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The global Contract Research Organization (CRO) services market size was valued at USD 85.54 billion in 2024. The market is projected to grow from USD 92.27 billion in 2025 to USD 175.53 billion by 2032, exhibiting a CAGR of 9.6% during the forecast period.
Contract Research Organizations (CROs) are companies providing research services, such as early phase development, clinical trials, research management plans, and others, to pharmaceutical, biotechnology, and medical device companies on a contractual basis. The growing awareness regarding outsourcing of clinical trial services, along with the increasing demand for effective therapeutics, is responsible for the market’s rapid growth.
Moreover, small and mid-sized pharmaceutical and life science companies prefer outsourcing their research and development processes for cost-effective and efficient conduction of the research studies. Therefore, the growing emergence of small and mid-sized biopharmaceutical companies is also responsible for the growth of the Contract Research Organization (CRO) services market.
Growing Number of Clinical Trials to Fuel the Demand for Contract Research Organization (CRO) Services
In order to fuel the increasing demand for effective diagnosis and treatment, healthcare companies have increased their focus on conducting clinical trials to develop advanced and effective medical devices and therapeutics. The number of clinical trials conducted annually has been growing significantly worldwide.
From research till the final drug approval, the drug development process is quite long and costly, for instance, as per the data published and updated by Sofpromed in January 2024, on average, phases 1, 2, and 3 can cost around USD 4.0 million, USD 13.0 million, and USD 20.0 million, respectively.
Moreover, not all the pipeline candidates need to get approved and commercialized; some are terminated, and some go on hold because of trial budgets and other such challenges. For instance, as per the data published by the Congress Budget Office in April 2021, only 12.0% of the drugs undergoing clinical trials are approved by the Food and Drug Administration (FDA).
In order to overcome these challenges, many small and mid-sized pharmaceutical companies have increased their focus on outsourcing their R&D activities to the CROs, as the CROs help these companies save time and money in developing their therapeutics or medical devices.
Stringent Regulatory Scenario along with Limitations in R&D Funds Restricts Market Growth
To set up a research site, the examiners are required to go through rigid administrative and ethical measures and regulatory strategies. The administrative methodology is vital in guaranteeing the well-being of the selected patients.
However, the whole regulatory procedure can cause delays in the recruitment and trial conduction if the time needed to get all the approvals is not considered in the planning phase.
Such complex and stringent regulatory scenarios varying from country to country have been restricting market growth.
Emergence of Promising Discoveries and Growing Funding is Expected to Fuel Need for Contract Research Organization (CRO) Services
The number of research studies being conducted is quite less for specific conditions such as perinatal conditions, congenital anomalies, and others. For instance, as per the data published by the World Health Organization (WHO), in 2024, the number of clinical trials registered for congenital anomalies was only 328, whereas the number of clinical trials registered for malignant neoplasms was around 5,306. However, a number of promising discoveries have emerged, and with the help of additional research, funding, and partnerships among the companies could lead to the drug discovery of advanced treatments.
Therefore, the increasing number of research studies on promising discoveries is expected to fuel the Contract Research Organization (CRO) services market growth in the forecast period.
Regulatory Heterogeneity acts as a Challenge for Market Players’ Growth
Varying regional compliance standards require CROs to maintain deep regulatory expertise and regular check-ups for any changes or updates in the regulations.
Increasing cyber threats and tighter data protection laws have been restricting patients from participating in research studies.
The limited availability of skilled workforce has been restricting the efficiency of the services provided through CROs.
Technological upgrades and compliance demand continuous investment in infrastructure and talent.
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Rise in the Outsourcing of Clinical Trials due to High R&D Cost to Drive Market Growth
Due to the increasing demand for effective diagnosis and therapeutics, pharmaceutical, biotechnology, and medical device companies have increased their focus on R&D spending. This factor has been fueling the number of clinical trials being conducted globally.
Due to this, many biotechnology and pharmaceutical companies have increased their focus on outsourcing their R&D studies to Contract Research Organization (CRO) services providers. For instance, in March 2023, ICON plc LEO Pharma partnered together to conduct clinical trials to develop new effective medicines for dermatology indications.
CROs are leveraging AI for patient recruitment, protocol design, trial monitoring, and predictive analytics to enhance the efficiency of the studies.
COVID-19 fast-tracked the shift to remote monitoring, wearable tech, and virtual patient engagement. This created awareness regarding the advantages of decentralized clinical trials and has been fueling its adoption for cost-effective and convenient R&D.
The demand for personalized medicine is rising due to advancements in genomics, proteomics, and metabolomics, enabling tailored treatments based on individual characteristics and the growing awareness of the benefits of precision medicine. This factor has been fueling the demand for CRO services.
Lifesciences increased their focus on outsourcing complex clinical trials such as rare diseases, cancer, and others, which have low chances of positive results and have to undergo stringent regulatory scenarios. The aim of outsourcing these trials is to reduce the cost and total duration of the trial completion.
During the COVID-19 pandemic in 2020, the market experienced a significant boost in its market value. This was due to the increased demand for COVID-19 vaccines and therapeutics in order to control the disease burden. Many pharmaceutical and biopharmaceutical companies boosted their R&D and manufacturing processes to develop and distribute test kits, vaccines, and drugs against the SARS-CoV-2 virus. To accelerate the R&D process, many pharmaceutical and biotechnology companies have partnered with CRO services offering companies.
Furthermore, the market grew significantly post-COVID-19 due to the initiation of the delayed and postponed clinical trials.
Early Phase Development Services Segment Dominated Due to Rising Focus of Lifesciences Companies on Development of Advanced Products
By type, the market is divided into early phase development services, clinical, laboratory services, and others.
