Clinical Trials Market (By Phase: Phase 1, Phase 2, Phase 3, and Phase 4; By Study Design: Observational, Interventional, and Expanded Access; By Indication: Oncology, Autoimmune/Inflammation, Diabetes, Central Nervous System, Cardiovascular, Pain Management, and Others) - Global Market Size, Share, Trends Analysis, Segment Forecasts, Regional Outlook 2024 - 2033
The global clinical trials market size was valued at USD 57.37 billion in 2023 and is predicted to hit USD 90.59 bn by 2033 with a registered CAGR of 4.67% during the forecast period 2024 to 2033. The U.S. clinical trials market size was valued at USD 27.81 billion in 2023.
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Key Market Insights:
Clinical trials are a process of clinical research that is governed by a defined protocol which is carefully established to answer a precise patient care query. Clinical trials can be divided into five phases, with every phase playing a distinct purpose within the clinical trial. Every trial adheres to a procedure that designates what types of individuals may participate in the study.
The trials also outline exact plan of procedures, tests, medications, and doses within the trial apart from specifying the span of the study. In recent years, the costs associated with drug development have increased significantly, driving pharma and biotech companies to look for modernizations and smarter ways of conducting business.
One important trend is the outsourcing of clinical research activities by manufacturers. By subcontracting their R&D activities, pharma and biotech companies are reforming the drug development facilities business. The R&D service providers have risen from just a few establishments providing restricted clinical trial facilities to big conglomerates offering a extensive range of facilities like study design, preclinical evaluations, clinical trial management and planning, autonomous safety data audit, bio-statistical analysis and several more. CROs (Contract Research Organizations) started off by providing preclinical & clinical trial services, however they are now venturing into project administration.
Crucial factors accountable for market growth are:
The U.S. clinical trials market size was estimated at USD 27.81 billion in 2023 and is expected to reach around USD 39.24 billion by 2033 with a CAGR of 3.50% from 2024 to 2033.
The research study covers key prospects and trends of clinical trials products throughout different regions including Europe, North America, Asia-Pacific, Middle East and Africa, and Latin America. Regionally, clinical trials market is dominated by North America due to high incidence of chronic disorders and presence of latest healthcare infrastructure. North America accounted largest revenue share 53.48% in 2023.
On the other hand, Asia-Pacific is anticipated to witness the rapid growth rate 7.16%, on account of increasing investment by governments in research and growing awareness regarding precision medicine.
| Report Highlights | Details |
| Market Size | USD 90.59 Billion by 2033 |
| Growth Rate | CAGR of 4.67% from 2024 to 2033 |
| Largest Market | North America |
| Fastest Growing Market | Asia Pacific |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Phase, Study Design, Indication |
| Companies Mentioned | Parexel, IQVIA, Charles River Laboratory, Omnicare, Kendle, Chiltern, and Pharmaceutical Product Development, LLC. |
ADOPTION OF NEW TECHNOLOGY IN CLINICAL RESEARCH
Digitization in biomedical research is also paving the way for the market growth. Digitization also helps in meeting stringent regulations by maintaining patient data records that reduces trial process errors through adoption of software such as electronic clinical outcome assessment (e-COA). Digitization helps in streamlining the clinical trial process thereby probing sponsors to invest more in the clinical trial process as chances of successful clinical trials are more through the adoption of newer technologies.
SHIFT TOWARDS PERSONALIZED MEDICINE
The paradigm shift towards personalized medicine is expected to have a positive impact on the clinical trial market. The classic clinical trial process is carried out on thousands of people while personalized medicine will focus only on the effect of drugs on individual patients for a specific period. Very few medicines in the development phase pass all phases of a clinical trial due to the traditional clinical trial approach. The mentality of “one size will fit all” is acting as a barrier for drugs that are currently in pipeline but would never see the day. The use of pharmacogenetics in the clinical trial process is expected to increase the number of drugs passing all phases of the clinical trial process. The shift towards personalized medicine is expected to increase the use of pharmacogenetics in the clinical trial phase thereby increasing the pipeline of drugs. This trend is expected to instigate biopharmaceutical companies to invest more in the clinical trial phase.
GROWING DISEASE VARIATION AND PREVALENCE
Growing prevalence of disease and incidence of new disease is expected to give further boost to the clinical trial market. Worldwide population has varied disease profile with emerging countries having the most diverse disease profile. This is expected to boost the clinical trial of new or rare disease which otherwise would not have found any sponsors. More number of patients having a specific disease would act as a stimulus for biopharmaceutical companies to invest more in clinical trials for a disease segment. Diverse population would also mean easy recruitment of patients and faster clinical trial process. Rare diseases are given a status of “Orphan disease” in U.S and biopharmaceutical companies who sponsor clinical trials for Orphan drugs would get incentives for the process. This trend is likely to have a positive impact on clinical trials for rare disease thereby increasing the global clinical trials market.
