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December 2024
The global clinical trials market size is calculated at USD 54.39 billion in 2024 and is expected to be worth USD 94.68 billion by 2034, expanding at a CAGR of 5.7% from 2024 to 2034.
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R&D spending on pharmaceutical companies helps in the innovation of new drug development-boosting clinical trials market.
A clinical trial is a collection and integration validation of clinical trial data. 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. Clinical trials are conducted for many reasons to establish the effectiveness and safety of a new medicine or device for human use and research other approaches of using current, approved treatments or standard treatments to make them more usable, more effective, or have fewer negative effects, gain knowledge about how to safely provide treatment to a group for which it has not yet undergone testing, such as youngsters.
The trials also outline the 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 an extensive range of facilities like study design, preclinical evaluations, clinical trial management and planning, autonomous safety data audit, bio-statistical analysis, and several more.
The major challenge of the market is the patient recruitment for clinical trials. Clinical trials require both healthy and diseased patients to assess the safety and efficacy of novel medicinal products. However, the lack of sufficient safety data and risk of adverse effects restricts the participation of subjects in clinical trials, thereby hindering the market.
Another major challenge is the stringent regulatory guidelines. Organizations need to follow the regulations of every country in which the clinical trial is conducted. This makes the process more complex and hampers the market.
Since the COVID-19 epidemic has hampered transportation and population movements all over the world, many clinical trial participants are unable to visit trial locations, while PIs (principal investigators) and other clinical staff are restricted to staying at home. As a result, the COVID-19 pandemic had a minor negative effect on the clinical trials market, 2020 saw a significant setback for the market as fewer or no people were recruited to participate in research trials to prevent contracting the virus. But shortly the sector saw a sharp increase in growth. This is due to an increase in clinical research efforts and a growth in the demand for potent and cutting-edge medications and vaccines. The COVID-19 pandemic has also caused significant changes in the market and redirected many commercial and research organizations’ attention to the creation of novel COVID-19 vaccines and treatments. The expansion of COVID-19-specific services by clinical research organizations is anticipated to contribute to the market's continued growth. The market has been stimulated by large expenditures made to support the manufacturing capacities targeted at completing the necessary production of COVID-19 vaccines and medicines.
Most healthcare, pharmaceutical, biopharmaceutical, and medical device companies continue working on research and development and heavily invest in the development of novel drugs and devices. Pharmaceutical companies highly invest in research and development to deliver high-quality and innovative products for patients. Nowadays top pharma companies are increasing their research and development efficiencies through high investment in R&D and collaborative efforts. The increase in research and development expenditure of pharmaceutical and biopharmaceutical companies is prompting them to opt for providing fully integrated or functional outsourcing services, from the early development phase to the last phase for both drug development and discovery. Big pharmaceutical companies have enormous pressure for a fixed cost of the drugs and time limit for development as they fully involve in outsourcing drugs, most pharmaceutical and biopharmaceutical companies tend to outsource their testing functions during R&D to improve profitability, to meet the timelines involved in drug development, and save costs. The increasing number of drugs required outsourcing various drug development stages to manage capacities and access scientific and process innovations to develop cost-effective and efficient drug molecules. This trend is expected to drive the growth of the clinical trial market. The industry is expected to grow as technologically sophisticated digital solutions become more widely used with several government initiatives. Another factor driving the burden of chronic disease demand for clinical trials is the growing elderly population. With the rising prevalence of chronic diseases, pharmaceutical companies have increased their attention to creating novel treatments for rare or hereditary diseases that necessitate specialized clinical studies. This is expected to accelerate the growth of the sector.
Crucial factors accountable for market growth are:
The increased uptake of cutting-edge medical technologies and the expanding demand for novel pharmaceuticals are driving up demand for the clinical trials sector. Additionally, the high costs and substantially lower approval rates of the medication development process make it exceedingly dangerous for pharmaceutical and biotechnology companies, which restricts the market growth for clinical trials. As a result, contract research organizations (CROs) are increasingly being used to conduct clinical trials, which allows sponsors to focus primarily on the development of new drugs and improves the prognosis for the market. Additionally, the size and number of clinical trials have increased as the commercialization of clinical research spreads from Europe and the US to most of the world. As a result, pharmaceutical companies are under more pressure to meet deadlines. Even huge pharmaceutical companies are finding it challenging to handle the rising workload, which is driving up outsourcing. So, during the projection period, the market is expected to grow as demand for clinical trial outsourcing rises.
The Clinical Trial Market is segmented according to By Phase, By Study Design, By Indication, and By Region. The phases as classified as Phase 1, Phase 2, Phase 3, and Phase 4.
The phase 3 segment recorded the major market stake in the worldwide clinical trials market in 2022 and has garnered a revenue share of more than 55%. Implementation on a large scale is the major reason for the high market share of phase 3. Other factors, such as high cost and the increasing trend of outsourcing, are expected to boost the demand over the estimated period. As of October 2024, around 45,788 phase 3 trials are registered on the clinicaltrials.gov website. Phase 2 clinical trials are anticipated to advance at the maximum CAGR through the forecast period as there is an increase in pharmacokinetics and pharmacodynamics studies. Phase 2 trials are part of the initial studies performed on humans to check the safety and efficacy of the medicinal product. On the clinicaltrials.gov website, 80,842 phase 2 trials are registered as of October 2024.
The requirement for clinical trials in developing diagnostic tests and vaccines for viral diseases such as SARS-CoV-2 has augmented the demand for clinical trials exponentially. Thus, the high incidence of novel viral diseases and ongoing technological improvements in clinical trials are major reasons for the high revenue share of interventional studies. The interventional study segment is expected to grow at a CAGR of 5.4% from 2022 to 2030. The interventional design segment accounted largest market share 46% in 2022.
Constant research on cancer treatment and increasing demand for precision medicine are the major reasons responsible for the high market share of oncology. The oncology segment was valued at USD 25 billion by 2030. The oncology segment accounted for a revenue share of 24% in 2021 and is expected to witness growth at a CAGR of 6.4% over the forecast period from 2022 to 2030.
North America held the largest share of the clinical trials market in 2023. The increasing number of clinical trials, the presence of major pharmaceutical & biotechnology giants, technological advancements, and favorable scientific infrastructure drive the market. Clinical trials in the US are governed by the Food and Drug Administration. The US FDA ensures that clinical trials are designed, conducted, analyzed, and reported according to the laws. Health Canada is responsible for the conduct of clinical trials in Canada. The National Institute of Health invests most of its $48 billion budget in medical research for Americans. In August 2023, Project NextGen by the US Department of Health and Human Services granted $1 billion for COVID-19 vaccine clinical trials and $326 million for monoclonal antibodies.
Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period. The rising incidences of chronic disorders, expanding healthcare infrastructure, increasing number of clinical trials, and increasing investments & collaborations drive the market. Clinical trials are rapidly increasing in developing countries like India, Thailand, Vietnam, Philippines, etc. India reports a surge in phase 2 and 3 clinical trials from 2017 to 2023, growing from 15% to 18%. Similarly, in China, 4,300 clinical trial registrations were done in 2023, accounting for a 26.1% surge from 2022. China also reports an average consistent 16% growth in five-year clinical trials.
Badhri Srinivasan, Head of Global Clinical Operations, Novartis stated that the Indian regulators are modifying regulations to make clinical trials easier, more accelerated, more accessible, etc. India will have more transparency, standardization, and clarity on what the ethics committee can do.
By Phase
By Study Design
By Indication
By Geography
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