1 序文
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 一次情報源
2.3.2 二次情報源
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 主要な業界動向
5 世界の医薬品分析試験アウトソーシング市場
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 種類別市場内訳
6.1 医薬品有効成分（API）
6.1.1 市場動向
6.1.2 市場予測
6.2 添加物
6.2.1 市場動向
6.2.2 市場予測
6.3 最終製品
6.3.1 市場動向
6.3.2 市場予測
7 サービス別市場
7.1 バイオ分析試験
7.1.1 市場動向
7.1.2 主要企業
7.1.2.1 臨床
7.1.2.2 非臨床
7.1.3 市場予測
7.2 試験法開発およびバリデーション
7.2.1 市場動向
7.2.2 主要企業
7.2.2.1 抽出および溶出
7.2.2.2 不純物分析法
7.2.2.3 技術コンサルティング
7.2.2.4 その他
7.2.3 市場予測
7.3 安定性試験
7.3.1 市場動向
7.3.2 主要企業
7.3.2.1 医薬品原体
7.3.2.2 安定性試験法バリデーション
7.3.2.3 加速安定性試験
7.3.2.4 光安定性試験
7.3.2.5 その他
7.3.3 市場予測
7.4 その他
7.4.1 市場動向
7.4.2 市場予測
8 エンドユーザー別市場内訳
8.1 製薬会社
8.1.1 市場動向
8.1.2 市場予測
8.2 バイオ製薬会社
8.2.1 市場動向
8.2.2 市場予測
8.3 医薬品開発業務受託機関
8.3.1 市場動向
8.3.2 市場予測
9 地域別市場
9.1 北米
9.1.1 米国
9.1.1.1 市場動向
9.1.1.2 市場予測
9.1.2 カナダ
9.1.2.1 市場動向
9.1.2.2 市場予測
9.2 アジア太平洋地域
9.2.1 中国
9.2.1.1 市場動向
9.2.1.2 市場予測
9.2.2 日本
9.2.2.1 市場動向
9.2.2.2 市場予測
9.2.3 インド
9.2.3.1 市場動向
9.2.3.2 市場予測
9.2.4 韓国
9.2.4.1 市場動向
9.2.4.2 市場予測
9.2.5 オーストラリア
9.2.5.1 市場動向
9.2.5.2 市場予測
9.2.6 インドネシア
9.2.6.1 市場動向
9.2.6.2 市場予測
9.2.7 その他
9.2.7.1 市場動向
9.2.7.2 市場予測
9.3 ヨーロッパ
9.3.1 ドイツ
9.3.1.1 市場動向
9.3.1.2 市場予測
9.3.2 フランス
9.3.2.1 市場動向
9.3.2.2 市場予測
9.3.3 イギリス
9.3.3.1 市場動向
9.3.3.2 市場予測
9.3.4 イタリア
9.3.4.1 市場動向
9.3.4.2 市場予測
9.3.5 スペイン
9.3.5.1 市場動向
9.3.5.2 市場予測
9.3.6 ロシア
9.3.6.1 市場動向
9.3.6.2 市場予測
9.3.7 その他
9.3.7.1 市場動向
9.3.7.2 市場予測
9.4 ラテンアメリカ
9.4.1 ブラジル
9.4.1.1 市場動向
9.4.1.2 市場予測
9.4.2 メキシコ
9.4.2.1 市場動向
9.4.2.2 市場予測
9.4.3 その他
9.4.3.1 市場動向
9.4.3.2 市場予測
9.5 中東およびアフリカ
9.5.1 市場動向
9.5.2 国別の市場内訳
9.5.3 市場予測
10 SWOT分析
10.1 概要
10.2 強み
10.3 弱み
10.4 機会
10.5 脅威
11 バリューチェーン分析
12 ポーターのファイブフォース分析
12.1 概要
12.2 バイヤーの交渉力
12.3 サプライヤーの交渉力
12.4 競争の度合い
12.5 新規参入の脅威
12.6 代替品の脅威
13 価格分析
14 競合状況
14.1 市場構造
14.2 主要企業
14.3 主要企業のプロフィール
Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.)
