The North American Markets For PCR Technologies

Study Goal And Outline

Rationale For This Study

Targeted Audience

Market Definition And Scope

Information Sources And Methodologies

Customization Of This Study

Disclaimer

EXECUTIVE SUMMARY

CHAPTER 1: OVERVIEW

Definition Of Polymerase Chain Reaction

History Of PCR

Table 1: Timeline Of PCR Technology History (1983 – 2013)

Table 2: Timeline Of Real-Time PCR History

Table 3: Timeline Of Digital PCR History

The Concept

Important Considerations

Table 4: Some Important Factors To Be Considered While Planning PCR Experiments

PCR Platforms – Popular And Emerging

Allele-Specific PCR (AsPCR)

Amplified Fragment Length Polymorphisms PCR (Aflp-PCR)

Assembly PCR

Asymmetric PCR

Capillary PCR

Colony PCR

Table 5: Key Players And Their Products In The Field Of Colony PCR

Digital PCR (DPCR)

Table 6: Key Players And Their Products In The Field Of Digital PCR

Direct PCR

Table 7: Key Players And Their Products In The Field Of Direct PCR

Hot-Start PCR

Table 8: Key Players And Their Products In The Field Of Hot-Start PCR

Situ PCR

Table 9: Key Players And Their Products In The Field Of In Situ PCR

Inter-Simple Sequence Repeat PCR (Issr-PCR)

Inverse PCR

Long PCR

Table 10: Key Players And Their Products In The Field Of Long PCR

Long Accurate PCR (La PCR)

Table 11: Key Players And Their Products In The Field Of Long Accurate PCR

Methylation-Specific PCR

Table 12: Key Players And Their Products In The Field Of Methylation-Specific PCR

Mini Primer PCR

Multiplex PCR

Table 13: Key Players And Their Products In The Field Of Multiplex PCR

Nanoparticle Assisted PCR (Nano PCR)

Nested PCR

Table 14: Key Players And Their Products In The Field Of Nested PCR

Overlap-Extension PCR (Oe-PCR)

Quantitative Fluorescence PCR (Qf-PCR)

Table 15: Key Players And Their Products In The Field Of Quantitative Fluorescence PCR

Random Amplified Polymorphic Dna (Rapd) PCR

Table 16: Key Players And Their Products In The Field Of Random Amplified Polymorphic Dna PCR

Real-Time PCR

Table 17: Commonly Used Detection Chemistries In Real-Time PCR

Table 18: Key Players And Their Products In The Field Of Real-Time PCR

Repetitive Sequence-Based PCR (Rep-PCR)

Reverse Transcription PCR (Rt-PCR)

Table 19: Key Players And Their Products In The Field Of Reverse Transcription PCR

Single Cell PCR

Table 20: Key Players And Their Products In The Field Of Single Cell PCR

Solid Phase PCR

Thermal Asymmetric Interlaced PCR (Tail-PCR)

Touchdown PCR

Universal Fast Walking PCR (Ufw)

Table 21: Key Players And Their Products In The Field Of Universal Fast Walking PCR

End-Use Segments Of PCR

Medical Diagnostics Segments

Cancer

Table 22: Key Players Offering PCR-Based Cancer Diagnostics Products In The Market

Infectious Diseases

Table 23: Key Players Offering PCR-Based Diagnostics Products Targeting Human Infections

Prenatal Diagnostics

Table 24: Key Players Offering PCR-Based Prenatal Diagnostics Products In The Market

Food Safety Testing, Agricultural, And Environmental Segments

Food-Borne And Water-Borne Infections

Table 25: Common Commercial Systems Used For Food Pathogen Detection

I. Campylobacter And Its Subspecies (Campylobacter Spp.)

Table 26: International Standards And Guidelines For Campylobacter Spp. Identification

Table 27: Key Players Offering PCR-Based Kits To Detect Campylobacter And Its Subspecies

II. Escherichia Coli (E. Coli)

Table 28: International Standards And Guidelines For Escherichia Coli Detection

Table 29: Key Players Offering PCR-Based Kits To Detect Pathogenic Escherichia Coli And Its Subspecies

