LONDON, Sept. 16, 2014 /PRNewswire/ -- This report analyzes the worldwide markets for Molecular Diagnostics in US$ Thousands by the following Applications: Infectious Disease Testing, Blood Screening, Cancer Screening, and Other Applications. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 165 companies including many key and niche players such as -
Abbott Laboratories
Becton, Dickinson and Company
bioMérieux SA
Cepheid
CytoCore Inc.
Download the full report: https://www.reportbuyer.com/product/90566/
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
II. EXECUTIVE SUMMARY
1. OUTLOOK II-1
Molecular Diagnostics - A Prelude II-1
Current and Future Analysis II-2
US and Europe - Leaders in Molecular Diagnostics Adoption II-3
Developing Countries Excel in Growth Prospects II-3
Major Growth Drivers II-5
Key Market Trends in a Nutshell II-5
Major Technology Trends II-6
Major Issues and Challenges II-6
The Future in Store II-6
2. MEDICAL DIAGNOSTICS MARKET - A REVIEW II-8
Clinical Diagnostics Industry - Trends and Tendencies II-8
Global In-Vitro Diagnostics (IVD) Market: A Prelude II-9
Table 1: Global In Vitro Diagnostics Market by Leading
Players (2013): Percentage Share Breakdown of Revenues for
Abbott Laboratories, bioMérieux, Danaher, J&J, Roche
Diagnostics, Siemens and Others (includes corresponding
Graph/Chart) II-10
Table 2: Global In-Vitro Diagnostics Market by Segment
(2013): Percentage Breakdown of Value Sales for Hematology,
Hemostasis, Immunochemistry, Microbiology, Molecular
Diagnostics, Point-of-Care Diagnostics, Self-Monitoring Blood
Glucose, and Tissue Diagnostics (includes corresponding
Graph/Chart) II-10
Table 3: Global In-Vitro Diagnostics Market by Sector (2013):
Percentage Breakdown of Revenues for Decentralized & Patient
Self-Testing and Hospital & Commercial Laboratories (includes
corresponding Graph/Chart) II-11
Classification of Diagnostic Tests II-11
Molecular Diagnostics - A Replacement and Enabling Technology II-11
Advancements in Molecular Diagnostics - A Boon for the Industry II-12
Nucleic Acid Diagnostics Market - An Overview II-12
3. MOLECULAR DIAGNOSTICS INDUSTRY - AN OVERVIEW II-14
Molecular Diagnostics - A Rapidly Advancing Market II-14
Molecular Diagnostics: Marking the Convergence of Numerous
Technologies II-15
Towards Tailoring the Right Treatment for the Right Disease II-15
Business Opportunities in the Offing II-15
Improving Healthcare Expenditure Turbo Charges Demand II-16
Table 4: Per-Capita Healthcare Expenditure in Select Regions
(2013) (includes corresponding Graph/Chart) II-16
Table 5: Top 20 Countries with the Highest Healthcare
Spending as a Percentage of GDP (2012) (includes
corresponding Graph/Chart) II-17
Table 6: Top 10 Countries with Highest Private Spending on
Health Care (2011) (includes corresponding Graph/Chart) II-18
Demographics Spell Growth Opportunities II-18
Table 7: Global Population Statistics for the 65+ Age Group
(2013) (includes corresponding Graph/Chart) II-19
Table 8: Elderly Population (60+ Years) as a Percentage of
the Total Population (2012 & 2050) (includes corresponding
Graph/Chart) II-20
Table 9: Global Aging Population by Age Group: 1975-2050
(includes corresponding Graph/Chart) II-21
Table 10: Aging Population by Age Group in More Developed
Countries (1975-2050) (includes corresponding Graph/Chart) II-22
Table 11: Aging Population by Age Group in Less Developed
Countries (1975-2050) (includes corresponding Graph/Chart) II-23
Table 12: Aging Population by Age Group in Least Developed
Countries (1975-2050) (includes corresponding Graph/Chart) II-24
Table 13: Life Expectancy at Age 60 and 80 Years -
(2010-2015), (2020-2025) & (2045-2050) (includes
corresponding Graph/Chart) II-25
Technological Innovations Set to Drive the Market II-25
The Role of Molecular Diagnostics in Personalized Medicine II-27
Companion Diagnostics Make Way for Personalized Medicine II-28
List of Select FDA-Cleared Companion Diagnostic Devices II-28
Biomarkers as Companion Diagnostics II-29
Proteomics Technologies: Growing in Significance II-30
New Developments in Proteomics Technologies II-31
New Applications Hold Promising Potential II-31
Molecular Diagnostics for Lymphoid Malignancies II-32
Next-Generation Sequencing Technologies Keep Up the Momentum II-33
Select Commercial NGS Technologies II-33
Select Promising NGS Technologies in Development (As of 2012) II-34
Rising Emphasis on Lab Automation to Augur Well for Market Growth II-34
List of Fully Automated and Rapid Molecular Diagnostics II-35
Molecular Diagnostics and Intellectual Property II-35
Medical Training and Practice Challenges II-36
The Enlightened Consumer of the 21st Century II-36
Information Handling & Processing: The Soft Side of Diagnostics II-36
Hurdles All the Way for Companies Eyeing Molecular Diagnostics II-36
