Table of Content

Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst’s Credentials
BCC Custom Research
Related BCC Research 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 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

 

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