Next-Generation Cancer Diagnostics Market Forecast 2015-2025

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Next-Generation Cancer Diagnostics
Market Forecast 2015-2025
Opportunities for Leading Companies Developing Advanced PCR
Techniques, CTC Tests, FISH Tests, Microarrays and NGS Technologies

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Contents
1. Report Overview
1.1 Overview of Findings
1.2 Structure of the Report
1.3 Global Next-Generation Cancer Diagnostics Market Segmentation
1.4 Why You Should Read This Report
1.5 How This Report Delivers
1.6 Key Questions Answered by This Analytical Report
1.7 Who is This Report For?
1.8 Methodology
1.9 Frequently Asked Questions (FAQ)
1.10 Associated Visiongain Reports
1.11 About Visiongain
2. Introduction to Next-Generation Cancer Diagnostics
2.1 What Is Cancer?
2.2 Cancer Diagnostics: An Overview
2.2.1 Screening
2.2.2 Diagnosis
2.2.3 Staging
2.3 Cancer Diagnosis Methods
2.3.1 Physical Examination
2.3.2 Imaging Techniques
2.3.2.1 Ultrasound
2.3.2.2 Computed Tomography (CT)
2.3.2.3 Magnetic Resonance Imaging (MRI)
2.3.2.4 Positron Emission Tomography (PET)
2.3.3 Histopathological and Cytological Techniques
2.3.4 Immunohistochemistry (IHC) Analysis
2.3.5 Circulating Tumour Cell (CTC) Analysis
2.3.6 Molecular Diagnostics and IVD
2.3.6.1 Polymerase Chain Reaction (PCR)
2.3.6.2 Multiplex PCR
2.3.6.3 Real-Time PCR (RT-PCR or qPCR)
2.3.6.4 Digital PCR (dPCR)
2.3.6.5 In Situ Hybridisation (ISH)
2.3.6.6 Microarray

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2.3.6.7 Next-Generation Sequencing (NGS)
2.4 Tests for Inherited and Acquired Genetic Mutations
2.5 Companion Diagnostics (CDx)
2.6 Laboratory Developed Test (LDT)
2.7 Precision Medicine
2.8 Government Regulations
2.8.1 The US Approval and Regulation System
2.8.2 The EU Approval and Regulation System
2.9 Market Definition
3. Next-Generation Cancer Diagnostics: World Market 2015-2025
3.1 The Global Next-Generation Cancer Diagnostics Market: Overview
3.2 The Global Next-Generation Cancer Diagnostics Market Forecast 2015-2025
3.3 How Will Segmental Market Shares Change to 2025?
3.4 Biomarkers and Molecular Diagnostics
3.4.1 Biomarkers and Diagnostic Tests for Breast Cancer
3.4.2 Biomarkers and Diagnostic Tests for Prostate Cancer
3.4.3 Biomarkers and Diagnostic Tests for Colorectal Cancer
3.5 Companion Diagnostics and Collaborations between Two Industries
3.6 LDTs to be Replaced by Approved Tests
3.7 Decentralisation of Diagnostic Tests
3.8 Next-Generation Cancer Diagnostics: Drivers and Restraints 2015-2025
4. Next-Generation Cancer Diagnostics Submarkets 2015-2025
4.1 Advanced PCR Techniques
4.1.1 Advanced PCR Techniques Market Forecast 2015-2025
4.1.2 Leading Products in the Real-Time PCR Market
4.1.2.1 cobas 4800 System & Oncology Tests (Roche)
4.1.2.2 QuantStudio Dx & 7500 Fast Dx (Thermo Fisher)
4.1.2.3 Rotor-Gene Q & therascreen Tests (Qiagen)
4.1.2.4 Oncotype DX (Genomic Health)
4.1.3 Leading Products in the Digital PCR Market
4.1.4 Pap Tests Being Replaced by PCR Assays
4.1.5 Advanced PCR-Based Techniques: Drivers and Restraints 2015-2025
4.2 In Situ Hybridisation (ISH)
4.2.1 ISH Cancer Diagnostics Market Forecast 2015-2025

