Table of Contents
CHAPTER 1: EXECUTIVE SUMMARY
NUCLEIC ACID AMPLIFICATION TESTING OVERVIEW
SCOPE AND METHODOLOGY
MARKET OVERVIEW
Table 1-1: PCR and Other NAAT Market, Worldwide, 2016 and 2021 [All NAATs – Life Science and Clinical Markets] (in millions USD)
FUTURE PROSPECTS IN THE PCR MARKET
CHAPTER 2: INTRODUCTION
DEVELOPMENT AND EVOLUTION OF POLYMERASE CHAIN REACTION AND OTHER NUCLEIC ACID AMPLIFICATION TESTS
Development and Evolution of PCR
Other Nucleic Acid Amplification Test Methods
Advances in Nucleic Acid Amplification Technology and Emerging Applications
POINT-OF-VIEW
CHAPTER 3: TECHNOLOGY TRENDS AND INNOVATION
POLYMERASE CHAIN REACTION (PCR) – OVERVIEW
PCR, RT-PCR, and qPCR
Digital PCR
Table 3-1: Selected Companies with Digital PCR Technology (For Research and/or Diagnostic Tests)
Multiplex PCR
Table 3-2: Selected Companies with Multiplex PCR Technology [Note: This is not a comprehensive list of all companies with multiplex
PCR technology/tests.]
Other Modifications of PCR
Table 3-3: Selected Companies with Innovative PCR-Based Methods
OTHER NUCLEIC ACID AMPLIFICATION TEST (NAAT) METHODS
Isothermal NAAT Methods in Clinical Laboratories
Rapid Isothermal NAAT Methods in Decentralized Settings – Near Patient and Point-of-Care
Table 3-4: Companies with Other Nucleic Acid Amplification Test Methods
PLATFORMS USED IN DIFFERENT NAAT MARKETS – RESEARCH, CLINICAL LABORATORIES, AND POINT-OF-CARE TESTING
Table 3-5: Selected Companies Marketing PCR Instruments/Reagents to the Life Sciences Market
Table 3-6: Selected Companies Marketing NAAT Platforms/Tests to Clinical Laboratories
Table 3-7: Selected Companies with NAAT Platforms and Tests for Decentralized Testing or Point-of-Care Settings
NEW APPLICATIONS OF PCR – COMBINING PCR WITH OTHER TECHNOLOGIES
PCR as Part of Sample Prep before DNA Sequencing
Table 3-8: Examples of Companies Using PCR during Sample Prep before DNA Sequencing
PCR before Mass Spectrometry
Table 3-9: Selected Companies Developing Platforms That Use PCR before Analysis by Mass Spectrometry
Other Technologies Being Used with PCR
Table 3-10: Selected Companies Using PCR with Other Technologies (Beyond Sequencing and Mass Spectrometry)
CHAPTER 4: NUCLEIC ACID AMPLIFICATION TESTS IN RESEARCH AND THE CLINICAL LABORATORY
RESEARCH APPLICATIONS OF POLYMERASE CHAIN REACTION
INFECTIOUS DISEASE DIAGNOSTICS
Infectious Disease Diagnostic Tests
Table 4-1: Selected Common Microorganisms Detected by Clinical NAAT Tests
Table 4-2: Selected Companies Marketing PCR/NAAT Infectious Disease Tests (Single or Limited Number of Analytes)
Table 4-3: Selected Companies Marketing PCR/NAAT Syndromic Tests/Panels for Infectious Diseases
Antibiotic Resistance/Susceptibility Testing
Table 4-4: Selected Companies Marketing PCR/NAAT-Based Antibiotic Resistance/Susceptibility Tests
Rapid Near-Patient or Point-of-Care Testing for Infectious Diseases
Table 4-5: Selected Companies Marketing Rapid Near-Patient/Point-of-Care PCR/NAAT Infectious Disease Tests
Table 4-6: CLIA Waived NAAT Infectious Disease Tests
ONCOLOGY
Cancer Risk
Cancer Screening
Table 4-7: Selected Companies Developing/Marketing Diagnostic Tests for HPV
Table 4-8: Selected Companies Developing/Marketing PCR/NAAT Tests for Cancer Screening (Not including HPV Tests for Cervical
Cancer)
Cancer Diagnostics (Diagnosis, Prognosis, Monitoring, Response to Therapy)
Table 4-9: Selected Companies Developing/Marketing PCR/NAAT Tests for Diagnosis/Prognosis/Predicting Response to Cancer Therapy