III. Listeria Monocytogenes And Its Subspecies (Listeria Spp.)

Table 30: International Standards And Guidelines For Listeria Detection

Table 31: Key Players Offering PCR-Based Kits To Detect Listeria Monocytogenes And Its Subspecies

IV. Salmonella And Its Subspecies (Salmonella Spp.)

Table 32: International Standards And Guidelines For Salmonella Detection

Table 33:Key Players Offering PCR-Based Kits To Detect Salmonella And Its Subspecies

V. Other Food-Borne And Water-Borne Pathogens

Table 34: Key Players Offering PCR-Based Kits To Detect Other Selected Food-Borne And Water-Borne Pathogens

Veterinary Infection Diagnostics

Table 35: Key Players Offering PCR-Based Veterinary Diagnostics Products

Plant Infection Diagnostics

Table 36: Key Players Offering PCR-Based Diagnostics Products Targeting Plant Infections

Gmo Foods/Plants Testing

Table 37: Key Players Offering PCR-Based Kits To Detect Gmo Foods/Plants In The Market

Food Allergens And Animal Species In Food

Table 38: Key Players Offering PCR-Based Kits To Detect Food Allergens And Animal Species In Food In The Market

Forensic Sciences

Table 39: Key Players Offering PCR-Based Human Identity And Forensic Testing Products In The Market

Life Sciences Research

miRNA Analysis

Table 40: Key Players Offering Products For Microrna Analysis Involving PCR Technology

Mutations Detection

Table 41: Key Players Offering PCR-Based Mutations Detection Products

SNP Detection And Genotyping

Table 42: Key Players Offering PCR-Based Products For Snps Detection And Genotyping

Sequencing

Table 43: Key Players Offering PCR-Based Sequencing Products

Application Of PCR In Ngs Library Quantification

Table 44: Key Players Offering Ngs Library Quantification Products That Incorporate PCR Technology

Genetic Fingerprinting

Table 45: Key Players Offering PCR-Related Products For Genotyping/DNA Fingerprinting

Site-Directed Mutagenesis (SDM)

Table 46: Key Players Offering PCR-Based Site-Directed Mutagenesis Products

Market Trends

Widening Application Scope

Patent Expiries During The Forecast Period

Table 47: Basic PCR Patents Expired In 28 March 2005 In USA

Table 48: Key Patents In Selected PCR Market Segments And Their Expiry Dates In USA

Dominance Of PCR Over Alternative Pathogen Diagnostics Options

Technological Advancements Enabling High Throughput As Well As Point-Of-Care (Poc)

Diagnostics

Advent Of Digital PCR

Strong Growth Trends In Single-Cell Analysis (SCA)

The Rising Demand For Molecular Diagnostics

The Rising Food Safety Testing Regulations

Market Drivers

Table 49: Market Drivers Of The North American PCR Market

Market Challenges

Table 50: Market Restraints Of The North American PCR Markets

The Rising Merger And Acquisition Trends

Table 51: Key Mergers And Acquisitions During The Past Five Years Relevant In PCR Market (2010-2014)

CHAPTER 2: INDUSTRY STRUCTURE
Analysis Of PCR Technology Markets

Table 52: Global PCR Technology Markets, By Value (USD, Million)

Figure 1: Market Shares And Forecasts Of Global PCR Technology Market Segments

The North American Markets

Table 53: PCR Market Segments And Their Growth Trends In North America, By Value (USD, Million)

Analysis Of Key End-Use Segments

Table 54: Global PCR Technologies Demand By End-Use Segments, By Value (USD, Million)

Table 55:PCR Technologies Demand By End-Use Segments In North America, By Value (USD, Million)

Medical Diagnostics

Food, Agriculture, Etc.

Life Sciences Research

Figure 2: Market Shares And Forecasts Of PCR Technologies Demand By End-Use Segments

CHAPTER 3: LEGISLATION AND REGULATION

MIQE Guidelines And R|DML

Regulatory Landscape Of PCR Technologies In Medical Diagnostics Fields

Table 56: Regulatory Agencies Responsible For Molecular Diagnostics In North America

Table 57: Regulatory Agencies Influencing Genetic Testing In USA

Table 58: Laws And Regulations Influencing PCR-Based Medical Diagnostics Markets In USA

Regulation Of Laboratory Developed Tests (Ldts) In USA

Table 59: Key Laws And Regulations Influencing PCR-Based Medical Diagnostics Markets In Canada

