As per Vision Research Reports, the global clinical trials market size is expected to surpass around USD 95 billion by 2030 from valued USD 51.78 billion in 2022, expanding growth at a CAGR of 7.07% during forecast period 2022 to 2030.
As per Vision Research Reports, the global clinical trials market size is expected to surpass around USD 95 billion by 2030 from valued USD 51.78 billion in 2022, expanding growth at a CAGR of 7.07% during forecast period 2022 to 2030. High prevalence and increase in incidence rate of chronic diseases and rise in R&D activities in biotechnology & pharmaceuticals industries are projected to drive the global clinical trials market during the forecast period.
Clinical trials are research studies conducted with human participants to evaluate the safety and effectiveness of medical interventions, such as drugs, medical devices, treatments, and procedures. These trials are a critical step in the development of new healthcare interventions and are essential for advancing medical science, improving patient care, and ensuring the safety of new treatments before they are widely used.
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Report Highlights
- North America accounted for 50.7% of the global market in 2021.
- Asia Pacific region is anticipated to grow at the fastest CAGR of 6.8% over the forecast period.
- The Phase III segment accounted for the largest revenue share 53.4% in 2021.
- The interventional design segment accounted 45.7% market share in 2021.
- The expanded access trials segment is expected to register growth at a CAGR of 6%.
- The interventional trials market for autoimmune/inflammation accounted for the largest share with 82.0% in 2021.
- The pharmaceutical & biopharmaceutical companies accounted for the largest share with 70.0% in 2021.
- The oncology segment accounted for the largest revenue share with 23.5% in the global market in 2021 and anticipated to witness the fastest CAGR of 6.3% over the forecast period.
Key features of clinical trials include:
- Research Objective: Clinical trials are designed to answer specific research questions. These questions could relate to the safety, efficacy, dosage, side effects, or optimal use of a new medical intervention.
- Controlled Environment: Clinical trials are conducted in a controlled and regulated environment to minimize biases and ensure the reliability of the results. Researchers follow a detailed study protocol that outlines how the trial will be conducted.
- Phases: Clinical trials are typically conducted in multiple phases:
- Phase 1: Initial testing in a small group of healthy volunteers to assess safety and dosage.
- Phase 2: Testing in a larger group of patients to evaluate effectiveness and side effects.
- Phase 3: Large-scale testing in a diverse patient population to confirm effectiveness, monitor side effects, and compare the new intervention with existing treatments.
- Phase 4 (Post-Marketing Surveillance): Ongoing monitoring of the intervention after it has been approved and is available to the public.
- Randomization and Blinding: Many clinical trials use randomization to assign participants to different groups, and blinding (single-blind or double-blind) to prevent bias in the results. Randomization ensures that each participant has an equal chance of receiving the intervention or a control group treatment.
- Informed Consent: Participants in clinical trials must provide informed consent, which means they are given detailed information about the trial, its purpose, potential risks and benefits, and their rights, and they must voluntarily agree to participate.
- Data Collection: Clinical trials collect and analyze data on a wide range of factors, including participant outcomes, safety, and any side effects. This data is carefully documented and reported to regulatory agencies and the scientific community.
- Regulatory Oversight: Clinical trials are subject to regulatory oversight by government agencies such as the U.S. Food and Drug Administration (FDA) in the United States. Regulatory agencies ensure that trials are conducted ethically, safely, and in accordance with established guidelines.
- Ethical Considerations: Clinical trials adhere to strict ethical principles, including respect for the autonomy and well-being of study participants. These principles are outlined in documents such as the Declaration of Helsinki and the Belmont Report.
Clinical trials are critical for determining whether a new intervention is safe and effective for a specific medical condition. They provide the evidence necessary for regulatory approval, guide treatment decisions, and contribute to the advancement of medical knowledge. Clinical trial results are published in scientific journals and help inform healthcare practices and public health policies.
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Why Clinical Trials?
