Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By End-use, By Category, By Indication, By Product Stage, By Service Provider, By Company Size, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global regulatory affairs market size was valued at USD 12.8 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 8.7% over the forecast period. The main drivers of this market are growth in emerging fields, such as orphan drugs, immunotherapies, personalized medicines, specialty therapies, and combination therapies, changes in regulatory requirements, and a rise in the prevalence of new diseases that require effective vaccines and therapies, which necessitate regulatory guidelines to maintain safety, quality, and effectiveness. Also, the COVID-19 pandemic has significantly impacted the market.

The demand for drugs related to COVID-19 was high during the pandemic, and that boosted the clinical development process and, in turn, increased the regulatory process for creating an effective and safe environment for the clinical trial process to proceed. The regulatory authorities have demonstrated flexibility in the development of COVID-19 products while maintaining high levels of effectiveness, quality, and tolerability. Furthermore, several regulatory authorities released guidelines related to the pandemic and released emergency use authorization of several products that are used against the coronavirus.

For instance, the U.S. Food and Drug Administration (FDA) released Emergency Use authorization, 51 guidance documents related to the COVID-19 pandemic, and has published a resource page with COVID-19 new, information and PPE kits. The globalization of biopharmaceuticals and medical device companies is likely to be one of the major market drivers. The emerging markets from the Asia Pacific, Latin America, and MEA offer low product development & manufacturing costs, tax benefits, and the availability of skilled labor at relatively low costs with supportive regulations.

The abovementioned factors have made the regional markets attractive prospects in terms of outsourcing and expansion for biopharmaceutical & medical device companies, thus, stimulating the demand for regulatory services. The healthcare industry is not only focusing on the development of new therapies for the treatment of different diseases but they are also shifting their focus on target gene therapy, precision medicine, and specialty drugs that are used to treat one or a specific kind of disorders and diseases. Furthermore, medical devices are combined with some of these products to enhance the quality of drug dose, delivery, and patient monitoring, thus complicating the regulatory strategy and pathway to market it.

Service Insights

Based on services, the global market for regulator affairs can be been further categorized into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, and other services. The regulatory writing & publishing segment dominated the market and accounted for the largest revenue share of 36.6% in 2021. This segment is further divided into writing and publishing. The main drivers of this segment are increased outsourcing of these services by large- and mid-size biopharmaceutical and medical device companies.

Outsourcing regulatory writing and publishing gives space to big pharma companies to develop their core competencies. The legal representation segment is expected to rise with the fastest CAGR during the forecast period. This is due to the increase in complexity of regulations in the healthcare and the increase in healthcare reforms, especially in emerging regions like the Asia Pacific and MEA. For instance, clinical trials in Europe cannot be conducted by sponsors who do not have their registered entity in the European Union and there is a mandatory requirement of legal representation provided by companies based in Europe to conduct clinical trials in any of the European Union member states.

Categories Insights

Based on categories, the global market for regulatory affairs can be broadly categorized into drugs, biologics, and medical devices. The medical device segment dominated the global market and accounted for the maximum share of more than 39.5% of the overall revenue in 2021. This segment is anticipated to expand further at the fastest CAGR retaining its dominant market position throughout the forecast years. This growth can be attributed to the increasing outsourcing activities of medical devices by pharmaceutical companies so they can focus on their core competencies.

The medical devices segment is further sub-categorized into diagnostics and therapeutics. Medical device regulations help ensure the safety & effectiveness of products and increase the transparency of a medical device that is useful for both manufacturer and insurer. The drugs segment is anticipated to account for the second-highest revenue share by 2030. The drugs segment is further sub-segmented into innovator and generics while the biologics segment is sub-segmented into biotech products, biosimilars, and Advanced Therapy Medicinal Products (ATMPs).

Product Stage Insights

The clinical studies product stage segment dominated the global market in 2021 and accounted for the maximum share of more than 46.00% of the global revenue. The emergence of new diseases and the rising prevalence of chronic diseases are the key factors that are anticipated to increase the number of clinical trials conducted to meet healthcare needs. These regulations make sure that the clinical studies are carried out transparently and guided so that the trials are authentic and are adequately exposed to humans and show credible data.

The preclinical product stage segment is expected to register the fastest growth rate during the forecast period. The fastest growth of this segment can be attributed to the increasing demand for novel disease treatments, such as COVID-19, Zika virus, and Ebola, as well as the increasing prevalence of various existing diseases, such as Cardiovascular Diseases (CVDs), cancer, and neurological diseases. Based on product stages, the global market for regulatory affairs can be further segmented into preclinical, clinical, and PMA stages.

Service Provider Insights

Based on service providers, the global market for regulatory affairs has been further sub-categorized into in-house services and outsourcing services. The outsourcing service provider segment dominated the global market in 2021 and accounted for the maximum share of more than 56.00% of the overall revenue in the same year. The outsourcing service provider segment is anticipated to expand further at the fastest growth rate maintaining its dominant industry position throughout the forecast period.

The high growth of this segment can be attributed to the rapidly increasing popularity of these services as outsourcing enables healthcare companies to reduce overall costs, prioritize strategic projects, reduce staff training time and helps in accessing specific technical and regulatory or geographic expertise and improve the overall efficiency as well as provides greater flexibility. The in-house service provider segment is also anticipated to grow at a significant CAGR during the forecast period and account for the second-highest share of the global revenue by 2030.

