Here is a myth that quietly derails early-stage drug programs: “We’ll think about commercialization once we have Phase 3 data.” It sounds reasonable, after all, why invest in market planning before you know whether the drug works? But this framing misunderstands what commercial strategy is, and when it matters. The hard reality: only 28% of first-time biotech product launches exceed pre-launch forecasts, compared to nearly 50% for experienced companies, and roughly 90% of biotech startups fail overall.[1] The gap between those who succeed and those who stumble is rarely the science. It is almost always the commercial decisions made (or avoided) early in development: the choice of patient population, the clinical endpoints selected, the comparator arm in the pivotal trial, the dosing schedule baked into the formulation. Each of these choices quietly sets a ceiling on your label, your payer coverage, and ultimately your launch. Commercial strategy for therapeutics founders means connecting science, evidence, and market so that the right patients can benefit from your drug and its available for their treatment plans. It is not a marketing plan. It is a design discipline that runs in parallel with development from the day you select your clinical candidate. This article is a practical primer for Pre-Seed through Series A teams who want to build that discipline into how they operate without a large commercial organization.
Start With the Problem, Not the Molecule
The most common mistake early founders make is falling in love with the mechanism before clearly defining the problem. A drug that solves a real, specific, underserved problem for a defined population will always find a path to market. A drug that is merely interesting scientifically, that has no compelling therapeutic story, will struggle, even with strong efficacy data, because no one in the ecosystem is waiting for it. Start by clarifying three things:
the target patient: who exactly experiences this condition, how are they diagnosed today, and what is their current treatment journey;
the setting of care: where are they treated, and by whom; and
the nature of the unmet need: where are current therapies failing (efficacy, safety, dosing, access, or patient experience).
If you are aiming for a U.S. launch, be explicit about that assumption now. Commercial strategy will need to be reassessed for any additional geographies.
Structured customer discovery is the tool for this work. It’s my experience that every company could do more and better customer discovery at all stages of R&D. Published research confirms that direct engagement with end users (clinicians, patients, and payers) identifies unmet needs that are routinely overlooked when product development is driven purely by technical breakthroughs or published outcomes data. The customer development process should start on Day 1, running in parallel with science. How do you do that? Build a one-page patient journey and a one-page provider journey for your target indication. Mark every step where your asset materially changes the experience. If you cannot mark at least three meaningful inflection points, your positioning problem deserves more work before you move forward.
Once you have defined the problem clearly, you need to understand the economics of the solution. Investors and potential partners will test this rigorously, and founders who cannot answer these questions confidently leave value and credibility on the table. The key questions to answer at this stage:
How many patients are addressable, and how many are reachable through the current care system?
Who pays? (Commercial insurance, Medicare/Medicaid, hospital DRG, self-pay?)
Who decides? (Specialists, primary care, tumor boards, pharmacy and therapeutics committees, integrated delivery networks?)
What is the current cost of care, and how does your drug change the total equation for payers?
Simple tools go a long way here: a basic TAM/SAM/SOM segmentation, a competitor grid with approved therapies and late-stage pipeline, and a one-page payer landscape summary covering the major coverage decision-makers in your category. You do not need a McKinsey market model. You need a defensible view of the market that you have tested with real stakeholders.
