Published: December 2015 - gate250.comgate250.com/dmiller/Global Molecular Diagnostics... · Molecular Diagnostics Market Overview 5.1 Current Market Size and Future Growth 6. Molecular

Published: December 2015

Global Molecular Diagnostics Market Outlook 2020

Table of Contents

1. Analyst View

2. Research Methodology

3. Molecular Diagnostics - An Introduction

4. Market Dynamics

4.1 Drivers

4.1.1 Rising Incidence of Cancer and Infectious Diseases

4.1.2 Benefits of Molecular Diagnostic Tests Over Traditional Methods

4.1.3 Increasing Awareness of Personalized Medicine, Biomarkers,& Companion Diagnostics

4.1.4 Technological Advancements

4.1.5 Improving Reimbursement Scenario

4.2 Restraints

4.2.1 High Costs of Molecular Diagnostics Tests

4.2.2 Regulatory Issues Related to Molecular Diagnostics Tests

4.3 Trends

4.3.1 Upsurge in the Number of Strategic Alliances

4.3.2 Automation & Multiplexing: A Growing Trend

4.4 Opportunities

4.4.1 Significant Growth Opportunities in Emerging Markets

4.4.2 Genetic Testing: A New Revenue Pocket for Molecular Diagnostics Market

5. Molecular Diagnostics Market Overview

5.1 Current Market Size and Future Growth

6. Molecular Diagnostics Market, By Application

6.1 Introduction

6.1.1 Infectious Diseases

6.1.2 Oncology

6.1.3 Blood Screening

6.1.4 Genetic Testing

7. Molecular Diagnostics Market, By Technology

7.1 Introduction

7.1.1 Polymerase Chain Reaction (PCR)


7.1.2 Nucleic Acid Hybridization

7.1.3 DNA Sequencing and Next Generation Sequencing (NGS)

8. Molecular Diagnostic Market, By Region

8.1 Introduction

8.1.1 North America

8.1.2 Europe

8.1.3 Asia Pacific

9. Key Player Analysis

9.1 Abbott Diagnostics (A Division of Abbott Laboratories)

9.2 Alere Inc.

9.3 Becton, Dickinson and Company

9.4 BioMérieux SA

9.5 Cepheid

9.6 Danaher Corporation

9.7 Roche Diagnostics (A Subsidiary of F. Hoffmann-La Roche AG)

9.8 Hologic, Inc.

9.9 QIAGEN N.V.

9.10 Siemens Healthcare

9.11 Thermo Fisher Scientific Inc.


List of Figures

Figure 5‑1: Global - Molecular Diagnostics Market (Billion US$), 2015-2020

Figure 6‑1: Global - Molecular Diagnostics Market by Application (%), 2015

Figure 6‑2: Global - Molecular Diagnostics Market by Application (%), 2020

Figure 6‑3: Global - Infectious Disease Market (Billion US$), 2015-2020

Figure 6‑4: Global - Oncology Market (Billion US$), 2015-2020

Figure 6‑5: Global - Blood Screening Market (Billion US$), 2015-2020

Figure 6‑6: Global - Genetic Testing Market (Billion US$), 2015-2020

Figure 7‑1: Global - Molecular Diagnostics Market by Technology (%), 2015

Figure 7‑2: Global - Molecular Diagnostics Market by Technology (%), 2020

Figure 7‑3: Global - PCR Market (Billion US$), 2015-2020

Figure 7‑4: Global - Nucleic Acid Hybridization Market (Billion US$), 2015-2020

Figure 7‑5: Global - DNA Sequencing and NGS Market (Billion US$), 2015-2020

Figure 8‑1: Global - Molecular Diagnostics Market by Region (%), 2015

Figure 8‑2: Global - Molecular Diagnostics Market by Region (%), 2020

Figure 8‑3: North America - Molecular Diagnostics Market (Billion US$), 2015-2020

