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Molecular Cancer Diagnostics Market

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SKU: 20-024 Categories: Diagnostics Market Research, Molecular & Nucleic Acid Testing, Oncology & Hematology Market Reports Tags: Assays, cancer diagnostics market, molecular assays including CDx, Molecular Cancer Diagnostics Market, molecular diagnostics market for oncology - Histology, molecular diagnostics oncology, molecular histology, molecular HPV Pages: 189
  • Description
  • Table of Contents
  • Latest reports

Description

The potential of molecular diagnostic tools was initially recognized by onco-hematologists during the 1980s based on the observation that specific chromosomal translocations may significantly aid the diagnosis of various types of leukemia and lymphoma. Later, the emergence of user-friendly molecular methods such as PCR has opened up practical applications that helped multiple approaches for cancer diagnosis and treatments. DNA sequencing is increasingly employed in cancer molecular diagnostics. PCR is the initial step used in isolating and amplifying specific regions of the genome, known as amplicons, before moving to sequencing of these regions, which are then compared with reference sequences to identify mutations.

This report contains market sizing and forecasts for this important area of molecular testing, including the following global market information:

  • Global Molecular Cancer Diagnostics Market, 2019-2025 ($ millions)
  • Molecular Cancer Diagnostics, Laboratory Developed Tests (LDT) Market Distribution, 2019 (%)
  • Global Molecular Cancer Diagnostics Markets, By Region (2019-2025) ($, Million) (North America, Europe, APAC, RoW, Total)
  • Global Molecular Cancer Diagnostics Markets, By Segment (2019-2025) ($, Million) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
  • Global Molecular Cancer Diagnostics Markets, Estimated Distribution of Sales by Technology/Method (2020-2025) (%) (PCR, ISH, Arrays, NGS, Others)

Regional Market Data
The report also examines molecular cancer diagnostics markets by region, including data points for North America, Europe, APAC, and rest of world:

North America:

  • North America Molecular Dx Market for Oncology – Histology, Assays, 2019-2025 ($ millions) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
  • North America (United States, Canada) Molecular Dx Market for Oncology, 2020-2025 ($ millions)

Europe:

  • Europe Molecular Dx Market for Oncology – Histology, Assays, 2019-2025 ($ millions) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
  • Europe (EU13, Eastern Europe, Russia, Switzerland) Molecular Dx Market for Oncology, 2020-2025 ($ millions)

APAC:

  • APAC Molecular Dx Market for Oncology – Histology, Assays, 2019-2025 ($ millions) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
  • APAC (Japan, China) Molecular Dx Market for Oncology, 2020-2025 ($ millions)

Market Trends
Cancer diagnostics is a highly dynamic field that consists of various types of platforms. Molecular diagnostics platforms are increasingly becoming popular as they enable accurate diagnosis as well as prognosis evaluation, which is important for treatment decisions. Some of the key market trends in the molecular cancer diagnostics market are identified and analyzed in Molecular Cancer Diagnostics Market, such as next generation sequencing in cancer diagnostics and the role of molecular diagnostics in hereditary cancer diagnosis.

Competitor Analysis
The report also provides analysis of leading market participants including:

  • Estimated Molecular Cancer Test Revenues of Selected IVD Vendors, 2019 ($ millions)
  • Estimated Molecular Cancer Test Market Value Distribution, 2019 (%)

Further, the report presents profiles of competitors in the market, including the following:

  • Abbott Diagnostics
  • Agendia BV
  • ARUP Laboratories
  • Asuragen Inc.
  • Biocartis
  • Biodesix
  • bioMérieux Inc.
  • BioReference Laboratories
  • Biotheranostics, Inc.
  • DiaSorin S.p.A
  • Enzo Biochem Inc.
  • Epigenomics AG
  • Exact Sciences Corp.
  • Exosome Diagnostics, Inc.
  • Guardant Health, Inc.
  • Helomics Corporation
  • Hologic, Inc.
  • Illumina, Inc.
  • LabCorp, Laboratory Corporation of America
  • Mayo Medical Laboratories
  • MDxHealth SA
  • Myriad Genetics, Inc.
  • NanoString Technologies, Inc.
  • NeoGenomics
  • OPKO Health, Inc.
  • Pacific Biosciences of California, Inc. (PacBio)
  • QIAGEN N.V.
  • Quest Diagnostics
  • Roche Diagnostics
  • Thermo Fisher Scientific Inc.
  • Trovagene, Inc.
  • Veracyte, Inc.

