Regulatory Affairs Outsourcing Market Trends, Analysis and Forecasts to 2030

Regulatory Affairs Outsourcing Market Growth & Trends

The global regulatory affairs outsourcing market size is expected to reach USD 13.9 billion by 2030, registering a CAGR of 8.9% over the forecast period, according to a new report by Grand View Research, Inc. Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities like training, technology, specialized knowledge, and facilities are driving outsourcing of regulatory affair functions. Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, is creating demand for these services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but in turn, complicate the operation for healthcare product manufacturing companies.

Regulatory Affairs Outsourcing Market Segmentation

Grand View Research has segmented the global regulatory affairs outsourcing market based on services, company size, category, indication, stage, end user, and region:

Based on the Services Insights, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services.

• The regulatory writing & publishing segment led the market in 2021 and accounted for the highest share of more than 36.5% of the global revenue. These services are offered from the early stages of product development to the post-marketing authorization phase. The segment is also anticipated to dominate the market during the forecast period owing to the adoption of outsourcing of these services by large- and mid-sized biopharmaceutical and medical device companies.
• The legal representation services segment is anticipated to witness the fastest growth rate over the forecast period. This is due to the increasing demand for legal representatives across the globe on account of the globalization of medical devices and pharmaceutical companies. The regulations are very complex and ever-changing. Changing the regulatory landscape in regions, such as Asia Pacific, MEA, and Latin America increases the demand for local experts for legal representation for obtaining regulatory approvals and custom clearance. These factors are promoting the demand for legal representation services globally.

Based on the Company Size Insights, the market is segmented into Small, Medium, Large.

• The large companies segment is projected to register the fastest growth rate of more than 9% over the forecast period. Large companies generally prefer to establish long-term relations with their service providers to avoid sudden disruption in their operations and thus, prefer a service provider that can meet their regulatory needs to support their various cross-scale and ramp-up operations. 
• The medium-sized companies segment accounted for the maximum revenue share in 2021 and is estimated to expand further retaining the leading position over the forecast period. The presence of several mid-sized established providers, especially privately-held ones, is anticipated to contribute to this segment share.

Based on the Category Insights, the market is segmented into Drugs, Biologics, and Medical Devices.

• The medical device segment accounted for the largest share of more than 37.5% of the global revenue in 2021. This can be attributed to the fact that medical devices companies are now focusing on their core competencies and outsourcing noncore functions to increase their productivity and operational efficiency. The growing demand for advanced medical devices and new technological advancements in medical devices are further contributing to the growth of the segment.
• However, the biologics segment is projected to register the forecast CAGR over the forecast period. The R&D productivity of small molecule drugs is declining, hence the focus is shifting to biologics, which is expected to register productive growth in the years to come.

Based on the Stage Insights, the market is segmented into Preclinical, Clinical, PMA (Post Market Authorization).

• The clinical studies segment accounted for the largest share of more than 46.5% in 2021. This can be attributed to the increasing number of clinical trial registrations over the past few years.
• The preclinical segment is anticipated to grow at the fastest CAGR over the forecast period. The rising demand for novel disease treatments, such as COVID-19, Zika virus, and Ebola, and the increasing prevalence of existing diseases, such as CVDs, cancer, and neurological diseases are the key factors contributing to the preclincial segment’s growth.

Based on the Indication Insights, the market is segmented into Oncology, Neurology, Cardiology, Immunology, Others.

• The oncology segment accounted for the largest share of more than 33% of the global revenue in 2021. The recent advances in the biology of cancer and the emergence of new tools for genome analysis have opened a clinical perspective in oncology, which has led to personalized medicine.
• The immunology segment is expected to grow at the fastest CAGR over the forecast. This is due to its potential in facilitating the treatment of various cardiovascular, neurological, oncological, and inflammatory diseases. The strategic initiatives undertaken by market players for immunology are anticipated to facilitate the segment growth.

Based on the End-use Insights, the market is segmented into Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies.

• The pharmaceutical companies end-use segment accounted for the largest share of more than 39% of the global revenue in 2021. The segment is anticipated to expand further at the fastest CAGR retaining its leading market position over the forecast period. This is due to the growth in evolving areas, such as biosimilar, orphan drugs, and personalized medicines, which are creating more demand for regulatory services, thereby boosting the segment growth.
• The medical device and biotechnology segments both have registered a substantial share in the market in 2021. This can be attributed to the increased demand for biopharmaceuticals, vaccines, advanced medical devices, and others. The growing demand for wearable technologies along with recent epidemic events is further contributing to the share of these segments.

Regulatory Affairs Outsourcing Regional Outlook

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Market Share Insights

• August 2021: ProPharma Group acquired iSafety Systems., an Indian pharmacovigilance service provider, for strengthening its market position in pharmacovigilance.
• July 2021: ICON plc acquired a CRO involved in providing drug development and regulatory consulting services, namely PRA Health Sciences. This acquisition was aimed at enhancing the services portfolio of ICON plc.

Key Companies Profile & Market Share Insights

Market players are undertaking various strategic initiatives, such as partnerships, collaborations, mergers & acquisitions, geographic expansion, to strengthen their product portfolio, manufacturing capacities, and provide competitive differentiation.

Some of the prominent players operating in the global regulatory affairs outsourcing market include,

• Accell Clinical Research, LLC
• GenPact Ltd.
• Criterium, Inc.
• PRA Health Sciences
• Promedica International
• Regenold GmbH
• BioMapas
• Zeincro Group
• Medpace
• ICON plc
• Covance
• Parexel International Corp.
• Freyr

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