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市場調查報告書
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2132595

體外診斷質譜分析全球市場（2026 年）

The Worldwide Market for Mass Spectrometry in IVD Markets, 2026
出版日期: | 出版商: Kalorama Information | 英文 233 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

體外診斷質譜分析全球市場（2026 年）

質譜技術正從專門的分析技術轉變為主流的臨床診斷平台，為臨床實驗室醫學創造了最重要的成長機會之一。

在很長一段時間裡，質譜（MS）技術僅限於研究機構、製藥公司實驗室和專業參考檢測機構。其無與倫比的分析靈敏度和特異性使其成為複雜診斷的關鍵技術，但高成本、複雜的技術以及耗時的工作流程阻礙了其在臨床領域的廣泛應用。然而，這種情況正在迅速改變。監管標準化、工作流程自動化、整合體外診斷（IVD）解決方案以及主要行業參與者的加大投入，正在加速質譜技術向常規臨床診斷的轉變。

市場機會龐大。未來五年，在全球質譜市場規模預計將成長近一倍的背景下，臨床應用日益廣泛、自動化技術不斷進步、人工智慧（AI）應用日益普及以及質譜技術持續從專業檢查室向主流診斷流程轉移，都將推動質譜市場的發展。儘管科學研究應用依然重要，但最具長期成長潛力的領域在於臨床診斷，目前質譜市場在該領域的滲透率仍處於起步階段，未來仍有巨大的成長空間。

Kalorama Information發布的報告《全球體外診斷質譜市場（2026）》檢驗了質譜技術如何變革臨床檢測，其應用範圍涵蓋微生物鑑定、治療藥物監測、類固醇和激素分析、維生素D檢測、新生兒篩檢、毒理學、代謝體學學以及新興的蛋白質組學診斷等諸多領域。該報告檢驗了推動質譜技術作為傳統免疫檢測替代方案的競爭優勢，並評估了其對臨床實驗室醫學可能帶來的顛覆性變革。

除了目前的應用領域，《2026年全球體外診斷（IVD）質譜市場》報告還分析了未來十年將影響市場發展的技術、監管和商業性因素。這些因素包括：全自動臨床工作流程的擴展、人工智慧（AI）在數據解讀和檢查室效率提升方面的應用日益廣泛、儀器的持續小型化、即時檢測的興起、質譜成像和太空生物學的進步，以及高通量分析和單細胞分析日益成長的重要性。尤其值得一提的是，自動化不僅被視為診斷趨勢，更被視為解決全球臨床檢查室長期面臨的勞動力短缺問題的關鍵方案。

對於企業主管、投資者和策略規劃者而言，《2026年全球體外診斷（IVD）質譜市場》報告揭示了儀器、耗材、IVD試劑盒、檢查室自建檢測（LDT）、軟體和工作流程解決方案等各個環節的價值創造所在。該報告評估了主要供應商的競爭地位，並檢驗了正在改變產業格局、影響未來市場領導地位的收購、合作、資金籌措和技術協作等措施。

對於行銷、產品管理和業務發展團隊而言，本研究深入分析了不斷變化的客戶需求、購買趨勢、採用障礙、報銷趨勢以及最有效地推動臨床質譜技術從利基技術過渡到常規實驗室實踐的市場故事。

這份面向全球發布的報告《2026年體外診斷質譜市場》分析了北美、歐洲、日本、中國、印度和其他新興市場的商業機會。報告還檢驗了檢查室開發測試和體外診斷產品法規環境的演變、更廣泛的經濟狀況的影響，以及預計在2030年前影響投資、採購決策和競爭策略的趨勢。

關於質譜技術是否適用於臨床檢查室的爭論如今已成為過去。現在的問題是，隨著臨床質譜技術成為主流方法，哪些公司能夠抓住其帶來的價值。

目錄

第1章執行摘要

第2章：質譜學簡介

  • 背景
  • 質譜簡史
  • 連字符技術
  • 其他方法
  • 人工智慧的最新趨勢和影響
  • 質譜市場細分
    • 臨床檢查室
    • 質譜實驗室自建檢測方法 (LDT)
    • 體外診斷醫療器材（IVD）
    • 質譜研究與應用
    • 質譜的其他應用