Table 4-10: Selected PCR/NAAT Based, FDA Cleared/Approved Companion Diagnostic Tests
CARDIOVASCULAR DISEASE
Table 4-11: Selected Companies Developing/Marketing PCR Tests for Risk of Thrombophilia
Table 4-12: Selected Companies Developing/Marketing PCR Warfarin Sensitivity Tests
Table 4-13: Selected Companies Developing/Marketing Other PCR-Based Cardiovascular Tests
GENETIC TESTING
Inherited (Genetic) Disorders
Table 4-14: Selected Companies Developing/Marketing PCR Tests for Risk of Inherited (Genetic) Disorders
Drug Metabolism – Pharmacogenomics Testing
Table 4-15: Pharmacogenomic Biomarkers in Drug Labeling
Table 4-16: Selected Companies Developing/Marketing PCR Tests for Pharmacogenomics (Drug Metabolism)
HLA Typing
Table 4-17: Selected Companies Developing/Marketing PCR Tests for HLA Typing
OTHER CLINICAL APPLICATIONS OF POLYMERASE CHAIN REACTION
Table 4-18: Selected Companies Developing/Marketing PCR Tests for Other Clinical Applications
TRANSFUSION MEDICINE – BLOOD SCREENING
Table 4-19: Selected Companies Developing/Marketing PCR Tests Transfusion Medicine
NON-CLINICAL APPLICATIONS OF POLYMERASE CHAIN REACTION
CHAPTER 5: DEALS – POLYMERASE CHAIN REACTION/NUCLEIC ACID AMPLIFICATION TEST COMPANIES
INVESTMENTS AND FINANCING AGREEMENTS
Table 5-1: Selected Investment and Financing Agreements in NAAT Companies
MERGERS AND ACQUISITIONS
Table 5-2: Selected Acquisitions of NAAT Companies
CORPORATE AGREEMENTS AND COLLABORATIONS (NOT INCLUDING PHARMACEUTICAL COMPANIES)
Table 5-3: Selected Agreements between NAAT Companies and Other Companies [Not Including Pharmaceutical Companies]
COLLABORATIONS/AGREEMENTS WITH PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES
Table 5-4: Selected Agreements between NAAT Companies and Pharmaceutical or Biopharmaceutical Companies
COLLABORATIONS AND OTHER AGREEMENTS WITH UNIVERSITIES, NON-PROFIT RESEARCH INSTITUTES AND GOVERNMENT
Table 5-5: Selected NAAT Company Agreements with Academic or Other Non-Profit Organizations
CHAPTER 6: MARKET DRIVERS AND CHALLENGES – NUCLEIC ACID AMPLIFICATION TEST MARKET
ISSUES AND HURDLES FACED BY PCR COMPANIES SELLING TO THE RESEARCH MARKET
CLINICAL MARKET DRIVERS
POINT-OF-CARE TESTING MARKET DRIVERS AND CHALLENGES/HURDLES
COMPETITION FROM COMPANIES UTILIZING PCR AND OTHER NAAT TECHNOLOGIES
COMPETITION AND MARKET OPPORTUNITIES DRIVEN BY OTHER (NON-NAAT) TECHNOLOGIES
Competition
Opportunities
REGULATION OF IN VITRO DIAGNOSTICS
LABORATORY DEVELOPED TESTS
REIMBURSEMENT
FUTURE PROSPECTS
Table 6-1: Trends in the Polymerase Chain Reaction/Nucleic Acid Amplification Test Market
CHAPTER 7: PCR MARKET ANALYSIS
PCR & NUCLEIC ACID AMPLIFICATION TEST MARKET OVERVIEW
Table 7-1: Nucleic Acid Amplification Test Market, Worldwide, 2016 and 2021 [All NAATs –Life Science and Clinical Markets] (in millions
USD) (Life Science NAAT Market, Clinical NAAT Market, Other NAAT Market, Total NAAT Market)
LIFE SCIENCE NAAT MARKET
Past and Future Growth of Overall Life Science PCR Market
Figure 7-1: Growth of the Life Science PCR Market (1990 – 2016) [# Abstracts Found per Year in PubMed search for “’polymerase chain
reaction’ or pcr”] (Accessed March 27, 2017)
Life Science PCR Market – Instruments versus Consumables
Table 7-2: Life Science PCR Market, Instruments versus Consumables, Worldwide, 2016 and 2021 (in millions USD)
(Reagents/Consumables, Instruments, Software & Services, Total life science PCR market)
Life Science PCR Market – By Geographical Distribution