The Target Product Profile (TPP) is arguably the most important commercial document an early-stage therapeutics company can produce. Introduced by the FDA as a planning tool to streamline drug development, the TPP summarizes the intended use, target patient population, key efficacy and safety parameters, dosing characteristics, and the regulatory strategy for your asset and it is designed to be updated continuously as development advances. But an effective TPP for a startup goes beyond regulatory documentation. The commercial TPP extends the regulatory version to include: the value proposition for payers (how does this drug change cost or quality of care?); usability and access attributes (route of administration, dosing schedule, setting of care compatibility); differentiation from current standard of care; and a realistic view of pricing and reimbursement positioning. As ICON’s biotech experts note, “Your TPP is your North Star — it’s not just a regulatory document, it is a map of all of the inflection points from bench to bedside.” [3]
Consider a dual-criteria approach for each TPP attribute: a Minimal Acceptance Criterion (the least favorable outcome still viable for approval and commercial launch) and a Preferred Acceptance Criterion (the ideal outcome that maximizes competitive positioning). This structure forces honest, early conversations about what your drug needs to achieve in the clinic and in the market before you commit to a trial design. The TPP is also the bridge between your development team and your investors. Biotechs that develop a commercially grounded TPP early are better positioned to attract funding and in/out-licensing agreements because they can articulate a clear, evidence-linked value story.
If you have not yet built a TPP, start today, even if it’s aspirational. A one-page version that covers intended use, target population, key efficacy/safety thresholds, differentiation from standard of care, and route to reimbursement is far better than nothing. Revisit and update it quarterly. Bootcamp.bio offers this detailed exposition for those who want to nerd out on the strategy. [4]
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Clinical trials are expensive. Early-stage founders rightly focus on what they must generate to achieve regulatory approval. But approval and access are not the same thing. After approval, “payers, prescribers, patients, and policymakers are in the driver’s seat” and reimbursement and access can be deeply unpredictable if your evidence package was not built with those audiences in mind. [1] Think of your evidence needs across three distinct audiences, and plan accordingly:
Regulators: Pivotal safety and efficacy data from well-controlled trials; risk-benefit profile.
Clinicians: Mechanism clarity, comparative effectiveness vs. standard of care, safety profile, and practical usability.
Payers and Health Technology Assessment (HTA) agencies: Health economics and outcomes research (HEOR) (quality of life, hospitalization rates, cost-effectiveness, and budget impact).
The critical insight from HEOR strategy experts is that payer conversations must begin well before Phase 3 to align clinical endpoints with HTA needs. This does not mean running expensive standalone HEOR studies alongside your pivotal trial. It means being deliberate: embed patient-reported outcomes (PROs) and quality-of-life instruments into your Phase 2 protocol, identify HTA requirements in your key markets early, and develop a simple economic model to pressure-test your value story before you finalize pivotal design. [5]
“First-in-class” or “best-in-class efficacy” are not commercial strategies; instead, they are scientific observations. Your commercial positioning needs to answer a more specific question: better for whom, on what outcome, and in what context? This is the wedge that translates scientific differentiation into commercial value. For early-stage teams without dedicated competitive intelligence functions, lightweight CI is entirely feasible. Monitor ClinicalTrials.gov for trials in your indication, track FDA label updates for approved competitors, follow guideline committee publications from ASCO, AHA, ADA, or other relevant specialty societies, and systematically review conference abstracts from key medical meetings. Set up Google Alerts for your therapeutic area and key competitor names. This is inexpensive, requires only a few hours per month, and will materially improve the quality of your positioning conversations.
Take the next step and translate your CI findings into a clear positioning statement that answers three questions:
Better in whom? — Define the patient subpopulation where your drug has the greatest advantage.
Better on what outcome? — Efficacy, safety, dosing convenience, tolerability, patient experience?
Better in what context? — Line of therapy, comorbidity profile, setting of care, or payer tier?
This positioning statement is not marketing copy. It is a strategic anchor that should inform your trial design, your endpoint selection, and your payer value narrative. Companies that skip this work often design scientifically sound trials that are commercially awkward: wrong comparator, wrong endpoint, wrong patient population.
Instead of a commercial launch plan at early stages (before Series A), build a credible go-to-market (GTM) concept. This is a working hypothesis about how your drug will reach patients that informs your clinical design, your manufacturing choices, and your financial model. GTM assumptions have direct upstream consequences that founders routinely underestimate. The key questions your GTM concept needs to address:
Channel: Hospital inpatient, outpatient infusion center, specialty office, specialty pharmacy, retail pharmacy, or direct-to-patient?
