NEWS: 公告在東京證券交易所JASDAQ標準市場新上市

表紙
市場調查報告書

臨床LDT(未經批准的監管檢查)服務和LDT耗材的全球市場

The Market for Clinical LDT Services and LDT Supplies

出版商 Kalorama Information 商品編碼 984997
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
價格
臨床LDT(未經批准的監管檢查)服務和LDT耗材的全球市場 The Market for Clinical LDT Services and LDT Supplies
出版日期: 2020年09月24日內容資訊: 英文
簡介

LDT(實驗室開發的測試)既不是新現像也不是最近的現象,但是對新的冠狀病毒感染(COVID-19)測試的需求是如此之大,以至於新的測試氾濫成災。監管指南已發生了巨大變化。這些測試以前稱為"自製測試"或"內部測試"。它是一種針對低風險診斷應用程序的小型,簡單且特徵明確的測試方法。如今,高風險,複雜的測試已被開發為LDT,並用於向醫生及其患者提供臨床結果。

如下圖所示,作為服務提供的LDT的市場規模超過120億美元。

本報告分析了臨床未經批准的檢測(LDT)服務和供應的全球市場,並概述了LDT,其主要使用領域(目標疾病)及其與類似檢測方法的關係。□我們正在調查差異,基本市場結構和主要促銷/限制因素,市場規模(實施數量/市場收入)趨勢展望,按細分/地區劃分的詳細趨勢,主要公司的概況等。

目錄

第1章執行摘要

第2章簡介

  • 未經批准的監管測試(LDT)和體外診斷測試(IVD)
  • IVD(體外診斷測試)
  • LDT(實驗室開發的測試)
  • 為什麼在實驗室中使用LDT?
  • 開展LDT的LDT市場臨床實驗室
  • 實驗室測試設備和試劑的製造商
  • 分析觀點和方法
  • LDT市場的獨特性

第3章未經批准的藥品事務檢查(LDT)

  • 概述
  • 什麼是LDT?
  • 定義
  • 法規批准和LDT
    • 通用試劑
    • 分析試劑專用試劑(ASR)
  • 使用診斷技術
    • 化學測試
    • 免疫學檢查
    • 組織染色
    • 免疫組織化學
    • 流式細胞儀
  • 核型分析
  • 原位雜交(ISH)
  • 聚合□鏈反應(PCR)/其他核酸擴增技術
  • 芯片
  • 蛋白質微陣列
  • DNA微陣列
  • 染色體微陣列
  • 組織芯片
  • 質譜
  • 序列

第4章臨床應用

  • 公司
  • 證候測試
  • 適用於COVID-19的LDT
  • 腫瘤
  • 癌症的遺傳風險
  • 癌症篩查
  • 癌症治療(個體藥物)的診斷,預後和治療決策
  • 基因檢測
  • 疾病風險測試-在癌症以外的地方擴大使用
  • 染色體分析和新的產前診斷(NIPT)
  • 遺傳性疾病檢測(產前檢測,產後檢測,攜帶者篩查)
  • 新生兒篩查
  • 其他基因檢測
  • 直接對個體進行基因檢測
  • 藥理基因組學
  • 質譜檢查
  • LDT的其他用途

第5章市場促進因素和挑戰

  • 技術
  • FDA批准的當前狀態/帶有CE標誌的檢查
  • COVID-19因大流行而發生的變化
  • 診所市場驅動力
  • 衝突
  • 個性化醫學和伴隨診斷
  • LDT法規-美國/海外
  • FDA(美國食品藥品監督管理局)
  • 指令98/79/EC
  • 醫療費用報銷
  • CMTP與希臘公園之間的業務合作
  • 分子病理學協會
  • 併購(併購)
  • 未來展望
  • 將CLIA檢查服務產品轉換為IVD套件

