How much is the Regulatory Affairs Outsourcing market worth?

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 and Other Services.

• The global market has been further divided into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, and 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.
• 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.

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

• 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 medium-sized pharmaceutical and medical device companies do not have enough capital to develop an in-house regulatory affairs team.

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.
• The biologics segment is projected to register the forecast CAGR over the forecast period.
• Biologics drugs have to follow complex and rigorous regulations, which, in turn, is further driving the demand for regulatory outsourcing for biologics, thereby driving the segment.

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

• The clinical studies segment accounted for the largest share of more than 46.5% in 2021.
• The preclinical segment is anticipated to grow at the fastest CAGR over the forecast period.
• According to ClinicalTrials.gov, nearly 401,716 trials were registered in January 2022, as compared to around 325,834 by the end of 2019.

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

• The oncology segment accounted for the largest share of more than 33% of the global revenue in 2021.
• The immunology segment is expected to grow at the fastest CAGR over the forecast.This isdue to its potential in facilitating the treatment of various cardiovascular, neurological, oncological, and inflammatory diseases.
• Contributing to the market growth. Other indications included in the scope of the study are neurology, cardiology, immunology, and others.

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

• The pharmaceutical companies end-use segment accounted for the largest share of more than 39% of the global revenue in 2021.
• The medical device and biotechnology segments both have registered a substantial share in the market in 2021.
• The significant number of new drugs entering the pharmaceutical industry has further improved the segment growth.

Regulatory Affairs Outsourcing Regional Outlook.

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)

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 in the in Regulatory Affairs Outsourcing market include:

• 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

Order a free sample PDF of the in Regulatory Affairs Outsourcing Market Intelligence Study, published by Grand View Research.