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市場調查報告書

藥事未核准檢驗(LDT:Laboratory Developed Test)的技術與市場

Laboratory-Developed Testing: Technologies and Markets

出版商 BCC Research 商品編碼 321812
出版日期 內容資訊 英文 104 Pages
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藥事未核准檢驗(LDT:Laboratory Developed Test)的技術與市場 Laboratory-Developed Testing: Technologies and Markets
出版日期: 2015年01月01日 內容資訊: 英文 104 Pages
簡介

美國的藥事未核准檢驗(LDT:Laboratory Developed Test)市場2013年記錄為81億美元,2014年為97億美元的市場規模。從2014年到2019年,預計以12.7%的年複合成長率發展,2019年成長到177億美元的規模。

本報告提供藥事未核准檢驗(LDT:Laboratory Developed Test)的技術和市場相關調查、LDT的技術及適應症種類與概要、LDT的利用的理由和FDA核准完畢檢驗的差異、市場規模的變化與預測、主要技術及專利詳細內容、相關法律、R&D趨勢、對市場成長的各種影響因素,產業課題等分析,主要經營者簡介等彙整資料。

第1章 簡介

第2章 摘要

第3章 產業結構

第3章 LDT概要

  • 臨床診斷檢驗的生命週期
  • 利用LDT的理由
  • 一般採用的技術
    • 聚合酵素鏈鎖反應(PCR)
    • 次世代定序
    • 其他分子技術
    • 質譜分析
    • HPLC-MS
    • MALDI-TOF
    • 免疫測量
  • 臨床適應症
    • 癌症
    • 感染疾病
    • 稀少疾病
    • 產科
    • 慢性疾病
  • LDT與FDA核准完畢檢驗的差異

第4章 LDT的利用

  • 特殊檢驗
  • 解剖病理
  • 公共醫療
  • 新技術
    • 分子診斷
    • 質譜分析
    • 基因學、次世代定序

第5章 市場區隔

  • 臨床診斷
    • 特殊檢驗室
    • 標準檢驗室
    • 學術醫療中心
    • 特定檢體試劑

第6章 藥事未核准臨床檢驗

  • 解剖病理
  • 基因檢驗
  • 質譜分析
  • 血清
  • 分子診斷

第7章 特定檢體試劑

  • 特定檢體試劑市場
  • 受託製造廠商
  • 特殊製造商

第8章 技術和專利

  • 自閉症相關遺傳基因標記:LINEAGEN
  • SEQUENOM
  • 改善發炎性大腸疾病診斷的手法:NESTLE/PROMETHEUS DIAGNOSTICS
  • 核酸的萬能檢測技術及結構:UNITAQ BIO
  • 老年癡呆症相關的遺傳基因多態性的檢測、利用法:CELERA/ QUEST DIAGNOSTICS
  • 判定前在腺癌的診斷、預後的材料、手法:UNIVERSITY OF CALIFORNIA/PROVERI的試劑
  • 微生物的特徵方法及套件:FRY LABORATORIES
  • 神經精神病的治療的監測的生物標記:RIDGE DIAGNOSTICS

第9章 LDT的R&D

  • 感染疾病的迅速檢測
  • 基因組LDT
  • 診斷中循環腫瘤細胞的利用

第10章 產業結構

  • 試劑製造商
  • 標準檢驗室
  • 學術醫療中心
  • 特殊檢驗室
  • 監督機關
  • 價格、性能趨勢
  • 產業的變化

第11章 政府的法律規章

  • 臨床診斷
  • CLIA vs FDA
  • FDA指南的LDT的影響
  • 美國以外的法律規章

第12章 產業課題

  • 產業分析
    • FDA vs LDT產業
    • 2層產業
    • 償付和保險者市場
    • 產業的推薦
  • 臨床實驗室改進法案(CLIA:Clinical Laboratory Improvement Amendment)

第13章 企業簡介

  • 23ANDME
  • ACCESS GENETICS
  • ARUP LABORATORIES
  • ASURAGEN
  • BD
  • BIOREFERENCE
  • BIOTHERANOSTICS
  • CYTOCELL
  • EMPIRE GENOMICS
  • ENZO BIOCHEM
  • EUROFINS
  • FRY LABORATORIES
  • GENECENTRIC DIAGNOSTICS
  • GENOMIC HEALTH
  • IDT
  • ILLUMINA
  • LABCORP
  • LUMINEX
  • MERCK KGAA
  • MOLECULARHEALTH
  • MYRIAD GENETICS
  • NEOGENOMICS
  • OLIGOS ETC.
  • PROVERI INC.
  • QUEST DIAGNOSTICS
  • RIDGE DIAGNOSTICS
  • ROSETTA GENOMICS
  • SELAH GENOMICS
  • SEQUENOM
  • SIEMENS
  • SIGNAL GENETICS
  • THERMO FISHER
  • UNITAQ BIO
  • VENTANA MEDICAL SYSTEMS INC.