Clinical trials are essential for a variety of reasons, serving critical roles in medical research, healthcare, and the development of new treatments and therapies. Here are some of the key reasons why clinical trials are conducted:
- Evaluating Safety and Efficacy: Clinical trials are the primary means by which researchers and healthcare professionals evaluate the safety and efficacy of new drugs, medical devices, and treatment strategies. They provide the necessary data to determine whether a new intervention is effective in treating a specific medical condition and whether its benefits outweigh potential risks.
- Advancing Medical Knowledge: Clinical trials contribute to the advancement of medical knowledge by providing insights into disease mechanisms, treatment approaches, and patient outcomes. This knowledge helps researchers and healthcare providers better understand various health conditions and how to manage them.
- Innovative Treatment Development: Clinical trials are instrumental in the development of new and innovative treatments, therapies, and medical technologies. They drive the discovery of novel drugs, medical devices, and surgical procedures that can improve patient care and outcomes.
- Patient Access to Experimental Therapies: Clinical trials provide eligible patients with access to experimental treatments and therapies that are not yet widely available. This can be a lifeline for individuals with serious or life-threatening conditions who have exhausted standard treatment options.
- Regulatory Approval: Before a new drug or medical device can be marketed and used in clinical practice, it must undergo clinical trials to demonstrate safety and efficacy. Regulatory agencies like the FDA (in the United States) require clinical trial data for approval.
- Comparative Effectiveness Research: Clinical trials allow for the comparison of different treatment approaches to determine which one is the most effective and suitable for specific patient populations. This information helps healthcare providers make evidence-based decisions.
- Patient Safety and Monitoring: Clinical trials involve rigorous monitoring and reporting of adverse events and side effects, ensuring that patient safety remains a top priority during the testing of new treatments.
- Quality Control and Standardization: Clinical trials help establish standardized treatment protocols and guidelines, ensuring that healthcare practices are based on the best available evidence. This contributes to consistency and quality in patient care.
- Healthcare Cost Management: By identifying more effective treatments, clinical trials can lead to cost savings in healthcare. If a treatment is proven to be more efficient or has fewer side effects, it can reduce the overall economic burden of a disease.
- Ethical Considerations: Clinical trials are conducted with a strong emphasis on ethical standards and patient rights. Researchers are required to obtain informed consent from participants and adhere to strict ethical guidelines to protect the well-being and autonomy of study subjects.
- Contributing to Scientific Knowledge: The data generated in clinical trials contribute to the body of scientific knowledge, informing future research, clinical practice, and public health policy.
In summary, clinical trials are conducted to assess the safety and effectiveness of new medical interventions, improve patient care, advance medical science, and ensure ethical and evidence-based healthcare practices. They are a crucial component of the healthcare system and play a pivotal role in the development and delivery of healthcare services.
High Prevalence and Increase in Incidence Rate of Chronic Diseases to Drive Market
Chronic diseases such as chronic respiratory diseases (CRD), diabetes, chronic kidney diseases (CKD), cancer, cardiac stroke, and neurological disorders are the leading causes of disability and mortality across the globe. The emergence and outbreak of various infectious and chronic diseases have created challenges and new opportunities for researchers to develop new diagnostic tools, tests, drugs, and vaccines for early diagnosis, prevention, and cure of such diseases. Hepatitis and HIV are the other major infectious diseases. According to the World Health Organization (WHO), as of October 2017, around 71 million people across the world were estimated to have hepatitis C infection. The WHO also stated that 36.7 million people were affected with HIV across the globe. These factors contribute to the growth of the global clinical trials market.
Rise in R&D Activities in Biotechnology and Pharmaceuticals Industries Propels Global Market
Clinical research organizations, diagnostic laboratories, and biotechnology players are engaged in the development of newer diagnostic tests to address the unmet needs in the healthcare industry. The life science industry’s R&D spending is driven primarily by the mass and research intensity of the biopharmaceutical sector, which accounts for nearly 85% of all expenditures. The acceleration in biopharmaceutical R&D innovation, buoyed by several contributing factors such as precision medicine getting into gear in rare diseases, cancer, and autoimmune diseases; immunotherapy, expansion of therapeutic modalities exploiting natural and synthetic biology innovation, and expedited regulatory pathways boost the growth of the clinical trials market.
