Belgium & Europe  ·  Est. 2015

Rare Disease
Commercial
Excellence

Turning orphan drug science into commercial success — through precision marketing, distribution mastery, and expert payer negotiations that secure the price your therapy deserves.

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Years of Expertise
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Major Pharma Clients
EU
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Tom Meuleman – Founder of RareGenetics
Tom Meuleman
Founder & Principal Consultant
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About RareGenetics

Over Two Decades Championing Rare Disease Access

"Rare diseases demand rare expertise. Standard pharma playbooks simply don't apply."

RareGenetics is a rare disease commercialization leading company, specializing in guiding companies new to rare diseases, from early strategic choices to successful market entry and sustainable growth.

With more than 23 years of hands-on experience in rare disease commercial sales and marketing, (pre) launch execution, optimized distribution strategies, lobby and pricing negotiations, the Tom Meuleman can deliver the kind of senior-level commercial leadership that most small and mid-size orphan drug companies cannot build in-house — and that generalist consultancies cannot replicate.

Based in Belgium and operating across Europe, RareGenetics combines strategic thinking with operational execution — from building bespoke go-to-market models to negotiating with payers and authorities to secure the best possible price and reimbursement position for your product.

Through RareGenetics, Tom operates on a clear conviction: rare disease assets don’t fail because of science, but they risk failing because companies apply the wrong commercial model. What works in primary care or specialty pharma breaks down completely in ultra-low prevalence settings.

This is where most startups and even established pharma entering rare diseases struggle:

  • No existing patient identification pathways
  • Fragmented expert networks
  • Unclear treatment positioning
  • Misaligned pricing and access strategies
  • Over-reliance on traditional sales force scaling
  • The wrong selling implementation by sales force teams

Commercial Launch Excellence Rare Disease Marketing Distribution Strategy Pricing & Payer Negotiation KOL Engagement Go-to-Market Strategy Orphan Drug Commercialisation European Reimbursement
Understanding the Challenge

The Rare Disease Patient Journey

Before a single therapy can reach a patient, there is a long, often harrowing journey — one that every market access strategy must deeply understand and respect.

1

Symptom Onset

Patients begin experiencing symptoms that are frequently misunderstood. With over 7,000 known rare diseases, recognising these early signs is a formidable challenge for healthcare professionals across Europe.

2

The Diagnostic Odyssey

On average, patients consult 8+ physicians over 5–6 years before receiving a correct diagnosis. Misdiagnosis rates are staggeringly high — 56% in some conditions — leading to delayed, inappropriate treatment and lasting psychological trauma.

3

Diagnosis & Specialist Referral

When finally diagnosed, patients must navigate fragmented specialist networks. Centers of Excellence are few and geographically dispersed. Access to genetic testing and expert interpretation varies dramatically across Europe.

4

Reimbursement & Access Barriers

Even once a therapy exists, patients face the labyrinth of reimbursement. Orphan drugs cost 3–7× more than standard treatments. In Belgium, navigation through NIHDI's processes — ETA, ETR, Medical Need Programs — demands specialist knowledge most companies lack in-house.

5

Treatment & Long-Term Support

Access to therapy is only the beginning. Ongoing patient support programs, adherence management, and real-world evidence collection are essential to sustaining reimbursement and improving outcomes long-term.

Every step of this journey is an opportunity to accelerate access — or to lose a patient entirely. RareGenetics exists to close these gaps.

What We Do

Rare Disease Commercial Expertise

Where science meets the market. RareGenetics delivers end-to-end commercial leadership — from crafting the go-to-market strategy to negotiating the price that makes your therapy financially sustainable.

Core Expertise
Core
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Rare Disease Commercial Marketing & Launch Excellence

Bespoke commercial strategies built around the specific dynamics of ultra-small patient populations, tight specialist networks, and high-value therapies — not scaled-down big pharma playbooks.

  • Orphan drug go-to-market strategy & execution
  • Cell & gene therapy commercialization strategy
  • Rare disease brand positioning & messaging
  • Specialty sales force model design & coaching
  • Patient support program design & oversight
  • Pre-launch disease awareness & market shaping
  • Multi-stakeholder engagement (HCPs, patients, payers)
  • New-to-rare disease market entry framework
Core
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Distribution Pathway Optimisation

We map, design, and optimise every link in your distribution chain to eliminate barriers between therapy and patient — a precision logistics and strategic challenge unique to rare disease.

  • Specialty pharmacy partner selection & management
  • Hospital & Centre of Excellence supply chain design
  • Cold-chain & high-value product logistics strategy
  • Named Patient & Compassionate Use distribution setup
  • Cross-border EU distribution pathway guidance
  • 3PL, CMO & vendor selection, onboarding & oversight
  • Distribution risk assessment & contingency planning
Core
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Pricing Negotiation & Payer Strategy

From building an evidence-based value narrative to sitting at the table with health authorities — securing the best sustainable price for your product through expert negotiation.

  • Orphan drug pricing strategy & benchmarking
  • Value dossier & economic case development
  • Strategic value narrative & payer storytelling
  • Payer negotiation preparation & advisory support
  • NIHDI & European authority engagement strategy
  • Managed entry agreement (MEA) design & negotiation
  • HTA body engagement & argumentation strategy
Supporting Services
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Pre-Launch Patient Journey Analysis

Map the full patient pathway from symptom onset to treatment, to identify diagnostic bottlenecks, referral gaps, and access barriers — intelligence that underpins smarter launch strategies.

