Molecular Diagnostics in Oncology, Genetic/Inherited Diseases, and NIPT, 2023-2028

Table of Contents

Chapter 1:  Executive Summary

Introduction

Oncology Molecular/Genetic Testing and Diagnostics

Liquid Biopsy Expanding New Possibilities

• Table 1-1: Comparison of Tissue and Liquid Biopsy

Successes in Prenatal, Newborn Testing, Rare Genetic/Inherited Diseases

Market Revenues

• Table 1-2: Molecular Diagnostics in Oncology, Genetic, NIPT, Market Revenues Forecast, 2023-2028 ($M)
• Figure 1-1: Global Genetic/Molecular Test Sales in Oncology, Inherited/Genetic, Prenatal, Newborn, NIPT, 2023-2028 ($M)

Scope and Methodology

Terminology Related to Companion Diagnostics, Precision/Personalized Medicine

• Table 1-3: Industry Recognized Terms for Companion Diagnostics and Personalized Medicine

 

Chapter 2: Introduction and Trends

DNA and RNA Variants

• Table 2-1: Selected Major Biomarkers in Oncology Personalized Medicine Tests

Cancer Markers in Widespread Usage

• Table 2-2: Relevant DNA/RNA Variants for Top Six Cancer Types (Breast, Colon, Gastric, Liver/Biliary, Lung, Prostate)
• Table 2-3: Relevant DNA/RNA Variants for High Incidence Cancer Types (excl. top six)

Molecular Diagnostics in Hereditary Cancer Diagnosis

• Table 2-4: Selected Companies Offering LDTs for Hereditary Risk of Cancer

Genetics of Inherited Diseases

• Table 2-5: Selected Inherited/Genetic Disorders

Thrombophilia, Coagulation

Inherited/Genetic Disease Tests in New Areas

• Table 2-6: Selected Genomic Tests for Inherited Diseases

Techniques Used in Genetic Analysis

Polymerase Chain Reaction (PCR)

• Table 2-7: Selected Companies Marketing Open PCR Platforms That Can be Used by Laboratories for LDTs

In Situ Hybridization (ISH)

• Table 2-8: Selected Advanced Histology Techniques
• Table 2-9: Selected In Situ Hybridization-based Tests

Next-Generation Sequencing (NGS)

• Table 2-10: Selected Companies Marketing Next Generation Sequencing Platforms to Clinical Laboratories

 

Chapter 3: Oncology Molecular Diagnostics and Genetic Testing

Introduction

• Table 3-1: Selected Molecular Tumor Marker Test Innovations

LDTs Used Across Diagnosis, Prognosis, Screening, Personalized Medicine

• Table 3-2: Selected Cancer Diagnosis/Prognosis/Personalized Medicine Test Services Based on LDTs
• Table 3-3: Selected Companies Offering LDTs for Risk of Disease – Cancer and Beyond

Companion Diagnostics

• Table 3-4: FDA Approved or Cleared Companion Diagnostic (CDx) Tests and Corresponding Therapies, Oncology

Pharmacodiagnostic Tests

Predictive Biomarker Tests for Drug-Gene Match

Histology, ISH, FISH Established

Significant Use in HPV Testing

• Table 3-5: Selected HPV Test Innovations

Liquid Biopsy

• Table 3-6: Selected Liquid Biopsy Innovations

Next Generation Sequencing

ctDNA and cfDNA Testing

• Table 3-7: Selected Liquid Biopsy Tests That Assess Multiple Analytes
• Table 3-8: Selected Liquid Biopsy Tests for Research Use Only

Colon Cancer Screening

Circulating Tumor Cells

• Table 3-9: Selected Innovations in CTC Technology

ctDNA Testing Companies and Technologies

• Table 3-10: Selected Market-Available ctDNA-based Liquid Biopsy Tests

Exosome Sequencing

• Table 3-11: Selected Exosome Test Innovations

The Future for Liquid Biopsy

AI in Liquid Biopsy

• Table 3-12: Selected AI/Liquid Biopsy Initiatives

 

Chapter 4: Rare Inherited/Genetic Diseases, NIPT, Newborn Testing

Introduction

Prenatal and Newborn Testing

• Table 4-1: Selected Molecular Tests for Prenatal Analysis
• Table 4-2: Selected Companies and Clinical Laboratories Offering PCR-based Tests
• Table 4-3: Selected Examples of Companies Marketing FISH Tests or Probes for Inherited Disorders
• Table 4-4: Selected Companies and Clinical Laboratories Offering Sequencing-based Tests
• Table 4-5: Selected Companies and Clinical Laboratories with Microarray-Based Tests
• Table 4-6: Selected Companies with Tests for Chromosomal Abnormalities

Non-Invasive Prenatal Testing (NIPT)

• Table 4-7: Selected Companies Developing and/or Marketing Non-Invasive Prenatal Tests

LDTs Used Across Prenatal and Genetic Disease Screening, Testing

• Table 4-8: Selected Companies/Laboratories with Genetic Tests or Screening Innovations Based on LDTs

Thrombophilia and Coagulation Markers

 

Chapter 5: Market Analysis and M&A Activity

Introduction

Market Revenues and Forecast

• Table 5-1: Global Genetic/Molecular Test Sales in Oncology, Inherited/Genetic, Prenatal, Newborn, NIPT, by Type, 2023-2028 ($M)
• Figure 1-1: Global Genetic/Molecular Test Sales in Oncology, Inherited/Genetic, Prenatal, Newborn, NIPT, by Type, 2023-2028 ($M)
• Table 5-2: Global Genetic/Molecular Testing in Oncology, Inherited/Genetic, Prenatal, Newborn, NIPT – Shares, by Type, 2023-2028 (%)
• Table 5-3: Global Genetic/Molecular Testing in Oncology, Inherited/Genetic, Prenatal, Newborn, NIPT – Regional Shares, 2023 & 2028 ($M) (%)
• Figure 5-2: Global Genetic/Molecular Testing in Oncology, Inherited/Genetic, Prenatal, Newborn, NIPT – Regional Shares, 2023 (%)
• Figure 5-3: Global Genetic/Molecular Testing in Oncology, Inherited/Genetic, Prenatal, Newborn, NIPT – Regional Shares, 2028 (%)

Market Drivers and Challenges

Clinical Utility Needed with Molecular Diagnostics

Slowly Emerging Practices with Rare Diseases

Incremental Nature of Technological, Medical Advances

Mergers & Acquisitions

• Table 5-4: Selected IVD Mergers and Acquisitions 2019-2023

 

Chapter 6: Company Profiles

Abbott

Companion Diagnostic Testing

Liquid Biopsy

Agilent Technologies

Genomics

Cytogenetic Analysis

Dako, Companion Diagnostics

Sequencing

Becton, Dickinson and Company (BD)

Cytology

BGI Genomics

Prenatal Testing

MGI

Biocept

Exact Sciences

Foundation Medicine

Guardant Health

Hologic

Panther Molecular System

Cytology

Illumina

Myriad Genetics

Natera

Neogenomics

Qiagen

Precision Medicine/Companion Diagnostics

Liquid Biopsy

Cervical Cancer Testing

Roche

Cancer Companion Testing

HPV

IT in Anatomical Pathology

Sysmex Inostics

Forging New Markets

Thermo Fisher Scientific

Next Generation Sequencing

Oncology Companion Diagnostics

Ventana Medical Systems (Roche)