Molecular Diagnostics Market & Forecast (By Application, Technology, Countries, Companies & Clinical

Trials) to 2017: Global Analysis

Renub Researchwww.renub.com

Published: April, 2013Copyright © 2013 Renub Research – All Rights Reserved

Global Molecular Diagnostics Market & Future Forecast to 2017 Overview

The global molecular diagnostics market is witnessing a period of profound growth. The growth

is coming from different regions and markets. The next five years will witness significant

developments in molecular diagnostics such as automation, as well as introduction of a wide

range of new products. Molecular Diagnostics involves multiple technologies to identify genetic

variations in individual patients. These technologies include PCR, FISH, hybrid capture,

sequencing and microarrays. The increase in the aging population and incidences of various

chronic diseases are driving the demand of molecular diagnostics world over. The industry is

getting a push from every side and many factors collectively are fuelling the growth in this

industry. Growing with a CAGR of 14.64 percent global molecular diagnostics market is

expected to double its market size in 2017 from the market of 2012.

Molecular Diagnostics Market - Application Segment Analysis

The infectious disease testing is the leading application in Molecular Diagnostic. It is

likely to hold XXXX% share in 2017.

Molecular oncology tests have emerged as a second significant rapidly growing market

segment. Genetic Testing and Blood Screening are at the third and fourth spot

respectively in 2012.

The cardiovascular disease testing and neurological testing are closely competing with

each other to gain the maximum market share.

Food testing market is expected to inch up to US$ XXXX Million in 2017.

Molecular Diagnostics Market - Technologies Segment Analysis

Biochips and PCR based test accounts for the largest shares in the molecular diagnostics

technologies segment with XXXX% and XXXX% respectively in 2012.

Fish & Innovations technology market is at the 3rd slot.

© Renub Research Page 3 of 21

The PCR related technologies and Non- PCR market is at the 4th and 5th position

respectively.

The biosensor and Molecular Imaging technology are also showing impressive growth.

Molecular Diagnostics Market - Geographical Analysis

United States molecular diagnostic market is expected to be more than double by 2017

from its current market in 2012.

Europe stands at the second position in the global molecular diagnostic market.

China, Japan and India are expected to stand at 3rd, 4th and 5th slot respectively.

The Mexico molecular diagnostics market is predicted to grow at a CAGR of 17%

between 2012 and 2017.

Molecular Diagnostics Market – Company Wise Analysis

The Roche molecular diagnostic share is greater than the combined share of Myriad

Genetics and Qiagen which holds the 2nd and 3rd position respectively.

Abbott stands at the 4th spot and expected to generate sales worth US$ XXXX Million by

the year 2017.

The Myriad Genetics molecular diagnostic sales were worth US$ XXXX Million in 2012.

Renub Research study titled “Molecular Diagnostics Market & Forecast (By Application,

Technology, Countries, Companies & Clinical Trials) to 2017: Global Analysis” provides a

comprehensive assessment of the fast-evolving, high-growth Global Molecular Diagnostics

market. This 157 page report with 81 Figures and 23 Tables studies the Global Molecular

Diagnostics: 1) Market and Forecast 2) Application Wise Market & Forecast 3) Geographical

Market & Forecast 4) Technology Wise Market & Forecast 5) Company Wise molecular

© Renub Research Page 4 of 21

Diagnostics sales & Forecast 6) Molecular Diagnostic & Personalized Medicines 7) Clinical trials

In Molecular Diagnostics Landscape.

The Report Covers the Following Points

Global Molecular Diagnostic Market (2010-12) and Forecast (2013 to 2017)

Global Molecular Diagnostic Application Segment (Infectious Disease Testing, Virology

Testing, HAI Testing, HPV Testing, Critical Care Infectious Testing, Blood Screening,

Genetic Testing, Oncology Testing, Tissue Typing, Cardiovascular Disease Testing,

Neurological Disorders Testing, Food Pathogen Detection Testing & Others) Market

(2010-2012) and Forecast (2013 to 2017)

Molecular Diagnostic Technology Segment (PCR Based Test, PCR Related Technologies ,

Non-PCR Test, Fish & Innovations Testing, Biochips/Microarrays, Biosensors, Molecular

Imaging, & Other Technologies) Market (2010-2012) and Forecast (2013 to 2017)

