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市場調査レポート

臨床診断PCR市場:タイプ(感染症、癌、心血管疾患、遺伝子疾患、他)、地域、技術別(PCR、TMA、その他のNAAT)

Clinical Diagnostics PCR Markets by Type (Infectious Disease, Cancer, Cardiovascular, Genetic, others) and Region (U.S., Europe, Japan, China, Latin America, World) and Technology (PCR, TMA, other NAAT)

発行 Kalorama Information 商品コード 520746
出版日 ページ情報 英文 260 Pages
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臨床診断PCR市場:タイプ(感染症、癌、心血管疾患、遺伝子疾患、他)、地域、技術別(PCR、TMA、その他のNAAT) Clinical Diagnostics PCR Markets by Type (Infectious Disease, Cancer, Cardiovascular, Genetic, others) and Region (U.S., Europe, Japan, China, Latin America, World) and Technology (PCR, TMA, other NAAT)
出版日: 2017年06月22日 ページ情報: 英文 260 Pages
概要

当レポートでは、世界の臨床診断PCR市場について調査し、市場の概要と分析、タイプ別、地域別、技術別動向、および市場に参入する主要企業のプロファイルなどをまとめています。

第1章 エグゼクティブサマリー

第2章 イントロダクション

第3章 動向と技術革新

  • デジタルPCR
  • 多重PCR
  • その他のPCR修飾
  • その他の核酸増幅試験法
  • 臨床試験所およびポイントオブケア検査で用いられるプラットフォーム

第4章 市場における臨床PCR検査

  • 感染症診断
  • 心血管疾患
  • 遺伝子検査
  • 薬物代謝
  • HLA型検査
  • その他の臨床応用
  • 輸血
  • 体外診断の規制
  • 試験所開発検査
  • 償還
  • 合併・買収

第5章 ポリメラーゼ連鎖反応(PCR)と核酸増幅検査(NAAT)市場分析

  • 臨床市場促進因子
  • ポイントオブケア検査市場の促進因子と課題/ハードル
  • 核酸増幅検査(NAAT)市場概要
  • 臨床PCR市場
  • 臨床NAAT市場
  • 新興のNAATに基づく癌スクリーニング
  • 癌診断/予後/個別化医療/モニタリング市場
  • 遺伝子検査
  • 移植診断
  • 地域別市場

第6章 企業プロファイル

  • Abbott Laboratories
  • Agilent Technologies Inc.
  • Alere Inc.
  • Asuragen, Inc.
  • Biocartis Group Nv
  • Biofire Diagnostics, Llc. (Acquired By Biomerieux)
  • Biomerieux Sa
  • Bio-Rad Laboratories, Inc.
  • Cepheid (A Danaher Company)
  • Genmark Diagnostics, Inc.
  • Hologic, Inc.
  • Luminex Corporation
  • Meridian Bioscience, Inc.
  • Qiagen N.V.
  • Quantumdx Group
  • Roche
  • Spartan Bioscience Inc.
  • T2 Biosystems, Inc.

図表

目次
Product Code: KLI15391787

This report provides crucial business planning data for companies in the clinical PCR (polymerase chain reaction) and other nucleic acid amplification test (NAAT) markets. Companies included in this report may be involved research instruments and reagents, platforms and tests for clinical laboratories, and/or platforms and tests for near-patient or point-of-care diagnostics. Other companies are using PCR technology as the first step of assays that utilize other technologies such as DNA sequencing or mass spectrometry.

PCR is a large field that covers a wide range of activities, and this is reflected in the topics covered in this report. This report includes a discussion of:

  • Overview of PCR and other NAAT technologies
  • Applications of NAAT in clinical diagnostic
  • Markets by segment (infectious disease, cancer, genetics)
  • Sub-segment markets within larger for infectious disease (Hepatitis, HIV, STDs, RSV, Others) and oncology (Screening, Diagnostics) and Genetic (Inherited, Thrombolia, Pharmacogenomics)
  • Regional Markets (U.S., Europe, Japan, China, Latin America, World)
  • Deals made by PCR and other NAAT companies, including investments and financing agreements, acquisitions, collaborations, and other agreements.
  • Market drivers, issues, and trends in the nucleic acid amplification market
  • Forecasts projected to 2021
  • Profiles of companies reflecting the wide range NAAT products and applications.

Development and Evolution of PCR

With these first PCR test technology (traditional PCR), detection of amplified DNA product (amplicon) takes place at the end of the reaction (end-point PCR) using a technique such as separation by electrophoresis in an agarose gel. Over time, changes and improvements have been developed. These include the use of different DNA polymerase enzymes and other modifications.

Another important advance was the development of reverse transcription PCR (RT-PCR), in which a reverse transcriptase enzyme is used to make a complementary DNA (cDNA) strand from RNA. This makes it possible to use PCR to detect RNA viruses such as HIV, and to measure gene expression by measuring mRNA. RT-PCR was developed in 1991, the same year that Roche acquired the rights to PCR.

Following acquisition of the rights to PCR, Roche established Roche Molecular Diagnostics. In 1993, Roche introduced an FDA 510(k) cleared test for detection of Chlamydia trachomatis.

Another significant advance was the development of real-time PCR. With real-time PCR, detection of the amplicon occurs in real-time as the amplification reaction progresses. This is accomplished using fluorescence-based detection. Real-time PCR assays can be quantitative assays, measuring the initial number of copies of the target or template DNA that is present in a sample. Real-time PCR is typically referred to as qPCR, while the term "RT-PCR" is usually reserved for reverse transcriptase PCR. In addition to quantitation, real-time PCR assays offer other advantages such as shorter assay times and the ability to automate the reaction process.

