Companion Diagnostics Market Overview
A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potentially serious side effects or risks.
Several factors significantly boosting the growth of the global Companion Diagnostics market such as advantages of companion diagnostics, the increasing need for targeted therapy, the rising importance of personalized medicine, and the ever-increasing application areas of companion diagnostics. Additionally, other important factors such as increasing demand for next-generation sequencing, the rising importance of companion diagnostics in drug development, and a large number of clinical trials are further propelling the growth of this market progressively.
Furthermore, the companion diagnostics market is anticipated to experience noteworthy growth throughout the forecast period due to growth in R&D of targeted therapies, the discovery of new biomarkers for numerous conditions, and a large number of unmet needs for the treatment of cancer are majorly escalating the growth of the global Companion Diagnostics market.
On the downside, poor reimbursement policies, and longer developmental and approval phases are factors that are hampering the growth of the Companion Diagnostics Market.
Covid-19 Impact on Companion Diagnostics Market
In addition, the current Companion Diagnostics Market study offers a detailed analysis of the current COVID-19 pandemic impact on the market growth and its influence on the future growth of the Companion Diagnostics Market. The recently published report demonstrates the elevation in the demand for the healthcare sector. The healthcare manufacturers have experienced long term as well as short term effect which includes supply shortages, panic buying, and stocking, regulation changes as short-term whereas approval delays and possible trend variations in consumption could be perceived as long-term impacts of COVID-19 on the health and pharmaceutical market.
The increasing need for a cure has pushed vaccine research and manufacturers to the limit. In addition to this, panic conditions have already spurred the demand for many healthcare products and services which are discussed in detail in this report. Moreover, the impact of COVID-19 on overall market revenue for the base year 2020 and its projection up to 2027 is provided in detail in this report.
Companion Diagnostics Market Segment Overview
Based on the Technology, the Polymerase Chain Reaction (PCR) segment has the largest share of the global Companion Diagnostics market. The large share of this segment can be primarily attributed to the easy use and extensive availability of PCR kits & reagents in companion diagnostic testing. In addition, other factors such as rising applications of PCR in the high-throughput detection of mutants with a limited or low allele frequency of genes and high turnaround time of PCR as compared to other technologies are further support to the growth of this segment.
By End User, the Pharmaceutical & Biopharmaceutical Companies is an important segment in the market. This is because of the widespread usage of companion diagnostics in these industries due to their increasing prominence in drug development and the rising importance of companion diagnostic biomarkers. In addition to this, the escalating demand for personalized medicine as well as the huge demand for targeted therapies for several diseases and disorders are also projected to boost the demand and acceptance of companion diagnostics among pharmaceutical & biopharmaceutical companies.
Companion Diagnostics Market, By Product & Service
· Assay kits & Reagents
· Software & Services
Companion Diagnostics Market, By Technology
· Polymerase Chain Reaction (PCR)
· In Situ Hybridization (ISH)
· Next-Generation Sequencing (NGS)
· Immunohistochemistry (IHC)
· Others
Companion Diagnostics Market, By Indication
· Pharmaceutical & Biopharmaceutical Companies
· Reference Laboratories
· CROs
· Others
Companion Diagnostics Market Regional Overview
In terms of region, North America is expected to dominate the global Companion Diagnostics Market. This is because of the rising incidence of cancer, increasing health care expenditure, and rising demand for personalized treatment in this region. Similarly, the companion diagnostics market in the Asia Pacific is anticipated to grow at a significant rate over the forecast period. The growth of the market in this region is mainly attributed to the increasing prevalence of cancer, remarkable growth in research funding, and rise in proteomics & genomics research. Moreover, increasing investments by pharmaceutical and biotechnology companies, and growing awareness about personalized therapeutics in many APAC countries are anticipated to propel the growth of the Asia Pacific market.
Companion Diagnostics Market, By Geography
· North America (US & Canada)
· Europe (UK, Germany, France, Italy, Spain, Russia & Rest of Europe)
· Asia-Pacific (Japan, China, India, Australia, & South Korea, & Rest of Asia-Pacific)
· LAMEA (Brazil, Saudi Arabia, UAE & Rest of LAMEA)
Companion Diagnostics Market Competitor overview
Some key developments and strategies adopted by manufacturers in Companion Diagnostics are highlighted below.