第3章：質譜儀及其製造商

  • 一家銷售質譜平台及相關產品的公司。
    • 表 3-1：銷售質譜儀和/或臨床檢查室檢測方法的主要公司（CE 標誌和/或 510(k)已通過核准）
  • 價格趨勢
  • 新產品開發和人工智慧的發展趨勢
  • 與人工智慧整合
  • 銷售和分銷趨勢

第4章 質譜市場的促進因素與挑戰

  • 市場促進因素
    • 技術進步
    • 質譜分析
    • 次世代定序
    • 人工智慧在雷射診斷技術開發的應用
    • 擴大質譜和NGS的應用範圍
    • 質譜分析
    • 次世代定序
    • 個人化醫療
    • 個人化醫療、多發性硬化症以及實驗室自建技術與人工智慧的交叉領域
    • 伴隨診斷
    • 全球衛生和生物安全
    • 桌上型和攜帶式質譜系統的興起
    • 自動化與資訊科學的融合
    • 遵守環境和食品安全法規
  • 市場挑戰
    • 監管變化
    • 從CLIA檢測服務過渡到體外診斷試劑盒
    • 贖回
    • 獲取投資者資金的管道受到限制。
    • 技術純熟勞工短缺
    • 供應鏈與地緣政治壓力

第5章：質譜市場分析

  • 全球質譜市場
  • 質譜市場（依技術分類）
  • 按地區分類的質譜市場
  • 競爭分析

第6章：實驗室自研檢測市場及質譜技術的作用

  • 市面上LDT的數量
    • 少量與大量
    • 疾病特異性細分實驗室自建檢測服務市場
    • 感染疾病
    • 腫瘤學
    • 基因檢測
    • 其他測試實驗室開發測試
  • LDT 服務市場（按地區分類）
  • LDT產品和試劑按市場細分（PCR、質譜、NGS、微陣列、其他）分類
  • 質譜分析
  • 體外診斷試劑盒
  • LDT市場中使用的產品和試劑的地理分佈

第7章：經濟影響

  • 臨床試驗
  • 當前經濟情勢

第8章：公司簡介

  • 908 DEVICES, INC.
  • ABBOTT LABORATORIES
  • ADVION
  • AGENA BIOSCIENCE
  • AGILENT TECHNOLOGIES INC.
  • ALIRI BIOANALYSIS
  • BECKMAN COULTER, INC
  • BGI
  • BIOCRATES LIFE SCIENCES, AG
  • BIODESIX, INC
  • BIOGNOSYS AG
  • BIOMERIEUX
  • BIO-RAD LABORATORIES
  • BRUKER CORPORATION
  • CELLCARTA
  • CHARLES RIVER LABORATORIES
  • DANAHER CORPORATION
  • JEOL, LTD
  • MICROSAIC SYSTEMS PLC
  • MOSAIQUES DIAGNOSTICS AND THERAPEUTICS AG
  • PERKINELMER, INC./REVVITY
  • PROTEOME SCIENCES PLC
  • ROCHE
  • SCIEX PTE LTD.
  • SERA PROGNOSTICS
  • SHIMADZU CORP
  • STANDARD BIOTOOLS
  • THERMO FISHER SCIENTIFIC, INC
  • VIOME LIFE SCIENCES
  • WATERS CORPORATION
簡介目錄
Product Code: 26-045KA

The Worldwide Market for Mass Spectrometry in IVD Markets, 2026

Mass spectrometry is transitioning from a specialized analytical technology into a mainstream clinical diagnostics platform, creating one of the most significant growth opportunities in laboratory medicine.

For much of its history, mass spectrometry (MS) was confined to research institutions, pharmaceutical laboratories, and specialized reference testing facilities. Its unmatched analytical sensitivity and specificity made it indispensable for complex testing, but high costs, technical complexity, and labor-intensive workflows limited broader clinical adoption. That dynamic is changing rapidly. Today, regulatory standardization, workflow automation, integrated IVD solutions, and growing investment from major industry players are accelerating the movement of mass spectrometry into routine clinical diagnostics.

