Feature
Article
The Strategies Behind Bringing a Novel Therapy to Market Successfully
Author(s):
Key areas may offer useful strategies for introducing innovative products to market.
David Bell
Vice president, business unit head
Uro-Oncology
Ferring Pharmaceuticals
In the biopharmaceutical industry, a product launch is more than a milestone – it’s a moment of transformation for patients, providers, and the company. While innovation often centers on novel mechanisms of action, clinical novelty alone isn’t the sole predictor for market success.
Take, for example, the launch of Adstiladrin (nadofaragene firadenovec-vncg), a novel gene therapy approved in 2022 by the U.S. Food and Drug Administration for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).1 By the end of 2024, Adstiladrin had been supplied to over 1,500 patients across all 50 U.S. states and was in use at most major medical and community care centers nationwide, ranking among the top five best-selling gene therapies.2
This rapid adoption was no accident. It was the result of rigorous planning, a deep understanding of patient and provider needs, and a strategic focus on key drivers such as clinical value, accessibility, and stakeholder engagement. The following key areas were critical to ensuring the success of a novel gene therapy in the marketplace––and may offer useful strategies for others introducing innovative products to market.
Strategic collaboration accelerates uptake
A successful product launch begins long before regulatory approval––it starts with a deep understanding of the unmet medical need and a clear vision of how to address it. In the case of NMIBC, where innovation had stagnated for nearly half a century, patients faced limited options.
Although the standard of care is effective for some, nearly one-third of patients do not respond,3 and for those who do respond, half eventually experience cancer recurrence or progression.4 Patients and their providers were left with difficult choices, including having to undergo radical, invasive bladder removal surgery (cystectomy) or risking further cancer recurrence and potentially progressing to more advanced stages with poorer prognoses.5
Recognizing the complexity of the challenge, early collaboration between commercial, medical, and R&D teams proved to be essential. By aligning early in development with outside experts, these teams ensured that clinical trials were designed not only to meet regulatory requirements but also to generate data that would be meaningful in real-world clinical practice application. This approach allowed the organization to anticipate and address the needs of both patients and providers, ultimately shaping a product profile that was clinically relevant and operationally viable.
In therapeutic areas that have experienced little to no innovation, differentiation is not optional––it’s foundational. Cross-functional collaboration enables identification of unique product attributes that can fill existing gaps or improve upon current standards, such as a quarterly dosing schedule administered through a familiar, in-office procedure. These features were not incidental; they were the result of deliberate planning informed by early market insights and medical expertise. When development is guided by this kind of strategic alignment, the resulting value proposition is more compelling, adoption is faster, and market performance is stronger.
Equally important was the early recognition that gene therapy manufacturing presents unique complexities. Rather than treat manufacturing as a downstream operational concern, the company made a strategic decision during clinical development to invest in building two dedicated, world-class manufacturing facilities.6 This forward-looking move ensured not only launch readiness but also long-term supply continuity––an essential factor in building trust with providers, health systems, and ultimately, patients. The bladder cancer market has historically struggled with drug supply.
For industry leaders, this model underscores the importance of integrating commercial foresight, medical insight, and operational planning from the earliest stages of development. It’s a blueprint for how cross-team integration can accelerate uptake – not just by launching a product, but by preparing the market to receive it. But even the best internal alignment must be paired with a deep understanding of the people the therapy is designed to serve.
Embedding patient insight into launch strategy
Developing a product that resonates with the market requires more than clinical efficacy––it demands a deep, sustained understanding of the lived experiences of patients, their families, and the healthcare professionals who care for them. Patients are looking for therapies that are not only effective but also tolerable and compatible with their daily lives. To meet these expectations, companies must engage early and meaningfully with the communities they aim to serve. These conversations uncover critical insights into the concerns and priorities of those who will ultimately use and prescribe the therapy.
This early engagement informs everything from product design to launch strategy. It helps shape a risk-benefit profile that supports informed decision making and guides the development of user-friendly administration protocols. Accessibility considerations, such as insurance coverage and patient assistance programs, must be built into the strategy, alongside efforts to reduce barriers to treatment and support adherence. Importantly, all communications must be clear, trustworthy, and tailored to the audience. When these elements are aligned, the product is positioned not just to meet clinical endpoints, but to resonate with the market.
A commitment to a patient-centered product launch strategy also is reflected in sharing real-world experiences. Featuring current patients and former clinical trial participants––in this case, some of whom have been treated for over five years remaining cancer free––in educational and marketing materials serves as a powerful reminder of why early listening matters, helping to set realistic expectations and demonstrate that the therapy is truly aligned with patient needs.
Bridging strategy and execution to drive launch excellence
Even the most innovative therapy can falter if the market isn’t prepared to understand and embrace it. This is especially true in established therapeutic areas where the standard of care has remained unchanged for decades. In such cases, education becomes a strategic imperative. Success hinges on helping patients and providers recognize the value of a new therapy and understand how it fits into clinical practice.