Prescriber base: A small, focused set of specialists (e.g., transplant programs, academic oncology centers) or broader primary care?
Go-to-market model: Small focused field team, partnership with an established commercial organization, or digital-led engagement?
Patient support: Will patients need hub services, co-pay assistance programs, or specialty distribution? (Especially critical for complex therapies.)
These choices flow directly back into clinical and CMC decisions. A drug that will be administered in a hospital setting has different formulation and stability requirements than one dispensed through specialty pharmacy. A drug targeting a rare disease treated by 200 specialists nationally has a very different salesforce model, and therefore a very different cost structure than one for a broad chronic condition. Get this wrong in development and you will pay to fix it at launch.
One of the most consequential strategic decisions a therapeutics founder will make is when and how to involve a partner. The answer depends heavily on your capital position, your asset’s differentiation, and your team’s appetite and capability to build a commercial organization. Each path involves tradeoffs that commercial strategy should inform early. The traditional model (out-license after Phase 2 to fund Phase 3 and gain commercial infrastructure) remains viable, but it is being actively rethought. Biopharma licensing hit $250 billion across 516 deals in 2025, with several large deals being recorded in early weeks of 2026. [6] But well-capitalized biotechs with differentiated assets are increasingly retaining global or regional rights longer, licensing from positions of strength after value-inflecting data readouts and using milestone-heavy structures that preserve optionality. [7] Out-licensing a Phase 2 asset typically yields $50–300M upfront with total deal value of $800M–$2.5B and royalty rates of 8–15%, economics that improve significantly with stronger data. [8]
For early-stage founders, the strategic options are:
Out-license after Phase 2: Provides upfront capital, risk transfer, and access to commercial infrastructure, at the cost of long-term economics and control.
Regional partnerships or co-development: Retain home-market rights while licensing ex-regional territories; a growing model especially for founders with differentiated platforms.
Build lean commercial for niche indications: Viable and increasingly feasible for rare diseases or specialty products with a concentrated prescriber base.
Critically, your commercial strategy should define what deal terms and timing look like before you enter any partnering conversation. Know your minimum acceptance criteria, your reversion rights requirements, and which development rights you are unwilling to cede. Deals negotiated from a position of commercial clarity consistently produce better terms than deals done reactively out of capital pressure.
Common Commercial Strategy Pitfalls for Founders
Commercial failures in therapeutics are rarely caused by bad science. They are caused by avoidable strategic mistakes, most of which were baked in long before Phase 3. The most common ones:
Designing trials that are scientifically elegant but commercially awkward: wrong comparator (placebo when payers will demand active control), wrong endpoint (surrogate marker when payers want functional outcomes), wrong patient population (broad inclusion that obscures the subgroup where you truly win).
Ignoring payers until post-approval: Many founders treat reimbursement as someone else’s problem. Early payer engagement, even informal advisory board conversations during Phase 1/2, can reveal coverage barriers before they are built into your evidence package.
Overestimating uptake speed: New drugs that require behavior change from clinicians face adoption curves that routinely surprise founders. If your drug disrupts established clinical workflow, budget for market development, not just launch logistics.
Building messaging around technology features instead of patient and clinician value: Payers and prescribers do not buy mechanisms of action. They buy solutions to their patients’ problems. Every external communication, from your investor deck to your advisory board slides, should start with the problem, not the molecule.
Assuming unmet clinical need equals market opportunity: A clinical gap and a commercial opportunity are not the same thing. You also need a viable payment pathway, an accessible prescriber base, and a market large or profitable enough to support the business model you need to build.
You do not need a commercial team to have a commercial strategy. Here is what good enough looks like at each early stage:
Draft a first-pass TPP with minimal and preferred acceptance criteria.
Complete patient and provider journey maps based on primary customer discovery conversations.
Build a basic TAM/SAM/SOM analysis and a competitor grid for approved and pipeline therapies.
