Biotech Go-to-Market Strategy Before Series B

I've had a version of this conversation dozens of times. A biotech founder — usually a scientist, usually brilliant, usually running on seed or Series A funding — reaches out because they're preparing for their Series B raise. They've built something genuinely innovative. The science is strong. The data is promising. The team is passionate. And when I ask them about their commercial strategy, I get some variation of: "We'll figure that out after we get regulatory clearance."

This is the single most expensive mistake a biotech company can make. Not because commercial strategy is more important than science — it isn't. But because by the time you have regulatory clearance, you've already made dozens of decisions that constrain your commercial options, and most of them were made without any commercial input. The indication you pursued. The endpoints you chose. The comparator you selected. The markets you filed in first. The clinical sites you partnered with. Each of these was a commercial decision masquerading as a scientific one, and reversing them post-clearance ranges from expensive to impossible.

Why Series B Is the Inflection Point

There's a reason I specifically flag Series B rather than Series A or Series C. It's not arbitrary.

At Series A, you're funding proof of concept. Investors are betting on the science and the team. A detailed go-to-market strategy at this stage would be premature — you may not even know your final product configuration, let alone your target market segment. Some commercial thinking is useful at Series A (particularly around indication selection and market sizing), but a full GTM strategy would be speculative.

At Series C and beyond, you're funding scale. By this point, you should already have commercial infrastructure, early market traction, and a proven go-to-market model. If you're raising Series C without a commercial strategy, something has gone badly wrong.

Series B is the sweet spot. You're funding the transition from development to commercialisation. Your product is taking shape. Your clinical programme is defined or underway. You're making decisions about regulatory pathways, market sequencing, and evidence generation that will determine your commercial trajectory for the next 3-5 years. And your investors are no longer just funding science — they're funding a commercial opportunity. They need to see a credible path to revenue, and "we'll hire a commercial team after approval" is not a credible path.

Here's what I tell every biotech founder who calls me six months before their Series B: your commercial strategy should be informing your development decisions right now, not the other way around.

The Decisions You're Making Right Now That Are Commercial Decisions

Indication Selection

Which indication you pursue first is simultaneously a scientific decision, a regulatory decision, and a commercial decision. Most biotech companies make this choice based on scientific rationale and regulatory feasibility — which are necessary criteria, but insufficient.

The commercially intelligent question is: which indication gives you the fastest path to revenue with the lowest market access barriers? That's not always the same as the indication with the strongest clinical data. A rare disease indication might have a smaller patient population but a clearer reimbursement pathway, faster regulatory review times, and less competitive pressure. A broader indication might represent a larger market but require a Phase 3 programme that takes three years longer and costs four times as much.

I've seen biotech companies pursue a broad indication because the TAM slide looked impressive in their pitch deck, only to discover that the competitive landscape, reimbursement hurdles, and evidence requirements made that market functionally unreachable within their funding runway. A more focused initial indication — with a clear path to expansion — would have been commercially superior and more attractive to investors.

Clinical Endpoint Selection

The endpoints you choose for your clinical trials determine what you can claim commercially. This sounds obvious, but the implications are frequently missed. If you choose a surrogate endpoint because it's faster and cheaper to measure, you may achieve regulatory clearance but struggle with market access — because payers and HTA bodies increasingly want clinical outcome data, not biomarker changes.

Conversely, if you design a trial powered for hard clinical endpoints, you'll have a stronger market access case but a longer, more expensive development programme. There's no universally right answer, but the decision should be made with full visibility of the commercial implications — not just the regulatory ones.

At minimum, your clinical development plan should include discussions with health economists about what evidence payers will need, market access specialists about what HTA bodies will expect, and commercial strategists about what claims will differentiate you in the market. If these conversations aren't happening before you finalise your protocol, you're designing a trial that optimises for regulatory approval without optimising for commercial success.

Market Sequencing

Which market do you enter first? For many biotechs, the default answer is "the US, because it's the biggest market." This is sometimes correct and sometimes catastrophically wrong.

The US market is large, but it requires the most expensive clinical programmes, the most complex market access navigation, and the most competitive commercial environment. For a biotech with limited resources, launching in the US first means committing the majority of your capital to one market before you have any commercial proof of concept.

Alternative sequencing strategies can be dramatically more capital-efficient. Launching in the UK or EU first — where regulatory pathways may be faster, evidence requirements may be different, and your clinical partnerships may already exist — gives you early revenue, real-world data, and commercial proof of concept that strengthens your position for US entry. Launching in Japan, where the PMDA offers regulatory pathways specifically designed for innovative therapies and where pricing can be highly favourable, may generate revenue that funds your US programme.

I've helped companies develop multi-market launch strategies that sequence regulatory submissions, evidence generation, and commercial launches across the UK, EU, US, and Japan in a way that maximises capital efficiency. The optimal sequence depends on your product, your indication, your competitive landscape, and your funding position — but it should never be "US first by default."

What a Pre-Series B GTM Strategy Should Actually Contain

Not a 60-page consulting document full of frameworks and TAM waterfall charts. A focused, evidence-based strategy that answers the questions your investors will ask and your development decisions depend on.

Market Sizing That Means Something

Investors are tired of top-down TAM/SAM/SOM slides. "The global oncology market is £180 billion" tells them nothing about your specific opportunity. What they want — and what your strategy needs — is a bottom-up analysis: how many patients have this condition, how many are diagnosed, how many are treated, how many are eligible for your product, how many are reachable through your planned channels, and what are they worth per year in your target markets? This is harder work than a top-down estimate, but it's the only sizing methodology that generates numbers you can actually plan against.

