An overview of the “Global Regulatory Affairs Outsourcing Market” the current state of the industry, market trends, significant market participants, product type, application, and geography are provided at the beginning of the study. It also covers how COVID-19 has affected market participants, end-user industries, future predictions, growth potential, and worldwide market trends.
Global Regulatory Affairs Outsourcing Market is valued approximately USD 5.72 billion in 2021 and is anticipated to grow with a healthy growth rate of more than 8.90 % over the forecast period 2022-2028.
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Regulatory affairs outsourcing is becoming more common in the healthcare industry. The adoption of regulatory outsourcing models is projected to be aided by an increase in geographical expansion activities by corporations seeking quick approvals in local markets. The regulatory affairs outsourcing market is quickly growing as a result of increased R&D activity, which is increasing the number of clinical trial applications and product registrations. Outsourcing of regulatory affairs duties is being driven by a significant increase in the fixed expenses of in-house resources for regulatory affairs and operations activities such as training, technology, specialist knowledge, and facilities.
For example, ProPharma Group bought iSafety Systems, an Indian pharmacovigilance service provider, in August 2021 to boost its pharmacovigilance market position. Similarly, in July 2021, ICON plc purchased PRA Health Sciences, contract research organization that specializes in medication development and regulatory consultation. The goal of this acquisition was to expand ICON plc’s service portfolio. The demand for these services is being driven by local legal challenges and frequent changes in the rules of major markets such as the United States, Europe, and Asia.. Amendments to current regulations are likely to make the regulatory process easier for the business, but they will also make it more difficult for healthcare product manufacturers to operate. As a result, regulatory affairs are being outsourced to service providers.
This is due to an increase in the number of clinical trial registrations in recent years. ClinicalTrials.gov reports that about 401,716 studies were registered in January 2022, up from around 325,834 by the end of 2019. Furthermore, an increase in the number of biologics, a high demand for innovative technologies, and a need for individualized orphan pharmaceuticals and medicine are all expected to drive segment growth throughout the projection period. However, over the projection period of 2022-2028, rigorous government regulations governing various medical items would stifle market growth.
The key regions considered for the global Regulatory Affairs Outsourcing Market study includes Asia Pacific, North America, Europe, Latin America, and Rest of the World. The Asia Pacific area had the largest share. Over the forecast period, the area is also expected to have the quickest CAGR. This can be linked to an increase in clinical trials as well as a rise in the number of enterprises attempting to penetrate developing markets such as India and China. Another element projected to drive regional market expansion is the availability of a competent labour in the region at cheaper costs than in the United States.
Major market player included in this report are:
- Accell Clinical Research, LLC
- GenPact Ltd.
- Criterium, Inc.
- PRA Health Sciences
- Promedica International
- Dr. Regenold GmbH
- BioMapas
- Zeincro Group
- Parexel International Corp.
- Charles River Laboratories International, Inc.
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The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players.
The detailed segments and sub-segment of the market are explained below:
By Services
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Other Services
By Company Size
Small
Medium
Large
By Category
Drugs
Generics
Innovators
Biologics
Biotech
ATMPs
Biosimilars
Medical devices
Therapeutic
Diagnostic
By Indication
Oncology
Neurology
Cardiology
Immunology
Others
By Stage
Preclinical
Clinical
PMA (Post Market Authorization)
By End-use
Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies
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By Region:
North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
ROE
Asia Pacific
China
India
Japan
Australia
South Korea
RoAPAC
Latin America
Brazil
Mexico
Rest of the World
Table of content
Market Overview
Market Definition and Scope
Market Dynamics
Market Industry Analysis
Market, Regional Analysis
Analysis of Leading Companies
Competitive Intelligence
Research Process
Market Analysis and Forecast, By Product Types
Some of the Key Questions Answered in this Report:
- What is the Market dimension at the regional and country-level?
- What are the key drivers, restraints, opportunities, and challenges of the Market, and how they are anticipated to influence the market?
- What is the international (North America, Europe, Asia-Pacific, South America, Middle East and Africa) income value, manufacturing value, consumption value, import and export of Market?
- Who are the world key producers of the Market Industry? How is their working state of affairs (capacity, production, sales, price, cost, gross, and revenue)?
- What are the Market possibilities and threats confronted via the carriers in the world Market Industry?
- Which application/end-user or product kind may also be seeking for incremental boom prospects? What is the market share of every kind and application?
- What targeted method and constraints are keeping the Market?
- What are the distinct sales, marketing, and distribution channels in the world industry?
- What are the upstream uncooked substances and manufacturing gear of Market alongside with the manufacturing technique of Market?
- What are the key market tendencies impacting the increase of the Market?
- Economic have an impact on the Market enterprise and improvement vogue of the Market industry.
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