바이오 분석 시험 서비스 시장 : 유형, 용도, 최종 사용자별 - 세계 예측(2025-2030년)

The Bioanalytical Testing Services Market was valued at USD 4.33 billion in 2023, expected to reach USD 4.74 billion in 2024, and is projected to grow at a CAGR of 9.63%, to USD 8.24 billion by 2030.

The bioanalytical testing services market encompasses a range of analytical methods employed to detect and quantify biomarkers and pharmaceuticals in biological systems. It is essential due to the increasing complexity of biologics and a growing pipeline of new drugs necessitating detailed and accurate testing for regulatory approvals and quality assurance. These services find applications in pharmacokinetics, pharmacodynamics, bioequivalence, and toxicology studies, serving end-use industries like pharmaceuticals, biotechnology, and contract research organizations. A surge in chronic diseases, the burgeoning biologic industry, and advances in personalized medicine are significant growth drivers, indicating a strong necessity for expanded bioanalytical capabilities.

Market growth is influenced by technological advancements such as liquid chromatography-tandem mass spectrometry (LC-MS/MS) for accurate quantitation and increased outsourcing of R&D activities by pharmaceutical companies to focus on core competencies. Emerging opportunities include the growing demand for biomarker testing and the increasing use of bioanalytical testing in companion diagnostics due to advancements in personalized therapy. Companies should invest in these burgeoning fields to capitalize on market potential. However, the bioanalytical testing services market faces challenges, including high competition among service providers, strict regulatory landscapes, and the need for continuous technological upgrades, which can be cost-prohibitive.

For innovation and research, companies should explore developing cost-effective and rapid testing methodologies, AI and machine learning integration for data analysis, and expanding capabilities in cell-based assay testing. The market, characterized by dynamic competition, necessitates continuous adaptation to technological advancements and evolving client requirements. Companies can gain a competitive edge by enhancing their service offerings and maintaining compliance with international regulatory standards. Investments in state-of-the-art laboratories, skilled personnel, and strategic partnerships are prudent recommendations to leverage the current growth opportunities while navigating market limitations effectively.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Bioanalytical Testing Services Market

The Bioanalytical Testing Services Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Rising focus on the analytical testing of biologics and biosimilars
  • Growing R&D expenditure in the pharmaceutical and biopharmaceutical industry
  • Rising adoption of the quality by design approach
• Market Restraints
  • Pricing pressure and dearth of skilled professionals faced by major players
• Market Opportunities
  • Rising demand for specialized bioanalytical testing services
  • Increasing economic efficiency offered for outsourcing rather than conducting an in-house study
  • Emergence of technological advancements and approvals of clinical trials in the bioanalytical testing services
• Market Challenges
  • Concerns regarding innovative formulations demanding a unique bioanalytical testing approach

Porter's Five Forces: A Strategic Tool for Navigating the Bioanalytical Testing Services Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Bioanalytical Testing Services Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Bioanalytical Testing Services Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Bioanalytical Testing Services Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Bioanalytical Testing Services Market

A detailed market share analysis in the Bioanalytical Testing Services Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Bioanalytical Testing Services Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Bioanalytical Testing Services Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Bioanalytical Testing Services Market

A strategic analysis of the Bioanalytical Testing Services Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Bioanalytical Testing Services Market, highlighting leading vendors and their innovative profiles. These include Absorption Systems LLC, Almac Group Limited, Altasciences, BioAgilytix Labs, LLC, Celerion, Inc., Charles River Laboratories International, Inc., Eurofins Scientific SE, Frontage Laboratories, Inc., Icon PLC, Intertek Group PLC, IQVIA Holdings Inc., Laboratory Corporation of America Holdings, LGC Limited, Lotus Labs Pvt. Ltd., Lotus Labs Pvt. Ltd. by Teva Pharmaceutical Industries Ltd., Medpace Holdings, Inc., NorthEast BioAnalytical Laboratories LLC, Pace Analytical Services LLC, Parexel International Corporation, PPD Inc., Q2 Solutions, SGS Societe Generale de Surveillance SA, Syneos Health, LLC, and WuXi AppTec Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Bioanalytical Testing Services Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Type, market is studied across Biomarker Testing, Cell-Based Assays, Method Development Optimization & Validation, Pharmacokinetic Testing, Serology, Immunogenicity, & Neutralizing Antibodies, and Virology Testing. The Cell-Based Assays is further studied across Bacterial Cell-Based Assays and Viral Cell-Based Assays. The Virology Testing is further studied across In Vitro Virology Testing, In Vivo Virology Testing, and Species-Specific Viral PCR Assays.
• Based on Application, market is studied across Cardiology, Gastroenterology, Infectious Diseases, Neurology, and Oncology.
• Based on End User, market is studied across Contract Development & Manufacturing Organizations, Contract Research Organizations, and Pharmaceutical & Biopharmaceutical Companies.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Rising focus on the analytical testing of biologics and biosimilars
    • 5.1.1.2. Growing R&D expenditure in the pharmaceutical and biopharmaceutical industry
    • 5.1.1.3. Rising adoption of the quality by design approach
  • 5.1.2. Restraints
    • 5.1.2.1. Pricing pressure and dearth of skilled professionals faced by major players
  • 5.1.3. Opportunities
    • 5.1.3.1. Rising demand for specialized bioanalytical testing services
    • 5.1.3.2. Increasing economic efficiency offered for outsourcing rather than conducting an in-house study
    • 5.1.3.3. Emergence of technological advancements and approvals of clinical trials in the bioanalytical testing services
  • 5.1.4. Challenges
    • 5.1.4.1. Concerns regarding innovative formulations demanding a unique bioanalytical testing approach
• 5.2. Market Segmentation Analysis
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Bioanalytical Testing Services Market, by Type

