Press release
Regulatory Affairs Outsourcing Market Is Estimated To Secure A Value Of US$ 15.11 Billion By 2032
The global regulatory affairs outsourcing market is estimated to secure a market value of US$ 15.11 Bn by 2032. The worth of the market is anticipated to be US$ 7 Bn in 2022, and the projected growth rate is 8% during the forecast period from 2022 to 2032.According to Fact. MR- a market research and competitive intelligence provider- demand for regulatory affairs outsourcing expanded at a value CAGR of 6.5% from 2015 to 2021, reaching a value of US$ 6 Bn. Regulatory affairs outsourcing services are widely used to develop generic and orphan drugs, which acts as a catalyst to market growth.
๐๐ผ๐๐ป๐น๐ผ๐ฎ๐ฑ ๐๐ฟ๐ฒ๐ฒ ๐ฆ๐ฎ๐บ๐ฝ๐น๐ฒ ๐๐ผ๐ฝ๐ ๐ผ๐ณ ๐๐ต๐ถ๐ ๐ฅ๐ฒ๐ฝ๐ผ๐ฟ๐- https://www.factmr.com/connectus/sample?flag=S&rep_id=7143?PJ
๐๐๐ฟ๐ฟ๐ฒ๐ป๐ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ง๐ฟ๐ฒ๐ป๐ฑ๐:
Complex Regulatory Landscape: The pharmaceutical and healthcare industries face an increasingly intricate regulatory landscape, characterized by evolving guidelines and global harmonization efforts. Navigating this complexity requires specialized expertise, prompting companies to turn to outsourcing partners.
Time-to-Market Pressures: The competitive nature of the life sciences industry demands swift product development and market entry. Regulatory affairs outsourcing allows companies to accelerate their regulatory submissions and approvals, reducing time-to-market.
Cost-Efficiency: Outsourcing regulatory affairs services can be more cost-effective than maintaining an in-house regulatory team. Companies can avoid the overhead costs associated with hiring, training, and retaining regulatory professionals.
Global Expansion: As life sciences companies expand into international markets, they must comply with various regulatory requirements. Regulatory affairs outsourcing providers offer global expertise, helping companies penetrate new markets more effectively.
Specialized Expertise: Regulatory affairs service providers are often staffed with specialized professionals who are well-versed in specific areas, such as medical devices, pharmaceuticals, or biotechnology. This expertise is valuable in navigating industry-specific regulations.
๐๐ฒ๐ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฆ๐ฒ๐ด๐บ๐ฒ๐ป๐๐ ๐๐ผ๐๐ฒ๐ฟ๐ฒ๐ฑ ๐ถ๐ป ๐๐ต๐ฒ ๐๐น๐ผ๐ฏ๐ฎ๐น ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ณ๐ณ๐ฎ๐ถ๐ฟ๐ ๐ข๐๐๐๐ผ๐๐ฟ๐ฐ๐ถ๐ป๐ด ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐
๐๐ ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐
Regulatory Consulting Outsourcing
Legal Representation Outsourcing
Regulatory Writing & Publishing Outsourcing
Other Regulatory Affairs Outsourcing Services
๐๐ ๐๐ผ๐บ๐ฝ๐ฎ๐ป๐ ๐ฆ๐ถ๐๐ฒ
Small Sized Companies
Medium Sized Companies
Large Sized Companies
๐๐ ๐๐ฎ๐๐ฒ๐ด๐ผ๐ฟ๐
Drugs
Generics
Innovators
Biologics
Biotech
ATMPs
Biosimilars
Medical Devices
Therapeutic
Diagnostic
๐๐ ๐๐ป๐ฑ๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป
Oncology
Neurology
Radiology
Immunology
Other Indications
๐๐ ๐ฆ๐๐ฎ๐ด๐ฒ
Pre-Clinical
Clinical
Post Market Authorization
๐๐ ๐๐ป๐ฑ ๐จ๐๐ฒ
Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies
๐ฅ๐ฒ๐ด๐ถ๐ผ๐ป๐
North America
MEA
Latin America
Europe
Asia-Pacific
๐๐ฒ๐ ๐ง๐ฎ๐ธ๐ฒ๐ฎ๐๐ฎ๐๐ ๐ณ๐ฟ๐ผ๐บ ๐๐ต๐ฒ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฆ๐๐๐ฑ๐
The global regulatory affairs outsourcing market to value US$ 7 Bn in 2022
From 2015-2021, regulatory affairs outsourcing demand flourished at a 6.5% CAGR
APAC to garner a market share of 37% in 2022 with respect to regulatory affairs outsourcing
Clinical studies segment procured the largest market share of 46% in 2021.
