Global Top 20 Pharma: First-in-Class Oncology Therapy Delivering precision medicine success through a multi-year commercialization partnership
The challenge
A global top 20 pharmaceutical company expanded into precision oncology by developing a first-in-class cancer therapy built on a novel biomarker.
This was the company’s first precision medicine launch—a milestone program with high stakes. While the therapy showed strong clinical promise, success depended on preparing the market for an entirely new approach, from building awareness of the biomarker to establishing testing pathways, navigating global complexity, and driving adoption by HCPs and labs.
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Novel biomarker: Virtually unknown among oncologists and labs, with no established testing ecosystem to support adoption.
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First precision medicine experience: The company needed to build an internal playbook for bringing a targeted therapy to market.
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Complex disease area: Cancer presented additional challenges, with low awareness of testing pathways, high variability across markets, and entrenched patient leakage points.
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Global regulatory uncertainty: The therapy’s launch coincided with Europe’s transition to the new In Vitro Diagnostic Regulation (IVDR), adding further complexity to timelines and approvals.
The company needed a partner to bridge scientific, diagnostic, and commercial gaps and prepare the testing infrastructure for launch at scale.
Our Approach
Diaceutics partnered with the client through a seven-year, embedded collaboration spanning early commercial planning, global launch and lifecycle management. Working as an extension of the client’s internal team, Diaceutics combined strategic foresight with practical execution to accelerate testing readiness and adoption.
Key elements of the partnership included:
- Building internal knowledge and competence: Developed education programs to equip global and regional teams with the expertise to manage a companion diagnostic-dependent launch.
- Understanding the diagnostic landscape: Delivered market intelligence that identified testing gaps, steered priorities, and forecasted uptake across multiple geographies.
- Designing for launch success: Created tactical playbooks, convened expert advisory boards, and shaped access and reimbursement strategies to prepare priority markets.
- Activating lab network: Secured early test validation, established new lab partnerships, and expanded diagnostic availability in routine clinical labs from zero to more than 200 pre-launch, within 12 months
- Accelerating field readiness: Halved the time needed to achieve 70% test readiness in priority markets across Europe and APAC.
- Sustaining adoption momentum: Monitored real-world uptake post-launch to optimize performance and secure long-term success.
The Impact
The collaboration delivered measurable outcomes that supported the therapy’s successful launch and uptake
- Testing availability: Expanded from zero labs at baseline to more than 200 across Europe, with multiple labs established in the US before launch.
- Accelerated timelines: The diagnostic field force was established 6–8 months faster than the competition, giving the therapy a first mover advantage. .
- Regulatory resilience: Maintained launch readiness throughout Europe’s IVDR transition.
- Commercial performance: The therapy achieved global sales beyond expectations and outperformed forecasted biomarker market penetration.
This became a blueprint for the client’s future precision medicine launches. The program demonstrates how early partnership with Diaceutics and integrated diagnostic planning drives commercial success.
The value of the embedded partnership lay in combining long-term strategic support with practical execution - helping the client build internal capability, accelerate diagnostic readiness, de-risk launch, and sustain adoption across markets.
Navigate complexity, accelerate adoption, and drive sustained growth.
Connect with us today to unlock your therapy's full potential.
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