Molecular Diagnostic Geographical Distribution (US, Europe, China, Japan, India, Brazil,

Mexico, South Korea and Rest of World) Market (2010-2012) and Forecast (2013 to 2017)

Molecular Diagnostic Sales Company Wise Analysis (Roche, Abbott, Myriad Genetics,

Qiagen, BioMérieux and Others ) Market (2010-2012) and Forecast (2013 to 2017)

Molecular Diagnostic and Road to Personalized medicine

Molecular Diagnostic Clinical Trial Statements (20 Clinical Trials Studied in the report)

Driving Forces & Challenges for Global Molecular Diagnostic Market

Data Sources

This report is built using data and information sourced from proprietary databases, primary and

secondary research and in-house analysis by Renub Research team of industry experts.

© Renub Research Page 5 of 21

Primary sources include industry surveys and telephone interviews with industry experts.

Secondary sources information and data has been collected from various printable and non-

printable sources like search engines, News websites, Government Websites, Trade Journals,

White papers, Government Agencies, Magazines, Newspapers, Trade associations, Books,

Industry Portals, Industry Associations and access to more than 100 paid databases.

© Renub Research Page 6 of 21

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© Molecular Diagnostics Market & Forecast (By Application, Technology, Countries, Companies

& Clinical Trials) to 2017: Global Analysis

Renub Research, 2013

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Table of Contents

1. Executive Summary

2. Molecular Diagnostics Market & Forecast – (2010 – 2017)

3. Molecular Diagnostics Market Share – (2010 – 2017)

3.1 Molecular Diagnostics Market Share & Forecast – Application Wise

3.2 Molecular Diagnostics Market Share & Forecast – Technology Wise

3.3 Molecular Diagnostics Market Share & Forecast – Region Wise

3.4 Molecular Diagnostics Market Share & Forecast – Company Wise

4. Molecular Diagnostics Market (Application Segment) – (2010 – 2017)

4.1 Infectious Disease Testing Market & Forecast

4.1.1 Virology (HIV, HCV, HBV) Testing Market & Forecast

4.1.2 Health – Associated Infections (HAI) Testing Market & Forecast

4.1.3 HPV Testing Market & Forecast

4.1.4 Critical Care Infectious Testing Market & Forecast

4.2 Blood Screening Market & Forecast

4.3 Genetic Testing Market & Forecast

4.4 Oncology Testing Market & Forecast

4.5 Tissue Typing (HLA Testing) Market & Forecast

4.6 Cardiovascular Disease Testing Market & Forecast

4.7 Neurological Disorders Testing Market & Forecast

4.8 Food Pathogen Detection Testing Market & Forecast

4.9 Miscellaneous Testing Market & Forecast

5. Molecular Diagnostics Market (Technologies Segment) – (2010 – 2017)

5.1 PCR Based Test Market & Forecast

5.2 PCR Related Technologies Market & Forecast

5.3 Non-PCR Test Market & Forecast

5.4 Fish & Innovations Testing Market (Fluorescent in-situ hybridization) & Forecast

5.5 Biochips/Microarrays Market & Forecast

5.6 Biosensors Market & Forecast

© Renub Research Page 9 of 21

5.7 Molecular Imaging Market & Forecast

5.8 Other Technologies Market & Forecast

6. Geographical Distribution – Molecular Diagnostics Market – (2008 – 2017)

6.1 United States Molecular Diagnostics Market & Forecast

6.2 Europe Molecular Diagnostics Market & Forecast

6.3 China Molecular Diagnostics Market & Forecast

6.4 Japan Molecular Diagnostics Market & Forecast

6.5 India Molecular Diagnostics Market & Forecast

6.6 Brazil Molecular Diagnostics Market & Forecast

6.7 Mexico Molecular Diagnostics Market & Forecast

6.8 South Korea Molecular Diagnostics Market & Forecast

6.9 Rest of World Molecular Diagnostics Market & Forecast

7. Molecular Diagnostics Market (Company Wise) – (2010 – 2017)

7.1 Roche Molecular Diagnostics Market & Forecast

7.2 Abbott Molecular Diagnostics Market & Forecast

7.3 Myriad Genetics Molecular Diagnostics Market & Forecast

7.4 Qiagen Molecular Diagnostics Market & Forecast

7.5 BioMérieux Molecular Diagnostics Market & Forecast

7.6 Other Companies Molecular Diagnostics Market & Forecast

