GxP/GMP Regulation Testing, Services Market in Food, Pharmaceuticals, Medical Devices, and Cosmetics

Report Scope:

This new report, “GxP/GMP Regulation Testing Service Market in Food, Pharmaceuticals, Medical Devices and Cosmetics,” provides a detailed analysis on GxP/GMP regulations, testing services, the current market and future prospects. The report provides a comprehensive analysis of trends in the GxP/GMP testing service market in a global context, including market forecasts and sales through 2024. The report is focused on an analysis of the GxP/GMP regulation testing service market by product type, region and end-use industry.

The report provides a comprehensive analysis of GxP services being offered globally in key sectors, including market forecasts and sales through 2024. The report analyzes the market by segmenting it into the various types of services offered (analytical testing, product development testing, microbiology and sterility testing, packaging and shelf-life testing, and audit testing). The end-user markets focus on the pharmaceutical, cosmetic, food and medical device sectors. This study surveys the GxP testing service market in all the following geographic regions: North America, Europe and the emerging market region. Emerging markets region include countries like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada and countries in Latin America.

The report also features new developments and regulations impacting market growth globally.

The new report provides comprehensive profiles of market players in the industry. The chapter on industry structure is focused on changing market trends, leading vendors, their market shares and service offerings. The chapter also covers mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that is expected to shape the industry.

Factors such as strengths, weaknesses, threats and opportunities that are expected to play a role in the evolution of the GxP testing service market have been evaluated.

Excluded from this report are discovery and manufacturing services being offered by contract service companies (CROs/CDMOs). Also excluded are clinical trial services/clinical support services.

The Report Includes:

56 data tables and 25 additional tables
An overview of the GxP/GMP regulations, testing services market in food, pharmaceuticals, medical devices, and cosmetics sectors
Analyses of global market trends with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024
Regional dynamics of the GxP testing services market in North America, Europe and Emerging markets that include countries like China, India, Korea, Taiwan, Australia, New Zealand, Canada and Africa
Information on the global market data by analytical and testing types and services, end users, application industry and regions
Examination of merger and acquisition deals, key competitive landscape and market share analysis of leading vendors
Assessment of existing government regulations and technological aspects of GxP guidelines and standards in food, pharma, medical devices, and cosmetic sectors
Company profiles of the leading market players in the industry, including Almac Group, Namsa, Pharmaceutical Product Development (PPD), Sartorius AG and Underwriters Laboratories, Inc. (UI)

Chapter 1 Introduction

Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst’s Credentials
Custom Research
Related Reports

Chapter 2 Summary and Highlights

Key Findings of the Report

Chapter 3 Market and Technology Background

Need for GxPs
Evolution of GxPs/GMPs
Agencies and Federal Bodies Governing GxP/GMP Regulations
Differences between International Standards and GxPs
Types of GxPs
Differences between GLPs, GCPs and GMPs
Good Laboratory Practices
Good Clinical Practices
Good Manufacturing Practices
Role of GMPs in Various Sectors
Food GMPs
Pharmaceutical GMPs
Medical Device GMPs
Cosmetic GMPs
GxP/GMP Regulation Testing Services
Analytical Testing Services
Product Development Services
Microbiology and Sterility Testing Services
Packaging and Shelf-Life Testing Services
Method Development and Validation Services
GxP/GMP Audit Services

Chapter 4 Market Breakdown by Technology/Service Type

In-house Testing vs. Outsourcing
Size of Manufacturing Facility
Type of Service Required
Market Analysis by Service Type
Market Overview
Market Revenue
Market Shares
Analytical Testing Services
Product Development Testing Services
Microbiology and Sterility Testing Services
Packaging Testing Services
Method Development and Validation Services
Audits and Certification Services

Chapter 5 Market Breakdown by End-Use Industry

Market Analysis by End-Use Industry
Market Revenue
Market Shares
End-Use Industry Market by Region
Food
Pharmaceuticals
Medical Devices
Cosmetics

Chapter 6 Market Breakdown by Region

Market Analysis by Region
Market Revenue
Market Shares
Analytical Testing Services
Market Revenue
Market Shares
Physical Characterization Services
Bioanalytical Testing Services
Chemical Characterization Services
Product Development Testing Services
Market Revenue
Market Shares
Raw Material Testing Services
Stability Testing Services
Release Testing Services
Heavy Metal Testing Services
Extractables and Leachables Testing Services
Microbiology and Sterility Testing Services
Market Revenue
Market Shares
Sterility Testing Services
Microbial Limits Testing/Bioburden Testing Services
Antimicrobial Efficacy Testing Services
Endotoxin Testing Services
Other Services
Packaging Testing Services
Market Revenue
Market Shares
Container Testing Services
Shelf-Life Testing Services
Container Closure Integrity Testing Services
Method Development and Validation Services
Market Revenue
Market Shares
Audits and Certification Services
Market Revenue
Market Shares

