1 はじめに
2 範囲と方法論
2.1 本調査の目的
2.2 利害関係者
2.3 データソース
2.3.1 一次ソース
2.3.2 二次ソース
2.4 市場推定
2.4.1 ボトムアップアプローチ
2.4.2 トップダウンアプローチ
2.5 予測方法論
3 エグゼクティブサマリー
4 はじめに
4.1 概要
4.2 主な業界動向
5 世界のGMP試験サービス市場
5.1 市場概要
5.2 市場実績
5.3 COVID-19の影響
5.4 市場予測
6 サービスタイプ別市場内訳
6.1 包装および保存可能期間試験
6.1.1 市場動向
6.1.2 市場予測
6.2 製品検証試験
6.2.1 市場動向
6.2.2 市場予測
6.3 バイオ分析サービス
6.3.1 市場動向
6.3.2 市場予測
6.4 その他
6.4.1 市場動向
6.4.2 市場予測
7 エンドユーザー別市場
7.1 製薬およびバイオ製薬会社
7.1.1 市場動向
7.1.2 市場予測
7.2 医療機器会社
7.2.1 市場動向
7.2.2 市場予測
8 地域別市場
8.1 北米
8.1.1 米国
8.1.1.1 市場動向
8.1.1.2 市場予測
8.1.2 カナダ
8.1.2.1 市場動向
8.1.2.2 市場予測
8.2 アジア太平洋地域
8.2.1 中国
8.2.1.1 市場動向
8.2.1.2 市場予測
8.2.2 日本
8.2.2.1 市場動向
8.2.2.2 市場予測
8.2.3 インド
8.2.3.1 市場動向
8.2.3.2 市場予測
8.2.4 韓国
8.2.4.1 市場動向
8.2.4.2 市場予測
8.2.5 オーストラリア
8.2.5.1 市場動向
8.2.5.2 市場予測
8.2.6 インドネシア
8.2.6.1 市場動向
8.2.6.2 市場予測
8.2.7 その他
8.2.7.1 市場動向
8.2.7.2 市場予測
8.3 欧州
8.3.1 ドイツ
8.3.1.1 市場動向
8.3.1.2 市場予測
8.3.2 フランス
8.3.2.1 市場動向
8.3.2.2 市場予測
8.3.3 イギリス
8.3.3.1 市場動向
8.3.3.2 市場予測
8.3.4 イタリア
8.3.4.1 市場動向
8.3.4.2 市場予測
8.3.5 スペイン
8.3.5.1 市場動向
8.3.5.2 市場予測
8.3.6 ロシア
8.3.6.1 市場動向
8.3.6.2 市場予測
8.3.7 その他
8.3.7.1 市場動向
8.3.7.2 市場予測
8.4 ラテンアメリカ
8.4.1 ブラジル
8.4.1.1 市場動向
8.4.1.2 市場予測
8.4.2 メキシコ
8.4.2.1 市場動向
8.4.2.2 市場予測
8.4.3 その他
8.4.3.1 市場動向
8.4.3.2 市場予測
8.5 中東およびアフリカ
8.5.1 市場動向
8.5.2 国別の市場内訳
8.5.3 市場予測
9 推進要因、阻害要因、機会
9.1 概要
9.2 推進要因
9.3 阻害要因
9.4 機会
10 バリューチェーン分析
11 ポーターのファイブフォース分析
11.1 概要
11.2 買い手の交渉力
11.3 売り手の交渉力
11.4 競争の度合い
11.5 新規参入の脅威
11.6 代替品の脅威
12 価格分析
13 競合状況
13.1 市場構造
13.2 主要企業
13.3 主要企業のプロフィール
Almac Group
Charles River Laboratories International Inc
Eurofins Scientific SE
ICON plc
Intertek Group plc
Merck KgaA
Nelson Laboratories LLC (Sotera Health Company)
North American Science Associates LLC
Pace Analytical Services LLC
PPD Inc. (Thermo Fisher Scientific Inc.)
Sartorius AG
Wuxi Apptec Co. Ltd

The global GMP testing service market size reached USD 1.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 2.5 Billion by 2033, exhibiting a growth rate (CAGR) of 5.08% during 2025-2033. The market is experiencing steady growth driven by the increasing level of regulatory scrutiny across various industries, the stringent regulatory environment compelling businesses to invest in GMP testing services, and the rise in contract manufacturing and outsourcing.

