세계의 임상 실험실 질량분석 시장(2024년)

Mass spectrometry (MS) is increasingly being integrated into clinical laboratories, revolutionizing diagnostics with its advanced sensitivity and specificity. This technology, once primarily utilized in research settings, is now making significant strides in clinical applications, particularly in areas like therapeutic drug monitoring, metabolite testing, steroid hormone analysis, and vitamin D testing. The growing demand for MS in clinical settings is driven by its ability to outperform traditional immunoassays in terms of accuracy and precision.

Kalorama Information's "The Worldwide Market for Mass Spectrometry in Clinical Labs, 2024" is a comprehensive market research report examines the global mass spectrometry market from 2023 to 2028, focusing on its expanding role in clinical diagnostics. It explores a wide range of applications, from microbial identification to proteomics and genomics, highlighting how MS technology is becoming disruptive in various areas of healthcare.

Key Highlights:

• Market Analysis: The report provides an in-depth analysis of the global MS market, with a focus on the leading regions-North America, Japan, and Western Europe-which account for the majority of current MS instrument sales.
• Clinical Applications: Detailed coverage of clinical MS applications, including therapeutic drug monitoring, vitamin D testing, neonatal screening, and more.
• Market Data: Sales estimates for 2023 and projections through 2028, alongside revenue analysis of top MS competitors over the past three years.
• Market Dynamics: Discussion of key drivers, challenges, and trends shaping the mass spectrometry market, as well as the broader impact of the global economy on clinical labs and MS markets.
• Impact of FDA Ruling on Laboratory Developed Tests (LDTs): Mass spectrometer manufacturers must adapt to new FDA regulations regarding LDTs. This report takes into account this new development, with sales projections that reflect greater barriers to entry for new devices and new, albeit phased-in, oversight requirements for current products.
• Company Profiles: Insights into companies developing or marketing MS platforms and products, focusing on those driving innovation in clinical settings.

This report is essential for stakeholders in the clinical laboratory and diagnostic industries, providing a comprehensive overview of the rapidly evolving mass spectrometry market and its potential to transform healthcare diagnostics.

Note: This report specifically focuses on human clinical applications of MS and does not delve into forensic, veterinary, or other non-clinical uses.

Table of Contents

Chapter 1: Executive Summary

• Overview
• Scope and Methodology
• Point-of-View
• Market Overview
  • Figure 1-1: Global Market for Mass Spectrometry Instruments, Microbiology vs. Non-Microbiology, 2023 ($ million)
• Future Prospects in the Mass Spectrometry Market

Chapter 2: Introduction to Mass Spectrometry

• Brief History of Mass Spectrometry
• Current Mass Spectrometry Technology
• 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
  • Orbitrap
• Hyphenated Techniques
  • GC/MS
  • LC/MS
  • TOF-MALDI
  • ICP-MS
  • CE/MS
• Other Techniques
  • Tandem Mass Spectrometry
  • Shotgun Proteomics
• 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
  • Changes Resulting from Covid Pandemic
  • New 2024 FDA Regulations and Implications
  • European Regulatory Landscape and Directive 98/79/EC
  • 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
• 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
• Companion Diagnostics
• Global Health and Biosecurity
• 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, 2018-2024
  • Mergers and Acquisitions
  • Table 4-3: Selected Acquisitions of or by Companies/Laboratories with LDTs, 2020-2024