Chapter 7 Industry Structure

Industry Trends
Expectations of a GxP/GMP Testing Provider
Outsourcing Relationships
Outsourcing Models
Collaborations and Partnerships
Mergers and Acquisitions
Leading Providers in the GxP/GMP Regulation Testing Market
Analytical Testing Services
Product Development Testing Services
Microbiology and Sterility Testing Services
Packaging Testing Services
Method Development and Validation Testing Services
Audits and Certification Services

Chapter 8 Current Trends and New Developments

Trends in GxP/GMP Regulation Testing Methods
Rapid Microbiological Methods (RMMs)
Extractables and Leachables (E&L) Testing
New Developments in GxP/GMP Regulation Testing Technologies

Chapter 9 Analysis of Market Opportunities

Strengths of GxP/GMP Testing Service Market
Growing Demand for Quality Products
Booming Biopharmaceuticals and Advanced Therapy Medicinal Products Market
Increased Consumer Spending
Innovation in Technology and Methods
Rising Federal Enforcement
Drive to Reduce Costs
Presence of Large Number of Players
Challenges in the GxP/GMP Testing Service Market
Finding an Ideal Testing Services Partner
Lack of Skilled Labor
Cost of Services
Regulatory Constraints
Opportunities in the GxP/GMP Testing Service Market
Emerging Markets
Flexing and Modernizing Government Regulations
Growth of Contract Research and Development Organizations
Acquisitions and Partnerships
Threats in the GxP/GMP Testing Service Market
Government Regulations
Competition

Chapter 10 Company Profiles

Albani Molecular Research, Inc. (Amri)
Almac Group
Avance Biosciences
Bioreliance Corp.
Boston Analytical
Charles River Laboratories, Inc.
Dicentra
Diapharm
Eurofins Scientific, Inc.
Exova Group Plc
Impact Analytical
Intertek Group Plc
Microchem Laboratory
Namsa
Pace Analytical
Pacific Biolabs
Pharmaceutical Product Development (Ppd)
Qima
Rephine
Sartorius Ag
SCS Global Services
SGS S.A.
Underwriters Laboratories, Inc. (Ul)
West Pharmaceuticals, Inc.
Wuxi App Tec