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4.2.2 Leading Products in the ISH Cancer Diagnostics Market
4.2.3 HER2 Tests for Breast Cancer
4.2.4 ISH Cancer Diagnostics: Drivers and Restraints 2015-2025
4.3 Circulating Tumour Cells (CTCs) Analysis
4.3.1 CTCs Analysis Market Forecast 2015-2025
4.3.2 Leading Product in the CTCs Analysis Market
4.3.2.1 CellSearch System (Janssen Diagnostics)
4.3.3 Epic Sciences and LabCorp to Expand in Asia Markets
4.3.4 CTCs Separation by Ultrasound
4.3.5 CTC Clusters More Likely to Cause Metastasis?
4.3.6 CTCs Analysis: Drivers and Restraints 2015-2025
4.4 Microarray
4.4.1 Microarray Cancer Diagnostics Market Forecast 2015-2025
4.4.2 Leading Products in the Microarray Market
4.4.2.1 OncoScan FFPE Assay Kit (Affymetrix)
4.4.2.2 MammaPrint (Agendia)
4.4.3 Microarray Cancer Diagnostics: Trends and Developments
4.4.3.1 Array Comparative Genomic Hybridisation (Array CGH)
4.4.4 Microarray Cancer Diagnostics: Drivers and Restraints 2015-2025
4.5 Next-Generation Sequencing (NGS)
4.5.1 NGS Cancer Diagnostics Market Forecast 2015-2025
4.5.2 Leading Products in the NGS Market
4.5.2.1 MiSeqDx (Illumina)
4.5.2.2 Ion PGM Dx System (Thermo Fisher)
4.5.2.3 GeneRead DNAseq Targeted Panels V2 (Qiagen)
4.5.3 NGS Cancer Diagnostics: Trends and Developments
4.5.3.1 Myriad Shifting from PCR to NGS Panel
4.5.3.2 Competition in the NGS Market
4.5.3.3 Bio-Rad to Commercialise NGS system for Clinical Use
4.5.3.4 Qiagen Launched NGS Bioinformatics Platform
4.5.4 NGS Cancer Diagnostics: Drivers and Restraints 2015-2025
5. Leading National Markets 2015-2025
5.1 World Next-Generation Cancer Diagnostics Market: Regional Forecast 2015-2025
5.1.1 How Will Regional Market Shares Change to 2025?
5.2 US Next-Generation Cancer Diagnostics Market Forecast 2015-2025
5.2.1 FDA Provides Guidance for Molecular Diagnostic Instruments with Combined Functions

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5.2.2 Obama Launched 'Precision Medicine Initiative'
5.2.3 FDA and CMS to Regulate LDTs
5.3 EU5 Next-Generation Cancer Diagnostics Market Forecast 2015-2025
5.3.1 Germany: Leading Market in the EU
5.3.2 France: Reduction in Healthcare Spending
5.3.3 UK: 100,000 Genomes Project
5.3.4 Spain: Recovering from Financial Crisis
5.3.5 Italy: Decreasing Reimbursement
5.4 Japanese Next-Generation Cancer Diagnostics Market Forecast 2015-2025
5.4.1 Takeda Collaborated with NCC in Genomic Screening Project
5.4.2 Qiagen Partnered Hitachi on PCR and NGS Technologies
5.4.3 Increase Cancer Rates in Fukushima after Nuclear Disaster?
5.5 Chinese Next-Generation Cancer Diagnostics Market Forecast 2015-2025
5.5.1 Illumina Entering the Chinese Market
5.5.2 Epigenomics Colorectal Cancer Test Approved in China
5.5.3 China Offered Free Screenings for Cervical and Breast Cancer
5.6 Indian Next-Generation Cancer Diagnostics Market Forecast 2015-2025
5.6.1 Lack of Genetic Testing Regulation
5.6.2 Cancer Genetics Launched NGS Cancer Panel in India
5.7 Brazilian Next-Generation Cancer Diagnostics Market Forecast 2015-2025
5.8 Russian Next-Generation Cancer Diagnostics Market Forecast 2015-2025
5.8.1 IBM’s Collaboration with Russian Companies to Advance Clinical Decision Making
6. Leading Companies in the Next-Generation Cancer Diagnostics
Market 2015
6.1 Roche Diagnostics
6.1.1 Roche Diagnostics: Product Portfolio, 2015
6.1.2 Roche Diagnostics: Diagnostics Sales Outlook
6.1.3 Cobas HPV Test Approved in the US in 2014
6.1.4 Roche Diagnostics: Recent M&A Activity
6.1.5 Roche Coming Back to the NGS Business?
6.2 Abbott Laboratories
6.2.1 Abbott: Next-Generation Cancer Diagnostics Product Portfolio 2015
6.2.2 Abbott: Diagnostics Sales Outlook
6.2.3 Abbott Obtained Exclusive License for Bladder Cancer Biomarker FGFR3
6.3 Qiagen