In 2003, Roche released the COBAS® TaqMan® Analyzer and three real-time in vitro diagnostic (IVD) PCR assays in Europe. These first real-time IVD assays were for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV). In 2007, Roche released the first fully automated real-time PCR system, which was called the COBAS® AmpliPrep/COBAS® TaqMan®. This system consisted of two instruments, one to automate sample processing and the other to perform the real-time PCR reaction. Roche now offers a portfolio of PCR-based tests for infectious diseases, oncology, and other diseases.

In addition, PCR technology has been widely licensed to other companies for both research and diagnostic applications, and many companies are now active in these fields. Real-time PCR (qPCR) has become the most widely used DNA amplification method today.

Companies are continuing to develop improved PCR methods. One significant improvement discussed in this report is digital PCR (dPCR). Unlike qPCR, digital PCR does not require the use of a standard curve for quantification. Instead, the sample is divided into partitions, and single PCR reactions are performed in each partition. With the method known as digital dropet PCR (ddPCR), these partitions are individual droplets. The reactions are detected by fluorescence, and droplets are scored as positive (containing the targeted sequence) or negative. Statistical analysis of the droplets provides an absolute quantitation of the amount of the targeted sequence that is present in the sample.

Other Nucleic Acid Amplification Test Methods

While qPCR is widely used in clinical diagnostics, a number of other nucleic acid amplification test (NAAT) methods have been developed and commercialized. Examples of isothermal NAATs include loop mediated isothermal amplification (LAMP), nicking enzyme amplification reaction (NEAR), strand displacement amplification (SDA), nucleic acid sequence based amplification (NASBA) and transcription-mediated amplification (TMA).

Isothermal NAATs are used in both laboratory and decentralized clinical molecular diagnostics for their comparative strengths in select applications and settings. Isothermal amplification takes place at a fixed temperature, thus eliminating the thermal cycling that is required with PCR.

Isothermal NAATs have been developed that can provide results more quickly than qPCR, sometimes in less than 30 minutes. Reduced equipment requirements, simpler workflows and applicability to sample-to-answer platforms make isothermal methods ideal for decentralized and point-of-care molecular diagnostics. Both isothermal NAAT and qPCR technologies are being applied to point-of-care and near-patient molecular diagnostics.

Advances in Nucleic Acid Amplification Technology and Emerging Applications

Polymerase chain reaction and other nucleic acid amplification technologies, including isothermal amplification methods, have advanced significantly since the early, manual, time and labor intensive, end-point PCR assays. This progress is continuing today.

New PCR technologies have been developed. For example, digital PCR (dPCR) offers an extremely sensitive means to quantify target nucleic acid sequences. Digital PCR is used in research applications, and some companies have started applying dPCR to diagnostic applications. Also, several multiplex PCR methods are being commercialized. These and other advances in PCR technology are continuing to expand what companies can do with PCR.

A major advance in nucleic acid amplification testing has been the development and commercialization of platforms for decentralized testing. Improvements in microfluidics and other technologies, combined with improvements in amplification and detection technologies, have made possible the development of rapid, fully automated platforms for near-patient or point-of-care NAAT applications. Many of these platforms use isothermal amplification. The first CLIA waved tests have reached the market, and more will follow as many companies are developing platforms and tests for this emerging market.

The growing availability of rapid, near-patient molecular diagnostic tests has opened up new markets that were not possible only a few years ago. An early but important application of these rapid tests is in pathogen identification and antibiotic resistance testing. With traditional microbiology methods, several days are required to identify the microbial pathogen infecting a patient and which antibiotic will be effective for treatment of bacterial infections. The ability to make this diagnosis rapidly represents a major advance in healthcare. While, early rapid tests for identification of specific pathogens have reached the market, there remains considerable room for further advancement and numerous companies working to fill this need.

As technology advances, use of nucleic acid amplification may be coupled to a second technology to further enhance the capabilities of a test. For example, in the search for rapid methods for pathogen identification and antibiotic resistance testing, some companies are developing platforms that use PCR to amplify target nucleic acids in a sample before analysis by mass spectrometry.

In another example, PCR is often used by researchers as part of the sample or library preparation step before next generation sequencing analysis. At least some early work to develop in vitro diagnostic (IVD) kits that utilize next generation sequencing is also using PCR for amplification of nucleic acids to be sequenced.

Nucleic acid amplification testing (NAAT) technologies and markets are evolving, opening up new opportunities for modern versions and applications of a technology (PCR) that was first developed over thirty years ago.

Companies Profiled in This Report Include:

  • Abbott Laboratories
  • Agilent Technologies Inc.
  • Alere Inc.
  • Asuragen, Inc.
  • Beckman Coulter, Inc. (A Danaher Corporation Company)
  • Biocartis Group Nv
  • Biofire Diagnostics, Llc. (Acquired By Biomérieux)
  • Biomérieux Sa
  • Bio-Rad Laboratories, Inc.
  • Cepheid (A Danaher Company)
  • Genmark Diagnostics, Inc.
  • Hologic, Inc.
  • Luminex Corporation
  • Meridian Bioscience, Inc.
  • Qiagen N.V.
  • Quantumdx Group
  • Quidel, Inc.
  • Roche
  • Spartan Bioscience Inc.
  • Stat-Diagnostica
  • T2 Biosystems, Inc.

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
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