第6章LDT市場分析:執行LDT的臨床實驗室

  • 全球LDT市場
  • 該城市實施的LDT數量
  • 小容量和大容量
  • LDT服務市場:按細分
  • LDT服務市場:按地區
  • LDT傳染病服務市場
  • 傳染病檢測和微生物檢測的LDT市場
  • LDT傳染病服務市場:按地區
  • LDT腫瘤服務市場
  • LDT腫瘤服務市場:按細分
  • 癌症遺傳風險測試服務市場
  • 癌症篩查服務市場
  • 癌症治療中的診斷/預後:治療決策制定(個體化醫學)
  • LDT腫瘤服務市場:區域分佈
  • 用於基因檢測的LDT服務市場
  • LDT基因測試市場:按細分
  • LDT基因測試市場:按地區
  • 其他LTD市場

第7章LDT市場分析:測試設備/試劑製造商

  • LDT產品/試劑:市場獨特性分析
  • LDT產品/試劑市場:按細分(PCR,質譜,NGS,微陣列等)
  • LDT產品/試劑市場:地區分佈

第8章公司簡介

  • 23andme,Inc.
  • 自適應生物技術公司
    • 最近的收入趨勢
    • 公司簡介
    • 新的冠狀病毒感染(COVID-19)
  • Admera Health
  • Agendia Nv
  • Agilent Technologies Inc.
  • Ambry Genetics Corp.
  • BGI
  • Biodesix, Inc.
  • Biotheranostics, Inc.
  • Bruker Corporation
  • Caredx, Inc.
  • Centogene Ag
  • Epic Sciences, Inc.
  • Eurofins
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
  • Helix
  • Illumina, Inc.
  • Invitae Corporation
  • Laboratory Corporation of America (Labcorp)
  • LunglifeAI
  • MDXHealth
  • Myriad Genetics, Inc.
  • Natera, Inc.
  • Neogenomics
  • Opko Health, Inc./Opko Diagnostics
  • Pacific Biosciences of California, Inc.
  • Perkin Elmer, Inc.
  • Qiagen N.V.
  • Quest Diagnostics
  • Roche Diagnostics
  • Rosetta Genomics Ltd.
  • SCIEX Pte Ltd.
  • Thermo Fisher Scientific, Inc.
  • Waters Corporation
目錄
Product Code: 20-047

Laboratory developed tests (LDTs) are not a new or recent phenomenon but due to the incredible need for testing of SARS-CoV-2, there has been a flood of new tests and the regulatory guidance has changed dramatically. Historically, these tests were called "home-brew tests" or "in-house tests." Also, historically, these tests were low-volume, simple and well characterized tests for low-risk diagnostic applications. Today, high-risk, complex tests have been developed as LDTs, and are being used to provide clinical results to physicians and their patients.

The market for LDTs offered as services is over 12 billion dollars, as indicated in this figure.

This is a unique report with a unique segmentation to help customers find the right segment for their needs. Two separate but related markets are discussed in this report: the market for clinical laboratory services using laboratory developed tests, and the market for products (platforms and consumables) sold to clinical laboratories who use these products to make LDTs. Both are large and rapidly growing markets. Chemistry Tests, Immunoassays Histology Stains, Flow Cytometry, Karyotyping, ISH, Gene Signatures, Microarrays are among the technologies used in lab develop tests. This report examines each technology category.

As part of the market analysis, the report offers the following data:

