Digital Polymerase Chain Reaction (PCR) Technology: Global Markets

NEW YORK, June 19, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Digital Polymerase Chain Reaction (PCR) Technology: Global Markets

http://www.reportlinker.com/p02171940/Digital-Polymerase-Chain-Reaction-PCR-Technology-Global-Markets.html

This BCC Research report analyzes the Polymerase Chain Reaction (PCR) industry, its trend forecasts and sales through 2018. It also identifies the market opportunities focusing on the position of PCR in the larger marketplace, its applications, and its implications on complementary applications, especially next generation sequencing. Key manufacturers, suppliers users and variety of factors influencing the technology are also mentioned in this report.

Use this report to:

- To focus on the equipment used within the digital PCR sector and the particular reagents used therein that are specifically dedicated within.

- To identify the plethora of market opportunities using digital PCR.

- Receive information on governmental regulations.

- Receive information on industry structure and a competitive analysis.

Highlights

- The global market for digital polymerase chain reaction (PCR) technology reached $81.8 million in 2012 and $139.3 million in 2013. The market is expected to grow to $489.8 million in 2018, a compound annual growth rate (CAGR) of 28.6% for the five-year period, 2013 to 2018.- The equipments segment of the market reached $68.2 million in 2013 and is expected to grow to $283.9 million in 2018, a CAGR of 33%.l The consumables market reached $71.1 million in 2013 and is expected to grow to $205.9 million in 2018, a CAGR of 23.7%.

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This report will provide BCC Research's analysis on the digital polymerase chain reaction (PCR) industry, including trend forecasts and sales through 2018. The keymanufacturers, suppliers, users and variety of factors influencing demand are discussed. This report will identify the plethora of market opportunities using digitalPCR, focusing on where it can establish itself in the broader PCR marketplace, the applications of the technology, and the implications this technology will have oncomplementary applications, in particular with next-generation sequencing as it enters the broader marketplace. Digital PCR has only been widely marketed in the past couple of years, but it will likely be on a similar growth path as real-time PCR technology 10 years ago.

REASONS FOR DOING THE STUDY

Digital PCR is a novel application of the now 30-year-old PCR technology. While there are a number of different technologies in the marketplace, the concept involves

partitioning a sample of DNA into small, microscopic droplets so that a given sample has either 0 or 1 copy of target DNA, much in the way a microchip has switches that

gives signals of 0 or 1 within a microchip. Once the sample is partitioned, a PCR reaction takes place in each droplet, which is then detected by technologies similar to

those used within quantitative PCR today. These results are interpreted with the use of Poisson statistics to determine the exact copy number of target DNA within a sample.

This methodology has the ability to quantify small copy numbers of DNA within a sample, and can have a wide variety of applications complementary to existing PCR

technology, as well as new uses of PCR that would not be feasible with other technologies — particularly as a complement to next-generation sequencing. There are

three different variations of digital PCR being marketed, and they all have their strengths and weaknesses in the marketplace.

SCOPE OF REPORT

The report will discuss in detail the marketplace for digital PCR. The focus of this report is on the equipment used within the digital PCR sector and the particular reagents used therein that are specifically dedicated within. The different technologies used for digital PCR and their associated reagents were analyzed to explore the scope of themarketplace that exists for this technology.

INTENDED AUDIENCE

The intended audience for this report is key thought leaders in the pharmaceutical, biotechnology and clinical diagnostics industries, executives within the pharmaceutical,

biotechnology and clinical diagnostics industries and the firms that market supplies and equipment to these firms, business development professionals within the

biotechnology industry, scientific and quality control staff.

INFORMATION SOURCES

The information for this BCC report was obtained through primary and secondary sources of data. Primary data sources include interviews with a number of executives,product managers and laboratory professionals across a number of different segments in the market. Secondary data sources include published literature in the field of digitalPCR, investment reports, company reports and media information for the laboratory industry.

The market data presented is based on the manufacturers' level. The base year of the market report is 2013, with historical data from 2011 and 2012, and forecasts to 2018.

Historical and forecast data are provided for all market segments referred to in this report. Competitor share estimates are provided based on data from the 2013 base

year.

