Clinical Laboratory, Molecular Diagnostics and Genomic Testing Services Market Trends and Forecasts 2016 to 2019 North America Version

Clinical Laboratory, Molecular Diagnostics and Genomic Testing Services Market Trends and Forecasts 2016 to 2019 North America Version

A market that just keeps on growing. Clinical laboratory testing is positioned to directly benefit from the explosion in biotechnology, especially genomics. Learn all about it in this new report from Howe Sound Research. A range of dynamic trends are pushing market growth and company valuations. Trends like ......

  • changing demographics
  • emerging economies and global prosperity
  • biotechnology advances in genetics
  • pathogen evolution
  • climate change
  • globalization
  • automation
Exciting technical developments especially in the area of molecular diagnostics and pharmacogenomics 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. "Clinical Laboratory, Molecular Diagnostic and Genomic Testing Services - 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 sharpen your pricing. Make facilities planning decisions. Forecast demand for new testing regimes or technologies. Make research investment decisions.

Order an Enterprise Version specifically customized for your organizations needs for distribution throughout your company.

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. Questions? Email us at service at We would be glad to let you know if we can be of help.

The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.

All report data is available in Excel format on request.

Make investment decisions and valuations with confidence using the latest data.

1. Introduction and Market Definition
1.2 Market Definition
1.2.1 Volumes
1.2.2 Prices
1.2.3 Revenue Market Size
1.3 Methodology
1.3.1 Authors
1.3.2 Sources
1.4 U.S. Medical Market and Clinical Laboratory Testing - Perspective
1.3.1 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 Companies
2.4.1 Quest Diagnostics
2.4.2 Laboratory Corporation of America
2.4.3 Lifelabs Medical Laboratory Services
2.4.4 ACM Medical Laboratory
2.4.5 Spectra Spectra Laboratories, Inc.
2.4.6 Bio-Reference Laboratories, Inc.
2.4.7 Signal Genetics LLC
2.4.8 CompuNet Clinical Laboratories, LLC
2.4.9 Genzyme Corporation
2.4.10 Sonic Healthcare Limited
2.4.11 Exagen Diagnostics, Inc.
2.4.12 Clongen Laboratories LLC
2.4.13 Clinical Reference Laboratory, Inc.
2.4.14 Rosetta Genomics Inc.
2.4.15 Mid America Clinical Laboratories, LLC
2.4.16 Alere Inc
2.4.17 Caris Life Sciences, Inc.
2.4.18 Psychemedics Corp.
2.4.19 Aurora Diagnostics, LLC
2.4.20 DL Reference Laboratory
2.4.21 Myriad Genetics, Inc.
2.4.22 Bioscientia Institut fuer Medizinische Diagnostik GmbH
2.4.23 Acibadem Labmed Laboratory
2.4.24 Claymon Biomnis Laboratories Ltd.
2.4.25 Biomnis (France)
2.4.26 The Doctor’s Laboratory (Sonic Healthcare U.K.)
2.4.27 Pathology Inc.
2.4.28 Gribbles Pathology
2.4.29 BP Lab
2.4.30 Adicon Clinical Laboratories, Inc.
2.4.31 Diagnósticos da América (DASA)
2.4.32 Medicus Phillipines Inc.
2.4.33 Kingmed Diagnostics
2.4.34 Ascend Clinical, LLC
2.4.35 Unilabs SA
2.4.36 American Pathology Partners, Inc.
2.4.37 Centrex Clinical Laboratories, Inc.
2.4.38 Integrated Regional Laboratories, Inc.
2.4.39 Vira Cor-Ibt Laboratories
2.4.40 Clarient, Inc.
2.4.41 Genomic Health, Inc.
2.4.42 ARUP Laboratories, Inc.
2.4.43 MEDTOX Scientific, Inc.
2.4.44 Solstas Lab Partners
2.4.45 Predictive Biosciences, Inc.
