GxP/GMP regulatory testing, services market in food, pharmaceuticals, medical devices and cosmetics (2018-2024). (2023)

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M2 PRESSWIRE-August 20, 2019-: GxP/GMP Regulatory Testing, Services Market in Food, Pharmaceuticals, Medical Devices and Cosmetics (2018-2024)



The report "GxP/GMP Regulation Testing, Services Market in Food, Pharmaceuticals, Medical Devices, and Cosmetics" has been added to the ResearchAndMarkets.com offering.

- 56 the data table an 25 extra table

- An overview of the GxP/GMP regulations, testing services on the market in the food, pharmaceutical, medical device and cosmetics sectors

- Analysis of global market trends with data from 2018, estimates for 2019 and projections of compound annual growth rates (CAGRs) through 2024

- Regional market dynamics for GxP testing services in North America, Europe and emerging markets, including countries such as 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

- Research M&A agreements, key competitive landscape and market share analysis of leading vendors

- Assessment of existing government regulations and technological aspects of GxP guidelines and standards in the food, pharma, medical device and cosmetics sectors

- Company profiles of the industry's leading players, including Almac Group, Namsa, Pharmaceutical Product Development (PPD), Sartorius AG and Underwriters Laboratories, Inc.

High-quality pharmaceuticals, food safety and the need for the production of safe medical devices and cosmetics are terms that are becoming increasingly popular. As global demand for pharmaceuticals, food (natural and processed), medical devices and consumer goods increases, so do concerns about quality and safety.

Changing production methods, especially for biological medicines, have significantly increased the use of plastics in the form of single-use systems, both in the upstream and downstream processing stages. In addition, the lists of chemical contaminants are also growing, including risks from pesticides, dioxins, heavy metals, packaging material migrants, and so on. From a safety point of view, microbial contamination has always been a concern for products used for human consumption.

Given these developments and increasing public awareness about product quality, the FDA and other international regulatory agencies are coming together to encourage manufacturers to adhere strictly to GxP/GMP regulatory guidelines. The FDA motivates manufacturing facilities to increase adoption of good manufacturing practices and risk-based quality-by-design (QbD) manufacturing strategy to ensure products are fit for intended use.

The FDA is enforcing these approaches by conducting an increasing number of inspections and audits of manufacturing facilities and their suppliers, requiring detailed testing and characterization data during regulatory submissions and by continually updating GxP/GMP guidelines .

The GxP/GMP testing service providers are emerging market players helping manufacturing companies in the food, pharmaceutical, medical device and cosmetics industries to comply with regulations. These companies offer a wide range of testing services at all stages of product development, including consultations, guided inspections, audits and certifications. The companies offer several benefits to manufacturing companies, such as reduced testing and compliance costs, improved productivity, customer trust, brand reputation and faster regulatory compliance.

The market for GxP/GMP regulatory testing services is driven by the increasing global demand for pharmaceutical drugs, especially biosimilars and biologic innovative drugs, as well as the increasing demand for new medical devices for diagnosis and treatment.

Increased spending power and emerging economies are also driving demand for food and cosmetic products. This increasing production demand has created a need for affordable testing services for these products, which can reduce time to market and eliminate the risk of product failures and recalls.

In addition, the FDA has drastically increased its regulatory assurance oversight and has been conducting inspections of manufacturing facilities, especially at the international locations (China and India, mainly due to the presence of a large number of contract manufacturing units in these countries), at an accelerated pace.

Main topics covered

Chapter 1 Introduction

- Study goals and objectives

- Reasons for doing this study

- Scope of the report

- Information sources

- Methodology

- Geographical breakdown

Chapter 2 Summary and Highlights

- Main findings of the report

Chapter 3 Market and Technology Background

- Need for GxPs

- Evolution of GxPs/GMPs

- Agencies and federal bodies that control 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 different sectors

