Clinical Trials Market Growth Report | Size & Share 2028

The clinical trials market size market was valued at US$ 55,051.94 million in 2022 and is projected to reach US$ 76,023.44 million by 2028; it is estimated to record a CAGR of 5.5% from 2023 to 2028.

Market Insights and Analyst View:

Clinical trials are research studies conducted to test a medical, surgical, or behavioral intervention in people. These clinical research trials are the primary ways of determining the safety and effectiveness of a new treatment or prevention (such as a new drug, diet, or medical device) in people. A clinical trial is often designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.

The clinical trial market is mainly driven by continuous efforts made by pharmaceutical and biotechnology, and medical device companies for product innovations. Other factors contributing to the market progress include the globalization of clinical trials, rapid advancements in associated technologies, and increased demand for CROs for conducting clinical trials. Furthermore, conferences such as “Global Clinical Trials Connect 2022” offer companies in this marketplace with a platform to get acquainted with advancements in clinical trials and clinical research. However, the rapidly increasing costs of conducting trials hinder the clinical trial market growth.

Growth Drivers and Challenges:

Increasing Adoption and Outsourcing of Clinical Trials

Clinical trials are performed to determine the safety, effectiveness, and efficacy of new treatments, prevention methods, and medical devices. The trials are mainly carried out during drug development. According to the data provided by the National Library of Medicine (NLM), ~52,000 new studies were registered with NLM (ClinicalTrials.gov) in 2020, which increased to ~58,000 in 2023. In January 2023, the NLM reported 38,837 active clinical trials in the US and 105,172 active trials worldwide. According to the European Medicine Agency, ~4,000 clinical trials are authorized annually in the European Union (EU), of which ~60% of clinical trials are associated with the pharmaceutical industry. An increasing number of clinical trials for developing different effective treatments due to the rising prevalence of chronic diseases globally is fueling the growth of the clinical trials market. Further, clinical trials are highly complex processes. Research-based organizations may fail to properly execute these processes or oversee the operations. To avoid errors due to improper execution, research-based organizations outsource clinical trials to clinical research organizations (CROs), which utilize their high-quality facilities and deep subject matter expertise to carry out clinical trials. CROs have begun acting as a backbone of the clinical trial industry through their efficient and cost-effective operations benefitting trial sponsors. According to a blog published on the Thermo Fisher Scientific website, in 2022, ~3 out of 4 clinical trials were carried out by CROs to reassure the clinical programs of drug developers, provide a wealth of expertise, drive time and cost efficiencies, and deliver customized, high-quality data. Thus, the development of cost-effective solutions and decreasing errors in CROs during the drug development process are among the factors driving the clinical trials market size.

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Clinical Trials Market: Strategic Insights

Market Size Value in	US$ 55,051.94 million in 2022
Market Size Value by	US$ 76,023.44 million by 2028
Growth rate	CAGR of 5.5% from 2023 to 2028
Forecast Period	2023-2028
Base Year	2023

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Expensive and Time-Consuming Process

The rising number of therapeutic molecules in the last phases of clinical trials has cost money and valuable time invested in the research and development of new drugs. According to the article “Importance of ADME/Tox in Early Drug Discovery,” published in year 2022, considering the current drug discovery and development pipeline, out of 1,000 molecules, only 10 screened hits are projected to enter the preclinical testing stage, and only 9.6% will enter clinical trials. The drug approval process is projected to take 15 years on average, and phases II and III are the most expensive phases of clinical trials. The preapproval expenditures for a drug is as high as US$ 2.56 billion, which further increases to US$ 2.87 billion in the post-approved stage. According to the study titled “Why 90% of Clinical Drug Development Fails and How to Improve It?”, published in year 2022, 90% of clinical drug development fails despite the implementation of many strategies. After entering clinical investigations, nine out of ten drug candidates fail during phase I, II, and III clinical trials and the drug approval process. Drug candidates rejected in preclinical stages are not included in the 90% failure rate of the drugs in clinical stages, as they don’t even enter the phase I clinical trials. If preclinical drug candidates are considered, the drug discovery and development failure rate will rise above 90%. New drug development is resource and time intensive, whereas later clinical stages result in significant costs. The discovery and development of each new drugs approved for clinical use is a lengthy, expensive, and challenging process that takes over 10–15 years and costs, on average, over US$ 1–2 billion. Due to such high investment costs for developing drugs or medical devices, limited companies invest in clinical trial processes, which is hampering the growth of the clinical trials market.

Report Segmentation and Scope:

The “Global Clinical Trials Market” is segmented based on study design, phase, indication, and geography. Based on study design, the clinical trials market is segmented into interventional, observational, and expanded access. Based on phase, the clinical trials market is segmented into Phase I, Phase II, Phase III, and Phase IV. Based on End Use, the clinical trials market is segmented into autoimmune/inflammation, pain management, oncology, CNS condition, diabetes, obesity, cardiovascular and others.

