Regulatory affairs outsourcing refers to the practice of hiring external experts or companies to complete various tasks related to regulatory compliance on behalf of a company. These tasks can include market authorization, product registration, and regulatory document submission, among others. It is a critical service used by pharmaceutical, biotechnology, medical device, and other life sciences companies to fulfill regulatory compliance requirements. The global regulatory affairs outsourcing market is likely to register a CAGR of over 13.25% with an incremental growth of USD 11.4 billion during the forecast period 2023-2029. One major driver for the Regulatory Affairs Outsourcing market is the increasing complexities of regulatory requirements across different regions and countries. With the globalization of business and trade, companies need to adhere to a growing number of regulations, guidelines, and standards for their products and services. As a result, it has become a significant challenge for organizations to keep up-to-date with the latest regulatory changes, interpretations, and enforcement policies.One major driver for the Regulatory Affairs Outsourcing market is the increasing complexities of regulatory requirements across different regions and countries. With the globalization of business and trade, companies need to adhere to a growing number of regulations, guidelines, and standards for their products and services. As a result, it has become a significant challenge for organizations to keep up-to-date with the latest regulatory changes, interpretations, and enforcement policies.
The report covers market size and growth, segmentation, regional breakdowns, competitive landscape, trends and strategies for global regulatory affairs outsourcing market. It presents a quantitative analysis of the market to enable stakeholders to capitalize on the prevailing market opportunities. The report also identifies top segments for opportunities and strategies based on market trends and leading competitors' approaches.
This industry report offers market estimates and forecasts of the global market, followed by a detailed analysis of the product, service type, company size, end user, and region. The global market for regulatory affairs outsourcing can be segmented by product: small molecule drugs, biologics, medical devices, others. The small molecule drugs segment captured the largest share of the market in 2022. Regulatory affairs outsourcing market is further segmented by service type: pre-authorization, marketing authorization, post-authorization. The pre-authorization segment held the largest share of the global regulatory affairs outsourcing market in 2022 and is anticipated to hold its share during the forecast period. Based on company size, the regulatory affairs outsourcing market is segmented into: small & mid-sized companies, large-sized companies. In 2022, the small & mid-sized companies segment made up the largest share of revenue generated by the regulatory affairs outsourcing market. On the basis of end user, the regulatory affairs outsourcing market also can be divided into: pharmaceutical, medical device, others. Among these, the pharmaceutical segment was accounted for the highest revenue generator in 2022. Regulatory affairs outsourcing market by region is categorized into: North America, Europe, Asia-Pacific, MEA (Middle East and Africa), Latin America.
Market Segmentation
By product: small molecule drugs, biologics, medical devices, others
By service type: pre-authorization, marketing authorization, post-authorization
By company size: small & mid-sized companies, large-sized companies
By end user: pharmaceutical, medical device, others
By region: North America, Europe, Asia-Pacific, MEA (Middle East and Africa), Latin America
The report also provides a detailed analysis of several leading regulatory affairs outsourcing market vendors that include IQVIA Holdings, Inc., PPD, Inc., ICON plc, Genpact Limited, PAREXEL International Corporation, Medpace Holdings, Inc., Labcorp Drug Development, Inc., among others. In this report, key players and their strategies are thoroughly analyzed to understand the competitive outlook of the market.
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Scope of the Report
• To analyze and forecast the market size of the global regulatory affairs outsourcing market.
• To classify and forecast the global regulatory affairs outsourcing market based on product, service type, company size, end user, region.
• To identify drivers and challenges for the global regulatory affairs outsourcing market.
• To examine competitive developments such as mergers & acquisitions, agreements, collaborations and partnerships, etc., in the global regulatory affairs outsourcing market.
• To identify and analyze the profile of leading players operating in the global regulatory affairs outsourcing market.
Why Choose This Report
• Gain a reliable outlook of the global regulatory affairs outsourcing market forecasts from 2023 to 2029 across scenarios.
• Identify growth segments for investment.
• Stay ahead of competitors through company profiles and market data.
• The market estimate for ease of analysis across scenarios in Excel format.
• Strategy consulting and research support for three months.
• Print authentication provided for the single-user license.
PART 1. INTRODUCTION
Report description
Objectives of the study
Market segment
Years considered for the report
Currency
Key target audience
PART 2. METHODOLOGY
PART 3. EXECUTIVE SUMMARY
PART 4. MARKET OVERVIEW
Introduction
Drivers
Restraints
PART 5. MARKET BREAKDOWN BY PRODUCT
Small molecule drugs
Biologics
Medical devices
Others
PART 6. MARKET BREAKDOWN BY SERVICE TYPE
Pre-authorization
Marketing authorization
Post-authorization
PART 7. MARKET BREAKDOWN BY COMPANY SIZE
Small & mid-sized companies
Large-sized companies
PART 8. MARKET BREAKDOWN BY END USER
Pharmaceutical
Medical device
Others
PART 9. MARKET BREAKDOWN BY REGION
North America
Europe
Asia-Pacific
MEA (Middle East and Africa)
Latin America
PART 10. KEY COMPANIES
IQVIA Holdings, Inc.
PPD, Inc.
ICON plc
Genpact Limited
PAREXEL International Corporation
Medpace Holdings, Inc.
Labcorp Drug Development, Inc.
DISCLAIMER
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