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市場調查報告書

臨床診斷的質量頻譜分析的全球市場

Mass Spectrometry in Clinical Applications

出版商 Kalorama Information 商品編碼 302664
出版日期 內容資訊 英文 250 Pages
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臨床診斷的質量頻譜分析的全球市場 Mass Spectrometry in Clinical Applications
出版日期: 2014年04月29日 內容資訊: 英文 250 Pages
簡介

說到偏光分析法和液體層析法等質量頻譜分析,到目前為止大致限定於藥物開發用途、臨床診斷、對新生兒的代謝疾病診察等利用範圍,不過現今情形突然一轉,質譜分析活用於微生物檢測和類固醇內分泌及維他命D檢驗,治療藥監測等,各種臨床診斷。

本報告以臨床診斷的質量頻譜分析的全球市場為焦點,提供即將到來的供需變化分析、預測、市場趨勢和課題、技術開發、競爭環境、主要加入企業等相關最新調查資訊。

第1章 摘要整理

  • 目標範圍和調查方法
  • 報告主要的結論

第2章 簡介

  • 質譜分析的優點

第3章 市場趨勢

  • 改變微生物學檢驗的基質輔助雷射脫附離子化飛行時間法(MALDI-TOF)
  • 急劇的質譜分析設備的技術進步
  • 應對、克服中的法規障礙
  • 臨床研究設備慢慢推進質量檢驗引進
  • 擴展的治療藥監測與藥物濫用
  • 慢慢普及的新生兒診察
  • 產品銷售最新資訊

第4章 合資企業體、聯合組織

  • Biomarkers Consortium
  • Biomarkers Research Initiatives in Mass Spectrometry(BRIMS)
  • CDC Vitamin D and Hormone Standardization Programs
  • Clinical Proteomic Tumor Analysis Consortium
  • Early Detection Research Network(EDRN)
  • New Biomarker Development Alliance
  • 臨床用途的質量頻譜分析相關近幾年的主要協定

第5章 收益預測及競爭分析

  • 臨床質量檢驗的預測收益
  • 臨床質量檢驗的預測收益成長率
  • 臨床質量檢驗市場佔有率 - 各供給企業
  • 臨床質量檢查裝置的市場組合比例 - 各產品(MALDI-TOF、toripurukwaddo、QTRAP、離子阱、GCMS、Orbitrap & ion-Orbitrap、QTOF等)

第6章 終端用戶調查

  • 研究設備的主要專門領域、科目
  • 研究設備的規定診斷目的之臨床質量檢驗使用率
  • 研究設備的產業、市場區隔分佈
  • 研究設備功能的分佈
  • 設備人員
  • 地區分佈(美國、歐洲、加拿大、澳洲)
  • 在研究設備使用的臨床質量檢查裝置的頻寬
  • 在研究設備使用的臨床質量檢查裝置的形式
  • 研究設備的樣品使用
  • 診斷目的臨床質量檢驗的引進、普及的課題
  • 研究設備尋求的改善點與挑戰主題
  • 診斷目的臨床質量檢驗的最重要趨勢
  • 購買預定

第7章 企業簡介

  • AB Sciex(DANAHER CORPORATION)
  • Agilent Technolgies
  • Bruker Corporation
  • Perkin Elmer
  • Thermo Fisher
  • Waters Corporation

第8章 課題

第9章 策略性建議

添加資料一覽

目錄
Product Code: KLI5235894

For capacity, accuracy, and specificity of analysis, the use of mass spectrometry in clinical diagnostics and clinical research has grown dramatically in recent years. This Kalorama Information report, Mass Spectrometry for Clinical Applications: Market Analysis and End User Survey , looks at the growth of Mass Spec systems being used in diagnostics and other clinical applications this year.

A Detailed Examination of the Market Opportunity for MS in Clinical Applications

Prior to the explosion in the last several years, GC-MS, LC-MS, and LC-MS/MS were being used in diagnostics primarily only for newborn screening of metabolic diseases. Clinical research applications related mainly to pharmaceutical development. But the situation has changed dramatically as a number of applications have seen particularly rapid adoption in the last few years, including testing for microbial identification, steroids/ endocrinology, vitamin D, and therapeutic drug monitoring (TDM). A large range of diagnostic tests are being researched for both small molecules and proteins. Depending on the application, MS can have many advantages over the immunoassays typically used for most diagnostics. In some cases, there is simply no alternative testing method available.

