Companion Diagnostics (CDx) is Revolutionizing the Global Clinical Next-generation Sequencing (NGS) Market

Companion Diagnostics (CDx) is Revolutionizing the Global Clinical Next-generation Sequencing (NGS) Market

Next-generation Blockchain-Powered Genomic Data Marketplaces are Creating New Growth Opportunities

RELEASE DATE
03-Feb-2021
REGION
North America
Research Code: K555-01-00-00-00
SKU: HC03383-GL-MT_25182

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Description

2020 will be remembered for the COVID-19 pandemic, masks, social distancing protocol, alternate care sites, Moderna, Pfizer, BioNTech, AstraZeneca, RT-PCR, and serology testing (or all the above). However, in the midst of our response to the global pandemic, remarkable advancements were made in another great frontier in medicine that remains unconquered—cancer. These advancements mark the dawn of precision diagnostics to deliver the promise of personalized medicine. The key enablers were the game-changing advancements in next-generation (NGS) workflow solutions, defining a new era in mutation testing, early detection, liquid biopsy, pan-cancer in vitro diagnostic (IVD) assays, companion diagnostics (CDx) tests, and blockchain-based direct-to-consumer (DTC) services. The role of liquid biopsy NGS tests will gain significance in the coming age of minimal residue disease monitoring.

2020 saw a rising trend of consolidation; 3 high-value acquisitions took place—Illumina and Grail (announced); Invitae and ArcherDx; and Exact Sciences and Thrive Earlier Detection. With the arrival of early blood-based cancer screening assays and advancements in NGS bioinformatics, the market holds immense potential. Additional consolidations are expected in future, particularly in early detection and artificial intelligence (AI)-enabled diagnostics at the point of care (PoC).

North America (the United States) is the largest market. Strong infrastructure, favorable coverage policies, and early approvals for NGS-based CDx act as market growth drivers. Asia-Pacific is in the early stage of growth; however, an increase in public-private partnerships, biopharma developers’ increasing focus on CDx tests, and the need to develop in-house multi-gene panels are setting the tone for widespread guideline-recommended genomic testing.

Market leader Illumina (with its planned acquisition of Grail) will reignite its growth engine by changing its value proposition from ‘research tools company’ to ‘clinical diagnostics supplier’. As the workflow solutions segment continues to grow at an explosive rate, the genomic data marketplace will become a key growth opportunity that market participants can explore.

Macroeconomic models aim to improve and increase the amount of data available for basic genomic science and personalized genomic medicine and monetize data sharing initiatives by providing patients greater access control to data through a cooperative marketplace. This will improve clinical uptake, catalyze innovation, and build trust in the ecosystem.

Immediate growth opportunity lies in the development of NGS-based CDx tests. Hence, assay developers are encouraged to adopt a multi-disciplinary, design-focused approach to test menus, assay design, and overall workflow. A holistic approach is encouraged, and this must cover patient need, physician perspective, and the integration of test results with an electronic medical record system. Simultaneously, more efforts to create awareness through partnerships, education, and outreach initiatives will ensure consistent clinical uptake.

Exploring the possibilities of delivering CDx tests at the PoC by leveraging existing standard products and tailoring them to be specific to an analyte of interest, supported by smartphone apps and readers, could be a winning strategy. As clinical and economic utility continues to improve, new care delivery models will emerge (for example, conversational AI-enabled diagnostics at the PoC) and simplify real-world clinical genomic data, thereby helping to develop a better understanding of disease areas and treatment decisions.

Author: Amartya Bose

RESEARCH: INFOGRAPHIC

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Table of Contents

Why Is It Increasingly Difficult to Grow?

The Strategic Imperative 8™

The Impact of the Top Three Strategic Imperatives on the Clinical NGS Market

Growth Opportunities Fuel the Growth Pipeline Engine™

Scope of Analysis

Market Segmentation

Key Competitors—Global

Key Growth Metrics for Clinical NGS

Growth Drivers for Clinical NGS

Growth Restraints for Clinical NGS

Forecast Assumptions—General Factors under Consideration

Forecast Assumptions—Clinical NGS

Forecast Assumptions—Clinical NGS (continued)

Aspirational Revenue Forecast—Clinical NGS

Conservative Revenue Forecast—Clinical NGS

Aspirational Revenue Forecast by Industry Vertical—Clinical NGS

Conservative Revenue Forecast by Industry Vertical—Clinical NGS

Aspirational Revenue Forecast by Region—Clinical NGS

Conservative Revenue Forecast by Region—Clinical NGS

Revenue Forecast Analysis by Region—Clinical NGS

Revenue Forecast Analysis by Region—Clinical NGS (continued)

