IVD 분야 질량 분석 시장(2026년)

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)