Regulatory Affairs Outsourcing Market Size is expected to Reach at USD 16,605 Million by 2030, Registering a CAGR of 10.4%, Owing to Changing Regulatory Environment over the Globe

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Acumen Research and Consulting recently published report titled “Regulatory Affairs Outsourcing Market and Region Forecast, 2022 – 2030”

LOS ANGELES, Dec. 01, 2022 (GLOBE NEWSWIRE) — The Global Regulatory Affairs Outsourcing Market Size accounted for USD 6,921 Million in 2021 and is estimated to achieve a market size of USD 16,605 Million by 2030 growing at a CAGR of 10.4% from 2022 to 2030.

Regulatory Affairs Outsourcing Market Statistics

  • Global regulatory affairs outsourcing market revenue was worth USD 6,921 million in 2021, with a 10.4% CAGR from 2022 to 2030
  • Asia-Pacific region was accounted 36.7% of regulatory affairs outsourcing market share in 2021
  • Europe regulatory affairs outsourcing market growth is expected to expand at a CAGR of 11.2% from 2022 to 2030
  • By service, regulatory writing and publishing segment capture over 36.2% of total market share in 2021
  • Increasing demand for a faster clearance process for novel medicines and devices, drives the regulatory affairs outsourcing market value

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Regulatory Affairs Outsourcing Market Coverage:

Market Regulatory Affairs Outsourcing Market
Regulatory Affairs Outsourcing Market Size 2021 USD 6,921 Million
Regulatory Affairs Outsourcing Market Forecast 2030 USD 16,605 Million
Regulatory Affairs Outsourcing Market CAGR During 2022 – 2030 10.4%  
Regulatory Affairs Outsourcing Market Analysis Period 2018 – 2030
Regulatory Affairs Outsourcing Market Base Year 2021  
Regulatory Affairs Outsourcing Market Forecast Data 2022 – 2030
Segments Covered By Service, By End-user, And By Geography
Regulatory Affairs Outsourcing Market Regional Scope North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
Key Companies Profiled Medpace Inc., Charles River Laboratories International Inc, Accell Clinical Research, PRA International, Wuxi AppTec, PAREXEL International Corporation, Criterium Inc., Quintiles Transnational Holdings, Clinilabs Inc., and Dr. Regenold GmbH.
Report Coverage Market Trends, Drivers, Restraints, Competitive Analysis, Player Profiling, Regulation Analysis

Regulatory Affairs Outsourcing Market Overview

Outsourcing regulatory affairs tasks to Contract Research Organizations (CROs) provides cost-effectiveness, reduced legal submission time, and quality assurance in the manufacturing process. These aspects are expected to fuel development over the estimated time span.

Extensive organizations deal with restricted challenges and a lack of awareness in their internal departments by distributing to smaller mid-sized organizations. It also eliminates the residual strain and integrates administrative offices to avoid duplication of work. Drug shipment approvals for clinical trials, drug master files, labeling, technical writing, serious adverse event reporting, evaluation of Chemistry, Interventional New Drug (IND) upkeep, Production, eCTD conversion, Controls (CMC), and query management are examples of regulatory affairs exercises.

Regulatory Affairs Outsourcing Market Trends

Advancements in Research and innovation procedures, particularly in the biopharmaceutical industry, for a reduction in the whole approval process by reducing delays in administrative filings, as well as an enhancement in the Return on Investment (ROI) and economic productivity, are expected to drive the growth. Furthermore, significant administrative commands are anticipated to push the adoption of the Food and Drug Administration’s (FDA) released ICH E17 guidance on multi-territorial clinical preliminary studies. This work is necessary to bring together international clinical preliminary studies under a single convention, which will be put together by numerous experts from diverse countries.

