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藥事未核准檢驗(LDT:Laboratory Developed Test)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 84 Pages
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藥事未核准檢驗(LDT:Laboratory Developed Test)技術與市場 Laboratory-Developed Testing: Technologies and Markets
出版日期: 2017年06月08日 內容資訊: 英文 84 Pages

美國藥事未核准檢驗(LDT:Laboratory Developed Test)市場規模2015年約達97億美元。2016年至2021年約6.3%CAGR、預計2016年可從約110億美元到2021年149億美元規模成長。

本報告針對藥事未核准檢驗(LDT:Laboratory Developed Test)技術與市場調查、提供LDT技術與適應症種類與概要、LDT使用理由與FDA已核准檢驗的不同、市場規模轉變與預測、主要技術與專利詳情、相關法規、R&D動向、市場成長各種影響因素、產業課題分析、主要業者檔案。

第1章 介紹

第2章 摘要、重點

第3章 LDT概要

  • 臨床診斷檢驗生命週期
  • 利用LDT的理由
  • 一般常用技術
    • 聚合酵素鏈鎖反應(PCR)
    • 次世代定序
    • 其他分子技術
    • 質譜分析
    • 免疫測量法
  • 臨床適應症
    • 癌症
    • 感染症
    • 稀少疾病
    • 婦產科
    • 慢性疾病
  • LDT與FDA核准完畢檢驗的差異

第4章 使用LDT

  • 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 LDT的區分

  • 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 LDT種類分類市場區分

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

第7章 市場區分:特定檢體試藥

  • 製造受託機關
  • 特殊製造業者

第8章 專利回顧/新開發

  • 專利回顧
  • 研究開發

第9章 產業構造

  • 試藥製造業者
  • 標準檢驗室
  • 學術醫療中心
  • 特殊檢驗室
  • 監督機關
  • 價格、性能動向
  • 產業變化

第10章 政府法規

  • 臨床診斷
  • CLIA vs FDA
  • FDA法規對LDT的影響
  • 法規回顧
  • LDT是什麼?

第11章 產業課題

  • 產業分析
    • FDA vs LDT產業
    • 雙層事業
  • 補償與保險者市場
  • 產業獎勵
  • 實例分析
  • 臨床檢驗室改善法(CLIA:Clinical Laboratory Improvement Amendment)

第12章 企業檔案



Product Code: HLC179B

Report Highlights

The global market for laboratory-developed tests reached nearly $9.7 billion in 2015. This market is expected to increase from nearly $11.0 billion in 2016 to $14.9 billion in 2021 at a compound annual growth rate (CAGR) of 6.3% for 2016-2021.

Report Includes:

  • An overview of the global market for laboratory-developed testing.
  • Analyses of global market trends, with data from 2014, 2015 and 2016, and projections of CAGRs through 2021.
  • 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, and trends in pricing and performance.
  • Relevant patent analysis, including key patents, new patents, and pending patents.
  • Analysis of the market's dynamics, specifically growth drivers, restraints, and opportunities.
  • Profiles of major players in the industry.

Report Scope

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 occasionally offer laboratory-developed tests to deal with unique patient needs. This report will also focus on the suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is 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 Credentials

Todd Graham is an experienced scientist who has worked in a variety of settings throughout the biotechnology industry for more than 10 years as a key technical resource for a variety of businesses. Among his accomplishments are coordinating the roll out of a new test for a major clinical laboratory services provider, developing pre-clinical and clinical assays in support of pharmaceuticals and medical devices, and being a key team member in developing novel technologies for molecular diagnostics.

Table of Contents

Chapter 1: Introduction

  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of Report
  • Information Sources
  • Methodology
  • Analyst's Credentials
  • Related BCC Research Reports

Chapter 2: Summary and Highlights

  • Key Trends
    • PAMA Is Taking a Hammer to Laboratory Test Prices
    • Regulatory Discretion Impacts Certain LDTs
    • Genomics Testing Comes of Age
    • Testing Mix Shifts within LDTs
    • Consolidation of the LDT Marketplace
    • The Understated Importance of Mass Spectrophotometry LDTs

