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

Publish Date: May 2019 | Category: Healthcare, Pharmaceuticals & Medical Devices | Publisher: BCC Research | Status: Publish

The global market for GxP/GMP regulation testing services should grow from $8.1 billion in 2019 to reach $14.2 billion by 2024 at a compound annual growth rate (CAGR) of 11.8% for the period of 2019-2024.

Report Scope:

This new BCC Research 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 BCC 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 are 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.

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)

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 is 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 an 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 presence of large number of contract manufacturing units in these countries), at an accelerated pace.

Table of Contents

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

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