Imagine a launch where the moment of regulatory approval seamlessly transitions to patient availability, not in weeks or months, but within 24 hours.
In 2023, the global biopharmaceutical industry generated $1.6 trillion in revenue, with 152 blockbuster drugs contributing a staggering $511 billion—nearly one-third of the total. Every single blockbuster launched belonged to one of the top 30 companies.
Given the nature of the biopharmaceutical business, all top companies must consistently launch blockbusters to offset the significant revenue churn from products that lose patent protection every 10-12 years and sustain growth at their size to remain viable on Wall Street.
Not every product, despite the medical need, moves the needle. So, a lot of work goes into selecting and advancing only the most promising blockbuster hopefuls through the pipeline. It takes years of R&D failures before a blockbuster hopeful emerges, at least on paper, based on clinical data and market opportunity.
Yet, converting the hypothetical blockbuster into a realistic one takes launch and lifecycle management prowess coupled with some serious distribution chops.
Launching a blockbuster is no small feat, so it is no wonder that only a dozen companies can be said to have truly mastered the process. Companies must overcome significant challenges, from the complexity of global regulatory processes to operational bottlenecks, to ensure their innovations reach patients quickly and efficiently.
Each day of launch delay represents not only a loss of priceless early revenue during the exclusivity period but also a missed opportunity to make a tangible difference in more patients’ lives.
Sometimes, although rarely, it makes sense to delay access to your innovation from patients after FDA approval for strategic reasons. For example, your drug’s efficacy and safety data are so good that soon after EMA approval, you want to make a splash at the upcoming largest congregation of physicians of your indication’s specialty and get everyone talking about it at the same time so that the momentum helps many more patients get access to your drug globally.
Other than strategic reasons, 100% of all launch delays are avoidable with better organizational alignment, execution foresight, and operational agility.
Despite being adequately resourced, leading companies encounter roadblocks that prevent their blockbuster from hitting the ground running. Here are some of the most common barriers to timely market entry:
Manufacturing and supply chain issues often emerge as the first major hurdles in drug launches. Transitioning from clinical to commercial-scale production magnifies the complexity, introducing bottlenecks and disruptions that can derail timelines.
Clinical-scale production focuses on limited batches, but commercial-scale manufacturing requires ramping up capacity to meet market demand. This transition involves complex handoffs between R&D, manufacturing, and supply chain teams.
Misaligned processes or gaps in handoffs can result in significant delays. For example, in 2023, Travere Therapeutics had to pause enrollment in its Harmony study after discovering that the desired drug substance profile was not achieved during the scale-up process, necessitating improvements in manufacturing to meet commercial production standards.
Maintaining consistent batch quality becomes increasingly tricky at scale, especially when manufacturing is distributed across internal and external sites. Variability in raw materials or deviations in production parameters can lead to costly recalls or delays in product availability.
For example, in October 2024, the FDA declined to approve CAM2029 from Camurus, intended for treating acromegaly, due to issues at a third-party manufacturing facility; resolving these manufacturing problems is expected to delay the drug’s approval and launch by up to a year, potentially pushing it to the fourth quarter of 2025.
Modern drug modalities, such as RNA-based therapies, Antibody-Drug Conjugates (ADCs), and biologics, rely on intricate supply chains. Sourcing raw materials, ensuring proper packaging, and meeting cold-chain logistics requirements introduce vulnerabilities. External factors, such as geopolitical tensions or natural disasters, further exacerbate these challenges.
Tepezza faced significant supply chain disruptions shortly after its initial launch, necessitating a re-launch that led to slower-than-anticipated sales uptake. This case underscores the vulnerabilities inherent in biopharmaceutical supply chains, particularly for biologics like Tepezza, which rely on intricate manufacturing processes and specialized contract manufacturers.
A drug’s price and its reimbursement status are critical to market success, yet securing agreements with payers is a time-consuming process.
Balancing competitive pricing with cost recovery is challenging, particularly in multi-regional launches. Negotiations with public and private insurers often stretch across months, delaying access.
For instance, Daiichi Sankyo and AstraZeneca’s cancer drug Enhertu was deemed too expensive by NICE, hindering its availability to patients, and this was despite its approval in 17 other European countries; NICE’s assessment of cost-effectiveness over standard treatments delayed its market entry in the UK.
Even with a favorable price point, companies must secure advantageous formulary placements to ensure uptake. This process requires demonstrating the drug’s value to both payers and providers.
In Australia, for example, patients consistently experience significant delays in accessing medications approved by the TGA, with an average wait time of about 591 days.
Innovative therapies often face scrutiny regarding cost-effectiveness. Additional real-world evidence (RWE) is frequently needed to support claims, further delaying market entry.
