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GxP/GMP規定試験・サービス市場:食品・医薬品・医療機器・化粧品

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

発行 BCC Research 商品コード 877642
出版日 ページ情報 英文 248 Pages
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GxP/GMP規定試験・サービス市場:食品・医薬品・医療機器・化粧品 GxP/GMP Regulation Testing, Services Market in Food, Pharmaceuticals, Medical Devices, and Cosmetics
出版日: 2019年06月26日 ページ情報: 英文 248 Pages
概要

世界のGxP/GMP規定試験・サービス市場は、2019年の81億米ドルから、2024年までに142億米ドルまで拡大すると見られています。市場は、2019年〜2024年のCAGR (複合年間成長率) で、11.8%の成長が予測されています。

当レポートでは、世界のGxP/GMP規定試験・サービス市場について調査分析し、市場の概要、市場動向の分析と予測、地域動向、試験タイプ・サービス、エンドユーザー、アプリケーション産業および地域別による市場データ、および主要企業のプロファイルなど、体系的な情報を提供しています。

第1章 イントロダクション

第2章 サマリー・ハイライト

第3章 市場・技術背景

  • GxPのニーズ
  • GxP/GMPの進化
  • GxP/GMP規定を管理する機関・連邦機関
  • 国際規格とGxPの違い
  • GxPの種類
  • 様々な部門におけるGMPの役割
  • GxP/GMP規定試験サービス

第4章 市場分析:技術/サービスタイプ

  • 社内試験 vs. アウトソーシング
  • 市場分析:サービスタイプ別

第5章 市場分析:エンドユーズ産業別

  • 市場分析:エンドユーズ産業別
  • エンドユーズ産業市場:地域別

第6章 市場分析:地域別

  • 市場分析:地域別
  • 分析試験サービス
  • 製品開発試験サービス
  • 微生物・滅菌検査サービス
  • パッケージング検査サービス
  • 手法の開発・評価サービス
  • 監査・認証サービス

第7章 産業構造

  • 産業動向
  • GxP/GMP規定試験市場における主要プロバイダー

第8章 現在の動向・新規開発

  • GxP/GMP規定試験手法における動向
  • GxP/GMP規定試験技術における新規開発

第9章 市場機会の分析

  • GxP/GMP試験サービス市場の強み
  • GxP/GMP試験サービス市場における課題
  • GxP/GMP試験サービス市場における機会
  • GxP/GMP試験サービス市場における脅威

第10章 企業プロファイル

第11章 付録:頭字語リスト

図表

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
目次
Product Code: HLC228A

Report Highlights:

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.

Product development testing services as a segment of GxP/GMP regulation testing services should grow from $2.0 billion in 2019 to reach $3.6 billion by 2024 at a CAGR of 12.8% for the period of 2019-2024.

Analytical testing services as a segment of GxP/GMP regulation testing services should grow from $1.9 billion in 2019 to reach $3.5 billion by 2024 at a CAGR of 13.2% 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)

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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