The clinical trials market is projected to register a CAGR of 5.05% during the forecast period, with a revenue of approximately USD 38,213.3 million in 2020 and expected to reach USD 51,356.0 million by 2026.
The major factors found propelling the growth of the market include the high demand for clinical trials in emerging markets, high R&D spending of the pharmaceutical industry, an increasing prevalence of diseases, and the focus on rare diseases and multiple orphan drugs in the pipeline.
The COVID-19 pandemic has tremendously impacted the market for clinical trials, as there has been a rising focus on the development of new therapeutics or vaccines to curb or treat the disease. Also, COVID-19 has brought a slight shift in terms of the way clinical trials were performed. In the clinical trial space, usually, there has been an increased interest in virtual/decentralized trials and those have been featured on conference agendas and in magazine articles for a long time. Despite that most companies still opting for the same processes. However, COVID-19 has, essentially, forced some of the trials is to move to a virtual model to keep the trials on track at this pandemic situation.
Ageing is also found to be the major factor that is driving the market growth for the burden of diseases and demand for market studied. With the increase in the increasing burden of diseases, there has been a rising focus of the market players for developing the new therapeutics for the rare or genetic disorders that need specialization and focused clinical trials and expected to boost the demand for market growth.
As per the World Health Organization (WHO), the burden of chronic diseases is increasing. This is expected to increase the demand for the development of new drugs and further raise the demand for clinical trials. It has been observed that almost half of the total chronic disease deaths are attributable to cardiovascular diseases, obesity, and diabetes which are showing increasing trends. The WHO 2018 Report has also stated that chronic disease kills 41 million people every year, which is equivalent to 71% of all deaths globally.
The market is growing at a robust pace, owing to the advancements in healthcare and growing patented new chemical entities (NCE) indicated for various health conditions. There are also government initiatives that have motivated the small, medium, and large players to enter into drug development. Thus, there are multiple drugs in the pipeline. As a result, Novartis, GlaxoSmithKline, and Pfizer (among others) have entered this field. It has thus been found that the clinical trials market has taken bigger strides in the developing countries of Asia-Pacific and the Middle East and there is still very less development in the market.
There are also stringent regulations for countries like China and India that are currently working on overcoming this issue and are successful to a considerable extent, most emerging countries still suffer from poor regulatory infrastructure. Hence, these stringent regulations in the emerging markets are hindering the growth of the market studied.
Key Market Trends
Phase III is the Largest Segment Under Phases that is Expected to Grow During the Forecast Period
The market is expected to be dominated by Phase III, with Phase I expected to witness the fastest growth. Phase III is one of the most critical phases assessing the effectiveness of the new intervention, as well as its value in clinical practice.
Moreover, the COVID-19 pandemic has brought significant changes in the clinical trials industry, as well as shifted the focus of many of the research and commercial organizations to focus on the development of the new therapies and vaccines for COVID-19. For instance, in August 2020, China-based Sinopharm has commenced a Phase III clinical trial of its COVID-19 vaccine candidate at the Bahrain International Exhibition and Convention Centre (BIECC).
These phase III clinical trials are done to evaluate the comparative effect of the new medication over the previous medications available or conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials. These clinical trials remain a comparatively higher need for outsourcing services than phase II and phase I trials, owing to their greater complexity and need for a larger patient pool.
The government initiatives in emerging economies for the promotion of drug discovery and continuous technological innovations are also expected to propel the market growth.
North America Reported with the Largest Growth that is Expected to Follow the Same Trend over the Forecast Period
North America has been dominating the overall market, owing to the presence of big outsourcing firms and increasing R&D in the region. This is mainly due to factors such as the increasing R&D investments and increasing demand for drug development are the major factors responsible for the market emergence in the United States.
With the increasing COVID-19 pandemic, there is an increased burden that has shifted focus on the development of the new therapeutics for COVID-19 and many of the organizations, with the support of the government and non-government organizations. Hence with the rising number of COVID infections, there are increasing investments in R&D activities that have led to an increasing market for clinical trials in the market.
There are also favourable government initiatives regarding the clinical trials in the U.S. that is anticipated to boost the market growth. For instance, in March 2020, the FDA has launched a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to speed-up the development of treatment for the global disease caused by the coronavirus.
