DUBLIN–(BUSINESS WIRE)–The “GxP/GMP Regulation Testing, Services Market in Food, Pharmaceuticals, Medical Devices, and Cosmetics” report has been added to ResearchAndMarkets.com’s offering.
- 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
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Company profiles of the leading market players in the industry, including Almac Group, Namsa, Pharmaceutical Product Development (PPD), Sartorius AG and Underwriters Laboratories, Inc.
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.
Key Topics Covered
Chapter 1 Introduction
- Study Goals and Objectives
- Reasons for Doing This Study
- Scope of Report
- Information Sources
- Methodology
- Geographic Breakdown
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
For more information about this report visit https://www.researchandmarkets.com/r/ny5zlb
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