Contract Research Organization (CRO) Market Report & Analysis 2028

[Research Report] The contract research organization (CRO) market is projected to reach US$ 88,835.19 million by 2028 from US$ 50,093.56 million in 2021; it is estimated to grow at a CAGR of 8.5% from 2021 to 2028.

A contract research organization (CRO) is a company that provides research services to pharmaceutical, biotechnology, and medical device companies, as well as academic institutions and government agencies. CRO offers range of services including clinical trail management, regulatory affairs, data management and analysis medical writing and quality assurance. They can also provide expertise in the specific therapeutic areas or specialized technologies. These organizations are appointed by the companies to conduct clinical trails on their behalf as they have the expertise and resources to efficiently manage the complex process of developing new drugs and medical devices. The increase in R&D activities and expenditures along with surge in outsourcing activities by the manufacturers and developers are create the demand for CRO. Additionally, increase in clinical trials globally followed by specialized testing services and increase in biosimilars and biologics are expected to create ample opportunities for the contract research organization (CRO) market growth.

Growth Drivers and Challenges:

The pharmaceutical companies need to perform various testing services throughout the development of the product to comply with the international and national regulatory standards as per the specification. LC/MS testing, protein profiling, extractables/leachable testing, inorganic analysis, microbiology testing, and environmental testing among others are the specialized testing which require enormous amount of high technological set up and skilled professional dedicated for these particular services to avoid even the slightest of errors. Pharmaceutical companies need to increase the cost for the maintenance of high-end technologically advanced machineries to perform these specialized testing services. The time required for these testing services is also more than that of the other services, which may hamper the other process of drug development. Therefore, to avoid the increasing labour cost and time companies are outsourcing these services to the CROs. Additionally, to comply with the regulatory standards and validate their data for these services, some of the pharmaceutical companies are outsourcing these services to the specialized/boutique CROs. The growing demand of the specialized testing services among the pharmaceutical companies may stimulate the market growth during the forecast period.

However, the rising demand for the drug development has led to the challenges at certain extent to the pharmaceutical and biotech companies. Compliance with the stringent regulatory guidelines is creating a massive pressure on the industry in order to get the product approval. To maintain the revenue and combat challenges, biopharmaceutical and pharmaceutical companies are outsourcing the services to the CRO industry in order to minimize the cost and time required for testing. CRO industry requires highly skilled professionals to achieve the proper result for the testing services and to comply with the national and international regulatory standards. Data integration and manipulation done by the professionals to meet the standard specification can lead to product recall in the market by the regulatory authorities. Therefore, the CRO industry face the burden of recruiting highly qualified and skilled professionals for the testing services. The lack of training provided for the testing services in the CROs can lead to the malfunction in testing services. Therefore, the unavailability of the skilled professionals and increased in variable cost of training the professionals is expected to create a negative impact on the overall industry at certain extent.

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Contract Research Organization (CRO) Market: Strategic Insights

Market Size Value in	US$ 50,093.56 Million in 2021
Market Size Value by	US$ 88,835.19 Million by 2028
Growth rate	CAGR of 8.5% from 2021-2028
Forecast Period	2021-2028
Base Year	2021

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Report Segmentation and Scope:

The “Global Contract Research Organization Market” is segmented based on type, end user, and geography. Based on type, the contract research organization market is segmented into early phase development services, clinical research services, laboratory services, and post-approval services. Based on end user, the contract research organization market is bifurcated into pharmaceutical and biotechnology companies and medical device companies. The contract research organization market based on geography is segmented into North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Russia, and Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).

Segmental Analysis:

Based on type, the contract research organization market is bifurcated into early phase development services, clinical research services, laboratory services, and post-approval services. The clinical research services segment held the largest share of the market in 2021, and the same segment is anticipated to register the highest CAGR of 9.0% in the market during the forecast period. The verified and tested compounds in the pre-clinical studies for a particular project are further tried and tested through a long evaluation procedure to determine the safety and efficacy of the compound. Clinical trials comprise a long duration and can require six to seven years for successful completion. These trials include the use of placebos with randomization and follow up of double blinded protocols to minimize biases of the drug. The outsourcing of clinical trials research services helps the drug manufacturers to invest in expensive research infrastructure and thus use the available capital in various other areas that will lead to grow the profit margins. Moreover, the clinical trials outsourcing facilitates wider range of expertise and increased flexibility than that of the in-house activities. The aforementioned factors are expected to increase the market for global CROs market over the forecast period.

Contract Research Organization Market, by Type – 2021 and 2028

Based on end user, the contract research organization market is bifurcated into pharmaceutical and biotechnology companies and medical devices companies. The pharmaceutical and biotechnology companies segment held the larger share of the market in 2021, and the same segment is anticipated to register the higher growth rate during the forecast period. Pharmaceutical and biotechnology companies are the major end users of contract research organizations. The major reason for big shots in pharmaceutical and biotechnology companies to require CROs for conducting research and development is that the CROs specializes in conducting research in comparison to pharmaceutical companies that are indulged more in other revenue generation activities such as production, sales and marketing of the drugs or medicinal products. Thus, the CROs bring value to the pharmaceutical and biotechnology companies by saving huge infrastructure and R&D facilities costs, as well as reduce the time period required to conduct a clinical trial. Moreover, these services are also availed by the drug manufacturing companies due to lack of skilled and knowledge-rich scientists that are unable to successfully conduct drug development procedures. Moreover, the emerging pharmaceutical companies that do not have sufficient knowledge regarding regulatory affairs in the industry helps them to establish a legal presence in the economy as well as industry through various services provided by CROs. Thus, the increasing number of pharmaceutical and biotechnology companies, unavailability of skilled professionals and rising demand for new therapeutics to treat various medical conditions are expected to drive the growth of this segment over the forecast years.