  • Clinical MS Market and Revenues Forecast
  • Market Share of Clinical MS Systems by Product (MALDI-TOF, triple quad, QTRAP, ion trap, GCMS, Orbitrap & ion-Orbitrap, QTOF, Other)
  • Clinical MS Market Share by Supplier
  • Overview of Types of MS and Clinical Use
  • Challenges
  • Strategic Recommendations
  • Company Profiles

INCLUDES: An End User Survey on Applications, Brand Ownership, Handling of Regulated Samples, Future Plans

A survey of 50 labs was conducted to get a better picture of the usage and trends with MS in clinical labs. Labs included in the survey are those running regulated patient samples for routine diagnostics, or unregulated patient samples for diagnostics/prognostics/ theranostics-oriented research. A wide breadth of labs was targeted in order to obtain a richer picture of the market. Results provided by the survey respondents include:

  • Brands of MS Systems Used by Regulated/Not Regulated
  • Types of MS Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, isotope ratio MS, ICP-MS, N/D, Other) Used in Labs
  • Labs' Certification/ Accreditation for Diagnostic MS
  • Future Purchase Time Frame
  • Brands of Systems Considered Most Appealing by Regulated/Not Regulated
  • Most Important Trends in Clinical MS

Several MS systems and kits have now received regulatory approval for diagnostic use. These enable labs to run the tests without the extra work and expense involved with laboratory developed tests (LDTs), also referred to as "homebrew" tests. The area of LDTs has also been evolving in recent years as the FDA and other related agencies determine how best to regulate an area that has been somewhat of a grey area.

The use of MALDI-TOF MS for microbiology testing is a somewhat distinct application which appears poised for explosive growth over the next several years. The major advantages over alternatives are its ability to identify microbes in a much shorter time, with less work, and with greater accuracy. From a culture or colony, the system can identify the microbes in minutes rather than many hours required with older techniques. In a clinical diagnostic setting, the time savings can equate to a major benefit in terms of treatment and economics. The patient receives a more accurate diagnosis and/or earlier treatment, and these result in significant savings.

While MS has grown rapidly and holds great promise, there are several challenges relating to its use in clinical applications, including its complexity, high upfront cost, lack of user-friendliness, low throughput (except MALDI) as well as the complexity of the science and the associated regulatory process. These will need to be addressed in order to penetrate further into more routine testing settings. These are also presented in the report and are part of the analysis.

The report includes profiles of the following companies:

  • AB Sciex (DANAHER CORPORATION)
  • Agilent Technologies
  • Bruker Corporation
  • Perkin Elmer
  • Thermo Fisher
  • Waters Corporation

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

  • Scope and Methodology
  • Main Conclusions of the Report

CHAPTER TWO: INTRODUCTION

  • Advantages of Mass Spectrometry

CHAPTER THREE: MARKET TRENDS

  • MALDI-TOF Revolutionizing Microbiology Testing
  • Rapid Technological Advances in Mass Spectrometry Systems
  • Regulatory Hurdles Being Addressed, Overcome
  • Clinical Labs Increasingly Driven Towards Mass Spectrometry
  • Increase in Therapeutic Drug Monitoring and Drugs of Abuse
  • Gradual Expansion of Newborn Screening
  • Recent Product Introductions

CHAPTER FOUR: CONSORTIA / ALLIANCES

  • The Biomarkers Consortium
  • Biomarkers Research Initiatives in Mass Spectrometry (BRIMS)
  • CDC Vitamin D and Hormone Standardization Programs
  • Clinical Proteomic Tumor Analysis Consortium
  • Early Detection Research Network (EDRN)
  • New Biomarker Development Alliance
  • Key Deals in Recent Years Related to Mass Spectrometry Technology
  • in Clinical Applications

CHAPTER FIVE: REVENUES FORECAST & COMPETITIVE ANALYSIS

  • Clinical Mass Spectrometry Revenues Forecast
  • Clinical Mass Spectrometry Revenue Forecast
  • Clinical Mass Spectrometry Revenue Forecast Growth Rate
  • Clinical Mass Spectrometry Market Share by Supplier
  • Clinical Mass Spectrometry Market Share by Supplier
  • Market Share of Clinical Mass Spectrometry Systems by Product (MALDI-TOF, triple quad,
  • QTRAP, ion trap, GCMS, Orbitrap & ion-Orbitrap, QTOF, Other)