For example, high-cost therapies like CAR-T treatments must substantiate their benefits through robust clinical and post-market data. Case in point, RWE was successfully used to support HTA submissions for Zolgensma and Eyrysdi in the UK and France.
Regulatory processes, while designed to ensure safety and efficacy, often present significant delays in launches. More so when companies are simultaneously trying to seek launch approvals across FDA, EMA, CFDA, and PMDA.
Agencies may impose post-approval commitments, such as Risk Evaluation and Mitigation Strategies (REMS), which must be satisfied before the drug can be marketed.
For instance, in the US, developing the necessary systems for REMS can take six to twelve months, and a wait-and-see approach can postpone the launch if the FDA requires a REMS unexpectedly. For example, in 2021, despite decades of evidence supporting its safety, the FDA imposed REMS requirements on Mifepristone post-approval, which majorly impacted its market introduction and accessibility.
Finalizing drug labels, particularly for therapies with complex indications, is increasingly time-consuming. Incomplete or ambiguous labeling delays provider education and market readiness, further extending timelines.
For instance, approved by the FDA in September 2016, Exondys 51 was the first DMD therapy; the extended labeling negotiations between the FDA and Sarepta contributed to delays in the drug’s market availability, impacting patients awaiting treatment.
Even after manufacturing and regulatory hurdles are cleared, inadequate market preparation can stall a drug’s launch. Companies often underestimate the time needed to achieve commercial readiness.
Healthcare providers, key opinion leaders (KOLs), and patients need education about the drug’s benefits and appropriate use. Without timely awareness campaigns, generating the first prescriptions can be slow.
For example, Eli Lilly faced delays in the launches of its weight-loss and diabetes drugs, Mounjaro and Zepbound, due to reductions in U.S. wholesale inventory. The company postponed advertising and international launches to focus on inventory levels, which affected the timing and effectiveness of its market entry strategies.
A well-prepared commercial team is essential for effective drug promotion. Training sales representatives to communicate value propositions requires time, particularly if they lack experience in the therapeutic area.
For example, approved by the FDA in January 2020, Tepezza’s launch was impacted by the COVID-19 pandemic. The restrictions hindered traditional in-person marketing and sales activities, necessitating a rapid shift to virtual engagement with healthcare providers. This transition posed challenges in effectively communicating the drug’s benefits, leading to slower-than-anticipated initial uptake.
Developing compliant promotional materials involves internal reviews, regulatory approvals, and dissemination. Delays in these processes can jeopardize launch readiness.
For example, delays in producing a critical piece of “Day One” collateral can seriously affect launch timing. The launches of migraine treatments Ubrelvy (Allergan) and Nurtec (Biohaven) were delayed due to the COVID-19 pandemic. Companies had to adapt by implementing virtual sales forces, developing digital marketing collateral, and retraining sales reps in new tools, which required additional time and resources, leading to the postponement of the drugs’ market introductions.
The competitive landscape is fraught with challenges that can obstruct or delay a launch.
Patent disputes and challenges from competitors can result in lengthy legal battles, delaying market entry.
A notable example is the case of Sun Pharma’s Leqselvi, which, despite receiving approval, was stopped from launching due to a legal dispute with Incyte.
Disputes over exclusivity rights, such as orphan drug or pediatric exclusivity, can prolong negotiations and defer launches.
Case in point: Liquidia has faced delays in realizing the full potential of Yutrepia due to a market exclusivity dispute with United Therapeutics’ Tyvaso DPI. The FDA granted Tyvaso DPI a three-year exclusivity period, preventing Yutrepia’s market entry until the expiration of this term.
Competitors may strategically launch similar products or preemptively offer discounts to disrupt market entry plans. These actions require swift countermeasures to mitigate the impact.
For instance, in 2016, legal action brought by Abbvie culminated in a settlement where Amgen agreed to delay the US launch of its biosimilar, Amjevita, until 2023.
Ensuring that drugs reach patients involves overcoming logistical and institutional challenges.
Setting up financial assistance programs for underinsured or uninsured patients is critical but can extend launch timelines.
Take the case of Vyndamx; Pfizer aimed to cover co-payments for eligible patients but faced opposition from the HHS, which led to court proceedings, thereby preventing Pfizer from implementing the PAP for the under and uninsured.
Specialty drugs often require unique distribution networks. Establishing these direct-to-provider distribution pathways, along with wholesaler agreements, can be time-intensive.
For example, despite the strong demand for Cabenuva, a lack of capacity in the physician’s office (a lack of nurses and capacity to manage the reimbursement process) became a barrier to uptake.
