Article
Avoiding common pitfalls in early commercialization planning
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Kim Riggs
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Nancy Young
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Samantha Gleason
Regulatory approval isn’t the finish line — early commercialization planning is critical to avoid access barriers and protect long-term value.
In the pressure to meet regulatory milestones and investor expectations, many emerging biotechnology and biopharmaceutical companies—particularly sponsors advancing through phase 2 and phase 3—treat regulatory approval as the finish line. In practice, it is only the starting point. Companies that delay commercialization planning until late-stage development often encounter avoidable access and market barriers that materially constrain long-term value.
Early commercialization planning is not an administrative exercise; it is a strategic discipline. When neglected, sponsors risk downstream consequences such as misaligned comparators, incomplete or insufficient evidence packages, constrained regulatory labels, and limited global market opportunities. These issues directly affect reimbursement, uptake, and ultimately, patient access.
By contrast, organizations that integrate commercialization considerations early—alongside clinical and regulatory strategy—are better positioned to anticipate access challenges, inform development decisions, and preserve strategic flexibility as assets mature. The cost of waiting is often not visible until it is irreversible.
Early commercialization planning is not an administrative exercise; it is a strategic discipline. When neglected, sponsors risk downstream consequences such as misaligned comparators, incomplete or insufficient evidence packages, constrained regulatory labels, and limited global market opportunities. These issues directly affect reimbursement, uptake, and ultimately, patient access.
By contrast, organizations that integrate commercialization considerations early—alongside clinical and regulatory strategy—are better positioned to anticipate access challenges, inform development decisions, and preserve strategic flexibility as assets mature. The cost of waiting is often not visible until it is irreversible.
This article outlines the most common commercialization pitfalls encountered by emerging biopharmaceutical companies and highlights practical strategies to mitigate risk before it becomes embedded in development programs.
Maximizing the evidence package and label strategy
The strategic challenge
Clinical development programs are frequently designed with a narrow focus on regulatory approval in a single launch market. While this approach may achieve approval, it often leaves sponsors exposed to evidence gaps that undermine commercial success—particularly in global markets with distinct health technology assessment (HTA) and reimbursement requirements.
Common challenges include:
For example, companies pursuing broader regulatory labels may find themselves commercially constrained by access restrictions tied to patient definitions, line-of-therapy language, or diagnostic requirements embedded in labeling. In Europe, failure to include accepted local comparators in registrational trials can have implications not just for individual countries, but for an entire regional launch strategy.
Common challenges include:
- Restrictive inclusion or exclusion criteria that limit the addressable patient population
- Reliance on surrogate or composite endpoints that lack payer acceptance
- Use of severity measures or scales (e.g., quality-adjusted life-years [QALYs]) that may support higher reimbursement but are not aligned with real-world clinical practice
- Absence of locally relevant comparators, particularly for European markets
For example, companies pursuing broader regulatory labels may find themselves commercially constrained by access restrictions tied to patient definitions, line-of-therapy language, or diagnostic requirements embedded in labeling. In Europe, failure to include accepted local comparators in registrational trials can have implications not just for individual countries, but for an entire regional launch strategy.
Strategic imperatives to avoid these pitfalls
Design evidence with commercialization in mind
Evidence planning should be an integrated, forward-looking strategy—not a reactive exercise. Sponsors should begin building the evidence architecture required for commercial success in parallel with phase 2 planning, while development programs still have flexibility.
Beyond the core clinical trial program, best practice includes planning for and initiating complementary evidence generation such as systematic literature reviews, indirect treatment comparisons, budget impact models, and real-world evidence studies as part of a cohesive health economics and outcomes research (HEOR) strategy. The objective is not volume of data, but relevance to decision-makers.
Beyond the core clinical trial program, best practice includes planning for and initiating complementary evidence generation such as systematic literature reviews, indirect treatment comparisons, budget impact models, and real-world evidence studies as part of a cohesive health economics and outcomes research (HEOR) strategy. The objective is not volume of data, but relevance to decision-makers.
