The global regulatory affairs outsourcing market size was valued at USD 6.3 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 11.9% from 2020 to 2027. The outsourcing of regulatory affairs has become an increasingly important practice in the pharmaceutical and biotechnology industry. An increase in geographical expansion activities by companies that aim for speedy approvals in global markets is expected to contribute to the adoption of outsourcing models for regulatory affairs. The outsourcing market for regulatory affairs is expanding rapidly due to the increase in the R&D activities, clinical trial applications, product registration, and drug pipeline. Companies are under constant pressure to procure timely clinical approvals from regulators in different regions. Regulatory approval procedures are becoming more stringent and time-consuming, and market players aim to obtain approval for the product in the first attempt to gain higher market shares.
Companies are required to have an in-house regulatory department or outsource their regulatory affairs due to stringent regulatory requirements in developed countries and changing regulations in developing countries. Establishing an in-house regulatory affairs department in offshore countries is not feasible. Hence, companies are adopting different outsourcing models based on the size and priority of the projects, thereby contributing to the market for regulatory affairs outsourcing.
The regulatory affairs function is challenging. The demand to obtain approval for new products, maintain compliance, and doing more with less have increased during the last decade. Simultaneously, investments in the regulatory information systems have increased considerably to keep pace with the need to automate activities like publishing and regulatory operations. In this scenario, outsourcing is becoming a gradually vital part of the regulatory capability mix.
The pressure to reduce costs by life sciences companies is very high. The shift toward outcome-based model, increase in the use of generics, and demand for drugs and medical devices at a lesser price are expected to increase the need to reduce healthcare costs. An increase in out-of-pocket expenses, uneven economic growth, and measures taken by various governments to contain the cost of drugs are expected to contribute to the economic and competitive pressure.
Life science companies are now focusing on their core competencies and outsourcing non-core functions to increase their productivity and operational efficiency. These companies commonly outsource R&D functions to emerging markets, such as the Asia Pacific and MEA, and have now started outsourcing regulatory affairs function to CROs or regulatory service providers for reducing cost and increasing focus on core functions.
The regulatory writing and publishing segment led the market for regulatory affairs outsourcing with the highest revenue share of 35.8% in 2019. These services are offered from the early stages of product development to the premarket approval phase. Based on services, the regulatory affairs outsourcing market is segmented into legal representation, product registration and clinical trial applications, regulatory writing and publishing, regulatory consulting, and other services.
The legal representation services segment is anticipated to witness the fastest growth over the forecast period due to the increasing demand for legal representatives across the globe caused by the globalization of medical device companies. For instance, companies not locally present in Europe require legal representatives to gain market authorization.
Based on company size, the large companies segment accounted for the highest revenue share of 46.7% in 2019 in the market for regulatory affairs outsourcing. This segment is anticipated to maintain its dominance over the forecast period. Large companies offer outsourcing services to various pharma industries in order to manage tactical tasks and help adopt best practices. It is learned that good partnerships offer efficiencies in terms of greater market share and skills and capabilities that enable products to be brought to market more rapidly in diverse markets. The introduction of new products in the market and ever-expanding pharmaceutical industries has led to increasing demand for outsourcing services for regulatory affairs.
Based on company size, the market for regulatory affairs outsourcing is further sub-segmented into small and medium companies. Small and medium-sized companies are independent organizations. The development of biopharmaceutical inventions, for example, the introduction of new products, processes, and services in the U.S. has been attributed to increasing demand for small and medium-sized companies.
The drugs segment dominated the market for regulatory affairs outsourcing and accounted for the largest revenue share of 47.8% in 2019. The major factor that contributes to the growth of this segment is the increasing prevalence of various chronic diseases such as cancer, diabetes, and cardiovascular disease. Increasing expenditure on healthcare contributes to significant demand for drugs in the near future. Hence the segment is expected to show growth over the forecast period. The drug segment is further sub-segmented into generic and innovators. generic drugs are expected to witness higher activity within the regulatory affairs space owing to increasing demand for generics and an increasing number of patent expired branded drugs.
Based on the category, the market for regulatory affairs outsourcing is further sub-segmented into biologics and medical devices. The R&D productivity of small molecule drugs is declining, hence shifting the focus on biologics which are expected to register productive growth in the coming years. Various pharma industries are focusing on the development of several biopharmaceutical products in order to keep up with the industry trends and maintain their market position. Besides, an increased understanding of the genetic and molecular basis of disease has opened up the development of a range of targeted treatments. For instance, recombinant proteins aid the immune system in the identification and binding of foreign substances.
The oncology segment holds the largest revenue share of 43.2% in 2019 in the market for regulatory affairs outsourcing. Cancer involves the abnormal growth of cells that results in the formation of a tumor. According to the WHO report 2018, around 18.1 billion people were suffering from cancer. An increase in the number of pipeline products and high demand for personalized medicines are factors likely to boost segment growth during the forecast period, thereby impacting the regulatory affairs requirements. Another aspect of impacting market share is the higher scrutiny levels that are maintained for cancer-related research studies and product development.
Based on indication, the market for regulatory affairs outsourcing is further sub-segmented into neurology, cardiology, immunology, and others. Neurology disorder is recognized as a major cause of death globally. According to the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) Report 2016, around 95% of people were suffering from neurological disease. It is estimated that the global population will reach 9 billion by 2050. Proactive government initiatives and an increase in external funding for R&D are among the key factors driving the market. Furthermore, rapid advancement in the field of neurology and technology has provided startups with opportunities to investigate new products, thereby showcasing a high CAGR over the forecast period.
