藥物分析測試外包市場規模、佔有率、成長分析、按服務、按最終用途、按地區 - 行業預測，2024-2031 年

Pharmaceutical Analytical Testing Outsourcing Market Size, Share, Growth Analysis, By Services, By End Use, By Region - Industry Forecast 2024-2031

出版日期: 2024年10月06日 | 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

2022年全球藥物分析測試外包市場規模估值為76.2億美元，從2023年的83.2億美元成長到2031年的158.9億美元，並預計在預測期內成長（2024年-2031年)預計將以複合年成長率8.42%成長。

製藥業分析測試服務外包旨在提高業務效率、降低成本並利用專業實驗室的專業知識，確保符合監管標準並維持產品品質。鑑於製藥業嚴格的監管要求，分析測試對於檢驗藥品的安全性、有效性和品質至關重要。藥物分析測試外包市場的成長受到多種因素的推動，包括生技藥品和個人化藥物等產品日益複雜，這些產品需要專業知識和先進的分析技術。此外，FDA 和 EMA 等監管機構的嚴格監管指南需要進行大量測試和記錄，這使得外包成為克服這些挑戰的有效策略。然而，公司還必須考慮資料安全、保密問題以及對測試過程可能缺乏控制等挑戰，這可能會影響計劃進度。主要市場趨勢包括採用高效液相層析(HPLC) 和質譜 (MS) 等先進技術，以及強調基於風險的方法和測試自動化。該市場提供了巨大的成長機會，特別是由於藥品核准數量不斷增加、對創新療法的研究和開發的關注以及亞太和拉丁美洲新興市場開拓的潛力。

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

競爭格局

前5名企業對比
主要企業市場定位（2023年）
主要市場參與者所採取的策略
近期市集活動
主要企業市場佔有率（2023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

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.

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