Gene Panel: UK-Japan International Launch

Navigating Two Regulatory Worlds Simultaneously

Client: Diagnostics Company | Sector: Genomics / IVD
Services: Go-to-Market Strategy, Regulatory-Commercial Alignment, Multi-Market Launch

Context

The client was a diagnostics company that had developed a gene panel for inherited retinal diseases (IRDs) — a group of rare genetic conditions that cause progressive vision loss and, in many cases, blindness. The gene panel had strong clinical evidence: validated analytical performance, clear clinical utility for guiding treatment decisions, and the potential to significantly improve diagnostic pathways for patients with suspected hereditary eye conditions.

The company was already established in the genomics diagnostics space, with a portfolio spanning oncology (tissue and liquid biopsy), hereditary cancer, and rare disease panels. But this product represented a new therapeutic area and a significant international expansion opportunity. The IRD gene panel was to be launched in both the UK and Japan — two markets with completely different regulatory frameworks, reimbursement systems, clinical practice patterns, and buyer decision-making processes.

This was the kind of launch that separates companies with genuine commercial capability from those that have a good product but no plan for getting it adopted across borders.

The Challenge

The UK and Japan launches had been developing independently — separate teams, separate timelines, separate strategies. This isn't unusual in diagnostics companies. Regulatory requirements differ so significantly between markets that it's tempting to treat each launch as an isolated project. But fragmentation creates problems that compound over time:

• Duplicated effort. Both teams were doing competitive analyses, building KOL maps, developing clinical evidence summaries, and creating sales materials — independently. The work was largely the same, but performed twice with no coordination
• Inconsistent positioning. The UK team was positioning the panel one way; the Japan team another. For a small company, this creates brand confusion. For a product in a rare disease area, where the clinical community is small and globally connected, inconsistent positioning is a genuine commercial risk — the same KOL might encounter different stories at different conferences
• Regulatory-commercial misalignment. The regulatory submissions in each market were being developed primarily by the regulatory affairs team, with limited commercial input. But regulatory decisions have profound commercial implications. The indications you pursue, the comparators you choose, the performance claims you can make — these shape your positioning for years. In the UK, the regulatory strategy needed to align with NICE evaluation criteria and NHS procurement requirements. In Japan, it needed to support National Health Insurance (NHI) reimbursement applications
• No coordinated launch sequence. Which market should launch first? Should approvals be synchronised or staggered? How does the UK launch evidence inform the Japan submission? How does Japan reimbursement success affect the UK pricing argument? These questions had no answers because nobody was looking at the two launches as a connected strategy

The Regulatory Landscape

Understanding what made this launch particularly complex requires understanding how differently the UK and Japan evaluate and adopt diagnostic products.

United Kingdom: The regulatory pathway involved MHRA (Medicines and Healthcare products Regulatory Agency) for product approval and UKCA marking. But regulatory approval is only the beginning. The commercial pathway required alignment with NICE (National Institute for Health and Care Excellence) evaluation criteria for diagnostic technologies, NHS Supply Chain procurement processes, and Integrated Care Board commissioning decisions. The evidence package needed to demonstrate not just analytical validity but clinical utility, cost-effectiveness, and impact on patient pathways. NHS procurement committees evaluate diagnostics through a health economics lens — "does this test change a clinical decision, and does that decision justify the cost?"

Japan: The regulatory pathway involved PMDA (Pharmaceuticals and Medical Devices Agency) approval, which has its own evidence requirements and review timelines. But the critical commercial milestone in Japan is National Health Insurance (NHI) reimbursement — without NHI coverage, the product effectively has no market because healthcare providers won't use a test that patients can't get reimbursed for. The NHI application process requires a different evidence package than MHRA/NICE, with particular emphasis on the diagnostic's role in the Japanese clinical pathway and its alignment with Japanese clinical practice guidelines.

