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市場調查報告書
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2046318

大型分子生物分析技術市場－全球產業規模、佔有率、趨勢、機會、預測：按產品/服務、應用、地區和競爭對手分類，2021-2031年

Large Molecule Bioanalytical Technologies Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Products & Services (Product, Service), By Application, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 185 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球大分子生物分析技術市場預計將從 2025 年的 97.3 億美元大幅成長至 2031 年的 176.4 億美元，複合年成長率達 10.42%。

這些技術，例如液相層析法質譜聯用和配體結合分析，對於生物檢體中生物製藥的定量分析和表徵至關重要。市場成長的根本驅動力在於全球慢性病盛行率的不斷上升，以及製藥業對複雜生物製藥（例如單株抗體）日益成長的關注，而這些產品需要進行全面的藥物動力學評估。

市場概覽
預測期 2027-2031
市場規模：2025年 97.3億美元
市場規模：2031年 176.4億美元
複合年成長率：2026-2031年 10.42%
成長最快的細分市場 生物製藥
最大的市場 北美洲

歐洲製藥業在 2024 年對研發投入了約 550 億歐元，這凸顯了對開發這些新治療方法必需的精確分析工具的強烈需求。

市場促進因素

推動市場發展的關鍵因素之一是生物製藥和生物相似藥開發平臺的快速擴張，這需要進行全面的生物分析測試以確保其安全性和有效性。隨著治療候選藥物數量的增加，特別是單株抗體和重組蛋白，對用於免疫抗原性和藥物動力學評估的高通量、高靈敏度平台的需求日益成長。例如，根據監管事務專業人員協會（RAPS）2025年1月報道，美國食品藥物管理局（FDA）在2024年核准了創紀錄的18種生物相似藥。歐洲藥品管理局（EMA）也在2024年建議核准114種新藥上市，其中許多是創新型大分子藥物。

此外，將生物分析檢測外包給合約研究組織 (CRO) 的做法日益普遍，正在顯著改變市場格局。製藥公司正利用 CRO 來減少對先進設備的資本投入，並利用其在複雜大分子化合物方面的專業知識，從而最佳化研發進度並滿足監管要求。藥明康德旗下專注於寡核苷酸和胜肽類藥物的 TIDES 業務部門，在 2024 年實現了 70.1% 的同比成長，凸顯了製藥公司對外包此類專業技術的高度依賴。

市場挑戰

市場面臨的主要障礙是高靈敏度分析儀器，特別是用於表徵單株抗體的先進平台，需要大量的資本投入。這種經濟負擔對小規模實驗室和合約研究機構（CRO）的影響尤其嚴重，限制了它們獲得關鍵分析能力，並阻礙了整個產業產能的擴張。

嚴峻的投資環境加劇了這項挑戰，導致可用於成長和技術應用的資金減少。例如，根據生技創新組織（BIO）的報告，生技新創公司的資金籌措從2025年第一季的26億美元驟降至第二季的9億美元。這種下降將直接阻礙新公司獲得必要的生物分析工具和熟練人員，導致高性能技術的應用延遲、產能短缺、藥物動力學評估延誤，並最終減緩生物製藥市場的整體成長。

市場趨勢

一個顯著的市場趨勢是將人工智慧 (AI) 整合到生物分析工作流程中。這正在改變實驗室管理複雜數據和微調檢測參數的方式。機器學習正被擴大用於自動化諸如液相色譜-質譜聯用 (LC-MS) 中的峰積分等任務，以及預測大分子化合物的免疫抗原性風險，從而減少人工數據審核的時間並提高結果的可重複性。這項創新滿足了高效處理高解析度質譜分析所獲得大量數據的需求，使科學家能夠專注於更複雜的數據解讀任務。根據皮斯托亞聯盟 (Pistoia Alliance) 發布的《2025 年未來實驗室》調查報告，77% 的生命科學實驗室計劃在兩年內實施人工智慧，使其成為加速研發的首要投資重點。

同時，我們看到細胞和基因療法專用檢測方法的開發正發生顯著變化。與傳統生物製藥不同，這些先進治療方法需要獨特的生物分析方法來量化病毒載體、評估病毒脫落並監測基因轉殖表現。根據再生醫學聯盟發布的2025年簡報，隨著這些治療方法的法律規範日趨完善和核准數量的成長，這種需求也不斷增加。 2024年，創紀錄的九種細胞和基因療法核准，因此對新型高靈敏度檢測方法的需求日益成長。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：大型分子生物分析技術的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 依產品/服務分類（產品（耗材/配件、設備、試劑/試劑盒）、服務）
    • 依應用領域（生物製劑、寡核苷酸衍生藥物/分子、病毒載體、細胞/基因療法、奈米顆粒/聚合物、其他）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美大型分子生物分析技術市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲大型分子生物分析技術市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區大型分子生物分析技術市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲大型分子生物分析技術市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲大型分子生物分析技術市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章 全球大分子生物分析技術市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • 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 BV

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 28302

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.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 9.73 Billion
Market Size 2031USD 17.64 Billion
CAGR 2026-203110.42%
Fastest Growing SegmentBiologics
Largest MarketNorth America

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