Chapter 5: Mass Spectrometry Market Analysis

• Worldwide Mass Spectrometry Market
  • Table 5-1: Global Market for Mass Spectrometry Instruments, Microbiology vs. Non-Microbiology, 2023-2028 ($ million)
  • Figure 5-1: Global Market for Mass Spectrometry Instruments, Microbiology vs. Non-Microbiology, 2023-2028 ($ million)
  • Table 5-2: Global Market for Mass Spectrometry Instruments, Microbiology vs. Non-Microbiology, 2023-2028, Share of Total MS Instrument Market (%)
  • Figure 5-2: Global Market for Mass Spectrometry Instruments, Microbiology vs. Non-Microbiology, 2023-2028 (%)
• Mass Spectrometry Market by Technology
  • Table 5-3: Global Market for Mass Spectrometry Instruments, by Technology, 2023-2028 ($ million) (FT/MS & Ion Trap, GC/MS, ICP-MS, LC/MS-MS, LC-TOF/Q-TOF, MALDI-TOF)
  • Figure 5-3: Global Market for Mass Spectrometry Instruments, by Technology, 2023-2028 ($ million) (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, 2023-2028, Share of Total MS Instrument Market (%) (FT/MS & Ion Trap, GC/MS, ICP-MS, LC/MS-MS, LC-TOF/Q-TOF, MALDI-TOF)
  • Figure 5-4: Global Market for Mass Spectrometry Instruments, by Technology, 2023-2028, Share of Total MS Instrument Market (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, 2023-2028 ($ million) (China, Europe, India, Japan, Latin America, US & Canada, Rest of World)
  • Figure 5-5: Global Market for Mass Spectrometry Instruments, by Region, 2023-2028 ($ million) (China, Europe, India, Japan, Latin America, US & Canada, Rest of World)
  • Table 5-6: Global Market for Mass Spectrometry Instruments, by Region, 2023-2028, Share of Total MS Instrument Market (%) (China, Europe, India, Japan, Latin America, US & Canada, Rest of World)
  • Figure 5-6: Global Market for Mass Spectrometry Instruments, by Region, 2023-2028, Share of Total MS Instrument Market (%) (China, Europe, India, Japan, Latin America, US & Canada, Rest of World)
• Competitive Analysis
  • Table 5-7: Total Estimated MS Sales and Share of Key MS Players, by Company, 2023 ($ million) (%) (Agena Bioscience, Agilent, bioMerieux, Bruker Corp., PerkinElmer, SCIEX, Shimadzu, Thermo Fisher Scientific, Waters, Others)
  • Figure 5-7: Market Shares of Key MS Players, by Company, 2023 (%) (Agena Bioscience, Agilent, bioMerieux, Bruker Corp., PerkinElmer, SCIEX, Shimadzu, Thermo Fisher Scientific, Waters, Others)

Chapter 6: The Laboratory-Developed Test Market and Role of Mass Spectrometry

• Overview
• 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, by Major Clinical (Disease) Segments, 2023-2028, ($ million) (Genetic Testing, Infectious Disease, Oncology LDT Services Market)
  • Figure 6-1: Laboratory-Developed Test Services Market, by Major Clinical (Disease) Segments, 2023-2028, ($ million) (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, 2023-2028 ($ million) (China, Europe, Japan, Latin America, United States, Rest of World)
  • Figure 6-2: Laboratory-Developed Test Services Market, by Geographical Distribution, 2023-2028 ($ million) (China, Europe, Japan, Latin America, United States, Rest of World)
• 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, 2023-2028 ($ million) (Mass Spectrometry, Next Generation Sequencing, Polymerase Chain Reaction, Other Assays)
  • Figure 6-3: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 ($ million) (Mass Spectrometry, Next Generation Sequencing, Polymerase Chain Reaction, Other Assays)
• Mass Spectrometry
  • Figure 6-4: MS Applications by Clinical Category, Share of Total MS Applications, 2023 and 2028 (%) (Metabolomics, Microbiology, Newborn Screening, Proteomics, Steroid Hormones, Therapeutic Drug Monitoring, Toxicology, Vitamin D Metabolite Quantitation)
• Geographic Distribution of Product and Reagents Used for LDT Market
  • Table 6-4: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 ($ million) (China, Europe, Japan, Latin America, United States, Rest of World)
  • Figure 6-5: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 ($ million) (China, Europe, Japan, Latin America, United States, Rest of World)