The clinical communities in both markets are also different. The UK's inherited retinal disease clinical pathway involves a specific set of ophthalmology centres and genetic testing laboratories. Japan's pathway involves a different set of institutions with different referral patterns. The KOLs who matter in each market overlap partially (rare disease is a globally connected community) but are not identical.

The Approach

Unified commercial framework. The first step was creating a single go-to-market framework that served both markets. This wasn't about making the UK and Japan strategies identical — it was about building a shared architecture that maintained consistent positioning while allowing market-specific adaptation. The framework defined:

• Core positioning: What clinical value does this gene panel deliver, regardless of market? This became the anchor for both launches
• Market-specific framing: How does the clinical value translate into the specific decision criteria used by NHS procurement (UK) and NHI reimbursement boards (Japan)?
• Evidence strategy: What evidence supports the global positioning, and what additional evidence is required for each market's regulatory and reimbursement requirements?
• Timeline coordination: How do the regulatory milestones in each market create opportunities for the other?

Regulatory-commercial alignment. I worked with the regulatory affairs team to ensure that the regulatory submission strategy in each market actively supported the commercial narrative. In the UK, this meant framing the clinical evidence in terms that aligned with NICE evaluation criteria and NHS procurement requirements — not just proving the panel worked, but demonstrating how it improved the diagnostic pathway and generated health economic value. In Japan, this meant aligning the PMDA submission evidence with the NHI reimbursement application requirements, ensuring that regulatory approval created a direct pathway to reimbursement.

Parallel market access strategies. For the UK, I developed the market access plan for NHS procurement — positioning the gene panel within the existing clinical pathway for inherited retinal diseases, engaging with the relevant commissioning bodies, and building the health economic argument. For Japan, I coordinated the NHI reimbursement strategy, working with the local team to develop the application, engage with the relevant medical societies, and navigate the reimbursement negotiation process.

KOL engagement across markets. I mapped the KOL landscape in both markets — identifying the clinicians, geneticists, and laboratory directors who would influence adoption decisions. In rare diseases, the clinical community is relatively small and globally connected, which meant that some KOLs were relevant in both markets. The engagement strategy accounted for this: ensuring that the messaging was consistent when the same KOL encountered the product at both UK and international conferences. I managed advisory boards in both markets and coordinated scientific communication across European oncology and genetics conferences.

Launch sequencing. Rather than attempting simultaneous launch, I designed a phased sequence that maximised the impact of each regulatory milestone. Early UK regulatory progress generated clinical evidence and real-world data that strengthened the Japan submission. Japan's NHI reimbursement success — securing national coverage — created a reference point that supported the UK health economic argument. Each market's progress reinforced the other's commercial position.

The Results

What Happened Next

The unified framework developed for the IRD gene panel became a template for the company's subsequent international launches. Rather than treating each new market entry as an independent project, the company adopted a coordinated approach — shared positioning architecture with market-specific adaptation, regulatory-commercial alignment from the outset, and sequenced launches designed to create commercial momentum across markets.

The success in Japan was particularly significant. Securing NHI reimbursement for a genomics diagnostic from a non-Japanese company is a substantial achievement that required navigating regulatory, reimbursement, and clinical adoption challenges simultaneously. The framework for how this was accomplished — the regulatory-commercial alignment, the KOL engagement, the evidence strategy — became a reusable asset for future APAC expansion.

Key Insight

Multi-market launches in diagnostics fail when companies treat each market as an independent project. The regulatory requirements are different, yes. The reimbursement systems are different. The clinical pathways are different. But the product is the same, and the clinical value proposition should be consistent. The companies that succeed are the ones that build a unified commercial architecture — consistent positioning, coordinated evidence strategy, sequenced regulatory milestones — and then adapt that architecture to each market's specific requirements.

The alternative — independent teams building independent strategies — creates duplication, inconsistency, and missed opportunities. When each market's regulatory success reinforces the other's commercial position, the whole becomes significantly more than the sum of its parts. That's what a coordinated multi-market launch delivers, and it's what I build.

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