Regulatory Affairs Outsourcing Market Worth $13.9 Billion By 2030

The global regulatory affairs outsourcing market is projected to be worth USD 13.9 billion by the year 2030, advancing at a steady CAGR of 8.9% from 2022 to 2030. The constant changes and amendments in regulatory policies by governments worldwide to improve the healthcare ecosystem have created a very strong demand for outsourcing services. Companies lack the required capability to conduct these procedures in an efficient manner, a fact which is made more difficult by the complexity of this operation. Regulatory affairs outsourcing includes services that are utilized by the medical device, biotechnology, and pharmaceutical companies for receiving regulatory approvals at a faster rate and in a cost-efficient manner, thus enabling them to focus on their core competencies.

In a race to accelerate their growth, companies have concentrated their attempts on expanding geographically by launching drugs and medical devices to address the unmet needs of regional populations. However, this also brings numerous policies and guidelines into effect that must be strictly adhered to by these companies, which necessitates the outsourcing of regulatory services to organizations. The healthcare industry, in the coming years, is expected to witness sustained competitive and economic pressure due to extensive measures by governments globally to contain drug costs, as well as periods of irregular economic growth. This is expected to play a major part in the advancement of the regulatory affairs outsourcing industry in the coming years.

The coronavirus pandemic impacted the market negatively, as mass closure of clinical trial sites, along with related activities, were witnessed in the first phase of the outbreak. Additionally, a shift of focus toward supply chain tracking by regulatory bodies meant that all of their other activities were paused. However, in subsequent months, as the necessity of vaccines and medical devices became apparent, and authorities such as the US FDA were compelled to provide emergency use authorization (EUA) to various testing devices and instruments, the demand for outsourcing regulatory services gradually increased. In the coming years, it is expected that accelerated innovations in the medical device space will prove advantageous for regulatory affairs outsourcing market growth. 

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Regulatory Affairs Outsourcing Market Report Highlights

• In terms of service, the regulatory writing and publishing segment held the dominant share of over 36.5% in terms of revenue. The significant contribution of these services is due to the fact that they are being offered from early product development stages till the phase of post-marketing authorization

• In terms of size of the company, the large companies segment is expected to advance at the fastest pace through 2030, as such organizations generally look towards establishing long-term partnerships with outsourcing companies; an article by GEP in 2020 stated that large-sized pharma companies usually outsource around 50% of their regulatory affairs requirements

• On the basis of product category, the medical device segment accounted for the largest share of over 37.5% in 2021, as these companies are increasingly focusing on their core competencies and outsourcing non-core functions for enhancing their productivity; additionally, the growing demand and production of medical devices is expected to drive segment growth

• In terms of indication, the oncology segment accounts for a substantial share of the overall regulatory affairs outsourcing market revenue, on account of constant advancements being made in this space and the emergence of novel genome analysis tools. Other indication segments include neurology, immunology, and cardiology, among others

• The global market is defined by companies undertaking strategies such as mergers and acquisitions, partnerships, and geographical expansions to strengthen their positioning. The advent of the COVID-19 pandemic added additional challenges for companies in terms of pressure to launch drugs and testing kits, wherein regulatory affairs outsourcing companies stepped in by employing their capabilities to keep the healthcare industry on the move

• Over the past couple of years, some of the notable developments in the industry include the acquisition of iSafety Systems, a pharmacovigilance service provider from India, by ProPharma Group, to strengthen its position in this category. This followed ICON plc’s acquisition of PRA Health Sciences in February 2021, to improve its offerings in the medical affairs service space 

Regulatory Affairs Outsourcing Market Report Segments

Regulatory Affairs Outsourcing Services Outlook (Revenue, USD Million, 2018 - 2030)
    • Regulatory Consulting
    • Legal Representation
    • Regulatory Writing & Publishing
    • Product Registration & Clinical Trial Applications
    • Other Services

Regulatory Affairs Outsourcing Company Size Outlook (Revenue, USD Million, 2018 - 2030)
    • Small
    • Medium
    • Large

Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2018 - 2030)
    • Drugs
        • Generics
        • Innovators
    • Biologics
        • Biotech
        • ATMPs
        • Biosimilars
    • Medical Devices
        • Therapeutic
        • Diagnostic

Regulatory Affairs Outsourcing Stage Outlook (Revenue, USD Million, 2018 - 2030)
    • Preclinical
    • Clinical
    • PMA (Post Market Authorization)

Regulatory Affairs Outsourcing Indication Outlook (Revenue, USD Million, 2018 - 2030)
    • Oncology
    • Neurology
    • Cardiology
    • Immunology
    • Others

Regulatory Affairs Outsourcing End-use Outlook (Revenue, USD Million, 2018 - 2030)
    • Medical Device Companies
    • Pharmaceutical Companies
    • Biotechnology Companies

Regulatory Affairs Outsourcing 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
        • 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

List of Key Players in the Regulatory Affairs Outsourcing Market
    • Accell Clinical Research, LLC
    • GenPact Ltd.
    • Criterium, Inc.
    • PRA Health Sciences
    • Promedica International
    • Dr.Regenold GmbH
    • BioMapas
    • Zeincro Group
    • Medpace
    • ICON plc
    • Covance
    • Parexel International Corp.
    • Freyr