CHAPTER SIX: END-USER SURVEY

  • Lab's Main Specialization(s)/ Discipline(s)
  • Labs' Mass Spectrometry Usage for Regulated Diagnostics
  • Labs' Distribution of Industry/ Segment
  • Distribution of Lab Function(s)
  • Lab Personnel
  • Regional Distribution (United States, Europe, Canada, Australia)
  • Brands of Mass Spectrometry Systems Used in Labs
  • Types of Mass Spectrometry Systems Used in Labs
  • Labs' Certification/ Accreditation for Diagnostic Mass Spectrometry
  • Labs' Certification/ Accreditation for Diagnostic Mass Spectrometry
  • Lab Use of Samples
  • Challenges for Adoption/ Growth of Diagnostic Mass Spectrometry
  • Improvements/ Changes Wanted by Labs
  • Most Important Trends in Clinical Mass Spectrometry
  • Future Purchases

CHAPTER SEVEN: CORPORATE PROFILES

  • AB Sciex (DANAHER CORPORATION)
  • Agilent Technolgies
  • Bruker Corporation
  • Perkin Elmer
  • Thermo Fisher
  • Waters Corporation

CHAPTER EIGHT: CHALLENGES

CHAPTER NINE: STRATEGIC RECOMMENDATIONS

LIST OF EXHIBITS

CHAPTER FOUR: CONSORTIA / ALLIANCES

  • Table 4-1: Key Deals in Recent Years Related to MS Technology in Clinical Applications

CHAPTER FIVE: REVENUES FORECAST & COMPETITIVE ANALYSIS

  • Table 5-1: Clinical MS Revenues Forecast
  • Figure 5-1: Clinical MS Revenue Forecast ($M)
  • Figure 5-2: Clinical MS Revenue Forecast Growth Rate
  • Table 5-2: Clinical MS Market Share by Supplier
  • Figure 5-3: Clinical MS Market Share by Supplier
  • Table 5-3: Market Share of Clinical MS Systems by Product (MALDI-TOF, triple quad, QTRAP, ion trap, GCMS, Orbitrap & ion-Orbitrap, QTOF, Other)
  • Figure 5-4: Market Share of Clinical MS Systems (2013)