Market Developments, Technology and Product Introduction
Molecular Cancer Diagnostics Market also reviews expected developments such as technology and product introduction. Expectations for molecular diagnostics in cancer include the introduction of more biofluid-based (e.g., blood, urine) samples and tests indicated for cancer detection and monitoring, though the current market remains largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types. Some of the most significant developments in this field that may have an impact in shaping cancer diagnostics and treatment management are assessed throughout the report. The report includes statistical information for cancers by type on a global level.

Table of Contents

One: Executive Summary
Introduction
Market for Molecular Cancer Diagnostics

    • Table 1-1: Global Molecular Cancer Diagnostics Market, 2019-2025 ($ millions)

Scope and Methodology

Two: Industry Overview
Introduction
Global Cancer Burden

    • Figure 2-1: Global Cancer Incidence Trends 2010-2040
    • Figure 2-2: Incidence of Cancer by Type, 2018 (Lung, Breast, Colorectum, Prostate, Stomach, Liver, Oesophagus, Cervix uteri, Thyroid, Bladder)
    • Figure 2-3: Distribution of Cancer Incidence by Type, 2018 (%) (Lung, Breast, Colorectum, Prostate, Stomach, Liver, Oesophagus, Cervix uteri, Thyroid, Bladder, Others)

Market Trends in Molecular Diagnostics

  • Next Generation Sequencing or Massively Parallel Sequencing in Cancer Diagnostics
    • Figure 2-4: Distribution of Sequencing Diagnostic Trials, as of February 2020 (%) (Lung/Bronchial, Gastrointestinal/Digestive, Leukemia, Breast, Others)
  • Role of Molecular Diagnostics in Hereditary Cancer Diagnosis
    • Table 2-1: Select Innovations in Molecular Cancer Risk Detection and Prevention
  • Predictive Biomarker Tests for Identifying Drug-Gene Match
  • Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
    • Table 2-2: Companies Offering Liquid Biopsy-based Molecular Cancer Assays
  • Molecular Diagnosis of Cancers of Unknown Primary Site (CUP)
  • Artificial Intelligence

Evolution of Molecular Cancer Diagnostics and Current Status

    • Table 2-3: Selected Molecular Companion and Complementary Assays for Cancer
  • Clinical Utility of Molecular Diagnostics
  • Laboratory Developed Tests (LDT)
    • Figure 2-5: Molecular Cancer Diagnostics, LTD Market Distribution, 2019 (%)

Three: Global Cancer Molecular Diagnostics Market
Introduction

    • Table 3-1: Global Molecular Cancer Diagnostics Markets, By Region (2019-2025) ($, Million) (North America, Europe, APAC, RoW, Total)
    • Table 3-2: Global Molecular Cancer Diagnostics Markets, By Segment (2019-2025) ($, Million) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
    • Table 3-3: Global Molecular Cancer Diagnostics Markets, Estimated Distribution of Sales by Technology/Method (2020-2025) (%) (PCR, ISH, Arrays, NGS, Others)

Competitor Analysis

    • Table 3-4: Estimated Molecular Cancer Test Revenues of Selected IVD Vendors, 2019 ($ millions)
    • Figure 3-1: Estimated Molecular Cancer Test Market Value Distribution, 2019 (%)

Relevant DNA/RNA Variants

    • Table 3-5: Human Genome and Cancer Gene Identification
    • Table 3-6: Global Molecular Cancer Diagnostics Markets by Select Cancer Target (Breast/Ovarian, Colorectal, Leukemia/Lymphoma, Lung, Melanoma), 2019-2025 ($ millions)
    • Table 3-7: Cancer Incidence by Type, 2018 data
    • Table 3-8: Relevant DNA/RNA Variants for Top Six Cancer Types
    • Table 3-9: Relevant DNA/RNA Variants for High Incidence Cancer Types (excluding top six)

