Molecular Diagnostics: Infectious Disease, Genetic and Oncology Testing, Market Size, Strategies and Forecasts 2016-2019 - North America Version

  • ID: 3753208
  • Report
  • Region: Global, North America
  • 189 Pages
  • Howe Sound Research
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Next Generation Sequencing and new Molecular Diagnostics Tests drive market growth while lowering costs


  • 14M Genomics
  • Baylor College of Medicin
  • DioGenix
  • Glyconics
  • MolecularMD
  • Quest Diagnostics
  • MORE
A market that just keeps on growing. Molecular Diagnostics is positioned to directly benefit from the explosion in genomics knowledge. A range of dynamic trends are pushing market growth and company valuations.

Trends like:

- personalized medicine
- pharmacogenomics
- pathogen evolution
- next generation sequencing
- emergence of new economies with large markets
- greater understanding of the role of genetic material in Disease and Health

Exciting technical developments especially in the area of pharmacogenics hold the promise of a dynamic, growing and evolving world market that is moving out of the national and regional orientation and onto a global stage.

The report data is designed to be used! The unit volumes of tests performed is presented. Use our pricing scenarios or use your own. Project your market share and your price to reliably generate revenue forecasts or understand your own current market share position. Detailed Market Forecasts provide Price, Volume and Revenue Forecasts individually broken out by year for Infectious Disease, Genetic Testing, Oncology Testing.

In addition customization work, assistance and support is included with every report.

"Molecular Diagnostics: Infectious Disease, Genetic and Oncology Testing Market Size, Strategies and Forecasts 2016 to 2019 North America Version" provides data that analysts and planners can use. Hundreds of pages of information including a complete list of Current 2015 United States Medicare Fee Payment Schedules to help understand test pricing in detail. See lists of all current FDA Approved Molecular Diagnostic Tests. Make facilities planning decisions. Forecast demand for new testing regimes or technologies. Make research investment decisions. Based on extensive primary and secondary research the testing volume data is broken down into price and volumes allowing researchers and investors to quickly create informed and reasonable forecasts of demand. Assistance in providing specific growth and market size estimates for new technology tests is normally provided without additional charges. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities growth. Again, assistance in using the information is normally provided without additional charges.

“This is an impressive piece of work.” Doug Buchanan, Managing Director and CEO BC Biomedical Laboratories Ltd.

The report includes detailed breakouts for 18 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.

Make investment decisions and valuations with confidence using the latest data. Be completely up to date with summaries of important industry developments.
Note: Product cover images may vary from those shown
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  • 14M Genomics
  • Baylor College of Medicin
  • DioGenix
  • Glyconics
  • MolecularMD
  • Quest Diagnostics
  • MORE
1. Introduction and Market Definition
1.1 What is Molecular Diagnostics
1.2 The Diagnostics Revolution
1.3 Market Definition
1.3.1 Volumes
1.3.2 Prices
1.3.3 Revenue Market Size
1.4 Methodology
1.4.1 Authors
1.4.2 Sources
1.5 U.S. Medical Market and Clinical Laboratory Testing - Perspective
1.5.1 U.S. Medicare Expenditures for Clinical Testing

2. Market Overview
2.1 Market Participants
2.1.1 Supplier/pharmaceutical
2.1.2 Independent lab specialized/esoteric
2.1.3 Independent lab national/regional
2.1.4 Independent lab analytical
2.1.5 Public National/regional lab
2.1.6 Hospital lab
2.1.7 Physician lab
2.1.8 Audit body
2.2 Market Segments
2.2.1 Traditional Market Segmentation
2.2.2 Laboratory Focus and Segmentation
2.3 Industry Structure
2.3.1 Hospital Testing Share
2.3.2 Economies of Scale
2.3.3 Physician Office Lab’s
2.3.4 Physician’s and POCT
2.4 Profiles of Key MDx Companies
2.4.1 Roche Molecular Diagnostics
2.4.2 Illumina
2.4.3 Hologic
2.4.4 Agilent/Dako
2.4.5 Qiagen
2.4.6 Myriad Genetics
2.4.7 Becton, Dickinson & Co.
2.4.8 Abbott Laboratories
2.4.9 Cepheid
2.4.10 Genomic Health
2.4.11 Grifols
2.4.12 bioMérieux
2.4.13 Foundation Medicine
2.4.14 Agendia
2.4.15 Thermo Fisher
2.4.16 Signal Genetics LLC
2.4.17 Siemens Healthcare
2.5 Market Shares of Key MDx Players - Analysis