Alcami Corporation Inc
Boston Analytical Inc
Catalent Inc
Charles River Laboratories International Inc
Eurofins Scientific SE
Intertek Group plc
Laboratory Corporation of America Holdings
Pace Analytical Services LLC
SGS S.A
Thermo Fisher Scientific Inc
West Pharmaceutical Services Inc
WuXi AppTec Inc
Pharmaceutical analytical testing outsourcing is a testing activity used in the pharmaceutical industry to minimize in-house production costs by outsourcing parts of the work to a third party. As an extension of contract research organizations, pharmaceutical analytical testing outsourcing services have begun replacing a significant portion of in-house analytical development and testing. As part of the development process for drugs and therapies, pharmaceutical testing plays a vital role from the beginning through the commercialization of the product. It entails determining the structures of chemicals, purifying a mixture of substances, and synthesizing and characterizing active medicinal ingredients (APIs). Formulation development and early-phase manufacturing are usually involved in this initiative to speed up compound activities.
Pharmaceutical Analytical Testing Outsourcing Market Trends:
The market is majorly driven by the increasing adoption of outsourcing practices in pharmaceutical companies, contract research organizations, and biotech companies. This can be attributed to the escalating demand for analytical information on the end-to-end process of drug development by various regulatory agencies. Additionally, continual technological advancements with an enhanced focus on shortening the product lifecycle have resulted in the rapid development of new products, which is providing an impetus to the market. The rising need for product safety and quality, changing regulations for in vivo and in vitro tests, and an augmented emphasis on customized care is also impacting the market positively. The development of combination products, biosimilar, and other innovative medicines leading to the introduction of specific types of tests and specialty product manufacturing are further fueling the market. Some of the other factors contributing to the market include numerous innovations in the pharmaceutical industry, the pricing benefits of outsourcing, extensive research and development (R&D) conducted to develop sustainable drugs, favorable initiatives by the governments of several countries, and the growing number of clinical trial registrations.
Key Market Segmentation:
IMARC Group provides an analysis of the key trends in each sub-segment of the global pharmaceutical analytical testing outsourcing market report, along with forecasts at the global, regional and country level from 2025-2033. Our report has categorized the market based on type, service and end user.
Breakup by Type:
Active Pharmaceutical Ingredients (API)
Additives
Finished Products
Breakup by Service:
Bioanalytical Testing
Clinical
Non-Clinical
Method Development and Validation
Extractable and Leachable
Impurity Method
Technical Consulting
Others
Stability Testing
Drug Substance
Stability Indicating Method Validation
Accelerated Stability Testing
Photostability Testing
Others
Others
Breakup by End User:
Pharmaceutical Companies
Biopharmaceutical Companies
Contract Research Organizations
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
Competitive Landscape:
The competitive landscape of the industry has also been examined along with the profiles of the key players being Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.), Alcami Corporation Inc., Boston Analytical Inc., Catalent Inc., Charles River Laboratories International Inc., Eurofins Scientific SE, Intertek Group plc, Laboratory Corporation of America Holdings, Pace Analytical Services LLC, SGS S.A., Thermo Fisher Scientific Inc., West Pharmaceutical Services Inc. and WuXi AppTec Inc. Kindly, note that this only represents a partial list of companies, and the complete list has been provided in the report.
The global pharmaceutical analytical testing outsourcing market size reached USD 9.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 15.9 Billion by 2033, exhibiting a growth rate (CAGR) of 6.49% during 2025-2033. The market is driven by the growing focus on new drug delivery systems, such as liposomes, nanoparticles, and microspheres, increasing prevalence of chronic diseases like cancer, diabetes, and cardiovascular disease, and rising emphasis on drug development.
Pharmaceutical analytical testing outsourcing is a testing activity used in the pharmaceutical industry to minimize in-house production costs by outsourcing parts of the work to a third party. As an extension of contract research organizations, pharmaceutical analytical testing outsourcing services have begun replacing a significant portion of in-house analytical development and testing. As part of the development process for drugs and therapies, pharmaceutical testing plays a vital role from the beginning through the commercialization of the product. It entails determining the structures of chemicals, purifying a mixture of substances, and synthesizing and characterizing active medicinal ingredients (APIs). Formulation development and early-phase manufacturing are usually involved in this initiative to speed up compound activities.
Pharmaceutical Analytical Testing Outsourcing Market Trends:
The market is majorly driven by the increasing adoption of outsourcing practices in pharmaceutical companies, contract research organizations, and biotech companies. This can be attributed to the escalating demand for analytical information on the end-to-end process of drug development by various regulatory agencies. Additionally, continual technological advancements with an enhanced focus on shortening the product lifecycle have resulted in the rapid development of new products, which is providing an impetus to the market. The rising need for product safety and quality, changing regulations for in vivo and in vitro tests, and an augmented emphasis on customized care is also impacting the market positively. The development of combination products, biosimilar, and other innovative medicines leading to the introduction of specific types of tests and specialty product manufacturing are further fueling the market. Some of the other factors contributing to the market include numerous innovations in the pharmaceutical industry, the pricing benefits of outsourcing, extensive research and development (R&D) conducted to develop sustainable drugs, favorable initiatives by the governments of several countries, and the growing number of clinical trial registrations.