The market opportunity is substantial. Over the next five years, the global mass spectrometry market is expected to nearly double in size, driven by expanding clinical adoption, increasing automation, growing use of artificial intelligence, and the continued shift of mass spectrometry from specialist laboratories into mainstream diagnostic workflows. While research applications remain important, the most significant long-term growth opportunity lies within clinical diagnostics, where mass spectrometry remains in the early stages of market penetration and substantial room for expansion remains.

Kalorama Information’s The Worldwide Market for Mass Spectrometry in IVD Markets, 2026 examines how mass spectrometry is reshaping clinical laboratory testing across applications including microbial identification, therapeutic drug monitoring, steroid and hormone analysis, vitamin D testing, newborn screening, toxicology, metabolomics, and emerging proteomic diagnostics. It explores the competitive advantages driving adoption over traditional immunoassay-based methods and assesses where mass spectrometry is likely to become a disruptive force in laboratory medicine.

Beyond current applications, The Worldwide Market for Mass Spectrometry in IVD Markets, 2026 analyzes the technological, regulatory, and commercial forces that will define the market over the next decade. These include the expansion of fully automated clinical workflows, increasing use of artificial intelligence for data interpretation and laboratory efficiency, continued miniaturization of instruments, the emergence of point-of-need testing, advances in mass spectrometry imaging and spatial biology, and the growing importance of high-throughput and single-cell analysis. Particular attention is given to automation not as a diagnostic trend alone, but as a critical response to the chronic workforce shortages facing clinical laboratories worldwide.

For executives, investors, and strategic planners, The Worldwide Market for Mass Spectrometry in IVD Markets, 2026 identifies where value creation is occurring across instruments, consumables, IVD kits, laboratory-developed tests, software, and workflow solutions. It evaluates the competitive positions of leading suppliers while examining acquisitions, partnerships, financings, and technology alliances that are reshaping the industry and influencing future market leadership.

For marketing, product management, and business development teams, the study provides insight into evolving customer needs, purchasing trends, adoption barriers, reimbursement dynamics, and the market narratives that are most effectively driving adoption as clinical mass spectrometry moves from a niche capability toward routine laboratory practice.

Global in scope, The Worldwide Market for Mass Spectrometry in IVD Markets, 2026 analyzes opportunities across North America, Europe, Japan, China, India, and other emerging markets. It also examines the evolving regulatory environment for laboratory-developed tests and IVD products, the impact of broader economic conditions, and the trends expected to influence investment, purchasing decisions, and competitive strategy through 2030.

The question is no longer whether mass spectrometry belongs in the clinical laboratory. The question is which companies will capture the value created as clinical mass spectrometry moves into the mainstream.

Table of Contents

CHAPTER 1: EXECUTIVE SUMMARY

  • ABOUT KALORAMA INFORMATION
  • OVERVIEW
    • History
    • Current Use of Mass Spectrometry
    • SCOPE AND METHODOLOGY
    • Point of View
  • MARKET OVERVIEW
  • FUTURE PROSPECTS IN THE MASS SPECTROMETRY MARKET
    • Miniaturization and Point-of-Need Analysis
    • Artificial Intelligence and Autonomous Automation
    • Clinical and Spatial Integration
    • High-Throughput Omics and Single-Cell Analysis

CHAPTER 2: INTRODUCTION TO MASS SPECTROMETRY

  • BACKGROUND
  • BRIEF HISTORY OF MASS SPECTROMETRY
    • Ionization Techniques
      • Electrospray Ionization (ESI)
      • Matrix-Assisted Laser Desorption/Ionization (MALDI)
      • Atmospheric Pressure Chemical Ionization (APCI)
      • Atmospheric Pressure Photoionization (APPI)
    • Mass Analyzers
      • Quadrupole
      • Time-of-Flight (ToF)
      • Ion Trap
      • Ion Cyclotron Resonance
  • Hyphenated Techniques
    • GC/MS
    • LC/MS
    • TOF-MALDI
    • ICP-MS
    • CE/MS
  • Other Techniques
    • Tandem Mass Spectrometry
    • Shotgun Proteomics
  • Latest Developments and the Impact of AI
    • Trapped Ion Mobility Spectrometry-Mass Spectrometry (TIMS-MS)
    • High-Speed Hybrid Analyzers
    • High-Resolution Charge Detection Mass Spectrometry (CDMS)
    • AI-Driven Computational Mass Spectrometry & Real-Time Data Acquisition
  • MASS SPECTROMETRY MARKET SEGMENTS
    • Clinical Laboratories
      • Oncology
      • Infectious Disease
      • Other Clinical Applications of Mass Spectrometry
    • Laboratory-Developed Tests (LDTs) for Mass Spectrometry
      • Historical FDA Regulation of LDTs
      • Current 2026 Status of FDA Regulations and Implications
      • European Regulatory Landscape
      • Regulation in Rest of World
    • In Vitro Diagnostics (IVDs)
      • Regulatory Environment
      • MS Instrument Regulatory Approval
    • Research Applications of Mass Spectrometry
    • Other Applications of Mass Spectrometry

