Clinical Spatial Biology + Digital Pathology Competitive Intelligence Report - H1 2022

Technologies that profile the tumor microenvironment (TME) have become a central tool for biomarker discovery and validation, especially in the field of immuno-oncology (I/O). In addition to their utility in discovery / translational applications, technologies like multiplex tissue analysis (MTA) and AI-guided digital pathology (DP) are fast solidifying as diagnostics as well.

In this report, we take a deep dive into the clinical maturity of MTA / DP technologies, and benchmark how this activity varies across top industry players (biopharma, diagnostics developers, tools developers). These data are summarized as a competitive intelligence assessment across industry-led, translational-clinical stage activity including clinical trials, high-impact publications, oncology conference abstracts, press releases, and other clinically-oriented news from 2020-H1 2022. Our key intent is to highlight catalysts indicative of the movement of MTA / DP into the clinic and to benchmark some of the top players driving these efforts.

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Key takeaways discussed in this report include:

Dx / Tools companies still lead MTA / DP activity, though biopharma activity is increasing

• Dx companies are driving MTA / DP adoption and continuously evolving platforms / applications
• Despite significant recent partnering, pharma-led studies rarely name the supporting Dx vendor

Tech ecosystem partnering’ has been a key tactic for expanding MTA / DP capabilities in 2022

• Multiple Dx / tools partnerships enable cohesive end-to-end workflows with integrated AI
• End users may benefit from platform-agnostic solutions for AI-driven tissue biomarker development

Despite a ~40% increase in YoY clinical outcomes data, prospective ‘spatial’ trials are rare

• ~3 pharma players deployed MTA biomarkers prospectively in H1 2022, but all late-stage activity is retrospective
• Several observational trials are deploying DP tools prospectively; CDx status unlikely without randomized clinical trials

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Scope & Table of Contents

Included

• Industry authored / sponsored activity that includes MTA and / or digital pathology for translational or clinical stage activity. All data is publicly available and spans 2020-H1 2022.

Excluded

• Any non-public activity that does not include an industry author (e.g., academic-led), is pre-clinical in focus / a non-human study, or lacks explicit mentions of MTA / DP. Any pre-2020 activity and low-impact publications (e.g., H-Index <10) were excluded given the focus on identifying the most impactful near-term clinical catalysts for these markets.

Table of Contents

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Executive Summary

• Key Takeaways
• Level of Activity by Top Industry Players
• Top H1 2022 Findings
• Clinical Trial Activity Overview
• Key Player Competitive Positioning

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Top Pharma Profiles

MTA / DP approach, top H1 2022 Developments, MTA / DP Clinical Trial Activity

• Roche
• Merck
• BMS
• AstraZeneca
• 3D Medicines

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Top Diagnostic / Tools Developer Profile

MTA / DP approach, top H1 2022 Developments, MTA / DP Clinical Trial Activity

• Akoya
• PathAI
• Ultivue
• NanoString
• Lunit

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Appendix

2022 Benchmark of other top MTA / DP developers (established and emerging)

• Standard Biotools, Visiopharm, Neogenomics, Halio Dx (Veracyte), 10X Genomics, Paige.AI, Proscia, Vizgen, Nucleai, Lunaphore

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