Description
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.
Related Report: SDi Mass Spectrometry 2023 Market Opportunity Report
Interested in even more market research about mass spectrometry? Explore the SDi Mass Spectrometry 2023 Market Opportunity Report, published by Kalorama’s sister brand, Strategic Directions International (SDi). This report is a valuable resource for anyone looking to deepen their understanding of the market.
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, bioMérieux, 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, bioMérieux, 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
bioMérieux
Company Overview
Financials
- Table 8-7: Revenues for bioMérieux, 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)