8. Molecular Diagnostics and Personalized Medicine

8.1 Road to Personalized Medicine

8.1.1 Historical perspective: HIV & Oncology

8.1.2 Other Applications: Met & Unmet Therapy Areas

8.2 Molecular Diagnostics Technologies

8.2.1 Expression Profiling - RNA & Pharmacogenomics

8.2.2 Expression Profiling - Proteins & Pharmacoproteomics

8.2.3 DNA Sequence Profiling - Pharmacogenetic & SNP Analysis

8.2.4 DNA Sequence Profiling - High-Throughput Sequencing

8.3 Molecular Diagnostics and Personalized Medicine: Value-Assessed Opportunities for Multiple

Stakeholders Values, Needs & Expectations

© Renub Research Page 10 of 21

8.4 Regulatory Authorities

8.5 Molecular Diagnostics as Companion Diagnostics: Value-Driven Adoption

8.5.1 Behavioral Impact

8.5.2 Economic Impact (Value-Based vs. Cost-Plus Pricing)

9. Molecular Diagnostics Clinical Trial Statement

9.1 Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples

9.2 Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase

(ALK) Translocation

9.3 A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

9.4 Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

9.5 A Two Arm, Multi-Centre Clinical Evaluation of the xTAG Respiratory Viral Panel v3 Test

9.6 Collecting and Storing Tissue Samples from Patients with Rare or Cutaneous Non-Hodgkin

Lymphoma

9.7 Biopsies of Cancer Patients for Tumor Molecular Characterization

9.8 Daptomycin versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA

Bacteremia

9.9 Collection of Tissue Samples for Cancer Research

9.10 Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

9.11 Total Therapy Study XVI for Newly Diagnosed Patients with Acute Lymphoblastic Leukemia

9.12 Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy

9.13 Congenital Muscle Disease Study of Patient and Family Reported Medical Information

9.14 Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer from Fine Needle

Aspirates

9.15 Extending Molecular Responses with Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia

(CML) Patients in Chronic Phase

9.16 CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

9.17 Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile

9.18 Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

9.19 Radotinib versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid

Leukemia Chronic Phase Patients

© Renub Research Page 11 of 21

9.20 Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)

10. Molecular Diagnostics Market – Drivers

10.1 Various Developments in the Molecular Diagnostics Landscape

10.2 Increasing Investment in Genomics & Proteomics Research

10.3 Technological Advances in Molecular Diagnostics

10.4 Increasing Acceptance of the Personalized Medicine

10.5 Growing Molecular Diagnostics for Food Safety

11. Molecular Diagnostics Market – Challenges

11.1 Regulatory Issues

11.2 Various Factors Slowing Growth of Molecular Diagnostics

11.3 Reimbursement Capabilities

11.4 Quality Checkpoints, Awareness & Acceptance

© Renub Research Page 12 of 21

List of Figures:

Figure 2-1: Global – Molecular Diagnostics Market (Million US$), 2010 – 2012

Figure 2-2: Global – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 3-1: Global Molecular Diagnostics – Application Wise Market Share (Percent), 2010 – 2012

Figure 3-2: Global Molecular Diagnostics – Forecast for Application Wise Market Share (Percent), 2013 –

2017

Figure 3-3: Global Molecular Diagnostics – Technology Wise Market Share (Percent), 2010 – 2012

Figure 3-4: Global Molecular Diagnostics – Forecast for Technology Wise Market Share (Percent), 2013 –

2017

Figure 3-5: Global Molecular Diagnostics – Region Wise Market Share (Percent), 2010 – 2012

Figure 3-6: Global Molecular Diagnostics – Forecast for Region Wise Market Share (Percent), 2013 – 2017

Figure 4-1: Global – Infectious Disease Testing Market (Million US$), 2010 – 2012

Figure 4-2: Global – Forecast for Infectious Disease Testing Market (Million US$), 2013 – 2017

Figure 4-3: Global – Virology Testing Market (Million US$), 2010 – 2012

Figure 4-4: Global – Forecast for Virology Testing Market (Million US$), 2013 – 2017

