がん診断の世界市場：2024年～2029年

正確な診断、治療法の選択、治療効果のモニタリング、がん再発の早期発見に不可欠な分子・タンパク質バイオマーカーにより、がん診断の状況は進化しています。

当レポートでは、世界のがん診断市場について調査し、重要なカテゴリーに焦点を当てる一方で、イメージング、血液学、臨床化学、フローサイトメトリー、パップスメア、従来の染色についても網羅します。がんIVD市場を形成する主な発展、製品上市、規制当局の発表を分析し、2024年から2029年までの市場成長予測を掲載しています。

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、背景、概要

• 世界のがんの負担
• がんの概要
• がん細胞の生化学
• がん増殖の原因が治療の糸口となる可能性
• 環境要因、DNA、RNA
• 細胞がん遺伝子
• 腫瘍抑制遺伝子
• 幅広いIVDの適用
• 組織学と細胞学
• インサイチューハイブリダイゼーション（ISH）
• 免疫測定
• ポリメラーゼ連鎖反応（PCR）
• コンパニオン診断
• 薬物遺伝子適合のための予測バイオマーカー検査
• DNAとRNAの変異体
• 遺伝性がんの診断
• 広く使用されているがんマーカー
• がん治療のアプローチ
• 精密がん治療とは何か

第3章 市場動向

• 精密医療、コンパニオン診断、関連用途の成長
• 薬物診断検査
• 液体生検に基づく非侵襲性がん分子診断
• 循環腫瘍細胞（CTC）検査
• サンプル収集製品
• エキソソーム配列解析
• 次世代シーケンシング検査
• 全ゲノム配列解析
• エクソームシークエンシング
• RNAシークエンシング
• 規制の影響
• 企業
• 高度な分析ソリューション
• 組織学の自動化
• 人工知能
• 質量分析
• 規制と償還の動向
• 保険償還の進歩と課題
• 次世代シーケンシングカバレッジ
• コンパニオン診断の規制の開発
• 臨床検査（LDT）
• 食品医薬品局
• 指令98/79/EC
• カナダ保健省の変更と予想される措置
• 国際的成長機会

第4章 市場収益と予測

第5章 競合分析

第6章 企業プロファイル

• Abbott Diagnostics
• Agendia BV
• Agilent Technologies
• Asuragen (Bio-Techne)
• Beckman Coulter (Danaher)
• Becton, Dickinson and Company (BD)
• Bio-Rad Laboratories
• Biocartis
• Biodesix
• Biotheranostics, Inc. (Hologic)
• Danaher Corp.
• Exact Sciences
• Exosome Diagnostics (Bio-Techne)
• Hologic
• Illumina
• Leica Biosystems (Danaher)
• Menarini-Silicon Biosystems
• Qiagen
• Roche
• Sysmex Inostics
• Thermo Fisher Scientific

The landscape of cancer diagnostics is evolving with molecular and protein biomarkers indispensable for accurate diagnosis, therapy selection, monitoring treatment response, and early detection of cancer recurrence. Kalorama Information's "The World Market for Cancer Diagnostics, 2024-2029" delivers an authoritative and comprehensive analysis of the global cancer in vitro diagnostics (IVD) market, including industry-defining trends, market sizing, and growth opportunities.

This report offers an in-depth review of the cancer IVD market, including expert insights into significant segment markets:

• Oncology molecular assays (including companion diagnostics)
• Molecular screening for colorectal cancer
• Immunohistochemistry (IHC)
• Tumor marker immunoassays
• In situ hybridization (ISH/FISH)
• Human papillomavirus (HPV) tests
• Circulating tumor cell (CTC) assays

While focusing on these pivotal categories, the report provides limited coverage of imaging, hematology, clinical chemistry, flow cytometry, Pap smears, and traditional stains. Key developments, product launches, and regulatory announcements that shape the cancer IVD market are analyzed, along with forecasts for market growth from 2024 to 2029.

Key Highlights

• Shift to Biofluid-Based Diagnostics: Although tissue-based diagnostics dominate the current market, there is growing momentum toward biofluid-based tests (e.g., blood, urine) for cancer detection and monitoring.
• Market Dynamics: The forecasted growth reflects anticipated product innovations, cancer epidemiology trends, and demographic shifts, with revenue estimates based on factory-level sales to end users.
• Comprehensive Insights: The report incorporates global cancer statistics, technological advancements, and competitive trends to provide a nuanced view of the market's evolution.

Report Structure

• 1. Executive Summary - A concise overview of key findings and market scope.
• 2. Introduction and Overview - Background and terminology for context.
• 3. Market Trends - Emerging trends shaping the cancer diagnostics industry.
• 4. Market Revenues and Forecasts - Detailed revenue projections by segment through 2029.
• 5. Competitive Analysis - Analysis of key market players and competitive developments.
• 6. Corporate Profiles - Profiles of leading companies in the cancer diagnostics space.

