Published Jan 22, 2016 |
2100 Pages |
Pub ID: KLI5757702
This Kalorama Information In Vitro Diagnostics (IVD) Market Bundle represents three reports, as published in 2015. These reports, representing over 2,000 pages of market information,
delve into some of the fastest-growing and most critical areas of
clinical diagnostics: cancer diagnostics, molecular assays and systems,
and infectious disease tests. Together, these three in vitro diagnostic
areas represent nearly one-half of the IVD market and the best growth
opportunities. The Bundle features the exact published content in each of the three major Kalorama studies, sold as intact PDFs with separate table of contents, including the following:
The World Market for Molecular Diagnostics, 6th Edition
In the World Market for Molecular Diagnostics, 6th Edition, Kalorama IVD market analyst Shara Rosen, R.T., MBA provides complete analysis of the IVD molecular testing kit and reagent industry by segment. In this report, exclusive market sizing and forecasts are provided for the following diagnostic segments:
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.
The World Market for Cancer Diagnostics, 6th Edition
Kalorama has, in five previous editions of The World Market for Cancer Diagnostics, defined the oncology testing market. This 850-page report contains detailed market data on the following IVD segments for their use in cancer diagnostics:
Cancer IVD Market
Cancer Test Services Market
Sequencing in Cancer Testing
Tissue Function Tests
PSA, CEA and Other Immunoassays
Pap and HPV Testing
FOB and Other Rapid Tests
Molecular Oncology Assays
In situ hybridization (ISH)
Circulating Tumor Cells
Companion Testing and CDX Products
The report also details investments and financing agreements for cancer diagnostics companies, selected agreements between cancer diagnostic companies, selected agreements between cancer diagnostic companies and other diagnostic companies, pharmaceutical companies and non-profit organizations, and selected acquisitions of cancer diagnostic companies. The report provides detailed company profiles in several sections.
The World Market for Infectious Disease Diagnostics
This Kalorama Information report, The World Market for Infectious Disease Tests, contains detailed market estimates and forecasts for four major areas of infectious disease testing. Specific market details provided include:
ID/AST Test Market by Type (Auto ID/AST Systems, Manual ID/AST Systems, Blood Culture, Chromogenic Media, Rapid Micro)
ID/AST Leader Market Shares
Infectious Disease Immunoassays by Type (Lab-Based, POC, Home Testing)
Infectious Disease Diagnostic Sales by Region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020)
Blood Screening Test Market Size and Company Market Share
Trends in infectious diseases and in products are discussed. The information contained in this report has been assembled from primary and secondary data. Primary research was conducted via telephone conversations with selected diagnostic marketers of in vitro diagnostics to assess the current market and trends in laboratory medicine
IVD Market Bundle
I. The World Market for Cancer Diagnostics, 6th Edition (Histology [ISH, IHC, HPV, Pap], Flow Cytometry, PSA, CEA, Liquid Biopsy, FOB and Other Rapid, Image Cytometry, Sequencing, Digital Pathology, Molecular Assays)
ONE: EXECUTIVE SUMMARY
Scope and Methodology
Prognosis for Growth
Diagnosis and Treatment of Cancer
Point of View
THREE: TECHNOLOGIES USED IN CANCER DIAGNOSTICS
Chromosome Analysis (Karyotyping)
Tests for Fecal Occult Blood
Overview - Immunoassays
Immunoassay Instrument Platforms
Fluorescence in situ Hybridization (FISH) and Chromogenic in situ Hybridization(CISH)
Nucleic Acid Amplification Technologies
Analysis of Gene Expression Patterns (Gene Signatures)
Early Next Generation Sequencing Technologies
Sequencing by Synthesis (SBS)
Supported Oligonucleotide Ligation and Detection (SOLiD)
Ion Torrent Sequencing
