Clinical Trials Market Share Analysis Report, 2023-2032
The global clinical trials market size was exhibited at USD 51.79 billion in 2022 and is projected to hit around USD 91.87 billion by 2032, growing at a CAGR of 5.9% during the forecast period 2023 to 2032.
Key Pointers:
However, the market growth was hindered in 2020 due to the COVID-19 pandemic. In 2020, Parexel and Synairgen plc formed a strategic collaboration for conducting a Phase III study of an Interferon-beta (IFN-beta) treatment for COVID-19 patients. Such strategic initiatives by CROs are expected to minimize the hindrance and boost the market growth. Hence, the market is expected to grow owing to factors such as globalization of clinical trials, rapid technological evolution, and a rise in demand for CROs for conducting research activities.
The current pandemic has led to changing the ways of conducting ongoing or upcoming clinical trials. Regulatory agencies, such as the U.S. FDA, the European Medicines Agency (EMA), the National Institutes of Health (NIH), and China’s National Medical Products Administration, have issued various guidelines for conducting trials during the pandemic, which completely supports the implementation of virtual services. The current scenario across the globe and the need for several new treatment options have also led to the conducting of fast-track clinical trials.
Clinical Trials Market Report Scope
|
Report Coverage |
Details |
|
Market Size in 2023 |
USD 54.84 Billion |
|
Market Size by 2032 |
USD 91.87 Billion |
|
Growth Rate from 2023 to 2032 |
CAGR of 5.9% |
|
Base year |
2022 |
|
Forecast period |
2023 to 2032 |
|
Segments covered |
Phase, Study Design, Indication |
|
Regional scope |
North America; Europe; Asia Pacific; Central and South America; the Middle East and Africa |
|
Key companies profiled |
By Phase, By Study Design, By Indication, By Service Type, By Sponsor, By End User, By Application |
Clinical Trials Market Dynamics
Driver: Increase in number of clinical trials
This significant growth in the number of clinical trials across the globe is expected to drive the demand for clinical trial services and, in turn, propel market growth. According to the clinical trials registry of the WHO, as of June 2021, North America and Europe accounted for the largest number of clinical trials. US registered more than 30% of the clinical trials by February 2023. Additionally, the frequency of decentralised clinical trials has increased by more than 25% in 2022. Decentralisation of clinical trial elements have offered significant momentum to the number of clinical trials conducted each year.
Challenges: Requirement of unique analytical testing approaches for innovative drug molecules
Over the years, competition in the pharmaceutical and biopharmaceutical market to develop cutting-edge therapies and gain patent exclusivity through quick drug development has increased significantly. In all phases of pharmaceutical and biopharmaceutical development, bioanalytical testing plays a major role and is the most outsourced process among all the chemistry, manufacturing, and control (CMC) activities. CMC data is also pivotal to meet regulatory expectations and acquire Investigational New Drug (IND) approval. The diversity of CMC requirements for biopharmaceutical IND and the development of novel drug delivery systems pose a variety of challenges and require a myriad of analytical methods for testing new drug molecules.
Market Trends: Adoption of artificial intelligence-based tools for drug discovery
Artificial intelligence (AI) and machine learning (ML) make the drug discovery process more efficient and substantially improve success rates at the early stages of drug development. AI algorithms ingest and analyze a vast amount of information and can identify potential drug candidates in shorter periods of time. Deep learning systems can also be used for generating molecules with properties that are likely to be effective against specific diseases without adverse side effects. Such advantages have encouraged the adoption of AI for drug discovery by various pharmaceutical and biotechnology companies. For instance, Benevolent Ltd. (UK) focuses on applying deep learning and natural language processing to understand and analyze large volumes of information for drug discovery.
Phase Insights
The Phase III segment accounted for the largest revenue share in 2022, contributing to 54.9% of the global market. This is because Phase III trials are the most expensive and involve huge subjects. The median cost for a single Phase III trial is around USD 20.0 million with 59 new therapeutic agents approved by the FDA from 2015 to 2016. Also, Phase III requires a higher number of patients and often a longer treatment period. The Phase II segment followed in terms of market share accounting for 21.7% in 2022. It is also the second most expensive stage after Phase III. This study is performed in two parts; the first part includes exploring a range of doses along with efficacy studies and the second part includes finalizing the dose.
Phase II plays a crucial role, especially in oncology-related studies. The FDA estimates that about 34.0% of the medications are usually under Phase II trial. Moreover, there are various therapeutics and vaccines currently in Phase II that are indicated for the treatment of COVID-19, thereby boosting the market growth. For instance, currently, there are 43 therapeutics under Phase II for COVID-19. Companies engaged in the development of these vaccines are AstraZeneca plc; Arch Biopartners, Inc.; Applied Therapeutics, Inc.; Apeiron Biologics GmbH; 4D Pharma plc; AB Science SA; and others.
Companies are collaborating to accelerate the development of therapeutics and vaccines. For example, Eli Lilly partnered with AbCellera for the development of vaccines; GSK, Novartis, and MSD are working with the Bill & Melinda Gates Foundation; and GSK and Sanofi are working together to develop an adjuvanted COVID-19 vaccine.
Study Design Insights
The interventional design segment dominated the market and accounted for the largest revenue share with 46.9% in 2022. It is one of the most prominent methods used in clinical trials. Interventional studies comprised 80.0% of the total registered studies as of May 2020, out of which the majority of studies were for drug or biologics, followed by behavioral, clinical procedure, and device interventional studies. These studies contribute to 95.0% of the total studies that posted results, out of which drug or biologics contribute the most, followed by behavioral, devices, and clinical procedure intervention studies.
