臨床檢驗室的質譜分析的全球市場:2024年
市場調查報告書
商品編碼
1554594

臨床檢驗室的質譜分析的全球市場: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個工作天內

價格
簡介目錄

質譜 (MS) 以其高靈敏度和特異性徹底改變了診斷方法,並且越來越多地被引入臨床實驗室。該技術曾經主要用於研究環境,現在在臨床應用中取得了重大進展,特別是在治療藥物監測、代謝物測試、類固醇激素分析和維生素 D 測試等領域。臨床實踐中對 MS 不斷增長的需求是由於其在精確度和準確性方面超越傳統免疫測定的能力所推動的。

本報告提供全球臨床檢驗室的質譜分析市場相關調查,提供市場概要,以及2023年的實際成果和2028年為止的預測,主要企業的收益分析,市場推動因素與課題,及加入此市場的主要企業簡介等資訊。

目錄

第1章 摘要整理

第2章 質譜分析法簡介

  • 質譜簡史
  • 目前的質譜技術
  • 電離技術
  • 質譜儀
  • 連字技術
  • 其他
  • 質譜細分市場
  • 臨床實驗室
  • 質譜實驗室開發測試 (LDT)
  • 體外診斷 (IVD)
  • 質譜研究應用
  • 其他應用

第3章 質譜分析產品和廠商

  • 銷售質譜分析平台及相關產品的企業
  • 價格趨勢
  • 新產品開發趨勢
  • 銷售流通的趨勢

第4章 質譜分析的市場的推動要素與課題

  • 市場推動因素
  • 技術進步
  • 人工智慧在 LDT 開發的應用
  • 擴大 MS 和 NGS 的應用
  • 個人化醫療服務
  • 伴隨診斷
  • 世界衛生與生物安全
  • 市場挑戰
  • 監理變化
  • 從 CLIA 實驗室服務提供轉變為 IVD 試劑盒
  • 贖回
  • 獲得投資者資本的機會減少

第5章 質譜分析市場分析

  • 全球質譜分析市場
  • 質譜分析市場,各技術
  • 質譜分析市場,各地區
  • 競爭分析

第6章 臨床檢驗市場與質譜分析所扮演的角色

第7章 經濟的影響

第8章 企業簡介

  • 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
簡介目錄
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)