圖表

目錄
Product Code: HLC179A

REPORT HIGHLIGHTS

The laboratory-developed test market within the U.S. was valued at $8.1 billion in 2013 and $9.7 billion in 2014. The market is expected to reach roughly $17.7 billion in 2019, a compound annual growth rate (CAGR) of 12.7% from 2014 to 2019.

This report provides:

  • Analyses of global market trends, with data from 2012, 2013 and 2014, and projections of CAGRs through 2019.
  • Coverage of different types of tests including esoteric, public health, anatomic technology, genomic testing, mass spectrophotometry, and other new technologies.
  • Information on the industry's structure, with focuses on reagent manufacturers, reference laboratrories, academic medical centers, trends in pricing and performance, as well as other areas.
  • Relevant patent analysis, including key patents, new patents, and pending patents.
  • Analysis of the market's dynamics, specifically growth drivers, restraints, and opportunities.

SCOPE OF REPORT

This report will focus on companies that rely on laboratory-developed testing for at least 10% of their revenue. This is meant to avoid focusing on companies and laboratories that only occasionally offer laboratory-developed tests to deal with unique patient needs. This report will also focus on suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is a key to the successful development of these tests. While various technologies will be highlighted with relation to their use in laboratory-developed testing, we will not explore the markets for these different technologies in depth.

ANALYST'S CREDENTIALS

Todd Graham is a licensed medical technologist in New York State with a strong background in assay development and clinical diagnostics. He has worked as a bench-level technologist for Quest Diagnostics and for hospital laboratories throughout the New York metropolitan area. He has also developed laboratory testing that is currently marketed in the United States. Todd works as an analyst for BCC Research and as a consultant to biotechnology and pharmaceutical firms on scientific and quality control matters.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • SCOPE OF REPORT
  • INTENDED AUDIENCE
  • INFORMATION SOURCES
  • ANALYST'S CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 - SUMMARY

  • SUMMARY TABLE: MARKET FOR U.S. LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
  • SUMMARY FIGURE: MARKET FOR U.S. LABORATORY-DEVELOPED TESTS, 2012-2019 ($ MILLIONS)
  • KEY TRENDS
    • THE RISE OF FDA REGULATION
    • GENOMIC RAMP-UP
    • DECLINE OF THE ACADEMIC MEDICAL CENTER
    • EVOLUTION OF THE LABORATORY-DEVELOPED TEST (LDT)
    • MOLECULAR DIAGNOSTICS EXPLOSION
    • SHIFTS TOWARDS LICENSING AND STARTUP INVESTMENT
    • SLOW DECLINE OF SEROLOGY

CHAPTER 3 - OVERVIEW: DESCRIPTION OF LABORATORY-DEVELOPED TESTS

  • LIFE CYCLE OF CLINICAL DIAGNOSTIC TESTS
    • TABLE 1: LIFE CYCLE OF CLINICAL DIAGNOSTIC TESTS
  • WHY USE AN LDT
  • COMMON TECHNOLOGIES USED
    • POLYMERASE CHAIN REACTION (PCR)
      • How PCR Works in an LDT
    • NEXT-GENERATION SEQUENCING
      • How NGS Works in LDTs
        • Sequencing by Synthesis
        • SOLiD Sequencing
        • Semiconductor Sequencing
    • OTHER MOLECULAR TECHNOLOGIES
    • MASS SPECTROMETRY
      • How Mass Spectrophotometry Works in LDTs
    • HPLC-MS
    • MALDI-TOF
    • IMMUNOASSAYS
      • How an Immunoassay Works in an LDT
  • CLINICAL INDICATIONS
    • ONCOLOGY
    • INFECTIOUS DISEASE
    • RARE DISEASES
    • MATERNITY
    • CHRONIC DISEASE
  • DIFFERENCES BETWEEN LDTS AND FDA APPROVED TESTS

CHAPTER 4 - USES OF LABORATORY-DEVELOPED TESTS

  • TABLE 2: USES OF LABORATORY-DEVELOPED TESTS
  • ESOTERIC TESTING
  • ANATOMIC PATHOLOGY
  • PUBLIC HEALTH
  • NEW TECHNOLOGY
    • MOLECULAR DIAGNOSTICS
    • MASS SPECTROPHOTOMETRY
    • GENOMICS AND NEXT-GENERATION SEQUENCING

