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1 IQ4I Research and Consultancy Research and Consultancy v4023/ Publisher Sample Phone: (US) or or (Int'l) Hours: Monday - Thursday: 5:30am - 6:30pm EST Fridays: 5:30am - 5:30pm EST customerservice@marketresearch.com MarketResearch.com

2 [Techniques (Standard PCR, Real Time PCR/ qpcr, Reverse transcriptase PCR, Digital PCR, Assembly PCR, Multiplex PCR, Hot Start PCR, Others (Nested, Inverse, Immuno, Long PCR)), Products (Instruments, Reagents & Consumables, Software, and Services), Applications (Clinical diagnostics, Industry applications, and Others), End-Users (Hospitals and laboratories, Pharmaceuticals, CRO's and Biotech companies, Academics, and Others), Region (North America, Europe, APAC and RoW)] 2014 Forecast to 2020 Copyright 2014 IQ4I All Rights Reserved. This document contains highly confidential information and is the sole property of IQ4I. No part of it may be circulated, copied, quoted, or otherwise reproduced without the approval of IQ4I. IQ4I Research & Consultancy Pvt. Ltd.

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14 1.1 REPORT DESCRIPTION The Polymerase Chain Reaction (PCR) is the most powerful technology in molecular biology enabling researchers to produce millions of copies of specific DNA sequence in a very short duration. The global PCR market is valued at $7.6 billion in 2013 and is expected to grow at a CAGR of 8.7% to reach $13.4 billion by The PCR market is mainly segmented by techniques, products, applications, and by geography. The booming healthcare technology market with demand for innovative technology for early and accurate diagnosis of life threatening diseases, rising investments in companion diagnostics, advent of digital PCR, expiry of key players PCR patents, increasing demand for PCR in genetic and molecular testing are some of the factors driving the PCR market growth. However stringent government regulations, lack of awareness of this technology and unavailability of skilled labor, emergence of alternate technology such as Next Generation Sequencing, high cost of some of the commercial PCR s are expected to hamper the PCR market growth. The global PCR market by technique is segmented into standard PCR, real time quantitative PCR, reverse transcriptase PCR, digital PCR, assembly PCR, multiplex PCR, hot start PCR and others. Real time quantitative PCR accounted for the largest revenue of $XX billion in 2013 and is poised to reach $XX billion by 2020, at a CAGR of XX%. Further, digital PCR market segment is expected to grow at the highest double digit CAGR of 12.2% during the forecast period. Based on products PCR market is segmented into instruments, reagents and consumables, software and services. Reagents and consumables commanded the largest market of $XX billion in 2013 and are expected to reach $XX billion in 2020 with a CAGR of XX%. Services segment is expected for high growth rate of XX% during the forecast period. Developed regions such as North America commanded the largest market of $XX billion in 2013 and are expected to reach $XX billion by 2020 at a CAGR of XX%. High investments in healthcare infrastructures, availability of government funds improved market growth in this region. However, Asia-pacific region is expected to grow at the highest CAGR of XX% during the forecast period due to increased healthcare awareness, improved economic growth and increasing disposable incomes. Significant mergers and acquisitions, collaborations, joint ventures are the industry trends that are playing a major role for the market growth. IQ4I Research & Consultancy Pvt. Ltd. Page 13

15 Major players in PCR market include Abbott Laboratories, Inc. (U.S.), Becton, Dickinson and Company (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Qiagen N.V. (Netherlands), Promega Corporation (U.S.), Sigma Aldrich (U.S.), Roche Diagnostics (Switzerland), Siemens Healthcare (Germany), Thermo Fisher Scientific, Inc. (U.S.) etc. Thermo Fisher scientific is a dominant player with a share of 24.4%, followed by Biorad laboratories, Qiagen N.V., Roche Diagnostics, Sigma Aldrich and Promega Corporation. The report analyzes PCR market globally with detailed information of various segments and products & services offered by various players. It further discussed market dynamics, industry trends, and challenges of PCR market. The report provides an in depth market analysis of the above mentioned segments across the following regions: North America Europe Asia-Pacific Rest of the World (RoW) IQ4I Research & Consultancy Pvt. Ltd. Page 14