Chapter 11 Appendix: List of Acronyms

List of Tables

Summary Table: Global Market for GxP/GMP Regulation Testing Services, by Type, Through 2024
Table 1: Recent Examples of GxP/GMP Violations
Table 2: Brief Timeline Showing Evolution of GxPs/GMPs, 1902-2013
Table 3: Agencies Responsible for GMP Regulations in Major Countries
Table 4: Differences Between ISO, HACCP, and GMP Guidelines
Table 5: Definitions of Important GxPs
Table 6: Differences between GLPs, GCPs, GMPs
Table 7: GxP/GMP Guidelines for Microbiological Safety
Table 8: List of CCIT Tests
Table 9: Advantages and Disadvantages of Outsourcing Testing Services
Table 10: Global Market for GxP/GMP Regulation Testing Services, by Type, Through 2024
Table 11: Global Market Share of GxP/GMP Regulation Testing Services, by Type, 2018
Table 12: Global Market for Analytical Testing Services, by Type, Through 2024
Table 13: Global Market Share of Analytical Testing Services, by Type, 2018
Table 14: Global Market for Product Development Testing Services, by Type, Through 2024
Table 15: Global Market Share of Product Development Testing Services, by Type, 2018
Table 16: Global Market for Microbiology and Sterility Testing Services, by Type, Through 2024
Table 17: Global Market Share of Microbiology and Sterility Testing Services, by Type, 2018
Table 18: Global Market for Packaging Testing Services, by Type, Through 2024
Table 19: Global Market Share of Packaging Testing Services, by Type, 2018
Table 20: Global Market for Method Development and Validation Services, by Type, Through 2024
Table 21: Global Market for Audits and Certification Services, by Type, Through 2024
Table 22: Global Market for GxP/GMP Regulation Testing Services, by End-Use Industry, Through 2024
Table 23: Global Market Share of GxP/GMP Regulation Testing Services, by End-Use Industry, 2018
Table 24: Global Market for GxP/GMP Regulation Testing Services, by Region, Through 2024
Table 25: Food Safety Testing Services Companies
Table 26: Global Market for GxP/GMP Regulation Testing Services in the Food Industry, by Region, Through 2024
Table 27: Pharmaceutical Testing Services Companies
Table 28: Global Market for GxP/GMP Regulation Testing Services in the Pharmaceutical Industry, by Region, Through 2024
Table 29: Global Market for GxP/GMP Regulation Testing Services in the Medical Device Industry, by Region, Through 2024
Table 30: Global Market for GxP/GMP Regulation Testing Services in the Cosmetics Industry, by Region, Through 2024
Table 31: Regional Analysis of Warning Letters Issued by FDA, 2017 to March, 2019
Table 32: Global Market for GxP/GMP Regulation Testing Services, by Region, Through 2024
Table 33: Global Market Share of GxP/GMP Regulation Testing Services, by Region, 2018
Table 34: Global Market for Analytical Testing Services, by Region, Through 2024
Table 35: Global Market Share of Analytical Testing Services, by Region, 2018
Table 36: Global Market for Physical Characterization Services, by Region, Through 2024
Table 37: Global Market for Bioanalytical Testing Services, by Region, Through 2024
Table 38: Global Market for Chemical Characterization Services, by Region, Through 2024
Table 39: Global Market for Product Development Testing Services, by Region, Through 2024
Table 40: Global Market Share of Product Development Testing Services, by Region, 2018
Table 41: Global Market for Raw Material Testing Services, by Region, Through 2024
Table 42: Global Market for Stability Testing Services, by Region, Through 2024
Table 43: Global Market for Release Testing Services, by Region, Through 2024
Table 44: Global Market for Heavy Metal Testing Services, by Region, Through 2024
Table 45: Global Market for Extractables and Leachables Testing Services, by Region, Through 2024
Table 46: Global Market for Microbiology and Sterility Testing Services, by Region, Through 2024
Table 47: Global Market Share of Microbiology and Sterility Testing Services, by Region, 2018
Table 48: Global Market for Sterility Testing Services, by Region, 2017-2024
Table 49: Global Market for Microbial Limit Testing/Bioburden Testing Services, by Region, Through 2024
Table 50: Global Market for Antimicrobial Efficacy Testing Services, by Region, Through 2024
Table 51: Global Market for Endotoxin Testing Services, by Region, Through 2024
Table 52: Global Market for Other Services, by Region, Through 2024
Table 53: Global Market for Packaging Testing Services, by Region, Through 2024
Table 54: Global Market Share of Packaging Testing Services, by Region, 2018
Table 55: Global Market for Container Testing Services, by Region, Through 2024
Table 56: Global Market for Shelf-Life Testing Services, by Region, Through 2024
Table 57: Global Market for Container Closure Integrity Testing Services, by Region, Through 2024
Table 58: Global Market for Method Development and Validation Services, by Region, Through 2024
Table 59: Global Market Share of Method Development and Validation Services, by Region, 2018
Table 60: Global Market for Audits and Certification Services, by Region, Through 2024
Table 61: Global Market Share of Audits and Certification Services, by Region, 2018
Table 62: Collaborations and Partnerships in the GxP/GMP Regulation Testing Service Market, 2016 to March 2019
Table 63: Mergers and Acquisitions in the GxP/GMP Regulation Testing Service Market, 2016 to March 2019
Table 64: Acquisitions by Eurofins Scientific in the GxP/GMP Regulation Testing Market, 2016 to March 2019
Table 65: Leading GxP/GMP Analytical Testing Service Providers, 2018
Table 66: Global Market Share of Leading GxP/GMP Analytical Testing Service Providers, 2018
Table 67: Leading GxP/GMP Product Development Testing Service Providers, 2018
Table 68: Global Market Share of Leading GxP/GMP Product Development Testing Service Providers, 2018
Table 69: Leading GxP/GMP Microbiology and Sterility Testing Service Providers, 2018
Table 70: Global Market Share of Leading GxP/GMP Microbiology and Sterility Testing Service Providers, 2018
Table 71: Leading GxP/GMP Packaging Testing Service Providers, 2018
Table 72: Global Market Share of Leading GxP/GMP Packaging Testing Service Providers, 2018
Table 73: Leading GxP/GMP Method Development and Validation Testing Service Providers, 2018
Table 74: Global Market Share of Leading GxP/GMP Method Development and Validation Testing Service Providers, 2018
Table 75: Leading GxP/GMP Audits and Certification Service Providers, 2018
Table 76: Global Market Share of Leading GxP/GMP Audit and Certification Service Providers, 2018
Table 77: New Developments in GxP/GMP Regulation Testing Technologies, January 2016 to March 2019
Table 78: Examples of Technological Innovations Driving the GxP/GMP Regulation Testing Service Market, 2018 to March 2019
Table 79: FDA Product Recalls and Warning Letters, Jan. 1, 2017 to March 14, 2019
Table 80: Acronyms Used in GxP/GMP Regulation Testing Services

