Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Category (Pharmaceuticals, Medical Devices), By Company Size, By Indication, By Stage, By Services, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global regulatory affairs outsourcing market size was estimated at USD 7.0 billion in 2022 and is anticipated to expand at a compound annual growth rate (CAGR) of 8.0% from 2023 to 2030. 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 registrations.

Companies are under constant pressure to procure timely clinical approvals from regulators in different regions. Such actions are further promoting the demand for regulatory affairs services, thus contributing to market growth. Regulatory affairs functions are challenging. The increasing demand to obtain approval for new products while maintaining compliance and doing more with fewer drives the market. The pressure to reduce costs by life sciences companies is also very high. The use of generics and demand for drugs & medical devices at lesser prices are expected to rise 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, which, in turn, is expected to drive the demand for regulatory affairs outsourcing among life science companies. Product-specific clinical advice & strategy, along with regulatory compliance at the early stages of product development, can be critical to product approval. Failure to address regulatory compliance in the early development stages often leads to delays in the approval process owing to inappropriately designed studies, manufacturing oversights, omitted studies, and other failures to meet the regulatory requirements.

Such factors are likely to improve the demand for regulatory affairs outsourcing in the life sciences industry. The outbreak of the COVID-19 pandemic has created a negative impact on the market. The initial lockdown led to the closure of clinical trial sites and related activities. Moreover, regulatory bodies paused their activities for a while, focusing on tracking the supply chain activities. Nearly all the components critical to drug development to reduce the spread of the virus at the beginning of the pandemic had affected the market negatively.

However, the pandemic had created an urgent need for treatment of COVID-19 infection, owing to which regulatory authorities, such as the U.S. FDA and the European Union (EU), had given emergency use authorization for various COVID-19 testing devices and treatments. Such actions by regulatory agencies are expected to improve the demand for regulatory affairs outsourcing in the market post-pandemic. The market witnessed a rebound in revenue in 2022 as several companies focused on the development of novel therapeutics for the treatment of COVID-19 infection. Moreover, the growth in R&D activities for new vaccines, therapeutics, and medical devices has further driven the market growth post-2020.

Services Insights

The product registration and clinical trial applications segment dominated the market and accounted for the largest revenue share of more than 25.9% of the global revenue. The increasing number of clinical trials across the globe, stringent regulations in developed markets, and legal/regulatory reforms in emerging markets such as the Asia Pacific are driving the outsourcing trend for clinical trial applications.

The legal representation services segment is anticipated to witness the fastest growth rate of 8.5% over the forecast period of 2023-2030. This is due to the increasing demand for legal representatives across the globe on account of the globalization of medical devices and pharmaceutical companies. The regulations are very complex and ever-changing. The changing regulatory landscape in regions such as Asia Pacific, MEA, and Latin America increases the demand for local experts for legal representation for obtaining regulatory approvals and custom clearance. These factors are promoting the demand for legal representation services globally.

Company Size Insights

The large companies segment is projected to register the fastest growth rate of 8.4% over the forecast period. Large companies generally prefer to establish long-term relations with their service providers to avoid sudden disruption in their operations and thus, prefer a service provider that can meet their regulatory needs to support their various cross-scale and ramp-up operations. Apart from this, according to an article published by GEP (2020), large-scale pharma companies generally outsource about 50% of their regulatory affairs needs. These factors are contributing to the growth of this segment.

On the basis of company sizes, the market has been divided into small, medium, and large. The medium-sized companies segment accounted for 47.0% of the revenue share in 2022 and is estimated to expand further, retaining the leading position over the forecast period. The presence of several mid-sized established providers, especially privately-held ones, is anticipated to contribute to this segment share. Moreover, medium-sized pharmaceutical and medical device companies do not have enough capital to develop an in-house regulatory affairs team, which is further driving the demand for regulatory affairs outsourcing among these companies.