CHAPTER 3: MASS SPECTROMETRY PRODUCTS AND MANUFACTURERS

  • COMPANIES MARKETING MASS SPECTROMETRY PLATFORMS AND RELATED PRODUCTS
    • Table 3-1: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-marked and/or 510(k) cleared]
  • Pricing Trends
  • New Product Development Trends and AI
  • Integration with AI
  • Sales and Distribution Trends

CHAPTER 4: MARKET DRIVERS AND CHALLENGES IN MASS SPECTROMETRY

  • MARKET DRIVERS
    • Technological Advancements
    • Mass Spectrometry
    • Next Generation Sequencing
    • AI in LDT Development
    • Expanding Applications for MS and NGS
    • Mass Spectrometry
    • Next Generation Sequencing
    • Personalized Medicine
    • The Intersection of Personalized Medicine, MS and LDTs with AI
    • Companion Diagnostics
    • Global Health and Biosecurity
    • Rise of Benchtop and Portable MS Systems
    • Automation and Informatics Integration
    • Environmental and Food Safety Compliance
  • MARKET CHALLENGES
    • Regulatory Changes
    • Conversion from CLIA Lab Services Offerings to IVD Kits
      • Table 4-1: Selected FDA Approved/Cleared Laboratory-Developed Tests
    • Reimbursement
      • The Protecting Access to Medicare Act (PAMA)
    • Reduced Access to Investor Capital
      • Initial Public Offerings (IPOs) and Financings
      • Table 4-2: Selected IPOs of Key Clinical Diagnostics and/or LDT Players, 2020-2026
      • Mergers and Acquisitions
      • Table 4-3: Selected Acquisitions of or by Companies/Laboratories with LDTs, 2020-2026
    • Skilled Workforce Shortage
    • Supply Chain and Geopolitical Pressures
      • Semiconductor Shortages, AI Competition, and "Chipflation"
      • Strategic Implications for Clinical Laboratories

