The global Regulatory Affairs Outsourcing Market size is expected to reach USD 13.9 billion by 2030, registering a CAGR of 8.9% over the forecast period, according to a new report by Grand View Research, Inc. Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities like training, technology, specialized knowledge, and facilities are driving outsourcing of regulatory affair functions. Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, is creating demand for these services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but in turn, complicate the operation for healthcare product manufacturing companies.
Thus, leading to the regulatory affairs outsourcing to
service providers. The market witnessed a significant decline in 2020 due to
the outbreak of the COVID-19 pandemic, as there was a halt in clinical trial
activities including regulatory updates. Disruption in the supply chain and
closure of R&D sites resulted in a significant loss of revenues in 2020
across the industry. However, due to the pandemic, various healthcare companies
are opting for more regulatory advice, as companies push to speed up the
product development & approvals in therapies, vaccines, & devices for
COVID-19. Owing to the urgent need for medical devices and therapies for
COVID-19, regulatory authorities are providing emergency use authorization for
the majority of products. Such actions have further promoted the demand for
these services post 2020 and the positive rebound of sales across the industry
can be witnessed from 2021.
Related Press Release@ Regulatory Affairs Outsourcing Market Report
Regulatory Affairs Outsourcing
Market Report Highlights
- The regulatory writing & publishing services segment dominated
the market with the maximum revenue share in 2021as they are offered from
the early stages of development to the post-marketing authorization phase
and are vital for the success of a product
- The large companies segment is projected to witness the fastest
CAGR during the forecast period. The availability of a wide variety of
services and the presence of these providers in various geographies are
the key factors driving the segment growth
- The clinical studies stage segment accounted for the largest market
share in 2021 due to the increasing demand for clinical trials in
developing countries
- The pharmaceutical companies end-use segment is anticipated to
witness the fastest growth rate over the forecast period due to evolving
areas, such as orphan drugs and personalized therapies
- Asia Pacific held the maximum revenue share of the global market in
2021 owing to higher off shoring of such services into regions of economic
benefits and the expansion of life sciences companies in countries, such
as India & China
Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, the company offers market intelligence studies ensuring relevant and fact-based research across a range of industries including technology, chemicals, materials, healthcare and energy.
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