Regulatory Affairs Market Size, Share & Trends Report

Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Service Provider, By Company Size, By Categories, By Product Stage, By Indication, By End-use, By Region, And Segment Forecasts, 2020 - 2027

  • Published Date: Nov, 2020
  • Base Year for Estimate: 2019
  • Report ID: GVR-4-68039-065-9
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2018
  • Number of Pages: 187

Report Overview

The global regulatory affairs market size was valued at USD 10.97 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 8.4% from 2020 to 2027. 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 is also driven by the emergence of new diseases triggering the need for effective vaccines and therapies. Constant innovations in digital health and rapid technological advancements in data collection, analysis, and management are anticipated to create a need for digital transformation in one or more regulatory processes to improve the access and analysis of the continuously growing volume of information due to connected health products and programs.

The U.S. regulatory affairs market size, by service provider, 2016 - 2027 (USD Billion)

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 Artificial Intelligence (AI) for RI data processing activities.

At present, 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, which help treat specific diseases and disorders. Some of these products are also being combined with medical devices to enhance the quality of drug delivery and dose & patient monitoring or adherence, thus increasing the complexity of defining the regulatory strategy and pathway to market.

In addition, 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, indicate tremendous growth opportunities in the areas of intellectual property rights, commercialization strategies, and post-marketing strategies.

Service Insights

The regulatory writing & publishing segment held the largest market share of over 36% in 2019. 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 services, the market is categorized into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, and others.

The legal representation segment is anticipated to witness the fastest growth rate 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- and 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 accounted for the maximum revenue share of over 37% in 2019. This can be attributed to the increased competition due to the high demand for wearables and technological advancements in material science, design languages, personalized healthcare, and additive manufacturing, which encourages manufacturers & technology developers to focus on core competencies and outsource non-core activities. Based on the categories, the market is divided into drugs, biologics, and medical devices. The medical device category is sub-segmented into diagnostics and therapeutics.

The drugs segment is sub-segmented into innovator and generic 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 2019. Biologics are anticipated to witness the fastest CAGR over the forecast period. The growing number of product approvals and increasing demand for targeted therapies as well as the rise in the development of biosimilars are anticipated to contribute to segment growth.

Indication Insights

The oncology segment dominated the regulatory affairs market in 2019 and accounted for the largest revenue share of over 33%. The segment will expand further on account of the increasing prevalence of chronic diseases, such as cancer, along with the presence of several innovative pipeline products. For instance, in 2019, there were nearly 2731 anticancer immunological molecules in the pipeline. The immunology segment is anticipated to register the fastest CAGR 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 the segment growth.

Product Stage Insights

The clinical-stage led the market and accounted for 46.0% of the global revenue share in 2019. The increasing prevalence of chronic diseases and the emergence of new diseases are anticipated to increase the number of clinical trials conducted to meet healthcare needs. Furthermore, several companies conduct clinical trials on existing molecules for either indication expansion or combination therapy. For instance, 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 stage is anticipated to grow at the fastest CAGR over the forecast period. This can be attributed to the increasing number of molecules in the preclinical stage. For instance, according to the 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 the segment growth.

Service Provider Insights

The outsourcing segment accounted for the largest market share of more than 57% in 2019 and is anticipated to expand further at the fastest CAGR 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 service providers. Regulatory affairs outsourcing can be performed through RA consultants, individual contractors, specialist RA consultancies, and CROs.

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 four CROs, thereby maintaining a mix of vendors instead of relying on a single provider.

Company Size Insights

The medium-sized companies segment led the market and accounted for a revenue share of over 46%. The basis for the company size is employee strength and not revenue. The presence of several midsized established providers is anticipated to contribute to this segment’s growth.

The large-sized companies segment is anticipated to register the fastest CAGR over the forecast period. Large-size 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 accounted for the largest revenue share of over 38% in 2019 and is projected to grow at the fastest CAGR from 2020 to 2027. This growth is attributed 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.

Based on end use, the market has been segmented into pharmaceutical, biotechnology, and medical device companies. The end-use segment was introduced in addition to the categories segment, owing to one company catering to multiple categories but recognizing itself as part of one of the aforementioned three industries.

