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  4. > Digital Polymerase Chain Reaction (PCR) Technology: Global Markets

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 key
manufacturers, suppliers, users and variety of factors influencing demand are discussed. This report will identify the plethora of market opportunities using digital
PCR, focusing on where it can establish itself in the broader PCR marketplace, the applications of the technology, and the implications this technology will have on
complementary 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 the
marketplace 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 digital
PCR, 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 reagents
used 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 to
clinical laboratories and others.

Table Of Contents

Digital Polymerase Chain Reaction (PCR) Technology: Global Markets
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

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

CHAPTER 2 SUMMARY 6

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

CHAPTER 3 OVERVIEW: DESCRIPTION OF DIGITAL PCR TECHNOLOGY 10

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

CHAPTER 4 GOVERNMENT REGULATIONS 32

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

CHAPTER 5 MARKETS BY PRODUCTS 39

CONSUMABLES AND REAGENTS 39
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
EQUIPMENT 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
COMPANY PROSPECTS 48
BIO-RAD 48
RAINDANCE 49
FLUIDIGM 49
LIFE TECHNOLOGIES 49

CHAPTER 6 TECHNOLOGY 51

CURRENT OUTLOOK 51
KEY PATENTS 52
TABLE 18 KEY PATENTS IN THE PATENT LITERATURE FOR DIGITAL PCR, 2009 TO
2010 52
KEY LEADERS 53
Sequenom 53
Rustem Ismagilov (CalTech) 53
Dennis Lo (Chinese University of Hong Kong) 54
Fluidigm 54
Verinata Health 54
Ambergen 54
NuGEN Technologies 55
Ariosa Diagnostics 55
NEW PATENTS 55
TABLE 19 LIST OF PATENTS ISSUED FROM JANUARY 2009 TO JANUARY 2014 56
PATENTS BY CATEGORY 66
TABLE 20 DIGITAL PCR PATENTS ISSUED BY CATEGORY (NUMBER) 66
PATENTS BY SECTOR 66
TABLE 21 DIGITAL PCR PATENTS BY SECTOR (NUMBER) 67
PATENTS BY NATION 67
TABLE 22 DIGITAL PCR PATENTS BY COUNTRY (NUMBER) 67
PATENTS BY YEAR 68
TABLE 23 DIGITAL PCR PATENTS BY YEAR, 2009-2014 (NUMBER) 68
PENDING PATENTS 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
PATENT APPLICATIONS BY SECTOR 92
TABLE 26 PATENT APPLICATIONS FOR DIGITAL PCR BY SECTOR (NUMBER) 93
PATENT APPLICATIONS BY COUNTRY 93
TABLE 27 PATENT APPLICATIONS BY COUNTRY (NUMBER) 93
PATENT APPLICATIONS BY YEAR 94
TABLE 28 PATENT APPLICATIONS BY YEAR (NUMBER) 94

CHAPTER 7 INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS 96

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

CHAPTER 8 RESEARCH AND DEVELOPMENT 101

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

CHAPTER 9 COMPANY PROFILES 106

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

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