The clinical trials market was valued at approximately USD 38,213.3 million in 2020, and it is expected to reach USD 51,356.0 million by 2026, registering a CAGR of 5.05% during the forecast period, 2021-2026.
The major factors 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 are still opting for the same processes. However, COVID-19 has essentially forced some of the trials to move to a virtual model to keep the trials on track during this pandemic situation.
Aging is also found to be the major factor driving the burden of diseases and demand in the market studied. With the increasing burden of diseases, there has been a rising focus of the market players on developing new therapeutics for rare or genetic disorders that need specialization and focused clinical trials, which is expected to boost the 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 diseases kill 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 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 and shifted the focus of many research and commercial organizations to focus on the development of new therapies and vaccines for COVID-19. For instance, in August 2020, China-based Sinopharm 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 I and II 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 the Largest Growth and 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, which are the major factors responsible for the market emergence in the United States.
With the rising COVID-19 pandemic, there is an increased burden that has shifted the focus of many organizations to the development of new therapeutics for COVID-19 with the support of the government and non-government organizations. Hence, with the rising number of COVID-19 infections, there are increasing investments in R&D activities that have led to a growing market for clinical trials.
There are also favorable government initiatives regarding clinical trials in the United States that are anticipated to boost the market growth. For instance, in March 2020, the FDA 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, and it 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 is expected to rise in the coming few years.
The market is highly competitive in nature, and therefore, the major pharmaceutical companies are found making enormous investments in R&D, especially in the emerging nations, 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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1.2 Scope of the Study
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 in 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
5.1.1 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
5.3.1 North America
184.108.40.206 United States
220.127.116.11 United Kingdom
18.104.22.168 Rest of Europe
22.214.171.124 South Korea
126.96.36.199 Rest of Asia-Pacific
5.3.4 Middle-East and Africa
188.8.131.52 South Africa
184.108.40.206 Rest of Middle-East and Africa
5.3.5 South America
220.127.116.11 Rest of South America
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
6.1.10 F. Hoffmann-La Roche Ltd
6.1.11 Sanofi SA
6.1.12 Syneos Health
6.1.13 ClinDatrix Inc
6.1.14 Charles River Laboratory
A selection of companies mentioned in this report includes:
- Laboratory Corporation of America
- Eli Lilly and Company
- ICON PLC
- Novo Nordisk AS
- PAREXEL International Corporation
- Pfizer Inc.
- Pharmaceutical Product Development LLC
- F. Hoffmann-La Roche Ltd
- Sanofi SA
- Syneos Health
- ClinDatrix Inc
- Charles River Laboratory