全球未經許可藥物測試 (LDT) 市場：2023-2028

未經許可的藥物測試（LDT）被定義為由實驗室獨立開發的測試，與診斷公司製造的體外診斷（IVD）試劑盒不同。 LDT 在美國市場被視為體外診斷，並受到逐步監管。

本報告調查了全球非藥物測試 (LDT) 市場，並提供了市場概況、2023 年至 2028 年的市場預測以及進入該市場的公司概況。

目錄

第 1 章執行摘要

第 2 章簡介

第 3 章臨床測試 - 概述

• 什麼是臨床測試？
• Kalorama 的定義
• 監理審批和 LDT
• 其他重要術語
• 通用試劑：
• 分析物特異性試劑 (ASR)
• 使用診斷技術作為臨床測試
• 化學測試
• 免疫檢測
• 組織學染色
• 免疫組織化學
• 流式細胞儀
• 核型分析
• 原位雜交
• 聚合□連鎖反應與其他核酸擴增技術
• 基因表現模式分析（基因特徵）
• 微陣列晶片
• 蛋白質微陣列
• DNA 微陣列
• 染色體微陣列
• 組織微陣列
• 質譜分析
• 定序
• 其他

第 4 章臨床開發測試的臨床應用

• 傳染病
• 症候群測試
• 腫瘤學
• 癌症的遺傳風險
• 癌症篩檢
• 癌症治療中的診斷、預後與治療決策（個人化醫療）
• 基因檢測
• 疾病風險測試 - 超越癌症
• 染色體分析與非侵入性產前檢測 (NIPT)
• 遺傳疾病檢測（產前檢測、產後檢測、帶因者篩檢）
• 新生兒篩檢
• 其他基因測試
• 消費者基因檢測
• 藥物基因組學
• 以質譜法進行小分子測試
• 其他

第五章市場推廣因素/問題-臨床測試

• 臨床試驗監理：美國與非美國
• 美國
• 歐洲
• 其他領域
• 技術
• FDA 核准和 CE 標誌測試狀態
• 人工智慧在 LDT 開發的應用
• 臨床市場驅動因素
• 衝突
• 個人化醫療與伴隨診斷
• 贖回
• 《醫療保險保障法案》(PAMA)
• 分子病理學會
• 併購
• 首次公開發行 (IPO) 和融資
• 未來展望
• 從 CLIA 實驗室服務提供轉變為 IVD 試劑盒

第六章臨床實驗室市場分析-實施LDT的臨床實驗室

第七章臨床檢驗市場分析-設備與試劑製造商

第八章公司簡介

• 23andMe, Inc
• Adaptive Biotechnologies Corporation
• 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/LabCorp
• Laboratory Corporation of America (LabCorp)
• LungLife AI
• MDxHealth
• Myriad Genetics, Inc.
• Natera, Inc
• NeoGenomics
• OPKO Health, Inc./OPKO Diagnostics
• PacBio
• PerkinElmer, Inc.
• QIAGEN N.V.
• Quest Diagnostics
• Roche Diagnostics
• SCIEX Pte Ltd.
• Thermo Fisher Scientific, Inc.
• Waters Corporation

Kalorama Information's latest report, "The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028", is now available for purchase. This comprehensive study delves into the dynamic landscape of LDTs, exploring both the services market and the market for test products sold to clinical laboratories.

"The Worldwide Market for Laboratory-Developed Tests" includes comprehensive analysis of the effects of the FDA's new "Medical Devices: Laboratory Developed Tests" rule, passed in April 2024, which subjects LDTs to significantly greater regulatory oversight.

Inclusion Criteria for LDTs:

• 2023-2024: LDTs are defined as tests developed by laboratories for their own use, distinct from regulated in vitro diagnostic (IVD) kits manufactured by diagnostic companies.
• From 2025: LDTs are considered IVDs in the U.S. market, subject to phased-in regulations.

Key Points:

• Scope and Methodology:
  • Market data is provided in U.S. dollars for 2023-2028.
  • Revenues of key market players (where available) are analyzed for the preceding three years.

• Two Interrelated Markets:
  • Clinical laboratory services utilizing LDTs.
  • Products (platforms and consumables) sold to clinical laboratories for LDT development.

• Global Coverage with Regional Focus:
  • Developed regions (United States, Japan, Western Europe) dominate LDT performance.

• Focus on Major Clinical Disease Segments:
  • Infectious Disease
  • Oncology LDT Services Market
  • Genetic Testing

• Product Sales Approach:
  • Market data reflects factory sales to end users, considering instrumentation costs embedded in per-test prices.

• LDTs: Transforming Healthcare:
  • Exciting assays with potential to revolutionize healthcare delivery.

