The Global Regulatory Affairs Outsourcing Market is Expected to Reach $16.8 Billion By 2027. The Emergence of Virtual Trials & Virtual Communication Leading the Market - Arizton

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The global regulatory affairs outsourcing market was valued at $8.2 billion in 2021 and is expected to reach $16.8 billion by 2027.

Chicago, June 15, 2022 (GLOBE NEWSWIRE) -- According to the latest research report by Arizton, the global regulatory affairs outsourcing market is expected to grow at a CAGR of 12.73% during 2022-2027. The increasing use of digital platforms, changing regulatory landscape, and the emergence of virtual trials & virtual communication are the major factors in the market.

3D Communications has spent 20 years preparing companies for meetings with regulatory agencies, including FDA pre-submission and advisory board meetings and Committee for Medicinal Products for Human Use (CHMP) oral statements. Companies are facing new challenges as their regulatory teams all operate in different locations, and the FDA and EMA are instructing sponsors and applicants to prepare for virtual meetings.

The digital solutions have already been adopted in pharmaceutical R&D and pharmacovigilance, the regulatory process is largely manual and time-consuming due to the slow adoption of innovative digital approaches. However, new solutions are being developed to facilitate digital transformation in regulated environments. The combination of smarter work processes and the proper use of innovative technologies improve the efficiency of regulatory submissions while maintaining high quality and compliance standards. Ultimately, this can lead to time and resource savings for market approval and post-marketing requirements that will revolutionize the regulatory environment.

Regulatory Affairs Outsourcing Market Report Scope

Report Attributes	Details
MARKET SIZE (2027)	$8.2 Billion
MARKET SIZE (2021)	$16.8 Billion
CAGR (2022-2027)	12.73%
BASE YEAR	2021
FORECAST YEAR	2022-2027
MARKET SEGMENTS	Product, Company Size, End-user, Service Type
GEOGRAPHIC ANALYSIS	North America, Europe, APAC, Latin America, and Middle East & Africa
COUNTRIES COVERED	US, Canada, Germany, France, UK, Italy, Spain, China, Japan, Australia, South Korea, India, Brazil, Mexico, Argentina, Turkey, Saudi Arabia, UAE, and South Africa

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The global regulatory affairs outsourcing market is highly competitive with the presence of many global and regional vendors helping medical device, pharma/biotech, nutraceutical/dietary supplements manufacturing companies to receive approvals for their products from various regulatory bodies globally. In 2021, North America accounted for a 33.51% share of the global regulatory affairs outsourcing market. The US is the major revenue contributor to the North American regulatory affairs outsourcing market and accounted for a share of around 91.11% in 2021. In the same year, Canada accounted for a share of 8.9%. The country is also likely to experience healthy growth during the forecast period.

Key Insights

• The global regulatory affairs outsourcing market is likely to reach $16.8 billion by 2027 growing with a CAGR of 12.7%

• The presence of prominent market players, increasing mergers & acquisitions, and patent expirations of prescription biologics, developments of biosimilars/orphan drugs, and cell & gene therapy products are the primary factors for the significant market share in the region.

• The regulatory affairs outsourcing market in the US was valued at $4.9 billion in 2027 and has a major contributor to the North American regulatory affairs outsourcing market share of 91%.

• Pre-authorization is the major contributor to the global regulatory affairs outsourcing market, and it is likely to witness high incremental growth during the forecast period.

• Strategic acquisition & collaborations among life science companies, CROs, and private equity firms in regulatory affairs outsourcing services are major opportunities pertaining to the growth of the market.
  

Key Vendors

• Genpact

• Labcorp Drug Development

• Freyr

• ICON

• IQVIA

• Medpace

• Parexel International

• PPD

Other Prominent Vendors

• Accenture

• BlueReg

• Intertek Group

• Lachman Consultants

• NDA Group

• ProPharma Group

• PharmaLex

• Pharmexon

• Promedica International

• CRITERIUM

• Dicentra

• Nuventra Pharma Sciences

• PharmaLeaf

• MAVEN REGULATORY SOLUTIONS

• Global Regulatory Partners

• Sofpromed

• Charles River Laboratories

• Cambridge Regulatory Services

• APC Group

• Real Regulatory

• Voisin Consulting Life Sciences (VCLS)

• Regulatory Pharma Net

• Biomapas

• REGENOLD

Segmentation by Product

• Small Molecule Drugs

• Biologics

• Medical Devices

• Others

Segmentation by Company Size

• Small & Mid-Sized Companies

• Large-sized Companies

Segmentation by End-User

• Pharma & Biotech Companies

• Medical Device Companies

• Other Companies
  

Segmentation by Service Type

• Pre-Authorization

• Marketing Authorization

• Post-Authorization
  

Segmentation by Region

• North America

  • US

  • Canada

• Europe

  • Germany

  • France

  • UK

  • Italy

  • Spain

• APAC

  • China

  • Japan

  • Australia

  • South Korea

  • India

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East & Africa

  • Turkey

  • Saudi Arabia

  • UAE

  • South Africa

Explore our healthcare & lifesciences profile to know more about the industry.

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