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市场调查报告书

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1488254

药物分析测试外包市场 - 按服务（生物分析测试[临床、非临床]、方法开发和验证、稳定性测试）产品类型（API、添加剂、成品）、最终用户和预测，2024 年 - 2032 年

Pharmaceutical Analytical Testing Outsourcing Market - By Services (Bioanalytical Testing [Clinical, Non-clinical], Method Development & Validation, Stability Testing) Product Type (API, Additive, Finished Product), End-user & Forecast, 2024 - 2032

出版日期: 2024年03月19日 | 出版商:

Global Market Insights Inc. | 英文 190 Pages | 商品交期: 2-3个工作天内

价格

简介目录

预计 2024 年至 2032 年间，药品分析测试外包市场规模的复合年增长率为 8%。

外包分析测试服务使製药公司能够获得专业知识、先进技术和最先进的设施，以简化营运并缩短上市时间。例如，2023 年 11 月，食品和药品 CRO（合约研究组织）RSSL 启用了最先进的分析测试设施，以满足生命科学、医疗保健、食品和消费品领域日益增长的客户需求行业。

外包非核心活动以专注于核心能力的趋势不断增长，正在推动药物分析测试外包服务的采用。透过将分析测试任务外包给第三方服务供应商，製药公司可以更具策略性地配置资源，优先考虑研发计划，并加速药物开发创新，为市场成长创造机会。

药品分析测试外包产业根据服务、产品类型、最终用户和地区进行分类。

预计到2032 年，添加剂产品类型领域的产业规模复合年增长率将达到8.4%。监管标准。外包分析测试服务使製药公司能够获得添加剂分析的专业知识，包括添加剂的识别、定量和表征，而无需在专门设备和人员培训方面进行大量投资。

预计 2024 年至 2032 年，生物製药公司最终用户在药物分析测试外包市场的复合年增长率将达到 8.4%。生物製药产品（包括生物製剂、生物相似药和基因疗法）的风险不断上升，需要专门的分析测试来确保产品品质、安全性和有效性。外包合作伙伴还提供针对生物製药独特要求的全面分析测试能力，包括基于细胞的测定、纯度评估和聚醣分析。

由于製药业的蓬勃发展和研发活动投资的增加，亚太地区药品分析测试外包产业规模在2024-2032年将录得8.4%的成长率。该地区国内和跨国製药公司采用合约研究和製造服务的情况显着增加。监管协调工作的不断加强以及外包作为製药领域策略业务模式的接受程度不断提高，将刺激区域产业的成长。

产业生态系统分析
产业影响力
- 成长动力
  - 製药业的全球化
  - 监理框架
  - 分析仪器不断进步
  - 日益成长的外包趋势
- 产业陷阱与挑战
  - 品质问题和风险缓解
  - 保密和智慧财产权保护
成长潜力分析
监管环境
波特的分析
PESTEL分析

第 4 章：竞争格局

介绍
公司矩阵分析
主要市场参与者的竞争分析
竞争定位矩阵
战略仪表板

第 5 章：市场估计与预测：按服务划分，2018 年 - 2032 年

主要趋势
生物分析测试
- 临床
- 非临床
方法开发和验证
- 可萃取和可浸出
- 杂质法
- 技术咨询
- 其他方法开发和验证服务
稳定性测试
- 原料药检测
- 稳定性指示方法验证
- 加速稳定性测试
- 光稳定性测试
- 其他稳定性测试服务
其他服务

第 6 章：市场估计与预测：按产品类型，2018 年 - 2032 年

主要趋势
活性药物成分（API）
添加剂
製成品

第 7 章：市场估计与预测：按最终用户划分，2018 年 - 2032 年

主要趋势
製药公司
生物製药公司
学术界及研究机构

第 8 章：市场估计与预测：按地区划分，2018 年 - 2032 年

主要动向：按地区
北美洲
- 我们
- 加拿大
欧洲
- 德国
- 英国
- 法国
- 西班牙
- 义大利
- 欧洲其他地区
亚太地区
- 日本
- 中国
- 印度
- 澳洲
- 亚太地区其他地区
拉丁美洲
- 巴西
- 墨西哥
- 拉丁美洲其他地区
中东和非洲
- 南非
- 沙乌地阿拉伯
- 中东和非洲其他地区

第 9 章：公司简介

BA Sciences
Charles River Laboratories International, Inc.
Eurofins Scientific
Immunologix Laboratories
Indoco Analytical Solutions
Intertek Group plc
Labcorp Drug Development
Pace Labs
SGS Societe Generale de Surveillance SA.
STERIS
Thermo fisher Scietific, Inc.
Triclinic Labs, Inc.
West Pharmaceutical Services, Inc.
Wuxi AppTec

简介目录

Product Code: 8572

Pharmaceutical analytical testing outsourcing market size is estimated to register 8% CAGR between 2024 and 2032. The increasing complexity of pharmaceutical products and stringent regulatory requirements is necessitating comprehensive analytical testing throughout the drug development and manufacturing process.

Outsourcing analytical testing services enables pharmaceutical companies to access specialized expertise, advanced technologies, and state-of-the-art facilities for streamlining operations and reducing time-to-market. For instance, in November 2023, RSSL, a CRO (contract research organization) for food and pharmaceuticals, inaugurated its state-of-the-art analytical testing facility to fulfil increased client requirements in the life science, healthcare, food, and consumer goods industries.

