Contract Research Organization (CRO) Market Size By Service Type (Early Phase Development Services {Discovery Services, Chemistry, Manufacturing & Control (CMC), Pre-clinical Services [Pharmacokinetics/Pharmacodynamics (PK/PD), Toxicology Testing Services]}, Clinical Research Services {Phase I, Phase II, Phase III, Phase IV}, Laboratory Services {Bioanalytical Testing Services, Analytical Testing Services [Physical Characterization, Raw Material Testing, Batch Release Testing, Stability Testing]}, Regulatory Consulting Services), By Therapeutic Area (Oncology, Clinical Pharmacology, Cardiology, Infectious Disease, Neurology, Gastroenterology & Hepatology, Ophthalmology), By End-use (Pharmaceutical & Biopharmaceutical Companies, Medical Device Companies, Academic Institutes), Industry Analysis Report, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2022 – 2028

Industry Overview

Contract Research Organization Market size accounted for USD 53.9 billion in 2021 and is estimated to grow at 6.7% CAGR between 2022 and 2028. Rising adoption of advanced technologies for efficient R&D outcomes and the increasing outsourcing trends in the clinical trials industry has largely influenced the market growth. The significant shift from maintaining manual/paper-based records to digital data capture technologies is transforming and propelling the CRO market statistics.
 

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Moreover, the advent of COVID-19 has largely triggered the adoption of digital resources across clinical trials enhancing the quality of data while allowing greater flexibility. Furthermore, digital technologies can transform the companies’ approach towards clinical development by incorporating valuable insights from multiple sources and increasing the volume of data collected in trials enhancing clinical trial productivity, thereby fuelling the market demand over the forecast period.
 

Contract research organization, also known as clinical research organization, is a company that assists in managing complex clinical research and trial responsibilities, drug discovery, clinical development, and commercialization of new products for sponsor companies, primarily in the biotechnology, pharmaceutical, and medical device industries. These organizations offer services such as clinical trial management, preclinical research, clinical research, commercialization, and pharmacovigilance among other research services. These are outsourced on contract basis, also known as fee-for-service basis.
 

The emergence of COVID-19 pandemic had disrupted major aspects of CRO business and R&D activities around the globe. The strictly imposed lockdown and restrictions on the movement of people owing to the increasing number of COVID-19 cases were significantly noted to have impacted the CRO market outlook. However, as the pandemic progressed, several clinical trials resumed and an increasing amount of accelerated clinical trials pertaining to developing a vaccine were noted to be initiated. Hence, the COVID-19 pandemic had a moderate effect on the market.
 

Further, the CRO market witnessed growth owing to increasing number of clinical trials amid an increasing demand for effective and novel vaccines and drugs to control and curb the SARS-CoV2 virus. Many biotechnology and pharmaceutical companies are noted to have made long term agreements, collaborations, and partnerships with CROs. Moreover, CROs provide dedicated drug discovery and development services that propelled the market growth.
 

Increasing R&D expenditure worldwide will spur the CROs industry statistics

Increasing burden of chronic diseases worldwide is expected to propel the contract research organization market trends over the forecast period. Sedentary lifestyle, unhealthy eating habits, consumption of tobacco and smoking are some of the prominent factors contributing to the increasing burden of chronic diseases. Furthermore, the emergence of COVID-19 and Ebola pandemic has further increased the R&D expenditure worldwide. For instance, according to the Eurostat, in 2020, R&D expenditure in the European Union was noted to be 2.3% of GDP as compared to 2.2% in 2019.
 

Moreover, the focus on developing novel drugs to meet the unmet medical requirements are amongst the key value drivers of research-based pharmaceutical & biotechnology companies. The pharmaceutical sector develops several novel drugs that offer valuable clinical benefits. The surging number of investments by government as well as private organizations are amongst the prime variables driving the number of pharmaceutical research and development activities, thereby propelling the market growth over the forecast period.
 

Intellectual property issues may hamper the contract research organization industry growth

Intellectual property issues are one of the major concerns faced in outsourcing clinical trials that may potentially slow down the contract research organization market growth. Most of the medical devices and drug candidates are patented products and outsourcing the same to a contract research organization may increase the chances of data leakages.
 

Furthermore, pharmaceutical companies that develop novel solutions are obligatory to submit clinical data concerning safety and efficacy to respective government and regulatory authorities to get the approval of such drugs. Hence, issues concerning the patent along with the provisions for pre- and post-grant disagreement are quite burdensome. However, it improves the efficiency of scrutiny and has assisted to revoke patents. It is necessary to focus more on the clinical trial agreements as the government also closely inspects the issues concerning clinical trials. However, such issues hamper the CRO’s reputation and may possibly hinder the contract research organization industry expansion.
 

