Description
During the past three decades since its invention, PCR has evolved to become one of the fundamental technology platforms in life sciences sector. The application segments of this platform are still expanding, driven by the expiry of key PCR patents. The demand for fast, accurate, and affordable diagnosis tests in healthcare segment has been another key driver of the PCR market. The rising investments in the field of companion diagnostics have also been boosting the demand for PCR. Food safety testing is another significant end-use segment of the technology, driven by both consumer demand and regulatory requirements.
While developed countries still dominate the PCR market, the emerging markets are showing strong growth trends. In this latest study titled “The Worldwide Markets for PCR Technologies”, AcuBiz Consulting analysts identify market dynamics in various regions and forecasts the potential of the market related to product segments, technology segments, and end-use segments. The global market, which stood at $10.6 billion in 2013, is expected to grow at a CAGR of around 8% during 2013-2018. Even though North America had highest market share in 2013, the region is expected to grow at a relatively lower CAGR of around 6% during the forecast period, while Asia Pacific region is forecasted to grow at a CAGR of over 11% during the same period.
The report estimates the market size of the key product and application segments of PCR and forecasts the growth based on market dynamics of these segments, which can impact the demand for PCR. Various technology segments are also analysed in detail.
The study assesses alternate platforms that can potentially impact the demand for PCR. Evolving trends with respect to various aspects of PCR technology are also analysed in detail. This is followed by patent analysis to identify most active areas within PCR market that are gaining attention and investment by stake holders.Regulatory landscape of the key regional markets and end-use segments are also included in the report, since regulatory requirements directly impact the demand for PCR-based tests.
Finally, the report analyses the activities of key players in the market. The company profiles section divides the companies into Tier-1 companies and Tier-2 and other promising companies. This section includes nearly 90 profiles, and includes companies in the emerging markets such as China, India, Southeast Asia, Latin America, and East Europe.
Introduction
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
The Concept
Important Considerations
PCR Platforms – Popular and Emerging
Allele-specific PCR (ASPCR)
Amplified Fragment Length Polymorphisms PCR (AFLP-PCR)
Assembly PCR
Asymmetric PCR
Capillary PCR
Colony PCR
Digital PCR (dPCR)
Direct PCR
Hot-Start PCR
In Situ PCR
Inter-Simple Sequence Repeat PCR (ISSR-PCR)
Inverse PCR
Long PCR
Long Accurate PCR (LA PCR)
Methylation-Specific PCR
Mini Primer PCR
Multiplex PCR
Nanoparticle Assisted PCR (Nano PCR)
Nested PCR
Overlap-Extension PCR (OE-PCR)
Quantitative Fluorescence PCR (QF-PCR)
Random Amplified Polymorphic DNA (RAPD) PCR
Real-Time PCR
Repetitive Sequence-Based PCR (rep-PCR)
Reverse Transcription PCR (RT-PCR)
Single Cell PCR
Solid Phase PCR
Thermal Asymmetric Interlaced PCR (TAIL-PCR)
Touchdown PCR
Universal Fast Walking PCR (UFW)
End-Use Segments of PCR
Medical Diagnostics Segments
Cancer
Infectious Diseases
Prenatal Diagnostics
Food Safety Testing, Agricultural, and Environmental Segments
Food-Borne and Water-Borne Infections
I.Campylobacterand its subspecies (Campylobacter spp.)
II.Escherichia coli (E. coli)
III.Listeria monocytogenesand its subspecies (Listeria spp.)
IV.Salmonella and its Subspecies (Salmonella spp.)
V.Other Food-Borne and Water-Borne Pathogens
Veterinary Infection Diagnostics
Plant Infection Diagnostics
GMO Foods/Plants Testing
Food Allergens and Animal Species in Food
Forensic Sciences
Life Sciences Research
miRNA Analysis
Mutations Detection
SNP Detection and Genotyping
Sequencing
Application of PCR in NGS Library Quantification
Genetic Fingerprinting
Site-Directed Mutagenesis (SDM)
Market Trends
Widening Application Scope
Patent Expiries during the Forecast Period
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
Market Challenges
Rising Merger and Acquisition Trends
CHAPTER 2: INDUSTRY STRUCTURE
Analysis of Global PCR Technology Markets
Analysis of Key End-Use Segments
Medical Diagnostics
Food, Agriculture, etc.