The clinical trials market based on geography is segmented into North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Russia, and Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America)

Segmental Analysis:

Based on study design, the clinical trials market is into interventional, observational, and expanded access. The interventional segment held the largest share of the market in 2022, whereas the same segment is anticipated to register the highest CAGR of 5.8% in the market during the forecast period. An interventional study is a type of clinical research study wherein human participants receive one or more interventional drugs/treatments for a specific period to evaluate the effects of the drug/treatment on health. New potential drugs/medical devices/therapies must pass through phases of interventional testing to prove they are safe and effective before receiving approval from the Food and Drug Administration (FDA). Most of the interventional studies are placebo-controlled, where a group of participants receives a placebo, and the other group receives a drug under investigation. Researchers then compare the two groups to evaluate the drug's effectiveness under investigation.

Global Clinical Trials Market, by Study Design– 2022 and 2028

Phase Insights

Based on phase, the clinical trials market is segmented into Phase I, Phase II, Phase III, and Phase IV. The Phase III segment held the largest share of the market in 2022 and is estimated to register the highest CAGR in the market during the forecast period. Phase III clinical trial stage is carried out in large patient groups. The stage assists in determining the short-term and long-term efficacy of the active pharmaceutical ingredients. Thus, the assessment is done to know the total and associated therapeutic values of formulated drug. It is essential to maintain the efficacy, safety, and accuracy of the drug used in phase III clinical trials, which otherwise may adversely affect the patients under trials. Shertech Manufacturing offers phase III clinical trial services and comprehensive, definitive data related to efficacy and side effects to its customers. It also assists in complying with FDA standards that help introduce the drug into the market and complete the required licensing applications.

Indication Insights

The clinical trials market, by indication, has been segmented into autoimmune/inflammation, pain management, oncology, CNS condition, diabetes, obesity, cardiovascular disease, and others. The oncology segment held the largest clinical trial market share of the market in 2022 and is estimated to register the highest CAGR in the market during the forecast period. The increasing prevalence of cancer and the rising geriatric population contribute to the clinical trials market growth for the oncology segment. The American Cancer Society has estimated that in 2023, around 1,958,310 new cancer cases and 609,820 cancer deaths will occur in the US. Despite the significant progress in cancer diagnosis, prevention, and treatment procedures, there is a significant unmet medical need for treatments for primary cancers (e.g., prostate, lung, breast, and colon cancer). This is likely to increase cancer research and development activities. Pharmaceutical companies are focusing on developing new drugs to meet consumer needs. A clinical trial conducted in Tata Memorial Hospital, Mumbai, India, has found that an ultra-low dose of the immunotherapy drug nivolumab (Opdivo) was added to the standard treatment for head and neck cancer, which helped the patients to live longer.

Regional Analysis:

Based on geography, the clinical trials market is segmented into North America (US, Canada, and Mexico), Europe (UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East (UAE, Saudi Arabia, South Africa, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America). North America accounted for the largest clinical trials market share during the forecast period. Asia Pacific is expected to register the fastest CAGR in the clinical trials market during the forecast period. China, Japan, and India are the prime contributors to the market in APAC. Thus, the clinical trials market in APAC is driven by growing investments from international players, burgeoning government support, and advancing healthcare infrastructure.

Industry Developments and Future Opportunities:

• In January 2023, Rznomics announced a partnership with Charles River Laboratories International, Inc., a viral vector contract development and manufacturing organization (CDMO). Rznomics would leverage Charles River’s viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.
• In March 2023, LEO Pharma and ICON plc announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution in a patient-centric and cost-effective way. The partnership would also support LEO Pharma’s overall ambition of building one of the most effective and efficient clinical portfolio execution organizations in the industry.
• In February 2023, Syneos Health partnered with Haystack Health, a Roivant Health portfolio company engaged in developing advanced artificial intelligence (AI) and natural language processing (NLP) solutions to improve the identification and enrollment of patients for clinical trials.
• In February 2023, Parexel launched a new expert series, New Medicines, Novel Insights. The series features fresh insights from the company’s global, cross-functional experts analyzing drug development trends and offering evidence-based guidance to the biopharmaceutical industry.

Competitive Landscape and Key Companies:

IQVIA Holdings Inc, Parexel International Corp, IXICO Plc, Charles River Laboratories International Inc, ICON Plc, WuXi AppTec Co Ltd, SGS SA, Syneos Health Inc, SIRO Clinpharm Pvt Ltd, Thermo Fisher Scientific Inc, and Laboratory Corp of America Holdings are among the major clinical trials companies in the global market. These companies have been implementing various strategies that have helped their growth and, in turn, have brought about various changes in the market. The companies have utilized organic strategies such as launches, expansions, and product approvals and inorganic strategies such as product launches, partnerships, and collaborations.