For complex therapies like gene or cell treatments, healthcare providers need specialized training to administer the drug safely. This preparation can further delay availability.
For example, despite the market demand and patient interest, limited HCP time in the UK hindered the uptake of Leqvio.
For biopharma companies, blockbuster launches are moments of both promise and peril. Billions of dollars in R&D culminate in a critical window where operational precision determines whether a life-changing therapy reaches patients on the very day of approval—or languishes in delay.
Despite engaging top consulting firms armed with bespoke frameworks and tools, many companies find themselves grappling with launch inefficiencies that erode revenues, waste time, and, most importantly, delay patient access.
Why does this persist?
Unveiling the Core Challenges Launches are typically seen as high-intensity, short-term endeavors demanding seamless cross-functional collaboration among manufacturing, regulatory, commercial, and operational teams.
While this structured approach might seem robust, it frequently exposes deep-seated systemic flaws. Teams typically operate within fragmented processes, rely on department-specific tools, and function in siloed workflows that lack alignment.
The introduction of a “launch excellence tool” or the addition of an army of consultants as “process managers” often exacerbates these challenges.
Instead of addressing the root causes, these measures create extra layers of work, further complicating the process. Relying on brute force—adding headcount to manage cross-functional workflows for the duration of the launch—offers only a temporary fix.
Once the launch concludes, functional teams revert to their disjointed state of operations, perpetuating the cycle. As a result, with each new launch, companies often need to bring in yet another consulting team, effectively starting from scratch every time.
These systemic flaws fall into three primary categories:
The cornerstone of many pharmaceutical launches is often a tried and tested linear framework that segments the launch into discrete functional deliverables, timelines, and milestones.
While this structure is designed for clarity, it relies heavily on resource-intensive coordination and oversight, quickly becoming a bottleneck.
Traditional launches use standalone tools, such as isolated launch accelerators or trackers, spreadsheets, or rudimentary project management software. These tools are often disconnected from the day-to-day systems used by functional teams, creating an additional layer of work. Team members must manually update progress, requiring constant follow-ups by dedicated coordinators or external consultants.
To ensure progress, organizations rely on labor-intensive governance practices. These include weekly team meetings, 1:1 check-ins, steering committee reviews, and ad hoc coordination calls. While these meetings aim to maintain alignment, they consume valuable time and resources without necessarily driving actionable outcomes.
The lack of integration across departments—such as manufacturing, regulatory, marketing, medical, and commercial teams—creates inefficiencies. Handoffs between teams are prone to delays, errors, and misunderstandings, all of which can jeopardize timelines.
Due to the rigidity of traditional frameworks, accommodating unexpected changes—such as regulatory feedback, competitive actions, or supply chain disruptions—requires extensive manual rework. This lack of flexibility compounds delays and creates frustration across teams.
Labor-intensive coordination drains organizational resources and slows down decision-making, making launches inefficient and reactive rather than streamlined and proactive.
Metrics, dashboards, and reporting tools are essential for monitoring launch progress. However, the design and application of these tools in traditional approaches often render them ineffective at identifying upcoming challenges in real-time and creating opportunities to resolve them proactively.
Most launch trackers and dashboards are inherently retrospective, concentrating on completed deliverables and past performance. While they serve as a historical record of what has been accomplished, they fall short in illuminating the path forward. These tools seldom leverage predictive analytics or forward-looking indicators, leaving teams vulnerable to blind spots and unaware of emerging risks that could derail their progress.
A cultural tendency to “greenwash” metrics—where all indicators appear favorable—prevents teams from acknowledging and addressing problems early. No one wants to appear responsible for delays or inefficiencies, so issues are often downplayed until they escalate into crises.
Metrics are often problem-oriented rather than solution-focused. They highlight what went wrong but provide limited guidance on how to course-correct. As a result, leadership is often left grappling with uncertainty, struggling to determine the next steps.
The reliance on retrospective metrics delays problem identification and resolution, reducing the organization’s ability to adapt dynamically to challenges during a launch.
The pharmaceutical launch environment is inherently volatile. Regulatory changes, competitor actions, payer negotiations, and market dynamics can shift rapidly. Unfortunately, traditional launch practices are not equipped to handle this level of uncertainty.
Many launch teams focus solely on executing the “ideal” plan. Scenario planning, when it exists, is often limited to a handful of highly disruptive circumstances. As a result, when unexpected events occur—such as supply chain disruptions or adverse regulatory feedback—teams are caught unprepared.
When circumstances require strategic or tactical changes, decision-making often involves extensive deliberations. Launch steering committees must review the implications of the change, consult external partners, and coordinate across multiple functional groups. This process can take weeks or even months, during which valuable time is lost.