Increasing prevalence of chronic disease and demand for effective treatment will propel the market share

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Based on service type, the contract research organization market is segmented into early phase development services, clinical research services, laboratory services and regulatory consulting services. Clinical research services segment accounted for over USD 30.9 billion market revenue in 2021 and is estimated to register a lucrative growth of 6.8% over the forecast period. The clinical research services are further sub segmented into Phase I, Phase II, Phase III, Phase IV. The segmental growth is attributed to the increasing prevalence of chronic diseases and increasing demand for effective medications and diagnostics products.
 

Furthermore, various contract research organizations offer wide range of clinical trial research services and support different areas of medical device and drug development. Additionally, adoption of clinical trials with a better auditing mechanism to determine safety and efficiency parameters is expected to drive the market growth throughout the forecast period.
 

Increasing clinical trials and novel drug discovery for cancer treatment will fuel the oncology segment demand

Based on therapeutic area, the contract research organization market is bifurcated into oncology, clinical pharmacology, cardiology, infectious disease, neurology, gastroenterology & hepatology, ophthalmology, and others. Oncology segment is expected to surpass USD 46.5 billion by 2028. Increasing prevalence of cancer has compelled sponsors to focus on developing different therapies and medical devices for better management of cancer. Hence, leading to an increased number of clinical trials and discovery of various drugs for the cancer treatment. For instance, in 2020, according to the European Journal of Cancer report, 1.9 million cancer-related deaths are estimated annually with over 4 million new cancer cases being registered in Europe. Hence, owing to the aforementioned factors, the increasing cancer burden is expected to propel the segmental growth.
 

Pharma & biotech companies are developing new vaccines and medicine to treat and prevent various diseases that will boost the segmental outlook

Based on end-use, the contract research organization market is divided into pharmaceutical & biopharmaceutical companies, medical device companies and academic institutes. The pharmaceutical & biopharmaceutical companies’ segment is anticipated to witness 7.2% CAGR over the forecast period. The increasing segmental growth is majorly attributed to surge in outsourcing of R&D. Increasing demand for contract research organization owing to increasing number of clinical trials coupled with a paradigm shift toward outsourcing the same is expected to further facilitate the market expansion. Furthermore, increasing government support with increasing funding as well as subsidies with respect to conducting clinical trials is expected to promote the market statistics over the forecast period.
 

Strong presence of key market players and increasing government support will fuel the North America market demand

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On a regional front, North America contract research organization market exceeded USD 23.3 billion in 2021 and is projected to register significant growth throughout the forecast period. The significant market growth is attributed to higher density of pharmaceutical and biotechnology companies across the North America region. Moreover, increasing focus of pharmaceutical and biotechnology for outsourcing clinical trials for the treatment of various diseases is expected to fuel the North America market size.
 

Furthermore, increasing R&D expenditure and a robust legislative procedure further accelerates the market statistics in the region. Increasing adoption of information & communication technology tools to fast-track and simplify the clinical trials operations are anticipated to augment the regional market growth throughout the foreseeable future.
 

Inorganic growth strategies will offer various opportunities for market players operating in the industry

Major market players operating in the contract research organization industry include Charles River Laboratories, Inc., Laboratory Corporation of America Holdings, IQVIA, Pharmaceutical Product Development, PAREXEL International, and Syneos Health, among others. Mergers & acquisitions, partnerships & collaboration are some of the most adopted business strategies observed to sustain market position.
 

Some of the recent industry developments:

• In December 2021, Thermo Fisher Scientific Inc. acquired PPD, Inc., a global provider of clinical research services to biotech and biopharma industry. With this acquisition the Thermo Fisher Scientific Inc. will offer services ranging from managing clinical trial logistic to manufacturing and development of drug product. This strategy is expected to expand their customer base, thereby driving revenue generation.
   
• In September 2021, Syneos Health acquired StudyKIK, a leading retention and technology-enabled clinical trial recruitment company. This acquisition boosts Syneos Health’s ability to deliver insight-powered solutions and accelerate the clinical trial diversity, recruitment, and retention of the company.
   

The contract research organization (CRO) market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2017 to 2028, for the following segments:

By Service Type

• Early phase development services
  • Discovery services
  • Chemistry, manufacturing & control (CMC)
  • Preclinical services
    • Pharmacokinetics/Pharmacodynamics (PK/PD)
    • Toxicology services
    • Others
• Clinical research services
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
• Laboratory services
  • Bioanalytical testing services
  • Analytical testing services
    • Physical Characterization
    • Raw Material Testing
    • Batch Release Testing
    • Stability Testing
    • Others
• Regulatory consulting services

By Therapeutic Area

• Oncology
• Clinical pharmacology
• Cardiology
• Infectious disease
• Neurology
• Gastroenterology & Hepatology
• Ophthalmology
• Others

By End-use

• Pharmaceutical & Biopharmaceutical Companies
• Medical Device Companies
• Academic Institutes

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
• Latin America
  • Brazil
  • Mexico
• Middle East & Africa
  • South Africa
  • Saudi Arabia