Chapter 7: Impact of the Economy

• Clinical Laboratory Testing
• Mass Spectrometry
• Current Economic Climate

Chapter 8: Company Profiles

• 908 Devices, Inc.
  • Company Overview
  • Financials
    • Table 8-1: Revenues for 908 Devices, 2021-2023 ($ million)

• Abbott Laboratories
  • Company Overview
  • Financials
    • Table 8-2: Revenues for Abbott Laboratories, 2021-2023 ($ million)

• Advion
  • Company Overview
  • Financials

• Agena Bioscience
  • Company Overview
  • Financials

• Agilent Technologies Inc.
  • Company Overview
  • Financials
    • Table 8-3: Revenues for Agilent Technologies, 2021-2023 ($ million)

• Aliri Bioanalysis
  • Company Overview
  • Financials

• Applied Proteomics, Inc.
  • Company Overview
  • Financials

• Beckman Coulter, Inc.
  • Company Overview
  • Financials

• Becton Dickinson
  • Company Overview
  • Financials
    • Table 8-4: Revenues for BD, 2021-2023 ($ million)

• BGI
  • Company Overview
  • Financials
    • Table 8-5: Revenues for BGI, 2021-2023 ($ million)

• Biocrates Life Sciences, AG
  • Company Overview
  • Financials

• Biodesix, Inc.
  • Company Overview
  • Financials
    • Table 8-6: Revenues for Biodesix, 2021-2023 ($ million)

• Biognosys AG
  • Company Overview
  • Financials

• bioMerieux
  • Company Overview
  • Financials
    • Table 8-7: Revenues for bioMerieux, 2021-2023 ($ million)

• Bio-Rad Laboratories
  • Company Overview
  • Financials
    • Table 8-8: Revenues for Bio-Rad, 2021-2023 ($ million)

• Bruker Corporation
  • Company Overview
  • Financials
    • Table 8-9: Revenues for Bruker, 2021-2023 ($ million)

• Caprion Biosciences
  • Company Overview
  • Financials

• Charles River Laboratories
  • Company Overview
  • Financials
    • Table 8-10: Revenues for Charles River Laboratories, 2021-2023 ($ million)

• Danaher Corporation
  • Company Overview
  • Financials
    • Table 8-11: Revenues for Danaher, 2021-2023 ($ million)

• JEOL, Ltd.
  • Company Overview
  • Financials
    • Table 8-12: Revenues for JEOL, 2021-2023 ($ million)

• Microsaic Systems plc
  • Company Overview
  • Financials
    • Table 8-13: Revenues for Microsaic, 2021-2023 ($ million)

• Mosaiques Diagnostics and Therapeutics AG
  • Company Overview
  • Financials

• PerkinElmer, Inc.
  • Company Overview
  • Financials
    • Table 8-14: Revenues for PerkinElmer, 2021-2023 ($ million)

• Proteome Sciences plc
  • Company Overview
  • Financials
    • Table 8-15: Revenues for Proteome Sciences, 2021-2023 ($ million)

• SCIEX Pte Ltd.
  • Company Overview
  • Financials
    • Table 8-16: Revenues for Danaher, 2021-2023 ($ million)

• Sera Prognostics
  • Company Overview
  • Financials
    • Table 8-17: Revenues for Standard Sera Prognostics, 2021-2023 ($ million)

• Shimadzu Corp.
  • Company Overview
  • Financials
    • Table 8-18: Revenues for Shimadzu Corp., 2021-2023 ($ million)

• Standard BioTools
  • Company Overview
  • Financials
    • Table 8-19: Revenues for Standard BioTools, 2021-2023 ($ million)

• Thermo Fisher Scientific, Inc.
  • Company Overview
  • Financials
    • Table 8-20: Revenues for Thermo Fisher Scientific, 2021-2023 ($ million)

• Waters Corporation
  • Company Overview
  • Financials
    • Table 8-21: Revenues for Waters Corp., 2021-2023 ($ million)