Regulatory Landscape Of PCR Technologies Targeting Food And Agricultural Segments

Table 60: Main International Agencies Involved In Food Safety Aspects
USA

Table 61: Regulatory Agencies Responsible For Food Safety Testing Regulations In USA

Table 62: Food Safety Laws And Regulations Influencing PCR Technologies Markets In Usa

Canada

Table 63: Food Safety Laws And Regulations In Canada

Forensics

Table 64: Frequently Used PCR Kits Accepted At Ndis, USA

CHAPTER 4: TECHNOLOGY TREND ANALYSIS

Automation Of PCR

Touch-Screen Options For Ease-Of-Use

Networking And Remote Controlling Capabilities

Low Throughput Systems

Lab-On-A-Chip Formats And Portability

Application Of Microelectromechanical Systems (Mems) And Convection Principles In PCR

Automated High Throughput Instruments For Large Scale Applications

Table 65: Selected Companies Enabling High Throughput In QPCR

Table 66: Comparison Of The Reaction Formats Of Selected Real-Time PCR Instruments In The Market

Evolution In Heating Technologies For Efficient Thermal Cycling

Table 67: Comparison Of The Thermal Modules Of Selected Commercial Real-Time PCR Systems

Speed
Detectors
Light Source

Table 68: Comparison Of The Optical Modules Of Selected Real-Time PCR Systems In The Market

Improving Multiplexing Efficiency

Table 69: Technical Approaches Adopted For Limiting Off-Target Amplification In Multiplex QPCR Assays

Fluorescence Chemistry

Taqman Probe

Molecular Beacons And Scorpions

Table 70: Fluorescence Chemistry And Multiplex Capability Of Selected QPCR Systems In The Market

The Early Adopters Of DPCR

Widening Scope Within Molecular Biology Platforms

CHAPTER 5: ASSESSMENT OF PATENTING TRENDS In PCR Field
Assessing The Popularity Of PCR Platforms On The Basis Of Patenting Trends

Table 71: Comparison Of Patenting Trends In Selected PCR Segments (1983 – 2013)

Figure 3: PCR Platforms With Intense Patenting Activities During The Past Three Decades

Table 72: Selected Patents On Digital PCR

Table 73: Selected Patents On Inverse PCR

Table 74: Selected Patents On Multiplex PCR

Table 75: Selected Patents On Nested PCR

Table 76: Selected Patents On Real-Time PCR

Table 77: Selected Patents On Reverse Transcription PCR

Patenting Trends In Selected End-Use Segments Of PCR

Analysis Of Patenting Trends In Infectious Diseases Sector

Table 78: PCR-Based Diagnostics: Patenting Trends In Selected Infected Disease Areas

Analysis Of Patenting Trends In Cancer Sector

Table 79: PCR-Based Diagnostics: Patenting Trends In Selected Cancer Segments

Table 80: PCR-Based Diagnostics – Patenting Trends In Selected End-Use Segments

The Rising Popularity Of Real-Time PCR

Table 81: Assessing The Influence Of Real Time PCR In Selected End Use Segments

End-Use Segments Where Digital PCR Influence Is Growing

Table 82: End-Use Segments Where DPCR Patenting Activities Are Growing
Patenting Trends Of Key Players In The PCR Market

Patenting Trends Of Companies In The Real-Time PCR Segment

Table 83: Patents By Selected Key Players Related To Real-Time PCR

Patenting Trends Of Companies Within The Digital PCR Segment

Table 84: Patents By Key Players Related To Digital PCR

CHAPTER 6: COMPANY PROFILES

Abbott Laboratories

Figure 4: Abbott Revenue Shares, By Region, 2013

Actgene, Inc.

Affymetrix, Inc.

Table 85: Affymetrix Revenue Shares, By Business Unit, 2013

Figure 5: Affymetrix Revenue Shares, By Product Category, 2013

Agilent Technologies, Inc.

Figure 6: Agilent Technologies Revenue Shares, By Business Group, 2013

Ambry Genetics Corporation

Amresco, Llc

Biomérieux S.A.

Bio Basic Canada, Inc.

Bio-Rad Laboratories, Inc.

