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表紙：臨床検査室における質量分析の世界市場：2024年
市場調査レポート
商品コード
1554594

臨床検査室における質量分析の世界市場：2024年

The Worldwide Market for Mass Spectrometry in Clinical Labs, 2024

出版日
ページ情報
英文 175 Pages
納期
即日から翌営業日
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.99円
臨床検査室における質量分析の世界市場：2024年
出版日: 2024年09月11日
発行: Kalorama Information
ページ情報: 英文 175 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

質量分析（MS）は、その高度な感度と特異性によって診断学に革命をもたらし、臨床検査室への導入が進んでいます。かつては主に研究現場で利用されていたこの技術は、現在では臨床応用、特に治療薬モニタリング、代謝物検査、ステロイドホルモン分析、ビタミンD検査などの分野で大きな進歩を遂げています。臨床現場におけるMSの需要の高まりは、その精度と正確さにおいて従来の免疫測定法を凌駕する能力によってもたらされています。

当レポートでは、世界の臨床検査室における質量分析市場について調査し、市場の概要とともに、2023年の実績と2028年までの予測、主要企業の収益分析、市場の促進要因と課題、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 エグゼクティブサマリー

第2章 質量分析法イントロダクション

  • 質量分析の簡単な歴史
  • 現在の質量分析技術
  • イオン化技術
  • 質量分析装置
  • ハイフン技法
  • その他
  • 質量分析市場セグメント
  • 臨床検査室
  • 質量分析のための実験室開発検査（LDT）
  • 体外診断（IVD）
  • 質量分析の研究応用
  • その他の応用

第3章 質量分析製品とメーカー

  • 質量分析プラットフォームおよび関連製品を販売する企業
  • 価格動向
  • 新製品開発の動向
  • 販売と流通の動向

第4章 質量分析における市場促進要因・課題

  • 市場促進要因
  • 技術の進歩
  • LDT開発におけるAI
  • MSとNGSの用途拡大
  • パーソナライズ医療
  • コンパニオン診断
  • 世界ヘルスとバイオセキュリティ
  • 市場の課題
  • 規制の変更
  • CLIAラボサービスの提供からIVDキットへの変換
  • 償還
  • 投資家資本へのアクセスの減少

第5章 質量分析市場分析

  • 世界の質量分析市場
  • 質量分析市場、技術別
  • 質量分析市場、地域別
  • 競合分析

第6章 臨床検査市場と質量分析の役割

第7章 経済の影響

第8章 企業プロファイル

  • 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
目次
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)