• AI in LDT Development:
  • Discussion of the pivotal role AI could in revolutionizing the way LDT tests are developed, validated, and utilized in clinical settings, particularly in data analysis, assay design, quality control, result interpretation, and regulatory considerations

• Impact of the COVID-19 Pandemic:
  • Historical "home-brew" or "in-house" LDTs have evolved into high-risk, complex tests.
  • SARS-CoV-2 testing highlights their critical role.

• Defining LDTs:
  • Broader definition includes all clinical tests developed by laboratories for their own use, beyond the FDA's narrower view.

Table of Contents

Chapter 1: Executive Summary

• Overview
• Scope and Methodology
• Two Markets: The Market for Services and the Market for Test Products Sold to Labs
• Market Overview
• LDT Services Market Analysis
  • Table 1-1: Laboratory Developed Test Services Market, Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
  • Figure 1-1: Laboratory Developed Test Services Market, Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
• LDT Products Market Analysis
  • Table 1-2: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
  • Figure 1-2: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
• Market Drivers and Challenges Facing LDT Market
• Future Prospects in the Laboratory-Development Test Market
• New FDA Regulation in 2024
• LDT Business Landscape

Chapter 2: Introduction

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

Chapter 3: Laboratory Developed Tests - Overview

• What is a Laboratory-Developed Test?
• Kalorama Definition
  • Pre-2025 Definition
  • New 2025 Definition
  • Table 3-1: FDA Enforcement Discretion of New Regulation Phaseout Stage, by IVD Category, 2024
• Regulatory Approval and LDTs
• Other Important Terminology
• General purpose reagent:
• Analyte specific reagent (ASR):
• Use of Diagnostic Technologies as Laboratory-Developed Tests
• Chemistry Tests
• Immunoassays
• Histology Stains
  • Table 3-2: Selected Companies Marketing Histology Stains
  • Table 3-3: Selected Companies Marketing Microscopes
• Immunohistochemistry
• Flow Cytometry
  • Table 3-4: Selected Companies Marketing Antibodies for Immunohistochemistry and/or Flow Cytometry Testing in Clinical Laboratories
  • Table 3-5: Selected Companies Marketing Flow Cytometry Platforms
• Karyotyping
• In Situ Hybridization
  • Table 3-6: Selected Companies Marketing Probes for FISH-Based Tests in Clinical Laboratories
• Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
  • Table 3-7: 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 3-8: Selected Companies Marketing Mass Spectrometers
• Sequencing
  • Table 3-9: Selected Companies Marketing Next-Generation Sequencing Platforms to Clinical Laboratories
• Other Technologies

Chapter 4: Clinical Applications Where Laboratory-Developed Tests are Used

• Infectious Disease
  • Table 4-1: Selected Companies Offering Infectious Disease Test Services Based on LDTs (excluding microbial identification testing by culture)
• Syndromic Testing
• Oncology
• Hereditary Risk of Cancer
  • Table 4-2: Selected Companies Offering LDTs for Hereditary Risk of Cancer
• Cancer Screening
  • Table 4-3: Selected Companies Offering Cancer Screening Tests Based on LDTs
• Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
  • Table 4-4: Selected Companies Offering Cancer Diagnosis/Prognosis/Personalized Medicine Test Services Based on LDTs
• Genetic Testing
• Testing for Risk of Disease - Moving Beyond Cancer
  • Table 4-5: Selected Companies Offering LDTs for Risk of Disease - Cancer and Beyond
• Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
  • Table 4-6: Selected Companies Offering Non-Invasive Prenatal Testing (NIPT) Chromosome Analysis Based on LDTs
• Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening)
  • Cystic Fibrosis
  • Thrombophilia
  • Ashkenazi Jewish Genetic Panel
  • Other Inherited Disorders Caused by a Single Gene Mutation
  • Mitochondrial Disease
  • Table 4-7: Selected Companies Offering Genetic Testing for Inherited Disorders (prenatal, postnatal, carrier screening) Based on LDTs
• Newborn Screening
• Other Genetic Testing
  • Table 4-8: Selected Companies/Clinical Laboratories Offering Newborn Screening or Other Genetic Tests Based on LDTs
• Direct-to-Consumer Genetic Testing
  • Table 4-9: Selected Companies Offering Direct-to-Consumer Genetic Testing Based on LDTs
• Pharmacogenomics
  • Table 4-10: Selected Companies Offering Pharmacogenomic Test Services Based on LDTs
• Mass Spectrometry-Based Tests for Small Molecules
• Other Laboratory Developed Test Applications
  • Table 4-11: Selected Companies Offering Autoimmune/Inflammatory Test Services Based on LDTs
  • Table 4-12: Selected Companies Offering Cardiovascular Test Services Based on LDTs
  • Table 4-13: Selected Companies Offering Neurological Test Services Based on LDTs
  • Table 4-14: Selected Companies Offering Other Test Services Based on LDTs