Figure 8‑4: Europe - Molecular Diagnostics Market (Billion US$), 2015-2020

Figure 8‑5: Asia Pacific - Molecular Diagnostics Market (Billion US$), 2015-2020

Figure 9‑1: Abbott Laboratories - Break up of Revenue by Reportable Business Segment (%), 2014

Figure 9‑2: Alere Inc. - Break up of Revenue by Reportable Business Segment (%), 2014

Figure 9‑3: Alere Inc. - Professional Diagnostic Division Revenue by Segment (%), 2014

Figure 9‑4: Becton, Dickinson and Company - Break up of Revenue by Business Segment (%), 2014

Figure 9‑5: Becton, Dickinson and Company - Diagnostic Division Revenue by Segment (%), 2014

Figure 9‑6: bioMérieux SA - Break up of Revenue by Applications (%), 2014

Figure 9‑7: bioMérieux SA - Clinical Application Revenue by Segment (%), 2014

Figure 9‑8: Cepheid - Break up of Revenue by Business Segment (%), 2014

Figure 9‑9: Danher Corporation - Break up of Revenue by Business Segment (%), 2014

Figure 9‑10: Roche AG - Break up of Revenue by Business Segment (%), 2014

Figure 9‑11: Roche AG - Diagnostic Division Revenue by Segment (%), 2014

Figure 9‑12: Hologic, Inc. - Break up of Revenue by Business Segment (%), 2015

Figure 9‑13: Hologic, Inc. - Diagnostic Division Revenue by Segment (%), 2015

Figure 9‑14: QIAGEN N.V. - Break up of Revenue by Business Segment (%), 2014

Figure 9‑15: Thermo Fisher Scientific Inc. - Break up of Revenue by Business Segment (%), 2014


List of Tables

Table 6-1: Global - Molecular Diagnostic Market by Application (Billion US$), 2015

Table 6-2: Global - Molecular Diagnostic Market by Application (Billion US$), 2020

Table 7-1: Global - Molecular Diagnostic Market by Technology (Billion US$), 2015

Table 7-2: Global - Molecular Diagnostic Market by Technology (Billion US$), 2020

Table 8-1: Global - Molecular Diagnostic Market by Region (Billion US$), 2015

Table 8-2: Global - Molecular Diagnostic Market by Region (Billion US$), 2020

Table 9-1: Abbott Laboratories - Key Financials (Million US$), 2012-2014

Table 9-2: Alere Inc.- Key Financials (Million US$), 2012-2014

Table 9-3: Becton, Dickinson and Company - Key Financials (Million US$), 2012-2014

Table 9-4: bioMérieux SA - Key Financials (Million US$), 2012-2014

Table 9-5: Cepheid- Key Financials (Million US$), 2012-2014

Table 9-6: Danher Corporation - Key Financials (Million US$), 2012-2014

Table 9-7: Roche AG - Key Financials (Million US$), 2012-2014

Table 9-8: Hologic, Inc. - Key Financials (Million US$), 2013-2015

Table 9-9: QIAGEN N.V. - Key Financials (Million US$), 2012-2014

Table 9-10: Siemens Healthcare - Key Financials (Million US$), 2012-2014

Table 9-11: Thermo Fisher Scientific Inc. - Key Financials (Million US$), 2012-2014


Technological Advancements

The rise of molecular biology has revolutionized the diagnosis and treatment of diseases. The variety of technologies that are used in molecular diagnostics has transformed the clinical laboratory medicine. Novel platforms have become the basis for these tests, including PCR and real-time quantitative PCR, as well as high-throughput sequencing.

One of the technologies that has fuelled the growth of molecular technologies is Nucleic Acid Amplification(NAT), which is a biochemical technique that detects a virus or a bacterium. The technology includes any test that directly detects the genetic material of the infecting organism or virus. There are a number of tests, which can be included in this category of testing or examining nucleic acids, namely, Reverse Transcriptase based PCR, Transcription Mediated Amplification, and Branched DNA tests. These tests provide an advantage of shorter analysis time, thereby resulting in faster results in few hours. NAT is a leading molecular diagnostics technology, and PCR is one of the most common methods in the NAT toolbox used to discover new biomarkers and develop diagnostics tests. The most commonly available tests include PCR for respiratory pathogens like Bordetella pertussis, Mycoplasma pneumoniae; for genitourinary pathogens like Neisseria gonorrhoea, Mycoplasma genitalium, among others.