• 6.1. Introduction
• 6.2. Biomarker Testing
• 6.3. Cell-Based Assays
  • 6.3.1. Bacterial Cell-Based Assays
  • 6.3.2. Viral Cell-Based Assays
• 6.4. Method Development Optimization & Validation
• 6.5. Pharmacokinetic Testing
• 6.6. Serology, Immunogenicity, & Neutralizing Antibodies
• 6.7. Virology Testing
  • 6.7.1. In Vitro Virology Testing
  • 6.7.2. In Vivo Virology Testing
  • 6.7.3. Species-Specific Viral PCR Assays

7. Bioanalytical Testing Services Market, by Application

• 7.1. Introduction
• 7.2. Cardiology
• 7.3. Gastroenterology
• 7.4. Infectious Diseases
• 7.5. Neurology
• 7.6. Oncology

8. Bioanalytical Testing Services Market, by End User

• 8.1. Introduction
• 8.2. Contract Development & Manufacturing Organizations
• 8.3. Contract Research Organizations
• 8.4. Pharmaceutical & Biopharmaceutical Companies

9. Americas Bioanalytical Testing Services Market

• 9.1. Introduction
• 9.2. Argentina
• 9.3. Brazil
• 9.4. Canada
• 9.5. Mexico
• 9.6. United States

10. Asia-Pacific Bioanalytical Testing Services Market

• 10.1. Introduction
• 10.2. Australia
• 10.3. China
• 10.4. India
• 10.5. Indonesia
• 10.6. Japan
• 10.7. Malaysia
• 10.8. Philippines
• 10.9. Singapore
• 10.10. South Korea
• 10.11. Taiwan
• 10.12. Thailand
• 10.13. Vietnam

11. Europe, Middle East & Africa Bioanalytical Testing Services Market

• 11.1. Introduction
• 11.2. Denmark
• 11.3. Egypt
• 11.4. Finland
• 11.5. France
• 11.6. Germany
• 11.7. Israel
• 11.8. Italy
• 11.9. Netherlands
• 11.10. Nigeria
• 11.11. Norway
• 11.12. Poland
• 11.13. Qatar
• 11.14. Russia
• 11.15. Saudi Arabia
• 11.16. South Africa
• 11.17. Spain
• 11.18. Sweden
• 11.19. Switzerland
• 11.20. Turkey
• 11.21. United Arab Emirates
• 11.22. United Kingdom

12. Competitive Landscape

• 12.1. Market Share Analysis, 2023
• 12.2. FPNV Positioning Matrix, 2023
• 12.3. Competitive Scenario Analysis
• 12.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Absorption Systems LLC
• 2. Almac Group Limited
• 3. Altasciences
• 4. BioAgilytix Labs, LLC
• 5. Celerion, Inc.
• 6. Charles River Laboratories International, Inc.
• 7. Eurofins Scientific SE
• 8. Frontage Laboratories, Inc.
• 9. Icon PLC
• 10. Intertek Group PLC
• 11. IQVIA Holdings Inc.
• 12. Laboratory Corporation of America Holdings
• 13. LGC Limited
• 14. Lotus Labs Pvt. Ltd.
• 15. Lotus Labs Pvt. Ltd. by Teva Pharmaceutical Industries Ltd.
• 16. Medpace Holdings, Inc.
• 17. NorthEast BioAnalytical Laboratories LLC
• 18. Pace Analytical Services LLC
• 19. Parexel International Corporation
• 20. PPD Inc.
• 21. Q2 Solutions
• 22. SGS Societe Generale de Surveillance SA
• 23. Syneos Health, LLC
• 24. WuXi AppTec Co., Ltd.