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6.3.1 Qiagen: Next-Generation Cancer Diagnostics Product Portfolio 2015
6.3.1.1 Molecular Diagnostics Kits
6.3.1.2 Real-Time PCR: Rotor-Gene Q
6.3.1.3 Bioinformatics for NGS
6.3.2 Qiagen: Diagnostics Sales Outlook
6.3.3 HalioDx Created from Qiagen Marseille
6.4 Thermo Fisher Scientific
6.4.1 Thermo Fisher Scientific: Business Segments
6.4.2 Thermo Fisher: Next-Generation Cancer Diagnostics Product Portfolio 2015
6.4.2.1 QuantStudio 3D (Digital PCR)
6.4.2.2 In Situ Hybridisation
6.4.2.3 Microarray Slides
6.4.2.4 Next-Generation Sequencing
6.4.2.5 Real-Time PCR for Oncology in Pipeline?
6.4.3 Thermo Fisher: Life Sciences Sales Outlook
6.4.4 NGS Oncomine Focus Assay for Oncology Research
6.5 Agilent Technologies
6.5.1 Agilent: Next-Generation Cancer Diagnostics Product Portfolio 2015
6.5.1.1 NGS Enrichment Platforms
6.5.1.2 Cytogenetic Research and Microarrays
6.5.1.3 Other Products
6.5.2 Agilent: Life Sciences and Diagnostics Outlook
6.5.3 Partnerships and Collaborations for Companion Diagnostics
6.6 Hologic
6.6.1 Hologic: Next-Generation Cancer Diagnostics Product Portfolio 2015
6.6.1.1 Aptima HPV Assay and Cervista HPV Assay
6.6.1.2 Progensa PCA3 Assay
6.6.2 Hologic: Diagnostics Outlook
6.7 Illumina
6.7.1 Illumina: Technology and Product Portfolio 2015
6.7.1.1 Sequencing Technology
6.7.1.2 BeadArray Microarray
6.7.1.3 Consumables
6.7.1.4 Services
6.7.2 Illumina: Sales Outlook
6.7.3 Illumina: Recent M&A Activity
6.7.4 Joined Forces with UK Government for 100,000 Genomes Project

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6.7.5 Partnered with Merck Serono to Develop NGS Cancer Diagnostics
6.7.6 Investing on Synthetic DNA Manufacturing Technology
6.8 Myriad Genetics
6.8.1 Myriad: Next-Generation Cancer Diagnostics Product Portfolio 2015
6.8.2 Myriad: Sales Outlook
6.8.3 New Landscape in the BRCA Diagnostic Market
7. Qualitative Analysis of the Next-Generation Cancer Diagnostics
Market 2015-2025
7.1 SWOT Analysis of the Next-Generation Cancer Diagnostics Market
7.2 Strengths
7.2.1 Global Cancer Rates Set to Soar
7.2.2 Increasing Awareness of Molecular Cancer Diagnostics
7.2.3 The Trend in Precision Medicine
7.3 Weaknesses
7.3.1 Industry Facing Increasing Reimbursement Pressure
7.3.2 Physicians’ Reliance on Traditional Methods
7.4 Opportunities
7.4.1 Expanding Biomarkers and Cancer Test Menus
7.4.2 Emerging Market to Provide Future Growth
7.4.3 Companion Diagnostics on the Rise
7.5 Threats
7.5.1 Decreasing Healthcare Spending
7.5.2 Gene Patenting Banned in the US?
8. Research Interviews
8.1 Keith Cannon, Executive Vice President, Aviva Biosciences
8.1.1 Aviva: From Research Laboratories to Clinical and Diagnostic Markets
8.1.2 Ability to Distinguish CTCs is the Key
8.1.3 RedSift(TM): Automated Enrichment of Nucleated Cells
8.1.4 On Drivers and Restraints in the CTC Technologies Market
8.1.5 On the Growth in Regional Markets
8.2 Nobuyoshi Katagiri, Ph.D., Director, Diagnostics Development Department, Oncolys
BioPharma
8.2.1 On Future Growth of Oncolys BioPharma

