Global Pharmaceutical Regulatory Affairs Market Research Report - Industry Analysis, Size, Share, Growth, Trends and Forecast 2023 to 2030

Description

List of Tables

The global demand for Pharmaceutical Regulatory Affairs Market is presumed to reach the market size of nearly USD 17.6 BN by 2030 from USD 9.23 BN in 2022 with a CAGR of 8.4% under the study period 2023 - 2030.

Pharmaceutical regulatory affairs, often simply referred to as Regulatory Affairs (RA) in the pharmaceutical industry, is a critical function responsible for ensuring that pharmaceutical and biotechnology companies comply with all relevant regulations and laws governing the development, manufacturing, testing, marketing, and distribution of drugs and medical products. This field plays a central role in bringing safe and effective medications and healthcare products to market while ensuring that they remain in compliance with regulatory standards throughout their lifecycle.

MARKET DYNAMICS:

The Pharmaceutical regulatory affairs market is propelled by several critical factors that reflect the dynamic nature of the pharmaceutical industry and its regulatory landscape. The ever-changing rules and requirements governing drug development and marketing necessitate a robust Regulatory Affairs function within pharmaceutical and biotechnology companies. Globalization of drug development, the continuous emergence of new drugs and therapies, and the stringent emphasis on safety and quality standards are key drivers. The rise of biologic drugs, biosimilars, and generic medications presents unique regulatory challenges that demand expertise in navigating complex approval processes. Regulatory Affairs professionals assist in adapting to technological advances, addressing global health concerns like the COVID-19 pandemic, and ensuring data transparency and compliance. Healthcare reforms, patent expirations, and the growth of patient-centric approaches further underscore the significance of Regulatory Affairs in pharmaceutical operations. These factors collectively underscore the critical role of Regulatory Affairs in guiding pharmaceutical companies through the intricate regulatory landscape, ensuring that drugs and therapies are safe, effective, and compliant with diverse and evolving regulations worldwide. As the industry continues to evolve and expand, Regulatory Affairs remains at the forefront of pharmaceutical success and innovation.

The research report covers Porter's Five Forces Model, Market Attractiveness Analysis, and Value Chain analysis. These tools help to get a clear picture of the industry's structure and evaluate the competition attractiveness at a global level. Additionally, these tools also give an inclusive assessment of each segment in the global market of pharmaceutical regulatory affairs. The growth and trends of pharmaceutical regulatory affairs industry provide a holistic approach to this study.

MARKET SEGMENTATION:

This section of the pharmaceutical regulatory affairs market report provides detailed data on the segments at country and regional level, thereby assisting the strategist in identifying the target demographics for the respective product or services with the upcoming opportunities.

By Services

Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing (Writing, Publishing)
Product Registration & Clinical Trial Applications
Other Services

By Category

Drugs (Innovator, Generics)
Biologics (Biotech, ATMP, Biosimilars)

By Indication

Oncology
Neurology
Cardiology
Immunology
Others

By Product Stage

Preclinical
Clinical Studies
PMA

By Service Provider

In-House
Outsourcing

By Company Size

Small
Medium
Large

REGIONAL ANALYSIS:

This section covers the regional outlook, which accentuates current and future demand for the Pharmaceutical Regulatory Affairs market across North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa. Further, the report focuses on demand, estimation, and forecast for individual application segments across all the prominent regions.

The research report also covers the comprehensive profiles of the key players in the market and an in-depth view of the competitive landscape worldwide. The major players in the Pharmaceutical Regulatory Affairs market include Freyr, IQVIA Inc., ICON plc, WuXi AppTec, Charles River Laboratories, Labcorp Drug Development, Parexel International Corporation, Pharmalex GmbH, Pharmexon, Genpact. This section consists of a holistic view of the competitive landscape that includes various strategic developments such as key mergers & acquisitions, future capacities, partnerships, financial overviews, collaborations, new product developments, new product launches, and other developments.

In case you have any custom requirements, do write to us. Our research team can offer a customized report as per your need.

