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市場調查報告書

商品編碼

1488254

藥物分析測試外包市場 - 按服務（生物分析測試[臨床、非臨床]、方法開發和驗證、穩定性測試）產品類型（API、添加劑、成品）、最終用戶和預測，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個工作天內

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簡介目錄

預計 2024 年至 2032 年間，藥品分析測試外包市場規模的複合年成長率為 8%。

外包分析測試服務使製藥公司能夠獲得專業知識、先進技術和最先進的設施，以簡化營運並縮短上市時間。例如，2023 年 11 月，食品和藥品 CRO（合約研究組織）RSSL 啟用了最先進的分析測試設施，以滿足生命科學、醫療保健、食品和消費品領域日益成長的客戶需求行業。

外包非核心活動以專注於核心能力的趨勢不斷成長，正在推動藥物分析測試外包服務的採用。透過將分析測試任務外包給第三方服務供應商，製藥公司可以更具策略性地配置資源，優先考慮研發計劃，並加速藥物開發創新，為市場成長創造機會。

藥品分析測試外包產業根據服務、產品類型、最終用戶和地區進行分類。

預計到2032 年，添加劑產品類型領域的產業規模複合年成長率將達到8.4%。監管標準。外包分析測試服務使製藥公司能夠獲得添加劑分析的專業知識，包括添加劑的識別、定量和表徵，而無需在專門設備和人員培訓方面進行大量投資。

預計 2024 年至 2032 年，生物製藥公司最終用戶在藥物分析測試外包市場的複合年成長率將達到 8.4%。生物製藥產品（包括生物製劑、生物相似藥和基因療法）的風險不斷上升，需要專門的分析測試來確保產品品質、安全性和有效性。外包合作夥伴還提供針對生物製藥獨特要求的全面分析測試能力，包括基於細胞的測定、純度評估和聚醣分析。

由於製藥業的蓬勃發展和研發活動投資的增加，亞太地區藥品分析測試外包產業規模在2024-2032年將錄得8.4%的成長率。該地區國內和跨國製藥公司採用合約研究和製造服務的情況顯著增加。監管協調工作的不斷加強以及外包作為製藥領域策略業務模式的接受程度不斷提高，將刺激區域產業的成長。

產業生態系統分析
產業影響力
- 成長動力
  - 製藥業的全球化
  - 監理框架
  - 分析儀器不斷進步
  - 日益成長的外包趨勢
- 產業陷阱與挑戰
  - 品質問題和風險緩解
  - 保密和智慧財產權保護
成長潛力分析
監管環境
波特的分析
PESTEL分析

第 4 章：競爭格局

介紹
公司矩陣分析
主要市場參與者的競爭分析
競爭定位矩陣
戰略儀表板

第 5 章：市場估計與預測：按服務分類，2018 年 - 2032 年

主要趨勢
生物分析測試
- 臨床
- 非臨床
方法開發和驗證
- 可萃取和可浸出
- 雜質法
- 技術諮詢
- 其他方法開發和驗證服務
穩定性測試
- 原料藥檢測
- 穩定性指示方法驗證
- 加速穩定性測試
- 光穩定性測試
- 其他穩定性測試服務
其他服務

第 6 章：市場估計與預測：按產品類型，2018 年 - 2032 年

主要趨勢
活性藥物成分（API）
添加劑
製成品

第 7 章：市場估計與預測：按最終用戶分類，2018 年 - 2032 年

主要趨勢
製藥公司
生物製藥公司
學術界及研究機構

第 8 章：市場估計與預測：按地區分類，2018 年 - 2032 年

主要動向：按地區
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 英國
- 法國
- 西班牙
- 義大利
- 歐洲其他地區
亞太地區
- 日本
- 中國
- 印度
- 澳洲
- 亞太地區其他地區
拉丁美洲
- 巴西
- 墨西哥
- 拉丁美洲其他地區
中東和非洲
- 南非
- 沙烏地阿拉伯
- 中東和非洲其他地區

第 9 章：公司簡介

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

簡介目錄

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