List of Figures

Summary Figure: Global Market for GxP/GMP Regulation Testing Services, by Type, 2017-2024
Figure 1: Global Market for GxP/GMP Regulation Testing Services, by Type, 2017-2024
Figure 2: Global Market Share of GxP/GMP Regulation Testing Services, by Type, 2018
Figure 3: Global Market for Analytical Testing Services, by Type, 2017-2024
Figure 4: Global Market Share of Analytical Testing Services, by Type, 2018
Figure 5: Global Market for Product Development Testing Services, by Type, 2017-2024
Figure 6: Global Market Share of Product Development Testing Services, by Type, 2018
Figure 7: Global Market for Microbiology and Sterility Testing Services, by Type, 2017-2024
Figure 8: Global Market Share of Microbiology and Sterility Testing Services, by Type, 2018
Figure 9: Global Market for Packaging Testing Services, by Type, 2017-2024
Figure 10: Global Market Share of Packaging Testing Services, by Type, 2018
Figure 11: Global Market for Method Development and Validation Services, by Type, 2017-2024
Figure 12: Global Market for Audits and Certification Services, by Type, 2017-2024
Figure 13: Global Market for GxP/GMP Regulation Testing Services, by End-Use Industry, 2017-2024
Figure 14: Global Market Share of GxP/GMP Regulation Testing Services, by End-Use Industry, 2018
Figure 15: Global Market for GxP/GMP Regulation Testing Services, by Region, 2017-2024
Figure 16: Global Market for GxP/GMP Regulation Testing Services in the Food Industry, by Region, 2017-2024
Figure 17: Global Market for GxP/GMP Regulation Testing Services in the Pharmaceutical Industry, by Region, 2017-2024
Figure 18: Global Market for GxP/GMP Regulation Testing Services in the Medical Device Industry, by Region, 2017-2024
Figure 19: Global Market for GxP/GMP Regulation Testing Services in the Cosmetics Industry, by Region, 2017-2024
Figure 20: Global Market for GxP/GMP Regulation Testing Services, by Region, 2017-2024
Figure 21: Global Market Share of GxP/GMP Regulation Testing Services, by Region, 2018
Figure 22: Global Market for Analytical Testing Services, by Region, 2017-2024
Figure 23: Global Market Share of Analytical Testing Services, by Region, 2018
Figure 24: Global Market for Physical Characterization Services, by Region, 2017-2024
Figure 25: Global Market for Bioanalytical Testing Services, by Region, 2017-2024
Figure 26: Global Market for Chemical Characterization Services, by Region, 2017-2024
Figure 27: Global Market for Product Development Testing Services, by Region, 2017-2024
Figure 28: Global Market Share of Product Development Testing Services, by Region, 2018
Figure 29: Global Market for Raw Material Testing Services, by Region, 2017-2024
Figure 30: Global Market for Stability Testing Services, by Region, 2017-2024
Figure 31: Global Market for Release Testing Services, by Region, 2017-2024
Figure 32: Global Market for Heavy Metal Testing Services, by Region, 2017-2024
Figure 33: Global Market for Extractables and Leachables Testing Services, by Region, 2017-2024
Figure 34: Global Market for Microbiology and Sterility Testing Services, by Region, 2017-2024
Figure 35: Global Market Share of Microbiology and Sterility Testing Services, by Region, 2018
Figure 36: Global Market for Sterility Testing Services, by Region, 2017-2024
Figure 37: Global Market for Microbial Limit Testing/Bioburden Testing Services, by Region, 2017-2024
Figure 38: Global Market for Antimicrobial Efficacy Testing Services, by Region, 2017-2024
Figure 39: Global Market for Endotoxin Testing Services, by Region, 2017-2024
Figure 40: Global Market for Other Services, by Region, 2017-2024
Figure 41: Global Market for Packaging Testing Services, by Region, 2017-2024
Figure 42: Global Market Share of Packaging Testing Services, by Region, 2018
Figure 43: Global Market for Container Testing Services, by Region, 2017-2024
Figure 44: Global Market for Shelf-Life Testing Services, by Region, 2017-2024
Figure 45: Global Market for Container Closure Integrity Testing Services, by Region, 2017-2024
Figure 46: Global Market for Method Development and Validation Services, by Region, 2017-2024
Figure 47: Global Market Share of Method Development and Validation Services, by Region, 2018
Figure 48: Global Market for Audits and Certification Services, by Region, 2017-2024
Figure 49: Global Market Share of Audits and Certification Services, by Region, 2018
Figure 50: Global Market Shares of Leading GxP/GMP Analytical Testing Service Providers, 2018
Figure 51: Global Market Share of Leading GxP/GMP Product Development Testing Service Providers, 2018
Figure 52: Global Market Share of Leading GxP/GMP Microbiology and Sterility Testing Service Providers, 2018
Figure 53: Global Market Share of Leading GxP/GMP Packaging Testing Service Providers, 2018
Figure 54: Global Market Share of Leading GxP/GMP Method Development and Validation Testing Service Providers, 2018
Figure 55: Global Market Share of Leading GxP/GMP Audit and Certification Service Providers, 2018
Figure 56: SWOT Analysis of the GxP/GMP Regulation Testing Service Market

