Global Companion Diagnostics Market – Drivers, Restraints, Opportunities, Trends, and Forecasts: 2018–2024

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  • Published Date:
    17 Jul 2021
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    Healthcare & Pharmaceuticals
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Impact Analysis on the Growth of Market

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Market Overview:

Global Companion Diagnostics Market – Drivers, Restraints, Opportunities, Trends, and Forecasts: 2018–2024
Overview: Companion diagnostics are molecular tests that provide essential information for the safety and effective use of the corresponding drug. These tests assist healthcare professionals to decide whether a specific treatment product benefits patient for curing disease, predict drug toxicities, off-target effects of treatment, and other adverse effects related to the drug. It is also used during clinical trials to guide treatment, which can improve therapy responses and treatment outcomes. Currently, there are over 20 approved or cleared companion diagnostic tests and most of the tests are for cancer treatments targeting mutation. According to the estimation of National Cancer Institute, in the US, around 1.6 million new cases of cancer were diagnosed and 595,690 people have died due to cancer in 2016. According to the Canadian Cancer Society, 202,400 new cases of cancer and nearly 78,000 deaths were recorded in 2016. While in Europe, 1.3 million people were diagnosed in 2015. Further, according to the study of World Health Organization, approximately 14 million new cancer cases were diagnosed and is expected to grow by about 70% over the next 2 decades. The trend of increasing incidence of cancer & infectious diseases is catching up even in developing countries due to increased adoption of the Western lifestyle, which is expected to fuel the growth of the companion diagnostics market in coming years.
The companion diagnostics market is booming due to increasing patient base for infectious diseases & cancer globally, high adoption of companion diagnostics, growing demand for companion diagnostics, and emerging applications of companion diagnostics. Low awareness & lack of professionals to conduct tests and unfavorable reimbursement scenario in developed & developing countries are few of the factors hampering the market growth to an extent.
Market Analysis: The “Global Companion Diagnostics” market is estimated to witness a CAGR of 19.6% during the forecast period 2018–2024. The market is analyzed based on four segments – technology, applications, end-users, and regions.
Regional Analysis: The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (RoW). North America is set to be the leading region for the companion diagnostics market growth followed by Europe, Asia Pacific, and Rest of the World.
Technology Analysis: The global companion diagnostics market, by technology, is segmented into polymerase chain reaction, immunohistochemistry, in-situ hybridization, next-generation sequencing, and others. Polymerase chain reaction occupied the largest share in 2017, and next-generation sequencing is expected to grow at a high CAGR in the coming years.
Application Analysis: The global companion diagnostics market, by application, is segmented into cancer, infectious disease, and others. The cancer application is further segmented into colorectal cancer, breast cancer, lung cancer, melanoma, and others. In 2017, cancer application occupied a significant market share and is expected to be the same during the forecast period due to increasing incidence of cancer, changing lifestyle, and growing
For instance, in February 2017, Roche announced the launch of Elecsys AMH Plus immunoassay, the first companion diagnostic to be approved for use in fertility. The key market players are receiving product approvals that are helping them to increase the market share. For instance, in June 2017, the US FDA granted approval to Thermo Fisher Scientific for NGS-based test known as the Oncomine Dx Target test, which instantaneously evaluates 23 genes clinically related to NSCLC.
Benefits: The report provides complete details about the usage and adoption rate of companion diagnostics products in various regions. With that, key stakeholders can know about the major trends, drivers, investments, vertical player’s initiatives, government initiatives toward the test adoption in the upcoming years along with the details of commercial tests available in the market. Moreover, the report provides details about the major challenges that are going to impact on the market growth. Additionally, the report gives the complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.
Key Stakeholders:

Geography Analysis:

The report further discusses the market opportunity, compound annual growth rate (CAGR) growth rate, competition, new technology innovations, market players analysis, government guidelines, export and import (EXIM) analysis, historical revenues, future forecasts etc. in the following regions and/or countries:

  • North America (U.S. & Canada) Market size, Y-O-Y growth, Market Players Analysis & Opportunity Outlook
  • Latin America (Brazil, Mexico, Argentina, Rest of Latin America) Market size, Y-O-Y growth & Market Players Analysis & Opportunity Outlook
  • Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC(Finland, Sweden, Norway, Denmark), Ireland, Switzerland, Austria, Poland, Turkey, Russia, Rest of Europe), Poland, Turkey, Russia, Rest of Europe) Market size, Y-O-Y growth Market Players Analys  & Opportunity Outlook
  • Asia-Pacific (China, India, Japan, South Korea, Singapore, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific) Market size, Y-O-Y growth & Market Players Analysis & Opportunity Outlook
  • Middle East and Africa  (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of Middle East and Africa) Market size, Y-O-Y growth Market Players Analysis & Opportunity Outlook