The growing trend of outsourcing non-core activities for focusing on core competencies is driving the adoption of pharmaceutical analytical testing outsourcing services. By outsourcing analytical testing tasks to third-party service providers, pharmaceutical companies are allocating resources more strategically, prioritizing R&D initiatives, and accelerating innovation in drug development, creating opportunities for the market growth.

The pharmaceutical analytical testing outsourcing industry is classified based on service, product type, end-user and region.

The industry size from the additives product type segment is projected to witness 8.4% CAGR through 2032. The increasing complexity and diversity of additives used in pharmaceutical formulations is necessitating specialized analytical testing to ensure product quality, safety, and compliance with regulatory standards. Outsourcing analytical testing services allows pharmaceutical companies to access expertise in additive analysis, including identification, quantification, and characterization of additives, without the need for significant investment in specialized equipment and personnel training.

The biopharmaceutical companies end-user segment in the pharmaceutical analytical testing outsourcing market is anticipated to observe an 8.4% CAGR during 2024-2032. The rising risks of biopharmaceutical products, including biologics, biosimilars, and gene therapies is requiring specialized analytical testing to ensure product quality, safety, and efficacy. Outsourcing partners also offer a comprehensive range of analytical testing capabilities tailored to the unique requirements of biopharmaceuticals, including cell-based assays, purity assessments, and glycan analysis.

Asia Pacific pharmaceutical analytical testing outsourcing industry size will record 8.4% growth rate over 2024-2032, attributed to the burgeoning pharmaceutical sector and increasing investments in R&D activities. The adoption of contract research and manufacturing services by domestic and multinational pharmaceutical companies in the region has significantly risen. Growing regulatory harmonization efforts and increasing acceptance of outsourcing as a strategic business model in the pharmaceutical space will stimulate the regional industry growth.

Chapter 1 Methodology & Scope

1.1 Market scope & definitions
1.2 Base estimates & calculations
1.3 Data collection
1.4 Forecast parameters
1.5 Data validation
1.6 Data sources
- 1.6.1 Primary
- 1.6.2 Secondary
  - 1.6.2.1 Paid sources
  - 1.6.2.2 Public sources

Chapter 2 Executive Summary

2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

3.1 Industry ecosystem analysis
3.2 Industry impact forces
- 3.2.1 Growth drivers
  - 3.2.1.1 Globalization of the pharmaceutical industry
  - 3.2.1.2 Regulatory framework
  - 3.2.1.3 Growing advancements in analytical instrumentations
  - 3.2.1.4 Increasing outsourcing trends
- 3.2.2 Industry pitfalls & challenges
  - 3.2.2.1 Quality concerns and risk mitigation
  - 3.2.2.2 Confidentiality and intellectual property protection
3.3 Growth potential analysis
3.4 Regulatory landscape
3.5 Porter's analysis
- 3.5.1 Supplier power
- 3.5.2 Buyer power
- 3.5.3 Threat of new entrants
- 3.5.4 Threat of substitutes
- 3.5.5 Industry rivalry
3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

4.1 Introduction
4.2 Company matrix analysis
4.3 Competitive analysis of major market players
4.4 Competitive positioning matrix
4.5 Strategic dashboard

Chapter 5 Market Estimates and Forecast, By Service, 2018 - 2032 ($ Million)

5.1 Key trends
5.2 Bioanalytical testing
- 5.2.1 Clinical
- 5.2.2 Non-clinical
5.3 Method development & validation
- 5.3.1 Extractable & leachable
- 5.3.2 Impurity method
- 5.3.3 Technical consulting
- 5.3.4 Other method development & validation services
5.4 Stability testing
- 5.4.1 Drug substance testing
- 5.4.2 Stability indicating method validation
- 5.4.3 Accelerated stability testing
- 5.4.4 Photostability testing
- 5.4.5 Other stability testing services
5.5 Other services

Chapter 6 Market Estimates and Forecast, By Product Type, 2018 - 2032 ($ Million)

6.1 Key trends
6.2 Active pharmaceutical ingredient (API)
6.3 Additives
6.4 Finished products

Chapter 7 Market Estimates and Forecast, By End-User, 2018 - 2032 ($ Million)

7.1 Key trends
7.2 Pharmaceutical companies
7.3 Biopharmaceutical companies
7.4 Academics & research institutes

Chapter 8 Market Estimates and Forecast, By Region, 2018 - 2032 ($ Million)

8.1 Key trends, by region
8.2 North America
- 8.2.1 U.S.
- 8.2.2 Canada
8.3 Europe
- 8.3.1 Germany
- 8.3.2 UK
- 8.3.3 France
- 8.3.4 Spain
- 8.3.5 Italy
- 8.3.6 Rest of Europe
8.4 Asia Pacific
- 8.4.1 Japan
- 8.4.2 China
- 8.4.3 India
- 8.4.4 Australia
- 8.4.5 Rest of Asia Pacific
8.5 Latin America
- 8.5.1 Brazil
- 8.5.2 Mexico
- 8.5.3 Rest of Latin America
8.6 Middle East and Africa
- 8.6.1 South Africa
- 8.6.2 Saudi Arabia
- 8.6.3 Rest of Middle East and Africa