医薬品分析試験アウトソーシングの市場規模、シェア、成長分析、サービス別、最終用途別、地域別 - 産業予測、2024年～2031年

医薬品分析試験アウトソーシングの世界市場規模は、2022年に76億2,000万米ドルと評価され、2023年の83億2,000万米ドルから2031年には158億9,000万米ドルに成長し、予測期間中（2024-2031年）のCAGRは8.42％で成長する見通しです。

製薬業界における分析試験サービスのアウトソーシングは、業務効率の向上、コスト削減、専門ラボの専門知識の活用を目的としており、規制基準の遵守と製品品質の維持を保証します。医薬品業界を管理する厳しい規制要件を考えると、分析試験は医薬品の安全性、有効性、品質を検証する上で極めて重要です。医薬品分析試験アウトソーシング市場の成長は、専門的な専門知識と高度な分析技術を必要とする生物製剤や個別化医薬品のような製品の複雑化など、いくつかの要因によって牽引されています。さらに、FDAやEMAなどの規制当局による厳しい規制ガイドラインでは、広範な試験と文書化が必要となるため、アウトソーシングはこうした課題を克服するための効果的な戦略となっています。しかし、企業はデータ・セキュリティ、機密保持の懸念、試験プロセスの潜在的な管理不足といった課題も考慮しなければならず、これらはプロジェクトのスケジュールに影響を及ぼす可能性があります。市場の主な動向としては、高速液体クロマトグラフィー（HPLC）や質量分析（MS）などの先端技術の採用、リスクベースのアプローチや検査の自動化の重視などが挙げられます。特に医薬品承認数の増加、革新的な治療薬の研究開発への注力、アジア太平洋やラテンアメリカの新興市場における未開拓の可能性により、市場は大きな成長機会をもたらしています。

目次

イントロダクション

• 調査の目的
• 定義
• 市場範囲

調査手法

• 情報調達
• 二次データソースと一次データソース
• 市場規模予測
• 市場の想定と制限

エグゼクティブサマリー

• 市場概要見通し
• 供給需要動向分析
• セグメント別機会分析

市場力学と見通し

• 市場力学
  • 促進要因
  • 機会
  • 抑制要因
  • 課題
• ポーターの分析

主な市場の考察

• 主な成功要因
• 競合の程度
• 主な投資機会
• 市場のエコシステム
• 規制情勢
• PESTEL分析

医薬品分析試験アウトソーシング市場：サービス別

• 市場概要
• 生体分析試験
  • 臨床
  • 非臨床
• 手法開発と検証
  • 抽出可能および浸出可能
  • 不純物法
  • 技術コンサルティング
  • その他
• 安定性試験
  • 薬物成分
  • 安定性指示法の検証
  • 加速安定性試験
  • 光安定性試験
  • その他
• その他

医薬品分析試験アウトソーシング市場：最終用途別

• 市場概要
• 製薬会社
• バイオ医薬品企業
• 受託研究機関

医薬品分析試験アウトソーシング市場規模：地域別

• 市場概要
• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ（MEA）
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ地域

競合情勢

• 上位5社の比較
• 主要企業の市場ポジショニング（2023年）
• 主な市場企業が採用した戦略
• 市場における最近の活動
• 主要企業の市場シェア（2023年）

主要企業プロファイル

• Eurofins Scientific SE
• Laboratory Corporation of America Holdings
• Charles River Laboratories International, Inc.
• WuXi AppTec
• SGS SA
• PPD, Inc.
• Intertek Group plc
• Almac Group
• Pace Analytical Services, LLC
• Source BioScience plc
• Syneos Health
• BioReliance Corporation
• LGC Limited
• Pharmaceutical Product Development, LLC
• Toxikon Corporation
• Avista Pharma Solutions
• Harlan Laboratories Ltd
• Accutest Laboratories
• Neopharm Labs Inc.

Global Pharmaceutical Analytical Testing Outsourcing Market size was valued at USD 7.62 billion in 2022 and is poised to grow from USD 8.32 billion in 2023 to USD 15.89 billion by 2031, growing at a CAGR of 8.42% during the forecast period (2024-2031).