CHAPTER 5 - SEGMENTS

  • CLINICAL DIAGNOSTICS
    • TABLE 3: SEGMENTS OF THE CLINICAL DIAGNOSTIC INDUSTRY
    • SPECIALTY LABORATORIES
    • REFERENCE LABORATORIES
    • ACADEMIC MEDICAL CENTERS
    • ANALYTE-SPECIFIC REAGENTS
      • TABLE 4: SUMMARY OF LABORATORY-DEVELOPED TEST MARKET SEGMENTS

CHAPTER 6 - LABORATORY-DEVELOPED CLINICAL ASSAYS

  • TABLE 5: U.S. MARKET FOR LABORATORY-DEVELOPED CLINICAL ASSAYS, THROUGH 2019 ($ MILLIONS)
  • ANATOMIC PATHOLOGY
    • TABLE 6: U.S. MARKET FOR ANATOMIC PATHOLOGY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
  • GENOMIC TESTING
    • TABLE 7: U.S. MARKET FOR GENOMIC LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
  • MASS SPECTROPHOTOMETRY
    • TABLE 8: U.S. MARKET FOR MASS SPECTROPHOTOMETRY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
  • SEROLOGY
    • TABLE 9: U.S. MARKET FOR SEROLOGY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
  • MOLECULAR DIAGNOSTICS
    • TABLE 10: U.S. MARKET FOR MOLECULAR DIAGNOSTICS LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)

CHAPTER 7 - ANALYTE-SPECIFIC REAGENTS

  • ANALYTE-SPECIFIC REAGENT MARKET
    • TABLE 11: U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
  • CONTRACT MANUFACTURERS
    • TABLE 12: U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FROM CONTRACT MANUFACTURERS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
  • SPECIALTY MANUFACTURERS
    • TABLE 13: U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FROM SPECIALTY MANUFACTURERS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)

CHAPTER 8 - TECHNOLOGY AND PATENTS

  • AUTISM ASSOCIATED GENETIC MARKERS-LINEAGEN
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • LINEAGEN
    • COMPETITIVE ANALYSIS
  • DIAGNOSTIC PROCESSES THAT FACTOR EXPERIMENTAL CONDITIONS-SEQUENOM
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • SEQUENOM
    • COMPETITIVE ANALYSIS
  • METHODS FOR IMPROVING INFLAMMATORY BOWEL DISEASE DIAGNOSIS-NESTLE/PROMETHEUS DIAGNOSTICS
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • PROMETHEUS DIAGNOSTICS
    • COMPETITIVE ANALYSIS
  • METHODS AND COMPOSITIONS FOR UNIVERSAL DETECTION OF NUCLEIC ACIDS-UNITAQ BIO
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • UNITAQ BIO
    • COMPETITIVE ANALYSIS
  • GENETIC POLYMORPHISMS ASSOCIATED WITH ALZHEIMER'S DISEASE, METHODS OF DETECTION AND USES THEREOF-CELERA/ QUEST DIAGNOSTICS
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • QUEST DIAGNOSTICS
    • COMPETITIVE ANALYSIS
  • MATERIALS AND METHODS FOR DETERMINING DIAGNOSIS AND PROGNOSIS OF PROSTATE CANCER-THE REGENTS OF THE UNIVERSITY OF CALIFORNIA/PROVERI
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • PROVERI
    • COMPETITIVE ANALYSIS
  • METHOD AND KIT FOR CHARACTERIZING MICROORGANISMS-FRY LABORATORIES
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • FRY LABORATORIES
    • COMPETITIVE ANALYSIS
  • BIOMARKERS FOR MONITORING TREATMENT OF NEUROPSYCHIATRIC DISEASES-RIDGE DIAGNOSTICS
    • SUMMARY OF THE PATENT
    • IMPLICATIONS OF THE PATENT
    • RIDGE DIAGNOSTICS
    • COMPETITIVE ANALYSIS
      • TABLE 14: PATENT APPLICATIONS FOR LABORATORY-DEVELOPED TESTING

CHAPTER 9 - LABORATORY-DEVELOPED TEST R&D

  • RAPID DETECTION OF INFECTIOUS DISEASE
  • APPLICATION OF GENOMIC LDTS
  • USE OF CIRCULATING TUMOR CELLS IN DIAGNOSTICS

CHAPTER 10 - INDUSTRY STRUCTURE

  • REAGENT MANUFACTURERS
  • REFERENCE LABORATORIES
  • ACADEMIC MEDICAL CENTERS
  • SPECIALTY LABORATORIES
  • REGULATORY
  • TRENDS IN PRICE AND PERFORMANCE
  • INDUSTRIAL CHANGES