  • Authorized Molecular-Based LDTs for Detection of Nucleic Acid from COVID-19
  • Selected Companies Marketing Flow Cytometry Platforms
  • Selected Companies Marketing Probes for FISH Based Tests in Clinical Laboratories
  • Selected Companies Marketing Open PCR Platforms That Can be Used for LDTs
  • Selected Companies Marketing Mass Spectrometers
  • Selected Companies Marketing Next Generation Sequencing Platforms to Clinical Laboratories
  • Selected Companies Offering LDTs for Hereditary Risk of Cancer
  • Selected Companies Offering Pharmacogenomic Test Services Based on LDTs
  • Selected Companies Offering Non-Invasive Prenatal Testing (NIPT) Chromosome Analysis Based
  • Selected Companies Offering Autoimmune/Inflammatory Test Services Based on LDTs
  • Selected Companies Offering Cardiovascular Test Services Based on LDTs
  • Selected Companies Offering Neurological Test Services Based on LDTs
  • LDT Services Market by Segment
  • Infectious Disease (Infectious disease LDTs [not microbial ID by culture], Microbial identification [culture])
  • Oncology (Hereditary Cancer/Risk of Cancer, Cancer Screening, Cancer Diagnosis/Prognosis/Monitoring)
  • Genetic Testing (Risk of Disease (includes cancer), Chromosomal analysis/NIPT, Inherited disorders (prenatal, postnatal, carrier screening, other genetic testing applications, Diagnosis/Prognosis/Monitoring)
  • LDT Services Market by Geography:
    • United States
    • Europe
    • Japan
    • China
    • Latin America
    • Rest of World
  • LDT Products Market: Market for Products Used by Clinical Laboratories for LDTs - By Product
    • PCR
    • Mass Spectrometry
    • NGS
    • Microarrays
    • Other
  • LDT Products Market: Market for Products Used by Clinical Laboratories for LDTs - by Geography
    • United States
    • Europe
    • Japan
    • China
    • Latin America
    • Rest of World

In this report, laboratory developed tests (LDTs) include all clinical tests developed by laboratories for their own use, in contrast to in vitro diagnostic (IVD) kits that are manufactured and sold by diagnostic companies for use by many different clinical labs. Clinical laboratories can develop LDTs based on any diagnostic test technology used in the clinical lab. For some technologies, such as chemistry tests or immunoassays, automated platforms with large test menus are commercially available. As a result, in some labs, development and use of LDTs based on these technologies may be less than the number of LDTs based on newer technologies such as next generation sequencing. However, laboratories may develop tests on widely used technologies such as immunoassays to offer tests for rare diseases. Clinical laboratories may also perform tests on types of specimens that are not included in the approved labeling for a test or may have other reasons why they decide to develop an LDT.

This significant activity in the development of new LDTs, growing revenues from current LDTs, and large addressable markets for many of the emerging LDTs has attracted the interest of investors and also other companies looking for acquisitions.

There have also been a significant number of acquisitions in recent years. Consolidation among companies and laboratories offering LDTs is expected to continue in the future. This is not a new trend in the clinical laboratory market. Major companies such as Quest Diagnostics and LabCorp have made numerous acquisitions to reach their current market positions. Smaller clinical laboratories have also been making acquisitions. In the segment of this market focusing on companies and laboratories offering services based on LDTs, many new companies continue to be founded - providing a continuing stream of smaller companies trying to grow, and that may grow by acquisitions or may be acquired.

Laboratory developed tests is an exciting field and market in which assays are being developed that may have the potential to transform certain aspects of healthcare. There are great number of companies in the LDT market. New LDTs are being developed and introduced, and some segments of this market (especially the market for cancer diagnosis, prognosis, personalized medicine, and monitoring patients) have become very competitive. Some companies will not survive, but there are also examples of successful companies. This field has attracted considerable interest from investors and from companies making acquisitions.

Companies covered in this report include:

  • 23andme, Inc.
  • Adaptive Biotechnologies Corporation
  • Admera Health
  • Agendia Nv
  • Agilent Technologies Inc.
  • Ambry Genetics Corp.
  • BGI
  • Biodesix, Inc.
  • Biotheranostics, Inc.
  • Bruker Corporation
  • Caredx, Inc.
  • Centogene Ag
  • Epic Sciences, Inc.
  • Eurofins
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
  • Helix
  • Illumina, Inc.
  • Invitae Corporation
  • Laboratory Corporation of America (Labcorp)
  • LunglifeAI
  • MDXHealth
  • Myriad Genetics, Inc.
  • Natera, Inc.
  • Neogenomics
  • Opko Health, Inc./Opko Diagnostics
  • Pacific Biosciences of California, Inc.
  • Perkin Elmer, Inc.
  • Qiagen N.V.
  • Quest Diagnostics
  • Roche Diagnostics
  • Rosetta Genomics Ltd.
  • SCIEX Pte Ltd.
  • Thermo Fisher Scientific, Inc.
  • Waters Corporation

