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Companion Diagnostic Devices Market , 2012-2023

January 2018 | 220 pages | ID: CFD67013A71EN
Precision Business Insights (PBI)

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Global Companion Diagnostic Devices Market

Companion diagnostics are medical devices, often an in-vitro device and provides the information that essential for safe and effective use of the corresponding drug or biotechnology product. Companion diagnostics are often developed along with drugs to aid in selecting or excluding the patient groups for the treatment with particular drug on basis of their biological characters. Companion diagnostics are developed based on biomarkers technology to predict response or severe toxicity of the drugs or biotechnological compounds. Companion diagnostics are majorly used in oncology area.

Some of the factors like improved efficacy and safety profiles of drugs, Accelerated drug regulatory approvals, reduced healthcare expenditure and drug development costs, increasing partnerships between market players, government organizations and other research firms over the use of co diagnostics, emergence of new pharmaceuticals and diagnostics are driving the growth of the global companion diagnostics market. However, due to the regulatory uncertainty, complex clinical trial procedures and intellectual property issues in certain areas are the few issues which are restraining the growth of the global companion diagnostics devices market.

Global companion diagnostic devices are segmented on the basis of application, technology, end user and geographical region.

Based on the application, global companion diagnostic devices are segmented as:
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Urology
  • Melanoma
  • Gastric Cancer
  • Others
Based on the technology, global companion diagnostic devices are segmented as:
  • Immunohistochemistry
  • Molecular Diagnostics
  • In-situ Hybridization
  • FISH
  • CISH
  • Real-Time PCR
  • Gene Sequencing
Based on the end-user, global companion diagnostic devices are segmented as:
  • Hospitals
  • Diagnostic Centres
  • Others
The global companion diagnostic devices market is highly fragmented due to the presence of several established large and small suppliers. The competition in the market will intensify during the forecast period as vendors adopt strategies like M&A to develop new technologies. Product approval and launch will also help to increase the volume of available diagnostic devices in the market. In addition, the vendors also work on differentiating their products based on quality, the accuracy of results, and other value added services as it will help them to gain a competitive edge over their peers.

Geographically, companion diagnostic devices market is segmented into five regions: North America, Europe, Latin America, Asia-Pacific and Middle East & Africa. North America expected to be major market for companion diagnostics owing to growth innovative technologies in biomarkers, increase in R&D investment in the region. Asia-Pacific and Europe are expected to grow at a significant rate owing to large patent and consumer base, increasing government initiatives developing healthcare infrastructure, and growing disposable income.

Some of the players in companion diagnostic devices market are F. Hoffmann-La Roche Ltd.(Switzerland), Qiagen Ltd. (Germany), ARUP Laboratories (U.S.), Abbott Laboratories (U.S.), Biogenex Laboratories, Inc. (U.S), Thermo Fisher Scientific (U.S), Ventana Medical Systems Inc. (U.S), Myriad Genetics Inc. (U.S), and Danaher (U.S) and others.

In June 2015, Ventana Medical Systems, Inc. (RocheGroup) has received USFDA approval for its ventana alk cdx assay, companion diagnostic to aid in the identification of patients for, xalkori (crizotinib) (Pfizer’s FDA approved targeted therapy)

In July 2014, AstraZeneca collaborated with Roche to develop a plasma-based companion diagnostic test to support azd9291, for non-small-cell lung cancer

In 2014, Ventana Medical Systems, Inc., collaborated with ImmunoGen, Inc. to develop biomarker assays and a companion diagnostic immunohistochemistry test (IHC) for one ImmunoGen’s product candidates
1. EXECUTIVE SUMMARY

2. GLOBAL COMPANION DIAGNOSTIC DEVICES MARKET INTRODUCTION

2.1. Global Companion Diagnostic Devices Market – Taxonomy
2.2. Global Companion Diagnostic Devices Market –Definitions
  2.2.1. Technology
  2.2.2. Application

3. GLOBAL COMPANION DIAGNOSTIC DEVICES MARKET DYNAMICS

3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Global Companion Diagnostic Devices Market Dynamic Factors - Impact Analysis

4. GLOBAL COMPANION DIAGNOSTIC DEVICES MARKET ANALYSIS, 2012 – 2016 AND FORECAST, 2017 – 2023

4.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
4.2. Year-over-Year (Y-o-Y) Growth Analysis (%)
4.3. Market Opportunity Analysis

5. GLOBAL COMPANION DIAGNOSTIC DEVICES MARKET, BY TECHNOLOGY, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

5.1. Immunohistochemistry
  5.1.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  5.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  5.1.3. Market Opportunity Analysis
5.2. Molecular Diagnostics
  5.2.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  5.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  5.2.3. Market Opportunity Analysis
5.3. In-situ Hybridization
  5.3.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  5.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  5.3.3. Market Opportunity Analysis
5.4. FISH
  5.4.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  5.4.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  5.4.3. Market Opportunity Analysis
5.5. CISH
  5.5.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  5.5.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  5.5.3. Market Opportunity Analysis
5.6. Real-Time PCR
  5.6.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  5.6.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  5.6.3. Market Opportunity Analysis
5.7. Gene Sequencing
  5.7.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  5.7.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  5.7.3. Market Opportunity Analysis

