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The World Market for Molecular Diagnostics, 13th Edition

Publication Date: December 19, 2024

SKU: 24-053

Tags: Blood Banking, COVID-19, Genetic Diseases, Hepatitis, Infectious Diseases, Molecular Diagnostics, Oncology and Cancer, Respiratory Diseases

Pages: 365

SKU: 24-053

The molecular diagnostics market, a driving force within the global in vitro diagnostics (IVD) industry, continues to thrive several years post-pandemic, offering significant growth opportunities across infectious diseases, cancer, and transplant diagnostics. Kalorama Information’s latest report, The World Market for Molecular Diagnostics, 13th Edition, provides an unparalleled deep dive into this dynamic sector, revealing key trends, applications, and innovations shaping the market from 2024 to 2029.

 

Why This Report is a Must-Have:

  • Comprehensive Market Insights: Analyze global and regional molecular diagnostics markets, segmented by application areas such as infectious diseases, blood screening, cancer, and histology.
  • Cutting-Edge Trends: Understand how technologies like Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), and ISH are transforming healthcare.
  • Competitive Intelligence: Gain strategic insights into major players, including Roche Diagnostics, Thermo Fisher Scientific, and Illumina, along with emerging competitors.
  • Strategic Guidance: Navigate complex markets with detailed forecasts and actionable data to identify high-growth areas and untapped opportunities.

 

Key Market Highlights:

  • Molecular diagnostics plays a vital role in precise disease detection and treatment, from identifying antimicrobial-resistant infections to supporting personalized cancer therapies.
  • The demand for molecular diagnostics is surging in both developed and emerging markets, with North America and Europe leading adoption.
  • Segments like molecular infectious disease diagnostics, cancer diagnostics, and transplant diagnostics are driving innovation and growth.

 

With the integration of advanced molecular techniques into clinical settings, the market is poised to redefine healthcare standards globally.

 

Figure Molecular Diagnostic Growth Applications, by Revenue Growth, 2024-2029

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Table of Contents

Chapter One: Executive Summary

Size of Molecular Diagnostics Market

  • Table 1-1: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2023 vs 2024 ($ million)
  • Figure 1-1: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2023 vs 2024 ($ million)
  • Figure 1-2: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2024 ($ million)
  • Figure 1-3: Overall Molecular Diagnostics Global Market, 2023, 2024, 2029 ($ million)

Growth Areas in Molecular Diagnostics

  • Table 1-2: Growth Applications, by Segment Revenue Growth, 2024-2029 (%) (Cancer Assays, Circulating Tumor Cells, HAIs/Sepsis, Hepatitis, Histology [ISH, FISH], HIV, Inherited/Genetic, Molecular HPV, NIPT, Respiratory, STIs, Transplantation, Tuberculosis [TB])
  • Figure 1-4: Growth Applications, by Revenue Growth, 2024-2029 (%) (Cancer Assays, Circulating Tumor Cells, HAIs/Sepsis, Hepatitis, Histology [ISH, FISH], HIV, Inherited/Genetic, Molecular HPV, NIPT, Respiratory, STIs, Transplantation, Tuberculosis [TB])

Recent Developments

Emerging Trends

  • Avian Flu
  • Monkeypox
  • Automation
  • Molecular Point of Care
  • Table 1-3: Selected Molecular POC Diagnostic Platforms, 2024
  • Next-Generation Sequencing

Other Developments in Molecular Diagnostics, 2023-2024

 

Chapter Two: Molecular Diagnostics Market

Recent Brisk Activity

Recent Product Introductions and Regulatory Approvals

  • Table 2-1: Recent Product Introductions, 2018-2024
  • Table 2-2: Regulatory Approvals and Announcements, 2019-2024

Market Size and Forecast by Segments

  • Table 2-3: Molecular Diagnostic Market, by Segment, 2024 and 2029 ($ million) (Circulating Tumor Cells; Genetic [Inherited/Genetic, NIPT]; Infectious: [COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other]; NAT Blood Screening; Oncology [Cancer Assays, Histology [ISH/FISH], Molecular HPV]; Transplantation)
  • Figure 2-1: Molecular Diagnostic Market, by Segment, 2024 and 2029 ($ million) (Circulating Tumor Cells, Genetic; Infectious, NAT Blood Screening, Oncology, Transplantation)
  • Figure 2-2: Infectious Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other)
  • Figure 2-3: Infectious Molecular Diagnostic Market, by Segment Share, 2024 (%) (COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other)
  • Figure 2-4: Genetic Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (Inherited/Genetic, NIPT)
  • Figure 2-5: Genetic Molecular Diagnostic Market, by Segment Share, 2024 (%) (Inherited/Genetic, NIPT)
  • Figure 2-6: Oncology Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (Cancer Assays, Histology [ISH/FISH], Molecular HPV)
  • Figure 2-7: Oncology Molecular Diagnostic Market, by Segment Share, 2024 (%) (Cancer Assays, Histology [ISH/FISH], Molecular HPV)
  • Table 2-4: Molecular Diagnostic Market, by Region, 2024 ($ million) (APAC, Europe, North America, Rest of World)
  • Figure 2-8: Molecular Diagnostic Market, by Region, 2024 ($ million) (APAC, Europe, North America, Rest of World)
  • Figure 2-9: Molecular Diagnostics Market Share, by Region, 2024 (%) (APAC, Europe, North America, Rest of World)