While this report will discuss complementary technologies as applicable, it will not highlight their market specifics. Of particular note are the vast majority of reagentsused for PCR, as there is significant overlap between those used between digital PCR and real-time PCR. This report will focus on the equipment used for digital PCR,reagents specific to the technology and any particular applications. There will be significant coverage of the end users of this equipment, from academic to industry toclinical laboratories and others.

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY GOALS AND OBJECTIVES 2REASONS FOR DOING THE STUDY 2SCOPE OF REPORT 2INTENDED AUDIENCE 2INFORMATION SOURCES 3ANALYST'S CREDENTIALS 3RELATED BCC RESEARCH REPORTS 3BCC RESEARCH WEBSITE 3DISCLAIMER 4

CHAPTER 2 SUMMARY 6

INDUSTRY TRENDS 6EXPLOSIVE GROWTH IN DIGITAL PCR 6KEY PLAYERS IN THE EQUIPMENT AND ASSAY SEGMENTS 6THE END OF THE LDT 6TECHNIQUE MATTERS 7CURE FOR CANCER AND AIDS 7A CHEAPER WAY FOR ACADEMIA 7A SOLUTION TO CHALLENGING PCR PROBLEMS 7STEEP LEARNING CURVE 8SUMMARY TABLE GLOBAL MARKET FOR DIGITAL PCR TECHNOLOGY BY SEGMENT,THROUGH 2018 ($ MILLIONS) 8SUMMARY FIGURE GLOBAL MARKET FOR DIGITAL PCR TECHNOLOGY BY SEGMENT,2011-2018 ($ MILLIONS) 8

CHAPTER 3 OVERVIEW: DESCRIPTION OF DIGITAL PCR TECHNOLOGY 10

TRADITIONAL PCR 10EVOLUTION OF PCR TECHNOLOGY AND ITS IMPACT ON THE HEALTHCAREINDUSTRY 10FIGURE 1 IMPACT OF PCR TECHNOLOGY ON THE HEALTHCARE ENVIRONMENT 10TRENDS IN DEVICE DESIGN 11TRADITIONAL PCR VS. REAL-TIME PCR 11RAPID GROWTH IN THE MOLECULAR DIAGNOSTIC INDUSTRY 12PRODUCT INNOVATIONS INCREASE TECHNOLOGY ADOPTION ANDAPPLICATION AREAS 12WIDE RANGE OF APPLICATIONS 13MARKET CHALLENGES 13Lack of Awareness 13Requirement for Skilled Labor 14High Cost of Real-time PCR Instruments 14INSTRUMENT SELECTION CRITERIA 14TABLE 1 COMPARISONS OF DIGITAL PCR TECHNOLOGIES 15HISTORY OF DIGITAL PCR TECHNOLOGY 16HOW THE TECHNOLOGY WORKS 17VARIATIONS ON THE TECHNOLOGY 18MICROFLUIDIC DIGITAL PCR 18DROPLET DIGITAL PCR 18BEAM DIGITAL PCR 19SECTORS 19PHARMACEUTICAL/BIOTECH AND CLINICAL DEVELOPMENT 19CLINICAL DIAGNOSTICS 20ACADEMIA 21OTHER SECTORS 22USES 22ONCOLOGY 23HIV 25NEXT GENERATION SEQUENCING 26INFECTIOUS DISEASE 27NON-INVASIVE DIAGNOSTICS 27SNP DETECTION 28EMERGING USES 29SUMMARY 30

CHAPTER 4 GOVERNMENT REGULATIONS 32

CLINICAL DIAGNOSTICS 32LABORATORY DEVELOPED TESTS 32U.S. FOOD AND DRUG ADMINISTRATION 33CENTERS FOR MEDICARE AND MEDICAID SERVICES 34HEALTH CANADA 34LDT GOVERNANCE IN EUROPE, AUSTRALIA AND CHINA 35EUROPEAN MEDICINES AGENCY 35THERAPEUTIC GOODS ADMINISTRATION (AUSTRALIA) 35CHINA FOOD AND DRUG ADMINISTRATION 35JAPAN PHARMACEUTICAL AND MEDICAL DEVICE AGENCY 36PHARMACEUTICAL DEVELOPMENT 36OTHER REGULATORY ISSUES 37

