The Contract Research Organization Market was valued at approximately USD 44,049.76 million in 2021, and it is expected to witness a revenue of USD 66,106.81 million in 2027, with a CAGR of 7.0% over the forecast period.
The impact of the COVID-19 pandemic on the contract research organization market is expected to be significant due to the ongoing clinical trials on the verge of developing effective therapeutics and vaccines against the SARS-CoV2 virus. For instance, in January 2021, ICON PLC announced that it collaborated with Pfizer Inc. and BioNTech, and provided clinical trial services in the development of Pfizer and BioNTech's investigational COVID-19 vaccine program. As a part of this program, ICON worked in more than 153 sites in Europe, South Africa, the United States, and Latin America for the recruitment of 44,000 participants for the clinical trial studies and also provided site training, document management, along with the operational support for patient informed consent form review. ICON also coordinated eConsent in most countries and assisted with clinical supply management services. Additionally, in July 2020, IQVIA and AstraZeneca collaborated to aid in the development of AstraZeneca's COVID-19 vaccine as a part of the US Government's Operation Warp Speed Project, which is focused on the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Thus, owing to the increased focus on the vaccine development against COVID-19, there has been an increase in the clinical trials, which is expected to boost the contract research organization market during the COVID-19 pandemic era.
Contract research organizations provide support to the pharmaceutical, biotechnology, and medical device industries. The market growth can be attributed to the growing R&D expenditure, increased outsourcing of R&D activities, and a rising number of clinical trials. Efficiency is considered as the most important factor in light of the financial burden faced by pharmaceutical companies from all directions. Patent expiries leading to generic rivalry and stringent demands from regulators continue to have an impact on the bottom lines of pharmaceutical companies.
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the PhRMA members had invested nearly USD 83 billion in R&D activities in 2019. Furthermore, more than 260 vaccines are in the pipeline by the biopharmaceutical companies for various diseases, including COVID-19 as per PhRMA, 2020. As per the article published by UK Parliament, 2021, the total expenditure on R&D was EUR 37.1 billion, which accounted for EUR 558 per head, or the equivalent of 1.7% of GDP in 2018 in the United Kingdom. Hence, with the strong investment in R&D activities with a pipeline of therapeutics under development, the outsourcing services are expected to witness growth, which leads the contract research organization market to propel over the forecast period.
The increasing number of services offered by CROs and the rising trend of collaborations are also driving the market growth. For instance, in October 2020, PPD Inc. announced its expansion through the opening of a new multipurpose clinical research laboratory in Suzhou, China, to offer bioanalytical, biomarker, and vaccine services for clinical trials across all phases of pharmaceutical development. Thus, owing to the aforementioned factors, the studied market is expected to register significant growth over the forecast period.
Key Market Trends
The Early-phase Development Services Segment is Poised to Witness Robust Growth Over the Forecast Period
With a growing number of patents expiring, the competition from generic counterparts of drugs is increasing and drug makers are under pressure to replace the revenue loss due to generics. Furthermore, R&D costs are increasing due to the complexity of drug molecules and more stringent regulatory requirements. Drug discovery and development processes are becoming increasingly complex. To counter this complexity and streamline the operations, pharmaceutical firms are outsourcing early drug development processes. Additionally, leading CROs have developed significant expertise in the field of early-phase development, and CROs are leveraging this expertise to offer highly efficient and accurate early-phase development services. CROs are also allowing small- and mid-size firms to enter the complex drug development process without significant investment in capital equipment. Pertaining to these reasons, the early-phase development services segment is poised to register robust growth rates.
Additionally, as per clinical trials.gov, as of March 2020, nearly 1058 clinical trials were being conducted globally in the early phase development stage in the field of oncology. In November 2020, Parexel International also entered into a strategic partnership between Parexel's Early Phase Clinical Unit (EPCU) in Berlin, Germany, and Clinical Trial Center (CTC) North, a full-service CRO located at the University Medical Center Hamburg-Eppendorf (UKE), to meet the increasing demand for the early phase clinical trials during the current COVID-19 pandemic. Thus, in view of the above-mentioned factors, the studied segment is expected to propel significantly over the forecast period.
