform clinical trial access and accelerate just-in-time,
decentralized trials for cancer patients worldwide. Aligned with its debut at
the 2025 JPMorgan Healthcare Conference, Massive Bio’s $15 million initial
spending will drives its advanced AI-based clinical trial matching platform,
first-of-their-kind pre-screening hubs, and patient-centric ‘hub and spoke’
end-to-end activation model enabling more than 50,000 unique cancer patients
yearly and scaling to 250,000 patients globally by 2027. Integration of Advanced Technology in
Clinical Trials: Market’s Largest Potential The growing integration of advanced health
technologies is transforming clinical trial conduct and data collection. These
technologies, such as remote monitoring tools and wearable devices, allow
real-time and real-world
data (RWD) capture, improving patient compliance and engagement. These
technologies simplify the collection of objective health metrics, like physical
activity levels, medication adherence, and vital
signs, which offer valuable insights into treatment efficacy and
outcomes for patients. By advancing digital health technologies,
scientists can streamline information collection processes, reduce data
variability, and improve the reliability and precision of clinical trial
outcomes. • In January 2024, Beam Therapeutics
announced that they had dosed the first participant in their US-based phase 1/2
trial of a base editing therapy for severe SCD. Beam is using base editing to
turn on HbF. Base editing is a version of CRISPR-Cas9 technology that changes
single DNA letters, or nucleotides, without creating double-stranded breaks in
DNA, reducing certain safety risks. U.S. Clinical Trials Trends: In the United States, increasing advanced
technology to study of clinical trials, for instance, in 2024, artificial
intelligence, manage 50% of trial data tasks, cutting timelines by 20% and
enhancing data precision. Trialtrove captured 9,959 Phase I–III clinical trials
with a 2024 start date, investigating at least one drug, a 9.4% growth from the
prior year. As of May 2025, there are 22,985 clinical trials enlisting patients
in the U.S., according to the National Library of Medicine (NLM), which drives
the growth of the U.S. clinical trials market. U.S. Clinical Trials Market Report Scope Report Attribute Details Market Size in 2024 USD 43.43 Billion Market Size by 2034 USD 75.39 Billion Growth Rate From 2025
to 2034 CAGR of 6.32% Base Year 2024 Forecast Period 2025 to 2034 Segments Covered Phase, Study Design,
Indication Market Analysis
(Terms Used) Value (US$
Million/Billion) or (Volume/Units) Report Coverage Revenue forecast,
company ranking, competitive landscape, growth factors, and trends Key Companies
Profiled 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.
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U.S. Clinical Trials Market Segmentation
Analysis: By Phase Analysis: The phase III segment dominates in the U.S.
clinical trials market, as phase
III clinical trials compare the effectiveness and safety of the novel
therapies against the present standard treatment. Adverse effects of the treatments
are compared in this phase. If this trial is successful, the novel therapies
approved for application outside of clinical trials. These clinical trials are
more likely to be offered in local community hospitals and doctors’ offices.
These studies take a period that lasts longer than phase I and II trials. On the other hand, the phase I segment is
expected to grow significantly during the forecast period as phase I studies
are used to identify the peak dose of a novel treatment that given securely without
causing severe adverse effects. These studies support deciding on the ideal way
to give the novel treatment. Phase I trials study what the treatment does to
the body and what the body does with the treatment. Phase I trials typically
contain a small number of people, generally 10-30. Safety is the major concern.
The scientific team keeps a close eye on the participating people and watches
for any serious adverse effects. By Study Design Analysis: The interventional studies segment
dominates the U.S. clinical trials market, as interventional studies enable
scientists to control and manipulate variables, which helps establish
cause-and-effect relationships among interventions and results. Random
assignment in interventional studies supports minimizing bias and safeguards
that the treatment and control groups are comparable, improving the validity of
the outcomes. Interventional studies are frequently directly applicable to
medical practice, as they contribute to testing treatments or interventions in
real-world scenarios. On the other hand, the expanded access
studies segment is expected to grow significantly during the forecast period,
as expanded access studies provide choices to patients with unmet needs. It
provides informative efficacy and safety data to the manufacturers and the
scientific and government organizations. Expanded access is a regulatory
mechanism by which an investigational drug is made available outside of a
clinical trial to treat patients with severe or life-threatening conditions for
which there are no suitable treatment options. By Indication Analysis: The oncology
segment dominates the U.S. clinical trials market as most advanced cancer therapies
are accessible only through clinical trials. Cancer clinical trials are a
stimulating opportunity to get involved in science and create the opportunity
for future discovery. The novel treatment works better than the standard
treatment. It supports advanced cancer treatment for patients. The CNS conditions studies segment is
expected to grow significantly during the forecast period, as CNS clinical
trials the risks that can be tremendously high. CNS disorders pose noteworthy
challenges to patients, medical care providers, and society as a whole.
Evolving the field of CNS clinical trials is crucial for emerging novel
treatments that alleviate the load of these disorders. Clinical trials offer
the scientific evidence essential to help the adoption and approval of
ground-breaking therapies, eventually improving patient outcomes and quality of
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U.S. Clinical Trials Market Top Key
Companies: • 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. What is Going Around the Globe? • In January 2024, Sanofi and Inhibrx,
Inc., a publicly traded clinical-stage biopharmaceutical company focused on
developing a broad pipeline of novel biologic therapeutic candidates, entered
into a definitive agreement under which Sanofi has agreed to acquire Inhibrx
following the spin-off of non-INBRX-101 assets into New Inhibrx. • In November 2024, Kura Oncology, Inc. and Kyowa Kirin
Co., Ltd. announced they have entered into a global strategic collaboration to
develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor,
being investigated for the treatment of patients with acute myeloid leukemia
(AML) and other hematologic malignancies. • In May 2025, PBC Foundation partnered
with pRxEngage as it launched to revolutionise Clinical Trial Access and
Engagement. pRxEngage is a revolutionary platform designed to transform how
clinical trials connect with patients. 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 2034. 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 º Rheumatoid
Arthritis º Multiple
Sclerosis º Osteoarthritis º Irritable Bowel
Syndrome (IBS) º Others • Pain Management º Chronic Pain º Acute Pain • Oncology º Blood Cancer º Solid Tumors º Other • CNS Conditions º Epilepsy º Parkinson’s
Disease (PD) º Huntington’s
Disease º Stroke º Traumatic Brain
Injury (TBI) º Amyotrophic
Lateral Sclerosis (ALS) º Muscle
Regeneration º Others • Diabetes • Obesity • Cardiovascular • Others Immediate Delivery Available | Buy This Premium
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