Trusted BioCommercial Expansion Partner

We help emerging biotechs expand into Europe, the Middle East & Eurasia while minimizing risk and accelerating patient access.

Why biotechs are hesitant to enter Europe?

Due to many barriers, Expanding Rare Disease Drugs across EMEE remains a challenge despite it represents over 40% of Global sales.

Only ~30% of FDA orphan drugs approved in Europe

Only 260 drugs with orphan drug status are approved in the EU, while +/- 880 are approved in the USA.

EMEE region is complex & costly

Despite the EMEE region accounting for more than 40% of global rare disease drug sales, emerging biotechs struggle to expand due to high upfront investment, regulatory complexity, market fragmentation, and access barriers.

Growing market

The Next Decade: An expected +150% Surge in the Global Orphan Drug Market and Growth in Cell & Gene Therapies create an opportunistic environment for rare disease companies. The Rare Disease Market is estimated to be at $266.3bn in 2034 for Europe.

Mirava Bio’s solution:
From Go-to-Market Strategy to Full Commercialization - One Partner

We combine strategic go-to-market advisory with a fully licensed ready commercial platform. Our phased model de-risksentry, accelerates patient access, and ensures you retain control of your product and strategy.

Go-to-Market Strategy
& Advisory

We design de-risked entry strategies that align regulatory, market access, medical, and commercial priorities into one roadmap, fully integrated with your TPP, resource allocation, market prioritisation, and global vision to accelerate time-to-value.​
We integrate as your temporary commercial affiliate, offering a licence-ready platform that covers quality, safety, distribution, patient services, and field deployment — so you can launch across EMEE without building affiliates, while retaining full control of your product and strategy.​

Integrated
Commercial Platform​

Expanding Rare Disease Drugs across EMEE remains a challenge despite it represents over 40% of Global sales

Funding constraints and prioritizing US

Huge investment in setting up own footprint with high risks* & longer lead time

Pricing, access and logistical hurdles

Multiple healthcare systems, reimbursement processes and supply chain challenges

Regulatory and compliance risks

Complex regulatory pathways some markets carry greater exposure to compliance risks

Limited portfolio, small target pool

Limited portfolio of commercial assets reducing ROI & revenue opportunity

Inadequate Go-To-Market options

Exiting routes: Go-Alone, Distributors or out-licencing

The problem is severe as limited funds and high costs deter biotechs from expanding to EMEE, denying patients access to vital products, and causing revenue loss.

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