CHAPTER SIX: END-USER SURVEY

  • Table 6-1: Lab's Main Specialization(s)/ Discipline(s)
  • Figure 6-1: Lab's Main Specialization(s)/ Discipline(s) (% of Labs)
  • Table 6-2: Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated
  • Table 6-3: Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated (% of Systems)
  • Figure 6-2: Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated
  • Table 6-4: Labs' MS Usage for Regulated Diagnostics
  • Figure 6-3: Labs' MS Usage for Regulated Diagnostics (% of Labs)
  • Table 6-5: Distribution of Industry/ Segment
  • Figure 6-4: Distribution of Industry/ Segment (% of Labs)
  • Table 6-6: Distribution of Industry/ Segment by Regulated/Not Regulated
  • Table 6-7: Distribution of Industry/ Segment by Regulated/Not Regulated (% of Labs)
  • Figure 6-5: Industry/Segment Distribution by Regulated/Not Regulated (% of Labs)
  • Table 6-8: Distribution of Lab Function(s)
  • Figure 6-6: Distribution of Lab Function(s) (% of Labs)
  • Table 6-9: Lab's Function(s) by Regulated/Not Regulated
  • Table 6-10: Lab's Function(s) by Regulated/Not Regulated (% of Labs)
  • Figure 6-7: Lab's Function(s) by Regulated/Not Regulated (% of Labs)
  • Table 6-11: Number of Personnel Working in Lab
  • Figure 6-8: Number of Personnel Working in Lab (% of Labs)
  • Table 6-12: Position/ Role in Laboratory
  • Figure 6-9: Position/ Role in Laboratory (% of Labs)
  • Table 6-13: Overall Regional Distribution (United States, Europe, Canada, Australia)
  • Figure 6-10: Overall Regional Distribution (United States, Europe, Canada, Australia)
  • Table 6-14: United States Regional Distribution
  • Figure 6-11: United States Regional Distribution
  • Table 6-15: Brands of MS Systems Used in Labs
  • Figure 6-12: Brands of MS Systems Used in Labs (% of Systems)
  • Table 6-16: Brands of MS Systems Used by Regulated/Not Regulated
  • Table 6-17: Brands of MS Systems Used by Regulated/Not Regulated (% of Systems)
  • Table 6-18: Types of MS Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, isotope ratio MS, ICP-MS, N/D, Other) Used in Labs
  • Figure 6-13: Types of MS Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, isotope ratio MS, ICP-MS, N/D, Other) Used in Labs (% of Systems)
  • Table 6-19: Types of Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, ICP-MS, isotope ratio MS, N/D, Other) Used by Regulated/Not Regulated
  • Table 6-20: Types of Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, ICP-MS, isotope ratio MS, N/D, Other) Used by Regulated/Not Regulated (% of Systems)
  • Table 6-21: Triple Quad Systems by Brand (% of Systems)
  • Figure 6-14: Triple Quad Systems by Brand (% of Systems)
  • Table 6-22: Ion Trap Systems by Brand
  • Figure 6-15: Ion Trap Systems by Brand (% of Systems)
  • Table 6-23: MALDI-TOF Systems by Brand
  • Figure 6-16: MALDI-TOF Systems by Brand (% of Systems)
  • Table 6-24: GC-MS Systems by Brand
  • Figure 6-17: GC-MS Systems by Brand (% of Systems)
  • Table 6-25: Q-TOF Systems by Brand
  • Figure 6-18: Q-TOF Systems by Brand (% of Systems)
  • Table 6-26: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI-TOF/TOF, MALDI TOF, QTOF, N/D) Used in Labs
  • Figure 6-19: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI-TOF/TOF, MALDI TOF, QTOF, N/D) Used in Labs (% of Systems)
  • Table 6-27: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI TOF, QTOF, MALDI-TOF/TOF, N/D) by Regulated/Not Regulated
  • Table 6-28: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI TOF, QTOF, MALDI-TOF/TOF, N/D) by Regulated/Not Regulated (% of Systems)
  • Table 6-29: Types of Agilent Systems (GC/MS, triple quad, ion trap, QTOF, ICP-MS) Used in Labs
  • Figure 6-20: Types of Agilent Systems (GC/MS, triple quad, ion trap, QTOF, ICP-MS) Used in Labs (% of Systems)
  • Table 6-30: Types of Agilent Systems (GCMS, triple quad, ion trap, QTOF, ICP-MS) by Regulated/Not Regulated
  • Table 6-31: Types of Agilent Systems (GCMS, triple quad, ion trap, QTOF, ICP-MS) by Regulated/Not Regulated (% of Systems)
  • Table 6-32: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF, MALDI-TOF) Used in Labs
  • Figure 6-21: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF, MALDI-TOF) Used in Labs (% of Systems)
  • Table 6-33: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF) by Regulated/Not Regulated
  • Table 6-34: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF) by Regulated/Not Regulated (% of Systems)
  • Table 6-35: Types of Thermo Systems (triple quad, Orbitrap, ion trap, ion trap-Orbitrap, ICP-MS, GCMS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) Used in Labs
  • Figure 6-22: Types of Thermo Systems (triple quad, Orbitrap, ion trap, ion trap-Orbitrap, ICP-MS, GCMS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) Used in Labs (% of Systems)