Table of Contents

Chapter One: Executive Summary

  • Overview
  • Scope and Methodology
  • Two Markets: Market for Services and for Test Products Sold to Labs (for use in LDTs)
  • Market Overview
    • Kalorama's Analysis of the LDT Market
    • LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT)
      • Table 1-1: Laboratory Developed Test Services Market; Major Clinical (Disease) Segments (2020 - 2025) (in millions USD)
  • LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT)
    • Table 1-2: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs (2020-2025) (in millions USD)
  • Market Drivers and Challenges
  • Future Progress
  • Status of FDA Regulation

Chapter Two: Introduction

  • Laboratory-Developed Tests Versus In Vitro Diagnostic Tests
  • IVD
  • LDTs
  • Why Do Laboratories Use Laboratory-Developed Tests?
  • Laboratory Developed Tests Markets - Clinical Laboratories Performing LDTs
  • Instrument and Reagent Manufacturers Supplying Labs
  • Point of View and Methodology
  • Uniqueness of the LDT Market

Chapter 3: Laboratory-Developed Tests

  • Overview
  • What is an LDT?
  • Kalorama Definition
  • Regulatory Approval and LDTs
    • General purpose reagent:
    • Analyte specific reagent (ASR):
  • Use of Diagnostic Technologies
    • Chemistry Tests
    • Immunoassays
    • Histology Stains
      • Table 3-1: Selected Companies Marketing Histology Stains
      • Table 3-2: Selected Companies Marketing Microscopes
    • Immunohistochemistry
    • Flow Cytometry
      • Table 3-3: Selected Companies Marketing Antibodies for Immunohistochemistry and/or Flow Cytometry Testing in Clinical Laboratories
      • Table 3-4: Selected Companies Marketing Flow Cytometry Platforms
  • Karyotyping
  • In Situ Hybridization
    • Table 3-5: Selected Companies Marketing Probes for FISH Based Tests in Clinical Laboratories
  • Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
    • Table 3-6: Selected Companies Marketing Open PCR Platforms That Can be Used by Clinical Laboratories for LDTs Analysis of Gene Expression Patterns (Gene Signatures)
  • Microarrays
  • Protein Microarrays
  • DNA Microarrays
  • Chromosomal Microarrays
  • Tissue Microarrays
  • Mass Spectrometry
    • Table 3-7: Selected Companies Marketing Mass Spectrometers
  • Sequencing
    • Table 3-8: Selected Companies Marketing Next Generation Sequencing Platforms to Clinical Laboratories