Align patient population strategy with access realities
Overly restrictive trial criteria may simplify development but can significantly narrow reimbursement eligibility and real-world uptake. Regulatory label language—such as disease severity definitions, prior treatment requirements, or biomarker thresholds—has direct and lasting access implications.
Scenario planning around potential label outcomes allows sponsors to understand how development choices translate into addressable population size and commercial viability. Where misalignment exists between the target clinical population and access realities, companies should assess whether patient support mechanisms—such as hub services, voucher programs, or free goods—can responsibly bridge gaps without undermining the economic model. In some cases, a segmented patient population strategy may offer a more sustainable path: targeting a narrower population with a higher likelihood of access vs. a broader population with significant reimbursement friction. These trade-offs should be evaluated explicitly and early.
Scenario planning around potential label outcomes allows sponsors to understand how development choices translate into addressable population size and commercial viability. Where misalignment exists between the target clinical population and access realities, companies should assess whether patient support mechanisms—such as hub services, voucher programs, or free goods—can responsibly bridge gaps without undermining the economic model. In some cases, a segmented patient population strategy may offer a more sustainable path: targeting a narrower population with a higher likelihood of access vs. a broader population with significant reimbursement friction. These trade-offs should be evaluated explicitly and early.
Anticipate comparator expectations
Comparator selection is a strategic decision with long-term consequences. Payers and HTA bodies require evidence that reflects local standards of care. When those comparators are absent from registrational trials, sponsors must rely on indirect or supplementary analyses, often at a disadvantage.
Addressing regulatory and HTA requirements simultaneously requires deliberate trade-offs. Engaging in this discussion during phase 2 enables sponsors to shape phase 3 designs that support both approval and reimbursement across priority markets.
Addressing regulatory and HTA requirements simultaneously requires deliberate trade-offs. Engaging in this discussion during phase 2 enables sponsors to shape phase 3 designs that support both approval and reimbursement across priority markets.
Account for practical drivers of uptake
Commercial success is influenced not only by clinical outcomes, but by operational realities such as dosing, administration setting, monitoring requirements, and coding pathways.
These factors determine site-of-care economics and can materially affect provider adoption and reimbursement.
These factors determine site-of-care economics and can materially affect provider adoption and reimbursement.
Go-to-market strategy and launch sequencing
The strategic challenge
Launch sequencing decisions—where to launch, in what order, and under which operating model—have cascading implications for pricing, access, supply chain design, and organizational readiness.
Consider a United States (U.S.)-based biopharmaceutical company preparing to launch a niche product in Europe. Without a clearly articulated sequencing and pricing strategy informed by local HTA engagement, regulatory pathways, and infrastructure constraints, the company risks suboptimal pricing outcomes, delayed access, and downstream effects on other markets due to international reference pricing.
Consider a United States (U.S.)-based biopharmaceutical company preparing to launch a niche product in Europe. Without a clearly articulated sequencing and pricing strategy informed by local HTA engagement, regulatory pathways, and infrastructure constraints, the company risks suboptimal pricing outcomes, delayed access, and downstream effects on other markets due to international reference pricing.
Strategic actions to mitigate risk
Engage regulators early and proactively
Early advice is a strategic necessity. Regulatory agencies in both the U.S. and Europe offer formal pathways to engage innovators early, providing clarity on evidence expectations and development strategy.
Leveraging these opportunities allows sponsors to de-risk development plans before they are locked in.
Leveraging these opportunities allows sponsors to de-risk development plans before they are locked in.
Be deliberate about launch sequence
Launch order is not merely operational—it is strategic. Decisions about initial markets influence evidence needs, pricing corridors, and future market opportunities.
Sponsors must assess logistical considerations (importation, marketing authorization holder status, local presence) alongside strategic factors such as speed to revenue, access risk, and reference pricing exposure.
Sponsors must assess logistical considerations (importation, marketing authorization holder status, local presence) alongside strategic factors such as speed to revenue, access risk, and reference pricing exposure.