True Single Molecule Sequencing (tSMS)
Single Molecule Real Time (SMRT) Sequencing
DNA Nanoball Sequencing
Other Sequencing Technologies
Mass Spectrometry Technology
Research and Clinical Applications of Mass Spectrometry
Circulating Tumor DNA (Cell Free DNA)
Circulating Tumor Cells (CTCs)
Cell-Based Assays (Live Cell Cancer Tests)
Digital Pathology and Image Cytometry
FOUR: CANCER DIAGNOSTICS – APPLICATIONS
Assess Risk of Developing Cancer
Cancer Screening – Pap Smear and Human Papillomavirus (HPV) Testing
Table 3-2: Selected Companies with Immunoassays and/or Automated Immunoassay Platforms on the Market or In Development for Cancer Diagnostics
Table 3-3: Selected Examples of Companies Marketing Rapid Lateral Flow Tests for Tumor Antigens
Table 3-4: Selected Companies with Immunohistochemistry Tests on the Market or In Development for Cancer Diagnostics
Table 3-5: Selected Companies Marketing Flow Cytometry Platforms or Consumables
Table 3-6: Selected Companies with in situ hybridization tests on the Market or In Development for Cancer Diagnostics (Company, Comment, Market Status)
Table 3-7: Selected Companies with PCR or Other Nucleic Acid Amplification Based Tests for Cancer Diagnostics
Table 3-8: Selected Examples of Companies Analyzing Gene Expression Patterns (“Gene Signatures”) in Tissues
Table 3-9: Selected Companies Developing/Marketing Cancer Diagnostic Products Based on Microarray Technologies
Table 3-10: Selected Sequencing Technologies and Platforms
Table 3-11: Selected Diagnostic Companies and Clinical Laboratories with Sequencing-Based Cancer Tests
Table 3-12: Selected Companies Developing/Marketing Mass Spectrometry- Based Oncology Diagnostic Tests
Table 3-13: Selected Examples of Companies Developing/Commercializing Cancer Diagnostic Assays Based on ctDNA
Table 3-14: Selected Companies Working with Circulating Tumor Cells (CTCs)
Table 3-15: Selected Companies Developing or Commercializing Cell-Based Assays for Cancer Diagnostics
Table 3-16: Selected Digital Pathology Companies
FOUR: CANCER DIAGNOSTICS – APPLICATIONS
Table 4-1: Selected Companies Developing/Marketing Assays to Determine Risk of Cancer
Table 4-2: Selected Companies Developing/Marketing Diagnostic Tests for HPV
Table 4-3: Selected Companies Developing/Marketing Cancer IVD Tests for Colorectal Cancer Screening
Table 4-4: Selected Companies Developing/Marketing Screening Tests for Prostate Specific Antigen
Table 4-5: Selected Companies Developing/Marketing Other Tests for Prostate Cancer
Table 4-6: Selected Companies Developing/Marketing Screening Tests for Other Cancers
Table 4-7: Selected Widely Used Tumor Markers
Table 4-8: Selected Companies Developing/Marketing Tests for Diagnosis/Prognosis/Monitoring of Cancer
Table 4-9: Selected Companies Developing/Marketing Tests for Drug Metabolism – To Personalize Treatment of Cancer
Table 4-10: Selected Companies Developing/Marketing Tests to Predict Response to Therapy; Precision Medicine
Table 4-11: Selected FDA Cleared/Approved Companion Diagnostic Tests
FIVE: CANCER DIAGNOSTIC MARKETS
Table 5-1: Selected Examples - Companies Developing and Marketing Cancer Diagnostics Tests and Platforms to Clinical Laboratories
Table 5-2: Selected Examples - Companies Developing and/or Marketing Pointof-Care and/or Rapid Platforms and Tests for Cancer – Moving Beyond Lateral Flow
Table 5-3: Selected Examples - Companies Developing and/or Offering Cancer Diagnostic Tests as Laboratory Developed Tests
SIX: DEALS – CANCER DIAGNOSTICS
Table 6-1: Selected Investments and Other Financing Agreements for CancerDiagnostic Companies
Table 6-2: Selected Agreements Between Cancer Diagnostic Companies and Other Diagnostic Companies or Clinical Laboratories
Table 6-3: Selected Agreements Between Cancer Diagnostic Companies and Pharmaceutical or Biopharmaceutical Companies
Table 6-4: Selected Agreements Between Two Cancer Diagnostic Companies
Table 6-5: Selected Other Cancer Diagnostic Company Agreements
