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The Worldwide Market for Mass Spectrometry in Clinical Labs, 2024

Publication Date: September 11, 2024

SKU: 24-028

Tags: Clinical Diagnostics, Infectious Diseases, Mass Spectrometry, Oncology and Cancer

Pages: 175

SKU: 24-028

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: Global Market for Mass Spectrometry Instruments, by Technology, 2023-2028 ($ million)

Segment 2023 2028 CAGR (%)
MALDI-TOF $XX Million $XX Million XX%
LC/MS-MS $XX Million $XX Million XX%
GC/MS $XX Million $XX Million XX%
ICP-MS $XX Million $XX Million XX%
FT/MS & Ion Trap $XX Million $XX Million XX%
LC-TOF/Q-TOF $XX Million $XX Million XX%
Total $XX Million $XX Million XX%

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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)

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