Regulatory Affairs Outsourcing Market Projected to Grow at USD 15.5 billion with Top Players | Genpact (U.S.), CRITERIUM, INC. (U.S.), PRA Health Sciences (U.S.), Promedica International (U.S.) and Forecast to 2031

Global Regulatory Affairs Outsourcing Market in terms of revenue expected to reach USD 15.5 billion and is poised to grow at a CAGR of 10.66% to Forecast 2031, The regulatory affairs outsourcing market is primarily driven by a notable rise in fixed in-house costs related to activities such as training, technology, specialized knowledge, and facilities. Additionally, the increasing number of clinical trials contributes to this market's growth. Furthermore, there is an opportunity for the market due to improvements in pre-marketing and post-marketing processes, leading to reduced regulatory service costs.

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Increasing out-of-pocket expenses in both developed and developing nations, along with uneven economic growth and government efforts to reduce drug costs, are factors contributing to economic and competitive pressures. This is anticipated to drive demand for regulatory affairs outsourcing among life science companies. Early-stage product-specific clinical guidance and regulatory compliance are crucial for product approval. Failure to address regulatory compliance early in development often results in approval delays due to inadequately designed studies, manufacturing oversights, omitted studies, and other regulatory requirement failures.

Regulatory Affairs Outsourcing Market Companies:

Accell Clinical Research, LLC
Genpact
CRITERIUM, INC
PrimeVigilance
Freyr
PHARMALEX GMBH
NDA Group AB
ProPharma Group MIS Limited
Regulatory Pharma Net srl
ICON plc
Labcorp Drug Development
Parexel International Corporation
Pharmexon
APCER Life Sciences, Inc.
Real Regulatory Ltd
VCLS
REGENOLD GMBH

Market Segmentation:

By Service

Legal Representation
Product Registration & Clinical Trial Application
Regulatory Writing & Publication
Regulatory Consulting
Others

By Category

Medical Devices
Biologics
Drugs

By End User

Pharmaceutical Company
Medical Device Company
Biotechnology Company

By Indication

Oncology
Immunology
Cardiology
Neurology
Others

By Stage

Clinical
Preclinical
Post Market Authorization

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Regulatory Affairs Outsourcing Market Dynamics

Drivers:

Increasing Regulatory Complexity

Growing complexity in pharmaceuticals, biotechnology, and medical devices drives companies to seek specialized regulatory expertise from outsourcing partners for efficient compliance.
Rapid Technological Advances

Continuous innovation in industries like pharmaceuticals and medical devices necessitates outsourcing partners with specialized knowledge to navigate regulatory hurdles and accelerate product launch.
Focus on Core Competencies

Companies prioritize their core competencies, such as R&D and marketing, by outsourcing regulatory affairs tasks to experts, enabling more efficient resource allocation.
Flexibility and Scalability

The outsourcing model offers flexibility and scalability, allowing companies to adjust regulatory operations based on project needs, ensuring efficient resource utilization.

Key Developments:

In Jan 2023, AmerisourceBergen Corporation expanded its service portfolio by acquiring PharmaLex Holding GmbH, a leading provider of regulatory affairs services in the life sciences industry.

In Apr 2022, VCLS partnered with EC Innovations, a global translation services company with expertise in translating regulated life sciences and medical content. This collaboration aimed to enhance VCLS's offerings and operational capabilities.

Table of Contents

Executive Summary
Market Introduction
Research Methodology
Market Dynamics
Regulatory Affairs Outsourcing Market ANALYSIS by SEGMENT (COUNTRY LEVEL ANALYSIS)
NORTH AMERICA Regulatory Affairs Outsourcing Market analysis
EUROPE Regulatory Affairs Outsourcing Market analysis
ASIA PACIFIC Regulatory Affairs Outsourcing Market analysis
Rest of the World Regulatory Affairs Outsourcing Market analysis
Company Profiles

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This release was published on openPR.