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

  • Published: Dec 2021
  • Pages: 120
  • SKU: IRTNTR71647
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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?

Regulatory Affairs Outsourcing Market Size

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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?

Regulatory Affairs Outsourcing Market Market segmentation by region

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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?

Regulatory Affairs Outsourcing Market Segmentation

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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

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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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Executive Summary

Market Landscape

  • Market ecosystem
  • Value chain analysis

Market Sizing

  • Market definition
  • Market segment analysis
  • Market size 2021
  • Market outlook: Forecast for 2021 - 2026

Five Forces Analysis

  • Bargaining power of buyers
  • Bargaining power of suppliers
  • Threat of new entrants
  • Threat of substitutes
  • Threat of rivalry
  • Market condition

Market Segmentation by End-user

  • Market segments
  • Comparison by End-user
  • Pharmaceutical - Market size and forecast 2021-2026
  • Medical device - Market size and forecast 2021-2026
  • Biotechnology - Market size and forecast 2021-2026
  • Market opportunity by End-user

Customer landscape

Geographic Landscape

  • Geographic segmentation
  • Geographic comparison
  • APAC - Market size and forecast 2021-2026
  • North America - Market size and forecast 2021-2026
  • Europe - Market size and forecast 2021-2026
  • ROW - Market size and forecast 2021-2026
  • Key leading countries
  • Market opportunity by geography
  • Market drivers
  • Market challenges
  • Market trends

Vendor Landscape

  • Landscape disruption

Vendor Analysis

  • Vendors covered
  • Market positioning of vendors
  • 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.

Appendix

  • Scope of the report
  • Currency conversion rates for US$
  • Research methodology
  • List of abbreviations

Research Framework

Technavio presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources. The analysts have presented the various facets of the market with a particular focus on identifying the key industry influencers. The data thus presented is comprehensive, reliable, and the result of extensive research, both primary and secondary.

TechnavioINFORMATION SOURCES

Primary sources

  • Manufacturers and suppliers
  • Channel partners
  • Industry experts
  • Strategic decision makers

Secondary sources

  • Industry journals and periodicals
  • Government data
  • Financial reports of key industry players
  • Historical data
  • Press releases
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TechnavioDATA ANALYSIS

Data Synthesis

  • Collation of data
  • Estimation of key figures
  • Analysis of derived insights

Data Validation

  • Triangulation with data models
  • Reference against proprietary databases
  • Corroboration with industry experts
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TechnavioREPORT WRITING

Qualitative

  • Market drivers
  • Market challenges
  • Market trends
  • Five forces analysis

Quantitative

  • Market size and forecast
  • Market segmentation
  • Geographical insights
  • Competitive landscape
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Regulatory Affairs Outsourcing market growth will increase by $4631.52 million during 2021-2026.
The regulatory affairs outsourcing market is expected to grow at a CAGR of 12.15% during 2021-2026.
Technavio has segmented the regulatory affairs outsourcing market by end user (Pharmaceutical, Medical device, and Biotechnology) and geographic (APAC, North America, Europe, and ROW).
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. are a few of the key vendors in the regulatory affairs outsourcing market.
APAC will register the highest growth rate of 38.17% among the other regions. Therefore, the regulatory affairs outsourcing market in APAC is expected to garner significant business opportunities for the vendors during the forecast period.
The key factors driving the regulatory affairs outsourcing market growth are:
  • Growth of the pharmaceutical industry
The regulatory affairs outsourcing market vendors should focus on grabbing business opportunities from the pharmaceutical segment as it accounted for the largest market share in the base year.
  • What are the key global market and the regional market share?
  • What are the revenue-generating key market segments?
  • What are the key factors driving and challenging this market’s growth?
  • Who are the key market vendors and their growth strategies?
  • What are the latest trends influencing the growth of this market?
  • What are the variables influencing the market growth in the primary regions?
  • What are the factors influencing the growth of the parent market?
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