6. GLOBAL COMPANION DIAGNOSTIC DEVICES MARKET, BY APPLICATION, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

6.1. Breast Cancer
  6.1.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  6.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  6.1.3. Market Opportunity Analysis
6.2. Colorectal Cancer
  6.2.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  6.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  6.2.3. Market Opportunity Analysis
6.3. Lung Cancer
  6.3.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  6.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  6.3.3. Market Opportunity Analysis
6.4. Urology
  6.4.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  6.4.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  6.4.3. Market Opportunity Analysis
6.5. Melanoma
  6.5.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  6.5.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  6.5.3. Market Opportunity Analysis
6.6. Gastric Cancer
  6.6.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  6.6.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  6.6.3. Market Opportunity Analysis
6.7. Others
  6.7.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  6.7.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  6.7.3. Market Opportunity Analysis

7. GLOBAL COMPANION DIAGNOSTIC DEVICES MARKET, BY END USER, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

7.1. Hospitals
  7.1.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  7.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  7.1.3. Market Opportunity Analysis
7.2. Diagnostic Centers
  7.2.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  7.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  7.2.3. Market Opportunity Analysis
7.3. Others
  7.3.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  7.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  7.3.3. Market Opportunity Analysis

8. GLOBAL COMPANION DIAGNOSTIC DEVICES MARKET FORECAST, BY REGION, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

8.1. North America
  8.1.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  8.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  8.1.3. Market Opportunity Analysis
8.2. Europe
  8.2.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  8.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  8.2.3. Market Opportunity Analysis
8.3. Asia-Pacific
  8.3.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  8.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  8.3.3. Market Opportunity Analysis
8.4. Latin America
  8.4.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  8.4.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  8.4.3. Market Opportunity Analysis
8.5. Middle East and Africa
  8.5.1. Market Analysis, 2012 - 2016 and Forecast, 2017 – 2023 (Revenue, USD Mn)
  8.5.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
  8.5.3. Market Opportunity Analysis
8.6. Global Companion Diagnostic Devices Market - Opportunity Analysis Index, By Technology, By Application, By End User, and Region, 2017 – 2023

9. NORTH AMERICA COMPANION DIAGNOSTIC DEVICES MARKET ANALYSIS, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

9.1. Technology Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  9.1.1. Immunohistochemistry
  9.1.2. Molecular Diagnostics
  9.1.3. In-situ Hybridization
  9.1.4. FISH
  9.1.5. CISH
  9.1.6. Real-Time PCR
  9.1.7. Gene Sequencing
9.2. Application Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  9.2.1. Breast Cancer
  9.2.2. Colorectal Cancer
  9.2.3. Lung Cancer
  9.2.4. Urology
  9.2.5. Melanoma
  9.2.6. Gastric Cancer
  9.2.7. Others
9.3. End User Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  9.3.1. Hospitals
  9.3.2. Diagnostic Centres
  9.3.3. Others
9.4. Country Analysis 2016 and Forecast 2017 – 2023 by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
  9.4.1. U.S.
  9.4.2. Canada
9.5. North America Companion Diagnostic Devices Market - Opportunity Analysis Index, By Technology, By Application, By End User, and Country, 2017 – 2023
9.6. North America Companion Diagnostic Devices Market Dynamics – Trends

10. EUROPE COMPANION DIAGNOSTIC DEVICES MARKET ANALYSIS, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

10.1. Technology Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  10.1.1. Immunohistochemistry
  10.1.2. Molecular Diagnostics
  10.1.3. In-situ Hybridization
  10.1.4. FISH
  10.1.5. CISH
  10.1.6. Real-Time PCR
  10.1.7. Gene Sequencing
10.2. Application Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  10.2.1. Breast Cancer
  10.2.2. Colorectal Cancer
  10.2.3. Lung Cancer
  10.2.4. Urology
  10.2.5. Melanoma
  10.2.6. Gastric Cancer
  10.2.7. Others
10.3. End User Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  10.3.1. Hospitals
  10.3.2. Diagnostic Centres
  10.3.3. Others
10.4. Country Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
  10.4.1. Germany
  10.4.2. UK
  10.4.3. France
  10.4.4. Spain
  10.4.5. Italy
  10.4.6. Russia
  10.4.7. Poland
  10.4.8. Rest of Europe
10.5. Europe Companion Diagnostic Devices Market - Opportunity Analysis Index, By Technology, By Application, By End User, and Country, 2017 – 2023
10.6. Europe Companion Diagnostic Devices Market Dynamics – Trends