Table of Contents

Chapter 1: Executive Summary

• Overview
• Scope and Methodology
• Market Overview and Analysis
  • Figure 1-1: Global Cancer IVD Market Size and Forecast, 2024-2029 ($ million)

Chapter 2: Introduction, Background, and Overview

• Global Cancer Burden
  • Figure 2-1: Incidence of Cancer, by Type, 2020 (Bladder, Breast, Cervix Uteri, Colorectum, Liver, Lung, Oesophagus, Prostate, Stomach, Thyroid)
  • Figure 2-2: Global Distribution of Cancer Incidence, Estimated Number of New Cases, by Type, 2020 (%) (Breast, Cervix Uteri, Colorectum, Liver, Lung, Prostate, Stomach, Thyroid, Other Cancers)
• Introduction to Cancer
• Biochemistry of Cancer Cells
• Causes of Cancer Growth May Shed Light on Treatment
• Environmental Factors, DNA, RNA
  • Table 2-1: Virus Association with Human Cancer
• Cellular Oncogenes
• Tumor Suppressor Genes
• Large Range of IVDs Applied
• Histology and Cytology
• In Situ Hybridization (ISH)
• Immunoassays
• Polymerase Chain Reaction (PCR)
• Companion Diagnostics
  • Table 2-2: FDA Approved or Cleared Companion Diagnostic (CDx) Tests and Corresponding Therapies, Oncology
  • Table 2-3: Selected Major Biomarkers in Oncology Personalized Medicine Tests
• Predictive Biomarker Tests for Drug-Gene Match
• DNA and RNA Variants
  • Table 2-4: Human Genome and Cancer Gene Identification
  • Table 2-5: Relevant DNA/RNA Variants for Top Six Cancer Types (Breast, Colon, Gastric, Liver/Biliary, Lung, Prostate)
  • Table 2-6: Relevant DNA/RNA Variants for Top Six Cancer Types (excl. top six) (Brain, Cervical, Esophagus, Leukemia, Lymphoma, Melanoma, Ovarian, Pancreatic, Sarcoma, Thyroid)
• Diagnostics in Hereditary Cancer Diagnosis
  • Table 2-7: Select Innovations in Molecular Cancer Risk Detection and Prevention
  • Table 2-8: Selected Companies Offering LDTs for Hereditary Risk of Cancer
• Cancer Markers in Widespread Usage
• Cancer Treatment Approaches
  • Table 2-9: Characteristics of Cancer Treatment Approaches (Chemotherapy, Hormone Therapy, Precision Therapy)
• What is Precision Cancer Therapy?
  • Table 2-10: Industry Recognized Terms for Companion Diagnostics and Personalized Medicine

Chapter 3: Market Trends

• Growth in Precision Medicine, Companion Diagnostics, Related Applications
  • Table 3-1: Selected Molecular Companion and Complementary Assays for Cancer
  • Table 3-2: Selected Pharmacogenomic Biomarkers and Drugs' Labeling, FDA
  • Table 3-3: Selected FDA Cleared/Approved Companion Diagnostic Tests and Therapeutic Application
• Pharmacodiagnostic Tests
  • Table 3-4: Selected Liquid Biopsy Innovations
• Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
• Circulating Tumor Cell (CTC) Tests
• Sample Collection Products
• Exosome Sequencing
• Next-Generation Sequencing Tests
• Whole-Genome Sequencing
• Exome Sequencing
• RNA Sequencing
• Regulatory Influences
• Companies
• Advanced Analysis Solutions
  • Table 3-5: Selected Advanced Histology Techniques
• Automation of Histology
  • Table 3-6: Selected Histology Lab Automation Technologies
  • Table 3-7: Histology Information Technology Tools
• Artificial Intelligence
• Mass Spectrometry
  • Table 3-8: Selected Mass Spectrometry-Based Oncology Tests
• Regulatory and Reimbursement Trends
• Reimbursement Breakthroughs and Challenges
• Next Generation Sequencing Coverage
• Companion Diagnostics Seeing Development in Regulations
  • Table 3-9: FDA Approved Companion Diagnostics Labeled for Identifying Patients with NSCLC whose Tumors have EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations and the Associated Therapeutic Products
  • Figure 3-1: Growth in Precision Cancer Therapeutics by Company 2010 vs. 2022 ($ million)
  • Figure 3-2: Growth Trend by Company, 2010-2022 CAGR: Precision Cancer Therapeutics (%)
• Laboratory Developed Tests (LDTs)
• Food and Drug Administration
• Directive 98/79/EC
• Health Canada Changes and Forecasted Action
• International Growth Opportunities

