Cross-functional alignment is critical to avoid launch delays and compliance risks.
Key takeaways
Invest early in scalable systems and talent to support commercial-scale operations.
Adapt launch strategies to evolving market trends for sustained biopharma success.
Bringing a new biopharma product to market is one of the most complex milestones a company can face. Between regulatory hurdles, operational readiness challenges and shifting market dynamics, even the most promising therapies can stumble without the right launch strategy. Successful commercialization requires more than just a groundbreaking product—it demands seamless coordination across vendors, teams and infrastructure.
Despite the stakes, nearly half of all biopharma launches fail to meet revenue expectations in their first year. Why? The answer lies in a series of recurring pitfalls that can undermine even the best-prepared organizations. Below, we explore the seven most common reasons biopharma launches falter—and how an integrated, cross-functional approach can help companies navigate risk, accelerate readiness for Food and Drug Administration approval, and maximize commercial success.
1. Fragmented vendor and function coordination
Biopharma launches often involve a web of vendors and internal teams—finance, legal, market access, technology and supply chain—working on parallel tracks. Without a unified governance model, these functions can become misaligned, leading to missed deadlines, duplicated efforts and compliance risks. The absence of a central coordinator means that critical dependencies are overlooked and strategic decisions are made in isolation, jeopardizing commercialization success. Establishing a cross-functional steering committee and clear program governance is essential to break down silos and ensure alignment.
2. Underdeveloped back-office infrastructure
Many precommercial companies underestimate the operational lift required to support a launch. They may lack scalable systems for financial reporting, inventory management and regulatory compliance. As a result, they struggle to manage revenue recognition, track product distribution and respond to audits. These gaps can delay market entry and erode investor confidence at a critical moment. Investing early in robust business systems and data analytics is crucial for supporting commercial-scale operations.
3. Regulatory and pricing missteps
Navigating the biopharma regulatory landscape is a challenge even for seasoned teams. Missteps in gross-to-net calculations, government pricing compliance and regulatory reporting (such as under the Sunshine Act and the Drug Supply Chain Security Act) can result in costly penalties and reputational damage. Reporting submissions and deadlines vary by government agency and commercial partner. Being able to successfully track and meet the deadlines in their proper order can mitigate the risk of delays.
4. Lack of commercial strategy integration
Too often, commercialization is treated as a phase separate from research and development. This disconnect leads to poor market access planning, weak payer engagement and misaligned messaging. When commercial strategy isn’t embedded early in the development cycle, companies risk launching products that don’t resonate with stakeholders—or worse, that fail to secure reimbursement and proper access. Embedding commercial thinking from the outset ensures that clinical, regulatory and market access strategies are aligned for launch success.
5. Technology failures and inadequate digital readiness
Technology is a critical enabler of launch success, but it’s also a frequent source of failure. Companies often underestimate the complexity of integrating digital platforms, data management systems and automation tools across finance, supply chain, regulatory and commercial functions. When technology infrastructure is fragmented or outdated, teams struggle with data silos, manual processes and lack of real-time visibility, which can lead to compliance risks, delayed decision making and missed market opportunities. Prioritizing technology investment and integration is nonnegotiable for modern launches.
6. Talent and culture gaps
Rapid scaling can strain even the most resilient organizations. Without a clear talent strategy, companies face turnover, misalignment and execution risk. Launch teams may lack experience in commercialization, and cultural shifts from scientific to commercial thinking can create internal friction. These challenges are amplified when leadership is stretched thin or when roles and responsibilities are unclear. Onboarding experienced commercial leaders early and investing in training and change management are critical steps.
7. Failure to adapt to market trends
The biopharma landscape is evolving rapidly, with trends such as digital therapeutics, artificial intelligence-driven drug discovery and personalized medicine reshaping expectations. Companies that fail to adapt risk irrelevance. Investors and partners increasingly expect launch strategies that reflect innovation—not just in the product, but also in how it’s delivered, priced and supported. Static thinking in a dynamic market is a recipe for failure. Continuous learning and market monitoring are essential for sustained success.
Building a foundation for launch excellence
Avoiding these seven pitfalls requires more than tactical fixes—it demands a holistic, integrated approach to launch planning. Early preparation (ideally 18–24 months before launch), cross-functional alignment, realistic forecasting, and a commitment to compliance and operational readiness are the hallmarks of successful biopharma commercialization.
With a single point of contact across all launch-critical functions—finance, legal, compliance, market access and technology—companies can ensure their commercialization strategy is cohesive, compliant and scalable. Whether preparing for FDA approval or scaling post-launch operations, the right partner and the right plan can turn scientific innovation into commercial success.
RSM contributors
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Anthony DalongesManager -
James PowellDirector
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