CHAPTER 5: MASS SPECTROMETRY MARKET ANALYSIS

  • WORLDWIDE MASS SPECTROMETRY MARKET
    • Table 5-1: Global Market for Mass Spectrometry Instruments, Microbiology vs. Non-Microbiology Segments, 2025–2030 (US$ millions)
    • Figure 5-1: Global Market for Mass Spectrometry Instruments, Microbiology vs. Non-Microbiology Segments, 2025–2030 (US$ millions)
    • Table 5-2: Global Market for Mass Spectrometry Instruments by Segment, Share of Total, 2025 vs. 2030 (%) [Microbiology, Non-Microbiology]
    • Figure 5-2: Global Market for Mass Spectrometry Instruments by Segment, Share of Total, 2025 vs. 2030 (%) [Microbiology, Non-Microbiology]
  • Mass Spectrometry Market by Technology
    • Table 5-3: Global Market for Mass Spectrometry Instruments, by Technology, 2025–2030 (US$ millions) [FT/MS & Ion Trap, GC/MS, ICP-MS, LC/MS-MS, LC-TOF/Q-TOF, MALDI-TOF]
    • Figure 5-3: Global Mass Spectrometry Instrument Market by Technology, 2025 and 2030 (US$ millions) [FT/MS & Ion Trap, GC/MS, ICP-MS, LC/MS-MS, LC-TOF/Q-TOF, MALDI-TOF]
    • Figure 5-4: Mass Spectrometry Technologies, Market Size and Forecast CAGR, Size in 2025 vs. Growth to 2030 [FT/MS & Ion Trap, GC/MS, ICP-MS, LC/MS-MS, LC-TOF/Q-TOF, MALDI-TOF]
    • Table 5-4: Global Market for Mass Spectrometry Instruments by Technology, Share of Total, 2025 vs. 2030 (%) [FT/MS & Ion Trap, GC/MS, ICP-MS, LC/MS-MS, LC-TOF/Q-TOF, MALDI-TOF]
    • Figure 5-5: Global Mass Spectrometry Instrument Market Share, by Technology, 2025–2030 (%) [FT/MS & Ion Trap, GC/MS, ICP-MS, LC/MS-MS, LC-TOF/Q-TOF, MALDI-TOF]
  • Mass Spectrometry Market by Region
    • Table 5-5: Global Market for Mass Spectrometry Instruments, by Region, 2025–2030 (US$ millions) [China, Europe, India, Japan, Latin America, US & Canada, Rest of World]
    • Figure 5-6: Global Market for Mass Spectrometry Instruments by Region, 2025 vs. 2030 (US$ millions) [China, Europe, India, Japan, Latin America, US & Canada, Rest of World]
    • Figure 5-7: Mass Spectrometry Regional Market Size and Forecast CAGR, Size in 2025 vs. Growth to 2030 [China, Europe, India, Japan, Latin America, US & Canada, Rest of World]
    • Table 5-6: Global Mass Spectrometry Instrument Market Share, by Region, 2025–2030 (%) [China, Europe, India, Japan, Latin America, US & Canada, Rest of World]
    • Figure 5-8: Global Mass Spectrometry Instrument Market Share, by Region, 2025–2030 (%) [China, Europe, India, Japan, Latin America, US & Canada, Rest of World]
  • COMPETITIVE ANALYSIS
    • Table 5-7: Total Estimated Mass Spectrometry Sales and Share of Key Mass Spectrometry Players, 2025 (US$ millions)
    • Figure 5-9: Market Shares of Key Mass Spectrometry Players, 2025 (%)

CHAPTER 6: THE LABORATORY-DEVELOPED TEST MARKET AND ROLE OF MASS SPECTROMETRY

  • THE NUMBER OF LDTS ON THE MARKET
    • Small versus Large Volume
    • LDT Services Market by Disease Segment
      • Table 6-1: Laboratory-Developed Test Services Market, Major Clinical (Disease) Segments, 2025–2030, (US$ millions) [Genetic Testing, Infectious Disease, Oncology LDT Services Market]
    • Infectious Disease
    • Oncology
    • Genetic Testing
    • Other Laboratory-Developed Tests
  • LDT SERVICES MARKET BY GEOGRAPHY
    • Table 6-2: Laboratory-Developed Test Services Market by Geographical Distribution, 2025–2030, (US$ millions)
  • LDT PRODUCTS AND REAGENTS BY MARKET SEGMENT (PCR, MASS SPECTROMETRY, NGS. MICROARRAYS AND OTHER)
    • Table 6-3: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2025–2030 (US$ millions) [Mass Spectrometry, Next Generation Sequencing, Polymerase Chain Reaction, Other Assays (Microarrays, Other)]
  • Mass Spectrometry
    • Figure 6-1: Mass Spectrometry Applications by Clinical Category, Share of Total Mass Spectrometry Applications, 2025 and 2030 (%) [Metabolomics, Microbiology, Newborn Screening, Proteomics, Steroid Hormones, Therapeutic Drug Monitoring, Toxicology, Vitamin D Metabolite Quantitation]
  • IVD Kits
    • Table 6-4: Worldwide Market for Products IVD Kits Used by Clinical Laboratories, 2025–2030 (US$ millions) [Mass Spectrometry, Next Generation Sequencing, Polymerase Chain Reaction, Other Assays (Microarrays, Other)]
  • Geographic Distribution of Product and Reagents Used for LDT Market
    • Table 6-5: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2025–2030 (US$ millions) [China, Europe, India, Japan, Latin America, U.S. & Canada, Rest of World]

