醫藥分析測試外包市場規模、佔有率及成長分析(按類型、應用、最終用戶和地區分類)-產業預測,2026-2033年
市場調查報告書
商品編碼
1896770

醫藥分析測試外包市場規模、佔有率及成長分析(按類型、應用、最終用戶和地區分類)-產業預測,2026-2033年

Pharmaceutical Analytical Testing Outsourcing Market Size, Share, and Growth Analysis, By Type (Active Pharmaceutical Ingredient, Finished Products), By Application, By End User, By Region -Industry Forecast 2026-2033

出版日期: | 出版商: SkyQuest | 英文 219 Pages | 商品交期: 3-5個工作天內

價格
簡介目錄

預計到 2024 年,醫藥分析測試外包市場規模將達到 90.2 億美元,到 2025 年將達到 97.8 億美元,到 2033 年將達到 186.7 億美元,預測期(2026-2033 年)的複合年成長率為 8.42%。

外包藥物分析檢測正在變革藥物研發,並透過全面的檢測方法確保藥物安全。藥物療效依賴於精準的劑量控制和雜質的去除,凸顯了詳細分析評估的必要性。這些評估不僅最佳化了生產和儲存流程,也有助於生物製藥的特性分析,進而提升整體產品品質。對先進分析設備和專業技術人員日益成長的需求,以及許多公司內部資源的匱乏,共同推動了外包趨勢的發展。此外,生物製藥研發的快速發展也進一步刺激了外包檢測服務的需求。最終,這種策略方法使企業能夠在專注於自身核心競爭力的同時,確保其藥品的完整性和安全性。

醫藥分析測試外包市場促進因素

隨著全球監管要求日益嚴格,製藥公司正致力於確保藥品安全性和有效性符合標準。這種嚴格性促使更多企業尋求專業知識以符合複雜的法規要求,從而推動了對外包分析測試服務的需求。透過利用外部服務,企業可以提高產品品質和可靠性,同時降低違規風險。這一趨勢凸顯了製藥業向戰略夥伴關係的更廣泛轉變,在製藥業,分析測試外包對於保持競爭優勢和有效滿足嚴格的行業標準至關重要。

醫藥分析測試外包市場的限制因素

醫藥分析測試外包市場面臨許多挑戰,主要源自於對資料安全和保密的擔憂。製藥公司往往不願將分析測試服務外包,因為共用敏感的專有資訊有潛在風險。這種擔憂源於對未經授權披露和寶貴知識產權可能遭受損失的恐懼。因此,該行業已將制定強力的網路安全措施和建立合作夥伴之間的信任作為首要任務,以緩解這些擔憂。確保資料保護對於鼓勵該行業對外包持更積極的態度至關重要。

醫藥分析測試外包市場趨勢

受生物製藥和生物相似藥需求不斷成長的推動,醫藥分析檢測外包市場呈現顯著上升趨勢。隨著製藥公司擴大將生物分析檢測需求外包給外包合作夥伴,它們得以獲得開發複雜生物製藥所需的最尖端科技和專業知識。這種策略性外包不僅提高了藥物開發流程的效率,還確保了符合嚴格的品質和監管標準。因此,對創新療法日益成長的需求與合約服務供應商的回應能力之間的相互作用正在重塑醫藥分析檢測外包格局,並促進整個行業的成長與合作。

目錄

介紹

  • 調查目標
  • 定義
  • 市場覆蓋範圍

調查方法

  • 資訊收集
  • 二手和一手資料資訊來源
  • 市場規模預測
  • 市場假設與限制

執行摘要

    前景
  • 供需趨勢分析
  • 細分市場機會分析

市場動態與展望

  • 市場動態
    • 促進要素
    • 機會
    • 抑制因素
    • 任務
  • 波特分析

關鍵市場考察

  • 關鍵成功因素
  • 競爭程度
  • 關鍵投資機會
  • 市場生態系統
  • 監管環境
  • PESTEL 分析

按服務分類的製藥分析測試外包市場

  • 生物分析測試
    • 臨床
    • 非臨床
  • 方法開發與驗證
    • 萃取物/洗脫液
    • 雜質分析
    • 技術諮詢
    • 其他
  • 穩定性測試
    • 原料藥
    • 穩定性指示方法的驗證
    • 加速穩定性測試
    • 光穩定性測試
    • 其他
  • 其他