2.4.46 Enzo Biochem, Inc.
2.5 National and Regional Diversity
3. Market Trends
3.1 Factors Driving Growth
3.1.1 Impact of U.S. Health Reform (PPACA) on U.S. Market
3.1.2 Understanding the Impact of Aging Population.
3.1.3 Economic growth drives health spending.
3.1.4 Point of Care Testing can increase demand
3.1.5 Wellness concerns create growth
3.1.6 Esoteric Testing Moving Mainstream
3.1.7 Genetic Based Testing Creates New Department and New Discipline
3.2 Factors Limiting Growth
3.2.1 Lower costs trend to continue
3.2.2 Economic or population contraction.
3.2.3 Testing usage analysis curtailing growth.
3.2.4 Wellness has a downside
3.2.5 Test Displacement Impacts Important
3.2.6 Point of Care Testing
3.3 Automation
3.3.1 Stranded LIMS Investment
3.3.2 Software as a Service
3.3.3 Physician Office and Access Systems
3.4 Environment and Evolution
3.5 Diagnostic Technology Development
3.5.1 Next Generation Sequencing Fuels a Revolution
3.5.2 Impact of NGS on pricing
3.5.3 POCT/Self Testing Disruptive Force
3.5.4 Pharmacogenomics Blurs Diagnosis and Treatment
3.5.5 CGES Testing, A Brave New World
3.5.6 Molecular Diagnostics Technologies At The Forefront of Growth
3.5.7 Biochips/Giant magneto resistance based assay
4. Laboratory, Molecular Diagnostics and Genomic Testing 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 Quest Diagnostics to Acquire Clinical Laboratory Partners
4.3 Illumina, Almac to Collaborate on NGS CDx Assays
4.4 Rite Aid First U.S. Drugstore Chain to Offer Harmonyx Genetic Testing to Customers
4.5 US Patent Awarded to Singulex for Expanded Use of Biomarkers
4.6 Feds to scrutinize med tech Medicare reimbursement in fi
4.7 Trovagene's Urine-Based Liquid Biopsy Platform Shows Clinical Sensitivit
4.8 Roche Rapid Flu MDx Test Shown to Impact Patient Care in ER
4.9 CareDx Mobilizing Response Team After CMS Initial AlloMap Pricing Threatens Busines
4.10 PTS Diagnostics' Patent Enforcement Against Jant Pharmacal Gains Momentum
4.11 SeraCare Life Sciences Announces Early Access Programs for ctDNA and RNA Fusion
4.12 Eurofins Acquires Diatherix to Strengthen Specialty Clinical Diagnostics Focus
4.13 Abbott Laboratories to buy St. Jude Medical for $25 billion
4.14 CombiMatrix Gets Serious About Potential M&A Options in Wake of $8M Offering
4.15 Abbott to Acquire Alere, Becoming Leader in Point of Care Testing
4.16 Achieving Dx Ambitions Key to Avant-Amarantus-Theranostics Merger
4.17 LabCorp Agrees to Acquire Assets of Pathology Inc.
4.18 NeoGenomics Completes Acquisition of Clarient, Inc.
4.47 OpGen Files for IPO for up to $37M
4.48 Transgenomic Closes Public Offering of Stock, Warrants
4.49 Qiagen Discloses $114.2M Price Tag for Enyzmatics Acquisition
4.50 Laboratory Corporation of America Holdings Full Year Results
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.
4.56 LabCorp to Buy Covance for $6.1 Billion to Add Drug R&D
4.57 Trinity Biotech Revenues Gro
4.58 Google’s Latest Healthcare Initiative
4.59 Trinity Biotech Announces US Clinical Trials
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
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 Diagnost
4.75 NanoString's Q4 Revenues
4.76 New Aussie Firm Life Letters Launches Carrier, PGx Testing for Consumers
4.77 HTG Molecular Rep
4.79 LabCorp Posts 5 Percent Revenue Growth
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
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 D