  • Table 6-36: Types of Thermo Systems (triple quad, ion trap, Orbitrap, GCMS, ion trap-Orbitrap, ICP-MS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) by Regulated/Not Regulated
  • Table 6-37: Types of Thermo Systems (triple quad, ion trap, Orbitrap, GCMS, ion trap-Orbitrap, ICP-MS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) by Regulated/Not Regulated (% of Systems)
  • Table 6-38: Types of Waters Systems (triple quad, QTOF, ion mobility, N/D, isotope ratio MS, GC-TOF) Used in Labs
  • Figure 6-23: Types of Waters Systems (triple quad, QTOF, ion mobility, N/D, isotope ratio MS, GC-TOF) Used in Labs (% of Systems)
  • Table 6-39: Types of Waters Systems by Regulated/Not Regulated (No. of Systems) and by Type (triple quad, QTOF, ion mobility, isotope ratio, GC-TOF, N/D)
  • Table 6-40: Types of Waters Systems by Regulated/Not Regulated (% of Systems) and by Type (triple quad, QTOF, ion mobility, isotope ratio, GC-TOF, N/D)
  • Table 6-41: Models of AB Sciex Systems Used in Labs
  • Figure 6-24: Models of AB Sciex Systems Used in Labs (% of Systems)
  • Table 6-42: Models of Agilent Systems Used in Labs
  • Figure 6-25: Models of Agilent Systems Used in Labs (% of Systems)
  • Table 6-43: Models of Bruker Systems Used in Labs
  • Figure 6-26: Models of Bruker Systems Used in Labs (% of Systems)
  • Table 6-44: Models of Thermo Systems Used in Labs
  • Table 6-45: Models of Waters Systems Used in Labs
  • Table 6-46: Labs' Certification/ Accreditation for Diagnostic MS
  • Figure 6-27: Labs' Certification/ Accreditation for Diagnostic MS
  • Table 6-47: Areas Using MS (Neonatal/ pediatrics/ metabolic diseases, Steroids/ endocrinology, Therapeutic drug monitoring, Vitamin D, Toxicology, Microbiology/ infectious diseases, Amino acids, Cancer/ oncology, Cardiovascular, Vitamin B12, Nephrology, Genetic testing) for Regulated Patient Samples
  • Figure 6-28: Areas Using MS (Neonatal/ pediatrics/ metabolic diseases, Steroids/ endocrinology, Therapeutic drug monitoring, Vitamin D, Toxicology, Microbiology/ infectious diseases, Other) for Regulated Patient Samples (% of Labs)
  • Table 6-48: Areas Using MS (Cancer/ oncology, Diabetes/ nephrology, Microbiology/ infectious diseases, Cardiovascular, Therapeutic drug monitoring, Immunology/ autoimmune, Neurology, Pediatrics/ metabolic diseases, Steroids/ endocrinology, Toxicology, Multiple sclerosis, Vitamin D, Aging, Environmental health, Forensic toxicology, Gastrointestinal, Genetic testing, Hepatology, Pharmacokinetics, Preeclampsia, Sickle cell) for Non-Regulated Patient Samples
  • Figure 6-29: Areas Using MS (Cancer/ oncology, Diabetes/ nephrology, Microbiology/ infectious diseases, Cardiovascular, Therapeutic drug monitoring, Immunology/ autoimmune, Neurology, Pediatrics/ metabolic diseases, Steroids/ endocrinology, Toxicology, Multiple sclerosis, Vitamin D, Other) for Non-Regulated Patient Samples
  • Table 6-49: Number of MS Samples per Month
  • Figure 6-30: Number of MS Samples per Month
  • Table 6-50: Non-Patient Samples, Out of Total (2013)
  • Figure 6-31: Non-Patient Samples, Out of Total (2013)
  • Table 6-51: Non-Patient Samples, Out of Total (2014 est.)
  • Figure 6-32: Non-Patient Samples, Out of Total (2014 est.)
  • Table 6-52: Non-Regulated Patient Samples, Out of Total (2013)
  • Figure 6-33: Non-Regulated Patient Samples, Out of Total (2013)
  • Table 6-53: Non-Regulated Patient Samples, Out of Total (2014 est.)
  • Figure 6-34: Non-Regulated Patient Samples, Out of Total (2014 est.)
  • Table 6-54: Regulated Patient Samples, Out of Total (2013)
  • Figure 6-35: Regulated Patient Samples, Out of Total (2013)
  • Table 6-55: Regulated Patient Samples, Out of Total (2014 est.)
  • Figure 6-36: Regulated Patient Samples, Out of Total (2014 est.)
  • Table 6-56: Challenges for Adoption/ Growth of Diagnostic MS
  • Figure 6-37: Challenges for Adoption/ Growth of Diagnstic MS (% of Labs)
  • Table 6-57: Improvements/ Changes Wanted by Labs
  • Figure 6-38: Improvements/ Changes Wanted by Labs (% of Labs)
  • Table 6-58: Most Important Trends in Clinical MS
  • Figure 6-39: Most Important Trends in Clinical MS
  • Table 6-59: MS Systems Considered Most Appealing (% of Responses)
  • Table 6-60: Brands of Systems Considered Most Appealing
  • Figure 6-40: Brands of Systems Considered Most Appealing (% of Responses)
  • Table 6-61: Brands of Systems Considered Most Appealing by Regulated/Not Regulated
  • Table 6-62: Brands of Systems Considered Most Appealing by Regulated/Not Regulated (% of Responses)
  • Table 6-63: Future Purchase Time Frame
  • Figure 6-41: Future Purchase Time Frame (% of Labs)
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