The early phase development services are further segmented into Chemistry, Manufacturing and Controls (CMC), preclinical service, and discovery. Similarly, the clinical segment is further classified into phase 1, phase 2, phase 3, and phase 4.
The early phase development services dominated the market in 2024 and is expected to grow at the fastest CAGR during the forecast period. The dominance of the segment is attributed to the increasing focus of market players on boosting the early phase development services for chronic diseases. For instance, in December 2022, Phastar entered into Lean Life Science’s Oncology Development Programme (ODP2) with the aim of identifying and fueling the R&D for academics and early-stage companies.
The clinical segment is anticipated to experience significant growth during the forecast period. The segment’s growth is due to the growing number of small and mid-sized life science companies and research institutes with the aim of conducting clinical trials with the help of Contract Research Organization (CRO) services.
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Oncology Segment to Dominate Led by Growing Burden of Cancer Diseases
Based on application, the market can be segmented into oncology, neurology, cardiology, infectious disease, metabolic disorder, renal/nephrology, and others.
The oncology segment dominated the market in 2024 by accounting for a maximum Contract Research Organization (CRO) services market share. The burden of cancer has been growing at a significant rate. Such an increasing burden of the disease has increased the demand for effective treatment options. In order to fulfill this demand, many life science companies have emerged to develop effective treatments. The emergence of such small and mid-sized companies has been fueling the outsourcing of preclinical and clinical services.
The others segment accounted for the second most dominant market share in 2024. The growth of the segment is attributed to the growing burden of diseases such as digestive diseases, nutritional deficiencies, respiratory disorders, and others. Moreover, the increasing funding by pharmaceutical and biotechnological companies for the effective therapeutic development of these diseases has been fueling the market growth.
Moreover, the neurology segment is expected to grow at a significant CAGR during the forecast period due to the increasing prevalence of neurological disorders, such as Alzheimer’s, dementia, and others.
Pharmaceutical & Biotechnological Companies to Hold Dominant Share Backed by Increasing R&D
Based on end-user, the market is segmented into pharmaceutical & biotechnological companies, medical device companies, academic & research institutes, and others.
The pharmaceutical & biotechnology companies dominated the market in 2024. Pharmaceutical and biotechnology companies have increased their preference toward outsourcing their R&D due to the increased complexity, robust pipelines, and tight rules for performing trials. This factor is responsible for the segment’s growth.
The medical devices segment is expected to grow at the fastest CAGR during the forecast period due to the rise in the number of registered clinical trials for medical devices.
For instance, as per ClinicalTrials.gov, in January 2022, approximately 40,901 clinical trials were registered for medical devices.
In terms of region, the global market is studied across North America, Europe, Asia Pacific, and the rest of the world.
North America Contract Research Organization (CRO) Services Market Size, 2024 (USD Billion)
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The North American Contract Research Organization (CRO) services market was valued at USD 42.94 billion in 2024 and is expected to hold a leading share of the global market in the forecast period. The market’s growth in the region is attributed to the strong presence of market players such as Medpace, IQVIA Inc., Syneos Health, and others.
Moreover, the market in the U.S. is expected to grow significantly during the forecast period due to the growing number of clinical trials in the region.
Europe was the second-largest region in the global market in 2024 and is estimated to hold this position during the forecast period. The market growth in the region is attributed to the increasing investments by the pharmaceutical and biotechnology companies in R&D for new therapeutics development.
The Asia Pacific market is projected to grow at the fastest CAGR over the analysis period. The high growth is mainly attributed to the surge in R&D activity and the growing shift toward outsourcing. Furthermore, low-cost resources in the Asia Pacific region are one of the major factors driving the number of clinical trials being conducted in the region, thereby fueling the market growth.
The market in the rest of the world is expected to hold a limited share of the market during the forecast period. However, increasing healthcare expenditure in the rest of the world is expected to fuel market growth.
Focus of Market Players on R&D for the Enhancement of their Service Offerings is Responsible for their Revenue Growth
IQVIA Inc., ICON plc, Syneos Health, and Charles River Laboratories are among the significant players in the market. These companies have been focusing on the enhancement of their service offerings by adopting advanced technologies with the aim of increasing their revenue growth.
Moreover, other market players, such as Parexel International (MA) Corporation, Thermo Fisher Scientific Inc., and Medpace, have been focusing on new service launches to enhance their presence in the market.
The global market report provides a detailed market analysis. It focuses on key aspects such as an overview of the market, penetration of outsourcing in R&D and key countries, pricing analysis. Additionally, it includes key industry developments such as mergers, partnerships, & acquisitions, the impact of COVID-19 on the market, and brand analysis. Besides these, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over recent years. The report also covers a regional analysis of different segments.
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ATTRIBUTE | DETAILS |
Study Period | 2019-2032 |
Base Year | 2024 |
Estimated Year | 2025 |
Forecast Period | 2025-2032 |
Historical Period | 2019-2023 |
Growth Rate | CAGR of 9.6% from 2025-2032 |
Unit | Value (USD Billion) |
Segmentation | By Type
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By Application
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By End-user
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By Region
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Fortune Business Insights says that the global market size was USD 85.54 billion in 2024 and is projected to reach USD 175.53 billion by 2032.
In 2024, North America stood at USD 42.94 billion.
Growing at a CAGR of 9.6%, the market will exhibit steady growth in the forecast period.
The clinical segment is expected to be the leading segment in this market during the forecast period.
The increasing number of clinical trials and surge in the cases of chronic disease are some of the major factors driving the markets growth.
Labcorp and IQVIA are some of the major players in the global market.
North America dominated the market in 2024 by holding the largest market share.
The surge in the outsourcing of R&D by pharmaceutical organizations, along with increased efficiency and productivity, are factors that drive the adoption of the service.
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