Identify the top 2–3 payer archetypes who will make coverage decisions for your drug.
Refine TPP based on emerging safety/PK data; update commercial differentiation assumptions.
Begin informal payer advisory board conversations to understand formulary decision criteria.
Identify HEOR endpoints to embed in Phase 2 (PROs, QoL instruments, resource utilization).
Develop a one-page GTM concept summarizing channel, prescriber base, and launch model hypothesis.
Finalize your commercial TPP with input from payer, medical, and regulatory perspectives.
Develop a preliminary health economics model to frame the value story for pivotal design.
Define your strategic options (out-license, partnership, or build) and understand the deal terms that each path implies.
Establish a quarterly ‘commercial check-in’ cadence with your board.
Phase 2 is where bringing in external commercial expertise pays the highest return. A fractional Chief Commercial Officer, specialized commercialization consultant, or experienced advisory board member with payer or launch expertise can materially sharpen your strategy without the overhead of a full-time hire. Fractional go-to-market leaders deliver senior-level strategic guidance with the flexibility that early-stage capital structures require. If you are working with a board or investors who have not yet asked you about your commercial strategy, bring it up yourself. A proactive quarterly commercial update, even a simple one-page summary, signals founder maturity and builds the kind of confidence that helps raise the next round.
The most important point I want you to remember is commercial strategy is not a deliverable you produce once before a Series B raise. It is a continuous design process that runs alongside development from the earliest stages of your program. The founders who launch successfully are the ones who kept their science, their evidence plan, and their market reality in dialogue with each other throughout, updating assumptions as data emerged, pressure-testing positioning with real stakeholders, and making development decisions with the commercial endpoint in view. The good news is that most of this work is accessible to lean, early-stage teams. You do not need a commercial organization to build a commercial strategy. You need intellectual honesty about the market your drug will enter, the right frameworks to structure your thinking, and the discipline to revisit your assumptions regularly.
[1] Martin, C. (2025, September 17). From lab to market: Tracking today’s shifting pathways for biotech. Pharmaceutical Executive. https://www.pharmexec.com/view/from-lab-to-market-tracking-today-s-shifting-pathways-for-biotech
[2] National Institutes of Health SEED. (2023). Creating a target product profile for new drug products (NIH Publication No. SEED-TPP-2023). U.S. Department of Health and Human Services. https://seed.nih.gov/sites/default/files/2023-12/Creating-Target-Profile-for-New-Drug-Products.pdf
[3] ICON plc. (2025, June). Start with the end in mind and develop a TPP early. https://www.iconplc.com/insights/blog/2025/06/30/biotech-success-start-end-mind-and-develop-tpp-early
[4] Jordan, A. (2025). Target product profiles (TPP): Framework for life sciences startup success [PDF]. bootcamp.bio. https://bootcamp.bio/wp-content/uploads/2025/06/05.0-Pre-work-Target-Product-Profiles-TPP-2025-04-29-3.pdf
[5] Dabbous, O., & Becker, R. (2018). Now more than ever, HEOR plays a central role in forging the modern healthcare agenda [Slide deck]. Medical Affairs Professional Society. https://medicalaffairs.org/wp-content/uploads/2021/05/HEOR-healthcare-agenda.pdf.
[6] Burlingame, L. (2026, January 8). A look-back at the biopharma industry in 2025. Morse, Barnes-Brown & Pendleton, P.C. https://www.morse.law/news/a-look-back-at-the-biopharma-industry-in-2025/
[7] Murugan, V. (May, 2026). Why biotech companies are holding on the global rights longer: [Post] LinkedIn. https://www.linkedin.com/posts/activity-7454533612210831360-ILvP/
[8] IB Interview Questions. (2026, March 2). Biotech partnering and licensing: Healthcare IB guide. https://ibinterviewquestions.com/guides/healthcare-investment-banking/biotech-partnering-licensing
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