U.S. Market Entry Is Not a Binary Decision
We help ex-U.S. healthcare companies enter, scale, and build in the United States—from initial partnerships to full operating platforms.
There is no single path.
There is only the right path for your strategy.
The U.S. Market Requires a Different Approach
The United States is the most attractive—and most complex—healthcare market globally. It is not simply a larger version of other markets. Success requires:
- A tailored commercial and pricing strategy
- Deep understanding of regulatory and reimbursement dynamics
- The right operating model at the right stage
The Most Common Mistake
Companies approach U.S. entry as a one-time decision: Partner or Build
In practice, companies that succeed take a different approach:
They move along a strategic spectrum over time
A Structured Approach to U.S. Market Entry
1. Out-Licensing
3. Joint Ventures / Structured Entry
2. Strategic Partnerships
Fastest path to market with lowest upfront investment
- Grant U.S. rights to a partner
- Leverage existing commercial infrastructure
- Access the market without building internal capability
Trade-off: Limited control and long-term economic participation
2. Strategic Partnerships
3. Joint Ventures / Structured Entry
2. Strategic Partnerships
Balanced approach between access and ownership
- Co-development or co-commercialization structures
- Profit-sharing or hybrid arrangements
- Shared execution and risk
Trade-off: Requires alignment, governance, and active management
3. Joint Ventures / Structured Entry
3. Joint Ventures / Structured Entry
3. Joint Ventures / Structured Entry
Shared build with a U.S. partner
- Formation of a dedicated U.S. entity
- Combination of capital, assets, and capabilities
- Greater control than pure partnerships
Trade-off: Increased complexity and capital requirements
4. Direct Entry / Platform Build
3. Joint Ventures / Structured Entry
3. Joint Ventures / Structured Entry
Full control and long-term value capture
- Establish a U.S. subsidiary
- Build commercial, regulatory, and operational infrastructure
- Control pricing, market access, and growth strategy
Trade-off: Highest investment and execution complexity
Most Companies Don’t Stay Static
In our experience, the most effective companies evolve along the spectrum:
- Partner → Learn → Build → Scale
- Access capabilities → Selectively internalize capabilities
- Start capital-light → Increase investment with conviction
What Drives the Right Path
The optimal strategy depends on:
- Stage of the asset (early vs. commercial-ready)
- Internal capabilities (regulatory, commercial, manufacturing)
- Capital availability and risk tolerance
- Long-term strategic ambition in the U.S.
End-to-End U.S. Market Entry Execution
Strategy & Structuring
Partnering & Transactions
Partnering & Transactions
- Market entry strategy design
- Evaluation of licensing vs. partnership vs. build
- Target operating model definition
Partnering & Transactions
Partnering & Transactions
Partnering & Transactions
- Identification and negotiation of U.S. partners
- In-licensing and out-licensing execution
- Structuring of co-development and co-commercialization agreements
Company Build
Partnering & Transactions
Ongoing Evolution
- Formation of U.S. entities and platforms
- Build of commercial and operating capabilities
- Transition from partner-led to direct execution
Ongoing Evolution
Partnering & Transactions
Ongoing Evolution
- Reassessment of strategy as the company scales
- Selective expansion of internal capabilities
- Alignment of capital, structure, and growth objectives
From Entry to End-State
We focus on the question most companies overlook:
- What capabilities do you need to own to win in the U.S.—and when?
We work with clients to:
- Define the starting point (asset, capability, capital)
- Map the target end-state (partnered vs. fully integrated)
- Build a phased path between the two
U.S. Entry Is a Multi-Stage Build
The most successful companies don’t just “enter” the U.S. They:
- Learn the market
- Build capabilities over time
- Transition toward control where it creates value
The decision is not “partner or build" It is “when do you do each—and how do you evolve?”
Start with the Right Strategy
If you are evaluating U.S. market entry, we bring experience across the full spectrum—from initial licensing to full platform build.