Four: Cancer Molecular Diagnostics Markets, North America
Introduction

    • Table 4-1: North America Molecular Dx Market for Oncology – Histology, Assays, 2019-2025 ($ millions) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
    • Table 4-2: North America (United States, Canada) Molecular Dx Market for Oncology, 2020-2025 ($ millions)

The Burden of Cancer in North America

    • Table 4-3: United States – Top 10 Cancer Incidences, 2018
    • Figure 4-1: United States – Leading Cancer Incidence Distribution, 2018 (%) (Breast, Lung, Prostate, Colorectum, Bladder, Non-Hodgkin lymphoma, Melanoma of skin, Thyroid, Kidney, Corpus uteri, Others)
    • Table 4-4: Canada – Top 10 Cancer Incidences, 2018
    • Figure 4-2: Canada – Leading Cancer Incidence Distribution, 2018 (%) (Breast, Lung, Prostate, Colorectum, Bladder, Non-Hodgkin lymphoma, Melanoma of skin, Thyroid, Kidney, Corpus uteri, Others)

Reimbursement Structure, Challenges and Recent Activity

  • U.S. Reimbursement Structure
    • Table 4-5: Medicare Reimbursement Amounts for Molecular Diagnostics Oncology, 2018-2020
    • Figure 4-3: Average Medicare Reimbursement for Molecular Dx Oncology, 2018-2020 ($)
  • Canada Reimbursement Structure

Five: Cancer Molecular Diagnostics Markets, Europe
Introduction

    • Table 5-1: Europe Molecular Dx Market for Oncology – Histology, Assays, 2019-2025 ($ millions) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
    • Table 5-2: Europe (EU13, Eastern Europe, Russia, Switzerland) Molecular Dx Market for Oncology, 2020-2025 ($ millions)

Reimbursement Structure, Challenges and Recent Activity
EU15

    • Table 5-3: EU15 – Top 10 Cancer Incidences, 2018
    • Figure 5-1: EU15 – Leading Cancer Incidence Distribution, 2018 (%) (Breast, Lung, Prostate, Colorectum, Bladder, Non-Hodgkin lymphoma, Melanoma of skin, Pancreas, Kidney, Leukemia, Others)

Eastern Europe

    • Table 5-4: Eastern Europe – Top 10 Cancer Incidences, 2018
    • Figure 5-2: Eastern Europe – Leading Cancer Incidence Distribution, 2018 (%) (Breast, Lung, Prostate, Colorectum, Bladder, Corpus uteri, Kidney, Stomach, Pancreas, Melanoma of skin, Others)

Russia

    • Table 5-5: Russia – Top 10 Cancer Incidences, 2018
    • Figure 5-3: Russia – Leading Cancer Incidence Distribution, 2018 (%)

Switzerland

    • Table 5-6: Switzerland – Top 10 Cancer Incidences, 2018
    • Figure 5-4: Switzerland – Leading Cancer Incidence Distribution, 2018 (%) (Breast, Lung, Prostate, Colorectum, Melanoma of skin, Bladder, Non-Hodgkin lymphoma, Pancreas, Thyroid, Corpus uteri, Others)

Six: Cancer Molecular Diagnostics Markets, APAC
Introduction

    • Table 6-1: APAC Molecular Dx Market for Oncology – Histology, Assays, 2019-2025 ($ millions) (Molecular Histology; Molecular Assays, including CDx; Total. Molecular HPV)
    • Table 6-2: APAC (Japan, China) Molecular Dx Market for Oncology, 2020-2025 ($ millions)

Cancer Burden in APAC
Japan

    • Table 6-3: Japan – Top 10 Cancer Incidences, 2018
    • Figure 6-1: Japan – Leading Cancer Incidence Distribution, 2018 (%) (Colorectum, Lung, Stomach, Prostate, Breast, Pancreas, Bladder, Liver, Non-Hodgkin lymphoma, Gallbladder, Others)
  • Reimbursement Environment in Japan