· In August 2021, Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., and Precision Medicine Asia Co., Ltd. announced that the Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel as a companion diagnostic for TEPMETKO® a Merck KGaA, Darmstadt, Germany product that received approval by the Japanese MHLW in March 2020. TEPMETKO (tepotinib) is approved for use in patients with unresectable, advanced or recurrent non-small cell lung cancer with MET gene exon 14 skipping alterations.
· In August 2021, QIAGEN and OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel.
Companion Diagnostics Market, Key Players
· F. Hoffmann-La Roche AG
· Agilent Technologies, Inc.
· QIAGEN N.V.
· Abbott Laboratories, Inc.
· Almac Group
· Danaher Corporation
· Illumina, Inc.
· bioMérieux SA (France),
· Myriad Genetics, Inc.,
· Sysmex Corporation
· Thermo Fisher Scientific Inc.
· Abnova Corporation
· Guardant Health, Inc.
· Icon Plc
· Biogenex Laboratories, Inc.
A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potentially serious side effects or risks.
Several factors significantly boosting the growth of the global Companion Diagnostics market such as advantages of companion diagnostics, the increasing need for targeted therapy, the rising importance of personalized medicine, and the ever-increasing application areas of companion diagnostics. Additionally, other important factors such as increasing demand for next-generation sequencing, the rising importance of companion diagnostics in drug development, and a large number of clinical trials are further propelling the growth of this market progressively.
Furthermore, the companion diagnostics market is anticipated to experience noteworthy growth throughout the forecast period due to growth in R&D of targeted therapies, the discovery of new biomarkers for numerous conditions, and a large number of unmet needs for the treatment of cancer are majorly escalating the growth of the global Companion Diagnostics market.
On the downside, poor reimbursement policies, and longer developmental and approval phases are factors that are hampering the growth of the Companion Diagnostics Market.
Covid-19 Impact on Companion Diagnostics Market
In addition, the current Companion Diagnostics Market study offers a detailed analysis of the current COVID-19 pandemic impact on the market growth and its influence on the future growth of the Companion Diagnostics Market. The recently published report demonstrates the elevation in the demand for the healthcare sector. The healthcare manufacturers have experienced long term as well as short term effect which includes supply shortages, panic buying, and stocking, regulation changes as short-term whereas approval delays and possible trend variations in consumption could be perceived as long-term impacts of COVID-19 on the health and pharmaceutical market.
The increasing need for a cure has pushed vaccine research and manufacturers to the limit. In addition to this, panic conditions have already spurred the demand for many healthcare products and services which are discussed in detail in this report. Moreover, the impact of COVID-19 on overall market revenue for the base year 2020 and its projection up to 2027 is provided in detail in this report.
Companion Diagnostics Market Segment Overview
Based on the Technology, the Polymerase Chain Reaction (PCR) segment has the largest share of the global Companion Diagnostics market. The large share of this segment can be primarily attributed to the easy use and extensive availability of PCR kits & reagents in companion diagnostic testing. In addition, other factors such as rising applications of PCR in the high-throughput detection of mutants with a limited or low allele frequency of genes and high turnaround time of PCR as compared to other technologies are further support to the growth of this segment.
By End User, the Pharmaceutical & Biopharmaceutical Companies is an important segment in the market. This is because of the widespread usage of companion diagnostics in these industries due to their increasing prominence in drug development and the rising importance of companion diagnostic biomarkers. In addition to this, the escalating demand for personalized medicine as well as the huge demand for targeted therapies for several diseases and disorders are also projected to boost the demand and acceptance of companion diagnostics among pharmaceutical & biopharmaceutical companies.
Companion Diagnostics Market, By Product & Service
· Assay kits & Reagents
· Software & Services
Companion Diagnostics Market, By Technology
· Polymerase Chain Reaction (PCR)
· In Situ Hybridization (ISH)
· Next-Generation Sequencing (NGS)
· Immunohistochemistry (IHC)
· Others
Companion Diagnostics Market, By Indication
- Cardiovascular
- Neurological Diseases
- Cancer
- Breast Cancer
- Lung Cancer
- Colorectal Cancer
- Melanoma
- Gastric Cancer
- Infectious Diseases
- Others
· Pharmaceutical & Biopharmaceutical Companies
· Reference Laboratories
· CROs
· Others
Companion Diagnostics Market Regional Overview
In terms of region, North America is expected to dominate the global Companion Diagnostics Market. This is because of the rising incidence of cancer, increasing health care expenditure, and rising demand for personalized treatment in this region. Similarly, the companion diagnostics market in the Asia Pacific is anticipated to grow at a significant rate over the forecast period. The growth of the market in this region is mainly attributed to the increasing prevalence of cancer, remarkable growth in research funding, and rise in proteomics & genomics research. Moreover, increasing investments by pharmaceutical and biotechnology companies, and growing awareness about personalized therapeutics in many APAC countries are anticipated to propel the growth of the Asia Pacific market.
Companion Diagnostics Market, By Geography
· North America (US & Canada)
· Europe (UK, Germany, France, Italy, Spain, Russia & Rest of Europe)
· Asia-Pacific (Japan, China, India, Australia, & South Korea, & Rest of Asia-Pacific)
· LAMEA (Brazil, Saudi Arabia, UAE & Rest of LAMEA)
Companion Diagnostics Market Competitor overview
Some key developments and strategies adopted by manufacturers in Companion Diagnostics are highlighted below.
· In August 2021, Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., and Precision Medicine Asia Co., Ltd. announced that the Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel as a companion diagnostic for TEPMETKO® a Merck KGaA, Darmstadt, Germany product that received approval by the Japanese MHLW in March 2020. TEPMETKO (tepotinib) is approved for use in patients with unresectable, advanced or recurrent non-small cell lung cancer with MET gene exon 14 skipping alterations.
· In August 2021, QIAGEN and OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel.
Companion Diagnostics Market, Key Players
· F. Hoffmann-La Roche AG
· Agilent Technologies, Inc.
· QIAGEN N.V.
· Abbott Laboratories, Inc.
· Almac Group
· Danaher Corporation
· Illumina, Inc.
· bioMérieux SA (France),
· Myriad Genetics, Inc.,
· Sysmex Corporation
· Thermo Fisher Scientific Inc.
· Abnova Corporation
· Guardant Health, Inc.
· Icon Plc
· Biogenex Laboratories, Inc.
Companion Diagnostics Market Study Global Market Analysis, Insights and Forecast, 2020-2027
1. Introduction
- 1.1. Research Scope
- 1.2. Market Segmentation
- 1.3. Research Methodology
- 1.4. Definitions and Assumptions
2. Executive Summary
3. Market Dynamics
- 3.1. Market Drivers
- 3.2. Market Restraints
- 3.3. Market Opportunities
4. Key Insights
- 4.1. Key Emerging Trends – For Major Countries
- 4.2. Latest Technological Advancement
- 4.3. Regulatory Landscape
- 4.4. Industry SWOT Analysis
- 4.5. Porters Five Forces Analysis
5. Global Companion Diagnostics Market Analysis (USD Billion), Insights and Forecast, 2020-2027
- 5.1. Key Findings / Summary
- 5.2. Market Analysis, Insights and Forecast – By Product & Service
- 5.2.1. Assay kits & Reagents
- 5.2.2. Software & Services
- 5.3. Market Analysis, Insights and Forecast – By Technology
- 5.3.1. Polymerase Chain Reaction (PCR)
- 5.3.2. In Situ Hybridization (ISH)
- 5.3.3. Next-Generation Sequencing (NGS)
- 5.3.4. Immunohistochemistry (IHC)
- 5.3.5. Others
- 5.4. Market Analysis, Insights and Forecast – By Indication
- 5.4.1. Cardiovascular
- 5.4.2. Neurological Diseases
- 5.4.3. Cancer
- 5.4.3.1. Breast Cancer
- 5.4.3.2. Lung Cancer
- 5.4.3.3. Colorectal Cancer
- 5.4.3.4. Melanoma
- 5.4.3.5. Gastric Cancer
- 5.4.4. Infectious Diseases
- 5.4.5. Others
- 5.5. Market Analysis, Insights and Forecast – By End User
- 5.5.1. Pharmaceutical & Biopharmaceutical Companies
- 5.5.2. Reference Laboratories
- 5.5.3. CROs
- 5.5.4. Others
- 5.6. Market Analysis, Insights and Forecast – By Region
- 5.6.1. North America
- 5.6.2. Europe
- 5.6.3. Asia Pacific
- 5.6.4. Latin America, Middle East and Africa
6. North America Companion Diagnostics Market Analysis (USD Billion), Insights and Forecast, 2020-2027
- 6.1. Key Findings / Summary
- 6.2. Market Analysis, Insights and Forecast – By Product & Service
- 6.2.1. Assay kits & Reagents
- 6.2.2. Software & Services
- 6.3. Market Analysis, Insights and Forecast – By Technology
- 6.3.1. Polymerase Chain Reaction (PCR)
- 6.3.2. In Situ Hybridization (ISH)
- 6.3.3. Next-Generation Sequencing (NGS)
- 6.3.4. Immunohistochemistry (IHC)
- 6.3.5. Others
- 6.4. Market Analysis, Insights and Forecast – By Indication
- 6.4.1. Cardiovascular
- 6.4.2. Neurological Diseases
- 6.4.3. Cancer
- 6.4.3.1. Breast Cancer
- 6.4.3.2. Lung Cancer
- 6.4.3.3. Colorectal Cancer
- 6.4.3.4. Melanoma
- 6.4.3.5. Gastric Cancer
- 6.4.4. Infectious Diseases
- 6.4.5. Others
- 6.5. Market Analysis, Insights and Forecast – By End User
- 6.5.1. Pharmaceutical & Biopharmaceutical Companies
- 6.5.2. Reference Laboratories
- 6.5.3. CROs
- 6.5.4. Others
- 6.6. Market Analysis, Insights and Forecast – By Country
- 6.6.1. U.S.
