고분자 바이오 분석 기술 시장 : 산업 규모, 점유율, 동향, 기회, 예측 - 제품 및 서비스별, 용도별, 지역별 및 경쟁(2021-2031년)

The global market for large molecule bioanalytical technologies is projected to expand significantly, from USD 9.73 billion in 2025 to USD 17.64 billion by 2031, demonstrating a compound annual growth rate (CAGR) of 10.42%. These technologies, including liquid chromatography-mass spectrometry and ligand binding assays, are crucial for quantifying and characterizing biologic therapeutics in biological samples. The market's growth is fundamentally propelled by the rising incidence of chronic diseases worldwide and the pharmaceutical industry's increasing focus on complex biologics, such as monoclonal antibodies, which necessitate thorough pharmacokinetic assessments.

A robust investment of approximately €55 billion in research and development by the European pharmaceutical industry in 2024 highlights the strong demand for accurate analytical tools essential for developing these novel therapies.

Market Driver

A key market driver is the swift expansion of the research and development pipeline for biologics and biosimilars, which mandates comprehensive bioanalytical testing to ensure safety and efficacy. The growing number of therapeutic candidates, especially monoclonal antibodies and recombinant proteins, drives the need for high-throughput and sensitive platforms for immunogenicity and pharmacokinetic evaluations. For instance, the FDA approved a record 18 biosimilars in 2024, as reported by the Regulatory Affairs Professionals Society in January 2025, alongside the European Medicines Agency's recommendation for 114 new medicines for marketing authorization in 2024, many of which are innovative large molecules.

Furthermore, the market is significantly shaped by the increasing practice of outsourcing bioanalytical testing to Contract Research Organizations (CROs). Pharmaceutical firms engage CROs to reduce capital expenditures on advanced equipment and to leverage specialized expertise in complex large molecules, thereby optimizing development timelines and meeting regulatory demands. WuXi AppTec's TIDES business, focusing on oligonucleotide and peptide therapeutics, saw a 70.1% revenue increase year-over-year in 2024, emphasizing this reliance on outsourced specialized capabilities.

Market Challenge

A substantial hurdle for the market is the considerable capital investment required for high-sensitivity instrumentation, particularly for advanced platforms used in monoclonal antibody characterization. This financial burden disproportionately affects smaller laboratories and CROs, limiting their access to crucial analytical capabilities and hindering broader industry capacity.

This challenge is compounded by a stricter investment climate, which reduces the funding available for growth and technology procurement. For example, biotech startup funding fell sharply from $2.6 billion in Q1 2025 to $900 million in Q2, as reported by the Biotechnology Innovation Organization. This decline directly impedes new companies' ability to acquire essential bioanalytical tools and skilled personnel, thus slowing the adoption of high-performance technologies, creating capacity shortages, and delaying pharmacokinetic evaluations, ultimately retarding the overall growth of the biologic therapeutics market.

Market Trends

A notable market trend is the integration of artificial intelligence (AI) into bioanalytical workflows, transforming how laboratories manage intricate data and fine-tune assay parameters. Machine learning is increasingly employed to automate tasks like peak integration in LC-MS and to predict immunogenicity risks for large molecules, thereby decreasing manual data review time and boosting reproducibility. This innovation addresses the need for efficient processing of extensive data from high-resolution mass spectrometry, allowing scientists to concentrate on more complex interpretive work. The Pistoia Alliance's 2025 'Lab of the Future Survey' indicated that 77% of life sciences laboratories plan to adopt AI within two years, marking it as a top investment for accelerating R&D.

Parallel to this, there is a significant shift towards developing specialized assays for cell and gene therapies. These advanced treatments, unlike conventional biologics, require unique bioanalytical approaches to quantify viral vectors, assess shedding, and monitor transgene expression. This demand is growing as regulatory frameworks for these therapies mature and approvals rise, with a record nine cell and gene therapies approved in 2024, according to the Alliance for Regenerative Medicine's 2025 briefing, fueling the need for novel, high-sensitivity testing methods.

Key Market Players

• Intertek Group plc
• F. Hoffmann-La Roche Ltd
• Bio-Rad Laboratories, Inc.
• Solvias AG
• Bio-Techne Corp.
• Waters Corporation
• Verder Scientific GmbH & Co. KG
• Charles River Laboratories
• Merck KGaA
• Cergentis B.V.