16 Market Size ($MN) ( ) PCR Technologies Global Market FIGURE 1 EXECUTIVE SUMMARY: GLOBAL PCR MARKET SHARE, BY GEOGRAPHY (2013) Represents CAGR% ( ) 8.3% Asia-Pacific RoW Europe North America Source: National Human Genome Research Institute (NHGRI), National Centre for Genomic Resources (NCGR), Genome Science Centre (GSC), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), ASGT, NRCGEB, WHO, and Industry Expert Interviews IQ4I Research & Consultancy Pvt. Ltd. Page 15

17 TABLE 1 PCR GLOBAL MARKET REVENUE, BY TECHNIQUE, ( ) ($MN) Technique CAGR % ( ) Standard PCR XX XX XX XX XX Real time quantitative PCR XX 3,011 XX XX XX Reverse transcriptase PCR XX XX XX XX XX Digital PCR 513 XX XX XX 7.4 Assembly PCR XX XX XX XX XX Multiplex PCR XX XX XX XX XX Hot start PCR XX XX 220 XX XX Others XX XX XX XX XX Total 7,120 XX XX 13,433 XX Source: Associations of Molecular Pathology (AMP), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), American Society of Gene Therapy (ASGT), European Diagnostic Manufacturers Association (EDMA), World Health Organization (WHO), JACRI, NRCGEB and Industry Expert Interviews Real time quantitative PCR segment commanded the largest share valued at $3,011 million in 2013 and is expected to grow at a CAGR of XX% to reach $XX million by Digital PCR is expected grow at the highest double digit CAGR of XX% during the forecast period. The high growth is attributed to increasing applications such as mutational analysis, assessment of allelic imbalance in tissues, quantification of allele specific gene expression and detection of cancer in body fluid and stool DNA and favorable investments. IQ4I Research & Consultancy Pvt. Ltd. Page 16

18 Polymerase chain reaction (PCR) is one of the most affordable technologies in molecular biology for nucleic acid amplification. PCR market is driven by various factors such as the rising demand for rapid, accurate, and cost effective diagnostic tests in health care, increasing investments in the companion diagnostics field, the expiry of key PCR patents, its increasing usage in food safety testing etc. In addition the technological variants open new avenues for PCR technology. On the other hand the emergence of alternate technologies such as Next Generation Sequencing (NGS) along with regulatory interventions and lack of skilled labor are expected to hamper the PCR techniques market. Life Technologies offers different range of qpcr products such as QuantStudio qpcr system, ViiA 7 system, Step One Series, 7500 series Real time PCR systems. The Agilent s Mx3005P and Mx3000P qpcr systems are reliable and flexible instruments for gene expression analysis, SNP genotyping, microarray data validation, DNA methylation analysis, pathogen detection, and chromatin immuno-precipitation studies. Thermo Scientific s PikoReal, Roche s Light Cycler series and Bio-Rad s CFX96 and 384 touch ranges include advanced optical technology with precise thermal control. Digital PCR is used in many applications such as mutational analysis, assessment of allelic imbalance in tissues, quantification of allele specific gene expression and detection of cancer in body fluid and stool DNA. Some of the digital PCR s commonly used include Life Technology s QuantStudio 3D digital PCR system and Fluidigm s qdpcr 37K IFC which provides higher accuracy and throughput with average cost per sample. Raindance Technology s Raindrop digital PCR systems and Bio Rad s QX100 Droplet Digital PCR system are the well known Droplet Digital PCRs. IQ4I Research & Consultancy Pvt. Ltd. Page 17

19 FIGURE 2 GLOBAL PCR TECHNOLOGIES MARKET SHARE, BY KEY PLAYER S (2013) XX XX Qiagen N.V. (Netherlands) XX Sigma Aldrich Corporation (U.S.) Promega Corporation (U.S.) Others Source: National Human Genome Research Institute (NHGRI), National Centre for Genomic Resources (NCGR), Genome Science Centre (GSC), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), ASGT, NRCGEB, WHO, and Industry Expert Interviews IQ4I Research & Consultancy Pvt. Ltd. Page 18