CHAPTER 5 MARKETS BY PRODUCTS 39

CONSUMABLES AND REAGENTS 39TABLE 2 LIST OF CONSUMABLES USED EXCLUSIVELY IN DIGITAL PCR 40TABLE 3 SALES OF CONSUMABLES FOR THE DIGITAL PCR INDUSTRY, THROUGH2018 ($ MILLIONS) 40TABLE 4 SALES OF DIGITAL PCR INDUSTRY CONSUMABLES FOR PHARMACEUTICALRESEARCH AND DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 40TABLE 5 SALES FOR DIGITAL PCR INDUSTRY CONSUMABLES FOR CLINICALDIAGNOSTICS, THROUGH 2018 ($ MILLIONS) 41TABLE 6 SALES OF DIGITAL PCR INDUSTRY CONSUMABLES FOR ACADEMIA,THROUGH 2018 ($ MILLIONS) 41TABLE 7 SALES OF DIGITAL PCR FOR INFECTIOUS DISEASES, THROUGH 2018 ($MILLIONS) 42TABLE 8 SALES OF DIGITAL PCR FOR NGS, THROUGH 2018 ($ MILLIONS) 42TABLE 9 SALES FOR DIGITAL PCR FOR OTHER MOLECULAR BIOLOGIC USES,THROUGH 2018 ($ MILLIONS) 43EQUIPMENT 43TABLE 10 LIST OF AVAILABLE DIGITAL PCR EQUIPMENT 44TABLE 11 SALES OF DIGITAL PCR INDUSTRY FOR EQUIPMENT, THROUGH 2018 ($MILLIONS) 44TABLE 12 SALES OF DIGITAL PCR EQUIPMENT FOR PHARMACEUTICAL RESEARCHAND DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 44TABLE 13 SALES OF DIGITAL PCR EQUIPMENT FOR CLINICAL DIAGNOSTICS,THROUGH 2018 ($ MILLIONS) 45TABLE 14 SALES OF DIGITAL PCR EQUIPMENT FOR ACADEMIA, THROUGH 2018 ($MILLIONS) 46TABLE 15 SALES OF DIGITAL PCR EQUIPMENT FOR INFECTIOUS DISEASES,THROUGH 2018 ($ MILLIONS) 46TABLE 16 SALES OF DIGITAL PCR EQUIPMENT FOR NGS, THROUGH 2018 ($MILLIONS) 47TABLE 17 SALES OF DIGITAL PCR EQUIPMENT FOR OTHER MOLECULAR BIOLOGICUSES, THROUGH 2018 ($ MILLIONS) 48COMPANY PROSPECTS 48BIO-RAD 48RAINDANCE 49FLUIDIGM 49LIFE TECHNOLOGIES 49

CHAPTER 6 TECHNOLOGY 51

CURRENT OUTLOOK 51KEY PATENTS 52TABLE 18 KEY PATENTS IN THE PATENT LITERATURE FOR DIGITAL PCR, 2009 TO2010 52KEY LEADERS 53Sequenom 53Rustem Ismagilov (CalTech) 53Dennis Lo (Chinese University of Hong Kong) 54Fluidigm 54Verinata Health 54Ambergen 54NuGEN Technologies 55Ariosa Diagnostics 55NEW PATENTS 55TABLE 19 LIST OF PATENTS ISSUED FROM JANUARY 2009 TO JANUARY 2014 56PATENTS BY CATEGORY 66TABLE 20 DIGITAL PCR PATENTS ISSUED BY CATEGORY (NUMBER) 66PATENTS BY SECTOR 66TABLE 21 DIGITAL PCR PATENTS BY SECTOR (NUMBER) 67PATENTS BY NATION 67TABLE 22 DIGITAL PCR PATENTS BY COUNTRY (NUMBER) 67PATENTS BY YEAR 68TABLE 23 DIGITAL PCR PATENTS BY YEAR, 2009-2014 (NUMBER) 68PENDING PATENTS 68TABLE 24 PATENT APPLICATIONS IN DIGITAL PCR FROM JANUARY 2009 TOJANUARY 2014 69TABLE 25 PATENT APPLICATIONS FOR DIGITAL PCR BY PATENT CATEGORY(NUMBER) 92PATENT APPLICATIONS BY SECTOR 92TABLE 26 PATENT APPLICATIONS FOR DIGITAL PCR BY SECTOR (NUMBER) 93PATENT APPLICATIONS BY COUNTRY 93TABLE 27 PATENT APPLICATIONS BY COUNTRY (NUMBER) 93PATENT APPLICATIONS BY YEAR 94TABLE 28 PATENT APPLICATIONS BY YEAR (NUMBER) 94