Product Code: VMR112112255

1 . PREFACE

1.1. Report Description
- 1.1.1. Objective
- 1.1.2. Target Audience
- 1.1.3. Unique Selling Proposition (USP) & offerings
1.2. Research Scope
1.3. Research Methodology
- 1.3.1. Market Research Process
- 1.3.2. Market Research Methodology

2 . EXECUTIVE SUMMARY

2.1. Highlights of Market
2.2. Global Market Snapshot

3 . PHARMACEUTICAL REGULATORY AFFAIRS - INDUSTRY ANALYSIS

3.1. Introduction - Market Dynamics
3.2. Market Drivers
3.3. Market Restraints
3.4. Opportunities
3.5. Industry Trends
3.6. Porter's Five Force Analysis
3.7. Market Attractiveness Analysis
- 3.7.1 Market Attractiveness Analysis By Services
- 3.7.2 Market Attractiveness Analysis By Category
- 3.7.3 Market Attractiveness Analysis By Indication
- 3.7.4 Market Attractiveness Analysis By Product Stage
- 3.7.5 Market Attractiveness Analysis By Service Provider
- 3.7.6 Market Attractiveness Analysis By Company Size
- 3.7.7 Market Attractiveness Analysis By Region

4 . VALUE CHAIN ANALYSIS

4.1. Value Chain Analysis
4.2. Raw Material Analysis
- 4.2.1. List of Raw Materials
- 4.2.2. Raw Material Manufactures List
- 4.2.3. Price Trend of Key Raw Materials
4.3. List of Potential Buyers
4.4. Marketing Channel
- 4.4.1. Direct Marketing
- 4.4.2. Indirect Marketing
- 4.4.3. Marketing Channel Development Trend

5 . GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET ANALYSIS BY SERVICES

5.1 Overview by Services
5.2 Historical and Forecast Data
5.3 Analysis by Services
5.4 Regulatory Consulting Historic and Forecast Sales by Regions
5.5 Legal Representation Historic and Forecast Sales by Regions
5.6 Regulatory Writing & Publishing (Writing, Publishing) Historic and Forecast Sales by Regions
5.7 Product Registration & Clinical Trial Applications Historic and Forecast Sales by Regions
5.8 Other Services Historic and Forecast Sales by Regions

6 . GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET ANALYSIS BY CATEGORY

6.1 Overview by Category
6.2 Historical and Forecast Data
6.3 Analysis by Category
6.4 Drugs (Innovator, Generics) Historic and Forecast Sales by Regions
6.5 Biologics (Biotech, ATMP, Biosimilars) Historic and Forecast Sales by Regions

7 . GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET ANALYSIS BY INDICATION

7.1 Overview by Indication
7.2 Historical and Forecast Data
7.3 Analysis by Indication
7.4 Oncology Historic and Forecast Sales by Regions
7.5 Neurology Historic and Forecast Sales by Regions
7.6 Cardiology Historic and Forecast Sales by Regions
7.7 Immunology Historic and Forecast Sales by Regions
7.8 Others Historic and Forecast Sales by Regions

8 . GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET ANALYSIS BY PRODUCT STAGE

8.1 Overview by Product Stage
8.2 Historical and Forecast Data
8.3 Analysis by Product Stage
8.4 Preclinical Historic and Forecast Sales by Regions
8.5 Clinical studies Historic and Forecast Sales by Regions
8.6 PMA Historic and Forecast Sales by Regions

9 . GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET ANALYSIS BY SERVICE PROVIDER

9.1 Overview by Service Provider
9.2 Historical and Forecast Data
9.3 Analysis by Service Provider
9.4 In-house Historic and Forecast Sales by Regions
9.5 Outsourcing Historic and Forecast Sales by Regions

10 . GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET ANALYSIS BY COMPANY SIZE

10.1 Overview by Company Size
10.2 Historical and Forecast Data
10.3 Analysis by Company Size
10.4 Small Historic and Forecast Sales by Regions
10.5 Medium Historic and Forecast Sales by Regions
10.6 Large Historic and Forecast Sales by Regions

11 . GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET ANALYSIS BY GEOGRAPHY