20 TABLE 2 PCR GLOBAL MARKET REVENUE, BY PRODUCTS, ( ) ($BN) Product CAGR % ( ) Instruments XX XX XX XX XX Reagents & consumables XX XX 4,443 XX XX Software XX XX XX XX 8.0 Services XX XX XX 1,343 XX Total 7,120 XX XX 13,433 XX Source: Associations of Molecular Pathology (AMP), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), American Society of Gene Therapy (ASGT), European Diagnostic Manufacturers Association (EDMA), World Health Organization (WHO), JACRI, NRCGEB and Industry Expert Interviews The reagents and consumables commanded the largest share valued at $XX million in 2013 and is expected to grow at a CAGR of XX% to reach $XX million by PCR services segment is expected grow at the highest CAGR of XX% during the forecasted period. PCR reagents include the template DNA, PCR primers and probes, dntp s, PCR buffers, enzymes and master mixes. Consumable mostly include the PCR tubes, plates and other accessories to carry out the PCR reactions. DNA polymerase is the enzyme used to synthesize new strings of DNA. DNA polymerase from Thermus aquaticus called Taq polymerase is stable at 95 C and mediates in PCR amplification. The main drawback of this thermostable enzyme is to form primer-dimers in non optimized conditions even before the DNA denaturation process. The modifications in the existing Taq polymerase have resulted in the emergence of hot start recombinant Taq polymerases which becomes active only after the completion of denaturation process for the rest of the process to continue. IQ4I Research & Consultancy Pvt. Ltd. Page 19

21 In addition to Taq Polymerase, the other polymerases such as Pfu isolated from Pyrococcus furiosus and Vent or Tli polymerase isolated from Thermococcus litoralis are also used in amplification process. Thermo Scientific s Pfu polymerase have low error rate compared to other polymerases as it exhibits proofreading activity through 3 to 5 exonuclease activity which other polymerases lack. For the enzymes lacking this proofreading activity, the enzymes mix of thermostable polymerase with enzyme of 3 to 5 exonuclease activity is used. Genetically modified thermostable enzymes complexes of anti Tsp antibodies called Platinum Genotype Tsp DNA polymerase to amplify repeated loci of dinucleotide for genotyping was introduced by Life Technologies. Buffers one of the critical components of reagents registered a high growth during the forecast period. The readily available PCR buffers include Phusion buffers, Phire buffers, Taq DNA polymerase buffers and 40X yellow sample buffers provided by ThermoFisher Scientific. Life Technologies and Sigma Aldrich provide standard 10x buffer for PCR. Nuclease free also registered strong growth, some of the key players such as Life Technologies, Qiagen, Thermo Fisher, Promega Corporation provide diethylpyrocarbonate (DEPC)-treated water, nuclease-free water (not DEPC-treated), and RT-PCR grade water for PCR reaction. Life technologies Ambion and Ultra pure ranges for nuclease free water have been tested thoroughly for the presence of endo and exonucleases. IQ4I Research & Consultancy Pvt. Ltd. Page 20

