The global regulatory affairs outsourcing market size was valued at 6.3 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 11.9% from 2021 to 2028. The outsourcing of regulatory affairs has become an increasingly important practice in the healthcare industry. An increase in geographical expansion activities by companies that aim for speedy approvals in local markets is expected to contribute to the adoption of outsourcing models for regulatory services. The outsourcing market for regulatory affairs is expanding rapidly due to the increase in R&D activities, augmenting the volume of clinical trial applications, and product registration. Companies are under constant pressure to procure timely clinical approvals from regulators in different regions.
Regulatory affairs functions are challenging. The increasing need to obtain approval for new products, maintain compliance, and do more with less has 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. For example, LifeSphere Regulatory software is regulatory affairs and compliance software that offers companies regulatory solutions and can help in other departments, such as clinical trial registration, product registration, agency interactions, submission planning, and forecasting, global change management, and performance tracking. In this scenario, outsourcing is gradually becoming a vital part of the regulatory capability mix.
The pressure to reduce costs by life sciences companies is very high. The shift toward an 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.
Product-specific clinical advice and strategy, along with regulatory compliance at the early stages of the product development, can be critical to product approval. Webb Writes LLC offers services related to medical writing and statistical consulting. Failure to address regulatory compliance in the early development stage often leads to delay in the approval process owing to inappropriately designed studies, manufacturing oversights, omitted studies, and other failures to meet the regulatory requirements.
The coronavirus pandemic has brought many disruptions. Delays are occurring in R&D, manufacturing, supply chain, and nearly all the components critical to drug development that eventually leads to regulatory decisions and patient access to new drugs. Communications with regulatory bodies have become unpredictable with a long wait time to hear back from the review teams or agencies that are critical to moving along the development process. Moreover, timeline crunches and round-the-clock availability of personnel are certain challenges faced by the market participants. However, in terms of revenue at the global level, a large number of ongoing clinical studies as a response to the COVID-19 pandemic are contributing to the growth of the clinical trial service segment.
The regulatory writing and publishing segment led the market with a revenue share of 36.7% in 2020. These services are offered from the early stages of product development to the premarket approval phase. The segment is also anticipated to dominate the regulatory affairs outsourcing market during the forecast period owing to increased outsourcing of these services by large- and mid-size biopharmaceutical and medical device companies. For instance, as of 2019, regulatory writing and pharmacovigilance services by IQVIA within the Asia Pacific region contributed toward high revenue generation.
The legal representation segment is anticipated to expand at the fastest CAGR of 12.7% over the forecast period. This may be 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.
Medium-sized companies held the largest share of 46.8% in 2020. The presence of several midsized established providers, especially privately held ones, is anticipated to contribute to the segment growth. These companies have a strong presence in selected markets or multiple markets across the globe.
The large companies are projected to register the fastest growth rate of 12.3% over the forecast period. Large service providers are popular among the leading pharma and biotechnology and medical device firms. The availability of a wide variety of services and the presence of these providers in various geographies can enable ease of business and thus, act as the primary factors contributing to their popularity, especially among larger companies.
Based on category, the medical devices segment led the market with a share of 37.8% in 2020. This may be attributed to the fact that medical device companies are now focusing on their core competencies and outsourcing non-core functions to increase their productivity and operational efficiency.
The biologics segment is projected to grow rapidly during the forecast period. 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 to keep up with the industry trends and maintain their market position, thus eventually contributing to the segment growth.
The oncology segment held the largest revenue share of 33.1% in 2020. The recent advances in the biology of cancer and the emergence of new tools for genome analysis have opened a clinical perspective in oncology, which has led to personalized medicine. Scientific progress is driving an increase in the number of personalized medicine products and services subject to regulatory review, thereby contributing to the segment growth.
Other indications included in the scope of the study are neurology, cardiology, immunology, and others. The neurology segment is expected to register a high CAGR over the forecast period. Neurology disorders are 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.
The clinical segment accounted for the largest share of 46.7% in 2020. This can be attributed to the increasing number of clinical trial registrations over the past few years. According to ClinicalTrials.gov, nearly 347,033 trials were registered in the U.S. as of July 2020, as compared to around 325,834 by the end of 2019. Besides, a rise in the number of biologics, high demand for advanced technologies, and a requirement for personalized orphan drugs and medicine are other factors likely to fuel the segment growth during the forecast period.