North America Captured the Largest Market Share and it is Expected to Retain its Dominance Over the Forecast Period
Pricing pressure due to the changing reimbursement scenario and generic competition is causing major pharmaceutical firms to outsource R&D and clinical trials, which is supplementing the growth of CRO services in the North American region. The increasing R&D investment by pharmaceutical companies in the development of novel therapeutics is driving the studied market growth in the region. In October 2020, FDA awarded six new grants of an amount of more than USD 16 million for a period of 4 years to fund the clinical trials carried by academia and industry players, through the Orphan Products Grants Program, to advance the development of therapeutics in the treatment of rare diseases.
Additionally, as per the US Research and Development Funding and Performance: Fact Sheet, 2020, the R&D expenditures in the United States in 2018 were estimated to be USD 580 billion, of which USD 96.5 billion was invested on basic research, USD 115.0 billion on applied research, and USD 368.5 billion was employed in the development sector. The presence of key players in the region and strategic collaborations by these companies are driving the market growth. For instance, in February 2021, Parexel International partnered with Neogenomics to enable the application of Neogenomics' real-world genomics data in oncology clinical trials, thereby leading to the increased efficiency in patient matching and optimizing trial design, site selection, clinical development, and translational research. Thus, the high R&D investment and initiatives by key players in the expansion of the product portfolio are expected to boost the development of new drugs, in turn increasing the demand for outsourcing the services for clinical trials and drug development. Thus, the aforementioned factors are expected to boost the growth of the contract research organization market in the North American region.
The Contract Research Organization Market is highly competitive and consists of many players. However, globally, few major players control a major share of the market. The remaining market share is heavily fragmented, with the presence of several local and niche players. Companies like IQVIA, ICON PLC, Charles River Laboratories, Envigo, and PPD Inc. lead the contract research organization market. The major players in the market accumulated a huge amount of data, which is being employed to attain a competitive edge in the market. Additionally, the major players are involved in strategic alliances to secure a position in the global market. For instance, in September 2020, PPD Inc. collaborated with LUPUS Therapeutics with a strategy to expand and enhance lupus clinical research for PPD’s pharmaceutical and biotech customers.
- The market estimate (ME) sheet in Excel format
- 3 months of analyst support
1.2 Scope of the Study
4.2 Market Drivers
4.2.1 Growing R&D Activities by Biopharmaceutical Companies
4.2.2 Increasing Number of Clinical Trials
4.2.3 Growing Trend of Outsourcing and Cost Savings Enabled by Using CRO Services
4.3 Market Restraints
4.3.1 Shortage of Skilled Professionals
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 Clinical Research Services
220.127.116.11 Phase I Clinical Research Services
18.104.22.168 Phase II Clinical Research Services
22.214.171.124 Phase III Clinical Research Services
126.96.36.199 Phase IV Clinical Research Services
5.1.2 Early-phase Development Services
5.1.3 Laboratory Services
5.1.4 Consulting Services
5.2 By Therapeutic Area
5.2.2 Infectious Diseases
5.2.3 Central Nervous System (CNS) Disorders
5.2.4 Immunological Disorders
5.2.5 Cardiovascular Diseases
5.2.6 Respiratory Disorders
5.2.8 Other Therapeutic Areas
5.3 By End User
5.3.1 Pharmaceutical and Biopharmaceutical Companies
5.3.2 Medical Device Companies
5.3.3 Academic Institutes
5.4.1 North America
188.8.131.52 United States
184.108.40.206 United Kingdom
220.127.116.11 Rest of Europe
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.4.4 Middle-East and Africa
126.96.36.199 South Africa
188.8.131.52 Rest of Middle-East and Africa
5.4.5 South America
184.108.40.206 Rest of South America
6.1.1 Charles River Laboratories
6.1.3 ICON PLC
6.1.5 Laboratoty Corporation of America Holdings (Labcorp)
6.1.6 MeDPace Holdings Inc.
6.1.7 PSI CRO AG
6.1.8 Parexel International
6.1.9 PPD Inc.
6.1.10 PRA Health Sciences
6.1.11 SGS SA
6.1.12 Syneos Health
6.1.13 WuXi Pharmatech
6.1.14 Axcent Advanced Analytics (A3)
6.1.15 BIO Agile Therapeutics
A selection of companies mentioned in this report includes:
- Charles River Laboratories
- ICON PLC
- Laboratoty Corporation of America Holdings (Labcorp)
- MeDPace Holdings Inc.
- PSI CRO AG
- Parexel International
- PPD Inc.
- PRA Health Sciences
- SGS SA
- Syneos Health
- WuXi Pharmatech
- Axcent Advanced Analytics (A3)
- BIO Agile Therapeutics