China

    • Table 6-4: China – Top 10 Cancer Incidences, 2018
    • Figure 6-2: China – Leading Cancer Incidence Distribution, 2018 (%) (Colorectum, Lung, Stomach, Liver, Breast, Oesophagus, Thyroid, Pancreas, Cervix uteri, Prostate, Others)
    • Table 6-5: Recent Partnerships Established between Illumina and Diagnostics Companies in China
  • Reimbursement Environment in China

India

    • Table 6-6: India – Top 10 Cancer Incidences, 2018
    • Figure 6-3: India – Leading Cancer Incidence Distribution, 2018 (%) (Breast; Lip, oral cavity; Cervix uteri; Lung; Stomach; Colorectum; Oesophagus; Leukemia; Ovary; Larynx; Others)
  • Reimbursement Environment in India
  • ASEAN

Seven: Molecular Diagnostic Company Profiles
Abbott Diagnostics

    • Table 7-1: Abbott Diagnostics’ Recent Revenue History ($ millions)

Agendia BV
ARUP Laboratories

    • Table 7-2: ARUP Labs’ Recent Revenue History ($ millions)

Asuragen Inc.
Biocartis

    • Table 7-3: Biocartis’ Recent Revenue History ($ millions)

Biodesix
bioMÈrieux Inc.

    • Table 7-4: bioMÈrieux’s Recent Revenue History ($ millions)

BioReference Laboratories
Biotheranostics, Inc.
DiaSorin S.p.A

    • Table 7-5: DiaSorin’s Recent Revenue History ($ millions)

Enzo Biochem Inc.

    • Table 7-6: Enzo Biochem’s Recent Revenue History ($ millions)

Epigenomics AG
Exact Sciences Corp.

    • Table 7-7: Exact Sciences’ Recent Revenue History ($ millions)

Exosome Diagnostics, Inc.
Guardant Health, Inc.

    • Table 7-8: Guardant Health’s Recent Revenue History ($ millions)

Helomics Corporation
Hologic, Inc.

    • Table 7-9: Hologic’s Recent Revenue History ($ millions)

Illumina, Inc.

    • Table 7-10: Illumina’s Recent Revenue History ($ millions)

LabCorp, Laboratory Corporation of America

    • Table 7-11: LabCorp’s Recent Revenue History ($ millions)

Mayo Medical Laboratories
MDxHealth SA

    • Table 7-12: MDxHealth’s Recent Revenue History ($ millions)

Myriad Genetics, Inc.

    • Table 7-13: Myriad Genetics’ Recent Revenue History ($ millions)

NanoString Technologies, Inc.

    • Table 7-14: NanoString Technologies’ Recent Revenue History ($ millions)

NeoGenomics

    • Table 7-15: NeoGemonicsí Recent Revenue History ($ millions)

OPKO Health, Inc.

    • Table 7-16: OPKO Health’s Recent Revenue History ($ millions)

Pacific Biosciences of California, Inc. (PacBio)

    • Table 7-17: Pacific Biosciences of California’s Recent Revenue History ($ millions)

QIAGEN N.V.

    • Table 7-18: QIAGEN’s Recent Revenue History ($ millions)

Quest Diagnostics

    • Table 7-19: Quest Diagnostics’ Recent Revenue History ($ millions)

Roche Diagnostics

    • Table 7-20: Roche Diagnostics’ Recent Revenue History ($ millions)

Thermo Fisher Scientific Inc.

    • Table 7-21: Thermo Fisher’s Recent Revenue History ($ millions)

Trovagene, Inc.

    • Table 7-22: Trovagene’s Recent Revenue History ($ millions)

Veracyte, Inc.

    • Table 7-23: Veracyte’s Recent Revenue History ($ millions)
    Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 12th Edition
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    In Vitro Diagnostic (IVD) Trends and Market Update, 2025
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    In Vitro Diagnostics Business Outlook, 2025 (6 Issues)
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    Molecular Diagnostics Quarterly Datastream, 2025
    April 2, 2025

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