Regulatory affairs outsourcing witnessed a few significant industry events. For example, Syneos Health based in the United Kingdom, acquired Kinapse, a provider of pharmacovigilance consultancy and post-industry regulation services, in August 2018. The organization wants to double its counseling effects in Europe and connected business administration’s with this acquisition. In addition, in October 2018, PAREXEL International Corporation introduced new China Advisory Services to assist pharmaceutical businesses seeking market prospects in China in order to gain an early mover advantage. Office commitment, access to markets, and commercial methods are all part of the administration. This occurred against the backdrop of recent modifications implemented by the National Medicinal Products Administration (NMPA, such as expedited approvals, faster Multi-provincial Clinical Trials (MCT) submissions, and clinical study clearance in two months.

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Regulatory Affairs Outsourcing Market Segmentation                

The global regulatory affairs outsourcing market has been segmented by Acumen Research and Consulting based on service, and end-user. By service, the segment is separated into regulatory consulting, regulatory writing and publishing, product registration and clinical trial application, legal representation, and other regulatory service.

In terms of end-user, the market is categorized into pharmaceutical companies, medical device companies, and biotechnology companies. According to the regulatory affairs outsourcing market forecast, the biotechnology companies segment is predicted to develop significantly in the next years.

Regulatory Affairs Outsourcing Market Regional Overview                

Based on the region, the worldwide regulatory affairs outsourcing market segmentation is into Asia Pacific, Europe, North America, Middle East and Africa, and Latin America. According to regulatory affairs outsourcing industry analysis, North America is expected to be a major contributor to the global market’s growth. The existence of global pharmaceuticals and biological sciences firms, strong regulators such as the FDA, and the availability of a talent pool will all lead to total development. However, high administrative costs in comparison to Latin America and the Asia-Pacific are significant tests determining regional growth. Asia-Pacific is expected to be the fastest-growing region in the coming years. The convenience of work and increasing occurrences of regulatory filings are the drivers driving regional development. The expansion of global health sciences and pharmaceutical organizations is also expected to boost regional demand.

Several medical device and pharmaceutical organizations are under intense pressure all across the world. Relevant factors, such as increased hurdles, differing drug pricing regimes in multiple nations, and regional conflicts, such as Brexit, have pushed companies to move their activities to regional organizations. Similarly, increased R&D costs and the pressure to cut costs are fueling the regulatory affairs outsourcing trend.

Organizations are implementing unique functional prototypes to re-appropriate administrative problems work based on the organization’s kind and size. According to a 2016 Gens and Associates report, over 80.0% of the analyzed firms cited production efficiency, cost of operation, and administrative concerns as important factors for outsourcing.

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Regulatory Affairs Outsourcing Market Players

Some of the prominent regulatory affairs outsourcing market companies are Medpace Inc., Accell Clinical Research, Wuxi AppTec, Criterium Inc., Clinilabs Inc., Charles River Laboratories International Inc, PRA International, PAREXEL International Corporation, Quintiles Transnational Holdings, and Dr. Regenold GmbH.        

Questions Answered By This Report

  • What was the market size of Regulatory Affairs Outsourcing Market in 2021?
  • What will be the CAGR of Regulatory Affairs Outsourcing Market during the forecast period from 2022 to 2030?
  • Who are the major players in Global Regulatory Affairs Outsourcing Market?
  • Which region held the largest share Regulatory Affairs Outsourcing Market in 2021?
  • What are the key market drivers Regulatory Affairs Outsourcing Market?
  • Who is the largest end user Regulatory Affairs Outsourcing Market?
  • What will be the Regulatory Affairs Outsourcing Market value in 2030?

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About Acumen Research and Consulting:

Acumen Research and Consulting is a global provider of market intelligence and consulting services to information technology, investment, telecommunication, manufacturing, and consumer technology markets. ARC helps investment communities, IT professionals, and business executives to make fact-based decisions on technology purchases and develop firm growth strategies to sustain market competition. With the team size of 100+ Analysts and collective industry experience of more than 200 years, Acumen Research and Consulting assures to deliver a combination of industry knowledge along with global and country level expertise.

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