22 FIGURE 3 GLOBAL PCR CLINICAL DIAGNOSTIC APPLICATION MARKET SHARE, INFECTIOUS V S NON INFECTIOUS, (2013) Hepatitis B and C testing Tuberculosis diagnosis HIV diagnosis Other Infectious Applications Cancer therapy and determination Prenatal diagnosis Genetic testing for hereditory diseases Blood screening Infectious Non-Infectious Source: Associations of Molecular Pathology (AMP), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), American Society of Gene Therapy (ASGT), European Diagnostic Manufacturers Association (EDMA), World Health Organization (WHO), JACRI, NRCGEB and Industry Expert Interviews Among the infectious clinical segment various types of PCR tests are available for the diagnosis of Hepatitis C virus (HCV) such as HCV PCR viral detection test (for presence of virus), HCV PCR viral load test (estimating the amount of virus) and HCV PCR genotype test (identifying the strain of HCV). Abbott s Reverse Transcriptase based RealTime HCV PCR assay is used for the quantification of hepatitis C viral RNA in human serum and plasma of the infected individuals. Roche s COBAS TaqMan HCV test includes the COBAS TaqMan48 analyzer for HCV amplification and quantification in the sample. Siemens healthcare offers VERSANT HCV RNA 1.0 and VERSANT HCV genotype 2.0 assays for detecting hepatitis causing viral RNA. Hepatitis B infection can be acute or chronic and have vaccination for prevention of the disease. Anyhow the qpcr can be used for detecting the viral RNA in the serum sample. IQ4I Research & Consultancy Pvt. Ltd. Page 21

23 Abbott s Real time HBV assay and Siemens VERSANT HBV DNA 1.0 assay are some of the tests used for HBV detection. Among the infectious segment tuberculosis diagnosis registered the strong growth during the forecast period. According to WHO (World Health Organization), Mycobacterium tuberculosis causes approximately 2 million deaths each year. In recent years improvements in the diagnosis of Tuberculosis caused by Mycobacterium tuberculosis have led to the emergence of molecular techniques such as PCR. PCR is highly specific and sensitive compared to the traditional methods such as Ziehl-Neelsen (ZN) staining and chest X-ray methods. Multiplex PCR targets the 38 kda gene and IS6110 insertion sequence present in Mycobacterium tuberculosis, thus improving the specificity of the reaction. Roche s AMPLICOR mycobacterium PCR system is being used for diagnosis of pulmonary TB. Qiagen in March 2014 launched an accurate tuberculosis testing product Quanti FERON TB in China to expand its business globally. In November 2013, Becton Dickinson and company, and Foundation for Innovative New Diagnostics (FIND) (Switzerland) collaborated to develop lowcost image-based tuberculosis screening platform, focusing on rapid diagnosis, health improvement, and drug discovery. The tuberculosis pericarditis testing Xpert MTB/RIF is developed by Cepheid Corporation in collaboration with Foundation for Innovative New Diagnostics (FIND). Genetic testing for hereditory diseases registered the strong growth among the non-infectious clinical diagnostics segment during the forecast period Human cystic fibrosis RT2 Profiler PCR Array is useful in profiling 84 key genes which are differentially expressed during cystic fibrosis or which interact with CTFR gene. SABiosciences, a Qiagen company includes RT2 Profiler PCR array in their product portfolio. Early detection of Pseudomonas aeruginosa in lung of patient with cystic fibrosis is done by qpcr technique. Most of the State health departments due to cost and effort involved in diagnosing do not recommend screening of newborns for Fragile X syndrome. In order to overcome this, Quest Diagnostics (New Jersey) has introduced XSense test which utilizes an improved PCR-based method to detect more than 200 repeats making screening procedure more feasible and eliminates the need of Southern blotting. IQ4I Research & Consultancy Pvt. Ltd. Page 22

24 Market Size ($MN) PCR Technologies Global Market FIGURE 4 GLOBAL PCR SOFTWARE MARKET ( ), ($MN) Primer design and sequencing software PCR analyzer software Other software Source: Associations of Molecular Pathology (AMP), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), American Society of Gene Therapy (ASGT), European Diagnostic Manufacturers Association (EDMA), World Health Organization (WHO), JACRI, NRCGEB and Industry Expert Interviews PCR analyzer software proves to be the strongest growing segment among the PCR software market. Several key players provide data analysis software to aid in the different application areas such as gene expression, mutational analysis and pathogen detection. Most of the software packages are easy to use and include features such as multiple chart and quality control flags to improve the data analysis. Bio-Rad s CFX manager software offers high resolution melt (HRM) analysis. Fluidigm s Biomark real time PCR analysis software include features such as calculation of delta delta Ct, IQ4I Research & Consultancy Pvt. Ltd. Page 23

