U.S. launch options for ex-U.S. biotechs: partner, co-promote or build
The U.S. is usually the first and biggest market for a new medicine. How a biotech based outside the U.S. should choose between licensing, co-promotion and building its own launch.
Emilio Fernandez, Owner & CEO
· 4 min read
Picture a biotech based in Europe, Latin America or Asia. It has good data, a path to FDA approval in sight, and one big question: should we license the U.S. rights, find a co-promotion partner, or build our own U.S. launch? The question sounds like a deal decision. In my experience it is a strategy decision first, and the deal follows.
Why the U.S. decision matters so much
The U.S. is where most new medicines reach patients first. The IQVIA Institute counted 53 novel active substances launched in the U.S. in 2025 alone, and 270 over five years. It also reported that R&D deals between China-headquartered and international companies reached an all-time high, which means more ex-U.S. assets are competing for the same partners and the same prescribers.
Smaller companies are no longer the exception at launch. In a separate report, IQVIA found that emerging biopharma companies commercialized 197 of the 497 novel U.S. launches of the past decade, and that their share reached 46% in 2020 to 2024. U.S.-headquartered companies accounted for 74% of those emerging biopharma launches, so companies based elsewhere launched roughly a quarter of them. It can be done from outside the U.S. It just has to be planned.
Option 1: license the U.S. rights
Licensing gives you capital, an experienced commercial organization and less execution risk. You give up most of the long-term value and most of the control. It is usually the right answer when the asset needs a large primary-care field force, when the indication is crowded, or when your board would rather fund the pipeline than a sales team.
The mistake I see is licensing too early and too cheaply, before the company has built a credible view of the U.S. opportunity. A partner will value your asset on their forecast unless you bring a better one: the patient journey, the prescriber base, the access path and a realistic uptake curve.
Option 2: co-promote or co-commercialize
Co-promotion lets you keep a meaningful share of the value and learn the U.S. market while a partner carries part of the load, often access, distribution or a second field force. It works when the two companies bring different strengths and agree, in writing, who decides what. It fails when governance is vague, because two organizations, two cultures and two sets of incentives have to act as one launch team.
Option 3: build your own U.S. launch
Building keeps the value and the control, and it is more achievable than many boards think for specialty and rare-disease medicines, where a focused team can reach a concentrated group of specialists. It is also where the risk is highest. McKinsey found that roughly 40 percent of new assets between 2018 and 2023 were launched by companies with little or no commercialization experience, and that only 20 to 30 percent of first-time launchers exceeded launch expectations, compared with 40 to 50 percent of established companies.
The same research points to what separates the winners: more successful first-time launchers onboarded their market access team four to six months earlier than less successful peers, and companies that beat expectations invested about 1.5 times as much in launch activities.
What happens after launch
The choice is not permanent. Of the 197 launches by emerging companies that IQVIA tracked, 69 companies kept the drug and kept operating, 58 were acquired after launch and 21 out-licensed the launched drug. A strong self-launch often creates the best licensing or exit option later, because it proves the U.S. demand. IQVIA also found that launch success is most often associated with evidence development beyond approval, realistic product assessments and efficient promotion.
How I would choose
I ask five questions before recommending a path:
- Who prescribes, and how concentrated are they? A few thousand specialists is a different business from hundreds of thousands of primary-care physicians.
- How hard is access? Payer, channel and patient-support needs often decide the model more than the field force does.
- What capital and time do you really have? A self-launch needs funding well before approval.
- What else is in the pipeline? A U.S. organization is easier to justify if a second asset or indication will follow.
- Which partners need this asset, and when? Your negotiating position is strongest when you have a credible alternative.
The formula view
Through the Scalar Formula, People × Culture × Strategy × Communication × Adoption × Execution = Results, the launch model is a Strategy decision. It only works if the rest of the chain holds: the right U.S. leaders in place early, a Culture that can operate across time zones, one clear value story, real Adoption by the teams on both sides of any partnership, and launch-grade Execution. A strong asset with a zero in any of those still underdelivers.
Whichever path you choose, start the U.S. work earlier than feels comfortable. The companies that do it well treat the U.S. plan as part of development, not as something that starts after approval.
Sources
- IQVIA Institute, Expanding Options for Emerging Biopharma in the U.S.: A Decade of Change (October 2025)
- IQVIA Institute, Global R&D Trends 2026 (March 2026)
- McKinsey, Small but mighty: priming biotech first-time launchers (November 2024)
Figures are as reported by the sources above, accessed October 2026.
Recommended for: Preparing a U.S. launch