4.92 AltheaDx Increases Target Amount on Proposed IPO to $74.3M
4.93 BioMer
4.94 Cypher Genomics and Sequenom Announce Development Agreement
4.95 Abcam to Acquire Firefly BioWorks for $28M
4.96 PerkinElmer Opens Medical Laboratory in China
4.97 Human Longevity, Genentech Ink Deal to Sequence Thousands of Genomes
4.98 GenMark Proj
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
4.111 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
4.122 LabCorp Acquires Bode Technology
4.123 Personalized Medicine Firm Newtopia Garners Investment from Bloom Burton
4.124 Roche to Acquire Ariosa Diagnostics
4.125 CMS Issues Final Payment Decision
4.126 MDx Firm Curetis Closes $18M Series B Extension
4.127 Australia's Proteomics International Laboratories Launches A$6M IPO
4.128 Australian MDx Firm Genetic Signatures Eyes IPO for up to A$15M
4.129 N-of-One to Support Oncology Testing at BloodCenter of Wisconsin
4.130 Signal Genetics Q3 Revenues Mov
4.131 Sequenta, Illumina Strike IVD Deal
4.132 Veracyte Q3 Revenues S
4.133 Great Basin's Q3 Revenues
4.134 Response Genetics Q3 Revenues Improve 9 Percent
4.135 Roche Gets FDA Clearance for Strep A MDx Test
4.136 GeneNews Q3 Revenues up Sharply
4.138 Epigenomics Q3 Revenues Grow 7 Percent
4.139 CareDx Q3 Revenue
4.140 Exagen Records Sharp Increase in Revenues for First Nine Month
4.141 CollabRx, Cartagenia Partner to Provide Cancer Testing
4.142 Prostate Management Dx Closes $1.1M Series A Financing
4.143 Roka Bioscience Posts Jump in Q3 Revenues
4.144 Pacific Biosciences Files $150M Shelf Registration
4.155 Foundation Medicine Doubles Q3 Revenues
4.156 Nanosphere Q3 Revenues C
4.157 Hologic Fiscal Q4 Revenues Increase 6 Percent
4.158 MDxHealth Raises $15.4 Million in Private Stock Offering
4.159 Genomic Health Reports 5 Percent Revenue Growth in Third Quarter
4.160 NanoString P
4.161 AstraZeneca's MedImmune Acquiring Definiens for at Least $150M
4.162 PDI Acquires MDx Firm RedPath Integrated Pathology
5. Country Market Sizes – North America
5.1 United States of America
5.1.1 Clinical Chemistry – Volumes, Prices, Revenues
5.1.2 Microbiology – Volumes, Prices, Revenues
5.1.3 Hematology – Volumes, Prices, Revenues
5.1.4 Anatomic Pathology – Volumes, Prices, Revenues
5.1.5 Molecular Diagnostics – Volumes, Prices, Revenues
5.1.6 All Clinical Testing – Volumes, Prices, Revenues
5.1.7 Cardiac Biomarkers – Volumes, Prices, Revenues
5.1.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues
5.1.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues
5.2 Canada
5.2.1 Clinical Chemistry – Volumes, Prices, Revenues
5.2.2 Microbiology – Volumes, Prices, Revenues
5.2.3 Hematology – Volumes, Prices, Revenues
5.2.4 Anatomic Pathology – Volumes, Prices, Revenues
5.2.5 Molecular Diagnostics – Volumes, Prices, Revenues
5.2.6 All Clinical Testing – Volumes, Prices, Revenues
5.2.7 Cardiac Biomarkers – Volumes, Prices, Revenues
5.2.8 Molecular Diagnostic Oncology – Volumes, Prices, Revenues
5.2.9 Molecular Diagnostic Genetics – Volumes, Prices, Revenues
10. The Future of the Clinical Laboratory
I. United States Medicare System: Jan
Table of Tables
Table 1 Medicare Clinical Lab Expenditures Actual & Fore
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 Factors Affecting Local Clinical Testing Demand
Table 7 Seven Factors Driving Growth
Table 8 Six Factors Limiting Growth
Table 9 Key Diagnostic Laboratory Technology Trends

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