Company Size Insights

Based on company size, the global market has been further sub-categorized into small-sized, medium-sized, and large-sized companies. The medium-sized companies segment dominated the global market in 2021 and accounted for the largest share of more than 46.5% of the overall revenue in the same year. The presence of various mid-sized established providers, particularly privately held ones, is expected to contribute to this segment’s growth. These companies have a strong presence in multiple or selected markets around the world and provide various services, from a few to full length.

Large-scale service providers are popular among the leading pharma, biotechnology, and medical device firms. The presence of a broad range of services and the availability of these providers in various geographies can enable ease of business and thus act as the primary factor contributing to their popularity, especially among larger companies. Furthermore, large pharma companies generally prefer to have a long-term collaboration with their service providers to avoid sudden disturbances in their operations and, thus, prefer a service provider that can meet their regulatory needs to support their various ramp-up and cross-scale operations.

Indication Insights

The oncology segment accounted for the maximum revenue share of 33.0% in 2021. This can be attributed to the high prevalence of cancer, prompting a need for safe and effective treatment options. Furthermore, oncology is one of the most profitable markets for pharmaceutical & biotechnology companies, thereby increasing the R&D projects undertaken by these players. The immunology segment is expected to register the fastest CAGR during the forecast period due to its potential in facilitating the treatment of various cardiovascular, neurological, oncological, and inflammatory diseases.

This can be attributed to the presence of immune cells throughout the body, as well as the presence of tissue-specific immune cells in organs. These include microglia in the brain, T cells & resident dendritic in the skin, and gut resident immune cells. Based on indications, the global market has been further categorized into oncology, neurology, cardiology, immunology, and other indications. The others segment includes dermatology, ophthalmology, endocrinology, pain management, gastroenterology, pulmonary & respiratory, hematology, infectious diseases, vaccine & virology urology, and nephrology.

End-use Insights

Based on end-uses, the global market for regulatory affairs has been further sub-divided into medical device companies, biotechnology companies, and pharmaceutical companies. The pharmaceutical companies segment dominated the market in 2021 and accounted for the maximum share of more than 38.5% of the global revenue. The segment is also projected to register the fastest growth rate from 2022 to 2030. This growth can be attributed to the increase in the number of approved pharmaceutical products. For instance, in 2021, the U.S. FDA approved 50 novel drugs.

Thus, a rise in the commercialization of new drugs in the U.S. is anticipated to increase the demand, product approval, registration, licensing, and related regulatory services. Biotechnology companies are estimated to be the second-fastest-growing end-use segment during the forecast period. This is due to the high demand for biologics, rise in investment in manufacturing of biologics, and improvements in infrastructure, which are anticipated to boost the demand for regulatory services, such as audit & validation, quality & assurance, GMP practices, BLA filings, and patent filings.

Regional Insights

The Asia Pacific dominated the market & accounted for the largest revenue share of more than 37.00% in 2021. The region is anticipated to expand further at the fastest CAGRfrom 2022 to 2030 owing to the improved regulatory landscape, cost savings, growing number of clinical trials conducted in the region, and an increasing number of biopharmaceutical companies venturing into the region. Furthermore, the availability of a skilled workforce within the region at a lower cost compared to the U.S. is another factor expected to propel market growth. According to Worldometer, Asia Pacific accounts for 59.76% of the world’s population.

The growing geriatric population, rising prevalence of chronic diseases among people, and increase in government support for the healthcare sector are expected to increase the demand for cost-effective medicines. This is anticipated to increase the number of market entrants, thereby creating the need for regulatory services. North America is projected to be the second-fastest-growing regional market over the forecast period. This region has the most outstanding regulatory system in the world. The main driving factors for this market are, a rise in biologics approvals; an increase in outsourcing of regulatory affairs services by large biopharmaceuticals; and growing R&D expenditure.

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 & acquisitions, collaborations, and expansion of geographic presence to strengthen their market position. For instance, in February 2020, ICON plc acquired MedPass. The main aim of this acquisition is to strengthen ICON’s diagnostic research and medical device services by the addition of new clinical and regulatory capabilities in Europe. Some prominent players in the global regulatory affairs market include:

• Accell Clinical Research, LLC

• Genpact

• Criterium, Inc.

• PRA Health Sciences

• Promedica International

• WuXi AppTec, Inc.

• Medpace

• Charles River Laboratories International, Inc.

• ICON plc

• Covance, Inc.

• PAREXEL International Corp., 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 2018 to 2030. For this study, Grand View Research has segmented the global regulatory affairs market report based on services, category, indication, stage, service provider, company size, end-use, and region:

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

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

    • Writing

    • Publishing

  • Product Registration & Clinical Trial Applications

  • Other Services

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

  • Drugs

    • Innovator

      • Preclinical

      • Clinical

      • Post Market

    • Generics

      • 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, 2018 - 2030)

  • Oncology

  • Neurology

  • Cardiology

  • Immunology

  • Others

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

  • Preclinical

  • Clinical studies

  • PMA

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

  • In-house

  • Outsourced

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

  • Small

  • Medium

  • Large

• 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

    • The Netherlands

    • Switzerland

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Indonesia

    • Malaysia

    • Singapore

    • Thailand

    • Taiwan

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Egypt

    • Israel