INCREASING COLLABORATION IN BIOMEDICAL RESEARCH
The trend of combination trials and collaborations in clinical trial is expected to rise which would further boost the global clinical trials market. Due to high drug development cost biopharmaceutical companies are now forming an alliance with each other to increase the resources and share the risk of high cost. Immuno-oncology collaborations in 2015 is a prime example of increase collaboration to combat risk associated with clinical trials. Recent example of immuno-oncology collaboration is of MSD and Lily for clinical trial phase for treatment of advanced soft tissue sarcoma.
The race to launch the molecule in the market in a feasible timeline and cost will propel the need for CROs service provides. The pharmaceutical companies, along with the increased research cost, also witness global regulation complexity. All of these variables create a need for expertise in different portfolios, driving the need for outsourcing the market. Drug companies are not only outsourcing the production of medicines but also clinical trials. With the increasing clinical trial privatization, there is a surge in outsourcing to developing countries such as India, China, and Latin America.
The phase 3 segment held the largest share in clinical trials market in 2023. The phase 3 clinical trials market includes a wide range of activities associated with the last phase of testing for novel medications, medical devices, and treatments prior to their approval for use by the general public by regulatory bodies such as the European Medicines Agency (EMA) in Europe or the Food and Drug Administration (FDA) in the United States. Phase 3 trials demand a substantial time and financial commitment. To support these studies, companies frequently look to investors, venture capitalists, or government grants for funding. Risk management is considerably more important in Phase 3 studies because a larger and more diversified patient group is being tested.
On the other hand, the phase 2 segment is expected to be the fastest growing market. One important phase in the medication development process is the phase 2 stage of clinical trials. Phase 1 trials come after it, while Phase 3 trials come first. In phase 2, the main goals are to further analyze the safety profile of the drug candidate and determine how effectively it works in treating the intended condition or disease. The development of orphan medications and therapies for uncommon diseases is receiving more attention. In order to examine these innovative medicines in smaller patient populations, phase 2 trials are essential. Pharmaceutical companies frequently use CROs to handle their clinical trial operations in order to take advantage of their infrastructure and experience. This tendency of outsourcing helps fuel the market expansion for phase 2 clinical trials.
The interventional studies segment held the largest share in the clinical trials market. In the clinical trials market, interventional studies are a particular subset of clinical trials that are intended to assess the efficacy and safety of novel medical procedures, therapies, or interventions. These studies are usually carried out with human subjects in order to collect information about the possible advantages and disadvantages of the intervention under study. Evaluating the efficacy and safety of novel medical devices, such as implantable gadgets, diagnostic tools, or surgical instruments, is the goal of clinical trials. In certain interventional research, a combination of intervention, such as a novel medication used in conjunction with an established therapy—may be tested to see if the combined strategy produces better results than either treatment alone.
The observational studies segment is expected to be fastest growing market. Because observational studies offer important insights into real-world patient experiences, treatment outcomes, and disease trends, they are vital to the clinical trials market. Researchers can collect information on a variety of aspects of health and disease through these investigations, which usually include observing people in their natural habitats without intervention. Studies that compare the efficacy of various therapies or interventions in actual environments are observational in nature. Through the examination of various outcomes, including survival rates, disease progression, and quality of life, scientists can determine which medicines work best for specific patient populations. Observational studies look at healthcare inequities, resource use, and delivery systems. Researchers can determine areas where healthcare delivery needs to be improved by examining variables including patient outcomes, healthcare costs, and access to care.
The oncology segment holds the largest share in clinical trials market. A subset of the pharmaceutical and healthcare industries, the oncology clinical trials market is dedicated to carrying out research studies, or clinical trials, for novel medications, therapies, or treatments that are intended especially for cancer patients. Through assessing the safety and effectiveness of novel treatments prior to their approval for general use, this market is essential to the advancement of cancer research and the improvement of patient care. The value of patient participation in clinical research is becoming increasingly apparent. More patient-centered trials are being conducted as a result of the active participation of patient advocacy groups and organizations in clinical trial design and recruiting. Pharmacies are progressively carrying out clinical studies in a variety of geographical locations in order to reach a wider patient base, cut expenses, and expedite the medication development process.
The cardiovascular segment is expected to be fastest growing market. The market for cardiovascular clinical trials includes a wide range of research projects aimed at evaluating novel therapies, drugs, and medical equipment for different cardiovascular ailments. These studies are crucial for expanding our understanding of medicine, enhancing patient care, and getting new treatments approved by regulators. The need for clinical trials to create more potent therapies and interventions is fueled by the increased prevalence of cardiovascular illnesses (CVDs), which include heart disease, stroke, hypertension, and other conditions. As stakeholders work to alleviate the burden of cardiovascular diseases on healthcare systems, rising healthcare spending, especially in industrialized nations, makes funding for cardiovascular clinical trials easier. Expanding healthcare facilities and the increased incidence of cardiovascular disorders in developing nations offer chances to carry out clinical trials in areas with a variety of patient demographics and possibly reduced running expenses.
In order to better recognize the current status of clinical trials, and policies adopted by the foremost countries, Precedence Research predicted the future evolution of the clinical trials market. This research study bids qualitative and quantitative insights on clinical trials market and assessment of market size and growth trend for potential market segments.
Major Market Segments Covered:
By Phase
By Study Design
By Indication
By Geography
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