Chapter 4: Market Revenues and Forecast

• Market Revenue 2024-2029
  • Table 4-1: Cancer IVD Market Revenues, by Segment, 2024-2029 ($ million) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay - IHC; Immunoassay - Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
  • Figure 4-1: Cancer IVD Market Revenues, by Segment, 2024-2029 ($ million) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay - IHC; Immunoassay - Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
  • Figure 4-2: Cancer IVD Market Revenue, CAGR by Segment, 2024-2029 (%) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay - IHC; Immunoassay - Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
  • Table 4-2: Cancer IVD Market Revenues, Share by Segment, 2024 vs. 2029 (%) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay - IHC; Immunoassay - Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
  • Figure 4-3: Cancer IVD Market Revenues, Share by Segment, 2024 (%) (Colon Cancer Molecular Screen; CTCs; HPV; Immunoassay - IHC; Immunoassay - Tumor Markers; ISH/ FISH; Oncology Molecular Assays [including. CDx])
• Molecular Cancer Test Regional Distribution
  • Table 4-3: Global Molecular Cancer Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
  • Figure 4-4: Global Molecular Cancer Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
• Histology and Cytology
  • Table 4-4: Global Histology/Cytology Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
  • Figure 4-5: Global Histology/Cytology Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
• Molecular Cancer Diagnostics Segment by Technology/Method
  • Table 4-5: Techniques Used in Molecular Cancer Diagnostics, 2024 & 2029 (%) (Arrays, ISH, NGS, PCR, Others)
  • Figure 4-6: Techniques Used in Molecular Cancer Diagnostics, 2024 & 2029 (%) (Arrays, ISH, NGS, PCR, Others)
• HPV Market and Regional Distribution
  • Table 4-6: Selected HPV Test Innovations
  • Table 4-7: Global HPV Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
  • Figure 4-7: Global HPV Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, Rest of World)
• Drivers and Challenges
• Clinical Utility of Molecular Diagnostics
• Technological Advancements Including NGS Adopted Incrementally

Chapter 5: Competitive Analysis

• Recent Regulatory Approvals
  • Table 5-1: Recent Regulatory Approvals in Cancer IVD, May 2022 - December 2024
• Immunoassay Competitive Trends
• IHC Market
• Competition in ISH
• Molecular Cancer Diagnostics Landscape
• HPV
• Liquid Biopsy and CTCs
• Deals and Collaborations
  • Table 5-2: Recent Deals and Collaborations in Cancer IVD, January 2022 - December 2024
  • Table 5-3: CDx Relevant Partnerships and Collaborations
  • Table 5-4: Product/ Technology Introductions in Cancer IVD, January 2022 - November 2024

Chapter 6: Corporate Profiles

• Abbott Diagnostics
  • Company Overview
    • Companion Testing
    • Liquid Biopsy
• Agendia BV
  • Company Overview
• Agilent Technologies
  • Company Overview
    • Agilent in Genomics
    • Cytogenetic Analysis
    • Sequencing
    • CRISPR
    • Flow Cytometry
    • Companion Diagnostics
• Asuragen (Bio-Techne)
  • Company Overview
• Beckman Coulter (Danaher)
  • Company Overview
    • Immunoassays
• Becton, Dickinson and Company (BD)
  • Company Overview
    • Cytology and HPV
    • Flow Cytometry
    • Licensing
• Bio-Rad Laboratories
  • Company Overview
    • Immunoassays
    • Liquid Biopsy
    • Droplet Digital PCR
• Biocartis
  • Company Overview
• Biodesix
  • Company Overview
• Biotheranostics, Inc. (Hologic)
  • Company Overview
• Danaher Corp.
  • Company Overview
    • Other Acquisitions
• Exact Sciences
  • Company Overview
• Exosome Diagnostics (Bio-Techne)
  • Company Overview
• Hologic
  • Company Overview
• Illumina
  • Company Overview
• Leica Biosystems (Danaher)
  • Company Overview
    • Digital Pathology
    • Stain Reagents
    • Lab Systems
    • Sample Handling
    • Circulating Tumor Cells (CTCs)
    • Artificial Intelligence
• Menarini-Silicon Biosystems
  • Company Overview
• Qiagen
  • Company Overview
    • Precision Medicine / Companion Diagnostics
    • Sample Prep, Informatics
    • Digital PCR
    • Bioinformatics
    • Liquid Biopsy
• Roche
  • Company Overview
    • HPV
    • Cancer Companion Testing
    • Liquid Biopsy
    • IT in Anatomical Pathology
    • Information Technology
    • Roche Tissue Diagnostics / Ventana
    • Immunohistochemistry - IHC
    • Cervical Cancer Screening
    • Companion Diagnostics
• Sysmex Inostics
  • Company Overview
    • Hematology
    • Coagulation
    • Urinalysis
    • Immunoassays
    • Lab Information System
    • Information Technology
    • Flow Cytometry
    • Precision Medicine / Companion Test Diagnostics
    • Liquid Biopsy
    • Exosomes
    • Oncology
• Thermo Fisher Scientific
  • Company Overview
    • Next Generation Sequencing
    • Liquid Biopsy
    • Oncology Companion Diagnostics