3. Market Trends
3.1 Factors Driving Growth
3.1.1 New Diagnostic Definitions Create New Markets
3.1.2 Aging Population a Boon for Diagnostics.
3.1.3 Pharmacogenomics Drives Further Growth.
3.1.4 Point of Care Testing can increase demand
3.1.5 Liquid Biopsy
3.2 Factors Limiting Growth
3.2.1 Increased Competition Lowers Price
3.2.2 Lower Costs.
3.2.3 Testing usage analysis curtailing growth.
3.2.4 Wellness has a downside
3.2.5 Point of Care Testing
3.3 Instrumentation and Automation
3.3.1 Instruments Key to Market Share
3.3.2 Bioinformatics Plays a Role.
3.4 Diagnostic Technology Development
3.4.1 Next Generation Sequencing Fuels a Revolution
3.4.2 Impact of NGS on pricing
3.4.3 POCT/Self Testing Disruptive Force
3.4.4 Pharmacogenomics Blurs Diagnosis and Treatment
3.4.5 CGES Testing, A Brave New World
3.4.6 Biochips/Giant magneto resistance based assay

4. Molecular Diagnostics Recent Developments
4.1 Recent Developments - Importance and How to Use This Section
4.1.1 Importance of These Developments
4.1.2 How to Use This Section
4.2 Rand Capital to Provide Additional Funding to Empire Genomics
4.3 Luminex Corporation Signs Definitive Agreement to Acquire Nanosphere, Inc
4.4 Avant Completes Acquisitions of Amarantus, Theranostics Health
4.5 DiaSorin to Acquire Focus Diagnostics' Molecular And Immunoassay Product Business From Quest Diagnostics
4.6 Qiagen Makes $100M Bid to Acquire Exiqon
4.7 PerkinElmer Acquires Vanadis Diagnostics
4.8 CareDx Completes Allenex Acquisition
4.9 DNA Diagnostics Center Acquires All About Truth DNA Services
4.10 OvaGene Oncology Acquires Etta Healthcare
4.11 Immucor Acquires Sirona Genomics
4.12 Siemens Healthineers Acquires Molecular Dx Firm Neo New Oncology
4.48 Transgenomic Closes Public Offering of Stock, Warrants
4.49 Qiagen Discloses $114.2M Price Tag for Enyzmatics Acquisition
4.51 GenomeDx Biosciences Implements Clarity LIMS
4.52 Merck Serono and Sysmex Inostics Announce Testing Center
4.53 Lifecode Receives CAP Accreditation, Discloses Funding
4.54 Baylor College of Medicin, Miraca Holdings finalize joint venture
4.55 23andMe Gets FDA Clearance to Market Bloom Syndrome Carrier Test
4.57 Trinity Biotech Revenues Grow by 15%
4.58 Google’s Latest Healthcare Initiative
4.60 Agena Bioscience Launches Smaller Format MassArray
4.61 QuantRx® Biomedical Provides Update on Technological Progress
4.62 The Journal of Molecular Diagnostics Publishes Special Article
4.63 Caprion Licenses Indi's Xpresys as Part of Larger Clinical Push
4.64 MDxHealth's ConfirmMDx Genes Detect Prostate Cancer
4.65 Atossa Genetics Announces That Its Subsidiary The National Reference Laboratory for Breast Health Has Received Accreditation
4.66 Nuclea Bio Plans Entry into Clinical Proteomics
4.67 Personal Genome Diagnostics Aims for FDA Clearance
4.68 Enzo Biochem Announces New Molecular Platform
4.69 Multiplicom, Premaitha Develop CE-IVDs
4.70 Regulating the Next Generation of Genetic Testing
4.71 BioReference Laboratories, Inc. Launches an Advanced Tumor Sequencing Program
4.72 Cytogenetics Become First Certified Lab to Offer Microarray Testing
4.73 Results Support Clinical Validity of Quantose IGT(TM) Diabetes Test
4.74 Accelerate Diagnostics' 2014 Revenues Rise Sharply
4.75 NanoString's Q4 Revenues Jump 54 Percent
4.76 New Aussie Firm Life Letters Launches Carrier, PGx Testing for Consumers
