3 Mistakes Biotech Startups Make When Entering the U.S. Market
Avoid these common pitfalls when expanding into the most competitive biotech market in the world
The U.S. is the largest and most profitable biotech market on the planet, but it’s also one of the most complicated and competitive. For startups from Europe, Asia, the promise of U.S. expansion is often met with unexpected challenges, regulatory confusion, and commercial misfires.
After 20 years in biotech sales and commercialization, I’ve seen firsthand what separates the companies that scale successfully in the U.S. from those that stall or burn through cash trying.
Based on my experience here are the 3 biggest mistakes biotech startups make when entering the U.S. and some insight on how to avoid them.
Mistake #1: Underestimating the Commercial Complexity
The U.S. isn’t just a larger version of your home market but rather it’s a completely different commercial ecosystem.
In Europe, you might be used to centralized procurement, more consolidated healthcare systems, and public payer dominance. But in the U.S. you are dealing with:
- Fragmented healthcare providers
- Complicated payer networks (private + public)
- State-by-state regulations in some cases
- Longer sales cycles
- Intense competition and entrenched buying behaviors.
Symptoms of this mistake:
- Hiring a single U.S. rep and expecting rapid traction
- Using European messaging and pricing models unchanged
- Assuming FDA clearance = automatic market access
What to do instead:
- Build a U.S.-specific go-to-market strategy that accounts for buyer dynamics, value messaging, and reimbursement
- Use a phased market entry (something like pilots with reference labs or regional providers)
- Hire or consult with U.S.-based commercial experts who understand the customer landscape
Success in the U.S. requires more than a regulatory green light — it demands a tailored, boots-on-the-ground strategy.
Mistake #2: Ignoring the Reimbursement Landscape
Many biotech and diagnostics companies focus on clinical validation and regulatory approval, assuming that reimbursement will follow.
Spoiler alert: it usually doesn’t.
In the U.S., no reimbursement = no scalable revenue and this is especially for diagnostics, devices, and molecular tests.
Common issues:
- No existing CPT code for your test or technology
- Lack of payer engagement during development
- No health economic data to support cost-effectiveness
- No pathway to show clinical utility, not just analytical performance
What to do instead:
- Engage with reimbursement consultants or experts early
- Develop a reimbursement roadmap in parallel with regulatory and clinical efforts
- Conduct studies that demonstrate medical necessity and cost impact, not just accuracy
Payers don’t reimburse for innovation. They reimburse for outcomes and savings.
Mistake #3: Choosing the Wrong Commercial Partners
The U.S. market can’t be cracked with distribution alone — and yet many companies rely too heavily on third-party reps, OEMs, or generic distributor networks.
Why is this a problem:
- Distributor doesn’t prioritize your product
- Poor sales training leads to missed positioning
- OEM partner rebrands your tech with no credit to you
- Misaligned incentives between you and your channel
What to do instead:
- Vet U.S. partners rigorously: Do they have access to your target buyer? Do they understand your product’s value?
- Support your partners with training, tools, and data
- Consider a hybrid model: start with channel partners but keep a small direct team or U.S.-based commercial lead
- Structure contracts with performance metrics, not just exclusivity
Good partners amplify your strategy. Bad ones dilute your brand and burn your opportunity.
U.S. Expansion is Not a One-Time Event
Successful U.S. entry is not about “launching” — it’s about adapting.
You’ll likely need to:
- Reposition your product based on U.S. customer feedback
- Adjust pricing and packaging models
- Iterate your value proposition as you engage different stakeholders (clinicians, payers, procurement)
Think of your first 6–12 months in the U.S. as a learning period, not just a sales sprint.
Final Thoughts
Entering the U.S. biotech market is a huge opportunity — but also a trap for companies that treat it like a copy-paste expansion.
By avoiding these 3 common mistakes:
- Underestimating commercial complexity
- Ignoring reimbursement strategy
- Choosing the wrong commercial partners
…you dramatically increase your odds of success.