Key Market Segmentation:
IMARC Group provides an analysis of the key trends in each sub-segment of the global pharmaceutical analytical testing outsourcing market report, along with forecasts at the global, regional and country level from 2025-2033. Our report has categorized the market based on type, service and end user.
Breakup by Type:
Active Pharmaceutical Ingredients (API)
Additives
Finished Products
Breakup by Service:
Bioanalytical Testing
Clinical
Non-Clinical
Method Development and Validation
Extractable and Leachable
Impurity Method
Technical Consulting
Others
Stability Testing
Drug Substance
Stability Indicating Method Validation
Accelerated Stability Testing
Photostability Testing
Others
Others
Breakup by End User:
Pharmaceutical Companies
Biopharmaceutical Companies
Contract Research Organizations
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
Competitive Landscape:
The competitive landscape of the industry has also been examined along with the profiles of the key players being Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.), Alcami Corporation Inc., Boston Analytical Inc., Catalent Inc., Charles River Laboratories International Inc., Eurofins Scientific SE, Intertek Group plc, Laboratory Corporation of America Holdings, Pace Analytical Services LLC, SGS S.A., Thermo Fisher Scientific Inc., West Pharmaceutical Services Inc. and WuXi AppTec Inc. Kindly, note that this only represents a partial list of companies, and the complete list has been provided in the report.
Key Questions Answered in This Report:
How has the global pharmaceutical analytical testing outsourcing market performed so far and how will it perform in the coming years?
What has been the impact of COVID-19 on the global pharmaceutical analytical testing outsourcing market?
What are the key regional markets?
What is the breakup of the market based on the type?
What is the breakup of the market based on the service?
What is the breakup of the market based on the end user?
What are the various stages in the value chain of the industry?
What are the key driving factors and challenges in the industry?
What is the structure of the global pharmaceutical analytical testing outsourcing market and who are the key players?
What is the degree of competition in the industry?
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 Pharmaceutical Analytical Testing Outsourcing Market
5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast
6 Market Breakup by Type
6.1 Active Pharmaceutical Ingredients (API)
6.1.1 Market Trends
6.1.2 Market Forecast
6.2 Additives
6.2.1 Market Trends
6.2.2 Market Forecast
6.3 Finished Products
6.3.1 Market Trends
6.3.2 Market Forecast
7 Market Breakup by Service
7.1 Bioanalytical Testing
7.1.1 Market Trends
7.1.2 Key Players
7.1.2.1 Clinical
7.1.2.2 Non-Clinical
7.1.3 Market Forecast
7.2 Method Development and Validation
7.2.1 Market Trends
7.2.2 Key Players
7.2.2.1 Extractable and Leachable
7.2.2.2 Impurity Method
7.2.2.3 Technical Consulting
7.2.2.4 Others
7.2.3 Market Forecast
7.3 Stability Testing
7.3.1 Market Trends
7.3.2 Key Players
7.3.2.1 Drug Substance
7.3.2.2 Stability Indicating Method Validation
7.3.2.3 Accelerated Stability Testing
7.3.2.4 Photostability Testing
7.3.2.5 Others
7.3.3 Market Forecast
7.4 Others
7.4.1 Market Trends
7.4.2 Market Forecast
8 Market Breakup by End User
8.1 Pharmaceutical Companies
8.1.1 Market Trends
8.1.2 Market Forecast
8.2 Biopharmaceutical Companies
8.2.1 Market Trends
8.2.2 Market Forecast
8.3 Contract Research Organizations
8.3.1 Market Trends
8.3.2 Market Forecast
9 Market Breakup by Region
9.1 North America
9.1.1 United States
9.1.1.1 Market Trends
9.1.1.2 Market Forecast
9.1.2 Canada
9.1.2.1 Market Trends
9.1.2.2 Market Forecast
9.2 Asia-Pacific
9.2.1 China
9.2.1.1 Market Trends
9.2.1.2 Market Forecast
9.2.2 Japan
9.2.2.1 Market Trends
9.2.2.2 Market Forecast
9.2.3 India
9.2.3.1 Market Trends
9.2.3.2 Market Forecast
9.2.4 South Korea
9.2.4.1 Market Trends
9.2.4.2 Market Forecast
9.2.5 Australia
9.2.5.1 Market Trends
9.2.5.2 Market Forecast
9.2.6 Indonesia
9.2.6.1 Market Trends
9.2.6.2 Market Forecast
9.2.7 Others
9.2.7.1 Market Trends
9.2.7.2 Market Forecast
9.3 Europe
9.3.1 Germany
9.3.1.1 Market Trends
9.3.1.2 Market Forecast
9.3.2 France
9.3.2.1 Market Trends
9.3.2.2 Market Forecast
9.3.3 United Kingdom
9.3.3.1 Market Trends
9.3.3.2 Market Forecast
9.3.4 Italy
9.3.4.1 Market Trends
9.3.4.2 Market Forecast
9.3.5 Spain
9.3.5.1 Market Trends
9.3.5.2 Market Forecast
9.3.6 Russia
9.3.6.1 Market Trends
9.3.6.2 Market Forecast
9.3.7 Others
9.3.7.1 Market Trends
9.3.7.2 Market Forecast
9.4 Latin America
9.4.1 Brazil
9.4.1.1 Market Trends
9.4.1.2 Market Forecast
9.4.2 Mexico
9.4.2.1 Market Trends
9.4.2.2 Market Forecast
9.4.3 Others
9.4.3.1 Market Trends
9.4.3.2 Market Forecast
9.5 Middle East and Africa
9.5.1 Market Trends
9.5.2 Market Breakup by Country
9.5.3 Market Forecast
10 SWOT Analysis
10.1 Overview
10.2 Strengths
10.3 Weaknesses
10.4 Opportunities
10.5 Threats
11 Value Chain Analysis
12 Porters Five Forces Analysis
12.1 Overview
12.2 Bargaining Power of Buyers
12.3 Bargaining Power of Suppliers
12.4 Degree of Competition
12.5 Threat of New Entrants
12.6 Threat of Substitutes
13 Price Analysis
14 Competitive Landscape
14.1 Market Structure
14.2 Key Players
14.3 Profiles of Key Players
14.3.1 Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.)