Figure 7: Bio-Rad Laboratories Revenue Shares, By Region, 2013

Table 86: Bio-Rad Laboratories Revenue Shares, By Segment, 2013

Biochain Institute, Inc.

Biocontrol Systems, Inc.

Bionexus, Inc.

Bioserve Biotechnologies Ltd.

Biotium, Inc.

Bulldog Bio, Inc.

Cepheid, Inc.

Table 87: Clinical And Non-Clinical Revenue Shares, 2013

Figure 8: Cepheid Revenue Shares, By Region, 2013

E. I. Du Pont De Nemours And Company

Epicentre Biotechnologies (An Illumina Company)

Epigentek Group, Inc.

Eppendorf Ag

Figure 9: Eppendorf Revenue Shares, By Region, 2013

Eurofins Genomics

F. Hoffmann-La Roche Ltd.

Table 88: Roche Diagnostics – Main Businesses And Their Revenues, 2013

Figure 10: Roche Diagnostics Revenue Shares, By Region, 2013

Table 89: Selected PCR-Based Companion Diagnostics Under Development By Roche

Fluidigm Corporation

Figure 11: Fluidigm Revenue Shares, By Region, 2013

Funglyn Biotech, Inc.

Gene Link, Inc.

Hercuvan Lab Systems, Inc.

Icubate, Inc.

Illumina, Inc.

Table 90: Revenue Shares Of Illumina, By Product Category, 2012-2013 (USD, Million)

Figure 12: Illumina Revenue Shares, By Region, 2013

Infinigen Biotechnology, Inc.

Integrated Dna Technologies, Inc.

Instantlabs Invisible Sentinel, Inc.

Kapa Biosystems, Inc.

Kestrel Biosciences, Llc

Lucigen Corporation Maxim Biotech, Inc.

Merck Millipore International

Figure 13: Merck Millipore Revenue Shares, By Region, 2013

Table 91: Merck Millipore Revenue Shares, By Business Segments, 2013

Molecular Cloning Laboratories (MCLAB)

New England Biolabs, Inc.

Norgen Biotek Corporation

Pall Corporation

Premier Biosoft International

PrimeraDX, Inc.

Promega Corporation

QIAGEN N.V.

Figure 14: Revenue Distribution By Customer Categories, QIAGEN, 2013

Table 92: Geographic Distribution Of QIAGEN Revenues, 2012-2013 (USD, Million)

Quanta Biosciences, Inc.

Raindance Technologies, Inc.

Scientific Specialties Incorporated

Sigma-Aldrich Corporation

Table 93: Main Business Units Of Sigma-Aldrich And Their Revenue Shares, 2013

Figure 15: Revenue Shares Of Sigma-Aldrich Business Units, By Region, 2013

Takara Bio, Inc.

Figure 16: Takara Bio Revenue Shares, By Business Segment, Fiscal Year 2013

Table 94: Takara Bio Revenue Shares, By Business Segment, Fiscal Year 2013

Thermo Fisher Scientific, Inc.

Figure 17: Thermo Fisher Scientific Revenue Shares, By Region, 2013

Figure 18: Life Technologies Revenue Shares, By Region, 2012

Table 95: Thermo Fisher Scientific Revenue Shares, By Business Segments, 2013

Toyobo Co., Ltd

Table 96: Toyobo Revenue Shares, By Business Segment, Fiscal Year 2013

Zoologix, Inc.

GLOSSARY
List Of Tables
Table 1: Timeline Of PCR Technology History (1983 – 2013)
Table 2: Timeline Of Real-Time PCR History
Table 3: Timeline Of Digital PCR History
Table 4: Some Important Factors To Be Considered While Planning PCR Experiments
Table 5: Key Players And Their Products In The Field Of Colony PCR
Table 6: Key Players And Their Products In The Field Of Digital PCR
Table 7: Key Players And Their Products In The Field Of Direct PCR
Table 8: Key Players And Their Products In The Field Of Hot-Start PCR
Table 9: Key Players And Their Products In The Field Of In Situ PCR
Table 10: Key Players And Their Products In The Field Of Long PCR
Table 11: Key Players And Their Products In The Field Of Long Accurate PCR
Table 12: Key Players And Their Products In The Field Of Methylation-Specific PCR
Table 13: Key Players And Their Products In The Field Of Multiplex PCR
Table 14: Key Players And Their Products In The Field Of Nested PCR
Table 15: Key Players And Their Products In The Field Of Quantitative Fluorescence PCR
Table 16: Key Players And Their Products In The Field Of Random Amplified Polymorphic Dna PCR
Table 17: Commonly Used Detection Chemistries In Real-Time PCR
Table 18: Key Players And Their Products In The Field Of Real-Time PCR
Table 19: Key Players And Their Products In The Field Of Reverse Transcription PCR
Table 20: Key Players And Their Products In The Field Of Single Cell PCR
Table 21: Key Players And Their Products In The Field Of Universal Fast Walking PCR
Table 22: Key Players Offering PCR-Based Cancer Diagnostics Products In The Market
Table 23: Key Players Offering PCR-Based Diagnostics Products Targeting Human Infections
Table 24: Key Players Offering PCR-Based Prenatal Diagnostics Products In The Market
Table 25: Common Commercial Systems Used For Food Pathogen Detection
Table 26: International Standards And Guidelines For Campylobacter Spp. Identification
Table 27: Key Players Offering PCR-Based Kits To Detect Campylobacter And Its Subspecies
Table 28: International Standards And Guidelines For Escherichia Coli Detection
Table 29: Key Players Offering PCR-Based Kits To Detect Pathogenic Escherichia Coli And Its Subspecies
Table 30: International Standards And Guidelines For Listeria Detection
Table 31: Key Players Offering PCR-Based Kits To Detect Listeria Monocytogenes And Its Subspecies
Table 32: International Standards And Guidelines For Salmonella Detection
Table 33: Key Players Offering PCR-Based Kits To Detect Salmonella And Its Subspecies
Table 34: Key Players Offering PCR-Based Kits To Detect Other Selected Food-Borne And Water-Borne Pathogens Table 35: Key Players Offering PCR-Based Veterinary Diagnostics Products
Table 36: Key Players Offering PCR-Based Diagnostics Products Targeting Plant Infections
Table 37: Key Players Offering PCR-Based Kits To Detect Gmo Foods/Plants In The Market
Table 38: Key Players Offering PCR-Based Kits To Detect Food Allergens And Animal Species In Food In The Market Table 39: Key Players Offering PCR-Based Human Identity And Forensic Testing Products In The Market
Table 40: Key Players Offering Products For Microrna Analysis Involving PCR Technology
Table 41: Key Players Offering PCR-Based Mutations Detection Products
Table 42: Key Players Offering PCR-Based Products For Snps Detection And Genotyping
Table 43: Key Players Offering PCR-Based Sequencing Products
Table 44: Key Players Offering Ngs Library Quantification Products That Incorporate PCR Technology
Table 45: Key Players Offering PCR-Related Products For Genotyping/Dna Fingerprinting
Table 46: Key Players Offering PCR-Based Site-Directed Mutagenesis Products
Table 47: Basic PCR Patents Expired In 28 March 2005 In Usa
Table 48: Key Patents In Selected PCR Market Segments And Their Expiry Dates In USA
Table 49: Market Drivers Of The North American PCR Market
Table 50: Market Restraints Of The North American PCR Markets
Table 51: Key Mergers And Acquisitions During The Past Five Years Relevant In PCR Market (2010-2014)
Table 52: Global PCR Technology Markets, By Value (USD, Million)
Table 53: PCR Market Segments And Their Growth Trends In North America, By Value (USD, Million)
Table 54: Global PCR Technologies Demand By End-Use Segments, By Value (USD, Million)
Table 55: PCR Technologies Demand By End-Use Segments In North America, By Value (USD, Million)
Table 56: Regulatory Agencies Responsible For Molecular Diagnostics In North America
Table 57: Regulatory Agencies Influencing Genetic Testing In USA
Table 58: Laws And Regulations Influencing PCR-Based Medical Diagnostics Markets In USA
Table 59: Key Laws And Regulations Influencing PCR-Based Medical Diagnostics Markets In Canada
Table 60: Main International Agencies Involved In Food Safety Aspects
Table 61: Regulatory Agencies Responsible For Food Safety Testing Regulations In USA
Table 62: Food Safety Laws And Regulations Influencing PCR Technologies Markets In USA
Table 63: Food Safety Laws And Regulations In Canada
Table 64: Frequently Used PCR Kits Accepted At NDIS, USA
Table 65: Selected Companies Enabling High Throughput In QPCR
Table 66: Comparison Of The Reaction Formats Of Selected Real-Time PCR Instruments In The Market
Table 67: Comparison Of The Thermal Modules Of Selected Commercial Real-Time PCR Systems
Table 68: Comparison Of The Optical Modules Of Selected Real-Time PCR Systems In The Market
Table 69: Technical Approaches Adopted For Limiting Off-Target Amplification In Multiplex QPCR Assays
Table 70: Fluorescence Chemistry And Multiplex Capability Of Selected QPCR Systems In The Market
Table 71: Comparison Of Patenting Trends In Selected PCR Segments (1983 – 2013)
Table 72: Selected Patents On Digital PCR
Table 73: Selected Patents On Inverse PCR
Table 74: Selected Patents On Multiplex PCR
Table 75: Selected Patents On Nested PCR
Table 76: Selected Patents On Real-Time PCR
Table 77: Selected Patents On Reverse Transcription PCR
Table 78: PCR-Based Diagnostics: Patenting Trends In Selected Infected Disease Areas
Table 79: PCR-Based Diagnostics: Patenting Trends In Selected Cancer Segments
Table 80: PCR-Based Diagnostics – Patenting Trends In Selected End-Use Segments
Table 81: Assessing The Influence Of Real Time PCR In Selected End-Use Segments
Table 82: End-Use Segments Where DPCR Patenting Activities Are Growing
Table 83: Patents By Selected Key Players Related To Real-Time PCR
Table 84: Patents By Key Players Related To Digital PCR A
Table 85: Affymetrix Revenue Shares, By Business Unit, 2013
Table 86: Bio-Rad Laboratories Revenue Shares, By Segment, 2013
Table 87: Clinical And Non-Clinical Revenue Shares, 2013
Table 88: Roche Diagnostics – Main Businesses And Their Revenues, 2013
Table 89: Selected PCR-Based Companion Diagnostics Under Development By Roche
Table 90: Revenue Shares Of Illumina, By Product Category, 2012-2013 (USD, Million)
Table 91: Merck Millipore Revenue Shares, By Business Segments, 2013
Table 92: Geographic Distribution Of QIAGEN Revenues, 2012-2013 (USD, Million)
Table 93: Main Business Units Of Sigma-Aldrich And Their Revenue Shares, 2013
Table 94: Takara Bio Revenue Shares, By Business Segment, Fiscal Year 2013
Table 95: Thermo Fisher Scientific Revenue Shares, By Business Segments, 2013
Table 96: Toyobo Revenue Shares, By Business Segment, Fiscal Year 2013

List Of Figures
Figure 1: Market Shares And Forecasts Of Global PCR Technology Market Segments
Figure 2: Market Shares And Forecasts Of PCR Technologies Demand By End-Use Segments
Figure 3: PCR Platforms With Intense Patenting Activities During The Past Three Decades
Figure 4: Abbott Revenue Shares, By Region, 2013
Figure 5: Affymetrix Revenue Shares, By Product Category, 2013
Figure 6: Agilent Technologies Revenue Shares, By Business Group, 2013
Figure 7: Bio-Rad Laboratories Revenue Shares, By Region, 2013
Figure 8: Cepheid Revenue Shares, By Region, 2013
Figure 9: Eppendorf Revenue Shares, By Region, 2013
Figure 10: Roche Diagnostics Revenue Shares, By Region, 2013
Figure 11: Fluidigm Revenue Shares, By Region, 2013
Figure 12: Illumina Revenue Shares, By Region, 2013
Figure 13: Merck Millipore Revenue Shares, By Region, 2013
Figure 14: Revenue Distribution By Customer Categories, Qiagen, 2013
Figure 15: Revenue Shares Of Sigma-Aldrich Business Units, By Region, 2013
Figure 16: Takara Bio Revenue Shares, By Business Segment, Fiscal Year 2013
Figure 17: Thermo Fisher Scientific Revenue Shares, By Region, 2013
Figure 18: Life Technologies Revenue Shares, By Region, 2012