Table of Contents
1.1 Industry overview 9
1.2 Total addressable market 9
1.3 Industry Trends 10
2 Report Outline 10
2.1 Report Scope 10
2.2 Report Summary 11
2.3 Research Methodology 12
2.4 Report Assumptions 12
3 Market Snapshot 13
3.1 Market Definition – Infoholic Research 13
3.2 Importance of Companion diagnostics 13
3.3 Segmented Addressable Market (SAM) 13
3.4 Trends of the companion diagnostics market 14
3.5 Related Markets 15
3.5.1 Personalized medicine 15
3.5.2 Genetic testing Market 16
3.5.3 Point-Of-Care Diagnostics Market 16
4 Market Outlook 16
4.1 Overview 16
4.2 Regulatory Scenario 17
4.3 Market segmentation 18
4.4 PEST Analysis 18
4.5 Porter 5(Five) Forces 20
5 Market Characteristics 21
5.1 DRO – Global Companion Diagnostics Market Dynamics 21
5.1.1 Drivers 21 Growing incidence of cancer across the globe 21 Rising adoption of companion diagnostics tests 22 Growing demand of personalized medicine 23
5.1.2 Opportunities 23 Emerging applications of companion diagnostics 23 Growing demand for next-generation sequencing 23
5.1.3 Restraints 24 Uncertain reimbursement scenario in developed and developing countries 24 Lack of professionals to perform the test 25
6 Technology: Market Size and Analysis 27
6.1 Overview 27
6.2 Polymerase Chain Reaction 27
6.3 In Situ Hybridization 28
6.4 Immunohistochemistry 29
6.5 Next-Generation Sequencing 29
6.6 Others 30
7 Application: Market Size and Analysis 31
7.1 Overview 31
7.2 Cancer 31
7.2.1 Lung cancer 32
7.2.2 Breast cancer 33
7.2.3 Colorectal cancer 33
7.2.4 Melanoma 34
7.2.5 Others 34
7.3 Infectious disease 35
7.4 Others 35
8 End Users: Market Size and Analysis 36
8.1 Overview 36
8.2 Pharma and biopharma companies 36
8.3 Reference Laboratories 37
8.4 Others 37
9 Regions: Market Size and Analysis 37
9.1 Overview 38
9.2 North America 39
9.2.1 Overview 39
9.2.2 US 40
9.2.3 Canada 40
9.3 Europe 40
9.3.1 Overview 40
9.3.2 UK 41
9.3.3 Germany 42
9.3.4 France 42
9.3.5 Spain 42
9.4 APAC 42
9.4.1 Overview 42
9.4.2 India 43
9.4.3 China 44
9.5 Rest of the World 44
10 Competitive Landscape 46
10.1 Overview 46
11 Vendor Profiles 50
11.1 F.Hoffmann-La Roche Ltd 50
11.1.1 Overview 50
11.1.2 Business Unit 53
11.1.3 Geographic Presence 54
11.1.4 Business Focus 55
11.1.5 SWOT Analysis 55
11.1.6 Business Strategy 56
11.2 Qiagen N.V. 58
11.2.1 Overview 58
11.2.2 Geographic Presence 62
11.2.3 Business Focus 62
11.2.4 SWOT Analysis 63
11.2.5 Business Strategies 63
11.3 Abbott Laboratories 65
11.3.1 Overview 65
11.3.2 Business Unit 68
11.3.3 Geographic Presence 68
11.3.4 Business Focus 69
11.3.5 SWOT Analysis 70
11.3.6 Business Strategy 70
11.4 Myriad Genetics Inc. 72
11.4.1 Overview 72
11.4.2 Business Unit 74
11.4.3 Business Focus 75
11.4.4 SWOT Analysis 76
11.4.5 Business Strategy 76
11.5 Agilent Technologies Inc. 78
11.5.1 Overview 78
11.5.2 Business Units 81
11.5.3 Geographic Presence 82
11.5.4 Business Focus 83
11.5.5 SWOT Analysis 83
11.5.6 Business Strategies 84
12 Companies to Watch For 86
12.1 BioMerieux S.A. 86
12.1.1 Overview 86
12.1.2 BioMerieux S.A.: Recent Developments 86
12.2 Danaher Corporation (Leica Microsystems AG) 87
12.2.1 Overview 87
12.2.2 Danaher Corporation: Recent Developments 88
12.3 Resonance Health Limited 89
12.3.1 Overview 89
12.3.2 Resonance Health Limited: Recent Developments 89
12.4 Thermo Fisher Scientific 90
12.4.1 Overview 90
12.4.2 Thermo Fisher Scientific: Recent Developments 91
12.5 Genomic Health, Inc. 93
12.5.1 Overview 93
12.5.2 Genomic Health: Recent Developments 94
13 Annexure 96
13.1 Abbreviations 96

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F. Hoffmann-La Roche Ltd, Qiagen N.V., Abbott Laboratories, Myriad Genetics, Agilent Technologies, Inc., BioMerieux S.A., Danaher Corporation (Leica Microsystems AG), Resonance Health Limted, Thermo Fisher Scientific, Inc., Genomic Health, Inc
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