North America to Dominate the Healthcare Regulatory Affairs Outsourcing Market

Thu, 07 May 2020 4:17

The healthcare regulatory affairs outsourcing market’s most prominent drivers are complex regulatory requirements, declining revenues from the lost sales of blockbuster drugs, reduced healthcare costs, and increasing operational costs. Today, several leading regulatory consulting companies are offering their expertise across the complete product life cycle to sustain in the raging competition. Outsourcing of regulatory affairs can be an attractive option for sponsors to gain experience, optimize cost, and enhance productivity. Regulatory outsourcing companies are equipped with real experience and are in a better position to assess regulatory requirements.

The product-specific regulatory advice and strategies, along with healthcare regulatory compliance at the early stages of product development, are essential for product approval. Failure to address the compliance in the early stage of development often leads to delay in the approval process due to inappropriately filed documentation, manufacturing oversights, omitted regulatory studies, and other failures. Healthcare companies are now focusing on their core competencies and outsourcing noncore functions to increase their productivity and operational efficiency. These companies generally outsource regulatory functions to emerging markets, such as the Asia Pacific and MEA to, further driving the market growth

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Key Highlights

  • The healthcare regulatory affairs outsourcing market was valued at USD 6,530 million in 2019 and is expected to grow with a CAGR of 12.1%. Increasing regulatory pressure and rising demand for speedy approval of new products drive the market growth.
  • The regulatory writing and publishing segment holds the maximum share in the regulatory affairs outsourcing market.
  • The pharmaceutical segment holds the largest market share due to the increasing adoption of regulatory affairs outsourcing services and strong competition to get new drug approvals.
  • The biotechnology segment is projected to gain momentum due to the growing adoption of outsourcing services for regulatory filings to expand their presence in the healthcare market.

Key Development

  • In October 2017, PAREXEL International Corporation collaborated with Microsoft Corporation to gain access to cloud-based healthcare infrastructure developed by Microsoft to bolster integrated regulatory services

Key Players

  • ICON plc.
  • Pharmaceutical Product Development, LLC (PPD)
  • Charles River Laboratories International, Inc.
  • Covance
  • Parexel International Corporation, Inc.
  • WuXi AppTec Inc.,
  • Accell Clinical Research, LLC
  • GenPact Ltd.
  • Criterium, Inc.
  • PRA Health Sciences
  • Promedica International
  • Freyr

Healthcare Regulatory Affairs Outsourcing Market Segmentation

By Services

  • Regulatory consulting
  • Legal representation
  • Regulatory writing and publishing
  • Product registration and clinical trial applications

By End-User

  • Medical device
  • Pharmaceutical
  • Biotechnology
  • Food and beverages

By Region

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • The Middle East and Africa

" Crucial Insights The Report Provides:"

* Known and Unknown Adjacencies Influencing the Growth of Market

* Explorable Revenue Sources

* Customer Behaviour Analysis

* Target Partners

* Customized Geographical Data Based on Customers as well as Competitors

* Analysis of Market Size and CAGR between the Forecast Periods

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