Molecular Diagnostics - Moving from Centralization to
Decentralization II-37
Migrating to Decentralized Format II-37
Going Ahead with Decentralization II-38
Limited Reimbursements by Third Party Payers - A Stumbling Block II-38
4. AN INSIGHT INTO APPLICATIONS OF MOLECULAR DIAGNOSTICS II-39
Infectious Diseases Molecular Testing II-39
Overview II-39
Activity in the Field II-39
Identifying Multidrug Resistance II-40
Infectious Disease Treatment Monitoring II-40
Other Infectious Diseases Applications II-40
Key Trends II-40
Increasing Incidence of Infectious Diseases Fuel Adoption II-40
Table 14: Reported Cases of Major Infections by Select
Geographic Region: 2011 II-41
Rising Incidence of Hospital Acquired Infections Propels
Market Growth II-41
Comparison of Different Parameters for Select C. diff MDx
Tests II-43
Rising HIV Prevalence Provides Ample Growth Opportunities II-43
Table 15: Global Prevalence of HIV Infection in 2012 by
Region (in Millions) (includes corresponding Graph/Chart) II-44
Table 16: Newly Infected HIV Population in 2012 by Region
(in Millions) (includes corresponding Graph/Chart) II-44
Table 17: Global HIV Related Deaths in 2012 by Region (in
Millions) (includes corresponding Graph/Chart) II-45
Table 18: Top Twelve Countries in APAC with The Highest HIV
Incidence (2012) (includes corresponding Graph/Chart) II-45
Infectious Disease Testing - A Major Driver of Molecular
Diagnostics Market II-46
Select FDA-Cleared Molecular Diagnostic Tests for
Infectious Diseases II-47
Molecular Tests Gaining Prominence in GC/Chlamydia Testing
Market II-51
Molecular Diagnostics Opens New Avenues in Viral Hepatitis
Testing II-52
HPV Testing: A Fast Growing Segment in the Molecular
Diagnostic Testing Market II-53
List of Select HPV Molecular Diagnostic Tests by Company
and Technique II-54
Archaic TB Diagnostic Methods Opens Up Opportunities for
Molecular Diagnostics II-54
List of Select Commercially-Available TB Diagnostics II-56
An Overview of Select TB Diagnostics under Development II-56
Molecular POC Testing for Infectious Diseases: Yet to
Realize Its Full Potential II-57
PCR Plays a Vital Role in the Diagnosis of Infectious Diseases II-57
Blood Screening II-58
Molecular based Tests Ingrain Roots in Blood Donor Screening
Segment II-58
Cancer Screening & Diagnosis II-59
Overview II-59
Molecular Tests Lead the Way for Cancer IVD Market Growth II-60
Molecular Markers to Enhance Thyroid Cancer Diagnosis II-60
Oncology-Based Molecular Diagnostics: The Propitious Segment II-61
List of US-FDA Approved Biomarkers for Cancer II-63
Table 19: World Cancer Incidence by Geographic Region and
Gender (2012): Number of New Cancer Cases Reported (in
Thousands) for Asia-Oceania, Europe, North America, Latin
America & The Caribbean, and Africa (includes corresponding
Graph/Chart) II-64
Table 20: New Cancer Cases in the World by Affected Site
(2012) (in Thousands) (includes corresponding Graph/Chart) II-64
Table 21: Medical Costs Associated with Cancer by Affected
Site: 2010 (includes corresponding Graph/Chart) II-65
Growing Popularity of Chemo-Sensitivity Testing of CTCs II-65
Cervical Cancer Screening: Focus on Detection of CIN2 and
CIN3 Cancers II-66
Other Testing Applications II-66
Genetic Disease Testing Applications II-66
Overview II-66
Pharmacogenomics - Prognosis Based on Genomics II-67
Pharmacogenomics Development Augurs Growth of Genetic
Testing Market II-68
Prospects for Genetic Diagnostics and Testing Grow Brighter II-68
List of Select FDA-Cleared Genetic Tests by Disease II-70
Genetic Testing - An Indispensible Tool for Cystic Fibrosis II-71
Table 22: Most Common Mutations and Worldwide Frequency
(includes corresponding Graph/Chart) II-72
Genetic Testing Plays Pivotal Role in Diagnosing Inherited
Conditions II-72
Non-Invasive Prenatal Diagnostics - The Way Ahead II-73
Nucleic Acid Amplification Methods for Detection of
Antimicrobial Resistance II-73
PCR-Based Nucleic Acid Amplification for Detection of
Antimicrobial Agents II-73
Histocompatibility Testing II-74
Table 23: Global HLA Testing Market (2012-2016E): Revenue
Estimates for 2012 through 2016 (includes corresponding
Graph/Chart) II-74
5. COMPETITIVE DYNAMICS IN THE MOLECULAR DIAGNOSTICS MARKET II-75
Pharmaceutical Firms Carving Their Niche in Molecular
Diagnostic Market II-75
An Overview of Competitive Landscape in Molecular Diagnostics II-75
Table 24: Leading Players in the Global Molecular Diagnostics
Market (2012): Percentage Share Breakdown by Value Sales for
Abbott, Becton, Dickinson & Company, bioMérieux, Cepheid,
Hologic/Gen-Probe, Novartis, Qiagen, Roche Diagnostics,
Siemens and Others (includes corresponding Graph/Chart) II-76
Other Noteworthy Companies and their Competitive Position by
Segment II-76
Key Players and Their Technologies II-77
The Top Tier II-77
