The World Market for Molecular Diagnostics, 2014-2019, 6th Edition (Microbiology, Oncology, Blood Screening and Typing, Prenatal, Inherited Diseases, Coagulation, Organ Transplant, PCR, Sequencing, cfDNA, CTC, in situ hybridization, Others)

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Published Sep 30, 2015 | 1032 Pages | Pub ID: KLI5695907

Molecular tests are used in just about every facet of laboratory medicine: infectious diseases, inherited diseases, coagulation, transplant medicine, prenatal and postnatal screening and cancer.  In The World Market for Molecular Diagnostics, 6th Edition, Kalorama IVD market analyst Shara Rosen, R.T., MBA provides authoritative and complete analysis of the molecular testing industry. In this report, exclusive market sizing and forecasts are provided for the following diagnostic segments:
  • Cancer Markers & PGx
  • Histology (In situ hybridization, HPV)
  • Microbiology/Virology (HAI; HIV; Hepatitis; GC/Chlamydia; Respiratory; Organism ID; Mycobacteria, TB; Others)
  • Blood Screening
  • Coagulation & PGx
  • Prenatal Testing
  • Inherited Diseases Testing
  • Tissue Typing
  • Organ Transplant Testing (HLA Typing)
  • Circulating Tumor Cells (CTCs)
  • Clinical Sequencing
  • Flow Cytometry
The amount of activity over the last few years is short of phenomenal with a continuous stream of new platforms, tests and quality control materials for test standardization coming to market. There is intense competition but also opportunities for entrants in some areas.
Comprehensive Coverage of the Molecular Diagnostics Industry

Molecular diagnostics is one of the fastest growth segments in clinical diagnostics, and for the past five years there’s been a considerable rate of growth in the number of assays introduced. Moreover, growth of this segment is fuelled by rising incidence of chronic disorders, an increasing geriatric population and adoption of personalized medicines. 

This report not only contains current market data for business planning, it goes beyond the numbers to fully assess what is going on in the market and why. Since the last edition of this report, a lot has changed, and a lot has stayed the same.   

As part of its coverage, the report includes the following:
  • Over 1,000 Pages of Detailed Market Coverage
  • Over 70 Tables and Figures Makes Market Analysis More Accessible
  • Current Market Size and Forecast 2014-2019 for Several Specific Molecular IVD Segments 
  • Exome Sequencing, Metabolic Profiling, Hospital Acquired Infections, LDTs, Information Technology,
    Status of China and Emerging Markets and Other Trends
  • Infectious Disease Molecular Sales by Disease 
  • Over 190 Profiles of Molecular Diagnostic Competitors
  • Recent Mergers and Acquisitions
  • Revenues of Test Service Companies
  • Geographic Breakout of the Molecular Diagnostics Market by Region
  • Sample Preparation Trends
  • Breakout of Molecular Histology/Cytology Market 
  • Mergers, Partnerships, Distribution Agreements in Molecular IVD
More and more laboratories offer complex panels of tests that help physicians evaluate disease risk and make therapeutic decisions. Government and private healthcare payers have recognized the value of new molecular tools and have agreed to pay for them.  A desire for better and faster test results, a preference for tests that are aimed at the patent, renewed interest in IVD in general and more particularly in molecular IVD has led to the commercialization of a number of technological tools that make more sensitive and specific tests possible. Some of these technological innovations include cost-effective, multiplexed testing platforms coupled with high-powered software capabilities. 

Who to Watch: Top Leaders and Rising Innovators

Kalorama provides profiles of over 200 companies participating in the market. All of these companies have different strategies and compete in different areas, and Kalorama acknowledges this by separating the companies in a triage system based on where they stand in the molecular in vitro diagnostics market.

"IVD Leaders" - The top IVD companies participating in molecular diagnostics as well as dominating  the rest of testing.  Their activities in molecular testing and their results.
"Major Molecular Diagnostics Leaders" -The top companies focused on molecular testing.  
"Molecular Diagnostics  Participants"- Molecular diagnostic companies that are by now established in the market
"Great Expectation Companies"- Those companies that have potential with an innovative approach
"Molecular Diagnostics Newcomers"- IVD Companies that have novel or interesting approaches to keep an eye on
“CTC and Liquid Biopsy Test Providers” Biocept, Veridex, Qiagen and other companies in this high-interest molecular testing segment.
"Platform Innovators"- Companies that have developed new platform technologies
"Information Technology Companies" - Molecular testing relies on strong information systems to handle data.  These companies are in the forefront.
"Sample Prep Leaders" - Companies focused on sample preparation for molecular diagnostics
"Segment Specialist Companies" - In various areas (microbiology, histology, blood banking, etc)
Molecular diagnostics tests are rapidly being developed for genetic testing, infectious diseases testing, blood screening, oncology testing, cardiovascular testing and others. The report looks in detail at market segments, evaluating them in terms of selected tests, test innovations, advanced techniques, and companies in the segment, providing where possible segment revenue and company sales information. 