14.3.1.1 Company Overview
14.3.1.2 Product Portfolio
14.3.2 Alcami Corporation Inc.
14.3.2.1 Company Overview
14.3.2.2 Product Portfolio
14.3.3 Boston Analytical Inc.
14.3.3.1 Company Overview
14.3.3.2 Product Portfolio
14.3.4 Catalent Inc.
14.3.4.1 Company Overview
14.3.4.2 Product Portfolio
14.3.4.3 Financials
14.3.4.4 SWOT Analysis
14.3.5 Charles River Laboratories International Inc.
14.3.5.1 Company Overview
14.3.5.2 Product Portfolio
14.3.5.3 Financials
14.3.5.4 SWOT Analysis
14.3.6 Eurofins Scientific SE
14.3.6.1 Company Overview
14.3.6.2 Product Portfolio
14.3.6.3 Financials
14.3.6.4 SWOT Analysis
14.3.7 Intertek Group plc
14.3.7.1 Company Overview
14.3.7.2 Product Portfolio
14.3.7.3 Financials
14.3.7.4 SWOT Analysis
14.3.8 Laboratory Corporation of America Holdings
14.3.8.1 Company Overview
14.3.8.2 Product Portfolio
14.3.8.3 Financials
14.3.8.4 SWOT Analysis
14.3.9 Pace Analytical Services LLC
14.3.9.1 Company Overview
14.3.9.2 Product Portfolio
14.3.10 SGS S.A.
14.3.10.1 Company Overview
14.3.10.2 Product Portfolio
14.3.10.3 Financials
14.3.11 Thermo Fisher Scientific Inc.
14.3.11.1 Company Overview
14.3.11.2 Product Portfolio
14.3.11.3 Financials
14.3.11.4 SWOT Analysis
14.3.12 West Pharmaceutical Services Inc.
14.3.12.1 Company Overview
14.3.12.2 Product Portfolio
14.3.12.3 Financials
14.3.12.4 SWOT Analysis
14.3.13 WuXi AppTec Inc.
14.3.13.1 Company Overview
14.3.13.2 Product Portfolio
14.3.13.3 Financials
| ※参考情報 医薬品分析試験アウトソーシングとは、製薬業界において、製品の品質や効果を確認するための分析試験を外部の専門機関に委託することを指します。製薬会社は、新薬の開発から市販後の監視まで、多様な試験を実施する必要がありますが、これには高い専門性と設備が求められます。そのため、企業はリソースを最適化し、専門的な知見や技術を活用するためにアウトソーシングを行います。 医薬品分析試験の種類は多岐にわたります。代表的なものとしては、物理化学的試験、安定性試験、生物学的試験、微生物試験、分子生物学的試験などがあります。物理化学的試験には、薬剤の成分や純度を測定するための手法が含まれます。安定性試験は、製品が一定の条件下でどれだけ継続して効果を持つかを確認するもので、温度や湿度などの影響を評価します。生物学的試験では、薬剤の生物活性や副作用を確認することが求められます。また、微生物試験は、製品中の微生物の存在や数量を評価し、品質を保証するために重要です。