Mid-Sized and Small Companies II-77
Cepheid: Unquestioned Leader in the Rapid and Automated MDx
Market II-78
Price Comparison of Select Fully Automated and Rapid
Molecular Diagnostics II-79
Qiagen: The Leading Player in the Global HPV MDx Market II-79
Comparative Analysis of Select HPV MDx Tests II-79
Competitive Dynamics in the C. difficile Testing Market II-80
Table 25: Global Molecular Diagnostics Market for
Clostridium difficile by Leading Player (2013): Percentage
Breakdown of Revenues for Becton Dickinson, Cepheid,
Meridian and Others (includes corresponding Graph/Chart) II-80
List of Select Molecular C. difficile Test Products II-80
Competition in the Blood Screening MDx Market II-80
Table 26: Global Blood Screening MDx Market by Leading
Players (2013): Percentage Market Share Breakdown of Value
Sales for Hologic Gen-Probe, Roche and Others (includes
corresponding Graph/Chart) II-81
Competitive Landscape in the Global RT-PCR Market II-81
Table 27: Leading Players in Global RT-PCR Instruments
Market (2012): Percentage Breakdown of Value Sales for Life
Sciences Research by Leading Players - Life Technologies,
Bio-Rad, Roche, Agilent, Qiagen and Others (includes
corresponding Graph/Chart) II-82
Select Real-Time PCR Products by Company II-82
Competition Heats Up in dPCR Market II-82
Table 28: Leading dPCR Systems At a Glance II-83
Life Sciences Companies Eye on Lucrative Prostate Cancer MDx
Market II-83
Consolidation Activity Continues to Strengthen Driven by New
Entrants II-84
Major M&A Transactions in Molecular Diagnostics: 2011-2014 II-85
New Entrants in Molecular Diagnostics Landscape: 2010-2013 II-86
Some Examples of Recent Transactions by New Entrants in the
MDx Market II-87
Product Marketing - Key to Commercial Success II-87
6. PRODUCT & TECHNOLOGY OVERVIEW II-88
Molecular Diagnostics - Definition & Scope II-88
Molecular Diagnostics - Impact on Healthcare II-88
Utility of Molecular Diagnostic Tests II-89
Background of Molecular Diagnostics II-89
Major Milestones in the Evolution of Molecular Diagnostics II-89
Types of Molecular Diagnostics II-90
Conventional Diagnostics Vs. Molecular Diagnostics II-91
Unabated Developments in Molecular Diagnostics Technology II-91
Signal Amplification Technologies II-91
PCR - New Developments II-91
Quantitative Real-Time PCR for Molecular Diagnostics II-92
Signal Detection and Quantification II-93
Quantitative Real-Time RT-PCR Analysis II-93
Applications of Quantitative Real-Time PCR Analysis II-93
Digital PCR II-94
Non-PCR Methods II-94
Other Signal Amplification Technologies II-94
DNA Probe Based Products II-94
Direct Detection of Specific Nucleic Acid Sequences II-94
Nucleic Acid Amplification and Detection II-95
DNA Sequencing and Gene Detection II-95
Arrays of Immobilized Probes (DNA Chips) in Gene Detection II-96
RNA Diagnostics II-96
Complementary Molecular Diagnostic Technologies II-97
Fluorescent In-Situ Hybridization (FISH) II-97
DNA Biochips/Microarrays II-97
Biosensors II-98
Proteomic Technologies for Molecular Diagnostics II-98
Nanotechnology for Molecular Diagnostics II-99
Technologies on the Anvil II-99
Haplotype Analysis - A Distant Possibility II-99
Chronic Multi-Gene Defects Now Diagnosable II-100
Whole Genome Sequencing - Boon or Bane to Genetic Testing? II-100
7. PRODUCT APPROVALS/INTRODUCTIONS II-101
Grifols Obtains CE-Marking for ID CORE XT Molecular Diagnostic
Kit II-101
QIAGEN Rolls Out careHPV™ Test in India II-101
QIAGEN Gets PMA Approval from the US FDA for artus® CMV RGQ
MDx Kit II-101
Alere Obtains FDA Approval for Alere™ i Influenza A and B Test II-101
Qiagen Obtains Approval from the US Health Regulators for
Gene-Testing Kit II-101
Immucor Obtains the US FDA Approval for PreciseType HEA Test II-101
bioMérieux Obtains PMA Approval from the FDA for THxID™-BRAF
Companion Diagnostic Test II-102
Cepheid Obtains FDA Clearance for Xpert® MTB/RIF Test II-102
Roche Gains FDA 510(k) Approval to use Four Additional
Specimens with Cobas Ct/Ng V2.0 Test II-102
PrimeraDx Gains FDA 510(k) Clearance for ICEPlex System II-102
Illumina Receives FDA Premarket Approval for Miseqdx System II-102
Hologic Obtains Health Canada Approval for Aptima HPV Assay II-103
Life Technologies Obtains NDIS Approval for GlobalFiler
Express Kit II-103
Serascience Obtains CE Mark Approval for Seralite® II-103
IntelligentMDx Obtains US FDA Approval for Automated Molecular
Diagnostic Test II-103
Meridian Bioscience Obtains FDA Approval for illumigene®
Mycoplasma II-103
IntelligentMDx Obtains CE-Mark Approval for IMDx Flu A/B and
RSV Test II-103
BD Diagnostics Obtains FDA Approval for BD MAX™ Cdiff Assay II-104
Quidel Obtains 510(k) Approval for Quidel Molecular RSV + hMPV
Assay II-104
Roche Seeks FDA Approval for Cervical Cancer Primary Screening
Indication for the Cobas® Hpv Test II-104