A Global Focus

The various tests, technologies, and trends are discussed from the point of view of their present and potential market impact.   The report focuses on developments at work in both mature markets and in emerging nations, providing market penetration of clinical molecular diagnostics by geographic area for 2014 and 2019. The World Market for Molecular Diagnostics looks at how social and economic events in selected countries may affect the evolution of molecular testing worldwide. 

Regions covered include:
  • North America
  • Western Europe
  • Japan
  • China
  • India
  • Rest of World
 The report covers trends and issues concerning: globalization of markets and diseases, reimbursement of new technologies , Novel test platforms diagnostic biomarkers and genetic indicators.  The application of molecular technologies to clinical analyses has received widespread attention around the world and has made a significant mark in diagnostic systems, and will continue to do so. The report looks at what can be expected in the coming 5 to 10 years, presenting conclusions and strategic implications. 

In 2015 the technologies that were used for the Human Genome Project have become tools that molecular pathologists routinely use to diagnose diseases in patients that had remained a mystery for a long time. This is good for patient care but the evolution of sequencing and next generation sequencing-based tests have gone so quickly that government agencies and payers are scurrying to cope with the regulatory, reimbursement and ethical issues that accompany this new generation of tests. Only five years ago it would have been almost inconceivable that hospital and government funded programs would provide whole genome and whole exome sequencing for thousands and even millions of people. 

Information technology (IT) is an important tool that plays three essential roles, as detailed in this report: 1) data sharing to develop well-curated gene variations, 2) interpretation of gene variants to develop testing guidelines and 3) distribution of this information to clinicians for use in patient care. A discussion of developments in information technology and molecular diagnostics merits a report all to itself. Here Kalorama presents a bird’s eye view of the programs and initiatives that suggest how the IT-molecular diagnostics mix is evolving. Hundreds of genome studies are underway, worldwide, involving sometimes hundreds of thousands of patient test results. 