Table 6-6: Selected Acquisitions of Cancer Diagnostic Companies
Table 6-7: Selected Cancer Diagnostic Company Agreements with Academic or Other Non-Profit Organizations
EIGHT: IN VITRO CANCER DIAGNOSTICS MARKET ANALYSIS
Table 8-1: World Cancer Test Market (In Vitro Diagnostic Kits) by Region (North America, EU, Japan, ROW), 2014 and 2019 ($ millions)
Table 8-2: World Cancer Test Market (Clinical Laboratory Test Services), 2014 and 2019 ($ millions)
Table 8-3: Worldwide Market for Selected Cancer IVD Tests (Sold to ClinicalLabs) (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, CTCs), 2014 and 2019 ($ millions)
Figure 8-1: Geographical Distribution of Pap Smear Testing, 2013
Table 8-4: Worldwide Histology/Cytology Sales (Pap Smears, Other [non-Pap] Stains, HPV, Immunohistochemistry, and In Situ Hybridization), 2014 and 2019($ millions)
Table 8-5: Cancer Immunoassay Sales, Lab-Based (PSA, CEA, CA 125, AFP,Others), 2014 and 2019 ($ millions)
Table 8-6: Rapid Cancer Test Sales by Test Category (FOB, PSA, NMP22, Other)Worldwide, 2014 and 2019 ($ millions)
II. The World Market for Molecular Diagnostics, 6th Edition (Microbiology, Oncology, Blood Screening and Typing, Prenatal, Inherited Diseases, Coagulation, Organ Transplant, PCR, Sequencing, cfDNA, CTC, in situ hybridization, Others)
ONE: EXECUTIVE SUMMARY
Scope and Methodology
Size and Growth of the Market
The Buzz Is On
DTC in 2015 – Building Evidence
Sequencing Enters the Clinic
Information Technology Brings Clarity
Forensic Studies – An Emerging Opportunity
Molecular Test Expansion Supported by Quality Measures
Tests and Technologies in 2014
Molecular Diagnostics and Target Markets
THREE: DELIVERING MOLECULAR TESTS TO THE CLINIC
The Reimbursement Environment
The U.S. Experience
Personalized Precision Medicine Advances and Barriers
The Service Industry Is Here to Stay
FOUR: SEQUENCING – HOW FAR CAN WE GO?
Companies and Technologies
Sequencing Research Projects
Cancer More Personalized
FIVE: MARKET ANALYSIS: WORLD MARKETS
Worldwide Opportunities for Molecular Tests
The United States of America
SIX: THE MARKET FOR BLOOD MARKERS IN CANCER
Precision Medicine and a New Molecular Perception
Back to the Status Quo
SEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY: CELL-BASED MOLECULAR TESTS
EIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATION
NINE: HISTOLOGY AND CYTOLOGY
Advanced Analysis Tools
In Situ Hybridization
Circulating Tumor Cells
TEN: MICROBIOLOGY AND VIROLOGY
POC and Decentralized Testing
Antimicrobial Drug Resistance
Next Generation Sequencing in Microbiology
The Human Microbiome
Emerging Disease Threats
Blood Culture & Hospital Acquired Infections
Sexually Transmitted Diseases (STDs)
Respiratory Tract Infections
ELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINE
Blood Pathogen Screening
TWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENT
THIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEWBORN SCREENING
Introduction and Market Data
cfNIPT – Perception, Perception, Perception
Parental Carrier Screening
In Vitro Fertilization
cfDNA Market Expansion
FOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASES
FIFTEEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS
LDTs to Market Cleared Tests
Esoteric Testing Scenario in Europe
SIXTEEN: MAJOR VENDORS AND COMPANIES TO WATCH
Market Drivers and Leaders
Review of Top Companies
Acquisitions, Alliances and Collaborations
Looking Beyond Borders
SEVENTEEN: COMPANY PROFILES: THE TOP TIER
Beckman Coulter, Inc. / Danaher
Becton, Dickinson and Company (BD)
The BD MAX Enterprise
Bio-Rad Laboratories, Inc.
General Electric - GE Healthcare
Clarient Diagnostic Services, Inc.
The Gen-Probe Business
Infectious Disease Testing
Transplant Medicine and HAIs
Rotor-Gene Q – Clinical Diagnostics
Global Access Program for HIV
Core Molecular Tests
A POC Enterprise – Liat
Prenatal and cfDNA
Sequencing – Putting the Pieces Together
Siemens Healthcare Diagnostics
Thermo Fisher Scientific Inc.