4.77 HTG Molecular Reports 50 Percent Increase in 2014 Revenues
4.80 Genomic Vision, Quest Extend Pact for Molecular Combing Technology
4.81 ACT Genomics Raises $8M in Private Funding Round
4.82 NGS-based Cancer MDx Firm Lifecode Raises $20.5M, Receives CAP Accreditation
4.83 Invitae Goes Public with $101.6M Offering
4.84 Quidel Q4 Revenues Grow 27 Percent on Infectious Disease Sales
4.85 Rosetta Signs Deal to Promote Precipio's Cancer Diagnostics
4.86 Premaitha Iona NIPT Lands CE Mark
4.87 Sera Increases Series B Round to $25M with $5M from Gates Foundation
4.88 T2 Biosystems Inks $8.5M Lyme Disease Dx Deal with Canon US Life Sciences
4.89 Invitae Amends IPO Filing Targeting up to $92.3M
4.90 Biofortuna Closes $2.2M Funding Round
4.91 Roche MDx Sales Help Drive 2014 Diagnostics Revenues up 3 Percent
4.92 AltheaDx Increases Target Amount on Proposed IPO to $74.3M
4.93 BioMerieux 2014 Revenues Increase 7 Percent
4.94 Cypher Genomics and Sequenom Announce Development Agreement
4.95 Abcam to Acquire Firefly BioWorks for $28M
4.97 Human Longevity, Genentech Ink Deal to Sequence Thousands of Genomes
4.98 GenMark Projects 52 Percent Growth in Q4 Revenues
4.99 Amarantus Acquires DioGenix for up to $10.9M
4.100 Roche to Invest up to $1.2B in Foundation Medicine, Take Majority Stake
4.101 DiaCarta Raises $8M in Series A Round
4.102 Epic Sciences' Cancer Dx Laboratory Receives CLIA Certification
4.103 Adaptive Biotechnologies Acquires Sequenta
4.104 Aegis Sciences Acquires MDx Firm Diagnovus
4.105 Interleukin Genetics Secures $10M in Financing
4.106 Premaitha NIPT Test Receives ISO Certification
4.107 HTG Molecular Diagnostics Files for IPO of up to $60M
4.108 CardioDx Raises $35M
4.109 MolecularMD Receives CAP Accreditation
4.110 14M Genomics Secures £12.5M Equity Financing for Oncology Dx
4.111 Protagen Closes First Part of Financing Round
4.112 Glyconics Inks Exclusive Licensing Deal
4.113 Great Basin Scientific Begins Trial for Staph Assay
4.114 Response Genetics Receives NYS Approval for Cancer Test
4.115 Claritas Genomics Adopts NextCode Health Platform to Interpret NGS Tests
4.116 FDA Clears Quidel's MDx for Bordetella Pertussis
4.117 FDA Clears Additional Flu Strains for Focus' MDx Assay
4.118 Novacyt Raises $3.8M in Private Equity
4.119 Good Start Genetics Licenses PGS Technology from Johns Hopkins
4.120 Metamark's Cambridge Lab Receives CAP Accreditation
4.121 Australia's VCGS Inks Deal with Illumina to Develop NIPT
4.123 Personalized Medicine Firm Newtopia Garners Investment from Bloom Burton
4.124 Roche to Acquire Ariosa Diagnostics
4.125 Biological Dynamics secures $26.8M Series C for further molecular diagnostics growth
4.126 NEO New Oncology begins study on molecular diagnostics for lung cancer patients
4.127 Qvella raises $20 million U.S. Series A round
4.128 Enzo Biochem Demonstrates Greater Sensitivity of Its AmpiProbe™ Platform for Molecular Diagnostics

5. Country Market Sizes - North America
5.1 United States of America
5.1.1 MDx Infectious Disease - Volumes, Prices, Revenues
5.1.2 MDx Genetic Testing - Volumes, Prices, Revenues
5.1.3 MDx Oncology Testing - Volumes, Prices, Revenues
5.1.4 MDx Total - Volumes, Prices, Revenues
5.2 Canada
5.2.1 MDx Infectious Disease - Volumes, Prices, Revenues
5.2.2 MDx Genetic Testing - Volumes, Prices, Revenues
5.2.3 MDx Oncology Testing - Volumes, Prices, Revenues
5.2.4 MDx Total - Volumes, Prices, Revenues

