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临床检验室的质谱分析的全球市场:2024年
市场调查报告书
商品编码
1554594

临床检验室的质谱分析的全球市场:2024年

The Worldwide Market for Mass Spectrometry in Clinical Labs, 2024
出版日期: | 出版商: Kalorama Information | 英文 175 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

质谱 (MS) 以其高灵敏度和特异性彻底改变了诊断方法，并且越来越多地被引入临床实验室。该技术曾经主要用于研究环境，现在在临床应用中取得了重大进展，特别是在治疗药物监测、代谢物测试、类固醇激素分析和维生素 D 测试等领域。临床实践中对 MS 不断增长的需求是由于其在精确度和准确性方面超越传统免疫测定的能力所推动的。

本报告提供全球临床检验室的质谱分析市场相关调查，提供市场概要，以及2023年的实际成果和2028年为止的预测，主要企业的收益分析，市场推动因素与课题，及加入此市场的主要企业简介等资讯。

目录

第1章 摘要整理

第2章 质谱分析法简介

  • 质谱简史
  • 目前的质谱技术
  • 电离技术
  • 质谱仪
  • 连字技术
  • 其他
  • 质谱细分市场
  • 临床实验室
  • 质谱实验室开发测试 (LDT)
  • 体外诊断 (IVD)
  • 质谱研究应用
  • 其他应用

第3章 质谱分析产品和厂商

  • 销售质谱分析平台及相关产品的企业
  • 价格趋势
  • 新产品开发趋势
  • 销售流通的趋势

第4章 质谱分析的市场的推动要素与课题

  • 市场推动因素
  • 技术进步
  • 人工智慧在 LDT 开发的应用
  • 扩大 MS 和 NGS 的应用
  • 个人化医疗服务
  • 伴随诊断
  • 世界卫生与生物安全
  • 市场挑战
  • 监理变化
  • 从 CLIA 实验室服务提供转变为 IVD 试剂盒
  • 赎回
  • 获得投资者资本的机会减少

第5章 质谱分析市场分析

  • 全球质谱分析市场
  • 质谱分析市场，各技术
  • 质谱分析市场，各地区
  • 竞争分析

第6章 临床检验市场与质谱分析所扮演的角色

第7章 经济的影响

第8章 企业简介

  • 908 Devices, Inc.
  • Abbott Laboratories
  • Advion
  • Agena Bioscience
  • Agilent Technologies Inc.
  • Aliri Bioanalysis
  • Applied Proteomics, Inc.
  • Beckman Coulter, Inc.
  • Becton Dickinson
  • BGI
  • Biocrates Life Sciences, AG
  • Biodesix, Inc.
  • Biognosys AG
  • bioMerieux
  • Bio-Rad Laboratories
  • Bruker Corporation
  • Caprion Biosciences
  • Charles River Laboratories
  • Danaher Corporation
  • JEOL, Ltd.
  • Microsaic Systems plc
  • Mosaiques Diagnostics and Therapeutics AG
  • PerkinElmer, Inc.
  • Proteome Sciences plc
  • SCIEX Pte Ltd.
  • Sera Prognostics
  • Shimadzu Corp
  • Standard BioTools
  • Thermo Fisher Scientific, Inc.
  • Waters Corporation
简介目录
Product Code: 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 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)