Rising demand for regulatory affairs outsourcing services in the healthcare industry is one of the key drivers for market growth

The global healthcare regulatory affairs outsourcing market size is expected to reach USD 16.67 billion in 2028 and register a revenue CAGR of 12.5% over the forecast period, according to the latest report by Reports and Data. Market revenue growth is significantly driven by increasing RD activities across the pharmaceutical and biotechnology sectors, rising volumes of clinical trial applications, and growing need for timely product registration and approvals. Healthcare regulatory affairs outsourcing services predominantly include regulatory writing publishing, regulatory submissions, clinical trial application, product registration, and regulatory consulting and legal services offered by highly experienced medical writers, publishers, and quality control (QC) auditors. These services are mostly utilized by large and mid-sized pharmaceutical companies, biotechnology companies, and medical device manufacturing companies. Regulatory affairs outsourcing ensures that these companies strictly comply with the product quality and safety standards and policies set by regulatory authorities.

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Some Key Highlights from the Report:

• Based on service type, the regulatory writing publishing segment accounted for the highest revenue share of around 40% in 2020. Increasing need for high-quality, comprehensive and convincing regulatory filing documents and rising demand for regulatory writing publishing services among healthcare companies including medical device and biopharmaceutical companies are key factors supporting the growth of this segment.
• The clinical stage segment held the largest revenue share in 2020 and is expected to register the highest revenue CAGR over the forecast period. Growing number of clinical trial registrations and increasing development of biologics and personalized orphan drugs the major factors expected to fuel this segment’s growth.
• Based on end-use, the pharmaceutical companies segment is projected to register the highest CAGR during the forecast period. Factors majorly contributing to this segment’s growth are growing need for development of advanced pharmaceutical products, increasing number of clinical trials, and surging need for regulatory affairs outsourcing services.
• Among regional markets, the North America market was the most dominant in terms of revenue share contribution in 2020. Increasing life sciences research development programs, rise in drug discovery development activities, growing number of clinical trials, and presence of leading pharmaceutical and biotechnology companies in the region are the most important factors accounting for the North America market growth.

Regional Outlook:

North America is the largest market for healthcare, followed by Asia-Pacific, Western Europe and then the other regions. Due to favorable regulations and policies in these regions, healthcare industry is rapidly growing. As the market in developed countries is nearly saturated, market players have shifted their focus toward the developing regions, especially the emerging economies of Asia Pacific.

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Competitive Outlook:

The prominent factors favoring market growth include increasing launches and initiatives by the market players to provide rapid treatment for addressing the diseases of the patients in the healthcare industry. Market-trend-based strategies for the healthcare market include increasing the adoption of bundled payments, using digital tools, increasing collaborations across industries and companies, focusing on the development of new medicines, and adopting hybrid imaging technology. Players adopted strategies in the healthcare industry include acquiring companies in similar industries to expand their presence and focusing on offering quality products and services.

The competitive landscape section of the report discusses in detail the company overview, product and services portfolio, business expansion plans, production and manufacturing capacity, financial standing, and global market position. It further sheds light on the recent mergers and acquisitions, collaborations, partnerships, corporate and government deals, agreements, and product launches.

Top companies operating in the market and profiled in the report include:

Covance Group Ltd., Parexel International Corporation, Accell Clinical Research LLC, Clinilabs Inc., Pharmaceutical Product Development, Medelis Inc., Freyr Solutions, Quintiles Transnational Holdings, Inc., Charles River Laboratories International, Inc., KAI Research, Inc., Medpace Inc., Criterium Inc., Cardinal Health, IQVIA, and ICON Plc.

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Further, the report segments the Healthcare Regulatory Affairs Outsourcing market on the basis of product types, applications, end-use industries, and technology among others. The report offers insights into key factors influencing the revenue growth of the segment and provides information about lucrative investment opportunities to stakeholders, investors, and clients.

Healthcare Regulatory Affairs Outsourcing Market Segmentation:

Service Type Outlook (Revenue, USD Billion; 2018-2028)

• Regulatory writing publishing
• Regulatory submissions
• Clinical Trial Applications
• Product Registrations
• Regulatory Consulting and Legal Representation
• Others

Stage Outlook (Revenue, USD Billion; 2018-2028)

• Clinical
• Preclinical
• PMA (Post Market Authorization)

Category Outlook (Revenue, USD Billion; 2018-2028)

• Drugs
• Generics
• Innovators
• Biologics
• Biotech
• ATMPs
• Biosimilars
• Medical devices
• Therapeutic
• Diagnostic

End-use Outlook (Revenue, USD Billion; 2018-2028)

• Pharmaceutical Companies
• Biotechnology Companies
• Medical Device Companies

Regional Analysis covers:

• North America
  • US.
  • Canada
  • Mexico
• Europe
  • Germany
  • Italy
  • UK.
  • Rest of EU
• Asia Pacific
  • India
  • China
  • Japan
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Argentina
  • Rest of Latin America
• Middle East Africa
  • Saudi Arabia
  • South Africa
  • A.E
  • Rest of MEA

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