GMP testing service refers to good manufacturing practice testing, a crucial element in ensuring the quality and safety of various products including pharmaceuticals, food, and medical devices. The service is aimed at confirming that manufacturers adhere to established quality standards throughout the production process. By performing systematic tests, GMP testing services evaluate the efficacy, safety, and quality of products. This often involves assessing the cleanliness of the manufacturing environment, validation of manufacturing processes, and stringent quality control tests for the final products. The objective is to minimize the risks associated with cross-contamination, errors, and inconsistencies, thereby safeguarding consumer well-being. Utilizing GMP testing services is not only a regulatory requirement in many jurisdictions but also a mark of integrity and quality assurance for manufacturers. This service is instrumental in helping companies gain consumer trust and meet legal compliance, ultimately ensuring that only high-quality, safe, and effective products reach the market.

One of the most significant market drivers for good manufacturing practice (GMP) testing services is the increasing level of regulatory scrutiny across various industries, especially in the pharmaceutical, food, and medical device sectors. Therefore, the stringent regulatory environment compels businesses to invest in GMP testing services as a preventative measure against non-compliance, thereby driving demand for these services. Along with this, the rise in contract manufacturing and outsourcing is an additional factor propelling the growth of the GMP testing services market. Companies are increasingly turning to third-party manufacturers to produce their goods, which involves multiple stages of quality control to ensure that the products meet regulatory and customer expectations. This trend elevates the need for trustworthy GMP testing services that can assess the quality of products made by various manufacturers at different locations. In addition, transparency about sourcing, production methods, and environmental impact is increasingly being seen as a competitive advantage for businesses. To meet this demand, companies are scrutinizing their supply chains and production methods closely, further raising the demand for GMP testing services.

GMP Testing Service Market Trends/Drivers:
Rising Consumer Awareness and Expectations

Consumer behavior has evolved significantly with the advent of digital technologies that facilitate easy access to information. Along with this, consumers are informed about the products they use, from their ingredients to the ethical considerations surrounding their production. This increased awareness has set high expectations for product quality, safety, and efficacy, especially in sectors like healthcare and food production. In addition, consumers are now willing to pay a premium for products that guarantee these attributes, which puts additional pressure on manufacturers to comply with quality standards. In such a market context, GMP testing services serve as a verifiable way for companies to showcase their commitment to quality and safety. Third-party GMP certification acts as a mark of trust and can be a significant factor in purchasing decisions. Therefore, the rise in consumer awareness and expectations serves as a critical driver for the growth of the GMP testing service market.

Continuous Technological Advancements

The rapid technological advancements in analytical methods and equipment are another major driver in the GMP testing services market. In addition, the introduction of cutting-edge technologies such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry, and Next-Generation Sequencing allows for more accurate, efficient, and comprehensive testing procedures. These technologies provide a more in-depth understanding of product composition and potential contaminants, which is essential for ensuring quality and safety. Along with this, the utilization of these advanced technologies enables GMP testing services to offer more precise and timely results. This efficiency speeds up the time-to-market for products and helps manufacturers quickly identify and address any quality issues, thereby reducing the risks associated with product recalls or legal action. Moreover, companies are increasingly relying on GMP testing services equipped with the latest technologies to meet the ever-rising quality standards.

Globalization of Supply Chains

In today's interconnected world, supply chains have become increasingly globalized. Ingredients and components often come from multiple countries, each with its own set of regulations and quality standards. This complexity introduces several challenges in ensuring consistent quality and safety across all products. Furthermore, global supply chains are susceptible to various risks such as contamination, adulteration, and fraudulent practices, all of which can compromise product quality. In confluence with this, GMP testing services play a pivotal role in ensuring that products meet the quality and safety criteria irrespective of their origin. These services can audit and test products at various stages of the supply chain, ensuring compliance with international standards. This is particularly crucial for companies that export products, as they need to meet the regulatory requirements of both the country of origin and the destination markets. Therefore, the globalization of supply chains significantly contributes to the growing demand for comprehensive GMP testing services.