Life Sciences Research
Real-Time PCR vs. Other PCR Technologies
Regional Markets
North America
The European Union
Asia Pacific (APAC)
Rest of World (ROW)
CHAPTER 3: LEGISLATION AND REGULATION
MIQE Guidelines and RDML
Regulatory Landscape of PCR Technologies in Medical Diagnostics Fields
Regulation of Laboratory Developed Tests (LDTs) in USA
Regulatory Landscape of PCR Technologies Targeting Food and Agricultural Segments
USA
European Union (EU)
Japan
Australia and NewZealand
China
South Korea
Other Selected Countries (Brazil, Canada, India, Kenya, Malaysia, Russia and Singapore)
Forensics
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
Evolution in Heating Technologies for Efficient Thermal Cycling
Speed
Detectors
Light Source
Improving Multiplexing Efficiency
Fluorescence Chemistry
TaqMan Probe
Molecular Beacons and Scorpions
The Early Adopters of dPCR
Widening Scope within Molecular Biology Platforms
CHAPTER 5: PATENT ANALYSIS
Assessing the Popularity of PCR Platforms on the Basis of Patenting Trends
Patenting Trends in Selected End-Use Segments of PCR
Analysis of Patenting Trends in Infectious Diseases Sector
Analysis of Patenting Trends in Cancer Sector
The Rising Popularity of Real-Time PCR
End-Use Segments where Digital PCR Influence is Growing
Patenting Trends of Key Players in the PCR Market
Patenting Trends of Companies in the Real-Time PCR Segment
Patenting Trends of Companies within the Digital PCR Segment
CHAPTER 6: COMPANY PROFILES
Tier-1 Companies
Abbott Laboratories
Affymetrix, Inc.
Agilent Technologies, Inc.
bioMérieux S.A.
Bio-Rad Laboratories, Inc.
Cepheid, Inc.
Eppendorf AG
F. Hoffmann-La Roche Ltd.
Merck Millipore International
Promega Corporation
QIAGEN N.V.
Sigma-Aldrich Corporation
Takara Bio, Inc.
Thermo Fisher Scientific, Inc.
Toyobo Co., Ltd
Tier-2 and Other Promising Companies
A & A Biotechnology
AgriGen Biotech Pty. Ltd.
AITbiotech Pte. Ltd.
Altona Diagnostics GmbH
Analytik Jena AG
AnDiaTec GmbH & Co. KG
Aristogene Biosciences Pvt. Ltd.
Asia-Pacific Special Nutrients Sdn. Bhd.
AsiaGen Corporation
Bio Basic Canada, Inc.
Bibby Scientific Limited
Bioer Technology Co., Ltd.
Bioline Reagents Limited
BIONEER Corporation
Bionexus, Inc.
Biotium, Inc.
Chromous Biotech Pvt. Ltd.
DAAN Gene Co., Ltd.
DNA-Technology LLC
E. I. du Pont de Nemours and Company
Ecoli s.r.o
ELITech Group
Eurogentec S.A.
Favorgen BioTech Corporation
Fisher Biotec Pty. Ltd.
Fluidigm Corporation
Funglyn Biotech, Inc.
G-Storm
Gaia Science (M) Sdn. Bhd.
Geneflux Biosciences Sdn. Bhd.
GenoID Ltd.
geneOmbio Technologies Pvt. Ltd.
GeneReach Biotechnology Corporation
GeneTech Biotechnology Pvt. Ltd.
GeneWorks Pty. Ltd.
Genome Diagnostics Pvt. Ltd. / Professional Biotech Pvt. Ltd.
Guangzhou Dongsheng Biotech Co., Ltd.
Hy Laboratories Ltd.
i-DNA Biotechnology Pte. Ltd.
iCubate, Inc.
Illumina, Inc.
Inqaba Biotechnical Industries (Pty) Ltd.
Integrated DNA Technologies, Inc.
InterLabService Ltd.
JN Medsys Pte. Ltd.
Kapa Biosystems, Inc.
KIAGEN-Biotech
KogeneBiotech Co., Ltd.
Kyratec Ltd.
LGC Genomics Ltd.
LIR Biotech (Lab-Ind Resource Sdn. Bhd.)
Lucigen Corporation
Medical Innovation Ventures Sdn. Bhd.
Molecular Cloning Laboratories (MCLAB)
Multiplicom N.V.
New England Biolabs, Inc.
Next Gene Scientific Sdn. Bhd.
Norgen Biotek Corporation
Ocimum Biosolutions Ltd.
Olipro Biotechnology Sdn. Bhd.
PathoFinder B.V.
PREMIER Biosoft International
PrimeraDx, Inc.
RainDance Technologies, Inc.
RBC BioScience Corporation
Sacace Biotechnologies Srl
Seegene, Inc.
Shanghai Hongshi Medical Technology Co., Ltd.
Shanghai Kehua Bio-Engineering Co., Ltd.
ShineGene Bio-Technologies, Inc.
TransGen Biotech, Inc.
Xi’an Tianlong Science and Technology Co., Ltd.
