Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Categories (Biologics, Drugs), By Indication, By Product Stage, By End Use, By Service Providers, By Company Size, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global regulatory affairs market size was valued at USD 11.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.4% from 2021 to 2028. This growth can be attributed to the increasing demand for the faster approval process, changing regulatory landscape, growth in emerging fields such as specialty therapies, orphan drugs, personalized medicines, and companion diagnostics. The market for regulatory affairs is also driven by the emergence of new diseases triggering the need for effective vaccines and therapies.

The growing pace of innovation in digital health and the rapid technological advancements in data collection, analysis, and management is anticipated to create a need for digital transformation in one or more regulatory processes in order to improve the access and analysis of the continuously growing volume of information due to connected health products and programs. Furthermore, even several pharma/biotech companies are anticipated to upgrade their existing technologies to meet the growing healthcare needs. For instance, according to the 2018 Steve Gens Report, nearly 58% of survey pharma companies planned to enhance their Regulatory Intelligence (RI) capability while another study mentioned that 20 out of 22 participating companies considered leveraging AI for RI data processing activities. 

Presently, the healthcare industry is focused not only on the development of blockbuster therapies for the treatment of various diseases but also on targeted gene therapies, specialty drugs, and precision medicine that help treat specific diseases and disorders. Furthermore, some of these products are also being combined with medical devices to enhance the quality of drug delivery, dose, and patient monitoring or adherence, thus increasing the complexity of defining the regulatory strategy and pathway to market.

Furthermore, launched or soon to be launched therapies, such as AbbVie’s JAK1 inhibitor, Alexion’s Ultomiris, Novartis/Avexis’ Zolgensma, Boehringer Ingelheim/AbbVie’s Skyrizi, Aimmune’s Palforzia, and bluebird bio’s Zynteglo, are expected to be blockbusters products by 2023, indicating huge opportunities in areas of intellectual property rights, commercialization strategies, and post-marketing strategies.

Service Insights

The regulatory writing and publishing segment dominated the market for regulatory affairs and held the largest revenue share of more than 35.0% in 2020. This can be attributed to the increase in the outsourcing of selected regulatory functions by major life sciences companies while focusing on the core functions. Based on service, the market for regulatory affairs is broadly categorized into regulatory consulting, legal representation, regulatory writing and publishing, product registration and clinical trial applications, and others.

The legal representation segment is anticipated to witness rapid growth over the forecast period due to geographic expansion plans of biotech/pharma and medical device companies which is anticipated to increase the demand for local regulatory services. Entering new markets is a challenging process for many pharma/biotech and medical device companies, especially small/medium-sized ones. This can be attributed to the difference in local regulations and lack of sufficient internal resources to meet the required local expertise, thus creating a need for experienced service providers.

Categories Insights

The medical devices segment dominated the market for regulatory affairs and accounted for the largest revenue share of more than 39.0% in 2020. This can be attributed to the increased competition due to high demand for wearables and technological advancements in material science, design languages, personalized healthcare, and additive manufacturing which is expected to encourage manufacturers and technology developers to focus on core competencies and outsource non-core activities. 

Based on categories, the market for regulatory affairs is broadly categorized into drugs, biologics, and medical devices. The medical device category is sub-segmented into diagnostics and therapeutics. The drugs segment is sub-segmented into innovative and generics while the biologics segment is sub-segmented into biosimilars, advanced therapy medicinal products (ATMPs), and biotech products. Innovative drugs and therapeutic medical devices dominated the market in 2020.

The biologics segment is anticipated to witness the fastest growth over the forecast period. The growing number of product approvals, increasing demand for targeted therapies, and the rise in the development of biosimilars are factors anticipated to contribute to segment growth.

Indication Insights

The oncology segment dominated the market for regulatory affairs and accounted for the largest revenue share of 33.1% in 2020. This can be attributed to the increasing prevalence and mortality rate of cancer along with the presence of several innovative pipeline products. For instance, as of 2019, there were nearly 2731 anticancer immunological molecules in the pipeline

The immunology segment is anticipated to register the fastest growth over the forecast period. The growing use of immunological molecules in cancer therapy coupled with its potential in facilitating the treatment of various cardiovascular, neurological, and inflammatory diseases is anticipated to boost segment growth. 

Product Stage Insights 

The clinical segment dominated the market for regulatory affairs and accounted for the largest revenue share of more than 45.0% in 2020. Increasing prevalence of chronic diseases and the emergence of new diseases are factors anticipated to increase the number of clinical trials conducted to meet healthcare needs. Several companies conduct clinical trials on existing molecules for either indication expansion or combination therapy. For instance, a response to the novel coronavirus, several companies are conducting clinical trials for use of previously approved anti-viral, antibiotics, corticosteroids, and monoclonal antibodies to treat COVID-19. Such activities are anticipated to increase the need for regulatory services related to medical writing and regulatory labeling services.

The preclinical segment is anticipated to grow at a rapid pace over the forecast period. This can be attributed to the increasing number of molecules in the preclinical stage. For instance, according to Pharma R&D Annual Review 2019 Report, the number of molecules in the preclinical phase increased from 8,040 in 2018 to 8,520, in 2019, thereby fueling segment growth.