Quidel Gets FDA Nod for New Molecular Diagnostic Tests II-104
Abbott Launches RealTime Molecular Test for HPV II-104
Diagnovus Introduces ENGAUGE™-Cancer DLBCL Gene Panel II-104
Roche Introduces Cobas p 480 Instrument II-105
LabCorp Launches BRCAssureSM Breast Cancer Mutation Tests II-105
Cytocell Introduces Cytocell CLL FISH Probes II-105
Cancer Genetics Introduces FHACT™ DNA-Based Cervical Cancer
Diagnostic Test II-105
Abbott Releases IMDx C.difficile Test II-105
Myriad Genetics Introduces myPath™ Melanoma Molecular
Diagnostic Test II-105
Biocartis Develops New MDx Prototype Platform II-106
BioChain Collaborates with Epigenomics to Introduce Septin9
IVD Test II-106
Advanced Cell Diagnostics and Kindstar Partner to Introduce
New Molecular Diagnostic Assays II-106
EKF Diagnostics Introduces Four New PointMan™ DNA Enrichment Kits II-106
DiaCarta Introduces QClamp™ Somatic Mutation Real-Time PCR Tests II-106
Biocartis to Launch Idylla Molecular Diagnostic Platform II-106
Personalis Launches the ACE Clinical Exome™ II-106
Roche to Launch Cobas 6800 and Cobas 8800 MOLECULAR Dx Systems II-107
Illumina Launches TruSight One Sequencing Panel II-107
Abbott Laboratories Releases New FDA-Approved Molecular
Diagnostic Flu A/B and RSV Test II-107
Natural Molecular Testing Releases New Diagnostic Molecular
Tests for Women II-107
DiaSorin's Molecular Division Launches Iam Toxo Assay for T.
gondii Detection II-107
Myriad Genetics Introduces myRisk™ Hereditary Cancer Panel II-107
BD Diagnostics Launches FDA-Cleared BD ProbeTec™ Trichomonas
Vaginalis Qx Amplified DNA Assay II-108
ELITechGroup Molecular Diagnostics Introduces ELITe STAR II-108
Assurex Health Launches GeneSight Psychotropic 2.0 II-108
Theradiag Rolls Out two new Multiplexed Molecular Diagnostic
Assays II-108
Bioline Releases the MyTaq™ Extract-PCR Kit II-108
HTG Rolls Out HTG Edge DMPK Assay and HTG Edge TOA Assay II-108
BD Diagnostics Introduces Real-Time PCR Kit for Diagenode
Bordetella Pertussis/Parapertussis Detection II-109
Abbott Launches Real-time HCV Genotype II Test II-109
Abbott Introduces FDA-Approved Real-Time HCV Genotyping Test
Assay II-109
DiaSorin Releases New IAM PARVO Molecular Diagnostic Test for
Parvo Virus Detection II-109
GeneDx to Introduce Comprehensive Breast Cancer Genetic Tests II-109
Vela Diagnostics Develops New PCR-based Assays Targeting the
H7N9 Bird Flu Strain II-110
Cancer Genetics Introduces UroGenRA™ Urogenital Cancer Array II-110
Bioline Releases ISOLATE II Nucleic Acid Purification Kits II-110
MLabs Announces Commercial Availability of MiPS Test for
Prostate Cancer II-110
Cancer Genetics Introduces New Genetic Test for Cervical
Cancer Management II-110
Knight Diagnostic Laboratories Launches GeneTrails Cancer Tests II-110
Integrated Diagnostics Releases Xpresys™ Lung Blood Test II-111
Seegene Unveils Real-Time Array Technology for POC Testing II-111
Medical Diagnostic Laboratories Releases New Azithromycin
Resistance Reflex Assay for Chlamydia Trachomatis II-111
BD Diagnostics Introduces New Molecular Test II-111
Nanosphere Receives FDA Authorization for Marketing BC-GP Test II-111
Abbott Secures CE Marking for PLEX-ID™ System and Clinical Assays II-112
8. RECENT INDUSTRY ACTIVITY II-113
Thermo Fisher Scientific Acquires Life Technologies II-113
Myriad Genetics Takes Over Crescendo Bioscience II-113
AUT University Collaborates with Roche Diagnostics II-113
Corgenix Medical Obtains NIH Grant to Advance Development of
Ebola Rapid Diagnostic Test Kit II-113
Cepheid Collaborates with AstraZeneca, Cubist Pharmaceuticals
and GSK II-113
B Braun US and CeGaT Join Forces to Establish B Braun CeGaT II-113
Provista Diagnostics Expands Exclusive License Agreement for
Certain Biomarker and Autoantibody Technologies II-114
Veracyte and Fleury Partner to Offer the Afirma® Gene
Expression Classifier II-114
Integrated Diagnostics Attracts Financing for Xpresys Lung
Molecular Diagnostic Blood Test II-114
MDxHealth Enters into Agreement with Galaxy Health II-114
QIAGEN Acquires Exclusive Worldwide License to CALR Biomarker II-114
Zyomyx Obtains $7.5 Million from UNITAID to Launch MyT4™ POC
CD4 Test II-115
Human Longevity Inc. Commences its Operations II-115
Roche Takes Over IQuum II-115
Myriad Genetics and Sividon Diagnostics Ink Exclusive Co-
Marketing Agreement II-115
Grifols to Acquire Transfusion Diagnostics Unit of NOVARTIS
Diagnostics II-115
Life Technologies and Advanced Cell Diagnostics Enter into
Global Distribution Agreement II-115
Microbiologics Acquires Phthisis Diagnostics II-116
bioMérieux Enters into Agreement to Acquire BioFire Diagnostics II-116
Response Genetics Takes Over Substantial Assets of Pathwork
Diagnostics II-116
Mobidiag, Genewave and Amplidiag Merge II-116
EKF Diagnostics Holdings Established New Subsidiary II-116
