+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

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

  • ID: 4791042
  • Report
  • Region: Global
  • 248 Pages
  • BCC Research
1 of 5

FEATURED COMPANIES

  • Almac Group
  • Boston Analytical
  • Eurofins Scientific, Inc.
  • Intertek Group Plc
  • Pace Analytical
  • Rephine
  • MORE

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)
Note: Product cover images may vary from those shown
2 of 5

FEATURED COMPANIES

  • Almac Group
  • Boston Analytical
  • Eurofins Scientific, Inc.
  • Intertek Group Plc
  • Pace Analytical
  • Rephine
  • MORE

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

Note: Product cover images may vary from those shown
3 of 5

Loading
LOADING...

4 of 5

FEATURED COMPANIES

  • Almac Group
  • Boston Analytical
  • Eurofins Scientific, Inc.
  • Intertek Group Plc
  • Pace Analytical
  • Rephine
  • MORE

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.

Note: Product cover images may vary from those shown
5 of 5
  • 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
Note: Product cover images may vary from those shown
Adroll
adroll