CHAPTER 7: IMPACT OF THE ECONOMY

  • CLINICAL LABORATORY TESTING
    • Mass Spectrometry
  • CURRENT ECONOMIC CLIMATE
    • Impact on Mass Spectrometry

CHAPTER 8: COMPANY PROFILES

  • 908 DEVICES, INC.
    • Company Overview
    • Financials
      • Table 8-1: Revenues for 908 Devices, 2023–2025 (US$ millions)
  • ABBOTT LABORATORIES
    • Company Overview
    • Financials
      • Table 8-2: Revenues for Abbott Laboratories, 2023–2025 (US$ billions)
  • ADVION
    • Company Overview
    • Financials
  • AGENA BIOSCIENCE
    • Company Overview
    • Financials
  • AGILENT TECHNOLOGIES INC.
    • Company Overview
    • Financials
      • Table 8-3: Revenues for Agilent Technologies, 2023–2025 (US$ billions)
  • ALIRI BIOANALYSIS
    • Company Overview
    • Financials
  • BECKMAN COULTER, INC.
    • Company Overview
    • Financials
  • BGI
    • Company Overview
    • Financials
      • Table 8-4: Revenues for BGI, 2023–2025 (US$ millions)
  • BIOCRATES LIFE SCIENCES, AG
    • Company Overview
    • Financials
  • BIODESIX, INC.
    • Company Overview
    • Financials
      • Table 8-5: Revenues for Biodesix, 2023–2025 (US$ millions)
  • BIOGNOSYS AG
    • Company Overview
    • Financials
  • BIOMÉRIEUX
    • Company Overview
    • Financials
      • Table 8-6: Revenues for bioMérieux, 2023–2025 (US$ billions)
  • BIO-RAD LABORATORIES
    • Company Overview
    • Financials
      • Table 8-7: Revenues for Bio-Rad, 2023–2025 (US$ billions)
  • BRUKER CORPORATION
    • Company Overview
    • Financials
      • Table 8-8: Revenues for Bruker, 2023–2025 (US$ billions)
  • CELLCARTA
    • Company Overview
    • Financials
  • CHARLES RIVER LABORATORIES
    • Company Overview
    • Financials
      • Table 8-9: Revenues for Charles River Laboratories, 2023–2025 (US$ billions)
  • DANAHER CORPORATION
    • Company Overview
    • Financials
      • Table 8-10: Revenues for Danaher, 2023–2025 (US$ billions)
  • JEOL, LTD
    • Company Overview
    • Financials
      • Table 8-11: Revenues for JEOL, 2023–2025 (US$ billions)
  • MICROSAIC SYSTEMS PLC
    • Company Overview
    • Financials
      • Table 8-12: Revenues for Microsaic, 2023–2025 (US$ millions)
  • MOSAIQUES DIAGNOSTICS AND THERAPEUTICS AG
    • Company Overview
    • Financials
  • PERKINELMER, INC./REVVITY
    • Company Overview
    • Financials
      • Table 8-13: Revenues for PerkinElmer/Revvity, 2023–2025 (US$ billions)
  • PROTEOME SCIENCES PLC
    • Company Overview
    • Financials
      • Table 8-14: Revenues for Proteome Sciences, 2023–2025 (US$ millions)
  • ROCHE
    • Company Overview
    • Financials
  • SCIEX PTE LTD.
    • Company Overview
    • Financials
  • SERA PROGNOSTICS
    • Company Overview
    • Financials
  • SHIMADZU CORP.
    • Company Overview
    • Financials
      • Table 8-15: Revenues for Shimadzu Corp., 2023–2025 (US$ billions)
  • STANDARD BIOTOOLS
    • Company Overview
    • Financials
      • Table 8-16: Revenues for Standard BioTools, 2023–2025 (US$ millions)
  • THERMO FISHER SCIENTIFIC, INC.
    • Company Overview
    • Financials
      • Table 8-17: Revenues for Thermo Fisher Scientific, 2023–2025 (US$ billions)
  • VIOME LIFE SCIENCES
    • Company Overview
    • Financials
  • WATERS CORPORATION
    • Company Overview
    • Financials
      • Table 8-18: Revenues for Waters Corp., 2023–2025 (US$ billions)