Regional Analysis:

Based on geography, the contract research organization market is divided into five key regions: North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa. In 2021, North America held the largest share of the global contract research organization market, and Asia Pacific is estimated to register the highest CAGR during the forecast period. The growth of this market is primarily driven by increasing expenditure of research and development expenditures. Moreover, various pharmaceutical companies are facing short profit margins due to patent expiry due to which the spurring manufacturers have initiated to reduce the in-house R&D activities by outsourcing these studies through contract research organizations. This is responsible for CROs to experience a significant growth. The confrontation of biotechnology and pharmaceutical companies to lower the drug development costs is expected to propel the CROs market in the US. Moreover, the presence of top revenue generating pharmaceutical companies in the US that have capability to invest a large amount in R&D is also expected to boost the growth of CROs in the US.

However, Asia Pacific registered as the fastest-growing region in the global contract research organization (CRO) market. The market in this region is expected to grow significantly in countries such as China, Japan, and India. The market's growth is attributed to rising support from the government, presence of a larger patient population. In Asia Pacific, China is the largest market for contract research organization (CRO). The growth of the market is primarily attributed to the established pharmaceutical market, increasing R&D expenditures by the pharmaceutical and biopharmaceutical companies, increasing number of clinical trials due to lower cost, and favorable regulatory policies. China has the world’s second largest pharmaceutical market. The excessive population in China coupled with the rise of various communicable and non-communicable diseases are majorly driving the growth of the pharmaceutical companies in China and making it a prime market in the Asia Pacific region. Over the past few decades, the pharmaceutical industries in China are majorly focusing on the research and development to develop new drugs. According to America’s Department of Commerce, the national drug market in China is expected to grow from US$ 108 billion in 2015 to US$ 167 billion by 2020. In addition, China has emerged as the increasingly attractive R&D outsourcing destination for international pharmaceutical companies who are trying to reduce their product timeline and cost to the market.

Industry Developments and Future Opportunities:

Various initiatives taken by key players operating in the global contract research organization market are listed below:

1. In September 2021, Syneos Health has acquired StudyKIK, a leading technology-enabled clinical trial recruitment and retention company. The acquisition boosts Syneos Health’s ability to deliver technology-enabled, insight-powered solutions.
2. In March 2021, WuXi AppTec has acquired OXGENE, a pioneering United Kingdom-based contract research and development organization that designs and develops scalable gene therapy technologies. This acquisition enables WuXi AppTec to offer its customers end-to-end support in the creation and development of cutting-edge cell and gene therapies for patients in need across the world.
3. In April 2021, PPD, Inc. and Science 37 entered into collaboration. Science 37 is a developer of the Decentralized Clinical Trial Operating System (DCT OS). This collaboration will be fully enabled PPD to design, build, test, implement and execute digital trials using Science 37's DCT SaaS-based technology platform.

Covid-19 Impact: 

The COVID-19 pandemic affected economies and industries in various countries across the globe. Lockdowns, travel restrictions, and business shutdowns in North America, Europe, Asia Pacific (APAC), South & Central America (SAM), and the Middle East & Africa (MEA) hampered the growth of several industries, including healthcare industry. The pandemic has fuelled the research and development activities for drug and vaccine development to cope with COVID-19 infection. The increasing R&D investment by pharmaceutical companies in developing novel therapeutics is driving the studied market growth in the region. In October 2020, the FDA awarded six new grants of more than USD 16 million for four years to fund the clinical trials carried by academia and industry players through the Orphan Products Grants Program to advance therapeutics in the treatment of rare diseases. Additionally, successful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic. Clinical research plays a crucial role in developing diagnostics and medicines to fight the ongoing COVID-19 pandemic, through rapid and accurate clinical trials, and collect robust and reliable outcomes, in a variety of different settings, on a large scale. Intensive global research collaborations among all stakeholders and industry involving all countries are necessary to enable identification and testing of effective treatments, vaccines, and diagnostics. Thus, increasing focus on vaccine development against COVID-19 has increased clinical trials, and increase in strategic collaborations which boosts the CRO market during the COVID-19.

Competitive Landscape and Key Companies:

Some of the prominent players operating in the global contract research organization market include IQVIA, PARAXEl International Corporation, Laboratory Corporation of America Holdings, Syneos Health, PRA Health Sciences, Charles River, ICON plc, WuXi AppTec, and Medpace among others. These companies focus on new product launches and geographical expansions to meet the growing consumer demand worldwide and increase their product range in specialty portfolios. They have a widespread global presence, which provides them to serve a large set of customers and subsequently increases their market share.