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 Global PCR Market
Table 50: Market Restraints of the Global 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: Global PCR Technologies Demand by End-Use Segments, by Value (USD, Million)
Table 54: Global Demand for Real-Time PCR, By Value (USD, Million)
Table 55: Global PCR Technology Markets by Region, By Value (USD, Million)
Table 56: PCR Market Segments and their Growth Trends in North America, By Value (USD, Million)
Table 57: PCR Market Segments and their Growth Trends in the EU, By Value (USD, Million)
Table 58: PCR Market Segments and their Growth Trends in APAC, By Value (USD, Million)
Table 59: PCR Market Segments and their Growth Trends in ROW, By Value (USD, Million)
Table 60: Regulatory Agencies Responsible for Molecular Diagnostics in Key Markets
Table 61: Regulatory Agencies Influencing Genetic Testing in USA
Table 62: Laws and Regulations Influencing PCR-based Medical Diagnostics Markets in USA
Table 63: Laws and Regulations Influencing PCR-based Medical Diagnostics Markets in Australia
Table 64: Key Laws and Regulations Influencing PCR-based Medical Diagnostics Markets in Other Selected Countries
Table 65: Main International Agencies Involved in Food Safety Aspects
Table 66: GMO Labeling Regulations in Selected Countries
Table 67: Agencies Responsible for Food Safety Testing Regulations in USA
Table 68: Food Safety Laws and Regulations Influencing PCR Technologies Markets in USA
Table 69: Selected Regulatory Agencies Responsible for Food Safety and GMO Testing in EU
Table 70: Food Safety Laws and Regulations Influencing PCR Technologies Markets in EU
Table 71: Regulatory Agencies Responsible for Food Safety in Japan
Table 72: Food Safety Laws and Regulations Influencing PCR Technologies Market in Japan
Table 73: Regulatory Agencies Responsible for Food Safety in Australia and New Zealand
Table 74: Food Safety Laws and Regulations in Australia and New Zealand
Table 75: Food Safety Laws and Regulations in China
Table 76: Regulatory Agencies Responsible for Food Safety in South Korea
Table 77: Food Safety Laws and Regulations in South Korea
Table 78: Regulatory Agencies Responsible for Food Safety in Other Selected Countries
Table 79: Food Safety Laws and Regulations in Other Selected Countries
Table 80: Frequently Used PCR Kits Accepted at NDIS, USA
Table 81: Selected Companies Enabling High Throughput in qPCR
Table 82: Comparison of the Reaction Formats of Selected Real-Time PCR Instruments in the Market
Table 83: Comparison of the Thermal Modules of Selected Commercial Real-Time PCR Systems
Table 84: Comparison of the Optical Modules of Selected Real-Time PCR Systems in the Market
Table 85: Technical Approaches Adopted for Limiting Off-Target Amplification in Multiplex qPCR Assays
Table 86: Fluorescence Chemistry and Multiplex Capability of Selected qPCR Systems in the Market
Table 87: Comparison of Patenting Trends in Selected PCR Segments (1983 – 2013)
Table 88: Selected Patents on Digital PCR
Table 89: Selected Patents on Inverse PCR
Table 90: Selected Patents on Multiplex PCR
Table 91: Selected Patents on Nested PCR
Table 92: Selected Patents on Real-Time PCR
Table 93: Selected Patents on Reverse Transcription PCR
Table 94: PCR-Based Diagnostics – Patenting Trends in Selected Infectious Disease Areas
Table 95: PCR-Based Diagnostics – Patenting Trends in Selected Cancer Segments
Table 96: PCR-Based Diagnostics – Patenting Trends in Selected End-Use Segments
Table 97: Assessing the Influence of Real Time PCR in Selected End-Use Segments
Table 98: End-Use Segments where dPCR Patenting Activities are Growing
Table 99: Patents by Selected Key Players Related to Real-Time PCR
Table 100: Patents by Key Players Related to Digital PCR
Table 101: Affymetrix Revenue Shares, by Business Unit, 2013
Table 102: Bio-Rad Laboratories Revenue Shares, by Segment, 2013
Table 103: Clinical and Non-Clinical Revenue Shares, 2013
Table 104: Roche Diagnostics – Main Businesses and their Revenues, 2013