- 6.6.2. Canada
7. Europe Companion Diagnostics Market Analysis (USD Billion), Insights and Forecast, 2020-2027
- 7.1. Key Findings / Summary
- 7.2. Market Analysis, Insights and Forecast – By Product & Service
- 7.2.1. Assay kits & Reagents
- 7.2.2. Software & Services
- 7.3. Market Analysis, Insights and Forecast – By Technology
- 7.3.1. Polymerase Chain Reaction (PCR)
- 7.3.2. In Situ Hybridization (ISH)
- 7.3.3. Next-Generation Sequencing (NGS)
- 7.3.4. Immunohistochemistry (IHC)
- 7.3.5. Others
- 7.4. Market Analysis, Insights and Forecast – By Indication
- 7.4.1. Cardiovascular
- 7.4.2. Neurological Diseases
- 7.4.3. Cancer
- 7.4.3.1. Breast Cancer
- 7.4.3.2. Lung Cancer
- 7.4.3.3. Colorectal Cancer
- 7.4.3.4. Melanoma
- 7.4.3.5. Gastric Cancer
- 7.4.4. Infectious Diseases
- 7.4.5. Others
- 7.5. Market Analysis, Insights and Forecast – By End User
- 7.5.1. Pharmaceutical & Biopharmaceutical Companies
- 7.5.2. Reference Laboratories
- 7.5.3. CROs
- 7.5.4. Others
- 7.6. Market Analysis, Insights and Forecast – By Country
- 7.6.1. UK
- 7.6.2. Germany
- 7.6.3. France
- 7.6.4. Italy
- 7.6.5. Spain
- 7.6.6. Russia
- 7.6.7. Rest of Europe
8. Asia Pacific Companion Diagnostics Market Analysis (USD Billion), Insights and Forecast, 2020-2027
- 8.1. Key Findings / Summary
- 8.2. Market Analysis, Insights and Forecast – By Product & Service
- 8.2.1. Assay kits & Reagents
- 8.2.2. Software & Services
- 8.3. Market Analysis, Insights and Forecast – By Technology
- 8.3.1. Polymerase Chain Reaction (PCR)
- 8.3.2. In Situ Hybridization (ISH)
- 8.3.3. Next-Generation Sequencing (NGS)
- 8.3.4. Immunohistochemistry (IHC)
- 8.3.5. Others
- 8.4. Market Analysis, Insights and Forecast – By Indication
- 8.4.1. Cardiovascular
- 8.4.2. Neurological Diseases
- 8.4.3. Cancer
- 8.4.3.1. Breast Cancer
- 8.4.3.2. Lung Cancer
- 8.4.3.3. Colorectal Cancer
- 8.4.3.4. Melanoma
- 8.4.3.5. Gastric Cancer
- 8.4.4. Infectious Diseases
- 8.4.5. Others
- 8.5. Market Analysis, Insights and Forecast – By End User
- 8.5.1. Pharmaceutical & Biopharmaceutical Companies
- 8.5.2. Reference Laboratories
- 8.5.3. CROs
- 8.5.4. Others
- 8.6. Market Analysis, Insights and Forecast – By Country
- 8.6.1. China
- 8.6.2. India
- 8.6.3. Japan
- 8.6.4. Australia
- 8.6.5. South East Asia
- 8.6.6. Rest of Asia Pacific
9. Latin America, Middle East and Africa Companion Diagnostics Market Analysis (USD Billion), Insights and Forecast, 2020-2027
- 9.1. Key Findings / Summary
- 9.2. Market Analysis, Insights and Forecast – By Product & Service
- 9.2.1. Assay kits & Reagents
- 9.2.2. Software & Services
- 9.3. Market Analysis, Insights and Forecast – By Technology
- 9.3.1. Polymerase Chain Reaction (PCR)
- 9.3.2. In Situ Hybridization (ISH)
- 9.3.3. Next-Generation Sequencing (NGS)
- 9.3.4. Immunohistochemistry (IHC)
- 9.3.5. Others
- 9.4. Market Analysis, Insights and Forecast – By Indication
- 9.4.1. Cardiovascular
- 9.4.2. Neurological Diseases
- 9.4.3. Cancer
- 9.4.3.1. Breast Cancer
- 9.4.3.2. Lung Cancer
- 9.4.3.3. Colorectal Cancer
- 9.4.3.4. Melanoma
- 9.4.3.5. Gastric Cancer
- 9.4.4. Infectious Diseases
- 9.4.5. Others
- 9.5. Market Analysis, Insights and Forecast – By End User
- 9.5.1. Pharmaceutical & Biopharmaceutical Companies
- 9.5.2. Reference Laboratories
- 9.5.3. CROs
- 9.5.4. Others
- 9.6. Market Analysis, Insights and Forecast – By Country
- 9.6.1. Brazil
- 9.6.2. Saudi Arabia
- 9.6.3. UAE
- 9.6.4. Rest of LAMEA
