薬事未承認検査（LDT）の世界市場：2023年～2028年

薬事未承認検査（LDT）は検査室が独自に開発した検査と定義され、診断薬企業が製造する体外診断用医薬品（IVD）キットとは異なります。LDTは米国市場において体外診断用医薬品とみなされ、段階的な規制の対象となります。

当レポートでは、世界の薬事未承認検査（LDT）市場について調査し、市場の概要とともに、2023年～2028年の市場予測、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 エグゼクティブサマリー

第2章 イントロダクション

第3章 臨床検査- 概要

• 臨床検査とは何か
• カロラマの定義
• 規制当局の承認とLDT
• その他の重要な用語
• 汎用試薬：
• 分析対象物特異的試薬（ASR）
• 臨床検査としての診断技術の利用
• 化学テスト
• 免疫学的検査
• 組織学的染色
• 免疫組織化学
• フローサイトメトリー
• 核型分析
• インサイチューハイブリダイゼーション
• ポリメラーゼ連鎖反応およびその他の核酸増幅技術
• 遺伝子発現パターン（遺伝子シグネチャー）の解析
• マイクロアレイ
• タンパク質マイクロアレイ
• DNAマイクロアレイ
• 染色体マイクロアレイ
• 組織マイクロアレイ
• 質量分析
• シーケンシング
• その他

第4章 臨床開発検査の臨床応用

• 感染症
• 症候群検査
• 腫瘍学
• がんの遺伝的リスク
• がん検診
• がん治療における診断、予後、治療決定（個別化医療）
• 遺伝子検査
• 病気のリスク検査- がんを超えて
• 染色体分析と非侵襲的出生前検査（NIPT）
• 遺伝性疾患の検査（出生前検査、出生後検査、保因者スクリーニング）
• 新生児スクリーニング
• その他の遺伝子検査
• 消費者向け遺伝子検査
• 薬理ゲノム学
• 質量分析法別小分子の検査
• その他

第5章 市場促進要因・課題-臨床検査

• 臨床検査の規制：米国および米国外
• 米国
• 欧州
• その他の地域
• テクノロジー
• FDA承認およびCEマーク取得テストの状況
• LDT開発におけるAI
• 臨床市場促進要因
• 競合
• 個別化医療とコンパニオン診断
• 償還
• メディケアへのアクセス保護法（PAMA）
• 分子病理学協会
• 合併と買収
• 新規株式公開（IPO）と資金調達
• 今後の展望
• CLIAラボサービスの提供からIVDキットへの変換

第6章 臨床検査市場分析-LDTを実施する臨床検査室

第7章 臨床検査市場分析- 機器および試薬メーカー

第8章 企業プロファイル

• 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)