25 automatic setting of threshold and automatic calculation of curve quality score. Intergromics s Stat Miner V5.0 and Biogazelle s qbase and qbaseplus are some are some of the PCR data analysis software in use. GenEx is the latest sotware that offers advanced methods to analyze real time qpcr data. Qiagen s RT² profiler PCR array is an integrated software package for PCR array data analysis that automatically calculates fold changes. Life Technologies provides different types of application specific software for analysis of PCR data, gene expression and genotypes. TABLE 4 GLOBAL PCR END USERS MARKET REVENUE, BY TYPE ( ) ($MN) End-User CAGR % ( ) Hospitals and laboratories Pharmaceuticals, CRO's and Biotech companies XX XX 1,337 XX XX XX XX XX XX XX Academics XX XX XX XX 8.5 Other PCR End Users XX XX XX XX XX Total 7,120 XX XX 13,433 XX Source: Associations of Molecular Pathology (AMP), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), American Society of Gene Therapy (ASGT), European Diagnostic Manufacturers Association (EDMA), World Health Organization (WHO), JACRI, NRCGEB and Industry Expert Interviews Among PCR end users, the pharmaceuticals, CRO s and biotech end users accounted for the highest share of XX% followed by academics with XX%, hospitals and laboratories with XX% and other end users with XX% shares. Among them the hospitals and laboratories are expected to grow with high double digit CAGR of XX% during the forecasted period. The high growth is IQ4I Research & Consultancy Pvt. Ltd. Page 24

26 attributed to ease of usage and reduced costs led by the technological advancements, and rising demand among the hospitals. The commercial availability of analyte specific reagents and ready to use master kits are making many clinical laboratories to adapt the PCR into their work flow. The PCR systems for laboratory use are selected based on their testing volumes. For instance the Applied Biosystem s Prism series, Bio-Rad s MyiQ and icycler RT PCR s are useful in laboratories testing large number of samples but with low thermocycling capacity. The Roche s LightCycler series and Cepheid s SmartCycler II offer rapid thermocycling to test fewer samples and complete the reaction within 30 minutes. The readily available automated nucleic acid extraction kits from major players such as Roche Diagnostics, Qiagen N.V., Applied Biosystems, Biomerieux etc., mediates in the recovery of nucleic acids with minimum manipulations, thus reducing the risk of cross contamination often seen in manual methods. The Roche s S.T.A.R. buffer has pathogen-inactivating properties and provides laboratories an added level of safety for processing and transporting pathogens for nucleic acid analysis. In addition the quality control guidelines published by Clinical Laboratory Standards Institute for molecular diagnostic methods in infectious disease testing helps in the verification of the tests performed. IQ4I Research & Consultancy Pvt. Ltd. Page 25

27 1.1.1 RESEARCH SOURCES TABLE 5 PCR TECHNOLOGIES MARKET: RESEARCH SOURCES Primary Sources Secondary Sources Supply Side: Top-level Executives, Marketing Managers, Sales Managers, Regional Managers Demand Side: Hospital Medical Directors, Laboratory Managers, Research Scientists, Principal Scientists, Purchase/Procurement Managers, Laboratory Technicians, Academic Research, CRO s and Biotech Firms Others: Independent Consultants and Freelancers IQ4I Repository NGS Company-Specific annual reports, SEC filings, corporate presentations & Press releases Associations and Groups : World Health Organization (WHO), Associations of Molecular Pathology (AMP), Association of Clinical Research Professionals (ACRP), American Genetic Association (AGA), American Society of Gene Therapy (ASGT), European Diagnostic Manufacturers Association (EDMA), and The Japan Association of Clinical Reagents Industries (JACRI), National Research Center for Genetic Engineering and Biotechnology of IRAN (NRCGEB) Paid Sources : Factiva, OneSource, Hoovers, Bloomberg Social Networking & Databases: LinkedIn, Melt-Water, Zintro IQ4I Research & Consultancy Pvt. Ltd. Page 26