The clinical segment accounted for the largest revenue share of 46.0% in 2019 in the market for regulatory affairs outsourcing. The large share of this segment is attributed to the rising prevalence of chronic diseases and the increasing demand for clinical trials in developing countries. An increase in the number of biologics, high demand for advanced technologies, and the requirement for personalized orphan drugs and medicine are other factors likely to fuel segment growth during the forecast period.
In addition, factors such as technological evolution, globalization of clinical trials, and increased demand for CROs to conduct clinical trials are further anticipated to boost the growth of the market for regulatory affairs outsourcing over the forecast period. The increase in the experience of these CROs is also contributing to the growing demand for preclinical services by life science companies, as these clients are adopting strategic partnerships business models and outsourcing preclinical services to CROs.
The pharmaceutical companies segment accounted for the largest revenue of 38.9% in 2019 in the market for regulatory affairs outsourcing. This is due to the growth in evolving areas such as biosimilar, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs, which is boosting the market growth.
Shrinking pipeline of blockbuster drugs has led to efficient manufacturing and development of pharmaceutical products, which leads to the adoption of the full-time regulatory affairs outsourcing models by life sciences companies to reduce the overall cost of development. Small- and mid-size companies hire regulatory consultants to manage their regulatory affairs in the new territories. Thus, demand for regulatory consultants for small and mid-size life sciences companies is expected to increase owing to the expansion of these companies into new and emerging markets, which is expected to contribute to the growth of the market for regulatory affairs outsourcing.
The overall regulatory affairs outsourcing market was led by the Asia Pacific region with 43.0% in 2019 and is expected to witness the highest growth rate during the forecast. The growth of this market can be attributed to factors such as low costs of labor and increased availability of a skilled workforce. In addition, an increasing number of clinical trials and a rising number of companies trying to enter markets in countries such as India & China are expected to contribute to market growth.
North America and Europe are also expected to be key markets for regulatory affairs outsourcing owing to the presence of two major international regulatory agencies—the European Medicines Agency (EMA) and the U.S. FDA, respectively, which regulate more than half of medical devices worldwide.
Key companies are engaging in partnerships, mergers, and acquisitions, aiming to strengthen their product portfolio, manufacturing capacities, and to provide competitive differentiation. For example, in December 2018, Freyr launched an advanced version of its existing publishing and submission tool, SUBMIT PRO. It is designed with an additional focus on regional submission templates of the U.S. FDA, Health Canada, EMA, and other major global health authorities, thereby increasing its product offerings. Some of the prominent players in the regulatory affairs outsourcing market include:
Pharmaceutical Product Development, LLC (PPD)
Charles River Laboratories International, Inc.
Parexel International Corporation; Inc
Market size value in 2020
USD 7.1 billion
Revenue forecast in 2027
USD 15.6 billion
CAGR of 11.9% from 2020 to 2027
Base year for estimation
2016 - 2018
2020 - 2027
Revenue in USD million and CAGR from 2020 to 2027
Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Services, company size, category, indication, stage, end-user, region
North America; Europe; Asia Pacific; Latin America; Middle East & Africa
The U.S.; Canada; the U.K.; Germany; France; Italy; Spain; Russia; Turkey; Netherlands; Switzerland; Sweden; Japan; China; India; Australia; South Korea; Indonesia; Malaysia; Singapore; Thailand; Taiwan; Brazil; Mexico; Argentina; Colombia; Chile; South Africa; Saudi Arabia; UAE; Egypt; Israel
Key companies profiled
Accell Clinical Research, LLC; GenPact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; WuXiAppTec, Inc.; Medpace; Pharmaceutical Product Development, LLC (PPD); Charles River Laboratories International, Inc.; ICON plc; Covance, Parexel International Corporation; Inc.; Freyr
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global regulatory affairs outsourcing market report on the basis of services, company size, category, indication, stage, end-user, and region:
Services Outlook (Revenue, USD Million, 2016 - 2027)
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Company Size Outlook (Revenue, USD Million, 2016 - 2027)
Category Outlook (Revenue, USD Million, 2016 - 2027)
Indication Outlook (Revenue, USD Million, 2016 - 2027)
Stage Outlook (Revenue, USD Million, 2016 - 2027)
PMA (Post Market Authorization)
End-user Outlook (Revenue, USD Million, 2016 - 2027)
Medical Device Companies
Regional Outlook (Revenue, USD Million, 2016 - 2027)
Middle East & Africa
b. The global regulatory affairs outsourcing market size was estimated at USD 6.3 billion in 2019 and is expected to reach USD 7.1 billion in 2020.
b. The global regulatory affairs outsourcing market is expected to witness a compound annual growth rate of 11.9% from 2020 to 2027 to reach USD 15.6 billion by 2027.
b. Regulatory writing & publishing held the largest share of 35.8% in 2019 as they are offered from the early stages of product development to the premarket approval phase.
b. Some of the players operating in the market are Accell Clinical Research, LLC.; Genpact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; WuXi AppTec, Inc.; Medpace; Pharmaceutical Product Development, LLC (PPD); Charles River Laboratories International, Inc.; ICON plc; Covance, Parexel International Corporation; Inc.; and Freyr.
b. Key factors that are driving the market growth include an increase in geographical expansion activities by companies, an increase in the R&D activities, and rising clinical trial applications.
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With Covid-19 infections rising globally, the apprehension regarding a shortage of essential life-saving devices and other essential medical supplies in order to prevent the spread of this pandemic and provide optimum care to the infected also widens. In addition, till a pharmacological treatment is developed, ventilators act as a vital treatment preference for the COVID-19 patients, who may require critical care. Moreover, there is an urgent need for a rapid acceleration in the manufacturing process for a wide range of test-kits (antibody tests, self-administered, and others). The report will account for Covid19 as a key market contributor.