Outsourcing analytical testing services in the pharmaceutical industry aims to enhance operational efficiency, reduce costs, and leverage the expertise of specialized laboratories, ensuring compliance with regulatory standards and maintaining product quality. Given the stringent regulatory requirements governing the industry, analytical testing is crucial for verifying the safety, efficacy, and quality of pharmaceutical products. The growth of the pharmaceutical analytical testing outsourcing market is driven by several factors, including the increasing complexity of products such as biologics and personalized medicines, which demand specialized expertise and advanced analytical techniques. Additionally, stringent regulatory guidelines from authorities like the FDA and EMA necessitate extensive testing and documentation, making outsourcing an effective strategy for navigating these challenges. However, companies must also consider challenges such as data security, confidentiality concerns, and the potential lack of control over the testing process, which can affect project timelines. Key trends in the market include the adoption of advanced technologies like high-performance liquid chromatography (HPLC) and mass spectrometry (MS), as well as an emphasis on risk-based approaches and automation in testing. The market presents significant growth opportunities, particularly with the rising number of drug approvals, a focus on research and development of innovative therapeutics, and the untapped potential in emerging markets in Asia Pacific and Latin America.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Pharmaceutical Analytical Testing Outsourcing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Pharmaceutical Analytical Testing Outsourcing Market Segmental Analysis

Global Pharmaceutical Analytical Testing Outsourcing Market is segmented by Services, End Use, and region. Based on Services , the market is segmented into Bioanalytical Testing (Clinical, Non-clinical), Method Development & Validation (Extractable & Leachable, Impurity Method, Technical Consulting, Others), Stability Testing (Drug Substance, Stability Indicating Method Validation, Accelerated Stability Testing, Photostability Testing, Others), Others. Based on End Use, the market is segmented into Pharmaceutical Companies, Biopharmaceutical Companies, Contract Research Organizations. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Drivers of the Global Pharmaceutical Analytical Testing Outsourcing Market

A key factor driving the growth of the global pharmaceutical analytical testing outsourcing market is the rising demand for outsourcing services among pharmaceutical companies. By outsourcing analytical testing, these companies can concentrate on their core strengths, such as drug discovery and development, while benefiting from the expertise and specialized facilities of contract research organizations (CROs). This approach helps streamline operations, lower costs, and speed up the time-to-market for new drugs. For instance, a pharmaceutical firm might outsource analytical testing for quality control to ensure its products comply with regulatory standards and are safe for consumption.

Restraints in the Global Pharmaceutical Analytical Testing Outsourcing Market

A key restraint for the pharmaceutical analytical testing outsourcing market is the concern surrounding data security and confidentiality. Pharmaceutical companies manage sensitive and proprietary information related to drug formulations, manufacturing processes, and clinical trials. Outsourcing analytical testing necessitates sharing this critical data with external partners, which heightens worries about data protection and intellectual property rights. As a result, companies may be reluctant to outsource analytical testing due to the potential risks of data breaches or unauthorized use of their proprietary information. To address this challenge, it is essential to establish robust contractual agreements and implement stringent data security measures to safeguard the confidentiality and integrity of the shared data.

Market Trends of the Global Pharmaceutical Analytical Testing Outsourcing Market

A notable trend in the pharmaceutical analytical testing outsourcing market is the rising use of advanced analytical techniques. As innovative drug therapies and personalized medicine evolve, there is an increasing need for specialized testing services, including genomics, proteomics, metabolomics, and bioanalytical testing. Outsourcing partners with expertise in these areas can provide pharmaceutical companies access to state-of-the-art technologies and analytical knowledge, helping them maximize the potential of their drug candidates.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factor
• Degree of Competition
• Top Investment Pockets
• Ecosystem of the Market
• Regulatory Landscape
• PESTEL Analysis

Pharmaceutical Analytical Testing Outsourcing Market, By Services

• Market Overview
• Bioanalytical Testing
  • Clinical
  • Non-clinical
• Method Development & Validation
  • Extractable & Leachable
  • Impurity Method
  • Technical Consulting
  • Others
• Stability Testing
  • Drug Substance
  • Stability Indicating Method Validation
  • Accelerated Stability Testing
  • Photostability Testing
  • Others
• Others

Pharmaceutical Analytical Testing Outsourcing Market, By End Use

• Market Overview
• Pharmaceutical Companies
• Biopharmaceutical Companies
• Contract Research Organizations

Pharmaceutical Analytical Testing Outsourcing Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Eurofins Scientific SE
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Laboratory Corporation of America Holdings
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories International, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SGS SA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PPD, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Almac Group
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical Services, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Source BioScience plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Syneos Health
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BioReliance Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LGC Limited
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pharmaceutical Product Development, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Toxikon Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Avista Pharma Solutions
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Harlan Laboratories Ltd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accutest Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Neopharm Labs Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments