Regulatory affairs outsourcing assists life sciences and
healthcare companies to adhere to regulations while bringing products to
market. It helps Companies to efficiently complete the complex process of
submitting documents and getting required approvals from regulatory bodies.
Regulatory affairs outsourcing assists with regulatory strategy, product
registration, regulatory writing and publishing, and other regulatory and
compliance services. The global Regulatory Affairs Outsourcing Market is
estimated to be valued at US$ 8.71 billion in 2024 and is expected to exhibit a
CAGR of 9.4% over the forecast
period 2024 to 2031, as highlighted in a new report published by Coherent
Market Insights.
Market key trends:
Demane for regulatory affair outsourcing is growing from pharmaceutical and
medical device industries due to increasing R&D activities and stringent
regulatory policies. Pharmaceutical companies are outsourcing parts of
regulatory affairs to focus internal resources on core areas. In addition,
growing shortage of skilled workforce and need for cost reduction are also
driving demand. Regulatory service providers help companies remain compliant
and deliver products to market on time by carefully interpreting and following
regulatory guidelines. Emerging markets also present significant growth
opportunities in coming years.
Segment
Analysis
The global
regulatory affairs outsourcing market is dominated by clinical trials
application segment. Regulatory affairs outsourcing helps life sciences
companies as well as medical device manufacturers to conduct clinical trials to
get approvals for their products in different geographies. Outsourcing
regulatory services helps them focus on core research areas by allowing experts
to handle regulatory documentation and liasioning with health authorities.
Key Takeaways
The global
Regulatory Affairs Outsourcing Market analysis is expected to witness
high growth.
North America region holds the major share in regulatory
affairs outsourcing market currently owing to presence of large pharmaceutical
and biotech companies. Growing stringent regulations by FDA for product
approval and monitoring is also driving outsourcing needs in the region. Europe
follows North America in terms of market share due to similar stringent norms
by EMA. Asia Pacific region is expected to witness highest CAGR during forecast
period supported by expanding clinical trials and manufacturing activities in
major countries like China and India.
Key players
operating in the regulatory affairs outsourcing market are
Expandable Container Homes, HONOMOBO, Rhino Cubed, SG Blocks, Revolution
Precrafted, Quick Smart House Co., Ltd, Backcountry Containers. Expandable
Container Homes provides modular homes and expandable buildings using
refurbished cargo containers. HONOMOBO offers mobile and expandable homes using
recycled shipping containers. Rhino Cubed designs and manufactures container
homes as well as container office spaces by using ISO storage containers. SG
Blocks designs and supplies code engineered cargo shipping containers based structures.
Revolution Precrafted is engaged in prefabricated homes, cabins and structures
development using recycled steel containers. Quick Smart House Co., Ltd offers
container house design and construction services. Backcountry Containers
supplies container homes, cabins and other structures made from ISO storage
containers.
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