Chapter 3: Description of Laboratory-developed Tests

  • Life Cycle of Clinical Diagnostic Tests
  • Why Use an LDT?
  • Common Technologies Used
    • Polymerase Chain Reaction (PCR)
    • Next-generation Sequencing
    • Other Molecular Technologies
    • Mass Spectrometry
    • Immunoassays
  • Clinical Indications
    • Oncology
    • Infectious Disease
    • Rare Diseases
    • Maternity
    • Chronic Disease
  • Differences between LDTs and FDA-approved Tests

Chapter 4: Uses of Laboratory Diagnostic Tests

  • Esoteric Testing
  • Anatomic Pathology
  • Public Health
  • New Technology
  • Molecular Diagnostics
  • Mass Spectrophotometry
  • Genomics and Next-generation Sequencing

Chapter 5: Segments of Laboratory Diagnostic Tests

  • Clinical Diagnostics
  • Specialty Laboratories
  • Reference Laboratories
  • Academic Medical Centers
  • Analyte-specific Reagents

Chapter 6: Market Breakdown by LDT Type

  • Anatomic Pathology
  • Genomic Testing
  • Mass Spectrophotometry
  • Serology
  • Molecular Diagnostics

Chapter 7: Market Breakdown by Analyte-specific Reagent Use

  • Contract Manufacturers
  • Specialty Manufacturers

Chapter 8: Patent Review/New Developments

  • Patent Review
    • Quantitation of Tamoxifen and Metabolites Thereof by Mass Spectrometry
  • Research and Development
    • Companion Diagnostics in LDTs
    • Standardization of LDTs
    • LC-MS test for Urinary 8-iso-prostaglandin F2α
    • Expression Profiling in Cancer Diagnostics

Chapter 9: Industry Structure

  • Reagent Manufacturers
  • Reference Laboratories
  • Academic Medical Centers
  • Specialty Laboratories
  • Regulatory
  • Trends in Price/Performance
  • Industrial Changes

Chapter 10: Government Regulations

  • Clinical Diagnostics
  • CLIA versus FDA
  • The Impact of the FDA's Guidance on LDTs
    • Summary of the FDA's Draft Guidance
  • 2017 Regulatory Review
  • What is an LDT?
    • Computational Analysis
    • External Organizations
    • Direct-to-consumer Testing

Chapter 11: Industry Issues

  • Industry Analysis
    • FDA versus the LDT Industry
    • Two-tier Business
  • Reimbursement and Payer Markets
    • Coding a Test
    • Valuing the LDT
  • Potential Solutions
  • Industry Recommendations
    • Sell Off Intellectual Property
    • Encourage One-stop Shopping within Specialties for Laboratory-developed Tests
  • Case Studies
    • Proove BioSciences
    • The Rise of the Chinese Genomic Testing Market
  • Clinical Laboratory Improvement Amendments (CLIA): State Survey Agency Contacts

Chapter 12: Company Profiles

About BCC Research

  • About BCC Research
  • BCC Membership
  • BCC Custom Research

List of Tables

  • Table 1: Summary Table: Global Market for Laboratory-developed Tests, by Laboratory Type, Through 2021 ($ Millions)
  • Table 2: Life Cycle of Clinical Diagnostic Tests
  • Table 3: Uses of Laboratory-developed Tests
  • Table 4: Uses of Laboratory-developed Tests
  • Table 5: Summary of Laboratory-developed Test Market Segments
  • Table 6: Global Anatomic Pathology LDT Market, by Type, through 2021 ($Millions)
  • Table 7: Global Genomic Testing LDT Market, by Type, Through 2021 ($ Millions)
  • Table 8: Global Mass Spectrophotometry LDT Market, by Type, through 2021 ($Millions)
  • Table 9: Global Serology LDT Market, by Type, Through 2021 ($ Millions)
  • Table 10: Global Molecular Diagnostics LDT Market, by Type, through 2021 ($millions)
  • Table 11: Global Analyte-specific Reagent Market, by Type, Through 2021 ($ Millions)
  • Table 12: Global Analyte-specific Reagent Market from Contract Manufacturers, by Type, Through 2021 ($ Millions)
  • table 13: Global Analyte-specific Reagent Market from Specialty Manufacturers, by Type, Through 2021 ($ Millions)

List of Figures

  • FIGURE 1: Summary Figure: Global Market for Laboratory-developed Tests, by Lab Type, 2014-2021 ($ Millions)
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