Molecular Diagnostics: Market Segmentation and Opportunities - 4th Edition

  • ID: 2073116
  • Report
  • Region: Global
  • 117 Pages
  • DeciBio
1 of 5


  • 23andMe
  • Biodesix
  • HiFi DNA Tech
  • Molzym GmbH & Co
  • Quest Diagnostics
  • MORE
Molecular diagnostics (MDx) are a class of in vitro diagnostic (IVD) tests that identify nucleic acids, such as DNA. MDx tests may identify nucleic acids that are the genetic material of foreign organisms (e.g., HIV genotyping, MRSA screening) or the genetic markers of an individual patient (e.g., Her-2 overexpression for breast cancer, Factor V Leiden for coagulation). MDx tests continue to be the fastest growing segment within the IVD space, driven by high sensitivity, fast turnaround time, easy workflow and relatively low-cost compared to other techniques, such as culture-based or immune-based tests.

MDx involves platforms and assays that leverage multiple technologies to identify genetic variations. Technologies utilized include; PCR (e.g., HBV qualitative screening; Roche) qPCR (e.g., MRSA screening; Cepheid), TMA (CT/GC screening; Gen-Probe), FISH (PathVysion Her-2; Abbott), capillary electrophoresis (CE) sequencing (e.g., BRAC 1/2 testing; Myriad Genetics), next generation sequencing (Trisomy21 test; Sequenom), microarrays (Amplichip, Roche) and a host of other methods (e.g., pyrosequencing, bDNA, hybrid capture, hybridization beads, kPCR, electrochemical detection).
Analysis from this report indicates that the ~$5.9B MDx market (2011E) is expected to grow at >15% p.a. over the next 4 years, reaching $10.9B by 2015. MDx growth is expected to continue to be driven by increased incidence of chronic diseases due to an aging population, increased availability of various tests, and the further adoption of Pharmacogenomics / personalized medicine.

This report reviews the market size, growth, segments and trends of the MDx industry from 2007 through 2015. The market is segmented to provide insights on specific growth opportunities by therapeutic area (infectious diseases, oncology, HPV, others), technology (PCR, qPCR, TMA, hybrid capture, CE Sequencing, NGS, FISH, other), analytes tested (low and high plex level), test rationale (predisposition, screening, diagnosis, therapy selection, monitoring), test location (reference labs, academic hospitals, blood banks, other) and geography (U.S., Europe, Japan, rest of the world). Growth and growth drivers for each segment are quantified and reviewed.

Major competitors shaping the industry include BioPharma (e.g., Abbott, Roche), IVD/MDx pure-play companies (e.g., Myriad Genetics, Cepheid, Gen-probe) or research tool companies (e.g., Illumina, Life Technologies). Major competitors are reviewed along with their key platforms and underlying technologies.

MDx is a highly regulated space. IVD instruments/assays are treated as medical devices and often require 510(k)/IVD clearance to gain full adoption in the marketplace. We briefly review the various level of clearance for MDx tests.

Finally, this report explores opportunities and challenges in the MDx industry. In this fourth edition, we place an emphasis on NGS and its emerging adoption in clinical settings, as well as other emerging technologies (e.g., dPCR, CGH).
Note: Product cover images may vary from those shown
2 of 5


  • 23andMe
  • Biodesix
  • HiFi DNA Tech
  • Molzym GmbH & Co
  • Quest Diagnostics
  • MORE

Executive summary

In vitro diagnostics market overview

Molecular diagnostics market overview
Impact of the 2008-09 recession
MDx technologies

Market segmentation: Therapeutic areas

Market segmentation: Technology

Market segmentation: Number of analytes tested

Market segmentation: Test rationale

Market segmentation: Test location

Market segmentation: Geography
Major competitors
Large pharmaceutical companies
IVD pure-play and MDx pure-play companies
Life science and research tools companies Other companies

Coverage and reimbursement
Current situation
Impact of the 2010 Healthcare reform

MDx opportunities and challenges
MDx opportunity MDx challenges

Next generation sequencing in the clinic

Other emerging MDx technologies Appendix
LDT regulation HPV and Cervical Cancer
Selected company portfolios
List of key MDx players
Table of exhibits
Key abbreviations Glossary
Note: Product cover images may vary from those shown
3 of 5