Competitive Environment—Clinical NGS

Revenue Share—Clinical NGS

Revenue Share Analysis—Clinical NGS

Competitive Environment—Clinical NGS

Key Growth Metrics for the Clinical NGS Workflow Solutions Segment

Aspirational Revenue Forecast—Clinical NGS Workflow Solutions

Conservative Revenue Forecast—Clinical NGS Workflow Solutions

Forecast Analysis—Clinical NGS Workflow Solutions

Key Growth Metrics for the Clinical NGS Instruments Segment

Aspirational Revenue Forecast—Clinical NGS Instruments

Conservative Revenue Forecast—Clinical NGS Instruments

Forecast Analysis—Clinical NGS Instruments

Revenue Share by Disease Area—Clinical NGS

Key Disease Area Discussions

Growth Opportunity 1: Multi-Gene Panels and NGS Tests for NSCLC, Prostate Cancer, and Colorectal Cancer Treatment Pathways

Growth Opportunity 1: Multi-Gene Panels and NGS Tests for NSCLC, Prostate Cancer, and Colorectal Cancer Treatment Pathways (continued)

Growth Opportunity 2: NGS-based CDx for Targeted Cancer Therapeutics in Asia-Pacific

Growth Opportunity 2: NGS-based CDx for Targeted Cancer Therapeutics in Asia-Pacific (continued)

Growth Opportunity 3: DTC WGS Testing and Services

Growth Opportunity 3: DTC WGS Testing and Services (continued)

Growth Opportunity 4: Next-Generation Blockchain-based Genomic Data Marketplaces

Growth Opportunity 4: Next-Generation Blockchain-based Genomic Data Marketplaces (continued)

Conclusions—Key Takeaways

Your Next Steps

Why Frost, Why Now?

List of Exhibits

List of Exhibits (continued)

Legal Disclaimer

Related Research
2020 will be remembered for the COVID-19 pandemic, masks, social distancing protocol, alternate care sites, Moderna, Pfizer, BioNTech, AstraZeneca, RT-PCR, and serology testing (or all the above). However, in the midst of our response to the global pandemic, remarkable advancements were made in another great frontier in medicine that remains unconquered—cancer. These advancements mark the dawn of precision diagnostics to deliver the promise of personalized medicine. The key enablers were the game-changing advancements in next-generation (NGS) workflow solutions, defining a new era in mutation testing, early detection, liquid biopsy, pan-cancer in vitro diagnostic (IVD) assays, companion diagnostics (CDx) tests, and blockchain-based direct-to-consumer (DTC) services. The role of liquid biopsy NGS tests will gain significance in the coming age of minimal residue disease monitoring. 2020 saw a rising trend of consolidation; 3 high-value acquisitions took place—Illumina and Grail (announced); Invitae and ArcherDx; and Exact Sciences and Thrive Earlier Detection. With the arrival of early blood-based cancer screening assays and advancements in NGS bioinformatics, the market holds immense potential. Additional consolidations are expected in future, particularly in early detection and artificial intelligence (AI)-enabled diagnostics at the point of care (PoC). North America (the United States) is the largest market. Strong infrastructure, favorable coverage policies, and early approvals for NGS-based CDx act as market growth drivers. Asia-Pacific is in the early stage of growth; however, an increase in public-private partnerships, biopharma developers increasing focus on CDx tests, and the need to develop in-house multi-gene panels are setting the tone for widespread guideline-recommended genomic testing. Market leader Illumina (with its planned acquisition of Grail) will reignite its growth engine by changing its value proposition from ‘research tools company to ‘clinical diagnostics supplier. As the workflow solutions segment continues to grow at an explosive rate, the genomic data marketplace will become a key growth opportunity that market participants can explore. Macroeconomic models aim to improve and increase the amount of data available for basic genomic science and personalized genomic medicine and monetize data sharing initiatives by providing patients greater access control to data through a cooperative marketplace. This will improve clinical uptake, catalyze innovation, and build trust in the ecosystem. Immediate growth opportunity lies in the development of NGS-based CDx tests. Hence, assay developers are encouraged to adopt a multi-disciplinary, design-focused approach to test menus, assay design, and overall workflow. A holistic approach is encouraged, and this must cover patient need, physician perspective, and the integration of test results with an electronic medical record system. Simultaneously, more efforts to create awareness through partnerships, education, and outreach initiatives will ensure consistent clinical uptake. Exploring the possibilities of delivering CDx tests at the PoC by leveraging existing standard products and tailoring them to be specific to an analyte of interest, supported by smartphone apps and readers, could be a winning strategy. As clinical and economic utility continues to improve, new care delivery models will emerge (for example, conversational AI-enabled diagnostics at the PoC) and simplify real-world clinical genomic data, thereby helping to develop a better understanding of disease areas and treatment decisions. Author: Amartya Bose
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No Index No
Podcast No
Author Amartya Bose
Industries Healthcare
WIP Number K555-01-00-00-00
Is Prebook No
GPS Codes 9600-B1,9562-B1,9573-B1,9627-B1