Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Category (Biologics, Medical Devices), By Company Size (Medium, Large), By Indication, By Stage, By Services, By End Use, And Segment Forecasts, 2022 - 2030

Report Overview

The global regulatory affairs outsourcing market size was estimated at USD 6.5 billion in 2021 and is anticipated to expand at a compound annual growth rate (CAGR) of 8.9% from 2022 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 registration.

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 the 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 the life science companies. Product-specific clinical advice & strategy along with regulatory compliance at the early stages of the product development can be critical to product approval. 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.

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 had 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 the 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 2021 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.

Service Insights

On the basis of services, the global market has been further divided into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, and other services. The regulatory writing & publishing segment led the market in 2021 and accounted for the highest share of more than 36.5% of the global revenue. These services are offered from the early stages of product development to the post-marketing authorization phase. The segment is also anticipated to dominate the market during the forecast period owing to the adoption of outsourcing of these services by large- and mid-sized biopharmaceutical and medical device companies.

The legal representation services segment is anticipated to witness the fastest growth rate over the forecast period. 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. Changing the 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 more than 9% 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 the maximum revenue share in 2021 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, the 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 medium-sized companies.

Category Insights

On the basis of category, the global market has been further segmented into drugs, biologics, and medical devices. The medical device segment accounted for the largest share of more than 37.5% of the global revenue in 2021. This 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.

However, the biologics segment is projected to register the forecast CAGR over the forecast period. The R&D productivity of small molecule drugs is declining, hence the focus is shifting to biologics, which is expected to register productive growth in the years to come. Various pharmaceutical companies are focusing on the development of new biopharmaceutical products to keep up with the industry trends and maintain their position in the global market. In addition, biologics drugs have to follow complex and rigorous regulations, which, in turn, is further driving the demand for regulatory outsourcing for biologics, thereby driving the segment.

Indication Insights

The oncology segment accounted for the largest share of more than 33% of the global revenue in 2021. 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. Hence, contributing to the market growth. Other indications included in the scope of the study are neurology, cardiology, immunology, and others.

The immunology segment is expected to grow at the fastest CAGR over the forecast.This isdue 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 the segment growth. For instance, in 2020, Eli Lilly entered into an agreement to acquire Dermira’s immunology portfolio. In addition, the COVID-19 pandemic had 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

On the basis of stages, the global market has been divided into preclinical, clinical studies, and PMA. The clinical studies segment accounted for the largest share of more than 46.5% in 2021. 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 & medicine are other factors likely to fuel segment growth during the forecast period.

The preclinical segment is anticipated to grow at the fastest CAGR over the forecast period. 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 preclincial 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 agency for preclinical studies.

End-use Insights

On the basis of end uses, the global market has been further segmented into medical device companies, pharmaceutical companies, and biotechnology companies. The pharmaceutical companies end-use segment accounted for the largest share of more than 39% of the global revenue in 2021. The segment is anticipated to expand further at the fastest CAGR 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 the segment growth.

In addition, the significant number of new drugs entering the pharmaceutical industry has further improved the segment growth. The medical device and biotechnology segments both have registered a substantial share in the market in 2021. This can be attributed to the increased demand for biopharmaceuticals, vaccines, advanced medical devices, and others. The growing demand for wearable technologies along with recent epidemic events is further contributing to the share of these segments.

Regional Insight

On the basis of geographies, the market has been further divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The Asia Pacific region accounted for the maximum share of more than 38% of the global revenue in 2021. 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 America regional market also reported a significant share in the global industry. The presence of key pharmaceutical and medical devices companies and the rise in the R&D spending in the region and 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 U.S. FDA, which regulate more than half of medical devices worldwide.

Key Companies & Market Share Insights

Market players are undertaking various strategic initiatives, such as partnerships, collaborations, mergers & acquisitions, geographic expansion, to strengthen their product portfolio, 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, namely 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 are committed to deploying their resources & capabilities to help everyone in healthcare & keep things moving forward. This comprises of helping medical device & drug developers, as well as manufacturers, enable the successful initiation & conduct of clinical trials along with streamlining submission strategies & operations based on evolving main regulatory guidance around the world. Some prominent players in the global regulatory affairs outsourcing market are:

• Accell Clinical Research, LLC

• GenPact Ltd.

• Criterium, Inc.

• PRA Health Sciences

• Promedica International

• Dr. Regenold GmbH

• BioMapas

• Zeincro Group

• Parexel International Corp.

• Charles River Laboratories International, Inc.

• ICON plc

• Covance

• Freyr

Regulatory Affairs Outsourcing Market Report Scope

Segments Covered in the Report

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:

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

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Other Services

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

  • Small

  • Medium

  • Large

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

  • Drugs

    • Generics

    • Innovators

  • Biologics

    • Biotech

    • ATMPs

    • Biosimilars

  • Medical devices

    • Therapeutic

    • Diagnostic

• 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

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Indonesia

    • Malaysia

    • Singapore

    • Thailand

    • Taiwan

    • Asia Pacific CIS Countries

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Egypt

    • Israel