CHAPTER 7 INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS 96

EQUIPMENT MANUFACTURERS 96BIO-RAD 96LIFE TECHNOLOGIES 97RAINDANCE TECHNOLOGIES 98FLUIDIGM 98SYSMEX INOSTICS 98CONSUMABLE MANUFACTURERS 99

CHAPTER 8 RESEARCH AND DEVELOPMENT 101

INDUSTRY 101DIGITAL PCR AND DNA SEQUENCING KITS 101CELL-FREE DNA DIAGNOSTICS 101ACADEMIA 102GENE EDITING WITH TALEN AND CRISPR 102ENVIRONMENTAL AND MARINE MICROBIOLOGY 103TECHNOLOGY ISSUES 104FALSE POSITIVES IN DIGITAL PCR ASSAYS 104BEAMING DIGITAL PCR 104

CHAPTER 9 COMPANY PROFILES 106

454 LIFE SCIENCES CORP. 106ABBOTT LABORATORIES 106ADAPTIVE BIOTECHNOLOGIES CORP. 106ADVANCED LIQUID LOGIC, INC. 106AFFYMETRIX, INC. 107AMBERGEN 107ARIOSA DIAGNOSTICS, INC. 107AUEON, INC. 107BERRY GENOMICS CO., LTD. 108BEXMART 108BIODX, INC. 108BIODESY, LLC 108BIOLOGICAL DYNAMICS, INC. 109BIO-RAD LABORATORIES, INC. 109BOREAL GENOMICS CORP. 109CARIS LIFE SCIENCES, INC. 109CELULA, INC. 110COMPLETE GENOMICS 110ESOTERIX LABORATORY SERVICES, INC. 110EXACT SCIENCES CORP. 110FLUIDIGM CORP. 111GENCELL BIOSYSTEMS, LTD. 111GENETIC TECHNOLOGIES, LTD. 111GENOID 111HALGEN CORP. 112IMMUMETRIX, LLC 112INTEGEN X, INC. 112INTELLIGENT MEDICAL DEVICES, INC. 112LABORATORY CORPORATION OF AMERICA 113LIFE CODEXX 113LOXBRIDGE RESEARCH, LLP 113LUMINEX CORP. 113NATERA, INC. 114NETBIO, INC. 114NUGEN TECHNOLOGIES, INC. 114ONCOMED PHARMACEUTICALS, INC. 114PACIFIC BIOSCIENCES OF CALIFORNIA, INC. 115POPULATION DIAGNOSTICS, INC. 115POPULATION GENETICS TECHNOLOGIES, LTD. 115QUANTERIX CORP. 115RAINDANCE TECHNOLOGIES, INC. 116RARECELLS 116ROCHE DIAGNOSTICS OPERATIONS, INC. 116SEQUENOM, INC. 116SEQUENTA, INC. 117SLIPCHIP CORP. 117SONY CORPORATION 117THERMO FISHER SCIENTIFIC 117TOCAGEN, INC. 118TOOLGEN, INC. 118UNITAQ BIO 118VERINATA HEALTH, INC. 119VIOMICS, INC. 119VIPERGEN 119

LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR DIGITAL PCR TECHNOLOGY BY SEGMENT,