GMP Testing Service Industry Segmentation:
IMARC Group provides an analysis of the key trends in each segment of the global GMP testing service market, along with forecasts at the global levels from 2025-2033. Our report has categorized the market based on service type and end user.

Breakup By Service Type:
Packaging and Shelf-life Testing
Product Validation Testing
Bioanalytical Services
Others

Product validation testing dominates the market

The report has provided a detailed breakup and analysis of the market based on the service type. This includes packaging and shelf-life testing, product validation testing, bioanalytical services, and others. According to the report, product validation testing represented the largest segment.

Product validation testing within the GMP testing service industry is experiencing significant market growth, driven by the stringent regulatory requirements across sectors, such as pharmaceuticals, food, and medical devices necessitating rigorous validation testing to ensure products meet established safety and efficacy benchmarks. Failure to pass these validation tests can result in costly recalls, legal consequences, and reputational damage, making companies increasingly proactive in employing these services. Additionally, as technological advancements continue to introduce complex formulations and components, the need for sophisticated validation testing grows correspondingly to ensure that these new elements adhere to quality standards. Along with this, consumer awareness about product quality is at an all-time high, largely due to easy access to information. Consumers now demand transparency and evidence of product safety, making validation testing a significant market differentiator. Moreover, the globalization of supply chains makes validation testing indispensable for ensuring consistency in product quality, irrespective of the origin of components or the manufacturing location.

Breakup By End User:

Pharmaceutical and Biopharmaceutical Companies
Medical Device Companies

Pharmaceutical and biopharmaceutical companies hold the largest share in the market

A detailed breakup and analysis of the market based on the end user has also been provided in the report. These include pharmaceutical and biopharmaceutical companies and medical device companies. According to the report, pharmaceutical and biopharmaceutical companies accounted for the largest market share.

The growing demand for GMP testing services among pharmaceutical and biopharmaceutical companies is fueled by stringent guidelines laid out by authorities such as the FDA and EMA necessitate comprehensive GMP testing to ensure product safety and efficacy. Along with this, the increasing complexity of pharmaceuticals, especially with the rise of biologics and gene therapies, calls for advanced GMP testing to validate quality and performance. As companies continue to expand globally, the harmonization of quality standards becomes critical, making GMP testing essential for ensuring consistent quality across diverse markets. Another driving force is the accelerating pace of drug development and commercialization, especially evident during events like the rapid development of COVID-19 vaccines. This fast-tracking intensifies the need for reliable GMP testing services that can keep up with the accelerated timelines without compromising on quality control. Lastly, public and stakeholder scrutiny is higher than ever in the healthcare sector. Issues related to drug safety and effectiveness have far-reaching consequences, making it imperative for companies to invest in top-notch GMP testing services as a risk-mitigation strategy.

Breakup by Region:
North America
United States
Canada
Asia Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa

North America exhibits a clear dominance, accounting for the largest GMP testing service market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America exhibited the largest segment.

The market for GMP testing services in North America is experiencing robust growth, driven by the growing awareness and demand for high-quality and safe products. The North American market is characterized by well-informed consumers who seek transparency and assurance that the products they consume meet the highest safety and efficacy standards. Technological innovation is another critical factor. The availability of advanced testing technologies and methods enables more accurate and efficient quality control processes, thereby bolstering the GMP testing market.

Additionally, the prevalence of global supply chains in North America industries increases the complexity of ensuring consistent product quality, further fueling the need for comprehensive GMP testing. Furthermore, the region has a growing biotechnology sector, where rapid innovation and product development amplify the importance of reliable GMP testing services. These drivers collectively contribute to the strong demand for GMP testing services in North America.