COVID-19 Vaccines Boosts Market Growth
The coronavirus pandemic has brought research labs and healthcare institutions under great scrutiny for accelerating the clinical trials for COVID-19 vaccines. As such, the success in these clinical trials has led to global recognition of India for supplying several lack of free doses to Brazil, Bangladesh, Algeria, and South Africa. Countries such as Sri Lanka are following suit whilst creating incremental opportunities for stakeholders in the clinical trials market.
The Food & Drug Administration (FDA) is creating awareness about Coronavirus Treatment Acceleration Program (CTAP) in order to bring economies to normal. Companies in the clinical trials market are taking advantage of this program to make new treatments available to patients as quickly as possible.
Digital Health Innovations Give Impetus to IoMT for Enhancing Clinical Development Programs
The proliferation of digital innovations with the help of wearables and sensors is translating into value grab opportunities for companies in the clinical trials market. ICON plc— a clinical research organization company is researching how digital endpoints, including digital biomarkers can improve trial outcomes. This has led to the adoption of digital health technologies that enable appropriate device selection and data strategies.
Digital health innovations hold promising potentials to better manage chronic diseases and improve patient access to healthcare services. Stakeholders and sponsors are taking efforts to improve adherence to medications and prevent its complications in patients. The Internet of Medical Things (IoMT) has the potential to enhance clinical development programs involving med-tech and pharmaceutical companies.
Segment Insights
Phase Insights
The Phase III segment accounted for the largest revenue share in 2021, contributing to 53.4% 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 19.0 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 19.4% in 2021. 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 33.0% 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 45.7% in 2021. It is one of the most prominent methods used in clinical trials. Interventional studies comprised 79.0% 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 94.0% 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 6.0% 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 82.0% in 2021. 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 2021. 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 2020 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, 2021.
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 70.0% in 2021. 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 23.5% in the global market in 2021. The segment is also anticipated to witness the fastest CAGR of 6.3% 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 6.1% 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 65.0% global average decline in the enrollment of new patients year-over-year. An 84.0% 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 50.7% of the global market in 2021 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 6.8% 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.
Key Players
The report provides profiles of leading players operating in the global clinical trials market. These include Laboratory Corporation of America Holdings, IQVIA, Inc., Syneos Health, Parexel International Corporation, PRA Health Sciences, Inc., PPD, Inc., Icon plc, Charles River Laboratories, Inc., WuXi AppTec, and Medpace Holdings, Inc.
Global Clinical Trials Market Segmentation
- Phase Outlook
- Phase I
- Phase II
- Phase III
- Phase IV
- Study Design Outlook
- Interventional
- Observational
- Expanded Access
- Indication Outlook
- 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 Condition
- Epilepsy
- Parkinson’s Disease (PD)
- Huntington’s Disease
- Stroke
- Traumatic Brain Injury (TBI)
- Amyotrophic Lateral Sclerosis (ALS)
- Muscle Regeneration
- Others
- Diabetes
- Obesity
- Cardiovascular
- Others
- Autoimmune/Inflammation
- Indication by Study Design Outlook
- Autoimmune/Inflammation
- Interventional
- Observational
- Expanded Access
- Pain Management
- Interventional
- Observational
- Expanded Access
- Oncology
- Interventional
- Observational
- Expanded Access
- CNS Condition
- Interventional
- Observational
- Expanded Access
- Diabetes
- Interventional
- Observational
- Expanded Access
- Obesity
- Interventional
- Observational
- Expanded Access
- Cardiovascular
- Interventional
- Observational
- Expanded Access
- Others
- Interventional
- Observational
- Expanded Access
- Autoimmune/Inflammation
- Sponsor Outlook
- Pharmaceutical & Biopharmaceutical Companies
- Medical Device Companies
- Others
- Regional Outlook
- North America
-
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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