Because traditional frameworks are not designed for fluid adjustments, tactical shifts often occur in silos. For example, the regulatory team might address a labeling issue while the marketing team continues executing the original plan, leading to misalignment and inefficiencies.
Many companies rely heavily on external consultants or vendors to manage certain aspects of the launch, such as supply chain logistics or payer negotiations. While these partners bring expertise, they also add complexity and can slow down agility if their workstreams and tools are not tightly integrated into the launch ecosystem.
Poor agility results in slow responses to emerging challenges and missed opportunities to capitalize on market dynamics, ultimately reducing the effectiveness of the launch strategy.
The challenges of labor-intensive coordination, retrospective metrics, and poor agility do not exist in isolation. Instead, they compound one another, creating a cascade of inefficiencies:
To overcome these challenges, companies must embrace modernized launch practices that prioritize integration, foresight, and agility:
Launches are like snowflakes—no two are ever the same. Just as each snowflake’s uniqueness arises from the subtle interplay of temperature, humidity, and air currents during its descent, the distinctiveness of a launch outcome gets shaped by the diverse regulatory, commercial, production, and distribution market challenges encountered over its 60-month journey.
If benchmarking a snowflake is impossible, can one truly benchmark a launch?
Truth is, the secret to launch success lies in achieving seamless alignment across internal and external teams (without replacing their day-to-day tools and systems, instead uniting them) and maintaining sharp foresight (with predictive AI), enabling organizations to anticipate challenges and swiftly adapt to changing circumstances (using generative AI).
Yes, the challenges of launching a blockbuster drug are formidable, but they are not insurmountable. By transitioning from traditional, rigid frameworks to modernized, AI technology-driven approaches, biopharma companies can revolutionize how launches are executed.
A unified, agile, and predictive approach addresses the inefficiencies of current methods, allowing organizations to achieve alignment, anticipate obstacles, and adapt dynamically to changing circumstances.
Here’s how companies can implement this approach across the three critical dimensions:
Traditional approaches to launches often treat them as isolated, high-intensity projects. While this compartmentalized strategy may bring clarity, it also fosters silos that hinder collaboration across functions and with external partners. Misaligned processes, disconnected tools, and fragmented communication lead to inefficiencies that compromise launch timelines and quality.
A unified approach emphasizes seamless integration of systems, workflows, and organizations to ensure that all stakeholders—internal functional teams or external vendors—work in concert and that every action, update, and decision is visible to all relevant parties in real time.
Platforms like the Unipr AI Ecosystem enable real-time integration of tools used across departments, such as supply chain management systems, regulatory tracking software, and commercial planning tools. This eliminates the need for manual updates and ensures that everyone has access to the same information at the same time.
A centralized data repository acts as a system of record and ensures that all stakeholders are working with consistent, up-to-date information, reducing errors caused by miscommunication or outdated data.
Leaders can monitor real-time progress across functions—from manufacturing to market access—without the need for frequent check-ins or manual reporting, fostering transparency and accountability.
Integrated communication channels (Microsoft Teams and SharePoint, Slack) for cross-functional teams across geographies operate bidirectionally connected through the Unipr AI Ecosystem, which assures everyone on the teams access consistent, up-to-date information without needing manual updates.
By linking external partners and their tools through the Unipr AI ecosystem, companies streamline coordination with their partners: contract manufacturers, logistics providers, and payer negotiators.
Organizational alignment transforms launches from fragmented efforts into cohesive, well-coordinated operations. Teams can focus on execution rather than firefighting, improving both speed and quality.
Traditional launch tracking relies heavily on retrospective metrics—looking at past performance to identify issues. While these metrics offer insights into what went wrong, they provide little value in preventing future problems.
In the dynamic world of biopharmaceutical launches, where circumstances evolve rapidly, execution foresight, powered by predictive analytics, enables companies to anticipate challenges before they occur and make informed decisions to mitigate them.
By analyzing successful as well as problematic execution data from past launches, the Unipr AI Platform can identify patterns and flag potential risks.
Continuous monitoring of forward-looking KPIs allows companies to detect early warning signs, such as likely delays in manufacturing or slow payer negotiations.
Predictive models can simulate various “what-if” scenarios, helping teams prepare for a range of regulatory contingencies, access risks, or competitive actions.
Embedded predictive analytics in the Unipr AI Platform can pinpoint areas where progress will likely stall, such as quality control processes or labeling negotiations, enabling teams to allocate resources proactively.