Infectious Diseases

  • Table 2-5: Selected Molecular Hepatitis Tests

HIV Market and COVID-19 Impact

  • Table 2-6: Selected Molecular Test Products for HIV

NAT Blood Screening

COVID-19 Impact

  • Other Trends
  • Declining Blood Transfusions in Developed Markets

Molecular Histology and Cytology Diagnostics

HPV

Product Developments

Markets for Molecular Cancer Diagnostics

  • Liquid Biopsy

Molecular Transplant Diagnostics

  • Table 2-7: Selected Innovations in the Field of Molecular Transplant Diagnostics

Molecular Inherited Diseases Diagnostics

Thrombophilia and Coagulation Markers

Non-Invasive Prenatal Testing (NIPT)

  • NIPT and Research Areas

Inherited Disease Tests

Molecular Diagnostics Market Deals, Collaborations, Acquisitions

  • Table 2-8: Molecular Diagnostics Market Deals, Collaborations, Acquisitions, 2018-2024

 

Chapter Three: Trends to Watch – Sequencing, CRISPR, Automation

Sequencing

NGS and Companion Diagnostics

  • Table 3-1: Selected Clinical NGS Platforms

Outlook for NGS in Molecular Diagnostics

  • Table 3-2: Percent of the MDX Market Revenues, by Test Technique, 2024 (%) (ISH, Microarrays, NGS, PCR)
  • Figure 3-1: Percent of the MDX Market Revenues, by Test Technique, 2024 (%) (ISH, Microarrays, NGS, PCR)

Evolving Informatics Solutions in Clinical Sequencing

Sample Preparation and Quality Control

Lab Automation and Molecular Diagnostics

  • Table 3-3: Selected Automated/ Integrated Molecular Test Instrument Platforms

Gene Editing Applications in Molecular Diagnostics

CRISPR and Diagnostic Applications

  • Table 3-4: Selected Gene Editing / CRISPR Innovations

 

Chapter Four: Company Profiles

Abbott Diagnostics

Company Overview

Financial Review

  • Table 4-1: Abbott Diagnostics’ Revenue History, 2017-2023 ($ billion)
  • Figure 4-1: Abbott Diagnostics’ Molecular Diagnostic Revenue History, 2016-Q3 2024 ($ million)
  • Figure 4-2: Abbott Rapid Diagnostics Revenue History, Q4 2017-Q3 2024 ($ million)

FDA approval of Alinity m STI assay and High Risk HPV Assay

FDA approval of ALK Break Apart FISH Probe Kit

Alinity s System

WHO prequalification (PQ) approval of viral load test

Advanced Cell Diagnostics (Bio-Techne)

Company Overview

Agena Bioscience

Company Overview

Agendia BV

Company Overview

Agilent Technologies (incl. Dako)

Company Overview

Financial Review

  • Figure 4-3: Agilent Diagnostics and Genomics Segment Revenues, Fiscal 2016- Q3 2024 ($ million)

Genomics

Cytogenetic Analysis

Sequencing

Altona Diagnostics

Company Overview

Amoy Diagnostics

Company Overview

Applied Spectral Imaging

Company Overview

ARUP Laboratories

Company Overview

Asuragen Inc. (Bio-Techne)

Company Overview

Becton, Dickinson & Co. (BD)

Company Overview

Business Segments

  • BD Medical
  • BD Life Sciences
  • BD Interventional

Acquisitions

  • TVA Medical, Inc.
  • R. Bard, Inc.
  • CareFusion Corporation

Divestitures

  • Advanced Bio-processing
  • Respiratory Solutions and Vyaire Medical

Leading Position in the Flow Cytometry Market

Cytology

Revenue and Growth

  • Figure 4-4: BD Life Sciences Unit Quarterly Revenues, Fiscal 2018-Q4 2024 ($ million)

Molecular Diagnostics Focus

Beijing Genomics Institute (BGI)

Company Overview

PCR and Fluorescence

MGI Tech Co., Ltd.

Prenatal Testing

Test Services

Whole Genome Sequencing (WGS)

NGS Sequencing

Collaborations

Berry Genomics

Company Overview

binx health

Company Overview

Bio-Rad Laboratories, Inc.