4 of 5
- 23andMe
- 454 Life Sciences Corporation
- Abbott Diagnostics
- Abbott Molecular
- AdnaGen
- Adnavance Technologies
- Advanced Analytical Technologies
- AdvanDx
- Affymetrix
- Agendia
- Agilent Technologies
- Almac Diagnostics
- Althea Technologies
- Ambry Genetics Corporation
- Applera Corporation
- Arcxis Biotechnologies
- ARUP Labs
- AssueRx
- Asuragen
- Aureon Labs (ceased operation)
- Athena Diagnostics
- Inc.
- Atlas Genetics Limited
- AutoGenomics
- AviaraDx
- Bayer Diagnostics
- BD Diagnostics
- Beckman Coulter
- BG Medicine
- Biocept
- Biodesix
- Biogenex
- BioHelix Corporation
- BioMerieux
- BioNanomatrix
- Bio-Reference Laboratories
- Biotage AB
- Biotools
- B & M Labs
- BioTrove (Life Technologies)
- BlackBio
- Ceipheid
- Celera
- Cepheid
- China Medical Technologies
- Clarient Inc.
- Clinical Data
- CLONDIAG chip technologies
- CombiMatrix Molecular Diagnostics
- Compugen
- Consumer Genetics
- Correlogic Systems
- Crescendo Bioscience
- Curetis
- Curidium Medica
- CytoCore Inc
- Dako A/S
- deCode Genetics
- Delphic Diagnostics
- DiaGenic ASA
- Diatherix Laboratories
- Digene Corporation
- DNA Direct
- DxS
- eGene
- eGenomics
- Eiken Chemical Co.
- Enigma Diagnostics Limited
- Epigenomics
- Epistem
- Eppendorf Biochip Systems
- EraGen Biosciences
- EXACT Sciences Corporation
- eXagen Diagnostics
- Exiqon A/S
- Fluidigm Corporation
- Focus Diagnostics
- Fujifilm Diagnostics
- GE Healthcare
- Gene Express
- Genetix
- GenMark
- GenoID
- Genomas
- Genomic Health
- Genoptix
- Gen-Probe
- Genzyme Corporation
- Greiner Bio-One International
- Hain Lifescience
- Hamilton Thorne Biosciences
- HandyLab
- Health Discovery Corporation
- HiFi DNA Tech
- HistoRx
- Hologics
- Ikonisys
- Illumina
- Immunicon Corporation
- Innogenetics
- IntegraGen
- Intelligent Medical Devices
- InterGenetics
- Interleukin Genetics
- Invitrogen Corporation
- Ipsogen
- IQuum
- Iris BioTechnologies
- Kimball Genetics
- KREATECH Biotechnology
- Lab21 Healthcare
- LabCorp
- Life Technologies
- Luminex
- Med BioGene
- Microchip Biotechnologies
- Microgen Bioproducts
- MiraiBio
- Inc.
- Mobidiag
- Molzym GmbH & Co
- Monogram Biosciences
- Monogram Virologics
- Myconostica

- Myriad Genetics
- Nanogen
- Nanosphere
- Navigenics
- NeuroMark
- NorDiag ASA
- Novartis Vaccines & Diagnostics
- Nuvera Biosciences
- OncoMethylome Sciences
- One Lambda
- Orchid Cellmark
- Orion Genomics
- Ortho Clinical Diagnostics
- Osmetech Molecular Diagnostics
- Pacific Biosciences
- ParagonDx
- Pathwork Diagnostics
- Perceptronix Medical
- PerkinElmer
- PGx Health
- Prediction Sciences
- Prodesse
- Progenika Biopharma
- Psynomics Incorporated
- Q Chip
- Qiagen
- Quest Diagnostics
- Response Genetics
- Roche Diagnostics
- Rosetta Genomics
- Saladax Biomedical
- Seegene
- SensiGen
- Sequenom
- Siemens Healthcare Diagnostics
- SIRS-Lab
- Smart Genetics
- Smiths Detection
- Sysmex Corporation
- Tecan Group
- Tepnel Life Sciences
- TessArae
- The DNA Repair Company
- TheraGenetics
- Third Wave Technologies
- Transgenomic
- TrimGen
- Ventana
- Veredus Laboratories Pte
- Veridex
- Vita Genomics
- Xceed Molecular
- XDx
- Xenomics
- Zila
Note: Product cover images may vary from those shown
5 of 5
Note: Product cover images may vary from those shown