Based on end-user segment, the pharmaceutical companies segment to secure the largest market share of 38% in 2022.
๐๐ฒ๐ ๐ฃ๐น๐ฎ๐๐ฒ๐ฟ๐ ๐ผ๐ณ ๐๐ต๐ฒ ๐๐น๐ผ๐ฏ๐ฎ๐น ๐๐น๐ผ๐๐ฑ ๐๐ผ๐บ๐ฝ๐๐๐ถ๐ป๐ด ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐
Accell Clinical Research LLC
GenPact Ltd.
Criterium Inc.
PRA Health Sciences
Promedica International
WuxI AppTec Inc.
Medspace
Charles River Laboratories International Inc.
ICON Plc.
Labcorp
๐๐ผ๐บ๐ฝ๐ฒ๐๐ถ๐๐ถ๐๐ฒ ๐๐ฎ๐ป๐ฑ๐๐ฐ๐ฎ๐ฝ๐ฒ
The players of the global regulatory affairs outsourcing market focus on expanding their global influence. Some of the adopted strategies are partnerships, collaborations, and acquisitions. Recent key developments among key players are:
ProPharma Group, an Odyssey Investment Partners portfolio company, announced the acquisition of iSafety Systems in August 2021. Pharmacovigilance outsourcing company iSafety is based in India.
ICON plc bought PRA Health Sciences, a CRO, in July 2021. The acquisition was made with the intention of expanding ICON plc's offering of services. ICON will remain the company's official name. The organization seeks to become the most advanced clinical research organization and healthcare intelligence by bringing together 38,000 workers from 47 different nations.
๐๐ป๐ฑ๐๐๐๐ฟ๐ ๐ก๐ฒ๐๐ ๐ฎ๐ป๐ฑ ๐๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐๐:
Technological Advancements: Regulatory affairs outsourcing is benefiting from advancements in technology, such as regulatory information management (RIM) systems and artificial intelligence (AI) tools that enhance data management and submission processes.
Data Security and Compliance: Providers are continually enhancing data security and compliance measures to protect sensitive information and maintain adherence to data privacy regulations like GDPR.
Diversification of Services: Outsourcing firms are expanding their service portfolios to include not only regulatory submissions but also pharmacovigilance, quality assurance, and other related functions to offer comprehensive regulatory solutions.
Global Regulatory Network: Providers are establishing a global network to facilitate efficient communication with health authorities worldwide, streamlining the regulatory approval process for their clients.
Cross-Functional Collaboration: Collaboration with other service providers in the life sciences ecosystem, such as contract research organizations (CROs) and clinical research organizations (CROs), is increasing to provide integrated solutions that encompass multiple aspects of product development and regulatory approval.
๐๐ฒ๐ ๐๐๐๐๐ผ๐บ๐ถ๐๐ฎ๐๐ถ๐ผ๐ป ๐ผ๐ป ๐๐ต๐ถ๐ ๐ฅ๐ฒ๐ฝ๐ผ๐ฟ๐ ๐ณ๐ผ๐ฟ ๐ฆ๐ฝ๐ฒ๐ฐ๐ถ๐ณ๐ถ๐ฐ ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต ๐ฆ๐ผ๐น๐๐๐ถ๐ผ๐ป๐:https://www.factmr.com/connectus/sample?flag=RC&rep_id=7143?PJ
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