Cynvenio and CollabRx Collaborate for Cancer Molecular
Diagnostics II-116
bioTheranostics Inks Collaboration Agreement with Mayo Clinic
and Mayo Medical Laboratories II-116
bioMérieux Terminates Collaboration with Biocartis in
Molecular Biology Field II-117
Rosetta Genomics Expands Distribution Agreement with GeneKor
for microRNA Cancer Testing Services II-117
QIAGEN Enters into an Agreement with Eli Lilly II-117
Transgenomic Collaborates with PerkinElmer II-117
Diagnoplex and Unilabs Ink Collaboration Agreement to
Commercialize Colox II-117
Pacific Edge Inks Agreement with FedMed II-117
PDI and Transgenomic Sign Long-Term Collaboration Agreement
for CardioPredict™ Molecular Diagnostic Test II-117
HiberGene Obtains US Patent Rights for Molecular Diagnostic
Test for Meningococcus II-118
OncoDNA Signs Collaboration Agreement with IBBL II-118
MDxHealth Collaborates with HistoGeneX II-118
Co-Diagnostics Partners with DNA Logix to Form Infectious
Disease Dx Joint Venture II-118
Lumora and Promega Sign Supply Agreement for Ultra-Glo™
Luciferase II-118
MDxHealth Enters into Partnership with Summit Pharmaceuticals II-118
Myriad Genetic Enters into Agreement with TESARO II-118
Cancer Genetics Enters into Distribution Agreement with Excilone II-119
Cancer Genetics Italia Enters into Agreement with Nikon
Instruments II-119
CollabRx and OncoDNA Enter into Long-Agreement to Buy CollabRx
SaaS-based Technology and Content Resources II-119
CollabRx Enters into Partnership with Sengenics for Molecular
Diagnostics II-119
Diasorin Enters into Agreement with Seegene II-119
Cancer Genetics Appoints Cytogen and Cytogen Polska as
Distributors for CGI Italia DNA-FISH Probes II-119
FDA Re-Categorizes Meridian Bioscience's illumigene® Group A
Streptococcus and illumigene® Group B Streptococcus Tests II-120
Kreatech Signs Agreement with LCMC II-120
HiberGene Diagnostics Commences Manufacturing Process for
Meningococcus MDx Test II-120
SYGNIS Pharma to Foray into Molecular Diagnostics Products
Business II-120
IntelligentMDx Signs Long-Term Agreement with QIAGEN II-120
The Icahn School of Medicine Collaborates with Exosome
Diagnostics II-120
Tianjin Cancer Hospital Joins Forces with Tektronix II-120
Maverix Biomics Enters into Co-Marketing Agreement with QIAGEN II-121
CollabRx Enters into Multi-Year Agreement with Quest Diagnostics II-121
Personal Genome Diagnostics Collaborates with MolecularMD II-121
Applied Proteomics Collaborates with the German Cancer
Research Center II-121
Diagnoplex and Unilabs Ink Collaboration Agreement II-121
CombiMatrix Enters into Strategic Alliance with Manhattan Labs II-121
MRIGlobal and Evogen Ink Agreement for Molecular Diagnostics
Products Development II-121
Rheonix Signs Joint Development Agreement with Life Technologies II-122
Qiagen Collaborates with Exosome Diagnostics II-122
Diaxonhit and XDx Sign Definitive Exclusive License and
Distribution Agreement II-122
Genewiz Enters into Partnership with Chinese KeyTest Diagnostics II-122
IncellDx Inks Agreement with GeneCell Diagnostics II-122
PrimeraDx Enters into Agreement with Quest Diagnostics to Co-
Develop Companion Diagnostics II-122
Evogen Inks Licensing Agreement with Focus Diagnostics II-122
Lpath Enters into Collaboration and License Agreement with
Provista II-123
Lab21 Inks Agreement with IntegraGen II-123
Analytik Jena Acquires SIRS-Lab II-123
Swift Biosciences Enters into Licensing Agreement with Vela
Operations II-123
BioFire Secures $25 Million Fund from Athyrium II-123
9. FOCUS ON SELECT PLAYERS II-124
Abbott Laboratories (US) II-124
Abbott Molecular, Inc. (US) II-124
Becton, Dickinson and Company (US) II-125
bioMérieux SA (France) II-125
Cepheid (US) II-126
CytoCore Inc. (US) II-127
F. Hoffmann-La Roche Ltd. (Switzerland) II-128
GE Healthcare (US) II-129
Grifols International, S.A. (Spain) II-130
Hologic, Inc. (US) II-131
Hologic Gen-Probe Incorporated (US) II-132
QIAGEN N.V. (The Netherlands) II-132
Quest Diagnostics, Inc. (US) II-133
Celera Corp. (US) II-134
Siemens AG (Germany) II-135
Tecan Group Ltd. (Switzerland) II-136
The ELITechGroup SAS (France) II-136
Thermo Fisher Scientific (US) II-137
10. GLOBAL MARKET PERSPECTIVE II-138
Table 29: World Recent Past, Current & Future Analysis for
Molecular Diagnostics by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) II-138
Table 30: World Historic Review for Molecular Diagnostics by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-139
Table 31: World 15-Year Perspective for Molecular Diagnostics
by Geographic Region - Percentage Breakdown of Revenues for
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2006, 2014
and 2020 (includes corresponding Graph/Chart) II-140
Molecular Diagnostics Market by Application II-141
Table 32: World Recent Past, Current & Future Analysis for