CHAPTER 11 - GOVERNMENT REGULATIONS

  • CLINICAL DIAGNOSTICS
  • CLIA VS. FDA
    • TABLE 15: DIVISION OF LABORATORY SERVICE CENTERS FOR MEDICARE AND MEDICAID SERVICES, LABORATORIES BY TYPE OF FACILITY (EXEMPT/NON-EXEMPT COMBINED), CLIA UPDATE, THROUGH JUNE 2014
  • IMPACT OF THE FDA'S GUIDANCE ON LDTS
    • SUMMARY OF FDA'S DRAFT GUIDANCE
    • IMPLICATIONS
    • CASE STUDY: GOOGLE'S 23ANDME
  • REGULATIONS OUTSIDE OF THE UNITED STATES
    • REGULATIONS WITHIN ASIA
    • AUSTRALIAN LDT REGULATIONS
    • STATUS OF LDTS WITHIN EUROPE
    • HEALTH CANADA AND LDTS

CHAPTER 12 - INDUSTRY ISSUES

  • INDUSTRY ANALYSIS
    • FDA VERSUS THE LDT INDUSTRY
      • FDA's Perspective
      • LDT Industry's Perspective
      • Points of Contention
      • Potential Paths Forward
      • Evolution of Genomic Tests
    • TWO-TIER BUSINESS
    • REIMBURSEMENT AND PAYER MARKETS
      • CODING A TEST
      • VALUING THE LDT
      • POTENTIAL SOLUTIONS
    • INDUSTRY RECOMMENDATIONS
      • INVEST IN INFORMATION TECHNOLOGY PARTICULARLY DATABASE MANAGEMENT
      • ENCOURAGE TIE-INS WITH EXISTING ELECTRONIC HEALTH RECORD SYSTEMS
      • SUPPORT EFFORTS TO REGULATE LDTS FOR ROUTINE ANALYTES
      • SELL OFF INTELLECTUAL PROPERTY
      • ENCOURAGE ONE-STOP SHOPPING WITHIN SPECIALTIES FOR LABORATORY-DEVELOPED TESTS
  • CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA): STATE SURVEY AGENCY CONTACTS

CHAPTER 13 - COMPANY PROFILES

  • 23ANDME
  • ACCESS GENETICS
  • ARUP LABORATORIES
  • ASURAGEN
  • BD
  • BIOREFERENCE
  • BIOTHERANOSTICS
  • CYTOCELL
  • EMPIRE GENOMICS
  • ENZO BIOCHEM
  • EUROFINS
  • FRY LABORATORIES
  • GENECENTRIC DIAGNOSTICS
  • GENOMIC HEALTH
  • IDT
  • ILLUMINA
  • LABCORP
  • LUMINEX
  • MERCK KGAA
  • MOLECULARHEALTH
  • MYRIAD GENETICS
  • NEOGENOMICS
  • OLIGOS ETC.
  • PROVERI INC.
  • QUEST DIAGNOSTICS
  • RIDGE DIAGNOSTICS
  • ROSETTA GENOMICS
  • SELAH GENOMICS
  • SEQUENOM
  • SIEMENS
  • SIGNAL GENETICS
  • THERMO FISHER
  • UNITAQ BIO
  • VENTANA MEDICAL SYSTEMS INC.

LIST OF TABLES

  • SUMMARY TABLE: MARKET FOR U.S. LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 1: LIFE CYCLE OF CLINICAL DIAGNOSTIC TESTS
    • TABLE 2: USES OF LABORATORY-DEVELOPED TESTS
    • TABLE 3: SEGMENTS OF THE CLINICAL DIAGNOSTIC INDUSTRY
    • TABLE 4: SUMMARY OF LABORATORY-DEVELOPED TEST MARKET SEGMENTS
    • TABLE 5: U.S. MARKET FOR LABORATORY-DEVELOPED CLINICAL ASSAYS, THROUGH 2019 ($ MILLIONS)
    • TABLE 6: U.S. MARKET FOR ANATOMIC PATHOLOGY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 7: U.S. MARKET FOR GENOMIC LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 8: U.S. MARKET FOR MASS SPECTROPHOTOMETRY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 9: U.S. MARKET FOR SEROLOGY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 10: U.S. MARKET FOR MOLECULAR DIAGNOSTICS LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 11: U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 12: U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FROM CONTRACT MANUFACTURERS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 13: U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FROM SPECIALTY MANUFACTURERS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
    • TABLE 14: PATENT APPLICATIONS FOR LABORATORY-DEVELOPED TESTING
    • TABLE 15: DIVISION OF LABORATORY SERVICE CENTERS FOR MEDICARE AND MEDICAID SERVICES, LABORATORIES BY TYPE OF FACILITY (EXEMPT/NON-EXEMPT COMBINED), CLIA UPDATE, THROUGH JUNE 2014

LIST OF FIGURES

  • SUMMARY FIGURE: MARKET FOR U.S. LABORATORY-DEVELOPED TESTS, 2012-2019 ($ MILLIONS)
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