Report Scope

In this report, the Global Large Molecule Bioanalytical Technologies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Large Molecule Bioanalytical Technologies Market, By Products & Services

• Product
• Service

Large Molecule Bioanalytical Technologies Market, By Application

• Biologics
• Oligonucleotide Derived Drugs & Molecules
• Viral Vector
• Cell & Gene Therapy
• Nanoparticles & Polymers
• Others

Large Molecule Bioanalytical Technologies Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Large Molecule Bioanalytical Technologies Market.

Available Customizations:

Global Large Molecule Bioanalytical Technologies Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Large Molecule Bioanalytical Technologies Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Products & Services (Product (Consumables & Accessories, Instruments, Reagents & Kits), Service)
  • 5.2.2. By Application (Biologics, Oligonucleotide Derived Drugs & Molecules, Viral Vector, Cell & Gene Therapy, Nanoparticles & Polymers, Others)
  • 5.2.3. By Region
  • 5.2.4. By Company (2025)
• 5.3. Market Map

6. North America Large Molecule Bioanalytical Technologies Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Products & Services
  • 6.2.2. By Application
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Large Molecule Bioanalytical Technologies Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Products & Services
      • 6.3.1.2.2. By Application
  • 6.3.2. Canada Large Molecule Bioanalytical Technologies Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Products & Services
      • 6.3.2.2.2. By Application
  • 6.3.3. Mexico Large Molecule Bioanalytical Technologies Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Products & Services
      • 6.3.3.2.2. By Application

7. Europe Large Molecule Bioanalytical Technologies Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Products & Services
  • 7.2.2. By Application
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Large Molecule Bioanalytical Technologies Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Products & Services
      • 7.3.1.2.2. By Application
  • 7.3.2. France Large Molecule Bioanalytical Technologies Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Products & Services
      • 7.3.2.2.2. By Application
  • 7.3.3. United Kingdom Large Molecule Bioanalytical Technologies Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Products & Services
      • 7.3.3.2.2. By Application
  • 7.3.4. Italy Large Molecule Bioanalytical Technologies Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Products & Services
      • 7.3.4.2.2. By Application
  • 7.3.5. Spain Large Molecule Bioanalytical Technologies Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Products & Services
      • 7.3.5.2.2. By Application

8. Asia Pacific Large Molecule Bioanalytical Technologies Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Products & Services
  • 8.2.2. By Application
  • 8.2.3. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Large Molecule Bioanalytical Technologies Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Products & Services
      • 8.3.1.2.2. By Application
  • 8.3.2. India Large Molecule Bioanalytical Technologies Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Products & Services
      • 8.3.2.2.2. By Application
  • 8.3.3. Japan Large Molecule Bioanalytical Technologies Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Products & Services
      • 8.3.3.2.2. By Application
  • 8.3.4. South Korea Large Molecule Bioanalytical Technologies Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Products & Services
      • 8.3.4.2.2. By Application
  • 8.3.5. Australia Large Molecule Bioanalytical Technologies Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Products & Services
      • 8.3.5.2.2. By Application

9. Middle East & Africa Large Molecule Bioanalytical Technologies Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Products & Services
  • 9.2.2. By Application
  • 9.2.3. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Large Molecule Bioanalytical Technologies Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Products & Services
      • 9.3.1.2.2. By Application
  • 9.3.2. UAE Large Molecule Bioanalytical Technologies Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Products & Services
      • 9.3.2.2.2. By Application
  • 9.3.3. South Africa Large Molecule Bioanalytical Technologies Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Products & Services
      • 9.3.3.2.2. By Application

10. South America Large Molecule Bioanalytical Technologies Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Products & Services
  • 10.2.2. By Application
  • 10.2.3. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Large Molecule Bioanalytical Technologies Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Products & Services
      • 10.3.1.2.2. By Application
  • 10.3.2. Colombia Large Molecule Bioanalytical Technologies Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Products & Services
      • 10.3.2.2.2. By Application
  • 10.3.3. Argentina Large Molecule Bioanalytical Technologies Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Products & Services
      • 10.3.3.2.2. By Application

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Large Molecule Bioanalytical Technologies Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Intertek Group plc
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. F. Hoffmann-La Roche Ltd
• 15.3. Bio-Rad Laboratories, Inc.
• 15.4. Solvias AG
• 15.5. Bio-Techne Corp.
• 15.6. Waters Corporation
• 15.7. Verder Scientific GmbH & Co. KG
• 15.8. Charles River Laboratories
• 15.9. Merck KGaA
• 15.10. Cergentis B.V.

16. Strategic Recommendations

17. About Us & Disclaimer