  • Diagnostic pathway mapping
  • Center of Excellence identification
  • Patient advocacy group engagement
  • Disease awareness initiatives
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HCP Education & KOL Engagement

Identify, map, and engage Key Opinion Leaders and build the scientific exchange platforms that shape clinical practice in rare disease communities.

  • KOL identification & mapping
  • Medical education programs
  • Advisory board facilitation
  • Disease awareness campaigns
  • Medical affairs & commercial alignment
  • Congress presence & publication strategy
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Market Research & Landscape Analysis

Rigorous analysis of the competitive landscape, payer dynamics, patient populations, and clinical practice — to underpin every strategic and commercial decision.

  • Epidemiology & patient population sizing
  • Competitive landscape assessment
  • Payer & HTA environment analysis
  • Pricing benchmarking for orphan drugs
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Reimbursement, Market Access & Managed Access

End-to-end support for reimbursement submissions, managed access programs, and early patient access pathways across Belgium and European markets.

  • NIHDI dossier preparation & strategy
  • Early Temporary Authorization (ETA) guidance
  • Named Patient Program (NPP) setup & management
  • Early Access Program (EAP) & Compassionate Use design
  • Medical Need Program strategy & execution
  • Multi-country EU submission coordination
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European & International Expansion

Guide companies through the complex patchwork of European commercial and reimbursement landscapes, with openness to opportunities in the US, Middle East, and beyond.

  • BENELUX & EU commercial strategy
  • Cross-country launch sequencing
  • Cell & gene therapy cross-border access strategy
  • US & Middle East opportunity assessment
  • International KOL network development
  • Multi-country partner & distributor identification
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Fractional & Interim Commercial Leadership

Senior commercial leadership on demand — acting as your outsourced Commercial Director, VP of Market Access, or Head of Launch without the overhead of a full-time executive hire.

  • Outsourced CCO / Commercial Director engagement
  • Startup commercial infrastructure build-out
  • Launch team formation & coaching
  • Commercial due diligence for investors & BD teams
  • Board & C-suite advisory on rare disease strategy
  • Business development & partnership support
Why It Matters

Why Rare Disease Commercial Execution Is a Discipline of Its Own

Rare disease is not a niche version of mainstream pharma. It demands a fundamentally different commercial mindset — and taking the wrong approach early can cost far more than the consultancy fee.

01

Every Patient Journey Is an Opportunity to Make a Difference

With patient populations numbering in the few up to hundreds across an entire country, there is no room for blunt marketing. Rare disease demands surgical precision.

02

Pricing Is a Negotiation, Not a Calculation

Orphan drug pricing is higher than conventional treatments, and payers are increasingly resistant. Companies that protect their price walk into negotiations with a compelling value narrative and experienced negotiators.

03

Distribution Failure Is Patient Failure

In rare disease, supply chain breakdowns deny individual patients their only treatment option. A robust, purpose-built distribution pathway is a core commercial and ethical responsibility.

04

The Selling Model Is Relationship-Driven

There may be only a few to a very limited pool of physicians managing all patients with a given rare disease in an entire country. Winning here requires deep scientific credibility, a good pre-launch partnership, a long-term relationship building, and education, not volume-driven detailing.

05

Speed to Peak Is 4x Faster, If You Get It Right

Rare disease therapies reach peak market share in 4 years versus 10 for conventional drugs. But that acceleration only happens with flawless commercial execution from day one. Late launches or non-first movers are extraordinarily difficult to recover from, but not impossible with the right rare disease selling model.

06

Generalist Consultancies Get It Wrong

Most pharma consultancies apply scaled-down mainstream commercial frameworks to rare disease products, and they fail. The right toolkit, the stakeholder map, the rare disease selling model: all must be rebuilt from the ground up for orphan drugs.

A good pre-launch strategy, a single well-negotiated price or an optimised distribution pathway, and the right rare disease selling framework, can generate returns that dwarf the cost of specialist expertise. This is not overhead, but a well-spent investment with the right return.

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Trusted By

23 Years of Rare Disease Partnerships

Over 23 years, RareGenetics has built a track record working alongside some of the most innovative rare disease companies in the industry.

BioMarin
Enzyme replacement & gene therapies for rare metabolic diseases
Amicus Therapeutics
Rare lysosomal storage disorders & gene therapy
CSL
Plasma-derived therapies & rare bleeding disorders
Vifor Pharma
Iron deficiency, nephrology & rare disease
HRA Pharma
Rare disease department (Châtillon, Paris)
UCB
Neurology, rare immunology & specialty care
Enobia Pharma
Enzyme replacement therapy for hypophosphatasia & rare metabolic bone disorders
Clementia Pharmaceuticals
Ultra-rare bone disorders including FOP & multiple osteochondromas
Prosensa Therapeutics
Rare neuromuscular diseases; Duchenne muscular dystrophy

Geographic Coverage

Belgium Netherlands Luxembourg France Switzerland Austria Germany United Kingdom Nordics Southern Europe United States Middle East Other regions on request
Get in Touch

Ready to Accelerate Your Rare Disease Market Access?

Whether you are planning a first-in-human submission, navigating a complex reimbursement dossier, or building a commercial strategy for the European market — let's talk.

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Location
Belgium (Europe-wide coverage)

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