Table 105: Selected PCR-Based Companion Diagnostics Under Development by Roche
Table 106: Merck Millipore Revenue Shares, by Business Segments, 2013
Table 107: Geographic Distribution of QIAGEN Revenues, 2012-2013 (USD, Million)
Table 108: Main Business Units of Sigma-Aldrich and Their Revenue Shares, 2013
Table 109: Takara Bio Revenue Shares, by Business Segment, Fiscal Year 2013
Table 110: Thermo Fisher Scientific Revenue Shares, by Business Segments, 2013
Table 111: Toyobo Revenue Shares, by Business Segment, Fiscal Year 2013
Table 112: Revenue Shares of Illumina, By Product Category, 2012-2013 (USD, Million)List of Figures
Figure 1: Market Shares and Forecasts of PCR Technology Market Segments
Figure 2: PCR Instruments Markets by Region, 2013
Figure 3: PCR Reagents and Consumables Markets by Region, 2013
Figure 4: PCR Platforms with Intense Patenting Activities during the Past Three Decades
Figure 5: Abbott Revenue Shares, by Region, 2013
Figure 6: Affymetrix Revenue Shares, by Product Category, 2013
Figure 7: Agilent Technologies Revenue Shares, by Business Group, 2013
Figure 8: Bio-Rad Laboratories Revenue Shares, by Region, 2013
Figure 9: Cepheid Revenue Shares, by Region, 2013
Figure 10: Eppendorf Revenue Shares, by Region, 2013
Figure 11: Roche Diagnostics Revenue Shares, by Region, 2013
Figure 12: Merck Millipore Revenue Shares, by Region, 2013
Figure 13: Revenue Distribution by Customer Categories, QIAGEN, 2013
Figure 14: Revenue Shares of Sigma-Aldrich Business Units, by Region, 2013
Figure 15: Takara Bio Revenue Shares, by Business Segment, Fiscal Year 2013
Figure 16: Thermo Fisher Scientific Revenue Shares, by Region, 2013
Figure 17: Life Technologies Revenue Shares, by Region, 2012
Figure 18: Fluidigm Revenue Shares, by Region, 2013
Figure 19: Illumina Revenue Shares, by Region, 2013Tier-1 Companies
Abbott Laboratorie
Affymetrix, Inc.
Agilent Technologies, Inc.
bioMérieux S.A.
Bio-Rad Laboratories, Inc.
Cepheid, Inc.
Eppendorf AG
F. Hoffmann-La Roche Ltd.
Merck Millipore International
Promega Corporation
QIAGEN N.V.
Sigma-Aldrich Corporation
Takara Bio, Inc.
Thermo Fisher Scientific, Inc.
Toyobo Co., Ltd
Tier-2 and Other Promising Companies
A & A Biotechnology
AgriGen Biotech Pty. Ltd.
AITbiotech Pte. Ltd.
Altona Diagnostics GmbH
Analytik Jena AG
AnDiaTec GmbH & Co. KG
Aristogene Biosciences Pvt. Ltd.
Asia-Pacific Special Nutrients Sdn. Bhd.
AsiaGen Corporation
Bio Basic Canada, Inc.
Bibby Scientific Limited
Bioer Technology Co., Ltd.
Bioline Reagents Limited
BIONEER Corporation
Bionexus, Inc.
Biotium, Inc.
Chromous Biotech Pvt. Ltd.
DAAN Gene Co., Ltd.
DNA-Technology LLC
E. I. du Pont de Nemours and Company
Ecoli s.r.o
ELITech Group
Eurogentec S.A.
Favorgen BioTech Corporation
Fisher Biotec Pty. Ltd.
Fluidigm Corporation
Funglyn Biotech, Inc.
G-Storm
Gaia Science (M) Sdn. Bhd.
Geneflux Biosciences Sdn. Bhd.
GenoID Ltd.
geneOmbio Technologies Pvt. Ltd.
GeneReach Biotechnology Corporation
GeneTech Biotechnology Pvt. Ltd.
GeneWorks Pty. Ltd.
Genome Diagnostics Pvt. Ltd. / Professional Biotech Pvt. Ltd.
Guangzhou Dongsheng Biotech Co., Ltd.
Hy Laboratories Ltd.
i-DNA Biotechnology Pte. Ltd.
iCubate, Inc.
Illumina, Inc.
Inqaba Biotechnical Industries (Pty) Ltd.
Integrated DNA Technologies, Inc.
InterLabService Ltd.
JN Medsys Pte. Ltd.
Kapa Biosystems, Inc.
KIAGEN-Biotech
KogeneBiotech Co., Ltd.
Kyratec Ltd.
LGC Genomics Ltd.
LIR Biotech (Lab-Ind Resource Sdn. Bhd.)
Lucigen Corporation
Medical Innovation Ventures Sdn. Bhd.
Molecular Cloning Laboratories (MCLAB)
Multiplicom N.V.
New England Biolabs, Inc.
Gene Scientific Sdn. Bhd.
Norgen Biotek Corporation
Ocimum Biosolutions Ltd.
Olipro Biotechnology Sdn. Bhd.
PathoFinder B.V.
PREMIER Biosoft International
PrimeraDx, Inc.
RainDance Technologies, Inc.
RBC BioScience Corporation
Sacace Biotechnologies Srl
Seegene, Inc.
Shanghai Hongshi Medical Technology Co., Ltd.
Shanghai Kehua Bio-Engineering Co., Ltd.
ShineGene Bio-Technologies, Inc.
TransGen Biotech, Inc.
Xi’an Tianlong Science and Technology Co., Ltd.
Zoologix, Inc.