按最終用途分類的製藥分析測試外包市場

  • 製藥公司
  • 生物製藥公司
  • CRO(合約研究組織)

醫藥分析測試外包市場:按地區分類的市場規模:

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 西班牙
    • 法國
    • 英國
    • 義大利
    • 其他歐洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 韓國
    • 亞太其他地區
  • 拉丁美洲
    • 巴西
    • 其他拉丁美洲
  • 中東和非洲(MEA)
    • 海灣合作理事會國家
    • 南非
    • 其他中東和非洲地區

競爭格局

  • 前五大公司對比
  • 主要企業的市場定位(2025 年)
  • 主要市場參與者所採取的策略
  • 近期市集活動
  • 主要企業市佔率(2025 年)

主要企業簡介

  • 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.
簡介目錄
Product Code: SQMIG35C2024

Pharmaceutical Analytical Testing Outsourcing Market size was valued at USD 9.02 Billion in 2024 and is poised to grow from USD 9.78 Billion in 2025 to USD 18.67 Billion by 2033, growing at a CAGR of 8.42% during the forecast period (2026-2033).

Pharmaceutical analytical testing outsourcing is transforming drug development and ensuring safety through comprehensive testing methodologies. The efficacy of medications is dependent on precise dosages and the absence of contaminants, highlighting the necessity for detailed analytical evaluations. These evaluations not only optimize production and storage processes but also facilitate the characterization of biologics and enhance overall product quality. The growing need for sophisticated analytical instruments and skilled professionals drives the outsourcing trend, as numerous companies lack these resources in-house. Additionally, the rapid advancement in biological development further escalates the demand for outsourced testing services. Ultimately, with this strategic approach, companies can focus on their core competencies while ensuring the integrity and safety of their pharmaceutical products.

Top-down and bottom-up approaches were used to estimate and validate the size of the 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.

Pharmaceutical Analytical Testing Outsourcing Market Segments 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.

Driver of the Pharmaceutical Analytical Testing Outsourcing Market

As global regulatory requirements intensify, pharmaceutical manufacturers are increasingly focused on ensuring compliance with drug safety and efficacy standards. This heightened scrutiny propels the demand for outsourced analytical testing services, as companies seek specialized expertise to navigate complex regulations. By leveraging these external services, firms can reduce the risk of non-compliance while also enhancing the quality and reliability of their products. The trend underscores a broader shift towards strategic partnerships in the pharmaceutical sector, where outsourcing analytical testing becomes essential for maintaining competitive advantage and meeting stringent industry standards effectively.

Restraints in the Pharmaceutical Analytical Testing Outsourcing Market

The pharmaceutical analytical testing outsourcing market faces significant challenges primarily due to concerns about data security and confidentiality. Companies in the pharmaceutical sector are often hesitant to outsource their analytical testing services due to the potential risks associated with sharing sensitive proprietary information. This anxiety stems from the fear of unauthorized disclosures and the potential loss of valuable intellectual property. As a result, the industry places a high priority on developing robust cybersecurity measures and fostering trust between partners to mitigate these concerns. Ensuring data protection is essential for encouraging a more open attitude towards outsourcing in this sector.

Market Trends of the Pharmaceutical Analytical Testing Outsourcing Market

The Pharmaceutical Analytical Testing Outsourcing market is experiencing a significant upward trend, primarily fueled by the escalating demand for biologic drugs and biosimilars. As pharmaceutical companies increasingly turn to outsourcing partners for their bioanalytical testing needs, they gain access to cutting-edge technologies and specialized expertise essential for developing complex biologics. This strategic outsourcing not only enhances the efficiency of drug development processes but also ensures compliance with stringent quality and regulatory standards. Consequently, the interplay between heightened demand for innovative therapeutics and the capacity of contract service providers is reshaping the landscape of pharmaceutical analytical testing outsourcing, promoting growth and collaboration across the industry.

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 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, 2025
  • Strategies Adopted by Key Market Players
  • Recent Activities in the Market
  • Key Companies Market Share (%), 2025

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