Regulatory Affairs Outsourcing Market by End-user and Geography - Forecast and Analysis 2022-2026

The regulatory affairs outsourcing market share is expected to increase by USD 4.63 billion from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 12.15%.

This regulatory affairs outsourcing market research report provides valuable insights on the post COVID-19 impact on the market, which will help companies evaluate their business approaches. Furthermore, this report extensively covers regulatory affairs outsourcing market segmentation by end-user (pharmaceutical, medical device, and biotechnology) and geography (APAC, North America, Europe, and ROW). The regulatory affairs outsourcing market report also offers information on several market vendors, including Certara Inc., Charles River Laboratories International Inc., Genpact Ltd., Icon Plc, Laboratory Corp. of America Holdings, Medpace Holdings Inc., PPD Inc., PRA Health Sciences Inc., ProPharma Group Holdings LLC, and WuXi AppTec Co. Ltd. among others.

What will the Regulatory Affairs Outsourcing Market Size be During the Forecast Period?

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Regulatory Affairs Outsourcing Market: Key Drivers and Challenges

The growth of the pharmaceutical industry is notably driving the regulatory affairs outsourcing market growth, although factors such as delay in contractual obligations and upgrading new technologies may impede the market growth. Our research analysts have studied the historical data and deduced the key market drivers and the COVID-19 pandemic impact on the regulatory affairs outsourcing industry. The holistic analysis of the drivers will help in deducing end goals and refining marketing strategies to gain a competitive edge.

Key Regulatory Affairs Outsourcing Market Driver

One of the key factors driving growth in the regulatory affairs outsourcing market is the growth of the pharmaceutical industry. Rising drug pipeline, product registration, application of clinical trials, and R&D activities are increasing the demand for regulatory affairs outsourcing services. On average, a pharmaceutical company spends around 15%-20% of its revenue for R&D purposes. The high R&D spending by pharmaceutical manufacturers is expected to bring more pharmaceutical products to the market. This has increased the demand for pharmaceutical regulatory affairs outsourcing services. By adopting regulatory affairs outsourcing services, the pharmaceutical manufacturers can reduce their capital expenditure and operating cost associated with the labor costs and internal regulatory affairs department expansion with the growth of product portfolio.

Key Regulatory Affairs Outsourcing Market Challenge

The delay in contractual obligations and upgrading new technologies will be a major challenge for the regulatory affairs outsourcing market during the forecast period. These delays could be due to several factors such as labor disputes, political unrest, and other factors that are outside the control of the outsourcing company. Leading players in the medical device industry or OEMs face difficulty identifying reliable service providers and providing advanced technologies for outsourcing activities. Outsourcing service providers will need to make high investments for attaining the latest technologies to maintain their presence in the market. This is a time-consuming process and will delay contractual obligations, thereby affecting the growth of the market.

This regulatory affairs outsourcing market analysis report also provides detailed information on other upcoming trends and challenges that will have a far-reaching effect on the market growth. The actionable insights on the trends and challenges will help companies evaluate and develop growth strategies for 2022-2026.

Who are the Major Regulatory Affairs Outsourcing Market Vendors?

The report analyzes the market's competitive landscape and offers information on several market vendors, including:

 

• Certara Inc.
• Charles River Laboratories International Inc.
• Genpact Ltd.
• Icon Plc
• Laboratory Corp. of America Holdings
• Medpace Holdings Inc.
• PPD Inc.
• PRA Health Sciences Inc.
• ProPharma Group Holdings LLC
• WuXi AppTec Co. Ltd.

 

This statistical study of the regulatory affairs outsourcing market encompasses successful business strategies deployed by the key vendors. The regulatory affairs outsourcing market is fragmented and the vendors are deploying growth strategies such as forming strategic partnerships to compete in the market.

To make the most of the opportunities and recover from post COVID-19 impact, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

The regulatory affairs outsourcing market forecast report offers in-depth insights into key vendor profiles. The profiles include information on the production, sustainability, and prospects of the leading companies. 

Which are the Key Regions for Regulatory Affairs Outsourcing Market?

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38% of the market's growth will originate from APAC during the forecast period. China and Japan are the key markets for regulatory affairs outsourcing in APAC. Market growth in this region will be faster than the growth of the market in the North American and ROW regions.

The high market penetration of generic drugs and the increasing adoption of advanced technologies in developing countries such as India and China will facilitate the regulatory affairs outsourcing market growth in APAC over the forecast period. This market research report entails detailed information on the competitive intelligence, marketing gaps, and regional opportunities in store for vendors, which will assist in creating efficient business plans.

What are the Revenue-generating End-user Segments in the Regulatory Affairs Outsourcing Market?

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The regulatory affairs outsourcing market share growth by the pharmaceuticals segment will be significant during the forecast period. Process improvement, cost-effectiveness, and utilization of the capabilities of regulatory affairs manufacturing are some of the key factors that favor the market's growth. The growing product portfolio and clinical trials will drive the demand for regulatory affairs outsourcing services in pharmaceutical industries.

This report provides an accurate prediction of the contribution of all the segments to the growth of the regulatory affairs outsourcing market size and actionable market insights on post COVID-19 impact on each segment.

 

Regulatory Affairs Outsourcing Market Scope
Report Coverage	Details
Page number	120
Base year	2021
Forecast period	2022-2026
Growth momentum & CAGR	Accelerate at a CAGR of 12.15%
Market growth 2022-2026	$ 4.63 billion
Market structure	Fragmented
YoY growth (%)	11.24
Regional analysis	APAC, North America, Europe, and ROW
Performing market contribution	APAC at 38%
Key consumer countries	China, US, Germany, Japan, and UK
Competitive landscape	Leading companies, Competitive strategies, Consumer engagement scope
Key companies profiled	Certara Inc., Charles River Laboratories International Inc., Genpact Ltd., Icon Plc, Laboratory Corp. of America Holdings, Medpace Holdings Inc., PPD Inc., PRA Health Sciences Inc., ProPharma Group Holdings LLC, and WuXi AppTec Co. Ltd.
Market dynamics	Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the forecast period
Customization purview	If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Regulatory Affairs Outsourcing Market Report?

• CAGR of the market during the forecast period 2022-2026
• Detailed information on factors that will drive regulatory affairs outsourcing market growth during the next five years
• Precise estimation of the regulatory affairs outsourcing market size and its contribution to the parent market
• Accurate predictions on upcoming trends and changes in consumer behavior
• The growth of the regulatory affairs outsourcing industry across APAC, North America, Europe, and ROW
• A thorough analysis of the market's competitive landscape and detailed information on vendors
• Comprehensive details of factors that will challenge the growth of regulatory affairs outsourcing market vendors

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