10. Competitive Analysis
- 10.1. Company Market Share Analysis, 2018
- 10.2. Key Industry Developments
- 10.3. Company Profile
- 10.4. F. Hoffmann-La Roche AG
- 10.4.1. Business Overview
- 10.4.2. Segment 1 & Service Offering
- 10.4.3. Overall Revenue
- 10.4.4. Geographic Presence
- 10.4.5. Recent Development
- 10.5. Agilent Technologies, Inc.
- 10.6. QIAGEN N.V.
- 10.7. Abbott Laboratories, Inc.
- 10.8. Almac Group
- 10.9. Danaher Corporation
- 10.10. Illumina, Inc.
- 10.11. bioMérieux SA (France),
- 10.12. Myriad Genetics, Inc.,
- 10.13. Sysmex Corporation
- 10.14. Thermo Fisher Scientific Inc.
- 10.15. Abnova Corporation
- 10.16. Guardant Health, Inc.
- 10.17. Icon Plc
Research Process
Data Library Research are conducted by industry experts who offer insight on industry structure, market segmentations technology assessment and competitive landscape (CL), and penetration, as well as on emerging trends. Their analysis is based on primary interviews (~ 80%) and secondary research (~ 20%) as well as years of professional expertise in their respective industries. Adding to this, by analysing historical trends and current market positions, our analysts predict where the market will be headed for the next five years. Furthermore, the varying trends of segment & categories geographically presented are also studied and the estimated based on the primary & secondary research.
In this particular report from the supply side Data Library Research has conducted primary surveys (interviews) with the key level executives (VP, CEO’s, Marketing Director, Business Development Manager and SOFT) of the companies that active & prominent as well as the midsized organization
FIGURE 1: DLR RESEARH PROCESS
Extensive primary research was conducted to gain a deeper insight of the market and industry performance. The analysis is based on both primary and secondary research as well as years of professional expertise in the respective industries.
In addition to analysing current and historical trends, our analysts predict where the market is headed over the next five years.
It varies by segment for these categories geographically presented in the list of market tables. Speaking about this particular report we have conducted primary surveys (interviews) with the key level executives (VP, CEO’s, Marketing Director, Business Development Manager and many more) of the major players active in the market.
Secondary ResearchSecondary research was mainly used to collect and identify information useful for the extensive, technical, market-oriented, and Friend’s study of the Global Extra Neutral Alcohol. It was also used to obtain key information about major players, market classification and segmentation according to the industry trends, geographical markets, and developments related to the market and technology perspectives. For this study, analysts have gathered information from various credible sources, such as annual reports, sec filings, journals, white papers, SOFT presentations, and company web sites.
Market Size EstimationBoth, top-down and bottom-up approaches were used to estimate and validate the size of the Global market and to estimate the size of various other dependent submarkets in the overall Extra Neutral Alcohol. The key players in the market were identified through secondary research and their market contributions in the respective geographies were determined through primary and secondary research.
Forecast Model