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Executive Summary

High-quality drug products, food safety and need for production of safe medical devices and cosmetics are terms that are increasing in popularity. With global demand for pharmaceuticals, food (natural and processed), medical devices and consumer goods on the rise, quality, and safety concerns are also growing. Changing production methods, particularly for biologic drugs, have greatly augmented the use of plastics in the form of single-use systems in both upstream and downstream processing stages. Moreover, lists of chemical contaminants are also surging, including risks from pesticides, dioxins, heavy metals, migrants from packaging materials and so on. From a safety perspective, microbial
contamination has always been a point of focus for products used for human consumption.

Considering these developments and increasing public awareness about product quality, the FDA and other international regulatory bodies are coming together and encouraging manufacturers to strictly adhere to GxP/GMP regulatory guidelines. The FDA is motivating manufacturing facilities to increase the adoption of good practices during manufacturing and the risk-based quality-by-design (QbD) strategy of production to ensure that products are suitable for intended uses. The FDA is enforcing these approaches by conducting an increasing number of inspections and audits of manufacturing facilities as well as their suppliers, demanding detailed data of testing and characterization during regulatory submissions and continually updating GxP/GMP guidelines.

The GxP/GMP regulation testing service providers are emerging market players that are helping manufacturing companies in the food, pharmaceutical, medical device, and cosmetic sectors obtain regulatory compliance. These companies offer a diverse array of testing services spanning all stages of product development, including consultations, guided inspections, audits, and certifications. The companies provide several benefits to manufacturing companies, such as decreased costs of testing and compliance, improved productivities, customer trust, and brand reputation and faster regulatory guidance.

The market for GxP/GMP regulation testing services is driven by the increasing global demand for pharmaceutical drugs, particularly biosimilars and biologic innovator drugs, as well as increasing demand for novel medical devices for diagnosis and treatment. Increased spending capacities and rising economies are fostering the demand for food and cosmetic products, too. This rising production demand is propelling the need for affordable testing services for these products, which can decrease the time to market and eliminate the risk of product failures and recalls. Furthermore, the FDA has drastically increased its scrutiny for regulatory assurance and is carrying out inspections of manufacturing facilities, particularly in the international locations (China and India, primarily due to the presence of a large number of contract manufacturing units in these countries), at an accelerated pace.

Companies Mentioned

Albani Molecular Research, Inc. (Amri)
Almac Group
Avance Biosciences
Bioreliance Corp.
Boston Analytical
Charles River Laboratories, Inc.
Diapharm
Dicentra
Eurofins Scientific, Inc.
Exova Group Plc
Impact Analytical
Intertek Group Plc
Microchem Laboratory
Namsa
Pace Analytical
Pacific Biolabs
Pharmaceutical Product Development (Ppd)
Qima
Rephine
Sartorius Ag
SCS Global Services
SGS S.A.
Underwriters Laboratories, Inc. (Ul)
West Pharmaceuticals, Inc.
Wuxi App Tec

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Table of Contents

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Executive Summary

Companies Mentioned

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