THROUGH 2018 ($ MILLIONS) 8

TABLE 1 COMPARISONS OF DIGITAL PCR TECHNOLOGIES 15

TABLE 2 LIST OF CONSUMABLES USED EXCLUSIVELY IN DIGITAL PCR 40

TABLE 3 SALES OF CONSUMABLES FOR THE DIGITAL PCR INDUSTRY, THROUGH

2018 ($ MILLIONS) 40

TABLE 4 SALES OF DIGITAL PCR INDUSTRY CONSUMABLES FOR PHARMACEUTICAL

RESEARCH AND DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 40

TABLE 5 SALES FOR DIGITAL PCR INDUSTRY CONSUMABLES FOR CLINICAL

DIAGNOSTICS, THROUGH 2018 ($ MILLIONS) 41

TABLE 6 SALES OF DIGITAL PCR INDUSTRY CONSUMABLES FOR ACADEMIA,

THROUGH 2018 ($ MILLIONS) 41

TABLE 7 SALES OF DIGITAL PCR FOR INFECTIOUS DISEASES, THROUGH 2018 ($

MILLIONS) 42

TABLE 8 SALES OF DIGITAL PCR FOR NGS, THROUGH 2018 ($ MILLIONS) 42

TABLE 9 SALES FOR DIGITAL PCR FOR OTHER MOLECULAR BIOLOGIC USES,

THROUGH 2018 ($ MILLIONS) 43

TABLE 10 LIST OF AVAILABLE DIGITAL PCR EQUIPMENT 44

TABLE 11 SALES OF DIGITAL PCR INDUSTRY FOR EQUIPMENT, THROUGH 2018 ($

MILLIONS) 44

TABLE 12 SALES OF DIGITAL PCR EQUIPMENT FOR PHARMACEUTICAL RESEARCH

AND DEVELOPMENT, THROUGH 2018 ($ MILLIONS) 44

TABLE 13 SALES OF DIGITAL PCR EQUIPMENT FOR CLINICAL DIAGNOSTICS,

THROUGH 2018 ($ MILLIONS) 45

TABLE 14 SALES OF DIGITAL PCR EQUIPMENT FOR ACADEMIA, THROUGH 2018 ($

MILLIONS) 46

TABLE 15 SALES OF DIGITAL PCR EQUIPMENT FOR INFECTIOUS DISEASES, THROUGH

2018 ($ MILLIONS) 46

TABLE 16 SALES OF DIGITAL PCR EQUIPMENT FOR NGS, THROUGH 2018 ($

MILLIONS) 47

TABLE 17 SALES OF DIGITAL PCR EQUIPMENT FOR OTHER MOLECULAR BIOLOGIC

USES, THROUGH 2018 ($ MILLIONS) 48

TABLE 18 KEY PATENTS IN THE PATENT LITERATURE FOR DIGITAL PCR, 2009 TO

2010 52

TABLE 19 LIST OF PATENTS ISSUED FROM JANUARY 2009 TO JANUARY 2014 56

TABLE 20 DIGITAL PCR PATENTS ISSUED BY CATEGORY (NUMBER) 66

TABLE 21 DIGITAL PCR PATENTS BY SECTOR (NUMBER) 67

TABLE 22 DIGITAL PCR PATENTS BY COUNTRY (NUMBER) 67

TABLE 23 DIGITAL PCR PATENTS BY YEAR, 2009-2014 (NUMBER) 68

TABLE 24 PATENT APPLICATIONS IN DIGITAL PCR FROM JANUARY 2009 TO JANUARY

2014 69

TABLE 25 PATENT APPLICATIONS FOR DIGITAL PCR BY PATENT CATEGORY (NUMBER) 92

TABLE 26 PATENT APPLICATIONS FOR DIGITAL PCR BY SECTOR (NUMBER) 93

TABLE 27 PATENT APPLICATIONS BY COUNTRY (NUMBER) 93

TABLE 28 PATENT APPLICATIONS BY YEAR (NUMBER) 94

LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR DIGITAL PCR TECHNOLOGY BY SEGMENT,

2011-2018 ($ MILLIONS) 8

FIGURE 1 IMPACT OF PCR TECHNOLOGY ON THE HEALTHCARE ENVIRONMENT 10

To order this report: Digital Polymerase Chain Reaction (PCR) Technology: Global Markets http://www.reportlinker.com/p02171940/Digital-Polymerase-Chain-Reaction-PCR-Technology-Global-Markets.html

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