Clinical Trials Market Size By Phases (Phase I, Phase II, Phase III, Phase IV), By Study Design (Interventional Study, Observational Study, Expanded Access Study), By Therapeutic Area (Autoimmune Disease, Oncology, Cardiology, Infectious Disease, Dermatology, Ophthalmology), Industry Analysis Report, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2021 – 2027

Industry trends

Clinical Trials Market size was estimated at over USD 42.9 billion in 2020 and is projected to grow at 4.9% CAGR between 2021 and 2027. Increasing prevalence of chronic diseases coupled with growing demand for clinical trials in developing countries is escalating the market growth. Also, the market is driven by rising number of biologics and demand for CRO to conduct clinical trials. Furthermore, several pharmaceutical and biotechnology firms are currently initiating clinical trials for severe infectious and chronic conditions including cancer and HIV that will boost the market expansion.
 

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Clinical trials are large-scale research studies assessing novel tests & treatments and evaluating their effects on human health outcomes. Individuals voluntarily participate in clinical trials to test medical interventions including drugs, medical devices and other biological products. The clinical trials are conducted in four phases and require to be approved before initiation. People of all ages can participate in clinical trials.
 

Rising cases of COVID-19 has led to several disruptions in the healthcare sector while also severely impacting the execution of clinical trials globally. The major setback faced by clinical trials is that they usually deal with vulnerable populations that are at the highest risk of exposure to coronavirus such as geriatric population or patients with pre-existing conditions. Additionally, several clinical trials are noted to have been postponed or suspended amidst operational complications inflicted due to restriction on the movement of individuals. However, impact of COVID-19 pandemic is slowly dissipating over the industry as lockdown conditions have begun to ease in several parts of the world.
 

Growing demand for outsourcing clinical trials to CROs will spur the market value

As the demand for novel drugs and advanced medical devices emerge, the subsequent demand for efficient, fast-paced and reliable clinical trials program is noted to rise. Moreover, with significantly lower rates of approval and high costs associated, the drug development process is extremely risky for biotech/pharmaceutical companies. Therefore, outsourcing the clinical trials program to various contract research organizations (CRO) is identified to offer significant time and cost savings to the pharmaceutical company.  Also, specific CROs are observed to have specific regional penetration.
 

Complex regulatory framework & language barrier in APAC region may slow down the clinical trials market progression

Conducting clinical trials in various countries involves multiple regulatory hurdles that may hamper the market revenue. The regulations can be streamlined with the help of diversified regulatory authorities, but currently, a sluggish operational pace is observed. For instance, the Institutional Review Board (IRB) approval, regulatory, import licensing and contract negotiations are processed simultaneously in certain countries while others are observed to process these separately. This leads to increased time to launch clinical trials, thereby potentially decreasing the industry expansion. In addition, several countries require local language translation, import and export licensing alongside presenting data on local patients. Thus, a complex regulatory framework coupled with a significant language barrier may lower the regional growth.

Growing demand to evaluate the new treatment with existing treatment in phase III will influence the industry growth

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Phase III segment held 49.3% of the market share in 2020 and is predicted to showcase stable growth rate of 4.6% by 2027. Increasing demand to evaluate the new treatment with existing treatment in this phase will fuel the market demand in the upcoming years. Also, the focus of phase III clinical trials is to demonstrate and confirm the preliminary evidence gathered in the previous trials that drug is safe, beneficial and offers effective treatment for the intended indication. Phase III clinical trials determine if the new drug or combination of drugs is better or equivalent to the standard of care.
 

Various advantages associated with interventional study will spur the segment growth

Interventional study segment in the clinical trials market is poised to attain a CAGR of 5.1% through 2027 owing to various advantages associated with this study. The advantages include elimination of recall bias, as the data on exposure is obtained before disease develops. Furthermore, interventional study is amongst the top hierarchical pyramid of evidence, as this study is the better way to measure the efficacy of new intervention. The study is carried for majority of drugs or biologics followed by clinical procedures and device intervention studies, thereby increasing the demand for such studies in the future.
 

Rising prevalence of cancer across the world will increase the clinical activities for disease treatment

Clinical trials market for oncology segment is expected to reach USD 23.4 billion by 2027. Growing incidence of cancer will ultimately increase the new drug development and clinical trial activities for disease treatment, thereby impelling the market growth. Rise in the number of oncology CRO services is another contributing factor in the segment revenue.
 

Extensive drug development activities in the North America region will further fuel the industry progression

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North America clinical trials market size was over USD 23.9 billion in 2020. Increasing focus of pharmaceutical companies on novel drug development for treatment of various chronic diseases is anticipated to foster the industry revenue. Additionally, growing geriatric population is a contributing factor in industry growth. For instance, as per the U. S Census Bureau report, the geriatric population of U.S. aged 65 and above was around 54 million in 2019 and is set to reach 98.2 million by 2060. Such rapidly growing geriatric population suffering from various chronic disorders will surge the demand for medicines/drug therapies. This will ultimately boost the new drug development and clinical trial activities, thereby driving the regional expansion.
 

Adoption of business strategies will pave growth opportunities for companies operating in the market

Prominent players operating in the market include Laboratory Corporation of America Holdings, IQVIA, Pharmaceutical Product Development and PRA Health Science, PAREXEL International and Bioclinica among others. New service launch, partnerships and collaboration are the most adopted business strategies to sustain market position.
 

Some of the recent industry developments:

• In February 2020, PAREXEL International announced that it has completed the acquisition of Model Answers, a consultancy firm. The company has significant experience in developing preclinical pharmacokinetic (PK) and pharmacodynamic (PD) models for effectiveness and neutropenia, scaling to first-in-human studies, then supporting Phase I through to NDA submission. This acquisition strategy is slated to enhance its service offering and increase its industry demand.
   
• In April 2019, Bioclinica announced that it has assembled a team of experts dedicated to non-alcoholic fatty liver disease (NAFLD) and its more advanced form, non-alcoholic steatohepatitis (NASH), to develop therapeutics using medical imaging and other biomarkers in clinical trials. This strategy helped company to increase its industry value.
   

The clinical trials market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2016 to 2027, for the following segments:
 

Market, By Phases

• Phase I
• Phase II
• Phase III
• Phase IV

Market, By Study Design

• Interventional Study
• Observational Study
• Expanded Access Study

Market, By Therapeutic Area

• Autoimmune Disease
• Oncology
• Cardiology
• Infectious Disease
• Dermatology
• Ophthalmology
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • Singapore
  • Malaysia
  • Indonesia
  • Thailand
  • Philippines
• Latin America
  • Brazil
  • Mexico
• Middle East & Africa
  • South Africa
  • Saudi Arabia