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8.2.2 CTCs is Changing the Market
8.2.3 On Current Restraints in the Market
8.2.4 ctDNA May Compete with Oncolys BioPharma’s TelomeScan
9. Conclusions
9.1 The World Next-Generation Cancer Diagnostics Market
9.1.1 Current Leading Next-Generation Cancer Diagnostics Segments
9.1.2 Notable Next-Generation Cancer Diagnostics Companies
9.1.3 Leading Regional Markets
9.1.4 World Next-Generation Cancer Diagnostics Market Forecast 2015-2025
9.2 The Future of the Next-Generation Cancer Diagnostics Market

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Next-Generation Cancer Diagnostics Market Forecast 2015-2025:
Techniques, CTC tests, FISH tests, Microarrays and NGS Technologies
It was reported that Myriad uses the RainDance ThunderStorm enrichment platform to set up
picodroplet PCR reactions prior to sequencing. The targets then undergo a second round of PCR
to produce templates for Illumina sequencing. 23 of the 25 myRisk panel genes are performed on
the Illumina HiSeq 2500. The other two genes requiring long-range PCR are sequenced on the
Illumina MiSeq.
4.5.3.2 Competition in the NGS Market
Illumina is currently dominating the global NGS market, accounted for over 70% of the market.
While competitors are entering the market, its business is still strongly supported by the continuing
expansion of the NGS market. The company also developed a portfolio to target different markets,
applications, and throughput needs, such as the NextSeq 500, a benchtop sequencer.
Thermo Fisher holds second place in this market. Except the SOLiD system which uses similar
sequencing by synthesis approach with labelled nucleotides, the company is marketing the
nonoptical Ion Torrent system. The Ion Torrent system sequences unlabeled nucleotides on a
semiconductor chip.
Pacific Biosciences has invented a technology to allow an average reads of about 8,500 bases,
compared to a few hundred bases of Illumina and Ion Torrent. The company signed an agreement
with Roche in 2013 which allows Roche to market its machines for clinical use. Roche, after
intending to discontinue its 454 platform, is now investing on more advanced NGS technologies. In
2014, the company acquired Genia Technologies which was developing single-molecule,
semiconductor-based sequencing, and invested in Stratos Genomics, another company
investigating nanopore sequencing technologies.
4.5.3.3 Bio-Rad to Commercialise NGS system for Clinical Use
In 2014, Bio-Rad acquired GnuBio, a company developing a droplet-based NGS system that uses
"picoinjector" technology. According to Bio-Rad, GnuBio's droplet-based sequencing platform will
complement Bio-Rad's droplet digital PCR technology. The company wants to seek regulatory
clearance from the FDA for both the instrument and the assays for GnuBio's NGS platform. While
Illumina's MiSeqDx is currently the only MGS system to have FDA 510(k) clearance, Bio-Rad said
they may not submit a separate 510(k) application but register the system with the same “intended
use” of MiSeqDx.

Table 5.4 Japanese Next-Generation Cancer Diagnostics Market Forecast: Revenues
($m), AGR (%), CAGR (%), 2014-2025
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Japan ($m) 126 144 165 190 221 257 299 348 406 473 553 647
AGR (%) 14.1 14.7 15.4 15.9 16.4 16.5 16.5 16.6 16.6 16.8 16.9
CAGR (%, 2014-2019 &
2019-2025)
15.3 16.6
CAGR (%, 2014-2025) 16.0
Figure 5.8 Japanese Next-Generation Cancer Diagnostics Market Forecast: Revenues
($m), AGR (%), 2014-2025
5.4.1 Takeda Collaborated with NCC in Genomic Screening Project
In May 2015, it was reported that Takeda has joined the National Cancer Center (NCC)’s national
academic-industrial collaboration genomic screening project “SCRUM-Japan”. The project involves
nation-wide medical institutions and pharma industry to collaborate to screen oncogene
abnormalities and build a shared database of genetic and medical information. The NCC will study
basic research on the pathogenesis and susceptibility of a cancer to drugs. On the other hand,
Takeda will be responsible for developing treatments.
0
2
4
6
8
10
12
14
16
18
0
100
200
300
400
500
600
700
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 AGR%
Revenue($bn)
Year
Japan ($m) AGR (%)
Source: visiongain 2015
Source: visiongain 2015