Company Overview

Recent Revenue History

  • Table 4-2: Bio-Rad Diagnostics Revenue History, 2017-2023 ($ million)

Liquid Biopsy

Droplet Digital PCR

Sequencing

Biocartis

Company Overview

Financial Review

  • Table 4-3: Biocartis’ Revenue History, 2017-2023 ($ million)

Products and Technologies

Biodesix

Company Overview

bioMérieux

Company Overview

  • Figure 4-5: bioMérieux’s Revenue History, Molecular Biology and Microbiology Segments, 2016-Q1 2024 (€ million)

BIOFIRE Business

Molecular Diagnostics

CareDx, Inc.

Company Overview

  • Figure 4-6: CareDx Revenue, 2017-Q3 2024 ($ million)

Testing Services Offered by CareDx

  • AlloMap Tests
  • AlloSure Tests
  • Products Offered by CareDx

Danaher

Company Overview

Danaher’s 2023 Performance

  • Figure 4-7: Danaher Major Segment Revenues by Quarter, Q1 2018-Q3 2024 ($ million)

Life Sciences Business

Diagnostics Business

Cepheid

GeneXpert / Xpress Line

Tuberculosis

Microbiology

POC STI Testing

Cancer

Leica Biosystems

DiaSorin

Company Overview

Molecular Diagnostics

Molecular Oncology

Expansion

Eiken Chemical

Company Overview

Product News

Exact Sciences Corp.

Company Overview

Recent Revenues and Developments

Greiner Bio-One GmbH

Company Overview

Grifols, S. A

Company Overview

Molecular Immunohematology and Specialty Testing Products

NAT Blood Screening

Hologic, Inc.

Company Overview

  • Figure 4-8: Hologic Diagnostics Revenues, Calendar Q4 2019-Q3 2024 ($ million)
  • Table 4-4: Hologic’s Diagnostics Revenue History, by Segment, Fiscal 2017-2023 ($ million)

Acquisitions

PANTHER Molecular System

HIV Testing

Sexually Transmitted Infections

Infectious Diseases

Panther Fusion

Illumina, Inc.

  • Table 4-5: Illumina’s Revenue History, 2015-2023 ($ million)
  • Figure 4-9: Illumina’s Revenue History, 2017-Q3 2024 ($ million)

China

Meridian Bioscience Inc

Company Overview

  • Figure 4-10: Meridian Bioscience Pre-Merger Revenues, Calendar Q1 2015-Q4 2022 ($ million)

Myriad Genetics, Inc.

Company Overview

  • Table 4-6: Myriad Genetics Revenue History, 2017-2023 ($ million)

NanoString Technologies, Inc.

Company Overview

Oxford Nanopore Technologies Ltd

Company Overview

Promega Corporation

Company Overview

Qiagen

Company Overview

  • Table 4-7: QIAGEN’s Revenue History, 2017-2023 ($ million)

Molecular Expansion

Precision Medicine / Companion Diagnostics

Molecular Microbiology

Prenatal Testing

Next Generation Sequencing

Sample Prep, Informatics

Digital PCR

Liquid Biopsy

Cervical Cancer

Expansion and Other Developments

QuantuMDx Group

Company Overview

QuidelOrtho

Company Overview

The Solana Business

Molecular – Savanna

Revvity

Company Overview

Diagnostics

Sequencing /Genomics

Liquid Biopsy

Histology

Prenatal Business

Lab Services

Rheonix, Inc.

Company Overview

Roche Diagnostics

Company Overview

Financial Review

  • Figure 4-11: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016-Q2 2024 ($ million)
  • Table 4-8: Roche Diagnostics’ Revenue History, 2016-2023 ($ million)

Molecular Expansion

Core Molecular

Digital PCR

HPV

HIV

Coagulation

cobas Liat System – POC

Blood Bank

Transplant Medicine

Cancer Companion Testing

IT in Anatomical Pathology

Information Technology

Other Recent Developments

Seegene

Company Overview

Sekisui Diagnostics LLC

Company Overview

Sherlock Biosciences

Company Overview

Standard BioTools

Company Overview

T2 Biosystems

Company Overview

Thermo Fisher Scientific Inc.

Company Overview

  • Table 4-9: Thermo Fisher Scientific Estimated Clinical Diag. and NGS Revenues, 2017-2023 ($ million)
  • Table 4-10: Thermo Fisher Scientific Estimated Revenues by IVD Test Segment, 2017-2023 ($ million)

Microbiology

Molecular Test Business

Next Generation Sequencing

qPCR

Oncology Companion Diagnostics

Transplant Medicine

Microbiome

Other Collaborations and Acquisitions

Gene Editing and Cell Therapy

China

Vela Diagnostics

Company Overview

Veracyte, Inc.

Company Overview

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