Figure 7-2: Life Science PCR Market, by Geographical Distribution (%) (U.S., Europe, Japan, ROW)
Life Science PCR Market by Type of PCR
Figure 7-3: Life Science PCR Market, by Type of PCR, Worldwide, 2016 (%) (qPCR, dPCR)
Figure 7-4: Life Science PCR Market, by Type of PCR, Worldwide, 2021 (%) (qPCR, dPCR)
DIAGNOSTIC PCR MARKET – GLOBAL MARKET
Table 7-3: Clinical PCR and Other NAAT Market by Disease Indication, Worldwide, 2016 and 2021 (in millions USD) (Infectious Disease,
Oncology, Genetic Testing, Transplantation Diagnostics, Other; Total Diagnostics Segment; Blood Screening; Total Clinical NAAT Market)
Table 7-4: Clinical PCR and Other NAAT Market by Geographical Region, Worldwide, 2016 and 2021 (in millions USD) (United States,
Europe, Japan, China, Latin America, Rest of World, Total Clinical NAAT Market)
Figure 7-5: Clinical PCR and Other NAAT Market, by Type of NAAT, Worldwide, 2016 (%) (PCR, TMA, Other NAAT)
Figure 7-6: Clinical PCR and Other NAAT Market, by Type of NAAT, Worldwide, 2021 (%) (PCR, TMA, Other NAAT)
DIAGNOSTIC PCR MARKET MARKET – INFECTIOUS DISEASE
Table 7-5: Diagnostic Infectious Disease PCR and Other NAAT Market by Type of Infection, Worldwide, 2016 and 2021 (in millions USD)
(Hepatitis, HIV, Healthcare Acquired Infections and Sepsis, Respiratory Pathogens, Sexually Transmitted Diseases and Women’s Health,
Tuberculosis, Other, Total)
Table 7-6: Diagnostic Infectious Disease PCR and Other NAAT Market, Worldwide by Geographical Region, 2016 and 2021 (in millions
USD) (United States, Europe, Japan, China, Latin America, Rest of World, Total – World)
DIAGNOSTIC PCR MARKET – ONCOLOGY
Emerging Market for NAAT-Based Cancer Screening
Cancer Diagnosis/Prognosis/Personalized Medicine/Monitoring Market
Table 7-7: Diagnostic Oncology PCR and Other NAAT Market (Screening, Diagnosis/Prognosis/Personalized Medicine/Monitoring)
Worldwide, 2016 and 2021 (in millions USD) (Cancer screening market, Cancer diagnostics market, Total cancer NAAT market)
Table 7-8: Diagnostic Oncology PCR and Other NAAT Market by Geographical Distribution, Worldwide, 2016 and 2021 (in millions USD)
(United States, Europe, Japan, China, Latin America, Rest of World, World)
DIAGNOSTIC PCR MARKET – GENETIC TESTING
Table 7-9: Diagnostic PCR and Other NAAT Genetic Testing Market by Market Segment (Thrombophilia, Inherited Diseases,
Pharmacogenomics) Worldwide, 2016 and 2021(in millions USD) (Inherited Diseases, Thrombophilia, Pharmacogenomics, Total genetic
testing market)
Table 7-10: Diagnostic Inherited Disease PCR and Other NAAT Market by Geographical Distribution, Worldwide, 2016 and 2021 (in millions USD) (United States, Europe, Rest of World, World)
DIAGNOSTIC PCR MARKET – TRANSPLANTATION DIAGNOSTICS
Table 7-11: Diagnostic Transplantation Diagnostics PCR and Other NAAT Market by Geographical Distribution, Worldwide, 2016 and
2021 (in millions USD) (United States, Europe, Japan, Rest of World, World)
DIAGNOSTIC PCR MARKET
Table 7-12: PCR and Other NAAT Blood Screening Market, by Geographical Distribution, Worldwide, 2016 and 2021 (in millions USD)
(United States, Europe, Japan, China, Latin America, Rest of World, Total)
CHAPTER 8: COMPANY PROFILES
ABBOTT LABORATORIES
Recent Revenue History
Table 8-1: Abbott Revenues (2013 to 2016)
Company Overview – With a Focus on Polymerase Chain Reaction
AGENA BIOSCIENCE, INC.
AGILENT TECHNOLOGIES INC.
Recent Revenue History
Table 8-2: Agilent Technologies Revenues (2014, 2015, 2016)
Company Overview
ALERE INC.
