Breaking into Europe’s IVD market means navigating reimbursement, labs, and distributors —discover how GrowthMedics launched the world’s first predictive kidney test in Europe.
The Challenge
An Australian biotechnology company, a global leader in predictive diagnostics, developed the world’s first test for diabetic kidney disease (DKD). With strong success in their local market and starting success in the U.S., the company needed to expand into Europe but faced barriers: fragmented healthcare systems, complex reimbursement pathways, and limited awareness of predictive diagnostics compared to gold-standard methods.
Our Approach
GrowthMedics:
- Conducted a comprehensive market assessment: TAM/SAM, competition, reimbursement benchmarks, and SWOT analysis
- Identified and mapped KOLs, labs, nephrologists, endocrinologists, and distributorsin target markets (Netherlands, Belgium, Spain, Italy)
- Initiated hospital trials, lab collaborations, and distributor onboardingto build credibility and adoption
- Designed a multi-phase expansion plan, balancing early OOP testing, distributor-led sales, and long-term reimbursement approvals
- Executed marketing campaigns, webinars, and congress participationto raise awareness and support adoption
Results
- Secured multiple trials and LOIswith European labs, hospitals, and distributors
- Developed a strong funnel across 4 initial markets, expanding brand presence and validation in Europe
- Created a reimbursement roadmapfor Belgium, Germany, Italy, UK—aligning health economic models with ROI-driven adoption
- Client renewed the program after 12 monthsto continue scaling partnerships and reimbursement pathways
Why It Matters
For IVD and MedTech innovators, Europe offers vast opportunities but requires navigating fragmented regulations, reimbursement systems, and clinical validation needs. GrowthMedics’ structured market entry program turned a complex challenge into measurable traction—securing early adoption, distributor partnerships, and the foundation for long-term reimbursement-driven growth.
👉 Download the full case study to see how we accelerated market entry for a world-first predictive diagnostic test.
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