Molecular Diagnostics in Infectious Disease Testing by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-141
Table 33: World Historic Review for Molecular Diagnostics in
Infectious Disease Testing by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) II-142
Table 34: World 15-Year Perspective for Molecular Diagnostics
in Infectious Disease Testing by Geographic Region -
Percentage Breakdown of Revenues for US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America and Rest
of World Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) II-143
Table 35: World Recent Past, Current & Future Analysis for
Molecular Diagnostics in Blood Screening by Geographic Region -
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets Independently Analyzed
with Annual Revenue Figures in US$ Thousand for Years 2013
through 2020 (includes corresponding Graph/Chart) II-144
Table 36: World Historic Review for Molecular Diagnostics in
Blood Screening by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Revenue
Figures in US$ Thousand for Years 2006 through 2012 (includes
corresponding Graph/Chart) II-145
Table 37: World 15-Year Perspective for Molecular Diagnostics
in Blood Screening by Geographic Region - Percentage Breakdown
of Revenues for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-146
Table 38: World Recent Past, Current & Future Analysis for
Molecular Diagnostics in Cancer Screening by Geographic Region -
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets Independently Analyzed
with Annual Revenue Figures in US$ Thousand for Years 2013
through 2020 (includes corresponding Graph/Chart) II-147
Table 39: World Historic Review for Molecular Diagnostics in
Cancer Screening by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Revenue
Figures in US$ Thousand for Years 2006 through 2012 (includes
corresponding Graph/Chart) II-148
Table 40: World 15-Year Perspective for Molecular Diagnostics
in Cancer Screening by Geographic Region - Percentage
Breakdown of Revenues for US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Latin America and Rest of
World Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) II-149
Table 41: World Recent Past, Current & Future Analysis for
Molecular Diagnostics in Other Applications by Geographic
Region - US, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), Latin America and Rest of World Markets Independently
Analyzed with Annual Revenue Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) II-150
Table 42: World Historic Review for Molecular Diagnostics in
Other Applications by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Revenue
Figures in US$ Thousand for Years 2006 through 2012 (includes
corresponding Graph/Chart) II-151
Table 43: World 15-Year Perspective for Molecular Diagnostics
in Other Applications by Geographic Region - Percentage
Breakdown of Revenues for US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Latin America and Rest of
World Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) II-152
III. MARKET
1. THE UNITED STATES III-1
A.Market Analysis III-1
Molecular Diagnostics Maintain its Positive Momentum III-1
A Glance at Major Growth Drivers III-2
Key Challenges Facing the MDx Market III-3
qPCR and dPCR Instrumentation in the US: An Overview III-3
Ageing Demographics: Major Driving Factor III-3
Table 44: North American Elderly Population by Age Group:
1975-2050 (includes corresponding Graph/Chart) III-4
Table 45: US Population Breakdown by Age Group: 2012
(includes corresponding Graph/Chart) III-5
Increasing Burden of Chronic Diseases Drives Focus onto
Molecular Diagnostics III-5
US Individualized Medicine Market to Witness Significant Growth III-5
Companion Diagnostic Market in the US III-6
List of Select FDA-Cleared Companion Diagnostics III-7
Number of Companion Diagnostics under Development Keeps
Soaring III-7
Burgeoning Potential for Genetic Testing III-8
Direct-to-Consumer Testing - A Growing Market III-9
Epidemic Proportion of Cancer in the US - Key Driver for
Cancer Genetic Testing III-9
Table 46: New Cancer Cases by Gender and Affected Site in
the US (2013) III-10
Favorable Insurance Coverage for Cystic Fibrosis Genetic
Testing III-11
List of FDA-Cleared CF MDx Tests III-11
Table 47: CF Carrier Screening in the US (2012): Percentage
Breakdown of Population by Coverage Policy (includes
corresponding Graph/Chart) III-11
Table 48: CF Diagnostic Testing in the US (2012):
Percentage Breakdown of Population by Coverage Policy
(includes corresponding Graph/Chart) III-12
Molecular Diagnostics Tests Gaining Share in STD Testing Domain III-12
HPV Testing Market - A Review III-12
Table 49: Cervical Cancer by HPV Type in the US (2012):
Percentage Share Breakdown of Cervical Cancer Cases by HPV
Type (includes corresponding Graph/Chart) III-13
Competitive Landscape III-14