In the United States, pharmaceutical companies are found spending more money, time, and energy on R&D than most organizations. According to the National Institute of Health data, In the fiscal year 2017, clinical research funding by the NIH was around USD 12.7 billion U.S. dollars and it has increased to USD 15 billion in 2019. Also, the R&D budgets of the pharmaceutical companies have increased in the past few years, owing to the rising burden of diseases, complex molecules, and therapy segments. Moreover, with the increasing of diseases, the number of clinical trials are expected to rise in the coming few years.
The market is highly competitive in nature, therefore the major pharmaceutical companies are found making enormous investments in R&D, especially in the emerging nations, in order to gain opportunities for market growth in the major regions. The strategic partnerships among pharmaceutical companies and the CROs are expected to have a significant impact on the market's growth. In the coming years, few other players are expected to enter the market.
Also, a significant factor affecting the competitive nature is the quick adoption of advanced technology for improved healthcare. Also, to retain share and expand the product portfolio, major players are often involved in mergers and acquisitions along with new product launches.
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TABLE OF CONTENTS
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
- 4.1 Market Overview
- 4.2 Market Drivers
- 4.2.1 Demand for Clinical Trials in the Emerging Markets
- 4.2.2 High R&D Expenditure of the Pharmaceutical Industry
- 4.2.3 Rising Prevalence of Diseases
- 4.3 Market Restraints
- 4.3.1 Lack of Skilled Workforce Clinical Research
- 4.3.2 Stringent Regulations for Patient Enrollment
- 4.4 Porter' s Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
- 5.1 By Phase
- 5.1.1 Phase I
- 5.1.2 Phase II
- 5.1.3 Phase III
- 5.1.4 Phase IV
- 5.2 By Design
- 5.2.1 Treatment Studies
- 188.8.131.52 Randomized Control Trial
- 184.108.40.206 Adaptive Clinical Trial
- 220.127.116.11 Non-randomized Control Trial
- 5.2.2 Observational Studies
- 18.104.22.168 Cohort Study
- 22.214.171.124 Case Control Study
- 126.96.36.199 Cross Sectional Study
- 188.8.131.52 Ecological Study
- 5.3 Geography
- 5.3.1 North America
- 184.108.40.206 United States (By Phase, and By Design)
- 220.127.116.11 Canada (By Phase, and By Design)
- 18.104.22.168 Mexico (By Phase, and By Design)
- 5.3.2 Europe
- 22.214.171.124 Germany (By Phase, and By Design)
- 126.96.36.199 United Kingdom (By Phase, and By Design)
- 188.8.131.52 France (By Phase, and By Design)
- 184.108.40.206 Italy (By Phase, and By Design)
- 220.127.116.11 Spain (By Phase, and By Design)
- 18.104.22.168 Rest of Europe (By Phase, and By Design)
- 5.3.3 Asia-Pacific
- 22.214.171.124 China (By Phase, and By Design)
- 126.96.36.199 Japan (By Phase, and By Design)
- 188.8.131.52 India (By Phase, and By Design)
- 184.108.40.206 Australia (By Phase, and By Design)
- 220.127.116.11 South Korea (By Phase, and By Design)
- 18.104.22.168 Rest of Asia-Pacific (By Phase, and By Design)
- 5.3.4 Middle East and Africa
- 22.214.171.124 GCC (By Phase, and By Design)
- 126.96.36.199 South Africa (By Phase, and By Design)
- 188.8.131.52 Rest of Middle East and Africa (By Phase, and By Design)
- 5.3.5 South America
- 184.108.40.206 Brazil (By Phase, and By Design)
- 220.127.116.11 Argentina (By Phase, and By Design)
- 18.104.22.168 Rest of South America (By Phase, and By Design)
6 COMPETITIVE LANDSCAPE
- 6.1 Company Profiles
- 6.1.1 Clinipace
- 6.1.2 Laboratory Corporation of America
- 6.1.3 Eli Lilly and Company
- 6.1.4 ICON PLC
- 6.1.5 Novo Nordisk AS
- 6.1.6 PAREXEL International Corporation
- 6.1.7 Pfizer Inc.
- 6.1.8 Pharmaceutical Product Development LLC
- 6.1.9 IQVIA
- 6.1.10 F. Hoffmann-La Roche Ltd
- 6.1.11 Sanofi SA
- 6.1.12 Syneos Health
- 6.1.13 Covance Inc.
- 6.1.14 Theorem Clinical Research
- 6.1.15 Charles River Laboratory
7 MARKET OPPORTUNITIES AND FUTURE TRENDS