Define the go-to-market model intentionally
Emerging companies must determine whether to launch independently, partner, or out-license across different markets. These decisions should be grounded in realistic assessments of internal capabilities, capital availability, and the scalability of manufacturing and commercial infrastructure. Pressure-testing the go-to-market strategy through stakeholder input and mock commercialization scenarios can surface vulnerabilities early and inform more resilient planning.
Building organizational readiness
Commercialization success requires having capabilities in place well before launch. Sponsors must define the operating model, functional requirements, and resourcing strategy needed to execute—whether through internal teams, partners, or a hybrid approach.
For emerging biopharmaceutical companies, starting earlier is a necessity. Decisions made during development directly shape commercial feasibility, investment requirements, and execution risk.
For emerging biopharmaceutical companies, starting earlier is a necessity. Decisions made during development directly shape commercial feasibility, investment requirements, and execution risk.
Conclusion
Regulatory approval is not the commercial finish line. It is the moment when the negotiated label becomes the primary commercial asset.
Companies that integrate commercialization planning into phase 2 development—bringing together clinical, regulatory, access, and commercial perspectives—are better positioned to achieve faster reimbursement, broader access, and stronger prescriber adoption. Equally important, they preserve strategic flexibility and protect long-term value.
Early commercialization planning is ultimately about alignment: aligning evidence with access requirements, development decisions with market realities, and organizational capabilities with launch ambition. Sponsors that do this well are not just prepared to launch—they are positioned to succeed.
Companies that integrate commercialization planning into phase 2 development—bringing together clinical, regulatory, access, and commercial perspectives—are better positioned to achieve faster reimbursement, broader access, and stronger prescriber adoption. Equally important, they preserve strategic flexibility and protect long-term value.
Early commercialization planning is ultimately about alignment: aligning evidence with access requirements, development decisions with market realities, and organizational capabilities with launch ambition. Sponsors that do this well are not just prepared to launch—they are positioned to succeed.
Additional insights
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About the authors:
Kim Riggs is Vice President of Market Access & Healthcare Consulting at Cencora, where she advises biopharmaceutical companies on market access strategy, commercialization pathways, and evidence generation to support successful launches and sustained global access. Her work spans cross-functional collaboration across market access, HEOR, real-world evidence, medical affairs, and commercialization, reflecting her ability to integrate strategic insight across the full value continuum.
Nancy Young is Vice President of Commercialization Services at Cencora, where she supports clients with end-to-end commercialization strategy and execution. She brings deep experience in market access, market research, payer and provider field tools, reimbursement, and health policy across pharmaceutical, medical device, and diagnostic products. Ms. Young holds a Bachelor of Science in Nuclear Medicine from the University of Iowa and was a Mallinckrodt Scholar Award recipient.
Samantha Gleason serves as Senior Director of Commercialization at Cencora, where she focuses on the operational realities of bringing healthcare innovation to market. Her role encompasses market access strategy, supply chain readiness, partner coordination, patient services, and data alignment. A strong advocate for operational excellence, she highlights that the critical work of commercialization happens well before approval—through the systems, strategies, and collaboration that ultimately ensure patients can access new therapies.
Nancy Young is Vice President of Commercialization Services at Cencora, where she supports clients with end-to-end commercialization strategy and execution. She brings deep experience in market access, market research, payer and provider field tools, reimbursement, and health policy across pharmaceutical, medical device, and diagnostic products. Ms. Young holds a Bachelor of Science in Nuclear Medicine from the University of Iowa and was a Mallinckrodt Scholar Award recipient.
Samantha Gleason serves as Senior Director of Commercialization at Cencora, where she focuses on the operational realities of bringing healthcare innovation to market. Her role encompasses market access strategy, supply chain readiness, partner coordination, patient services, and data alignment. A strong advocate for operational excellence, she highlights that the critical work of commercialization happens well before approval—through the systems, strategies, and collaboration that ultimately ensure patients can access new therapies.
Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
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