11.1. Regional Outlook
11.2. Introduction
11.3. North America Sales Analysis
- 11.3.1. Overview, Historic and Forecast Data Sales Analysis
- 11.3.2. North America By Segment Sales Analysis
- 11.3.3. North America By Country Sales Analysis
- 11.3.4. United State Sales Analysis
- 11.3.5. Canada Sales Analysis
- 11.3.6. Mexico Sales Analysis
11.4. Europe Sales Analysis
- 11.4.1. Overview, Historic and Forecast Data Sales Analysis
- 11.4.2. Europe by Segment Sales Analysis
- 11.4.3. Europe by Country Sales Analysis
- 11.4.4. United Kingdom Sales Analysis
- 11.4.5. France Sales Analysis
- 11.4.6. Germany Sales Analysis
- 11.4.7. Italy Sales Analysis
- 11.4.8. Russia Sales Analysis
- 11.4.9. Rest Of Europe Sales Analysis
11.5. Asia Pacific Sales Analysis
- 11.5.1. Overview, Historic and Forecast Data Sales Analysis
- 11.5.2. Asia Pacific by Segment Sales Analysis
- 11.5.3. Asia Pacific by Country Sales Analysis
- 11.5.4. China Sales Analysis
- 11.5.5. India Sales Analysis
- 11.5.6. Japan Sales Analysis
- 11.5.7. South Korea Sales Analysis
- 11.5.8. Australia Sales Analysis
- 11.5.9. South East Asia Sales Analysis
- 11.5.10. Rest Of Asia Pacific Sales Analysis
11.6. Latin America Sales Analysis
- 11.6.1. Overview, Historic and Forecast Data Sales Analysis
- 11.6.2. Latin America by Segment Sales Analysis
- 11.6.3. Latin America by Country Sales Analysis
- 11.6.4. Brazil Sales Analysis
- 11.6.5. Argentina Sales Analysis
- 11.6.6. Peru Sales Analysis
- 11.6.7. Chile Sales Analysis
- 11.6.8. Rest of Latin America Sales Analysis
11.7. Middle East & Africa Sales Analysis
- 11.7.1. Overview, Historic and Forecast Data Sales Analysis
- 11.7.2. Middle East & Africa by Segment Sales Analysis
- 11.7.3. Middle East & Africa by Country Sales Analysis
- 11.7.4. Saudi Arabia Sales Analysis
- 11.7.5. UAE Sales Analysis
- 11.7.6. Israel Sales Analysis
- 11.7.7. South Africa Sales Analysis
- 11.7.8. Rest Of Middle East And Africa Sales Analysis

12 . COMPETITIVE LANDSCAPE OF THE PHARMACEUTICAL REGULATORY AFFAIRS COMPANIES

12.1. Pharmaceutical Regulatory Affairs Market Competition
12.2. Partnership/Collaboration/Agreement
12.3. Merger And Acquisitions
12.4. New Product Launch
12.5. Other Developments

13 . COMPANY PROFILES OF PHARMACEUTICAL REGULATORY AFFAIRS INDUSTRY

13.1. Company Share Analysis
13.2. Market Concentration Rate
13.3. Freyr
- 13.3.1. Company Overview
- 13.3.2. Company Revenue
- 13.3.3. Products
- 13.3.4. Recent Developments
13.4. IQVIA Inc.
- 13.4.1. Company Overview
- 13.4.2. Company Revenue
- 13.4.3. Products
- 13.4.4. Recent Developments
13.5. ICON plc
- 13.5.1. Company Overview
- 13.5.2. Company Revenue
- 13.5.3. Products
- 13.5.4. Recent Developments
13.6. WuXi AppTec
- 13.6.1. Company Overview
- 13.6.2. Company Revenue
- 13.6.3. Products
- 13.6.4. Recent Developments
13.7. Charles River Laboratories
- 13.7.1. Company Overview
- 13.7.2. Company Revenue
- 13.7.3. Products
- 13.7.4. Recent Developments
13.8. Labcorp Drug Development
- 13.8.1. Company Overview
- 13.8.2. Company Revenue
- 13.8.3. Products
- 13.8.4. Recent Developments
13.9. Parexel International Corporation
- 13.9.1. Company Overview
- 13.9.2. Company Revenue
- 13.9.3. Products
- 13.9.4. Recent Developments
13.10. Pharmalex GmbH
- 13.10.1. Company Overview
- 13.10.2. Company Revenue
- 13.10.3. Products
- 13.10.4. Recent Developments
13.11. Pharmexon
- 13.11.1. Company Overview
- 13.11.2. Company Revenue
- 13.11.3. Products
- 13.11.4. Recent Developments
13.12. Genpact
- 13.12.1. Company Overview
- 13.12.2. Company Revenue
- 13.12.3. Products
- 13.12.4. Recent Developments

Note - in company profiling, financial details and recent development are subject to availability or might not be covered in case of private companies