药物分析测试外包市场规模、份额、成长分析、按服务、按最终用途、按地区 - 行业预测，2024-2031 年

2022年全球药物分析测试外包市场规模估值为76.2亿美元，从2023年的83.2亿美元增长到2031年的158.9亿美元，并预计在预测期内增长（2024年-预计将以复合年增长率成长） 2031 年将成长 8.42%）。

製药业分析测试服务外包旨在提高业务效率、降低成本并利用专业实验室的专业知识，确保符合监管标准并维持产品品质。鑑于製药业严格的监管要求，分析测试对于检验药品的安全性、有效性和品质至关重要。药物分析测试外包市场的成长受到多种因素的推动，包括生技药品和个人化药物等产品日益复杂，这些产品需要专业知识和先进的分析技术。此外，FDA 和 EMA 等监管机构的严格监管指南需要进行大量测试和记录，这使得外包成为克服这些挑战的有效策略。然而，公司还必须考虑资料安全、保密问题以及对测试过程可能缺乏控制等挑战，这可能会影响计划进度。主要市场趋势包括采用高效液相层析(HPLC) 和质谱 (MS) 等先进技术，以及强调基于风险的方法和测试自动化。该市场提供了巨大的成长机会，特别是由于药品核准数量不断增加、对创新疗法的研究和开发的关注以及亚太和拉丁美洲新兴市场开拓的潜力。

目录

介绍

• 研究目的
• 定义
• 市场范围

调查方法

• 资讯采购
• 二手资料来源和主要资料来源
• 市场规模预测
• 市场假设与限制

执行摘要

• 市场概况展望
• 供需趋势分析
• 按细分市场的机会分析

市场动态及展望

• 市场动态
  • 促进因素
  • 机会
  • 抑制因素
  • 任务
• 波特的分析

主要市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 监管环境
• PESTEL分析

药物分析测试外包市场：依服务分类

• 市场概况
• 生物分析测试
  • 临床
  • 非临床
• 方法开发和检验
  • 可萃取和可浸出
  • 杂质法
  • 技术咨询
  • 其他的
• 稳定性测试
  • 药物成分
  • 稳定性指标检验
  • 加速稳定性测试
  • 光稳定性测试
  • 其他的
• 其他的

药物分析测试外包市场：依最终用途分类

• 市场概况
• 製药公司
• 生物製药公司
• 受託研究机构

按地区分類的药物分析测试外包市场规模

• 市场概况
• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地区
• 中东和非洲 (MEA)
  • 海湾合作委员会国家
  • 南非
  • 其他中东/非洲地区

竞争格局

• 前5名企业对比
• 主要企业市场定位（2023年）
• 主要市场参与者所采取的策略
• 近期市集活动
• 主要企业市场占有率（2023年）

主要企业简介

• 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