Category Insights

The pharmaceutical segment dominated the market and accounted for the largest share of 62.1% in 2022. The segment is currently leading the regulatory affairs outsourcing market due to the increasing demand for regulatory support services in the pharmaceutical industry. With the growing number of new drug applications and the increasing complexity of regulatory requirements, pharmaceutical companies are increasingly outsourcing their regulatory affairs functions to specialized service providers. Outsourcing enables these companies to access the expertise of regulatory professionals and reduce costs associated with maintaining an in-house regulatory affairs team. Additionally, the pharmaceutical segment is also witnessing growth due to the increasing focus on drug safety, efficacy, and quality, which requires extensive regulatory support.

However, the medical device segment is projected to register a considerable CAGR of 8.0% over the forecast period of 2023-2030, which can be attributed to the fact that medical devices companies are now focusing on their core competencies and outsourcing noncore functions to increase their productivity and operational efficiency. The growing demand for advanced medical devices and new technological advancements in medical devices are further contributing to the growth of the segment.

Indication Insights

The oncology segment dominated the market and accounted for the largest share of more than 33.1% in 2022. 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 the development of personalized medicines. Scientific progress is driving an increase in the number of personalized medicine products and services, subject to regulatory review, hence contributing to market growth. Other indications included in the scope of the study are neurology, cardiology, immunology, and others.

The immunology segment is expected to expand at the fastest CAGR of 9.5% over the forecast period of 2023-2030. This is due to its potential in facilitating the treatment of various cardiovascular, neurological, oncological, and inflammatory diseases. The strategic initiatives undertaken by market players for immunology are anticipated to facilitate segment growth. For instance, in 2020, Eli Lilly entered into an agreement to acquire Dermira’s immunology portfolio. In addition, the COVID-19 pandemic created an urgent need for vaccines. Thus, the development of vaccines for COVID-19 is likely to have a positive impact on segment growth.

Stage Insights

The clinical studies segment dominated the market and accounted for the largest revenue share of 47.0% in 2022. This can be attributed to the increasing number of clinical trial registrations over the past few years. According to ClinicalTrials.gov, nearly 401,716 trials were registered in January 2022, as compared to around 325,834 by the end of 2019. Moreover, this rise in the number of biologics, high demand for advanced technologies, and a requirement for personalized orphan drugs & medicines are other factors likely to fuel segment growth during the forecast period.

The preclinical segment is anticipated to expand at the fastest CAGR of 8.7% over the forecast period of 2023-2030. The rising demand for novel disease treatments, such as COVID-19, Zika virus, and Ebola, and the increasing prevalence of existing diseases, such as CVDs, cancer, and neurological diseases are the key factors contributing to the preclinical segment’s growth. Moreover, stringent regulations related to preclinical studies, laid down by global regulatory bodies, such as International Conference on Harmonization (ICH), WHO, FDA, EMEA (Europe), PMDA (Japan), ANVISA (Brazil), MHRA (UK), & ROEB (Canada), are further driving the demand for regulatory affairs outsourcing agencies for preclinical studies.

End-use Insights

The pharmaceutical companies segment dominated the market and accounted for the largest share of more than 39.2% in 2022. The segment is anticipated to expand further at the fastest CAGR of 8.0%, retaining its leading market position over the forecast period. This is due to the growth in evolving areas, such as biosimilar, orphan drugs, and personalized medicines, which are creating more demand for regulatory services, thereby boosting segment growth. In addition, the significant number of new drugs entering the pharmaceutical industry has further improved segment growth.

The medical device and biotechnology companies segments both have registered a substantial share in the market in 2022. This can be attributed to the increased demand for biopharmaceuticals, vaccines, advanced medical devices, and other products. The growing demand for wearable technologies, along with recent epidemic events, is further contributing to the substantial share of these segments. Furthermore, the increasing number of launches pertaining to medical devices is another significant factor boosting demand for regulatory affairs services, thus supporting segmental growth.

Regional Insights

The Asia Pacific region dominated the regulatory affairs outsourcing market and accounted for the largest revenue share of more than 38.5% in 2022. The region is also projected to witness the fastest CAGR 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 developing countries, such as India and China. Furthermore, the availability of a skilled workforce in the region at lower costs compared to the U.S. is another factor expected to propel the regional market growth.

The North American regional market also reported a significant share in the global industry. The presence of key pharmaceutical and medical device companies and the rise in R&D spending in the region are some of the key factors driving the market in North America. North America and Europe are expected to be the 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, which regulate more than half of the medical devices worldwide.

Key Companies & Market Share Insights

Market players are undertaking various strategic initiatives, such as partnerships, collaborations, mergers & acquisitions, and geographic expansion, to strengthen their product portfolio and manufacturing capacities, and provide competitive differentiation. For example, in August 2021, ProPharma Group acquired iSafety Systems., an Indian pharmacovigilance service provider, for strengthening its market position in pharmacovigilance. Similarly, in July 2021, ICON plc acquired a CRO involved in providing drug development and regulatory consulting services - PRA Health Sciences. This acquisition was aimed at enhancing the services portfolio of ICON plc.

Also, during the pandemic, market players like IQVIA’s Global Regulatory Affairs were committed to deploying their resources and capabilities to help everyone in healthcare & keep things moving forward. This comprised helping medical device & drug developers, as well as manufacturers, in enabling the successful initiation & conduction of clinical trials, along with streamlining submission strategies & operations based on evolving main regulatory guidance around the world. Some of the prominent players in the global regulatory affairs outsourcing market are:

• Accell Clinical Research, LLC

• Genpact

• CRITERIUM, INC

• Promedica International

• WuXi AppTec

• Medpace

• Charles River Laboratories

• ICON plc

• Covance, Inc. (Labcorp Drug Development)

• Parexel International Corporation

• Freyr

• PHARMALEX GMBH

• NDA Group AB

• Pharmexon

• Qvigilance

• BlueReg

• Cambridge Regulatory Services

• APCER Life Sciences, Inc.

• Real Regulatory Ltd

• VCLS

• PrimeVigilance

• ProPharma Group MIS Limited

• Regulatory Pharma Net srl

• ZEINCRO

• BioMapas

• REGENOLD GMBH

Regulatory Affairs Outsourcing Market Report Scope

Global Regulatory Affairs Outsourcing Market Report Segmentation

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 2018 to 2030. 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-use, and region:

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Regulatory Consulting

    • Strategy & Development Planning

    • QA Consulting

    • Others

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submission

  • Regulatory Operations

  • Other Services

• Company Size Outlook (Revenue, USD Million, 2018 - 2030)

  • Small

  • Medium

  • Large

• Category Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceuticals

    • Regulatory Consulting

      • Strategy & Development Planning

      • QA consulting

      • Others

    • Legal Representation

    • Regulatory Writing & Publishing

    • Product Registration & Clinical Trial Applications

    • Regulatory Submissions

    • Regulatory Operations

    • Other Services

  • Medical Device

    • Regulatory Consulting

      • Strategy & Development Planning

      • Qa Consulting

      • Others

    • Legal Representation

    • Regulatory Writing & Publishing

    • Product Registration & Clinical Trial Applications

    • Regulatory Submissions

    • Regulatory Operations

    • Other Services

• Indication Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Neurology

  • Cardiology

  • Immunology

  • Others

• Stage Outlook (Revenue, USD Million, 2018 - 2030)

  • Preclinical

  • Clinical

  • PMA (Post Market Authorization)

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Medical Device Companies

  • Pharmaceutical Companies

  • Biotechnology Companies

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.                     

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

    • Turkey

    • Netherlands

    • Switzerland

    • Sweden

    • Europe CIS Countries

    • Rest of Europe

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Indonesia

    • Malaysia

    • Singapore

    • Thailand

    • Taiwan

    • CIS Countries

    • Rest of APAC

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

    • Rest of Latin America

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Egypt

    • Israel

    • Rest of MEA