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

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个工作天内

价格

简介目录

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。

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.

简介目录

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