 Companies profiled include:
  • Abbott Diagnostics
  • Alere Inc.
  • Beckman Coulter, Inc. / Danaher
  • Becton, Dickinson and Company (BD)
  • Bio-Rad Laboratories, Inc.
  • bioMérieux Inc.
  • Danaher Corporation
  • General Electric - GE Healthcare
  • Hologic, Inc.
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Affymetrix Inc.
  • Agilent Technologies
  • Asuragen Inc.
  • BGI
  • Cepheid
  • Eiken Chemical Co., Ltd
  • Enzo Biochem Inc.
  • Illumina
  • Life Technologies Corporation
  • PerkinElmer, Inc. (PE)
  • RainDance Technologies, Inc.
  • AutoGenomics Inc.
  • Biocartis SA
  • DiaSorin S.p.A
  • EKF Diagnostics Holdings Plc
  • ELITech Group
  • Epigenomics
  • Exosome Diagnostics, Inc.
  • Fluidigm Corporation
  • Fujirebio Diagnostics, Inc.
  • GenMark Diagnostics
  • Genome Diagnostics BV (GenDx)
  • Luminex Corporation
  • Menarini Diagnostics
  • Nanostring Technologies, Inc.
  • Pacific Biosciences of California, Inc. (PacBio)
  • Quidel Corporation
  • Rubicon Genomics, Inc.
  • Transgenomic, Inc.
  • TrovaGene, Inc.
  • WaferGen Bio-systems, Inc.
  • Genomic Vision
  • IncellDx, Inc.
  • Inivata
  • IntegenX Inc.
  • Linkage Biosciences, Inc.
  • Savyon Diagnostics
  • Selventa
  • VolitionRx Limited
  • B Braun CeGaT, LLC
  • Canon BioMedical, Inc.
  • DestiNA Genomics Ltd.
  • DiamiR, LLC
  • Randox Laboratories Ltd.
  • 23andMe
  • Adaptive Biotechnologies Corporation
  • Agendia BV
  • AltheaDx Diagnostics, Inc.
  • Ambry Genetics
  • ARUP Laboratories
  • Assurex Health
  • Athena Diagnostics
  • Bio-Reference Laboratories, Inc. (BRLI)
  • bioTheranostics
  • Cancer Genetics, Inc. (CGI)
  • CareDx, Inc.
  • Caris Life Sciences
  • Centogene AG
  • Complete Genomics
  • Counsyl
  • Exact Sciences Corp.
  • Foundation Medicine Inc.
  • Genomic Health, Inc.
  • Helomics Corporation
  • IntegraGen
  • Invitae Corporation
  • LabCorp, Laboratory Corporation of America
  • Mayo Medical Laboratories
  • MDxHealth SA
  • Myriad Genetics
  • Pathway Genomics Corporation
  • Quest Diagnostics
  • Rosetta Genomics Ltd.
  • Veracyte, Inc.
  • Atlas Genetics Ltd.
  • Biomeme, Inc.
  • DiAssess Inc.
  • DNA Electronics Ltd (DNAe)
  • Enigma Diagnostics Limited
  • Entopsis
  • Epistem Holdings plc
  • InSilixa Inc.
  • Lucigen
  • PositiveID Corporation
  • QuantuMDx Group Limited
  • Rheonix, Inc.
  • Scanogen Inc.
  • Ubiquitome
  • Veredus Laboratories Pte Ltd
  • Xagenic
  • Horizon Discovery Group plc
  • MO BIO Laboratories, Inc.
  • PreAnalytiX GmbH
  • SeraCare Life Sciences, Inc.
  • Advaita Bioinformatics
  • Apple Inc.
  • Cartagenia
  • Cerner Corp.
  • CLC bio
  • CollabRx Inc.
  • DNAnexus
  • GenomOncology
  • Google Genomics
  • IBM Healthcare
  • Intel Corporation
  • Knome Inc.
  • N-of-One
  • PierianDx
  • Sophia Genetics
  • Advanced Cell Diagnostics (ACD)
  • Amoy Diagnostics Co. Ltd.
  • Applied Spectral Imaging Inc. (ASI)
  • BioView Ltd.
  • Circulomics Inc.
  • Covaris Inc.
  • Cymogen Dx, LLC
  • Dako A/S
  • Definiens
  • DxTerity Diagnostics Inc.
  • HTG Molecular Diagnostics
  • Leica Biosystems
  • PreTect AS (formerly Norchip)
  • Kapa Biosystems Inc.
  • Ventana Medical Systems Inc.
  • Accelerate Diagnostics, Inc.
  • Advanced Biological Laboratories, S.A. (ABL)
  • AdvanDx, Inc.
  • altona Diagnostics
  • Aperiomics
  • Co-Diagnostics HBDC
  • Curetis AG
  • DxNA, LLC
  • Fast-Track Diagnostics
  • Focus Diagnostics, Inc.
  • Genetic Analysis AS
  • Great Basin Scientific, Inc.
  • Greiner Bio-One International GmbH
  • Hain Lifescience GmbH
  • Hutman Diagnostics AG
  • Intelligent Medical Devices, Inc. (IMDx)
  • Meridian Bioscience, Inc.
  • Mobidiag Ltd
  • Molbio Diagnostics Pvt Ltd.
  • Nanosphere, Inc.
  • PathoGenetix, Inc.
  • Pathogenica
  • Reference Genomics Inc.
  • Seegene, Inc.
  • Specific Technologies
  • T2 Biosystems
  • AXO Science
  • Grifols
  • Immucor, Inc.
  • Ariosa Diagnostics, Inc.
  • Berry Genomics Co. Ltd
  • Combimatrix Corp.
  • Good Start Genetics, Inc.
  • Illumina
  • LifeCodexx AG
  • Multiplicom N.V.
  • Natera
  • Premaitha Health plc
  • Sequenom Inc.
  • Angle plc
  • ApoCell, Inc.
  • Biocept, Inc.
  • Clearbridge BioMedics
  • Cynvenio Biosystems, Inc.
  • Epic
  • Fluxion Biosciences, Inc.
  • Genyo – Centre for Genomics
  • Qiagen Hanover (formerly AdnaGen GmbH)
  • ScreenCell
  • Veridex, LLC
  • WaveSense LLC
The world market for molecular diagnostics is provided in U.S. dollars for the years 2014 to 2019. The report discusses tests and technologies that are currently available and those that are expected to take their place. All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the molecular test market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible.

The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics and molecular pathology.
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