Regulatory Affairs Outsourcing Market to to Grow with a CAGR of 9.73% through 2030
The
increasing demand to obtain approval for new products is expected to drive the
growth of Global in Regulatory Affairs Outsourcing during the forecast period,
2026-2030.
According
to TechSci Research report, “Regulatory Affairs Outsourcing Market -
Global Industry Size, Share, Trends, Opportunity, and Forecast, 2030F”,
Global Regulatory Affairs Outsourcing Market stood at USD 6.84 billion in
2024 and is anticipated to grow with a CAGR of 9.73% in the forecast period
through 2030. This can be ascribed to the pressure to reduce costs by life
sciences companies across the region. Additionally, use of generic drugs and
demand for drugs & medical devices at lower prices will further boost the
growth of the Global regulatory affairs outsourcing market in the forecast
period. Besides, uneven economic growth and measures taken by various
governments to contain the cost of drugs are driving the demand for regulatory
affairs outsourcing market during the forecast period. Also, growing number of
new drug applications and increasing complexity of regulatory requirements and
pharmaceutical companies are increasingly outsource their regulatory affairs to
specialized service providers which will further boost the growth of the market
over the years.
However,
regulatory affairs services involve navigating various languages, cultures, and
legal systems which can slow down the growth of the global regulatory affairs
outsourcing market in the forecast period. Also, lack of standardization may
restrict the growth of the global regulatory affairs outsourcing market.
Similarly, outsourcing regulatory affairs services may increase the risk of
errors and omissions which may hamper the growth of the market during the
forecast period.
Browse over
XX market data Figures spread through XX Pages and an in-depth TOC
on "Global Regulatory Affairs Outsourcing Market.”
Global
Regulatory Affairs Outsourcing market can be segmented by service, category,
company size, indication, products stage, end use, regional distribution
and company.
Based on Service,
the legal representation services segment is experiencing the fastest growth
among all service categories. This surge is primarily driven by the increasing
globalization of pharmaceutical and medical device companies, which
necessitates navigating complex and varying regulatory landscapes across
different regions. As companies expand into new markets, they face diverse
regulatory requirements, making local legal expertise crucial for obtaining
approvals and ensuring compliance.
The complexity and frequent changes in regulations, especially in regions like
Asia Pacific, the Middle East, and Latin America, have heightened the demand
for specialized legal representation. These regions often have unique
regulatory frameworks, and staying abreast of the latest requirements is
challenging for companies without local presence. By outsourcing legal
representation, companies can leverage the knowledge of local experts to
facilitate smoother regulatory processes, reduce the risk of non-compliance,
and expedite market entry.
Based on Region,
North America is witnessing significant growth in the regulatory affairs
outsourcing market, driven by a combination of increasing regulatory
complexity, rising development costs, and a growing reliance on specialized
external expertise. As pharmaceutical, biotechnology, and medical device
companies continue to innovate and expand their pipelines, navigating the
evolving and often stringent regulatory environment in the U.S. and Canada
requires a high level of precision and compliance. This has led to an increased
demand for third-party regulatory service providers who can offer focused
expertise, ensure faster approval timelines, and reduce the operational burden
on in-house teams. One of the major contributing factors to this regional
growth is the evolving regulatory landscape shaped by bodies like the U.S. Food
and Drug Administration (FDA) and Health Canada. These agencies are
increasingly focusing on patient safety, real-world evidence, and accelerated
pathways for innovative therapies. Keeping pace with these evolving regulations
requires continuous monitoring and strategic adaptation—areas where outsourcing
partners can provide strong value. Additionally, North America is home to many
early-stage biotech firms and startups that often lack the internal
infrastructure for comprehensive regulatory planning and execution, making
outsourcing a practical and strategic choice.
Major
companies operating in the global Regulatory Affairs Outsourcing market are:
- Accell
Clinical Research, LLC.
- Genpact
Ltd.
- CRITERIUM,
INC.
- Promedica
International.
- WuXi
AppTec Co Ltd.
- Medpace
Inc.
- Charles
River Laboratories Inc.
- ICON
plc.
- Covance,
Inc.
- Parexel
International Corporation.
Download Free Sample Report
Customers
can also request for 10% free customization on this report.
“North
America was expected to dominate in the Global Regulatory Affairs Outsourcing
Market on account due to growing research and development activity rising in
the number of clinical trials along with presence of key players in the region
and strategic collaborations by these companies. Similarly, the availability of
a skilled workforce in the region at lower costs compared to the U.S. is
another factor is expected to create lucrative growth in the market during the
forecast period. Also, the presence of key pharmaceutical and medical device
companies and the rise in R&D spending in the region is expected to drive
the growth of the market during the forecast period. Furthermore, owing to the
presence of two major international regulatory agencies, the European Medicines
Agency (EMA) and the U.S. FDA, which regulate more than half of the medical
devices worldwide will further be expected to create lucrative opportunities
for market growth” said Mr. Karan Chechi, Research Director of TechSci
Research, a research-based global management consulting firm.
“Regulatory Affairs Outsourcing Market - Global Industry
Size, Share, Trends, Opportunity, and Forecast, Segmented By Service
(Regulatory Consulting, Legal Representation, Regulatory Writing &
Publishing, Product registration & clinical trial applications, Regulatory
Submissions, Regulatory Operations, Other Services), By Category
(Pharmaceutical, Medical Device), By Company Size (Small Companies, Medium
Companies, Large Companies), By Indication (Oncology, Neurology, Cardiology,
Immunology, Other Indications), By Product Stage (Preclinical, Clinical,
Premarket Approval), By End Use (Medical Device Companies, Pharmaceutical
Companies, Biotechnology Companies), By Region and
Competition, 2020-2030F”, has evaluated the future growth potential of
Global Regulatory Affairs Outsourcing Market and provides statistics &
information on market size, structure and future market growth. The report
intends to provide cutting-edge market intelligence and help decision makers
take sound investment decisions. Besides, the report also identifies and
analyzes the emerging trends along with essential drivers, challenges, and
opportunities in Global Regulatory Affairs Outsourcing Market.
Contact
TechSci Research LLC
420 Lexington Avenue, Suite 300,
New York, United States- 10170
Tel: +1-332-258-6602
Email: [email protected]
Website: www.techsciresearch.com