EIGHTEEN: COMPANY PROFILES: MAJOR MOLECULAR COMPANIES
Agilent in Genomics
With Complete Genomics
Hospital Acquired Infections (HAI)
Eiken Chemical Co., Ltd
Enzo Biochem Inc.
CLIA Lab Service
Sample to Insight
Making a Market
Life Technologies Corporation
Instrumentation and Applications
Life Technologies an IVD Company
Life and Quidel Develop Diagnostics on the 7500 Fast Dx
PerkinElmer, Inc. (PE)
RainDance Technologies, Inc.
NINETEEN: COMPANY PROFILES: PARTICIPANTS
EKF Diagnostics Holdings Plc
Exosome Diagnostics, Inc.
Fujirebio Diagnostics, Inc.
Genome Diagnostics BV (GenDx)
Next Generation NxTag
Nanostring Technologies, Inc.
Pacific Biosciences of California, Inc. (PacBio)
Lyra Product Line
Solana Molecular System
AmpliVue Product Line
Savanna (formerly Wildcat)
Rubicon Genomics, Inc.
Diagnostic Tools Division
WaferGen Bio-systems, Inc.
TWENTY: COMPANY PROFILES: GREAT EXPECTATIONS
Linkage Biosciences, Inc.
TWENTY-ONE: COMPANY PROFILES: NEWCOMERS
B Braun CeGaT, LLC
Canon BioMedical, Inc.
DestiNA Genomics Ltd
Randox Laboratories Ltd.
TWENTY-TWO: COMPANY PROFILES: TEST SERVICE PROVIDERS
What a Difference a Few Years Makes
The Move to Building a Research Company
Outside the U.S.
Adaptive Biotechnologies Corporation
AltheaDx Diagnostics, Inc.
Bio-Reference Laboratories, Inc. (BRLI)
Cancer Genetics, Inc. (CGI)
The Response Genetics Acquisition
Caris Life Sciences
Exact Sciences Corp.
Foundation Medicine Inc.
Genomic Health, Inc.
Service Spin Off
LabCorp, Laboratory Corporation of America
Mayo Medical Laboratories
The U.S. Market
Pathway Genomics Corporation
Prenatal and Women’s Health
Quest Partners for Market Accessibility
Rosetta Genomics Ltd.
TWENTY-THREE: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS
Atlas Genetics Ltd.
DNA Electronics Ltd (DNAe)
Enigma Diagnostics Limited
Epistem Holdings plc
QuantuMDx Group Limited
Veredus Laboratories Pte Ltd
TWENTY-FOUR: COMPANY PROFILES: SAMPLE PREPARATION
Horizon Discovery Group plc
MO BIO Laboratories, Inc.
SeraCare Life Sciences, Inc.
TWENTY-FIVE: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTS
TWENTY-SIX: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS
Advanced Cell Diagnostics (ACD)
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging Inc. (ASI)
Cymogen Dx, LLC
DxTerity Diagnostics Inc.
HTG Molecular Diagnostics
PreTect AS (formerly Norchip)
Kapa Biosystems Inc.
Ventana Medical Systems Inc.
Virtuoso Software Update
TWENTY-SEVEN: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS
Accelerate Diagnostics, Inc.
Advanced Biological Laboratories, S.A. (ABL)
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)
Abbott Diagnostics Partnership
Meridian Bioscience, Inc.
Meridian Life Science
Molbio Diagnostics Pvt Ltd.
Reference Genomics Inc.
TWENTY-EIGHT: COMPANY PROFILES: BLOOD BANK SPECIALISTS
Blood Transfusion Novartis Business
TWENTY-NINE: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS
Ariosa Diagnostics, Inc.
Berry Genomics Co. Ltd
Good Start Genetics, Inc.
Premaitha Health plc
THIRTY: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS
Cynvenio Biosystems, Inc.
Fluxion Biosciences, Inc.
Genyo – Centre for Genomics
Qiagen Hanover (formerly AdnaGen GmbH)
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Table 1-1: Common Next Generation Molecular Test Traits
Table 1-2: Selected Salient Developments for Now and the Future
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