Chapter Four: Clinical Applications

  • Companies
    • Table 4-1: Selected Companies offering Infectious Disease Test Services Based on LDTs (excluding microbial identification testing by culture)
  • Syndromic Testing
  • COVID-19 Laboratory Developed Tests
    • Table 4-2: Authorized Molecular-Based LDTs for Detection of Nucleic Acid from SARS-CoV-2
  • Oncology
  • Hereditary Risk of Cancer
    • Table 4-3: Selected Companies offering LDTs for Hereditary Risk of Cancer
  • Cancer Screening
    • Table 4-4: Selected Companies offering Cancer Screening Tests Based on LDTs
  • Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
    • Table 4-5: Selected Companies offering Cancer Diagnosis/Prognosis/Personalized Medicine Test Services Based on LDTs
  • Genetic Testing
  • Testing for Risk of Disease - Moving Beyond Cancer
    • Table 4-6: Selected Companies offering LDTs for Risk of Disease - Cancer and Beyond
  • Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
    • Table 4-7: Selected Companies offering Non-Invasive Prenatal Testing (NIPT) Chromosome Analysis Based on LDTs
  • Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening)
    • Table 4-8: Selected Companies offering Genetic Testing for Inherited Disorders (prenatal, postnatal, carrier screening) Based on LDTs
  • Newborn Screening
  • Other Genetic Testing
    • Table 4-9: Selected Companies/Clinical Laboratories offering Newborn Screening or Other Genetic Tests Based on LDTs
  • Direct-to-Consumer Genetic Testing
    • Table 4-10: Selected Companies offering Direct-to-Consumer Genetic Testing Based on LDTs
  • Pharmacogenomics
    • Table 4-11: Selected Companies offering Pharmacogenomic Test Services Based on LDTs
  • Mass Spectrometry Tests
  • Other LDT Applications
    • Table 4-12: Selected Companies offering Autoimmune/Inflammatory Test Services Based on LDTs
    • Table 4-13: Selected Companies offering Cardiovascular Test Services Based on LDTs
    • Table 4-14: Selected Companies offering Neurological Test Services Based on LDTs
    • Table 4-15: Selected Companies offering Other Test Services Based on LDTs

Chapter 5: Market Drivers and Challenges

  • Technology
  • Status of Fda-Approved and Ce-Marked Tests
  • Changes Resulting From COVID-19 Pandemic
  • Clinical Market Drivers
  • Competition
  • Personalized Medicine and Companion Diagnostics
  • Regulation of Laboratory Developed Tests - Us and Outside The Us
  • FDA
  • Directive 98/79/EC
  • Reimbursement
  • CMTP and Greek Park Collaborative
  • Association for Molecular Pathology
  • Mergers and Acquisitions
    • Table 5-1: Selected Acquisitions of Or By Companies/Laboratories With LDTs (2018-Mid 2020)
  • Future Prospects
  • Conversion From Clia Lab Services offerings To Ivd Kits
    • Table 5-2: Selected Fda Approved/Cleared Laboratory Developed Tests

Chapter 6: Laboratory Developed Test Market Analysis - Clinical Laboratories Performing LDTs

  • LDT Market Worldwide
  • The Number of LDTs On The Market
  • Small Versus Large Volume
  • LDT Services Market By Segment
    • Table 6-1: Laboratory Developed Test Services Market; Major Clinical (Disease) Segments (2020 - 2025) (In Millions Usd)
  • LDT Services Market By Geography
    • Table 6-2: Laboratory Developed Test Services Market By Geographical Distribution (2020-2025) (In Millions Usd)
  • Infectious Disease Laboratory Developed Testing Services Market
  • Markets for LDTs for Infectious Disease Detection and Microbiology
    • Table 6-3: Infectious Disease Laboratory Developed Test Service Market, (2020-2025) (In Millions Usd) 121
  • LDT Infectious Disease Services Market By Geography
    • Figure 6-1: Geographical Distribution of The Infectious Disease Laboratory Developed Test Service Market (2020 and 2025) [Excluding Microbial Identification By Culture] (By %)
    • Figure 6-2: Geographical Distribution of The Infectious Disease Laboratory Microbial Identification Market (Culture) (2020 and 2025) (By %)
  • Oncology Laboratory Developed Testing Services Market
  • LDT Services Market for Oncology By Segment
    • Table 6-4: Oncology Laboratory Developed Test Services Market, Segmented By Clinical Application (2020-2025) (In Millions Usd)
  • Hereditary Risk of Cancer Testing Services Market
  • Cancer Screening Services Market
  • Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) In Cancer Care
  • Geographical Distribution of The Oncology Laboratory Developed Test Service Market
    • Figure 6-3: Geographical Distribution of The Oncology Laboratory Developed Test Services Market (Cancer Screening Plus Diagnosis/Prognosis/Monitoring (2020 and 2025) (By %)
  • Genetic Testing Laboratory Developed Testing Services Market
  • LDT Genetic Test Market By Segment
    • Table 6-5: Genetic Testing Laboratory Developed Test Service Market, Segmented By Clinical Application (2020- 2025) (In Millions Usd)
  • LDT Genetic Testing LDT Market By Geography
    • Figure 6-4: Geographical Distribution of The Genetic Testing Laboratory Developed Test Service Market (2020 and 2025) (By %)
  • Market for Other Laboratory Developed Tests