Figure 4-5: Global – HAI Testing Market (Million US$), 2010 – 2012

Figure 4-6: Global – Forecast for HAI Testing Market (Million US$), 2013 – 2017

Figure 4-7: Global – HPV Testing Market (Million US$), 2010 – 2012

Figure 4-8: Global – Forecast for HPV Testing Market (Million US$), 2013 – 2017

Figure 4-9: Global – Critical Care Infectious Testing Market (Million US$), 2008 – 2012

Figure 4-10: Global – Forecast for Critical Care Infectious Testing Market (Million US$), 2013 – 2017

Figure 4-11: Global – Blood Screening Market (Million US$), 2007 – 2012

Figure 4-12: Global – Forecast for Blood Screening Market (Million US$), 2013 – 2017

Figure 4-13: Global – Genetic Testing Market (Million US$), 2010 – 2012

Figure 4-14: Global – Forecast for Genetic Testing Market (Million US$), 2013 – 2017

Figure 4-15: Global – Oncology Market (Million US$), 2010 – 2012

Figure 4-16: Global – Forecast for Oncology Market (Million US$), 2013 – 2017

Figure 4-17: Global – Tissue Typing Market (Million US$), 2008 – 2012

Figure 4-18: Global – Forecast for Tissue Typing Market (Million US$), 2013 – 2017

Figure 4-19: Global – Cardiovascular Disease Testing Market (Million US$), 2010 – 2012

Figure 4-20: Global – Forecast for Cardiovascular Disease Testing Market (Million US$), 2013 – 2017

Figure 4-21: Global – Neurological Disorders Testing Market (Million US$), 2010 – 2012

Figure 4-22: Global – Forecast for Neurological Disorders Testing Market (Million US$), 2013 – 2017

Figure 4-23: Global – Food Pathogen Detection Testing Market (Million US$), 2010 – 2012

Figure 4-24: Global – Forecast for Food Pathogen Detection Testing Market (Million US$), 2013 – 2017

Figure 4-25: Global – Miscellaneous Testing Market (Million US$), 2010 – 2012

© Renub Research Page 13 of 21

Figure 4-26: Global – Forecast for Miscellaneous Testing Market (Million US$), 2013 – 2017

Figure 5-1: Global – PCR Based Test Market (Million US$), 2010 – 2012

Figure 5-2: Global – Forecast for PCR Based Test Market (Million US$), 2013 – 2017

Figure 5-3: Global – PCR Related Technologies Market (Million US$), 2010 – 2012

Figure 5-4: Global – Forecast for PCR Related Technologies Market (Million US$), 2013 – 2017

Figure 5-5: Global – Non-PCR Test Market (Million US$), 2010 – 2012

Figure 5-6: Global – Forecast for Non-PCR Test Market (Million US$), 2013 – 2017

Figure 5-7: Global – Fish & Innovations Market (Million US$), 2010 – 2012

Figure 5-8: Global – Forecast for Fish & Innovations Market (Million US$), 2013 – 2017

Figure 5-9: Global – Biochips/ Microarrays Market (Million US$), 2010 – 2012

Figure 5-10: Global – Forecast for Biochips/Micrroarrays Market (Million US$), 2013 – 2017

Figure 5-11: Global – Biosensors Market (Million US$), 2010 – 2012

Figure 5-12: Global – Forecast for Biosensors Market (Million US$), 2013 – 2017

Figure 5-13: Global – Molecular Imaging Market (Million US$), 2010 – 2012

Figure 5-14: Global – Forecast for Molecular Imaging Market (Million US$), 2013 – 2017

Figure 5-15: Global – Other Technologies Market (Million US$), 2010 – 2012

Figure 5-16: Global – Forecast for Other Technologies Market (Million US$), 2012 – 2017

Figure 6-1: US – Molecular Diagnostics Market (Million US$), 2002 – 2012

Figure 6-2: US – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-3: Europe – Molecular Diagnostics Market (Million US$), 2010 – 2012

Figure 6-4: Europe – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-5: China – Molecular Diagnostics Market (Million US$), 2010 – 2012

Figure 6-6: China – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-7: Japan – Molecular Diagnostics Market (Million US$), 2010 – 2012

Figure 6-8: Japan – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-9: India – Molecular Diagnostics Market (Million US$), 2010 – 2012

Figure 6-10: India – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-11: Brazil – Molecular Diagnostics Market (Million US$), 2007 – 2012

