The global clinical trials market was evaluated at USD 51.17 billion in 2023 and is expected to attain around USD 83.55 billion by 2032, growing at a CAGR of 5.6% from 2023 to 2032. The clinical trials market is observed to expand at a significant rate with the rising rate of research-based activities in the drug development sector.

The clinical trials market is continuously growing due to the continuous need for better human health outcomes. Continuous research, tests, and treatment procedures are conducted during the clinical trials to help develop new medications and treatment procedures. Different test medical interventions that are conducted during these clinical trials include drugs, biological products, preventive care, surgical procedures, behavioral treatments, and radiological procedures. The growth of the market continuously increases due to the occurrence of diseases, improvement of already existing treatment procedures and drugs, and development of new treatments and drugs. Hospitals, research firms, universities, and research laboratories are all involved in clinical trials.

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Key Insights

• The North America clinical trials market is expected to reach at a CAGR of 5.6% from 2023 to 2032.
• The Europe clinical trials market is projected to reach at a CAGR of 5.8% over the forecast period 2023 to 2032.
• The Asia Pacific clinical trials market is expanding at a CAGR of 6.8% over the forecast period.
• By region, North America dominated the clinical trials market in 2023 with revenue share of 51.7%.
• By phase, the phase 3 segment has captured 54.6% revenue share in 2023.
• By study design, the interventional segment dominated the clinical trials market in 2023 with revenue share of 46%.
• By sponsor, the pharmaceutical & biopharmaceutical companies’ segment has generated the largest market share in 2023.

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Regional Stance

North America dominated the clinical trials market in 2023. There are several reasons why North America is dominating, and one of the reasons is the North American Clinical Trials Network. The network is responsible for bringing promising therapy with strong evidence, safety, and effectiveness. The reason is that it focuses on research and development, and the governments also provide support and funding. The U.S. and Canada are among the top countries that conduct research for better health outcomes.

• According to the World Health Organization, the U.S. conducts the most clinical trials, and Canada is among the top 10 countries. According to the NIH, the U.S. registered 30% of studies as of March 2024, equivalent to 147,298 studies. The U.S. also provided 31% of recruiting studies.

Asia Pacific is expected to grow at the fastest rate during the forecast period. Countries like China, Japan, and India are responsible for this growth. According to the World Health Organization, these countries are among the top five countries responsible for conducting clinical trials. India is emerging as a favourable destination for conducting clinical trials. Biopharma companies can utilize the healthcare infrastructure to develop innovative treatments.

• According to the USA-India Chamber of Commerce, the top 20 Pharmaceutical companies have increased their sponsorship of clinical trials by 10%. Novartis, Pfizer, Eli Lilly, AstraZeneca, and J&J are the top five companies that will sponsor clinical trials in India.

Report Highlights

The phase 3 segment dominated the clinical trials market in 2023. Phase 3 studies are conducted on a larger population in different regions and countries. It is one of the biggest steps in clinical trials, after which the products, treatments, and procedures are approved. It requires the involvement of different stakeholders on a global level, which is why it has prominent growth in the market.

The interventional segment dominated the clinical trials market in 2023. Interventional trials are essential to check an intervention’s impact on people. It helps in understanding the effectiveness and negative impact of the intervention, which helps determine whether it can be used on a large scale or not. Interventional trials are essential for approving new drugs, treatments, and procedures, making it a dominating market segment.

The expanded access segment is expected to grow at the fastest rate during the forecast period. This trial is mostly conducted on people who have life-threatening diseases and are not qualified for the clinical trial. The growth of this segment is increasing due to the increased number of various diseases, including chronic conditions, which become worse with time. The increased number of aged populations is another reason for the growth of those who require immediate clinical attention due to the severe conditions that occur in old age.

• UCI Health started a newly expanded access protocol program for ALS drug testing in September 2023, during which the first participant was enrolled. The program is supported by the AxeALS Foundation, AMG Center for ALS, and Sean M. Healey.

The oncology segment dominated the clinical trials market in 2023. The increased number of cancer patients and the need for developing new drugs, treatments, and therapy procedures are needed. Cost reduction is essential when it comes to cancer treatment in order to make it affordable for middle and lower-class people. Cancer is among the top causes of death worldwide.

• According to the World Health Organization, around 734000 people are diagnosed with cancer every year, and by 2040, the number will rise by 50%.
• According to the WHO, the highest number of clinical trials are conducted on cancer, with 16,665 trials on neoplasm or uncertain and unknown behavior, 15,047 trials on malignant neoplasms, 14,236 trials on breast cancer, 11,214 trials on the trachea, bronchus, and lung cancer, 9888 trials on lymphomas & multiple myeloma, 9617 trials on colon & rectum cancer, and so on from 1999 to 2022.

The cardiovascular segment is growing at the fastest rate during the forecast period. Cardiovascular is the leading cause of death worldwide and needs continuous research to reduce the impact. The WHO says that 17.9 million people die due to cardiovascular diseases every year.

