세계의 의약품 분석 테스트 아웃소싱 시장 규모, 점유율, 성장 분석, 서비스별, 최종 용도별, 지역별 시장 규모, 점유율, 성장 분석 - 산업 예측(2024-2031년)

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.

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 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