Another area, gene expression profiling has also been gaining wide acceptance in the field of molecular diagnostics, involves measuring the activity - or expression - of thousands of genes at once, to create an overall picture of cellular function. Sequence based techniques, like serial analysis of gene expression (Sage and SuperSage) are used for gene expression profiling. The advent of next-generation sequencing has made sequence based expression analysis an increasingly popular alternative to microarrays.

Another upcoming area is microRNA-based molecular diagnostics. microRNAs (miRNAs) are small RNAs that act as regulators of protein synthesis. They are highly effective biomarkers. MicroRNAs’ advantage as biomarkers lies in their high tissue specificity, and their exceptional stability in routine preservation methods for biopsies, including Formalin-Fixed, Paraffin Embedded blocks of tissue.

SAMPLE SECTION FROM THE REPORT


Genetic Testing

Genetic tests could be defined as those medical tests that are used to identify changes in chromosomes, genes, or proteins. Genetic Testing identifies those at risk for a specific genetic disease. It also aids in predicting the possibility of future genetic disease, or determines the risk of transmitting such a disease by the individual to their offspring. Genetic Testing can also be used as part of the process to identify, confirm, or predict the possibility of a specific medical condition occurring and to develop a treatment plan. These tests are the most sophisticated form of techniques, which are used to test for genetic disorders.

In 2015, the Genetic Testing segment is valued at US$ XX Million, and is forecasted to grow with a CAGR of XX% by 2020, thereby reaching around US$ XX Billion.

Genetic Testing is used for a variety of reasons:

y Carrier Screening - It involves identifying the carrier of the diease (has one copy of the diseases carrying gene).

y Preimplantation genetic diagnosis – It involves screening embryos for a particular disease.

y Prenatal diagnostic testing

y Newborn screening

Source: RNCOS

Figure 6‑6: Global ‑ Genetic Testing Market (Billion US$), 2015‑2020

2015e 2016f 2017f 2018f 2019f 2020f


y Presymptomatic testing for predicting adult-onset disorders, such as Huntington’s Disease.

y Confirmational diagnosis of a symptomatic individual.

One of the most important drivers for genetic testing market is the emergence of Next Generation Sequencing (NGS). NGS platforms perform massively parallel sequencing, during which millions of fragments of DNA from a single sample are sequenced simultaneously. This technology thus facilitates high-throughput sequencing, which allows an entire genome to be sequenced in less than one day.

NGS finds application in personalized medicine where it is possible to identify the genetic alterations, thereby predict how a patient might respond to a specific drug, and in deciding the appropriate dose that might be effective. In the future, this technique could replace the traditional PCR and multiplex PCR for genetic testing. However, one of the biggest challenges with the NGS is the fact that specialized knowledge of bioinformatics is required to accumulate information from the sequenced data.

Nonetheless, given the rapid advances in molecular testing technology, it is conceivable that in the not too distant future, NGS sequencing and even genetic testing as a whole would be used as a routine procedure for screening and identification of any kind of gene mutations.


QIAGEN N. V.Spoorstraat 50

5911 KJ Venlo

The Netherlands

Phone: +31-77-320-8400

Fax: +31-77-320-8409

Website: www.qiagen.com

Business OverviewEstablished in 1986, and headquartered in Germany, Qiagen is a leading player in Molecular Diagnostics that provides innovative Sample and Assay Technologies. Sample technologies are used to extract, isolate and purify DNA, RNA, proteins from biologicals. Assay technologies provide a range of applications to transform molecular information from biological samples.