- Food GMPs

- Pharmaceutical GMPs

- GMPs for medical devices

- Cosmetic GMPs

- GxP/GMP regulatory testing services

- Analytical testing services

- Product development services

- Microbiology and sterility testing

- Packaging and shelf life tests

- Method development and validation services

- GxP/GMP audit services

Chapter 4 Market Breakdown by Technology/Service Type

- Internal testing versus outsourcing

- Size of the production facility

- Type service iced

- Market analysis by service type

- Market overview

- Market income

- Market shares

- Analytical testing services

- Testing services for product development

- Microbiology and sterility testing

- Packaging testing services

- Method development and validation services

- Audits and certification services

Chapter 5 Market Breakdown by End-User Industry

- Market analysis by end-user industry

- Market income

- Market shares

- End-use industry market by region

- Food

- Pharmaceutical

- Medical devices

- Cosmetics

Chapter 6 Market Breakdown by Region

- Market analysis per region

- Market income

- Market shares

- Analytical testing services

- Market income

- Market shares

- Physical characterization services

- Bioanalytical testing services

- Chemical characterization services

- Testing services for product development

- Market income

- Market shares

- Raw material testing services

- Stability testing services

- Release testing services

- Heavy metal testing services

- Testing services for extractables and leachables

- Microbiology and sterility testing

- Market income

- Market shares

- Sterility testing

- Microbial Limits/Bioburden Testing Services

- Testing services for antimicrobial efficacy

- Endotoxin testing services

- Other services

- Packaging testing services

- Market income

- Market shares

- Container testing services

- Shelf life testing

- Integrity testing for container closures

- Method development and validation services

- Market income

- Market shares

- Audits and certification services

- Market income

- Market shares

Chapter 7 Industry Structure

- Trends in the industry

- Expectations of a GxP/GMP test provider

- Outsource relationships

- Outsourcing models

- Collaborations and partnerships

- Mergers and acquisitions

- Leading providers in the GxP/GMP regulatory testing market

- Analytical testing services

- Testing services for product development

- Microbiology and sterility testing

- Packaging testing services

- Method development and validation testing services

- Audits and certification services

Chapter 8 Current trends and new developments

- Trends in GxP/GMP regulatory test methods

- Rapid Microbiological Methods (RMMs)

- Extractables in Leachables (E&L) test

- New developments in testing technologies for GxP/GMP regulations

Chapter 9 Market Opportunity Analysis

- Strengths of the market for GxP/GMP testing services

- Growing demand for quality products

- Booming market for biopharmaceuticals and advanced therapy drugs

- Increased consumer spending

- Innovation in technology and methods

- Rising federal enforcement

- Drive to reduce costs

- Presence of a large number of players

- Challenges in the market for GxP/GMP testing services

- Finding an ideal partner for testing services

- Lack of skilled workers

- Cost of services

- Regulatory restrictions

- Opportunities in the market for GxP/GMP testing services

- Emerging markets

- Relaxing and modernizing government regulations

- Growth of contract research and development organizations

- Acquisitions and partnerships

- Threats in the market for GxP/GMP testing services

- Government regulations

- Competition

Chapter 10 Company Profiles

- Albani Molecular Research, Inc. (AMRI)

- Almac group

- Advanced life sciences

- Bioreliance Corp.

-Boston Analytical

-Charles River Laboratories, Inc.

- Dicentra

- Diaphragm

- Eurofins Scientific, Inc.

-Exova Group Plc

- Impactanalyse

-Intertek Group Plc

- Microchem-laboratory

- Namsa

- Tempo analytical

- Pacific Biolabs

- Pharmaceutical Product Development (PPD)

- What?

- Refine

- Sartorius Ag

- SCS global services

- SGS S.A.

- Underwriters Laboratories, Inc. (UL)

-West Pharmaceuticals, Inc.

- Wuxi App Tec

For more information on this report, please visit https://www.researchandmarkets.com/r/6zk61n Research and Markets also offers Custom Research services that provide targeted, comprehensive and tailored research.



Laura Wood, senior manager


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What is GxP in pharmaceutical industry? ›

GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage and distribution.

What is GxP in FDA? ›

GxP (FDA 21 CFR Part 11) overview

The term GxP is a general abbreviation for good practice guidelines and regulations in the life sciences industry, including good clinical, laboratory, manufacturing, and other practices.

What are GxP regulated activities? ›

GxP is an acronym that refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications.

What does GxP compliance mean? ›

In the life sciences industry, GxP is an abbreviation referencing the various “good practice” regulations and guidelines that apply to organisations that manufacture products that are consumed or used by humans or animals. This includes medical, cosmetic, tobacco, products or devices and food products.


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