Competitive Landscape:
The global market is experiencing significant growth due to the rapid advancements in testing technologies that provide more efficient and accurate methods for quality control. Along with this, the emerging trend of outsourcing production to third-party manufacturers amplifies the need for universal quality standards, driving demand for GMP testing services. In addition, companies merging with or acquiring others inherit new systems and processes, necessitating GMP testing services to ensure that integrated systems meet all regulatory standards. Thus, this is positively influencing the market. Apart from this, modern consumers demand ethically produced and environmentally friendly products. GMP testing services can help companies verify that their products meet these sustainability standards, in addition to ensuring quality and safety. In confluence with this, brands expanding into new product lines require adaptable GMP testing services that can validate a variety of products against multiple sets of regulations, significantly supporting the market. Furthermore, the escalating demand for GMP testing services that offer rapid validation without compromising on quality is contributing to the market.

The market report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Almac Group
Charles River Laboratories International Inc.
Eurofins Scientific SE
ICON plc
Intertek Group plc
Merck KgaA
Nelson Laboratories LLC (Sotera Health Company)
North American Science Associates LLC
Pace Analytical Services LLC
PPD Inc. (Thermo Fisher Scientific Inc.)
Sartorius AG
Wuxi Apptec Co. Ltd.

Key Questions Answered in This Report

1. How big is the global GMP testing service market?
2. What is the expected growth rate of the global GMP testing service market during 2025-2033?
3. What are the key factors driving the global GMP testing service market?
4. What has been the impact of COVID-19 on the global GMP testing service market?
5. What is the breakup of the global GMP testing service market based on the service type?
6. What is the breakup of the global GMP testing service market based on the end user?
7. What are the key regions in the global GMP testing service market?
8. Who are the key players/companies in the global GMP testing service market?