Competitive Landscape That Includes the Status Quo

Most competitive analyses focus on direct competitors — other products in the same class, other companies pursuing the same indication. This misses the most important competitor: the current standard of care. Your product isn't competing against other innovative therapies (at least not primarily). It's competing against the existing treatment protocol, the current diagnostic workflow, the established clinical practice. Understanding why the status quo persists — the switching costs, the clinical inertia, the reimbursement structures that favour incumbents — is more strategically valuable than knowing what's in your competitor's pipeline.

Decision-Making Unit Mapping

Who actually decides whether your product gets adopted? In life sciences, the answer is never one person. It's a committee of stakeholders with different priorities, different concerns, and different influence. The clinician who evaluates the clinical evidence. The lab manager or pharmacist who assesses operational fit. The procurement team that negotiates pricing. The P&T committee that approves formulary additions. The payer that determines reimbursement. The patient who ultimately receives the treatment.

Mapping this decision-making unit — and understanding each stakeholder's decision criteria, influence, and potential objections — is essential for building a commercial strategy that actually drives adoption. If your sales approach targets the clinician but the decision bottleneck is at procurement, you'll generate clinical enthusiasm that never converts to revenue.

Pricing and Reimbursement Strategy

This is where many biotech companies defer to "we'll hire a market access team later." The problem is that market access strategy needs to inform clinical development decisions now — not after the trials are done.

Your pricing strategy determines your clinical evidence requirements. If you plan to price at a premium, you need health economic data showing cost-effectiveness. If you need HTA approval (in the UK, EU, or any market with formal health technology assessment), your clinical programme needs to generate the specific evidence that HTA bodies evaluate — which may not be the same evidence that regulators require. If your reimbursement depends on demonstrating superiority rather than non-inferiority, your trial design needs to reflect that.

At pre-Series B stage, you don't need a final price. You need a pricing framework that identifies the range, the value drivers, the comparators, and the evidence requirements — and feeds that back into your clinical development plan.

Evidence Generation Roadmap

Work backwards from market access. What evidence does each stakeholder need to say yes? Regulators need safety and efficacy. HTA bodies need cost-effectiveness and budget impact. Clinicians need clinical utility and peer-reviewed publications. Payers need health economic models. KOLs need data they can present at congresses.

Map all of these evidence requirements, identify which ones your current clinical programme addresses and which ones have gaps, and build an evidence generation roadmap that fills those gaps in the most capital-efficient sequence. This roadmap should be a living document that evolves as your development programme progresses — not a static slide created for fundraising and never revisited.

The Mistakes I See Most Often

"The Science Sells Itself"

No. It doesn't. It never has. The history of life sciences is littered with scientifically superior products that lost to commercially superior competitors. Beta-blockers with better data that lost market share to drugs with better positioning. Diagnostics with better sensitivity that lost tenders to products with better procurement relationships. Medical devices with better clinical outcomes that never achieved adoption because nobody built the health economic case.

If you're a scientist, I understand why this feels unfair. It is unfair. But it's reality, and the companies that accept it early — that treat commercial strategy as a core competency rather than an afterthought — are the ones that succeed.

Building for the Wrong Market First

Usually this means defaulting to the US because the market is largest. Sometimes it means defaulting to the UK because the founder is based there. Neither is necessarily wrong, but neither should be the default. Your first market should be chosen based on a strategic assessment of regulatory pathway, market access feasibility, competitive dynamics, and capital requirements — not geography or familiarity.

Hiring a Commercial Team Too Late — Or Too Early

Too late means waiting until after approval to hire your first commercial person. By then, you've missed the window to influence development decisions with commercial insight. Too early means hiring a VP of Sales two years before you have a product to sell, burning cash on a commercial team that has nothing to sell and a clinical team that doesn't want commercial input.

The right approach is usually a senior commercial strategist — fractional or full-time — who joins the leadership team at the pre-Series B stage and ensures commercial thinking is integrated into development decisions from that point forward. Not a sales team. Not a marketing department. A strategic commercial voice at the table.

What Your Investors Actually Want to See

I'll end with this, because ultimately the Series B raise is what's driving the timeline.

Series B investors are not looking for a perfect commercial plan. They know you're pre-revenue. They know the plan will change. What they're looking for is commercial thinking — evidence that the founding team understands the commercial landscape as deeply as the scientific one, and has made deliberate strategic choices about how to reach the market.

They want to see that your indication was chosen with commercial logic, not just scientific convenience. That your clinical programme generates the evidence market access requires, not just what regulators require. That you've thought about pricing in the context of value, not just cost. That your market entry sequence reflects strategic analysis, not default assumptions. That you understand who your customer is, what they care about, and why they would switch from the current standard of care.

A biotech company that can articulate this clearly — backed by evidence, grounded in market reality, and integrated with the development plan — is a dramatically more attractive investment than one with a better Phase 1 readout but no commercial narrative. I've watched companies with mediocre data and excellent commercial strategy raise larger rounds than companies with exceptional data and no commercial story. The science gets you to the table. The commercial strategy closes the deal.

If you're a biotech approaching Series B and your commercial strategy is still a placeholder slide, let's fix that.