Companies can continuously assess risks as circumstances evolve in real-time, identify challenges before they escalate, and ensure their strategies remain relevant and tactics practical. Unipr AI doesn’t just identify challenges—it recommends specific actions to address them, ensuring that leaders can make informed, timely decisions.
Execution foresight empowers teams to shift from reactive problem-solving to proactive planning, reducing delays and enhancing overall launch performance. For instance, if manufacturing capacity is likely to become a constraint, Unipr automatically notifies leaders early, allowing them to mitigate the issue before it impacts timelines.
Biopharma launches are rarely linear. Regulatory updates, market shifts, and competitor actions often require companies to change strategies mid-course. Traditional frameworks, with their static planning and cumbersome decision-making processes, struggle to adapt to the fluidity required for modern launches.
Operational agility involves not only reacting to changes but also preparing for them in advance and pivoting rapidly in evolving launch circumstances. By parallel-pathing preparations for multiple scenarios, teams can ensure readiness for any eventuality without wasting valuable time.
Unipr AI Platform enables teams to develop and maintain “digital twin” parallel strategies for multiple scenarios and alternative outcomes, such as different regulatory outcomes or varying levels of market competition.
Integrated tools allow teams to update strategies dynamically based on new information, such as payer feedback or competitor actions, without disrupting ongoing operations.
Empowering cross-functional teams to make decisions within predefined parameters reduces dependency on lengthy approvals from steering committees.
Unipr’s dynamic workflows automatically adapt to new priorities, reallocating resources and updating timelines to reflect the latest circumstances, ensuring minimal disruption.
Operational agility ensures that changes in one area, such as supply chain adjustments, are immediately reflected across related functions like commercial planning and regulatory submissions.
By linking external partner systems to the same agile ecosystem, companies can synchronize efforts quickly, even for complex tasks like implementing new cold-chain logistics requirements. Essential collaborators, such as CDMOs and PBMs, are seamlessly linked, ensuring that agility extends beyond internal teams to the entire launch network.
Operational agility allows companies to stay ahead of challenges, capitalize on opportunities, and maintain momentum, even in the face of unexpected disruptions. Whether it’s a sudden change in reimbursement policies or a competitor’s unexpected launch of a product extension or combination, Unipr can help teams adapt quickly, minimizing disruptions.
Together, the Unipr AI Ecosystem and Unipr AI Platform are at the forefront of transforming drug launches by addressing the critical dimensions of alignment, foresight, and agility.
Their combined capabilities redefine how biopharma companies can raise the probability of realizing the full potential of their future blockbusters by launching them the same day they are approved across geographies.
Companies that embrace this modernized launch execution approach can unlock significant advantages:
In the high-stakes world of biopharmaceuticals, everyday matters—every day saved is a day closer to transforming a patient’s life, and every day lost is an opportunity missed for innovation to make its impact.
The life of a drug is short, bound by the ticking clock of patent exclusivity and the relentless pace of market competition. Yet, in this urgency lies an extraordinary opportunity: to rethink, refine, and revolutionize how we approach launches.
Traditional methods, with their rigid frameworks, retrospective metrics, and reactive strategies, are no longer sufficient in today’s dynamic pharmaceutical landscape. They falter under the weight of inefficiency, leaving operational challenges to erode years of R&D investment and delay life-changing therapies from reaching the patients who need them most. These preventable delays not only compromise revenue but also delay the fulfillment of a company’s commitment to healthcare innovation and patient care.
The solution is clear and transformative: a proactive, unified, and predictive approach to drug launches.
By embracing tools like the Unipr AI Ecosystem, companies can integrate their operations and, coupled with the Unipr AI Platform, predict challenges before they materialize and maintain the agility to adapt to an ever-evolving environment. This isn’t just a technological shift; it’s a paradigm shift. It’s about fostering alignment across teams, leveraging data to anticipate the unexpected, and embracing agility as a core principle.
In 2025 and beyond, the most successful launch teams will not be those who simply manage challenges but those who anticipate, adapt, and excel. Imagine a launch where every stakeholder operates on the same page, every decision is data-informed, and every challenge is met with a proactive plan.
Imagine a launch where the moment of regulatory approval seamlessly transitions to patient availability, not in weeks or months, but within 24 hours. This vision is not a distant ideal; it is an achievable reality with the right mindset.
The future of pharmaceutical success lies in this shift—from reactive to proactive, fragmented to unified, static to agile. With platforms like Unipr guiding the way, companies can confidently navigate the complexity of launches, reclaim lost time, and secure their place as leaders in an increasingly competitive landscape.
More importantly, biopharma companies can fulfill their ultimate mission: ensuring that the breakthroughs of today become the medicines that change lives tomorrow.