​1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology
3 Executive Summary
4 Introduction
4.1 Overview
4.2 Key Industry Trends
5 Global GMP Testing Service Market
5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast
6 Market Breakup by Service Type
6.1 Packaging and Shelf-Life Testing
6.1.1 Market Trends
6.1.2 Market Forecast
6.2 Product Validation Testing
6.2.1 Market Trends
6.2.2 Market Forecast
6.3 Bioanalytical Services
6.3.1 Market Trends
6.3.2 Market Forecast
6.4 Others
6.4.1 Market Trends
6.4.2 Market Forecast
7 Market Breakup by End User
7.1 Pharmaceutical and Biopharmaceutical Companies
7.1.1 Market Trends
7.1.2 Market Forecast
7.2 Medical Device Companies
7.2.1 Market Trends
7.2.2 Market Forecast
8 Market Breakup by Region
8.1 North America
8.1.1 United States
8.1.1.1 Market Trends
8.1.1.2 Market Forecast
8.1.2 Canada
8.1.2.1 Market Trends
8.1.2.2 Market Forecast
8.2 Asia-Pacific
8.2.1 China
8.2.1.1 Market Trends
8.2.1.2 Market Forecast
8.2.2 Japan
8.2.2.1 Market Trends
8.2.2.2 Market Forecast
8.2.3 India
8.2.3.1 Market Trends
8.2.3.2 Market Forecast
8.2.4 South Korea
8.2.4.1 Market Trends
8.2.4.2 Market Forecast
8.2.5 Australia
8.2.5.1 Market Trends
8.2.5.2 Market Forecast
8.2.6 Indonesia
8.2.6.1 Market Trends
8.2.6.2 Market Forecast
8.2.7 Others
8.2.7.1 Market Trends
8.2.7.2 Market Forecast
8.3 Europe
8.3.1 Germany
8.3.1.1 Market Trends
8.3.1.2 Market Forecast
8.3.2 France
8.3.2.1 Market Trends
8.3.2.2 Market Forecast
8.3.3 United Kingdom
8.3.3.1 Market Trends
8.3.3.2 Market Forecast
8.3.4 Italy
8.3.4.1 Market Trends
8.3.4.2 Market Forecast
8.3.5 Spain
8.3.5.1 Market Trends
8.3.5.2 Market Forecast
8.3.6 Russia
8.3.6.1 Market Trends
8.3.6.2 Market Forecast
8.3.7 Others
8.3.7.1 Market Trends
8.3.7.2 Market Forecast
8.4 Latin America
8.4.1 Brazil
8.4.1.1 Market Trends
8.4.1.2 Market Forecast
8.4.2 Mexico
8.4.2.1 Market Trends
8.4.2.2 Market Forecast
8.4.3 Others
8.4.3.1 Market Trends
8.4.3.2 Market Forecast
8.5 Middle East and Africa
8.5.1 Market Trends
8.5.2 Market Breakup by Country
8.5.3 Market Forecast
9 Drivers, Restraints, and Opportunities
9.1 Overview
9.2 Drivers
9.3 Restraints
9.4 Opportunities
10 Value Chain Analysis
11 Porters Five Forces Analysis
11.1 Overview
11.2 Bargaining Power of Buyers
11.3 Bargaining Power of Suppliers
11.4 Degree of Competition
11.5 Threat of New Entrants
11.6 Threat of Substitutes
12 Price Analysis
13 Competitive Landscape
13.1 Market Structure
13.2 Key Players
13.3 Profiles of Key Players
13.3.1 Almac Group
13.3.1.1 Company Overview
13.3.1.2 Product Portfolio
13.3.1.3 SWOT Analysis
13.3.2 Charles River Laboratories International Inc.
13.3.2.1 Company Overview
13.3.2.2 Product Portfolio
13.3.2.3 Financials
13.3.2.4 SWOT Analysis
13.3.3 Eurofins Scientific SE
13.3.3.1 Company Overview
13.3.3.2 Product Portfolio
13.3.3.3 Financials
13.3.3.4 SWOT Analysis
13.3.4 ICON plc
13.3.4.1 Company Overview
13.3.4.2 Product Portfolio
13.3.4.3 Financials
13.3.4.4 SWOT Analysis
13.3.5 Intertek Group plc
13.3.5.1 Company Overview
13.3.5.2 Product Portfolio
13.3.5.3 Financials
13.3.5.4 SWOT Analysis
13.3.6 Merck KgaA
13.3.6.1 Company Overview
13.3.6.2 Product Portfolio
13.3.6.3 Financials
13.3.6.4 SWOT Analysis
13.3.7 Nelson Laboratories LLC (Sotera Health Company)
13.3.7.1 Company Overview
13.3.7.2 Product Portfolio
13.3.7.3 Financials
13.3.8 North American Science Associates LLC
13.3.8.1 Company Overview
13.3.8.2 Product Portfolio
13.3.9 Pace Analytical Services LLC
13.3.9.1 Company Overview
13.3.9.2 Product Portfolio
13.3.10 PPD Inc. (Thermo Fisher Scientific Inc.)
13.3.10.1 Company Overview
13.3.10.2 Product Portfolio
13.3.11 Sartorius AG
13.3.11.1 Company Overview
13.3.11.2 Product Portfolio
13.3.11.3 Financials
13.3.11.4 SWOT Analysis
13.3.12 Wuxi Apptec Co. Ltd.
13.3.12.1 Company Overview
13.3.12.2 Product Portfolio
13.3.12.3 Financials

*** GMP試験サービスの世界市場に関するよくある質問(FAQ) ***

・GMP試験サービスの世界市場規模は？
→IMARC社は2024年のGMP試験サービスの世界市場規模を16億米ドルと推定しています。

・GMP試験サービスの世界市場予測は？
→IMARC社は2033年のGMP試験サービスの世界市場規模を25億米ドルと予測しています。

・GMP試験サービス市場の成長率は？
→IMARC社はGMP試験サービスの世界市場が2025年～2033年に年平均5.1%成長すると展望しています。

・世界のGMP試験サービス市場における主要プレイヤーは？
→「Almac Group, Charles River Laboratories International Inc., Eurofins Scientific SE, ICON plc, Intertek Group plc, Merck KgaA, Nelson Laboratories LLC (Sotera Health Company), North American Science Associates LLC, Pace Analytical Services LLC, PPD Inc. (Thermo Fisher Scientific Inc.), Sartorius AG, Wuxi Apptec Co. Ltd.など ...」をGMP試験サービス市場のグローバル主要プレイヤーとして判断しています。

※上記FAQの市場規模、市場予測、成長率、主要企業に関する情報は本レポートの概要を作成した時点での情報であり、最終レポートの情報と少し異なる場合があります。

*** 免責事項 ***
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