11. ASIA-PACIFIC COMPANION DIAGNOSTIC DEVICES MARKET ANALYSIS, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

11.1. Technology Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  11.1.1. Immunohistochemistry
  11.1.2. Molecular Diagnostics
  11.1.3. In-situ Hybridization
  11.1.4. FISH
  11.1.5. CISH
  11.1.6. Real-Time PCR
  11.1.7. Gene Sequencing
11.2. Application Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  11.2.1. Breast Cancer
  11.2.2. Colorectal Cancer
  11.2.3. Lung Cancer
  11.2.4. Urology
  11.2.5. Melanoma
  11.2.6. Gastric Cancer
  11.2.7. Others
11.3. End User Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  11.3.1. Hospitals
  11.3.2. Diagnostic Centres
  11.3.3. Others
11.4. Country Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
  11.4.1. Japan
  11.4.2. China
  11.4.3. India
  11.4.4. ASEAN
  11.4.5. Australia & New Zealand
  11.4.6. Rest of Asia-Pacific
11.5. Asia-Pacific Companion Diagnostic Devices Market - Opportunity Analysis Index, By Technology, By Application, By End User, and Country, 2017 – 2023
11.6. Asia-Pacific Companion Diagnostic Devices Market Dynamics – Trends

12. LATIN AMERICA COMPANION DIAGNOSTIC DEVICES MARKET ANALYSIS, 2012 - 2012 - 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

12.1. Technology Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  12.1.1. Immunohistochemistry
  12.1.2. Molecular Diagnostics
  12.1.3. In-situ Hybridization
  12.1.4. FISH
  12.1.5. CISH
  12.1.6. Real-Time PCR
  12.1.7. Gene Sequencing
12.2. Application Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  12.2.1. Breast Cancer
  12.2.2. Colorectal Cancer
  12.2.3. Lung Cancer
  12.2.4. Urology
  12.2.5. Melanoma
  12.2.6. Gastric Cancer
  12.2.7. Others
12.3. End User Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  12.3.1. Hospitals
  12.3.2. Diagnostic Centres
  12.3.3. Others
12.4. Country Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
  12.4.1. Brazil
  12.4.2. Mexico
  12.4.3. Argentina
  12.4.4. Venezuela
  12.4.5. Rest of Latin America
12.5. Latin America Companion Diagnostic Devices Market - Opportunity Analysis Index, By Technology, By Application, By End User, and Country, 2017 – 2023
12.6. Latin America Companion Diagnostic Devices Market Dynamics – Trends

13. MIDDLE EAST AND AFRICA COMPANION DIAGNOSTIC DEVICES MARKET ANALYSIS, 2012 - 2016 AND FORECAST, 2017 – 2023 (REVENUE, USD MN)

13.1. Technology Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  13.1.1. Immunohistochemistry
  13.1.2. Molecular Diagnostics
  13.1.3. In-situ Hybridization
  13.1.4. FISH
  13.1.5. CISH
  13.1.6. Real-Time PCR
  13.1.7. Gene Sequencing
13.2. Application Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  13.2.1. Breast Cancer
  13.2.2. Colorectal Cancer
  13.2.3. Lung Cancer
  13.2.4. Urology
  13.2.5. Melanoma
  13.2.6. Gastric Cancer
  13.2.7. Others
13.3. End User Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
  13.3.1. Hospitals
  13.3.2. Diagnostic Centres
  13.3.3. Others
13.4. Country Analysis 2012 - 2016 and Forecast 2017 – 2023 by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
  13.4.1. Gulf Cooperation Council (GCC) Countries
  13.4.2. Israel
  13.4.3. South Africa
  13.4.4. Rest of MEA
13.5. MEA Companion Diagnostic Devices Market - Opportunity Analysis Index, By Technology, By End User, By Application, and Country, 2017 – 2023
13.6. MEA Companion Diagnostic Devices Market Dynamics – Trends

14. COMPETITION LANDSCAPE

14.1. Strategic Dashboard of Top Market Players
14.2. Company Profiles (Introduction, Financial Analysis, Product & Service Offerings, Key Developments, Strategies, and SWOT Analysis)
  14.2.1. F. Hoffmann-La Roche Ltd.(Switzerland)
  14.2.2. Qiagen Ltd. (Germany)
  14.2.3. ARUP Laboratories (U.S.)
  14.2.4. Abbott Laboratories (U.S.)
  14.2.5. Biogenex Laboratories, Inc. (U.S)
  14.2.6. Thermo Fisher Scientific (U.S)
  14.2.7. Ventana Medical Systems Inc. (U.S)
  14.2.8. Myriad Genetics Inc. (U.S)
  14.2.9. Danaher (U.S)

15. RESEARCH METHODOLOGY

16. KEY ASSUMPTIONS AND ACRONYM


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