Effective education needs to address three core questions: How does the therapy work? How is it administered? And how does it impact patient outcomes? For example, when launching a novel gene therapy, our team used simple, accessible language to demystify its innovative mechanism of action and differentiate it from common misconceptions. We also focused on practical, relevant details – like administration logistics – to help providers integrate the therapy into routine practice. These messages were shaped by insights from patients and healthcare professionals, ensuring relevance and clarity.
This kind of insight-driven education fosters trust and confidence, paving the way for early adoption. For pharmaceutical executives, this reinforces a core principle: successful launches are built not just on innovation, but on insight, integration, and intentional preparation. Of course, even the most well-executed launch strategy must be supported by a motivated, skilled team and a robust access framework.
Don’t make access an afterthought
For innovation to make a real impact, access must be embedded from the start into the development strategy. Building confidence in a new therapy depends on two critical factors: securing access and managing affordability.
As we all know, payer coverage is essential through strong value propositions and ensuring consistent reimbursement pathways for insured patients. For those facing economic hardship, patient assistance programs play a vital role in ensuring affordability. But access isn’t just about cost––it’s also about reducing complexity for providers and easing burden to the healthcare system. Programs that support both patients and healthcare professionals can help remove operational barriers, streamline reimbursement, and reduce administrative burden.
In the case of NMIBC, Ferring developed access support programs designed to address both financial and logistical challenges. For example: it offers therapy at little to no out-of-pocket cost for eligible patients and equips clinicians with tools to navigate healthcare efficiently––achieving over 99% payer coverage and timely reimbursement. This kind of multi-faceted support helps ensure that no cancer patient is left behind due to cost or complexity.
Access, however, also depends on reliable supply. In NMIBC, years of shortages for standard therapy left patients and physicians feeling anxious and underserved. That history made it clear: manufacturing must be a core part of the access strategy.7 Whether building internal capacity or partnering with trusted contract manufacturing, having scalable production in place before launch is essential to meeting market demand and maintaining confidence.
Charting a course for lasting value
A successful product launch is a milestone – but it’s not the finish line. Creating lasting impact in patient care requires a long-term commitment to innovation, collaboration, and a mission that goes beyond the product itself. It is truly reflected in the collective DNA of our team. There is no individual greater than the common goal to assist cancer patients and their families.
Experience with launching a novel gene therapy has shown that while an innovative product is essential, a great mission is transformative. Success today demands more than scientific achievement––it requires vision, resilience, and an unrelenting focus on the patient experience. These principles – rooted in innovation, partnerships, and patient-centeredness––serve as the foundation for sustained progress.
Strategic alignment across development, access, and education can help address significant unmet needs and deliver strong commercial performance. In the case of NMIBC, more than 1,500 patients were treated in the first year, and the therapy was recognized as already the fourth best-selling gene therapy.2
Such outcomes reflect the strength of a team defined by exceptional talent, deep expertise, and a shared commitment to advancing care – offering a model for how innovation, when paired with purpose, can deliver enduring value.
Sources
- ADSTILADRIN. Prescribing Information. Ferring Pharmaceuticals. 2024. https://ferringusa.com/wp-content/uploads/sites/12/2024/10/Adstiladrin_PI.pdf. Accessed July 2025.
- Ferring Pharmaceuticals. Ferring Achieved Record Sales Driven by Reproductive Medicine Combined with the Emergence of Adstiladrin. Published 9 Apr. 2025. www.ferring.com/ferring-achieved-record-sales-driven-by-reproductive-medicine-combined-with-the-emergence-of-adstiladrin/. Accessed July 2025.
- Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol 2021.
- Kamat AM, Lerner SP, O’Donnell M, et al. Evidence-based assessment of current and emerging bladder- sparing therapies for non–muscle-invasive bladder cancer after Bacillus Calmette-Guerin Therapy: a systematic review and meta-analysis. Eur Urol Onc. 2020;3(3):318-340.
- Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-Muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75-94
- Ferring Pharmaceuticals. U.S. FDA Approves Second Drug Product Manufacturing Facility for ADSTILADRIN® (nadofaragene firadenovec-vncg). Published 24 Apr. 2025. https://ferringusa.com/?press=u-s-fda-approves-second-drug-product-manufacturing-facility-for-adstiladrin-nadofaragene-firadenovec-vncg. Accessed July 2025.
- Ferring Pharmaceuticals. U.S. FDA Approves Second Drug Product Manufacturing Facility for ADSTILADRIN® (nadofaragene firadenovec-vncg). Published 24 Apr. 2025. https://ferringusa.com/?press=u-s-fda-approves-second-drug-product-manufacturing-facility-for-adstiladrin-nadofaragene-firadenovec-vncg. Accessed July 2025.
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