Chapter 5: Market Drivers and Challenges - Laboratory Developed Tests

• Regulation of Laboratory Developed Tests: U.S. and Outside the U.S.
• United States
  • FDA
  • Emergency Use Authorization
  • Historical Position
  • Changes Resulting from COVID Pandemic
  • New 2024 Regulations and Implications
• Europe
  • Directive 98/79/EC
• Rest of World
• Technology
• Status of FDA-approved and CE-marked Tests
• AI in LDT Development
• Clinical Market Drivers
• Competition
• Personalized Medicine and Companion Diagnostics
• Reimbursement
• The Protecting Access to Medicare Act (PAMA)
• Association for Molecular Pathology
• Mergers and Acquisitions
  • Table 5-1: Selected Acquisitions of or by Companies/Laboratories with LDTs, 2020-2024
• Initial Public Offerings (IPOs) and Financings
  • Table 5-2: Selected IPOs of Key Clinical Diagnostics and/or LDT Players, 2018-2022
• Future Prospects
• Conversion from CLIA Lab Services Offerings to IVD Kits
  • Table 5-3: Selected FDA Approved/Cleared Laboratory Developed Tests

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

• Worldwide Laboratory Developed Testing Service Market
• The Number of LDTs on the Market
• Small versus Large Volume
• LDT Services Market by Segment
  • Table 6-1: Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
  • Figure 6-1: Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023-2028 (in $ millions)
  • Figure 6-2: Compound Annual Growth Rate (CAGR) for Laboratory-Developed Test Services Market by Major Clinical (Disease) Segments, 2023-2028 (%)
• LDT Services Market by Geography
  • Table 6-2: Laboratory Developed Test Services Market by Geographical Distribution, 2023-2028 (in $ millions) (%)
  • Figure 6-3: Laboratory Developed Test Services Market by Geographical Distribution, 2023-2028 (in $ millions)
  • Figure 6-4: Laboratory Developed Test Services Market, Share by Geographical Distribution, 2023-2028 (%)
  • Figure 6-5: Compound Annual Growth Rate (CAGR) for Laboratory Developed Test Services Market by Geographical Distribution, 2023-2028 (%)
• Oncology Laboratory Developed Testing Services Market
• LDT Services Market for Oncology by Segment
  • Table 6-3: Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
  • Figure 6-6: Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
  • Figure 6-7: Compound Annual Growth Rate (CAGR) for Oncology Laboratory-Developed Test Services Market, Segmented by Clinical Application, 2023-2028 (%)
• 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 6-8: Geographical Distribution of the Oncology Laboratory-Developed Test Services Market (Cancer Screening plus Diagnosis/Prognosis/Monitoring), by Regional Market Share, 2023 and 2028 (%)
• Genetic Testing Laboratory-Developed Testing Services Market
• LDT Genetic Test Market by Segment
  • Table 6-4: Genetic Testing Laboratory-Developed Test Service Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
  • Figure 6-9: Genetic Testing Laboratory-Developed Test Service Market, Segmented by Clinical Application, 2023-2028 (in $ millions)
  • Figure 6-10: Compound Annual Growth Rate (CAGR) for Genetic Testing Laboratory-Developed Test Service Market, Segmented by Clinical Application, 2023-2028 (%)
• LDT Genetic Testing LDT Market by Geography
  • Figure 6-11: Geographical Distribution of the Genetic Testing Laboratory-Developed Test Service Market, by Regional Market Share, 2023 and 2028 (%)
• Infectious Disease Laboratory Developed Testing Services Market
• Markets for LDTs for Infectious Disease Detection and Microbiology
  • Table 6-5: Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (in $ millions)
  • Figure 6-12: Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (in $ millions)
  • Figure 6-13: Compound Annual Growth Rate (CAGR) for Infectious Disease Laboratory-Developed Test Service Market, 2023-2028 (%)
• LDT Infectious Disease Services Market by Geography
  • Figure 6-14: Geographical Distribution of the Infectious Disease Laboratory-Developed Test Service Market, by Regional Market Share, 2023 and 2028 (%)
• Market for Other Laboratory-Developed Tests

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

• Uniqueness of Market Analysis on LDT Products and Reagents
• LDT Products and Reagents by Market Segment (PCR, Mass Spectrometry, NGS. Microarrays and Other)
  • Table 7-1: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
  • Figure 7-1: Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
  • Figure 7-2: Compound Annual Growth Rate (CAGR) for Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (%)
• 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, 2023-2028 (in $ millions)
  • Figure 7-3: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (in $ millions)
  • Figure 7-4: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, by Regional Market Share, 2023 and 2028 (%)
  • Figure 7-5: Compound Annual Growth Rate (CAGR) for Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs, 2023-2028 (%)