Figure 6-12: Brazil – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-13: Mexico – Molecular Diagnostics Market (Million US$), 2007 – 2012

Figure 6-14: Mexico – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-15: South Korea – Molecular Diagnostics Market (Million US$), 2005 – 2012

Figure 6-16: South Korea – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 6-17: Rest of World – Molecular Diagnostics Market (Million US$), 2010 – 2012

Figure 6-18: Rest of World – Forecast for Molecular Diagnostics Market (Million US$), 2013 – 2017

Figure 7-1: Roche – Molecular Diagnostics Sales (Million US$), 2008 – 2012

Figure 7-2: Roche – Forecast for Molecular Diagnostics Sales (Million US$), 2013 – 2017

© Renub Research Page 14 of 21

Figure 7-3: Abbott – Molecular Diagnostics Sales (Million US$), 2010 – 2012

Figure 7-4: Abbott – Forecast for Molecular Diagnostics Sales (Million US$), 2013 – 2017

Figure 7-5: Myriad Genetics – Molecular Diagnostics Sales (Million US$), 2007 – 2012

Figure 7-6: Myriad Genetics – Forecast for Molecular Diagnostics Sales (Million US$), 2013 – 2017

Figure 7-7: Qiagen – Molecular Diagnostics Sales (Million US$), 2009 – 2012

Figure 7-8: Qiagen – Forecast for Molecular Diagnostics Sales (Million US$), 2013 – 2017

Figure 7-9: BioMérieux – Molecular Diagnostics Sales (Million US$), 2010 – 2012

Figure 7-10: BioMérieux – Forecast for Molecular Diagnostics Sales (Million US$), 2013 – 2017

Figure 7-11: Other Companies – Molecular Diagnostics Sales (Million US$), 2010 – 2012

Figure 7-12: Other Companies – Forecast for Molecular Diagnostics Sales (Million US$), 2013 – 2017

Figure 8-1: A Healthcare ‘Value-Net’

© Renub Research Page 15 of 21

List of Tables:

Table 3-1: Global Molecular Diagnostics – Company Wise Market Share (Percent), 2010 – 2012

Table 3-2: Global Molecular Diagnostics – Forecast for Company Wise Market Share (Percent), 2013 –

2017

Table 8-1: Molecular Platforms for Companion Diagnostics

Table 9-1: Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples – Clinical Trials,

2012

Table 9-2: Crizotinib Efficacy in Non-Small Cell Lung Cancer Patients with Anaplastic Lymphoma Kinase

Translocation – Clinical Trials, 2012

Table 9-3: A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus – Clinical

Trials, 2012

Table 9-4: Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the

AMLProfiler – Clinical Trials, 2012

Table 9-5: A Two Arm, Multi-Centre Clinical Evaluation of the xTAG Respiratory Viral Panel v3 Test –

Clinical Trials, 2013

Table 9-6: Collecting and Storing Tissue Samples from Patients with Rare or Cutaneous Non-Hodgkin

Lymphoma – Clinical Trials, 2012

Table 9-7: Biopsies of Cancer Patients for Tumor Molecular Characterization – Clinical Trails, 2012

Table 9-8: Daptomycin versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated

MRSA Bacteremia – Clinical Trials, 2013

Table 9-9: Collection of Tissue Samples for Cancer Research – Clinical Trials, 2012

Table 9-10: Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma – Clinical Trials, 2012

Table 9-11: Total Therapy Study XVI for Newly Diagnosed Patients with Acute Lymphoblastic Leukemia –

Clinical Trials, 2012

Table 9-12: Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy, 2013

Table 9-13: Congenital Muscle Disease Study of Patient and Family Reported Medical Information –

Clinical Trials, 2013

Table 9-14: Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer from Fine Needle

Aspirates – Clinical Trials, 2013

Table 9-15: Extending Molecular Responses with Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia

(CML) Patients in Chronic Phase – Clinical Trials, 2012

Table 9-16: CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib – Clinical Trial, 2013

Table 9-17: Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile –

Clinical Trials, 2013

Table 9-18: Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients –

Clinical Trials, 2012

© Renub Research Page 16 of 21

Table 9-19: Radotinib versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid

Leukemia Chronic Phase Patients – Clinical Trials, 2012

Table 9-20: Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) – Clinical Trials,

2012

© Renub Research Page 17 of 21

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