Description
The PCR testing market, which includes other NAAT technologies, is a large and diverse market. This market consists of three segments: the life science (research) NAAT market, the clinical NAAT market, and an “other” segment that includes forensics, environmental monitoring, veterinary, and other applications that do not involve life science research or human clinical (medical) applications. This report provides market size, growth, product information, trends and segmentation for the clinical PCR market. Sizing is provided for 2016 and forecasts to 2021.
Market analyses in this report cover world markets for clinical applications of NAAT technology. However, the reader will find a bias toward the developed areas of the globe — North America, Japan and Western Europe. These are also the areas in which much of the life science and clinical NAAT based testing is currently performed.
For products sold to clinical laboratories or researchers, market data in this report are based on factory sales to the end user, and not on retail pricing or reimbursement payments. The dollar value of a market segment is proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.
The information presented in this report is derived from publicly available information sources such as company reports and announcements, government reports and databases, medical organization reports, medical associations, and other publications. The analysis is based on the author’s industry knowledge combined with literature searches and discussions with industry professionals and experts in the areas where NAAT based assays are used.
It is important to note that the market areas covered by this report are evolving very quickly, and that some of the company and technology information may be outdated even as the report goes to press. Kalorama is fully aware of these developments. Even though some of the details may have changed by the time this report is published, the major themes, players and issues remain unchanged.
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
- Polymerase Chain Reaction (PCR) – Overview
- PCR, Rt-PCR, and QPCR
- 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: TRENDS AND INNOVATION
- 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 Clinical Laboratories and Point-of-Care Testing
- Table 3-5: Selected Companies Marketing NAAT Platforms/Tests To Clinical Laboratories
- Table 3-6: Selected Companies With NAAT Platforms and Tests for Decentralized Testing Or Point-of-Care Settings
CHAPTER 4: CLINICAL PCR TESTS ON THE MARKET
- 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
- Regulation of In Vitro Diagnostics
- Laboratory Developed Tests
- Reimbursement
- Mergers and Acquisitions
- Table 4-20: Selected Acquisitions of NAAT Companies
CHAPTER 5: POLYMERASE CHAIN REACTION (PCR) AND NUCLEIC ACID AMPLIFICATION TEST (NAAT) MARKET ANALYSIS
- Clinical Market Drivers
- Point-of-Care Testing Market Drivers and Challenges/Hurdles
- Nucleic Acid Amplification Test Market Overview
- Table 5-1: PCR and Other Nucleic Acid Amplification Test Market, Worldwide, 2016 and 2021 [All NAATs –Life Science and Clinical Markets] (In Millions USD)
- Clinical PCR Market – Global Market
- Table 5-2: Clinical PCR and Other NAAT Market By Disease Indication, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-3: United States Clinical PCR Market , Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-4: Europe Clinical PCR Market, 2016 and 2021 (In Millions USD)
- Table 5-5: Japan Clinical PCR Market, 2016 and 2021 (In Millions USD)
- Table 5-6: China Clinical PCR Market, 2016 and 2021 (In Millions USD)
- Table 5-7: Latin America Clinical PCR Market, 2016 and 2021 (In Millions USD)
- Table 5-8: Clinical PCR Market, 2016 and 2021 (In Millions USD)
- Figure 5-1: Clinical PCR and Other NAAT Market, By Type of NAAT, Worldwide, 2016 (PCR, TMA, Other NAAT)
- Figure 5-2: Clinical PCR and Other NAAT Market, By Type of NAAT, Worldwide, 2021