The Company caters to two major product categories - Consumable products and Instruments. Consumable products constitute the specialized kits to support the use of sample and assay technologies, and contribute to XX% of sales. Instruments are generally used along with consumables to automate the whole process of sample preparation to deliver the results, and contribute XX% of sales.

Qiagen serves four major business segments - Molecular Diagnostics, Applied Testing, Pharma, and Life Science/Academia. Qiagen’s growth in Molecular Diagnostics depends on four major factors, i.e. Prevention, Profiling, Personalized Care, and Point-of-Need.

The Company offers one of the broadest portfolios of molecular diagnostics. In prevention, the company is the market leader in providing screening tests for tuberculosis control, in addition to being the global leader in screening technologies for HPV. In terms of profiling, the company offers an extensive range of kits for diagnosing infectious diseases. The Company’s portfolio for personalized healthcare applications includes a wide range of technologies and biomarkers.


Key FinancialsTable 9‑9: QIAGEN N.V. ‑ Key Financials (Million US$), 2012‑2014

Fiscal Year End (Dec) 2012 2013 2014

Revenue XX XX XX

Gross Profit XX XX XX

Operating Profit XX XX XX

Net Income XX XX XX

Source: Annual Report

Source: Annual Report

Figure 9‑14: QIAGEN N.V. ‑ Break up of Revenue by Business Segment (%), 2014

Molecular Dx

Academia

Pharma

Applied Testing


Product PotfolioQIAGEN N. V. – Product Portfolio for Molecular Diagnostics

Product Category Product Name

Oncology (Companion Diagnostics) therascreen EGFR RGQ PCRtherascreen KRAS RGQ PCR

Sexually Transmitted Diseases Digene HC2 High Risk HPV DNA TestHC2 DNA Test

Next Generation Sequencing QIA Cube, REPLI-g Cell WGA & WTAQIA Amp Microbiome KitQIA Amp Circulating Nucleic Acid KitREPLI-g Single Cell KitREPLI-g single cell RNA library kitREPLI-g single cell DNA library kitGeneRead Pure mRNA kitGeneRead DNAseq Panel PCR Kit V2GeneRead DNAseq Targeted Panels V2GeneRead DNAseq Custom Panels V2QIAxpert System,

Pathogen Identification QuantiFast Pathogen +IC KitsQuanti tectVirus KitsQIAGEN One Step RT-PCR KitPyromark One Step RT-PCR Kit

Source: Company Website

Recent DevelopmentsYear Developments

2013 QIAGEN N.V. announced a partnership with Clovis Oncology to co-develop and co-commercialize a companion diagnostic test to guide the use of CO-XX, a novel Clovis Oncology product candidate currently in clinical development.

QIAGEN N.V. announced it has received approval by the U.S. Food and Drug Administration (FDA) to market the therascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim's new targeted therapy, GILOTRIFTM (afatinib), for treatment of metastatic NSCLC in patients whose tumors have certain EGFR gene mutations.

Table Continued


2014 QIAGEN N.V. announced a master collaboration agreement with Astellas Pharma Inc., an R&D-driven global pharmaceutical company headquartered in Japan, to develop and commercialize companion diagnostics paired with Astellas drugs for use in cancer and other diseases.

QIAGEN N.V. announced a collaboration agreement with AstraZeneca PLC (LSE, NYSE and OMX: AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca’s targeted therapy for Non-Small Cell Lung Cancer (NSCLC).

QIAGEN N.V. announced the launch of XX new GeneReadTM DNAseq V2 gene panels targeting an extensive range of cancer-related genes or gene regions. Gene panels are an integral part of many Next-Generation Sequencing (NGS) workflows.

QIAGEN N.V. announced collaboration with Eli Lilly and Company to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in common cancer types.

QIAGEN N.V. announced that its therascreen® KRAS RGQ PCR Kit (therascreen KRAS test) has received U.S. Food and Drug Administration (FDA) approval to guide the treatment of metastatic colorectal cancer patients with Amgen’s Vectibix® (panitumumab).