The pharmaceutical & biopharmaceutical companies segment dominated the clinical trials market in 2023 and is expected to sustain the dominance in the market during the forecast period. Drug testing is one of the major parts of clinical trials in which new drugs are tested and approved by the FDA, which is launched by the pharmaceutical & biopharmaceutical companies for commercial use; therefore, such companies sponsor.

• In the U.S., 37 novel drugs were approved by the FDA in 2022, out of which 20 drugs were developed for rare diseases.

Market Dynamics

Driver: Continuous need for new drugs and treatments

The continuous need for research and development of treatments and drugs to improve health outcomes drives the clinical trials market. Continuous research is needed to check the effectiveness and side effects of new or existing treatments. The evolving nature of diseases and the occurrence of new diseases need research and clinical trials. Trials are also helpful in diagnosing disease early at asymptomatic stages, which is useful in preventing the disease before it becomes severe. Without clinical trials, it would be unethical and unsafe to launch new treatments and drugs on the market.

Restraints

High cost of conducting trials

Clinical trials are divided into various phases, and each phase requires a lot of resources and manpower. Many trials are very lengthy, and it may take years to develop a product or treatment and finally get approved by the FDA, which increases the cost of the entire trial, making it a negative factor for the growth of the clinical trials market.

Lack of participants and skilled professionals

Clinical trials are conducted on people suffering from a disease as well as people who are healthy. It is difficult to convince people to participate in clinical trials, especially if they involve new drugs or treatments because they fear adverse effects that can occur during the procedure. Apart from this, a lot of skilled professionals are needed to conduct procedures. A lot of skills are needed during different stages, which becomes more important if the procedures and products are novel. The lack of participants and skilled professionals is among the leading causes of restraints in the clinical trials market.

Opportunities

Need for personalized medicines and treatments

The importance of personalized medicine has been recently understood, and research is ongoing in this field. Personalized medicines are highly specialized and effective and are developed on the basis of an individual’s needs, genetic materials, habits, lifestyle, and so on. Not only does the person-centric approach increase the speed of recovery, but it also impacts the overall quality of life. Clinical trials are essential to developing such person-centric treatments, and the trials can be improved with the help of evidence-based approaches and technological advancements.

• For instance, in September 2023, Deep 6 AI launched an AI-powered genomics module for the acceleration of precision medicines and oncology clinical trials. The module will analyse genomic data from the entire electronic medical record and help the professionals find patients with specific genetic markers in real time.

Technological advancements

Technological advancements boost the growth of the clinical trials market by simplifying and improving procedures, improving accuracy, reducing workload, simplifying data, providing suggestions, reducing the need for skilled professionals, and providing ideas. Artificial intelligence, machine learning, the Internet of Things, and cloud computing were utilized during the trials. These technologies have the power to change the way procedures have been done up until now and how they will be conducted in the future.

• For instance, in February 2024, Castor collaborated with Microsoft to incorporate AI in clinical trials. A modular and patient-centric AI-based platform will be provided that will reduce the burden on study teams, sponsors, and patients.

Recent Developments

• In March 2024, the first U.S. CAR T-cell clinical trial was launched by Seattle Children’s Hospital for children under 18 who are suffering from lupus.
• In February 2024, Trial Media, a clinical trial recruitment and retention company, launched an online portal. The portal’s purpose is to enable people worldwide to participate in clinical trials.
• In February 2024, the National Cancer Institute (NCI) took the initiative to tackle the issue of declined participation in clinical trials. NCI launched the NCI Virtual Clinical Trials Office, which will enable trials to be conducted remotely.
• In August 2023, WHO launched a global stakeholder survey. The survey will provide solutions to strengthen the infrastructure and capacity needed for clinical trials.
• In November 2023, the UK launched medicines schemes for clinical trials worth £400 million. This will accelerate the country’s clinical trials industry and try to save £14 billion over five years.

Top Players contending in the Market:

• Parexel
• IQVIA
• Charles River Laboratory
• Omnicare
• Kendle
• Chiltern
• Pharmaceutical Product Development, LLC

Major Market Segments Covered:

By Phase

• Phase 1
• Phase 2
• Phase 3
• Phase 4

By Study Design

• Observational
• Interventional
• Expanded Access

By Indication

• 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

By Service Type

• Protocol Designing
• Patient Recruitment
• Laboratory Services
• Site Identification
• Bioanalytical Testing Services
  • Cell-based Assays
  • Virology Testing
  • Method Development, Optimization, & Validation
  • Serology, Immunogenicity, & Neutralizing Antibodies
  • Biomarker Testing Services
  • PK/PD (Pharmacokinetics/Pharmacodynamics) Testing Services
  • Others
• Analytical Testing Services
• Clinical Trial Supply & Logistic Services
• Clinical Trial Data Management Services
• Decentralized Clinical Services
• Medical Device Testing Services
• Others

By Sponsor

• Pharmaceutical & Biopharmaceutical Companies
• Medical Device Companies
• Others

By End User

• Hospital
• Laboratories
• Clinics

By Application

• Vaccine
• Cell & Gene Therapy
• Small Molecules
• Others

By Geography

• • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa (MEA)

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