- Clinical (Diagnostic) NAAT Market – Infectious Disease
- Table 5-9: Hepatitis PCR Market, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-10: HIV Infectious Disease PCR Market, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-11:Hai Infectious Disease PCR Market, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-12: Respiratory Pathogens PCR Market, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-13: Sexually Transmitted Diseases PCR Market, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-14: Tuberculosis PCR Market, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-15: Other Infectious Disease PCR Market, Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-16: Infectious Disease PCR Market Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-17: Infectious Disease PCR Market, Worldwide By Geographical Region, 2016 and 2021 (In Millions USD)
- Clinical (Diagnostic) NAAT Market – Oncology
- Emerging Market for NAAT-Based Cancer Screening
- Cancer Diagnosis/Prognosis/Personalized Medicine/Monitoring Market
- Table 5-18: Oncology Clinical PCR Market (Screening, Diagnosis/Prognosis/Personalized Medicine/Monitoring) Worldwide, 2016 and 2021 (In Millions USD)
- Table 5-19: Oncology Clinical PCR Market By Geographical Distribution, Worldwide, 2016 and 2021 (In Millions USD)
- Clinical (Diagnostic) NAAT Market – Genetic Testing
- Table 5-20: DiagnosticPCR Genetic Testing Market By Market Segment (Thrombophilia, Inherited Diseases, Pharmacogenomics) Worldwide, 2016 and 2021(In Millions USD)
- Table 5-21: Diagnostic Inherited Disease PCR and Other NAAT Market By Geographical Distribution, Worldwide, 2016 and 2021 (In Millions USD)
- Clinical (Diagnostic) NAAT Market – Transplantation Diagnostics
- Table 5-22: Diagnostic Transplantation Diagnostics PCR and Other NAAT Market By Geographical Distribution, Worldwide, 2016 and 2021 (In Millions USD)
- NAAT Blood Screening Market By Geography
- Table 5-23: PCR and Other NAAT Blood Screening Market, By Geographical Distribution, Worldwide, 2016 and 2021 (In Millions USD)
CHAPTER 6: COMPANY PROFILES
- Abbott Laboratories
- Recent Revenue History
- Table 6-1: Abbott Revenues (2013 To 2016)
- Agilent Technologies Inc.
- Recent Revenue History
- Table 6-2: Agilent Technologies Revenues (2014, 2015, 2016)
- Company Overview
- Alere Inc.
- Recent Revenue History
- Table 6-3: Alere Inc. Revenues (2014, 2015, and First Three Quarters of 2016)
- Company Overview
- Asuragen, Inc.
- Beckman Coulter, Inc. (A Danaher Corporation Company)
- Revenue History
- Company Overview
- Biocartis Group Nv
- Recent Revenue History
- Table 6-4: 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 6-5: Biomérieux Revenues (2013 To 2016)
- Company Overview
- Bio-Rad Laboratories, Inc.
- Recent Revenue History
- Table 6-6: Bio-Rad Laboratories Net Sales (2014 To 2016)
- Company Overview
- Cepheid (A Danaher Company)
- Recent Revenue History
- Table 6-7: Cepheid Revenues (2013 – 2015)
- Company Overview
- Genmark Diagnostics, Inc.
- Recent Revenue History
- Table 6-8: Genmark Diagnostics Revenue (2013-2016)
- Company Overview
- Hologic, Inc.
- Recent Revenue History
- Table 6-9: Hologic Revenues (Fy2014 – Fy 2016)
- Company Overview
- Luminex Corporation
- Recent Revenue History
- Table 6-10: Luminex Corporation Revenues (2014 – 2016)
- Company Overview
- Meridian Bioscience, Inc.
- Recent Revenue History
- Table 6-11: Meridian Bioscience, Inc. Revenues (Fy2014 – Ft 2016)
- Company Overview
- Qiagen N.V.
- Recent Revenue History
- Table 6-12: Qiagen Revenues (2014, 2015, 2016)
- Company Overview
- Quantumdx Group
- Quidel, Inc.
- Recent Revenue History
- Table 6-14: Quidel Revenues (2014 – 2016)
- Company Overview
- Roche
- Recent Revenue History
- Table 6-15: Roche Revenues (2015 – 2016) (Mchf)
- Table 6-16: Roche Revenues (2015 – 2016) (Musd)
- Company Overview
- Spartan Bioscience Inc.
- Stat-Diagnostica
- T2 Biosystems, Inc.
- Recent Revenue History
- Table 6-17: T2 Biosystems, Inc. Revenues (2014-2016)
- Company Overview