これらの試験は、新薬の承認を受けるための必須条件となる場合が多く、厳正な管理が必要です。 医薬品分析試験の用途は多岐にわたりますが、主に新薬開発、承認申請、市販後の監視が挙げられます。新薬開発では、薬剤の有効性や安全性を確認するために、様々な分析試験が実施されます。これにより、薬剤の投与方法や適用範囲が決定されます。また、承認申請の際には、規制当局が求めるデータを提出する必要があり、そのための分析が必要不可欠です。市販後の監視では、製品の安定性や品質を継続的に確認し、消費者の安全を確保する役割を担っています。これにより、万が一副作用が発生した場合にも早期に対応を行うことが可能となります。 関連技術としては、HPLC（高性能液体クロマトグラフィー）、GC（ガスクロマトグラフィー）、質量分析（MS）、NMR（核磁気共鳴）、FTIR（フーリエ変換赤外分光法）などがあります。HPLCは、混合物中の成分を分離・定量するために使用され、製薬業界において広く活用されています。GCは揮発性化合物の分析に適しており、特に薬物の分離に効果的です。質量分析は、分子の質量を測定する方法で、構造の特定に非常に有用です。NMRは分子の構造を直接解析する手法であり、化合物の特定に役立ちます。FTIRは分子の官能基を特定するために使用され、薬剤の特性を把握するために重要です。 医薬品分析試験アウトソーシングの利点の一つは、専用の設備や技術を持つ専門機関に委託することで、企業は自社のコストを削減できる点です。分析設備の維持や運用コストは高いため、アウトソーシングを行うことでコストパフォーマンスを向上させることができます。また、専門機関は最新の技術や知見を持っているため、より高精度な分析結果を得ることができる可能性があります。 一方で、アウトソーシングにはリスクも伴います。情報漏洩のリスクや、外部機関とのコミュニケーションの問題などが考えられます。そのため、適切なパートナー選びや契約内容の明確化が重要です。信頼できるパートナーの選定は、製品の品質を守るために欠かせません。 医薬品分析試験アウトソーシングは、ますます重要性を増しています。グローバルな規模での競争が激化する中、企業は効率的なリソースの利用と高品質なデータの取得を求めています。これにより、製品の市場投入を迅速化し、競争力を向上させることが期待されています。今後も、この分野は技術革新とともに成長を続けていくことでしょう。 |
*** 医薬品分析試験アウトソーシングの世界市場に関するよくある質問(FAQ) ***
・医薬品分析試験アウトソーシングの世界市場規模は？
→IMARC社は2024年の医薬品分析試験アウトソーシングの世界市場規模を90億米ドルと推定しています。
・医薬品分析試験アウトソーシングの世界市場予測は？
→IMARC社は2033年の医薬品分析試験アウトソーシングの世界市場規模を159億米ドルと予測しています。
・医薬品分析試験アウトソーシング市場の成長率は？
→IMARC社は医薬品分析試験アウトソーシングの世界市場が2025年～2033年に年平均6.5%成長すると展望しています。
・世界の医薬品分析試験アウトソーシング市場における主要プレイヤーは？
→「Ajinomoto Bio-Pharma Services (Ajinomoto Co. Inc.), Alcami Corporation Inc., Boston Analytical Inc., Catalent Inc., Charles River Laboratories International Inc., Eurofins Scientific SE, Intertek Group plc, Laboratory Corporation of America Holdings, Pace Analytical Services LLC, SGS S.A., Thermo Fisher Scientific Inc., West Pharmaceutical Services Inc., WuXi AppTec Inc.など ...」を医薬品分析試験アウトソーシング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。
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