Large Molecule Bioanalytical Technologies Market

研究執行與發布：TechSci Research　·　發布日期 2026-05-01　·　185 頁
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出版商 TechSci Research 產業別 Healthcare & Life Sciences出版日期 2026-05-01頁數 185報告編號 TSR-28302

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Large Molecule Bioanalytical Technologies Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Products & Services (Product (Consumables & Accessories, Instruments, Reagents & Kits), Service), By Application (Biologics, Oligonucleotide Derived Drugs & Molecules, Viral Vector, Cell & Gene Therapy, Nanoparticles & Polymers, Others), By Region & Competition, 2021-2031F

報告摘要

Market Overview 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).

目錄 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

提及公司

1 Intertek Group plc2 F. Hoffmann-La Roche Ltd3 Bio-Rad Laboratories, Inc.4 Solvias AG5 Bio-Techne Corp.6 Waters Corporation7 Verder Scientific GmbH & Co. KG8 Charles River Laboratories9 Merck KGaA10 Cergentis B.V.

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