I. United States Medicare System: January 2015 Clinical Laboratory Fees Schedule - National Limit and Midpoint
II. FDA Approved Human Genetic Tests
III. FDA Approved Microbial Tests
III. FDA Approved Pharmacogenomics Tests

List of Tables:
Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2004 to 2020 ($Billion)
Table 2 Market Players by Type
Table 3 Clinical Laboratory Departments and Segments
Table 4 Laboratory Management Focus - Different Approaches
Table 5 Key Segmentation Variables Going Forward
Table 6 Five Factors Driving Growth
Table 7 Four Factors Limiting Growth
Table 8 Key Diagnostic Laboratory Technology Trends
Table 9 Next Generation Sequencing Technologies - Speed and Cost
Table 10 MDx Infectious Disease - Volume Price and Revenue Forecast
Table 11 MDx Genetic Testing - Volume Price and Revenue Forecast
Table 12 MDx Oncology - Volume Price and Revenue Forecast
Table 13 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 14 MDx Infectious Disease - Volume Price and Revenue Forecast
Table 15 MDx Genetic Testing - Volume Price and Revenue Forecast
Table 16 MDx Oncology - Volume Price and Revenue Forecast
Table 17 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 102 2015 Clinical Lab Fee Schedule

List of Figures:
Figure 1 Medicare Clinical Lab Expenditures 2004 to 2020 ($Million)
Figure 2 Chart of Market Shares of Key MDx Companies
Figure 3 Percentage of World Population Over 65
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- 14M Genomics
- 23andMe
- Abbott Laboratories
- Abcam
- Accelerate Diagnostics'
- ACT Genomics
- Adaptive
- Aegis Sciences
- Agena Bioscience
- Agendia
- Agilent/Dako
- All About Truth DNA Services
- Allenex
- AltheaDx
- Amarantus
- Ariosa Diagnostics
- Atossa Genetics
- Avant Completes
- Baylor College of Medicin
- Becton, Dickinson & Co.
- Biofortuna
- Biological Dynamics
- BioMerieux
- BioReference Laboratories, Inc.
- Bloom Burton
- Canon US Life Sciences
- Caprion
- CardioDx
- CareDx
- Cepheid
- Claritas Genomics
- Cypher Genomics
- Cytogenetics
- DiaCarta
- Diagnovus
- DiaSorin
- DioGenix
- DNA Diagnostics Center
- Empire Genomics
- Enyzmatics
- Enzo Biochem
- Epic Sciences
- Etta Healthcare
- Exiqon
- Firefly BioWorks
- Focus Diagnostics'
- Foundation Medicine
- Gates Foundation
- Genentech
- GenMark
- GenomeDx Biosciences
- Genomic Health
- Genomic Vision
- Glyconics
- Good Start Genetics
- Google
- Great Basin Scientific
- Grifols
- Hologic
- HTG Molecular Diagnostics
- Human Longevity
- Illumina
- Immucor
- Interleukin Genetics
- Invitae
- Life Letters
- Lifecode
- Luminex Corporation
- Merck Serono
- Metamark
- MolecularMD
- Multiplicom
- Myriad Genetics
- Nanosphere, Inc
- NanoString
- NEO New Oncology
- Newtopia Garners
- Novacyt
- Nuclea Bio
- OvaGene Oncology
- PerkinElmer
- Personal Genome Diagnostics
- Precipio
- Premaitha
- Protagen
- Qiagen
- Quantose IGT(TM)
- QuantRx® Biomedical
- Quest Diagnostics
- Quidel
- Qvella
- Rand Capital
- Response Genetics
- Roche Molecular Diagnostics
- Rosetta
- Sequenom
- Sequenta
- Sera
- Siemens Healthcare
- Signal Genetics LLC
- Sirona Genomics
- Sysmex Inostics
- T2 Biosystems
- The Journal of Molecular Diagnostics
- Theranostics Health
- Thermo Fisher
- Transgenomic
- Trinity Biotech
- Vanadis Diagnostics
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