Recent Revenue History
Table 8-3: Alere Inc. Revenues (2014, 2015, and first three quarters of 2016)
Company Overview
AMOY DIAGNOSTICS CO., LTD.
ASURAGEN, INC.
ATLAS GENETICS LTD
AUTOGENOMICS, INC.
BECKMAN COULTER, INC. (A DANAHER CORPORATION COMPANY)
Revenue History
Company Overview
BECTON, DICKINSON AND COMPANY (BD)
Recent Revenue History
Table 8-4: Becton Dickinson Revenues (2014 to 2016)
Company Overview
BIOCARTIS GROUP NV
Recent Revenue History
Table 8-5: Biocartis Revenues (2014 to 2016)
Company Overview
BIOFIRE DIAGNOSTICS, LLC. (ACQUIRED BY BIOMÉRIEUX)
Recent Revenue History and Other Financial Information
Company Overview
BIOMÉRIEUX SA
Recent Revenue History
Table 8-6: bioMérieux Revenues (2013 to 2016)
Company Overview
BIO-RAD LABORATORIES, INC
Recent Revenue History
Table 8-7: Bio-Rad Laboratories Net Sales (2014 to 2016)
Company Overview
BRUKER CORPORATION
Recent Revenue History
Table 8-8: Bruker Corporation Revenues (2013 – 2016)
Company Overview
CANON BIOMEDICAL
CEPHEID (A DANAHER COMPANY)
Recent Revenue History
Table 8-9: Cepheid Revenues (2013 – 2015)
Company Overview
CURETIS
Recent Revenue History
Table 8-10: Curetis Revenues (2014, 2015, and first three quarters of 2016)
Company Overview
DIASORIN S.P.A.
Recent Revenue History
Table 8-11: DiaSorin Revenues (2015 and 2016)
Company Overview
EIKEN CHEMICAL CO., LTD.
Recent Revenue History
Table 8-12: Eiken Chemical Co., Ltd. Revenues (FY2014 – FT 2016)
Company Overview
ELITECHGROUP
GENEPOC INC.
GENMARK DIAGNOSTICS, INC.
Recent Revenue History
Table 8-13: GenMark Diagnostics Revenue (2013-2016)
Company Overview
GENOMIC HEALTH, INC.
Recent Revenue History
Table 8-14: Genomic Health Revenues (2014 to 2016)
Company Overview
GRIFOLS
Recent Revenue History
Table 8-15: Grifols Revenues (2015 and 2016)
Company Overview
HOLOGIC, INC.
Recent Revenue History
Table 8-16: Hologic Revenues (FY2014 – FY 2016)
Company Overview
INVIVOSCRIBE TECHNOLOGIES, INC.
JANSSEN DIAGNOSTICS (DIVISION OF JANSSEN PHARMACEUTICA NV)
LUMINEX CORPORATION
Recent Revenue History
Table 8-17: Luminex Corporation Revenues (2014 – 2016)
Company Overview
MAST GROUP
MERIDIAN BIOSCIENCE, INC.
Recent Revenue History
Table 8-18: Meridian Bioscience, Inc. Revenues (FY2014 – FT 2016)
Company Overview
MULTIPLICOM NV (PART OF AGILENT TECHNOLOGIES)
QIAGEN N.V.
Recent Revenue History
Table 8-19: QIAGEN Revenues (2014, 2015, 2016)
Company Overview
QUANDX INC.
QUANTUMDX GROUP
QUIDEL, INC.
Recent Revenue History
Table 8-20: Quidel Revenues (2014 – 2016)
Company Overview
QVELLA CORPORATION
RAINDANCE TECHNOLOGIES, INC. (ACQUIRED BY BIO-RAD LABORATORIES)
ROCHE
Recent Revenue History
Table 8-21: Roche Revenues (2015 – 2016) (mCHF)
Table 8-22: Roche Revenues (2015 – 2016) (mUSD)
Company Overview
SIEMENS HEALTHINEERS
Recent Revenue History
Table 8-23: Siemens Revenues (2015 – 2016) (in millions of euros)
Company Overview
SPARTAN BIOSCIENCE INC
STAT-DIAGNOSTICA
T2 BIOSYSTEMS, INC.
Recent Revenue History
Table 8-24: T2 Biosystems, Inc. Revenues (2014-2016)
Company Overview
THERMO FISHER SCIENTIFIC, INC.
Recent Revenue History
Table 8-25: Thermo Fisher Scientific Revenues (2014-2016)
Company Overview