Table 50: Leading Players in the US HPV Testing Market
(2010 & 2011): Percentage Share Breakdown of Number of
Tests for QIAGEN, Hologic, and Roche (includes
corresponding Graph/Chart) III-14
List of FDA Approved HPV MDx Tests III-14
Regulatory Environment III-15
FDA Regulations III-15
Clinical Laboratory Improvement Amendments (CLIA) III-15
Table 51: CLIA-Certified Laboratories in the US (2013):
Percentage Share Breakdown of Number of Laboratories by
Certificate Type (includes corresponding Graph/Chart) III-17
Table 52: CLIA-Certified Laboratories in the US (2013):
Percentage Share Breakdown of Number of Labs by Lab Type
(includes corresponding Graph/Chart) III-17
Genetic Testing III-18
FDA to Implement Strict Measures for Cervical Cancer
Screening Tests III-18
Limited Reimbursements - A Major Hindrance III-19
New MoPath Codes for Reimbursement for Molecular
Diagnostics Tests III-19
Product Launches/Approvals III-20
Strategic Corporate Developments III-28
Key Players III-35
B.Market Analytics III-43
Table 53: US Recent Past, Current & Future Analysis for
Molecular Diagnostics by Application - Infectious Disease
Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-43
Table 54: US Historic Review for Molecular Diagnostics by
Application - Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-44
Table 55: US 15-Year Perspective for Molecular Diagnostics
by Application - Percentage Breakdown of Revenues for
Infectious Disease Testing, Blood Screening, Cancer
Screening and Other Applications Markets for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-45
2. CANADA III-46
A.Market Analysis III-46
Current and Future Analysis III-46
A Statistical Review of Cancer Incidence in Canada III-47
Table 56: New Cancer Cases in Canada by Gender and Affected
Site: 2012 (includes corresponding Graph/Chart) III-47
Table 57: New Cancer Cases in Canada by Province: 2012
(includes corresponding Graph/Chart) III-48
Product Approval III-49
B.Market Analytics III-49
Table 58: Canadian Recent Past, Current & Future Analysis
for Molecular Diagnostics by Application - Infectious
Disease Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-49
Table 59: Canadian Historic Review for Molecular Diagnostics
by Application - Infectious Disease Testing, Blood
Screening, Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-50
Table 60: Canadian 15-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of
Revenues for Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-51
3. JAPAN III-52
A.Market Analysis III-52
Current and Future Analysis III-52
Demographics Drive Market Growth III-52
Table 61: Percentage Breakdown of Japanese Population by
Age Group (2012) (includes corresponding Graph/Chart) III-52
Table 62: Japanese 65+ Years Population: 1950-2010
(includes corresponding Graph/Chart) III-53
B.Market Analytics III-54
Table 63: Japanese Recent Past, Current & Future Analysis
for Molecular Diagnostics by Application - Infectious
Disease Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-54
Table 64: Japanese Historic Review for Molecular Diagnostics
by Application - Infectious Disease Testing, Blood
Screening, Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-55
Table 65: Japanese 15-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of
Revenues for Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-56
4. EUROPE III-57
A.Market Analysis III-57
Current and Future Analysis III-57
Debt Crisis in Europe Affects Healthcare Industry III-57
European Healthcare System: In a State of Transition? III-57
Insight into Molecular Diagnostics Markets in Europe III-58
Table 66: Molecular Diagnostics Tests: Percentage Share
Breakdown by Function (includes corresponding Graph/Chart) III-59
Increasing Testing Needs of the Elderly: Business Case for
Molecular Diagnostics III-59
Table 67: Population Breakup by Age Group for Select
European Countries: 2012 (As a % of Total Population)
(includes corresponding Graph/Chart) III-60
PCR Reagents in Europe: An Overview III-61
Automated Systems Gain Preeminence III-61
Oncology-based Molecular Diagnostics Holds Immense Potential III-61
European Personalized Medicine Market to Exhibit Robust Growth III-62
HPV Testing in Europe: An Overview III-63
List of Select CE-Marked HPV Molecular Diagnostic Tests III-63
Table 68: Cervical Cancer Incidence and Mortality in
European Countries (2012) III-64
Table 69: Prevalence of Cervical Cancer in European
Countries (2012) III-65
Table 70: European HPV Testing Market (2011): Breakdown by
% of Women Tested; HPV Prevalence Rate and Cervical Cancer
Mortality Rates (includes corresponding Graph/Chart) III-66
Regulatory Scenario in Europe for Companion Diagnostics III-66
Select European Players with Strong Biomarker Pipeline in
Companion Diagnostics III-66
Product Approvals/Launches III-67
