Companion diagnostics (CDx) are critical enablers of personalized therapies, linking diagnostic testing to targeted treatment selection. Companies in this space face complex scientific, regulatory, and commercial challenges. Development requires alignment with the therapeutic it supports, extensive clinical validation, and close coordination with regulatory authorities. Adoption depends on clinical utility, reimbursement, and integration into care pathways, which can vary by geography. Payers demand evidence of cost-effectiveness and real-world impact, while hospitals and laboratories require seamless workflow integration and operational reliability. Geopolitical factors, including international regulatory divergence, trade policies, and data-sharing restrictions, add further complexity to global commercialization strategies. Rapid scientific innovation, including genomics, molecular profiling, and biomarker discovery, accelerates the pace of competition and raises the stakes for portfolio and R&D prioritization.
We support companion diagnostics companies across the full spectrum of strategic and operational capabilities.
- Corporate Strategy: we help define global ambitions, prioritize CDx portfolios, assess market opportunities, design business models, and develop multi-year growth plans, including market entry, partnerships, and alliances with therapeutic developers.
- Customer Insights: we map stakeholders – including oncologists, laboratory directors, payers, and patients – capture the voice of the customer, and refine value propositions to drive adoption and reimbursement
- Commercial Strategy: we develop go-to-market models, launch readiness programs, commercial excellence initiatives, competitive benchmarking, and differentiation strategies tailored to CDx solutions
- Medical Affairs: we provide guidance on evidence generation, clinical validation, biomarker strategy, and healthcare professional engagement
- Market Access: we advise on global access strategies, pricing and reimbursement assessment, and value-based healthcare frameworks to support adoption and coverage
- R&D and Innovation: we optimize innovation sourcing, portfolio prioritization, lifecycle management, and R&D processes to accelerate high-value CDx development
- M&A and Transactions: we conduct commercial and vendor due diligence, build-up strategies, acquisition planning, and post-merger integration
By combining deep sector expertise with end-to-end strategic and operational support, we help companion diagnostics companies accelerate growth, optimize portfolios, navigate regulatory and geopolitical complexity, strengthen adoption, and deliver precise, patient-centric therapeutic impact.
