Healthcare Regulatory Affairs Market (Service Outlook- Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services. By Company Size- Small, Medium, and Large. By Category- Drugs, Generics, Innovators, Biologics, Biotech, ATMPs, Medical devices, Therapeutic, and Diagnostic. By Indication Outlook- Oncology, Neurology, Cardiology, Immunology, and Others. By Stage Outlook- Preclinical, Clinical, and PMA (Post Market Authorization). By End-User- Medical Device Companies, Pharmaceutical Companies, and Biotechnology Companies. By Geography-North America, Europe, Asia Pacific, Latin America, Middle East, and Africa) - Global industry analysis, size, share, growth, trends, and forecast, 2021 - 2031.

The Global Healthcare Regulatory Affairs Market was valued at $56.1 Billion in 2020. Growing at a high CAGR of more than 10.21% between 2021 and 2031, it is estimated to reach $167.1 Billion by 2031”. The outsourcing of Healthcare Regulatory Affairs is becoming an essential practice in the biotechnology and pharmaceutical industry. An increasing geographical expansion activity by the companies that aim for speedy approvals in global markets is expected to drive the adoption of outsourcing models for Healthcare Regulatory Affairs. Regulatory approval procedures are becoming more time-consuming, and stringent and market players aim to obtain permission for the product in the first attempt to gain higher market shares. Now, moving forward, the robust demand for the Global Healthcare Regulatory Affairs Market in the Healthcare Regulatory Affairs department is further estimated to create new necessities and augment the market of growth over the forecast period of 2021-2031. 

Global Healthcare Regulatory Affairs Segment Is Estimated to Witness Remarkable Growth

Source: SAI Research

The Healthcare Regulatory Affairs market is segmented as service outlook, company size, category, indication outlook, stage outlook, and end-user. Service Outlook the global Healthcare Regulatory Affairs market is divided into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services. By Company Size, the global Healthcare Regulatory Affairs market has been bifurcated as Small, Medium, and Large. By Category Healthcare Regulatory Affairs market is divided into Drugs, Generics, Innovators, Biologics, Biotech, ATMPs, Medical devices, Therapeutic, and Diagnostic. By Indication Outlook, the global Healthcare Regulatory Affairs market has been segmented as Oncology, Neurology, Cardiology, Immunology, and Others. By Stage Outlook, the global Healthcare Regulatory Affairs market is bifurcated as Preclinical, Clinical, and PMA (Post Market Authorization). By End-User, the global Healthcare Regulatory Affairs market is divided into Medical Device Companies, Pharmaceutical Companies, and Biotechnology Companies.

By Region, Asia-Pacific is Holding the Major Market Share

The Healthcare Regulatory Affairs Market has been geographically segmented into North America, Asia Pacific, Latin America, Middle East, and Africa region. In addition to this, Asia-Pacific has a significant share among those regions. The availability of low-cost labor and increased availability of skilled workforce, an increasing number of clinical trials, and a rising number of companies are the prime factors that boost market growth over the region. Apart from that, favorable rules and regulations and other factors are drive market growth. Apart from that, North America and the Rest of the regions are expected to increase the growth rate in the upcoming forecast period of 2021 to 2031.

Major Players in the Global Healthcare Regulatory Affairs Market

The report covers a detailed outlook about the company, and it includes the company or industry profiles and market share of key players operating in the global market. Key players in the report include Accell Clinical Research LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Covance, Inc., Criterium Inc., Freyr, Inc., ICON PLC IQVIA, Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development LLC, WuXi AppTec, PRA Clinical Research, LLC, Promedica International, and Certara, L.P. among others.

Scope of the Report:

The Global Healthcare Regulatory Affairs Market Has Been Segmented into:

Global Healthcare Regulatory Affairs Market: By Service Outlook

• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
• Product Registration & Clinical Trial Applications
• Other Services

Global Healthcare Regulatory Affairs Market: By Company Size

• Small
• Medium
• Large

Global Healthcare Regulatory Affairs Market: By Category

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

Global Healthcare Regulatory Affairs Market: By Indication Outlook

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Global Healthcare Regulatory Affairs Market: By Stage Outlook

• Preclinical
• Clinical
• PMA (Post Market Authorization)

Global Healthcare Regulatory Affairs Market: By End-User

• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Global Healthcare Regulatory Affairs Market: By Region

• North America
• USA
• Canada
• Mexico
• Rest of North America
• Europe
• UK
• Germany
• France
• Spain
• Italy
• Russia
• Rest of Europe
• Asia Pacific
• India
• China
• Japan
• South Korea
• Rest of Asia Pacific
• Latin America, Middle East & Africa
• Brazil
• South Africa
• UAE
• Rest of LAMEA