28 1.2 RESEARCH METHODOLOGY FIGURE 5 PCR TECHNOLOGIES MARKET: RESEARCH APPROACH Secondary Research Technical information of PCR instruments and reagents Strategic insights, financial revenues and competitive intelligence of Key players Products and applications of PCR Market trends and growth scenario of sub markets and parent market Primary Research Market size, CAGR and market trends validation Market size of sub segments and market shares of major players Upcoming trends and technological advancements in techniques, products and applications Validation of factors influencing market and regional market shares Market Breakdown Bottom-up and Top-down approach Data triangulation Qualitative & Quantitative analysis PCR market segmentation IQ4I Research & Consultancy Pvt. Ltd. Page 27

29 1.2.1 MARKET SIZE ESTIMATION The Global PCR market size, its different segments and sub-segments is analyzed using both top-down and bottom-up approaches. The market size and revenue calculated using research methodology involves primary and secondary research of major players in the market, factors influencing the market, market segmentation and geographical market scenario. Secondary research of major players include the study of their annual and financial reports, press release while primary research involves interviews from the supply side (CEOs, directors, strategic growth managers, international/regional marketing managers, and marketing executives) and the demand side (reference laboratory heads, hospitals, and purchase managers). Primary and secondary sources helped in verification of percentage shares, splits, and breakdowns. This data is consolidated with detailed inputs and presented in this report. FIGURE 6 PCR TECHNOLOGIES MARKET: TOP-DOWN AND BOTTOM-UP APPROACH Global Medical device market Global PCR market Market share of PCR techniques, products and applications Overall market size and CAGR Regional market shares Market share of sub segments in regional markets Market share of the players in the overall PCR Market and sub markets Sub segments market size and CAGR Top players revenue Abbott Laboratories (U.S.), Bio-Rad Laboratories (U.S.), GE Healthcare (U.K.), Becton, Dickinson & Company (U.S.), Roche Diagnostics (Switzerland), Sigma Aldrich Corporation (U.S.), and Promega Corporation (U.S.) IQ4I Research & Consultancy Pvt. Ltd. Page 28

30 FIGURE 7 PCR TECHNOLOGIES MARKET: FORECASTING MODEL Historical Data and trends of PCR Market Technology Evolution Evolution Market Share Supply chain trend Company developments Adoption pattern Value Applications and volume Download analysis Pattern Regulatory Regulations Landscape Geographical Usage Factors Influencing Market Growth Market Drivers Increasing demand for innovative technologies Expiry of PCR patents Rising investments in the field of companion diagnostics Market Opportunities Increasing affinity for automated high throughput and robotic equipment Integration of Technologies Market Penetration Advent of digital PCR Increasing RT-PCR based food safety testing New product launch Contributed for 32.3% of market strategies Agreements & Joint ventures Contributed for 25.3%. Market Restraints High cost of commercial PCR assays Lack of awareness and requirement of skilled labour Investments In April 2014, Bio-Rad acquired GnuBio (U.S.), a developer of droplet based DNAsequencing technology Market Trend and Growth Forecasting Historical Market Data Impact Analysis of Market Trends Market Size & Forecast by Types Market Size & Forecast by Applications & End Users Global PCR Market Size, Segmental share and CAGR from IQ4I Research & Consultancy Pvt. Ltd. Page 29

31 1.2.2 MARKET BREAKDOWN & DATA TRIANGULATION FIGURE 8 PCR TECHNOLOGIES MARKET: MARKET BREAKDOWN & DATA TRIANGULATION Market share of PCR Market in Global Medical device market Top -down Financial/Annual reports Investor Presentations SEC filings Scientific Journals Organizations/ Associations & Groups Secondary Research PCR Market (~ Bn) (2013) Primary Research Demand & Supply side Laboratories, CRO s, Biotech and pharma companies, healthcare organizations Supply side: Executives from major companies, consultants Bottom -up Market share analysis of key players: Abbott, BD & Co, GE Healthcare, Roche. Sigma Aldrich and Others IQ4I Research & Consultancy Pvt. Ltd. Page 30

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