Contract Research Organization Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

The Contract Research Organization Market was valued at approximately USD 41,168 million in 2020 and is expected to witness a revenue of USD 63,160 million in 2026, with a CAGR of 7.4% over the forecast period.

The impact of the COVID-19 pandemic on the Contract Research Organization Market is expected to be significant due to ongoing clinical trials on the verge to develop 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 United States 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 in turn 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 being 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 total Research and Development expenditure by the Biopharmaceutical industry in the United States was estimated to be USD102 billion in 2018. Additionally, the PhRMA members had invested nearly USD 83 billion in R and D activities in 2019. Furthermore, more than 260 vaccines are in the pipeline by the biopharmaceutical companies for various diseases including COVID-19 ass per PhRMA, 2020. Also, as per the article published by UK Parliament, 2021, the total expenditure on R&D was EUR 37.1 billion, which accounted to EUR 558 per head, or the equivalent of 1.7% of GDP in 2018 in United Kingdom. Hence, with the strong investment in research and development 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.

Also, the increasing number of services offered by CROs and the rising trend of collaborations are 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

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. Also, in November 2020, Parexel International 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 in 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 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. Also, the increasing research and development investment by the 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 U.S. Research and Development Funding and Performance: Fact Sheet, 2020, the R&D expenditures in the United States, in 2018 was estimated to a total of 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. Also, the presence of key players in the region and strategic collaborations by these companies is 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 optimize trial design, site selection, clinical development, and translational research. Thus, the high R and D investment and the initiatives by key players in the expansion of the product portfolio are expected to boost the development of new drugs, which in turn increases 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.

Competitive Landscape

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 the 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.

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TABLE OF CONTENTS

1 INTRODUCTION

• 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 Growing Research and Development 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 MARKET SEGMENTATION

• 5.1 By Service Type
  • 5.1.1 Clinical Research Services
    • 5.1.1.1 Phase I Clinical Research Services
    • 5.1.1.2 Phase II Clinical Research Services
    • 5.1.1.3 Phase III Clinical Research Services
    • 5.1.1.4 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
  • 5.2.1 Oncology
  • 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
  • 5.2.7 Diabetes
  • 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 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Company Profiles
  • 6.1.1 Charles River Laboratories
  • 6.1.2 Envigo
  • 6.1.3 ICON PLC
  • 6.1.4 IQVIA
  • 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 S.A.
  • 6.1.12 Syneos Health
  • 6.1.13 WuXi Pharmatech
  • 6.1.14 Axcent Advanced Analytics (A3)
  • 6.1.15 BIO Agile Therapeutics

7 MARKET OPPORTUNITIES AND FUTURE TRENDS