The expanded access trials segment also referred to as compassionate use trials, is anticipated to register a CAGR of 6.1% during the forecast period. It is a potential pathway for patients with serious disease conditions to carry out treatment outside the trial when no satisfactory therapies are available. Increasing innovation in clinical trial methods is projected to drive the expanded access trials segment. For example, numerous oncology drugs are regularly administered to patients before their approval by the U.S. FDA and are considered part of the expanded access trial. Currently, there are 20 COVID-19 drugs in expanded access trials/compassionate use in Phase II/III.
Some of the companies currently engaged in expanded access trials include Incyte Corp.; Novartis AG; Capricor Therapeutics, Inc.; Alexion Pharmaceuticals, Inc.; Bellerophon Therapeutics, Inc.; Algernon Pharmaceuticals Inc. and its subsidiary Nash Pharmaceuticals; and Ansun Biopharma, Inc.
Indication by Study Design Insights
The interventional trials market for autoimmune/inflammation accounted for the largest share with 83.11% in 2022. This can be attributed to a large number of interventional studies on autoimmune/inflammation worldwide. The growth can also be attributed to advantages of interventional studies, such as minimization of the effects of confounding, avoidance of bias in allocation to exposure groups, and efficient detection of small to moderate clinically important effects. There are over 7,000 interventional studies listed on clinicaltrails.gov related to autoimmune/inflammation.
The observational trials market for autoimmune/inflammation accounted for the second-largest share in 2022. Out of the total autoimmune/inflammation studies listed on clinicaltrials.gov, more than 2,000 are observational. The expanded access segment accounted for the lowest share for autoimmune/inflammation in 2021. There are fewer than 40 expanded access studies as of 2021 for autoimmune/inflammation. For instance, there is an ongoing expanded access study titled “Expanded Access Protocol Thymus Transplantation for Immunodeficiency, Hematologic Malignancies, and Autoimmune Disease Related to Poor Thymic Function” as of March 7, 2022.
Sponsor Insights
The report further provides a deep dive into the sponsors of the industry, wherein it was identified that pharmaceutical & biopharmaceutical companies accounted for the largest share with 71.14% in 2022. This can be attributed to the greater interest of the pharmaceutical industry in the research field. In addition, there has been an increase in the number of clinical trials funded by pharmaceutical & biopharmaceutical companies. The pharmaceutical industry plays a vital role in financing the research for the development of new drugs.
Although grants from the National Institutes of Health (NIH) fund most of the basic research in academic laboratories, it is largely the industry that bears the cost of identifying new molecular entities and testing them on animal models and human subjects. Clinical studies account for the major portion of the estimated cost, ranging from USD 266 million to USD 802 million for bringing each new drug to the market. Currently, in the U.S., around 75% of all funding for clinical studies is received from corporate sponsors.
Indication Insights
The oncology segment accounted for the largest revenue share with 24.9% in the global market in 2022. The segment is also anticipated to witness the fastest CAGR of 6.4% over the forecast period. As per U.S. FDA and various other sources, more than USD 38.0 billion is currently being spent by the pharmaceutical industry on the preclinical and clinical development of oncology therapy products. The cardiovascular condition segment is also anticipated to witness lucrative growth at a CAGR of 6.2% over the forecast period. The growing prevalence and increased demand for cost-effective medications worldwide have led to significant investment in R&D in this segment with more than 190 drugs in the pipeline.
The majority of the drugs in the pipeline are indicated for heart failure, lipid disorders, vascular diseases, and stroke. Growing demand for cost-effective medicines in low- and middle-income countries is expected to boost the R&D investment by the government, thereby strengthening the market growth. However, the current pandemic has hindered clinical trials in finding effective treatments and cures. At least 18 pharma or biotech companies have reported disruption in clinical trials due to the pandemic. In March 2020, there was around a 66.0% global average decline in the enrollment of new patients year-over-year. An 85.0% and 43.0% decrease was reported in India and Japan, respectively, whereas the U.S. exhibited a decline of 67.0%.
Regional Insights
North America accounted for 51.16% of the global market in 2022 and is expected to continue its dominance over the forecast period. This can be attributed to an increase in R&D investments and a rise in the adoption of new technologies in clinical trials in this region. For instance, the implementation of virtual services in various stages of clinical trials by market players, such as IQVIA and PRA Health Sciences, is anticipated to further fuel the North American market growth.
Moreover, favorable government support in the U.S. market for clinical trials is anticipated to boost the demand. For instance, in March 2020, the FDA launched a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to accelerate the development of treatment for global diseases caused by the coronavirus. The program employs every available way to provide novel treatment to patients as rapidly as possible, simultaneously finding out whether they are harmful or helpful.
Asia Pacific region is anticipated to grow at the fastest CAGR of 6.9% over the forecast period owing to the availability of a large patient pool allowing easy recruitment. The global pandemic is one of the major factors driving the market. The Asia Pacific’s largest, expertized biotech CRO “Novotech”, has reported an increase in demand from biotechnology sponsors for studies due to good quality and quick turnaround. An increasing number of biotechnology firms prefer the APAC region for conducting COVID-19 trials to leverage a large patient pool and fast-track procedures.
Some of the prominent players in the Clinical Trials Market include:
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global Clinical Trials market.
By Phase
By Study Design
By Indication
By Service Type
By Sponsor
By End User
By Region
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers