Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Category (Biologics, Drugs), By Indication, By Product Stage, By End-use, By Service, By Company Size, By Region, And Segment Forecasts, 2020 - 2027

Report Overview

The global regulatory affairs market size was valued at USD 10.9 billion in 2019 and is projected 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 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 affairs in order to improve the access and analysis of the continuously growing volume of information due to connected health products and programs.

Furthermore, 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 surveyed 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.

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 blockbuster 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 36.8% in 2019. This can be attributed to the increase in the outsourcing of selected regulatory affairs by major life sciences companies while focusing on core affairs. The regulatory affairs market 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. 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 37.0% 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. This, in turn, is expected to encourage manufacturers and technology developers to focus on core competencies and outsource non-core activities.

Based on the 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 for regulatory affairs in 2019.

Biologics are anticipated to witness the fastest growth 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 is 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 33.2% in 2019. 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 the growth of the market for regulatory affairs.

Product Stage Insights

The clinical-stage segment dominated the market for regulatory affairs and accounted for more than 45.0% of the revenue share in 2019. The increasing prevalence of chronic diseases and emergence of new diseases is 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, in 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 affairs related to medical writing and regulatory labeling services.

The preclinical stage 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 the growth of the market for regulatory affairs.

Service Provider Insights

The outsourced segment dominated the market for regulatory affairs and accounted for the largest market share of more than 57.0% in 2019. The segment 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. 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 4 CROs, thereby maintaining a mix of vendors instead of relying on a single provider.

Company Size Insights

Medium-sized companies dominated the market for regulatory affairs in 2019 and accounted for more than 45.0% of the revenue share. 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 held the largest revenue share of 38.6% in 2019. The segment is anticipated to witness a CAGR of 8.7% over the forecast period owing to an 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 the late-stage development of their biologics, the biologics market is anticipated to witness substantial growth.

Regional Insights

Asia Pacific dominated the market for regulatory affairs in 2019 and accounted for the largest revenue share of more than 37.0%. 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. Supportive regulations are increasing the demand for local regulatory services.

A supportive regulatory landscape is also anticipated to favor the growth of the market for regulatory affairs. As of 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 market in Europe, thereby increasing the regulatory complications in the region.

Key Companies & Market Share Insights

The market for regulatory affairs is highly competitive, marked by the presence of a large number of domestic as well as international players. Key companies are engaging in product launch, 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 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, categories, product stage, company size, end-use, indication, and region:

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

  • Regulatory consulting

  • Legal representation

  • Regulatory writing & publishing

  • Product registration & clinical trial applications

  • Other services

• 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

  • Biosimilars

  • Preclinical

  • Clinical

  • Post-market

  • Medical devices

  • Diagnostics

  • Preclinical

  • Clinical

  • Post-market

  • Therapeutics

  • Preclinical

  • Clinical

  • Post-market

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

  • Oncology

  • Neurology

  • Cardiology

  • Immunology

  • Others

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

  • Preclinical

  • Clinical

  • PMA

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

  • Medical Device Companies

  • Biotechnology Companies

  • Pharmaceutical Companies

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

  • In-house

  • Outsourced

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

  • Small

  • Medium

  • Large

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

  • 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