Moreover, the coronavirus pandemic has further increased the demand for regulatory services. The global urgency to identify and commercialize an effective cure and/or vaccine for the COVID-19 disease has led to an increase in the number of clinical trials across the globe. Furthermore, supportive regulatory actions such as shortening of trial approval time, waiving of the waiting period, the release of industry guidance documents, and funding of clinical trials undertaken by regulatory authorities are anticipated to further boost the segment growth.
The pharmaceutical companies led the market and accounted for more than 38.0% share of the global revenue in 2020. The segment is also anticipated to expand at the fastest CAGR over the forecast period. This is attributed to the growth in evolving areas, such as biosimilar, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs, which is creating more demand for regulatory services, thereby boosting the segment growth.
The 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 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 global market.
The Asia Pacific led the market with a share of 37.9% in 2020. The region is also projected to witness lucrative growth over the forecast period. This can be attributed to the increasing number of clinical trials and the rising number of companies trying to enter markets in countries, such as India and China. Furthermore, the availability of a skilled workforce within the region at a lower cost compared to the U.S. is another factor expected to propel regional growth.
North America and Europe are expected to be the key regional 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.
Market players are undertaking various strategic initiatives, such as partnerships, collaborations, mergers & acquisitions, and geographic expansion, aiming to strengthen their product portfolio, expand manufacturing capacities, and provide competitive differentiation.
For example, in November 2019, Accell announced its collaboration with Syntax, another CRO service provider. Together, they aim at expanding their client reach in the Eastern European region. Syntax also provides regulatory services that are primarily focused on initial submissions and drug development process authorization.
Moreover, during the pandemic, market players like IQVIA’s Global Regulatory Affairs team are committed to deploying their resources and capabilities to help everyone in healthcare and keep things moving forward. This comprises of helping medical device and drug developers as well as manufacturers, enabling the successful initiation and conduct of clinical trials, along with streamlining submission strategies and operations based on evolving main regulatory guidance around the world. Some prominent players in the global regulatory affairs outsourcing market include:
WuXi AppTec, Inc.
Pharmaceutical Product Development, LLC (PPD)
Charles River Laboratories International, Inc.
Parexel International Corporation, Inc.
Accell Clinical Research, LLC
PRA Health Sciences
Market Size value in 2021
USD 6.8 billion
Revenue forecast in 2028
USD 14.9 billion
CAGR of 11.9% from 2021 to 2028
Base year for estimation
2016 – 2019
2021 - 2028
Revenue in USD million/billion and CAGR from 2021 to 2028
Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Service, company size, category, indication, stage, end-user, region
North America; Europe; Asia Pacific; Latin America; Middle East & Africa
U.S.; Canada; U.K.; Germany; France; Italy; Spain; Russia; Turkey; Netherlands; Switzerland; Sweden; Azerbaijan; Belarus; Kazakhstan; Moldova; Georgia; Ukraine; Japan; China; India; Australia; South Korea; Indonesia; Malaysia; Singapore; Thailand; Taiwan; Armenia; Kyrgyzstan; Tajikistan; Uzbekistan; Turkmenistan; 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; Parexel International Corporation, Inc.; Charles River Laboratories International, Inc.; Medpace
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This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global regulatory affairs outsourcing market report on the basis of service, company size, category, indication, stage, end-user, and region:
Service Outlook (Revenue, USD Million, 2016 - 2028)
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Company Size Outlook (Revenue, USD Million, 2016 - 2028)
Category Outlook (Revenue, USD Million, 2016 - 2028)
Indication Outlook (Revenue, USD Million, 2016 - 2028)
Stage Outlook (Revenue, USD Million, 2016 - 2028)
PMA (Post Market Authorization)
End-user Outlook (Revenue, USD Million, 2016 - 2028)
Medical Device Companies
Regional Outlook (Revenue, USD Million, 2016 - 2028)
Middle East & Africa
b. The global regulatory affairs outsourcing market size was estimated at USD 6.3 billion in 2020 and is expected to reach USD 6.8 billion in 2021.
b. The global regulatory affairs outsourcing market is expected to witness a compound annual growth rate of 11.9% from 2021 to 2028 to reach USD 14.9 billion by 2028.
b. Regulatory writing & publishing held the largest share of 36.7% in 2020 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 regulatory affairs outsourcing 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.