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MASH companion diagnostic landscape and partnership assessment

Screenshot 2026-10-09 173047

Industry

Pharmaceutical

The client

A biopharma company advancing a pipeline of therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease that often goes undiagnosed until it has advanced. Because the client's programs depended on identifying the right patients earlier, diagnostics had become a strategic question alongside its therapeutic work.

The challenge

As the client advanced its MASH therapeutic pipeline, it needed to understand what role it should play in the emerging companion diagnostic landscape. Liver disease diagnosis was fragmented across multiple tools, technologies, and biomarkers in varying stages of maturity, and the client had no structured view of which technologies to back, partner with, or ignore, a gap that put both its clinical development and business development timelines at risk.

The solution

BCE Consulting began with secondary research to map the stages of liver disease diagnosis, the tools used today, and emerging technologies and biomarkers in development, building a full map of the diagnostic landscape. For each technology category, BCE assessed strengths and weaknesses, time to market, and alignment with both the client's pipeline and competitor pipelines, giving the client a consistent, side-by-side view of where to focus.

The results

BCE recommended a portfolio approach, with investments spread across multiple early-stage diagnostic technologies, and identified an opportunity to pursue a laboratory-developed test (LDT) pathway alongside strategic partnerships. This gave the client a phased, risk-managed path to earlier patient identification that supported both its therapeutic development and business development agendas.

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