QIAGEN N.V. announced an expansion of its strategic partnership with Exosome Diagnostics Inc. to develop a first-in-class, non-invasive molecular in-vitro diagnostics for use in diagnosing and monitoring patients.

2015 QIAGEN N.V. announced the European launch of its RespiFast RG Panel, a molecular diagnostic kit that has received CE-IVD marking for the detection and differentiation of XX pathogens that cause respiratory tract infections in humans.

QIAGEN N.V. received U.S. marketing (PMA) approval of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca’s IRESSA (gefitinib) in the treatment of patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).

QIAGEN N.V. announced a collaboration in which Seegene Inc. (XX.KQ) will develop a menu of multiplex assay panels for its modular QIAsymphony RGQ MDx automation platform.

QIAGEN N.V. and Biotype Diagnostics GmbH announced that they have entered into a partnership to establish Biotype Innovation GmbH ("Biotype Innovation"). The new company will develop and commercialize molecular diagnostic workflows initially for personalized healthcare applications based on QIAGEN’s proprietary ModaPlex platform, which enables customers to detect, characterize and measure up to XX parameters simultaneously in a cost-effective and rapid manner.

QIAGEN N.V. announced the acquisition of the Enzyme Solutions Unit of Enzymatics, a world leader in the development, manufacturing, and OEM supply of enzymes essential to driving the adoption of Next-Generation Sequencing (NGS) and other genetic analysis technologies in life sciences research and clinical healthcare.

QIAGEN N.V announced the commercial launch of its QIAGEN Clinical Insight® (QCI™) bioinformatics content and software platform for clinical testing labs to interpret and report on genomic variants identified in Next-Generation Sequencing (NGS).

Hitachi High-Technologies Corporation and QIAGEN N.V. have entered into a long-term strategic collaboration, involving initiatives to deliver important advances in molecular testing.

Source: Company Press Releases


Strengths and WeaknessesStrengths

The company provides the broadest portfolio of molecular diagnostics

Molecular Diagnostics contributes about XX% to the total revenue

Market leader in screening technologies for tuberculosis and HPV

Strong portfolio for cancer related diagnostics

Weaknesses

Limited liquidity position

Negative growth in bottom line last fiscal

Source: RNCOS


Research Methodology

RNCOS’s dedicated team of industry experts intensively monitored and analyzed all the emerging trends in Global Molecular Diagnostics Market. According to the assessment by our team of experts, the increasing demand for novel molecular diagnostic techniques is the main factor responsible for the growth of the market.

For this study, we compiled information from various credible sources including company websites, domestic news sources, and some of our paid databases. Our team of experts have prudently evaluated all the collected information, and presented it in a chronological order to depict a meaningful and clear picture of the global molecular diagnostics industry. It is worth-mentioning here that while compiling the data, we have also cross-checked all the collected information from other multiple sources and data warehouses, so that we can present the most accurate and precise information on the sector.

We have also recognized and analyzed all budding trends including the main drivers and other supporting factors. We have also identified the possible growth areas in terms of technological developments, and regulatory environment globally in the coming years. With the harmonization of all the factors, we have provided a consistent analysis of the performance of the industry.

The industry forecasts are based on multiple economic models including co-relation and regression analysis, and most importantly judgmental analysis of our team of industry experts. As the forecasting method is the sum of statistical and judgmental analysis, it is free from all biases and reflects a true picture of the industry.

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About RNCOS

Established in 2002, RNCOS is a premier source of healthcare industry research and information provider. We bring first-hand information and prudent analysis on the healthcare industry, technologies, economic and non-economic market parameters, potential markets, and key competitors, to help clients identify prospective growth areas and gain competitive edge.

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Published: December 2015 - gate250.comgate250.com/dmiller/Global Molecular Diagnostics... · Molecular Diagnostics Market Overview 5.1 Current Market Size and Future Growth 6. Molecular

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