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Worldwide Regulatory Affairs Outsourcing Market Forecast, 2019 to 2026 - A $13.9 Billion Opportunity - ResearchAndMarkets.com

April 11, 2019

DUBLIN--(BUSINESS WIRE)--Apr 11, 2019--The “Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Service (Legal Representation, Regulatory Consulting, Regulatory Writing and Publishing), By Region, And Segment Forecasts, 2019 - 2026” report has been added to ResearchAndMarkets.com’s offering.

The global regulatory affairs outsourcing market size is expected to reach USD 13.9 billion by 2026, according to this report. It is projected to register a CAGR of 11.9% during the forecast period.

Outsourcing regulatory affairs activities to the Contract Research Organizations (CROs) offers cost efficiency, reduced regulatory submission time, and quality control in the overall manufacturing process. These factors are anticipated to propel the growth over the forecast period.

Large companies address capacity problems and lack of expertise in their internal departments through outsourcing to smaller mid-size companies. It also eliminates additional work load and consolidates regulatory departments to avoid duplication of work. Regulatory affairs include activities such as drug master files, technical writing, and review of Chemistry, Manufacturing, and Controls (CMC), eCTD conversion, query management, Investigational New Drug (IND) maintenance, serious adverse events reporting, labeling, and drug shipment approvals for clinical trials.

Regulatory affairs outsourcing witnessed few important industry events. For instance, in August 2018, U.K. based Syneos Health acquired Kinapse, a provider of pharmaco-vigilance consulting and post market regulatory services. With this acquisition, the company aims to double its consulting footprint in Europe and associated commercial services.

Moreover, in October 2018, PAREXEL International Corporation introduced the new China Advisory Services to help pharmaceutical companies in seeking market opportunities within China, to have an early mover advantage. The services include agency engagements, market access, and commercial strategies. This happened on the backdrop of recent reforms implemented by the National Medicinal Products Administration (NMPA), such as expedited approvals, faster Multi-regional Clinical Trials (MCT) applications, and clinical trial approvals in two months.

Further key findings from the report suggest:

  • The regulatory writing and publishing emerged as the largest segment with a market share of over 35% in 2018. Legal representation segment is expected to register the highest CAGR of 12.8%, over the forecast period, owing to regulatory reforms in the emerging nations.
  • North America regulatory affairs outsourcing market held the market share of over 20%, in 2018 owing to rising requirements in the region. Moreover, presence of big pharmaceutical and biotech companies seeking workload management is also favoring regional growth.
  • Asia Pacific is expected to witness substantial growth in near future, owing to unmet needs of the huge population base, low labor cost, and improving healthcare infrastructure.
  • Some of the companies operating in the market include Accell Clinical Research; PRA International; PAREXEL International Corporation; Quintiles Transnational Holdings; Charles River Laboratories International Inc.; Clinilabs Inc.; Criterium Inc.; Wuxi AppTec; and Medpace Inc.

Key Topics Covered

Chapter 1 Methodology and Scope

1.1 Market Segmentation & Scope

1.2 Information Procurement

1.3 Information Analysis

1.4 Market Formulation & Data Visualization

1.5 Data Validation & Publishing

Chapter 2 Executive Summary

2.1 Market Outlook

2.2 Segment Outlook

2.3 Competitive Insights

Chapter 3 Regulatory Affairs Outsourcing Market Variables, Trends & Scope

3.1 Market Lineage Outlook

3.2 Penetration & Growth Prospect Mapping

3.3 Product Pipeline Analysis, by Stage

3.4 User Perspective Analysis

3.5 List of Key End-Users, by Region / by Product / by Country

3.6 Regulatory Framework

3.7 Market Dynamics

3.8 Regulatory Affairs Outsourcing: Market Analysis Tools

Chapter 4 Regulatory Affairs Outsourcing Market: Segment Analysis, by Service, 2015 - 2026 (Usd Million)

4.1 Definitions & Scope

4.2 Services Market Share Analysis, 2018 & 2026

4.3 Segment Dashboard

4.4 Global Regulatory Affairs Outsourcing Market, by Service, 2015 to 2026

4.5 Market Size & Forecasts and Trend Analyses, 2015 to 2026 for the Following

Chapter 5 Regulatory Affairs Outsourcing Market: Regional Market Analysis, 2015 - 2026 (Usd Million)

5.1 Definitions & Scope

5.2 Regional Market Share Analysis, 2018 & 2026

5.3 Regional Market Dashboard

5.4 Regional Market Snapshot (Market Size, Cagr, Top Verticals, Key Players, Top Trends)

5.5 Regional Market Share and Leading Players, 2018

5.6 SWOT Analysis, by Factor (Political & Legal, Economic and Technological)

5.7 Market Size, & Forecasts, Value and Trend Analysis, 2018 to 2025:

5.8 North America

5.9 Europe

5.10 Asia Pacific

5.11 Latin America

5.12 Middle East & Africa

Chapter 6 Regulatory Affairs Outsourcing Market - Competitive Analysis

6.1 Recent Developments & Impact Analysis, by Key Market Participants

6.2 Company/Competition Categorization (Key Innovators, Market Leaders, Emerging Players)

6.3 Vendor Landscape

6.4 Public Companies

6.5 Private Companies

6.6 Supplier Ranking

6.7 Key Companies Profiled

6.7.1 Accell Clinical Research

6.7.2 Genpact Ltd.

6.7.3 Criterium Inc.

6.7.4 PRA Health Sciences Inc.

6.7.5 Promedica International

6.7.6 Wuxi AppTec

6.7.7 Medpace Inc.

6.7.8 Pharmaceutical Product Development (PPD) LLC

6.7.9 PARAXEL International Corporation

6.7.10 Charles River Laboratories International Inc.

Chapter 7 KOL Commentary

Chapter 8 Recommendations

For more information about this report visit https://www.researchandmarkets.com/r/x4akp0

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Related Topics:Consulting and Outsourcing



SOURCE: Research and Markets

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