Global regulatory affairs market share, by end-use, 2019 (%)

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

Regional Insights

Asia Pacific was the dominant regional market in 2019 and accounted for more than 37% of the overall share. 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, Singapore, and China. A supportive regulatory landscape is also anticipated to favor the region’s growth. In 2019, more than 95 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 the In-vitro Diagnostics Regulation (IVDR) and new Medical Device Regulation (MDR) is anticipated to increase the time and cost required for entering the Europe market, thereby increasing the regulatory complications in the regional market.

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 focus on product launch, mergers, acquisitions, collaborations, and geographical expansion 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 key companies profiled in the regulatory affairs market are:

  • Accell Clinical Research, LLC.

  • GenPact Ltd.

  • Criterium, Inc.

  • PRA Health Sciences

  • Promedica International

  • WuXi AppTec, Inc.

  • Medpace

  • Charles River Laboratories International, Inc.

  • Icon plc

  • Covance

  • Parexel International Corporation

  • Freyr

Regulatory Affairs Market Report Scope

Report Attribute

Details

Market size value in 2020

USD 11.85 billion

Revenue forecast in 2027

USD 20.90 billion

Growth Rate

CAGR of 8.4% from 2020 to 2027

Base year for estimation

2019

Historical data

2016 - 2018

Forecast period

2020 - 2027

Quantitative units

Revenue in USD million/billion and CAGR from 2020 to 2027

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Service, service provider, company size, categories, product stage, indication, end-use, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; U.K.; Germany; France; Italy; Spain; Russia; Turkey; The Netherlands; Switzerland; Sweden; China; India; Japan; 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; WuXi AppTec, Inc.; Medpace; Charles River Laboratories International, Inc.; Icon plc; Covance; Parexel International Corporation; Freyr

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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 2027. For the purpose of this study, Grand View Research has segmented the global regulatory affairs market report on the basis of service, service provider, company size, categories, product stage, indication, end-use, and region:

  • Service Outlook (Revenue, USD Million, 2016 - 2027)

    • Regulatory Consulting

    • Legal Representation

    • Regulatory Writing & Publishing

    • Product Registration & Clinical Trial Application

    • Other Services

  • Service Provider Outlook (Revenue, USD Million, 2016 - 2027)

    • In-house

    • Outsourcing

  • Company Size Outlook (Revenue, USD Million, 2016 - 2027)

    • Small

    • Medium

    • Large

  • Categories Outlook (Revenue, USD Million, 2016 - 2027)

    • Drugs

      •  Innovator

        • Preclinical

        • Clinical

        • Post Market

      •  Generic

        • Preclinical

        • Clinical

        • Post Market

    • Biologics

      • Biotech

        • Preclinical

        • Clinical

        • Post Market

      • ATMP

        • Preclinical

        • Clinical

        • Post Market

      • Biosimilar

        • Preclinical

        • Clinical

        • Post Market

    • Medical Devices

      • Diagnostic

        • Preclinical

        • Clinical

        • Post Market

      • Therapeutic

        • Preclinical

        • Clinical

        • Post Market

  • Product Stage Outlook (Revenue, USD Million, 2016 - 2027)

    • Preclinical

    • Clinical

    • PMA

  • Indication Outlook (Revenue, USD Million, 2016 - 2027)

    • Oncology

    • Neurology

    • Cardiology

    • Immunology

    • Others

  • End-use Outlook (Revenue, USD Million, 2016 - 2027)

    • Medical Device Companies

    • Pharmaceutical Companies

    • Biotechnology Companies

  • Regional Outlook (Revenue, USD Million, 2016 - 2027)

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Italy

      • Spain

      • Russia

      • Turkey

      • The Netherlands

      • Switzerland

      • Sweden

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

      • South Korea

      • Indonesia

      • Malaysia

      • Singapore

      • Thailand

      • Taiwan

    • Latin America

      • Brazil

      • Mexico

      • Argentina

      • Colombia

      • Chile

    • MEA

      • South Africa

      • Saudi Arabia

      • UAE

      • Egypt

      • Israel

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