6.3.1.1 Molecular Diagnostics Kits
Qiagen provides two companion diagnostic assays for determining an individual's mutation status.
The tests (the therascreen EGFR RGQ PCR Kit and KRAS RGQ PCR Kit) are detailed in 4.1.2.3.
The company also provides digene HC2 High-Risk HPV DNA Test for the detection of HPV. The
product utilises Qiagen’s Hybrid Capture 2 technology to detect 13 high-risk HPV types. The in
vitro nucleic acid hybridisation assay uses chemiluminescence for the qualitative detection in
cervical specimens.
6.3.1.2 Real-Time PCR: Rotor-Gene Q
Qiagen provides Rotor-Gene Q, the first rotary qPCR cycler system, supplied as an integral
component of its QIAsymphony RGQ, a lab automation system. In use, each tube spins in a
chamber of moving air, keeping all samples at the same temperature during thermal cycling.
Qiagen also offers PyroMark, a high-resolution detection platform with pyrosequencing.
6.3.1.3 Bioinformatics for NGS
Through the acquisitions of the Ingenuity and CLC software portfolios in 2013, Qiagen currently
offers several tools for NGS applications. The bioinformatics can be used standalone or integrated
with other Qiagen consumables and instruments.
• CLC Genomics Workbench: Cross-platform desktop application for analysing,
comparing, and visualising NGS data; can be used in analysing genomics, transcriptomics,
and epigenomics; supports all major NGS platforms; cancer-focused informatics solution
• Ingenuity Variant Analysis: cloud-based platform for analysis and interpretation of
human sequencing data generated with NGS technologies; uses expertly curated
biological interactions and functional annotations from the Ingenuity Knowledge Base and
other additional sources to identifies disease-causing variants
6.3.2 Qiagen: Diagnostics Sales Outlook
Qiagen’s molecular diagnostics revenue in 2014 increased 3.3% in which approximately1% were
from acquisitions of Ingenuity, CLC bio and BIOBASE. Facing increasing competition from Roche
and Hologic, the sales of HPV tests used for cervical cancer screening decreased in the US in
2014.

8.2 Nobuyoshi Katagiri, Ph.D., Director, Diagnostics Development
Department, Oncolys BioPharma
In July 2015, visiongain interviewed Mr Nobuyoshi Katagiri, Director of Diagnostics Development at
Oncolys BioPharma. The company is focused on “drug discovery and development standing on
virology”. Oncolys BioPharma has developed 3 products in the pharmaceutical and 2 in the
diagnostic business. In the cancer diagnostic business, the company has developed the
TelomeScan F35 test utilising a specific gene-modified virus. We thank Mr Katagiri for his time and
opinion.
8.2.1 On Future Growth of Oncolys BioPharma
visiongain: What are Oncolys BioPharma’s plans for growth? Where do you see the company
heading in the next five years or so?
NK: One of our possible goals of business is a distributor of diagnostic device and/or reagents, not
just a diagnostic laboratory. Currently, we’re planning joint business with other platform companies
in the cancer diagnostic field world-wide.
8.2.2 CTCs is Changing the Market
visiongain: Are there any recent developments that will change the cancer diagnostics market?
NK: Yes. Genetic and immunochemical diagnostics using fluidic samples including blood, ascites
and urine as a substitute for solid tissue which is named liquid biopsy is a potential innovative
technique in the cancer diagnostics market. Liquid biopsy will make repeated biopsy possible in
patients who have difficulty to tissue biopsy. Currently, circulating nucleic acid (ctDNA and
exosomal miRNA) is frequently used for liquid biopsy in addition to circulating tumor cells (CTCs).
We’ll be able to evaluate sensitiveness and tolerance to cancer therapy through detection of
genetic mutation and protein expression status directly using these cells or molecules in fluidic
samples easily.
8.2.3 On Current Restraints in the Market
visiongain: What is the current greatest restraint to the cancer diagnostics market (e.g. regulatory
obstacles)?
NK: Quality standardization of each test is one of the greatest restraint factors.

Next-Generation Cancer Diagnostics Market Forecast 2015-2025

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Next-Generation Cancer Diagnostics Market Forecast 2015-2025