B.Market Analytics III-68
Table 71: European Recent Past, Current & Future Analysis
for Molecular Diagnostics by Geographic Region - France,
Germany, Italy, UK, Spain, Russia and Rest of Europe Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-68
Table 72: European Historic Review for Molecular Diagnostics
by Geographic Region - France, Germany, Italy, UK, Spain,
Russia and Rest of Europe Markets Independently Analyzed
with Annual Revenue Figures in US$ Thousand for Years 2006
through 2012 (includes corresponding Graph/Chart) III-69
Table 73: European 15-Year Perspective for Molecular
Diagnostics by Geographic Region - Percentage Breakdown of
Revenues for France, Germany, Italy, UK, Spain, Russia and
Rest of Europe Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-70
Table 74: European Recent Past, Current & Future Analysis
for Molecular Diagnostics by Application - Infectious
Disease Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-71
Table 75: European Historic Review for Molecular Diagnostics
by Application - Infectious Disease Testing, Blood
Screening, Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-72
Table 76: European 15-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of
Revenues for Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-73
4a. FRANCE III-74
A.Market Analysis III-74
Current and Future Analysis III-74
Product Launch III-74
Strategic Corporate Development III-74
Key Players III-74
B.Market Analytics III-76
Table 77: French Recent Past, Current & Future Analysis for
Molecular Diagnostics by Application - Infectious Disease
Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-76
Table 78: French Historic Review for Molecular Diagnostics
by Application - Infectious Disease Testing, Blood
Screening, Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-77
Table 79: French 15-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of
Revenues for Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-78
4b. GERMANY III-79
A.Market Analysis III-79
Current and Future Analysis III-79
Overview III-79
Strategic Corporate Developments III-79
Siemens AG - A Key Player III-80
B.Market Analytics III-81
Table 80: German Recent Past, Current & Future Analysis for
Molecular Diagnostics by Application - Infectious Disease
Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-81
Table 81: German Historic Review for Molecular Diagnostics
by Application - Infectious Disease Testing, Blood
Screening, Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-82
Table 82: German 15-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of
Revenues for Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-83
4c. ITALY III-84
A.Market Analysis III-84
Current and Future Analysis III-84
Product Launches III-84
Strategic Corporate Developments III-85
B.Market Analytics III-85
Table 83: Italian Recent Past, Current & Future Analysis for
Molecular Diagnostics by Application - Infectious Disease
Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-85
Table 84: Italian Historic Review for Molecular Diagnostics
by Application - Infectious Disease Testing, Blood
Screening, Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-86
Table 85: Italian 15-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of
Revenues for Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-87
4d. THE UNITED KINGDOM III-88
A.Market Analysis III-88
Current and Future Analysis III-88
SMIP for Pharmacogenomic Testing III-88
Product Launches III-88
Strategic Corporate Developments III-89
B.Market Analytics III-90
Table 86: The UK Recent Past, Current & Future Analysis for
Molecular Diagnostics by Application - Infectious Disease
Testing, Blood Screening, Cancer Screening and Other
Applications Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2013 through 2020
(includes corresponding Graph/Chart) III-90
Table 87: The UK Historic Review for Molecular Diagnostics
by Application - Infectious Disease Testing, Blood
Screening, Cancer Screening and Other Applications Markets
Independently Analyzed with Annual Revenue Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-91
Table 88: The UK 15-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of
Revenues for Infectious Disease Testing, Blood Screening,
Cancer Screening and Other Applications Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-92
4e. SPAIN
Download the full report: https://www.reportbuyer.com/product/90566/
About Reporbuyer
Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers
http://www.reportbuyer.com
For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: [email protected]
Tel: +44 208 816 85 48
Website: www.reportbuyer.com
SOURCE ReportBuyer
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
Newsrooms &
Influencers
Digital Media
Outlets
Journalists
Opted In
Share this article