Chapter 7: Laboratory Developed Test Market Analysis - Instrument and Reagent Manufacturers

  • Uniqueness of Market Analysis On LDT Product and Reagents
  • LDT Products and Reagents By Segment (Pcr, Mass Spectrometry, Ngs. Microarrays and Other)
    • Table 7-1: Worldwide Market for Products (Instruments and Consumables) Used By Clinical Laboratories for LDTs (2020-2025) (In Millions Usd)
  • Geographic Distribution of Product and Reagents Used for LDT Market
    • Table 7-2: Geographical Distribution of The Market for Products (Instruments and Consumables) Used By Clinical Laboratories for LDTs (2020-2025) (In Millions Usd)

Chapter 8: Company Profiles

  • 23andme, Inc.
  • Adaptive Biotechnologies Corporation
    • Recent Revenue History
      • Table 8-1: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Admera Health
  • Agendia Nv
  • Agilent Technologies Inc.
    • Recent Revenue History
      • Table 8-2: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Ambry Genetics Corp.
  • BGI
    • Table 17-85: Revenues (2017-2020) ($ Millions)
    • COVID-19
  • Biodesix, Inc.
  • Biotheranostics, Inc.
  • Bruker Corporation
    • Recent Revenue History
      • Table 8-3: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Caredx, Inc.
    • Recent Revenue History
      • Table 8-4: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Centogene Ag
  • Epic Sciences, Inc.
  • Eurofins
    • Recent Revenue History
      • Table 8-5: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Foundation Medicine, Inc.
  • Guardant Health, Inc.
    • Recent Revenue History
      • Table 8-6: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Helix
    • COVID-19
  • Illumina, Inc.
    • Recent Revenue History
      • Table 8-7: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Invitae Corporation
    • Recent Revenue History
      • Table 8-8: Revenues (2017-2020) ($ Thousands)
    • Company Overview
  • Laboratory Corporation of America (Labcorp)
    • Recent Revenue History
      • Table 8-9: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • LunglifeAI
  • MDXHealth
    • Recent Revenue History
      • Table 8-10: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Myriad Genetics, Inc.
    • Recent Revenue History
      • Table 8-11: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Natera, Inc.
    • Recent Revenue History
      • Table 8-12: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Neogenomics
    • Recent Revenue History
      • Table 8-13: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Opko Health, Inc./Opko Diagnostics
    • Recent Revenue History
      • Table 8-14: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Pacific Biosciences of California, Inc.
    • Recent Revenue History
      • Table 8-15: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Perkin Elmer, Inc.
    • Recent Revenue History
      • Table 8-16: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Qiagen N.V.
    • Recent Revenue History
      • Table 8-17: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Quest Diagnostics
    • Recent Revenue History
      • Table 8-18: Revenues (2017-2020) ($ Millions)
    • Company Overview
  • Roche Diagnostics
    • Recent Revenue History
      • Table 8-19: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Rosetta Genomics Ltd.
  • SCIEX Pte Ltd.
  • Thermo Fisher Scientific, Inc.
    • Recent Revenue History
      • Table 8-21: Revenues (2017-2020) ($ Millions)
    • Company Overview
    • COVID-19
  • Waters Corporation
    • Recent Revenue History
      • Table 8-22: Revenues (2017-2020) ($ Millions)
    • Company Overview