Service Provider Insights

The outsourcing segment dominated the market for regulatory affairs and accounted for the largest revenue share of nearly 57.0% in 2020 and is anticipated to witness rapid growth over the forecast period. Several start-up medical devices, pharmaceutical, and biotechnology companies generally lack the budget and infrastructure for a sustainable in-house regulatory affairs team and mainly rely on outsourcing, thus providing huge opportunities for regulatory affairs service providers

Moreover, several regulatory service providers are hired by companies on a project or event basis, thus reducing the dependence on a single vendor. For instance, according to a 2017 study, the participants outsourced to an average of 4 CROs, thereby maintaining a mix of vendors instead of relying on a single provider.

Company Size Insights 

The medium-sized companies segment dominated the market for regulatory affairs and accounted for the largest revenue share of more than 45.0% in 2020. The presence of several midsized established providers, especially privately held ones, is anticipated to contribute to this segment’s market share. 

The large-sized companies segment is anticipated to grow at a rapid pace over the forecast period. Large companies generally tend to prefer service providers of similar size to meet various regulatory needs arising due to their large geographic network, wide product lines, and tend to seek long-term partnerships with service providers. 

End-use Insights 

The pharmaceutical companies segment dominated the market for regulatory affairs and accounted for the largest revenue share of 8.8% in 2020. The segment is anticipated to witness a CAGR of 8.8% over the forecast period, owing to the increase in the number of approved pharmaceutical products. For instance, the U.S. FDA approved 22, 46, and 59 novel drugs in 2016, 2017, and 2018, respectively.

Biopharmaceutical companies are actively involved in the development of innovative molecules that fulfill unmet patient needs. With an increasing number of companies in late-stage development of their biologics, the biologics market is anticipated to witness substantial growth.

Regional Insights

Asia Pacific dominated the regulatory affairs market and accounted for the largest revenue share of more than 36.0% in 2020. It is also anticipated to be the fastest-growing region owing to relatively lower cost for outsourcing, skilled workforce with technical expertise, tax benefits, and expansion of healthcare companies in countries such as India and China. Supportive regulations are thus increasing the demand for local regulatory services. 

A supportive regulatory landscape is also anticipated to favor the growth of the market in the region. As of August 2016, nearly 60 biosimilars were approved in India. This can be attributed to a less rigorous approval pathway for biosimilars in the country and other similar emerging markets as compared to highly regulated markets. 

The implementation of In-vitro Diagnostics Regulation (IVDR) and new Medical Device Regulation (MDR) is anticipated to increase the time and cost required for entering a European market, thereby increasing the regulatory complications in the region.

Key Companies & Market Share Insights

The market is highly competitive, marked by the presence of a large number of domestic as well as international players. Companies are engaging in product launches, mergers, and acquisitions, collaborations, and expansion of geographic presence in order to strengthen their market position. For instance, in 2019, WuXi AppTec acquired Pharmapace that offers biometric services for regulatory submissions, phases of clinical trials, and post-marketing support. This acquisition was aimed at enhancing the clinical development portfolio of WuXi AppTec.  Some of the prominent players in the regulatory affairs market include:

• 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.

• Freyr

Regulatory Affairs 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 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global regulatory affairs market report on the basis of service, service provider, categories, product stage, company size, end use, indication, and region:

• Service Outlook (Revenue, USD Million, 2016 - 2028)

  • Regulatory consulting

  • Legal representation

  • Regulatory writing & publishing

  • Product registration & clinical trial applications

  • Other services

• Categories Outlook (Revenue, USD Million, 2016 - 2028)

  • Drugs

    • Innovator

      • Preclinical

      • Clinical

      • Post market

    • Generic

      • Preclinical

      • Clinical

      • Post market

  • Biologics

    • Biotech

      • Preclinical

      • Clinical

      • Post market

    • ATMP

      • Preclinical

      • Clinical

      • Post market

    • Biosimilars

      • Preclinical

      • Clinical

      • Post market

  • Medical devices

    • Diagnostics

      • Preclinical

      • Clinical

      • Post market

    • Therapeutics

      • Preclinical

      • Clinical

      • Post market

• Indication Outlook (Revenue, USD Million, 2016 - 2028)

  • Oncology

  • Neurology

  • Cardiology

  • Immunology

  • Others

• Product Stage Outlook (Revenue, USD Million, 2016 - 2028)

  • Preclinical

  • Clinical

  • PMA

• End-use Outlook (Revenue, USD Million, 2016 - 2028)

  • Medical Device Companies

  • Biotechnology Companies

  • Pharmaceutical Companies

• Service Provider Outlook (Revenue, USD Million, 2016 - 2028)

  • In-house

  • Outsourced

• Company Size Outlook (Revenue, USD Million, 2016 - 2028)

  • Small

  • Medium

  • Large

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Switzerland

    • Netherlands

    • Sweden

    • Russia

    • Turkey

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Malaysia

    • Indonesia

    • Singapore

    • Thailand

    • Taiwan

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Chile

    • Colombia

  • MEA

    • South Africa

    • Saudi Arabia

    • Israel

    • Egypt

    • UAE