Chapter 8: Company Profiles

• 23andMe, Inc.
  • Company Overview
  • Financials
    • Table 8-1: Revenues for 23andMe, 2021-2023 (in $ millions)

• Adaptive Biotechnologies Corporation
  • Company Overview
  • Financials
    • Table 8-2: Revenues for Adaptive Biotechnologies, 2021-2023 (in $ millions)

• Agendia NV
  • Company Overview
  • Financials

• Agilent Technologies Inc.
  • Company Overview
    • Dako
  • Financials
    • Table 8-3: Revenues for Agilent Technologies, 2021-2023 (in $ millions)

• Ambry Genetics Corp.
  • Company Overview
  • Financials

• BGI
  • Company Overview
  • Financials
    • Table 8-4: Revenues for BGI, 2021-2023 (in $ millions)

• Biodesix, Inc.
  • Company Overview
  • Financials
    • Table 8-5: Revenues for Biodesix, 2021-2023 (in $ millions)

• Biotheranostics, Inc.
  • Company Overview
  • Financials

• Bruker Corporation
  • Company Overview
  • Financials
    • Table 8-6: Revenues for Bruker, 2021-2023 (in $ millions)

• CareDx, Inc.
  • Company Overview
  • Financials
    • Table 8-6: Revenues for CareDx, 2021-2023 (in $ millions)

• CENTOGENE AG
  • Company Overview
  • Financials
    • Table 8-7: Revenues for CENTOGENE, 2021-2023 (in $ millions)

• Epic Sciences, Inc.
  • Company Overview
  • Financials

• Eurofins
  • Company Overview
  • Financials
    • Table 8-8: Revenues for Eurofins, 2021-2023 (in $ millions)

• Foundation Medicine, Inc.
  • Company Overview
  • Financials

• Guardant Health, Inc.
  • Company Overview
  • Financials
    • Table 8-9: Revenues for Guardant Health, 2021-2023 (in $ millions)

• Helix
  • Company Overview
  • Financials

• Illumina, Inc.
  • Company Overview
  • Financials
    • Table 8-10: Revenues for Illumina, 2021-2023 (in $ millions)

• Invitae Corporation/LabCorp
  • Company Overview
  • Financials
    • Table 8-11: Revenues for Invitae, 2021-2023 (in $ millions)

• Laboratory Corporation of America (LabCorp)
  • Company Overview
  • Financials
    • Table 8-12: Revenues for LabCorp, 2021-2023 (in $ millions)

• LungLife AI
  • Company Overview
  • Financials

• MDxHealth
  • Company Overview
  • Financials
    • Table 8-13: Revenues for MDxHealth, 2021-2023 (in $ millions)

• Myriad Genetics, Inc.
  • Company Overview
  • Financials
    • Table 8-14: Revenues for Myriad Genetics, 2021-2023 (in $ millions)

• Natera, Inc.
  • Company Overview
  • Financials
    • Table 8-15: Revenues for Natera, 2021-2023 (in $ millions)

• NeoGenomics
  • Company Overview
  • Financials
    • Table 8-16: Revenues for NeoGenomics, 2021-2023 (in $ millions)

• OPKO Health, Inc./OPKO Diagnostics
  • Company Overview
  • Financials
    • Table 8-17: Revenues for OPKO Health, 2021-2023 (in $ millions)

• PacBio
  • Company Overview
  • Financials
    • Table 8-18: Revenues for PacBio, 2021-2023 (in $ millions)

• PerkinElmer, Inc.
  • Company Overview
  • Financials
    • Table 8-19: Revenues for PerkinElmer, 2021-2023 (in $ millions)

• QIAGEN N.V.
  • Company Overview
  • Financials
    • Table 8-20: Revenues for QIAGEN, 2021-2023 (in $ millions)

• Quest Diagnostics
  • Company Overview
  • Financials
    • Table 8-21: Revenues for Quest Diagnostics, 2021-2023 (in $ millions)

• Roche Diagnostics
  • Company Overview
  • Financials
    • Table 8-22: Revenues for Roche, 2021-2023 (in $ millions)

• SCIEX Pte Ltd.
  • Company Overview
  • Financials
    • Table 8-23: Revenues for Danaher, 2021-2023 (in $ millions)

• Thermo Fisher Scientific, Inc.
  • Company Overview
  • Financials
    • Table 8-24: Revenues for Thermo Fisher Scientific, 2021-2023 (in $ millions)

• Waters Corporation
  • Company Overview
  • Financials
    • Table 8-25: Revenues for Waters Corp., 2021-2023 (in $ millions)