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2014

IQ4I Research & Consultancy Pvt. Ltd.

[email protected]

www.iq4i.com

PCR Technologies Global Market

[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)]

– 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. Page 2


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Table of Contents



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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 2020. 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.



–Forecast to 2020

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)



–Forecast to 2020

FIGURE 1

EXECUTIVE SUMMARY: GLOBAL PCR MARKET SHARE,

BY GEOGRAPHY (2013)

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

2012 2013 2014 2015 2016 2017 2018 2019 2020

Asia-Pacific RoW Europe North America

Represents CAGR% (2014 – 2020)

8.3%

Mar

ket S

ize

($M

N) (

20

12

-20

20

)



–Forecast to 2020

TABLE 1

PCR GLOBAL MARKET REVENUE, BY TECHNIQUE,

(2012-2020) ($MN)

Technique 2012 2013 2014 2020 CAGR %

(2014-2020)

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 2020. 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.



–Forecast to 2020

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.



–Forecast to 2020

FIGURE 2

GLOBAL PCR TECHNOLOGIES MARKET SHARE, BY KEY PLAYER’S

(2013)

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

XX

XX

Qiagen N.V. (Netherlands)

XX

Sigma Aldrich Corporation (U.S.)

Promega Corporation (U.S.)

Others



–Forecast to 2020

TABLE 2

PCR GLOBAL MARKET REVENUE, BY PRODUCTS,

(2012-2020) ($BN)

Product 2012 2013 2014 2020 CAGR %

(2014-2020)

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





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 2020. 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.



–Forecast to 2020

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.



–Forecast to 2020

FIGURE 3

GLOBAL PCR CLINICAL DIAGNOSTIC APPLICATION MARKET SHARE,

INFECTIOUS V’S NON INFECTIOUS, (2013)




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.

Cancer therapy and determination

Prenatal diagnosis

Genetic testing for hereditory diseases

Blood screening

Hepatitis B and C testing

Tuberculosis diagnosis

HIV diagnosis

Other Infectious Applications

Infectious Non-Infectious



–Forecast to 2020

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 low-

cost 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.



–Forecast to 2020

FIGURE 4

GLOBAL PCR SOFTWARE MARKET (2012-2020), ($MN)




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,

2012 2013 2014 2015 2016 2017 2018 2019 2020

Primer design and sequencing software PCR analyzer software Other software

Mar

ket S

ize

($M

N)



–Forecast to 2020

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

(2012-2020) ($MN)

End-User 2012 2013 2014 2020 CAGR %

(2014-2020)

Hospitals and laboratories

XX XX 1,337 XX XX

Pharmaceuticals, CRO's and Biotech companies

XX XX XX XX XX

Academics XX XX XX XX 8.5

Other PCR End Users XX XX XX XX XX





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



–Forecast to 2020

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.



–Forecast to 2020

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



–Forecast to 2020

1.2 RESEARCH METHODOLOGY

FIGURE 5

PCR TECHNOLOGIES MARKET: RESEARCH APPROACH

• Bottom-up and Top-down approach

• Data triangulation

• Qualitative & Quantitative analysis

• PCR market segmentation

• 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

• 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

Market

Breakdown

Primary

Research

Secondary

Research



–Forecast to 2020

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

Market share of PCR techniques, products

and applications

Regional market shares

Market share of sub

segments in regional markets

Sub segments

market size and

CAGR

Overall

market size and CAGR

Market share of the players in

the overall PCRMarket and sub markets

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.)

Global PCR market



–Forecast to 2020

FIGURE 7

PCR TECHNOLOGIES MARKET: FORECASTING MODEL

Historical Data

and trends of

PCR Market

Evolution

Company

developmentsApplications

Download Pattern

Regulatory

Landscape

Factors Influencing

Market Growth Market Opportunities

• Increasing affinity for

automated high throughput

and robotic equipment

• Integration of Technologies

New product launch

Contributed for 32.3% of

market strategies

Agreements & Joint

ventures Contributed for

25.3%.

Technology

Evolution

Supply chain

trendAdoption pattern Regulations

Market ShareValue and volume

analysis

Geographical

Usage

Market Penetration

• Advent of digital PCR

• Increasing RT-PCR based

food safety testing

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

DNA sequencing technology

Market Drivers

• Increasing demand for

innovative technologies

• Expiry of PCR patents

• Rising investments in the

field of companion

diagnostics

.

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 2014-2020

Market Trend and

Growth Forecasting



–Forecast to 2020

1.2.2 MARKET BREAKDOWN & DATA TRIANGULATION

FIGURE 8

PCR TECHNOLOGIES MARKET: MARKET BREAKDOWN & DATA

TRIANGULATION

Demand & Supply side

Laboratories, CRO’s,

Biotech and pharma

companies, healthcare

organizations

Supply side:

Executives from major

companies, consultants

Market share of PCR

Market in Global

Medical device market

Top -down

Primary

Research

Bottom -up

Secondary

Research

PCRMarket

(~ Bn)

(2013)

•Financial/Annual reports

•Investor Presentations

•SEC filings

•Scientific Journals

•Organizations/

Associations & Groups

Market share analysis

of key players:

Abbott, BD & Co, GE

Healthcare, Roche.

Sigma Aldrich and

Others



–Forecast to 2020

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sample- - IQ4I Research · PDF filePCR Technologies Global Market –Forecast to 2020 ... Services segment is expected for high growth rate of ... It further discussed market dynamics,