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Identifying the Most Prevalent Challenges that Impact Product Launch Success


In-depth study outlines the top five reasons biopharma products miss launch forecasts.

Image credit: leowolfert | stock.adobe.com

Image credit: leowolfert | stock.adobe.com

The world of biopharma is rife with challenges beyond the cost of research and development, including increased competition, patent expirations, and new regulatory guidance. As such, companies are under pressure to launch their products as quickly and efficiently as possible. An in-depth study conducted by Indegene and Everest Group delved into these challenges by identifying and addressing the key reasons that new products miss their launch forecasts.1

“In this uncertain and risky environment, biopharma companies face a definitive need to achieve launch success and forecast attainment,” the study authors wrote. “The development and execution of a successful launch strategy is becoming increasingly critical with an evolving payer and commercial landscape post-pandemic, increasing regulatory complexity, and the discovery of new treatments with smaller patient populations. Additionally, due to the COVID-19 pandemic and other economic pressures, the level of incremental differentiation required to be meaningful has changed, thus increasing the importance of effective communication that reflects changing customer behavior and preferences.”

The study pointed to an analysis of new prescription medications launched worldwide between 2009 and 2017, which found that 40% of products failed to meet their two-year sales forecasts.2 In addition to the constantly-evolving market headwinds biopharma faces, recent years have been impacted even greater by the COVID-19 pandemic.

For the study, the Everest Group interviewed 15 experts in product commercialization and launch domains. These experts were asked to rank their major parameters and sub-parameters that posed challenges in product launches. Following aggregation of the interview results, the five key reasons for products missing launch forecasts, according to the experts emerged as:

1. Payer activation and reimbursement challenges

According to the study, 93% of the experts identified payer activation and reimbursement challenges as having the greatest impact on product launch. “A product cannot reach the patient without swift and adequate coverage,” the study authors explain. “Delays in obtaining access can significantly reduce HCP adoption, as can underestimating the timeline for obtaining access.”

The study suggests manufacturers should develop a comprehensive strategy that considers payer needs, pain points, and includes reliable information gathered from the development process.1 To address this challenge during clinical development, the investigators suggest defining the unmet need and clinical differentiation; defining the target patient plus secondary endpoints gathered in clinical trials or real-world studies; and during market preparation, work to alter these obstacles by evaluating payer structure using clinical and real-world data.

2. Regulatory roadblocks and competition

Regulatory roadblocks and competition were identified by 80% of the experts as having a significant impact on launch success. A label with important and accurate information is key to product launch success; however, this can be difficult to achieve with an evolving regulatory landscape.

“A common downfall occurs when the development plan does not adequately incorporate both regulatory considerations and the likely competitive landscape,” the study authors wrote. “Additional regulatory reviews and unexpected delays further add to the challenge and can negatively impact key assumptions about launch timelines and forecasts.”

For this area, the experts suggest gaining support for commercial communication during clinical development and understanding “the tradeoffs of getting approved efficiently versus getting approved with a strong label and supporting evidence.”

3. Inadequate market adoption by healthcare professionals (HCPs)

Inadequate market adoption by HCPs ranked as the third greatest challenge in launch success. Approximately half of the experts identified this area as having the highest impact, with 40% ranking it as having medium impact.

“Securing product adoption by HCPs is crucial for successful patient onboarding and product adoption, which requires precise segmentation and targeting of HCPs—and continued omnichannel engagement throughout the product journey,” the study authors wrote. “HCPs are increasingly interested in data and outcomes beyond the regulatory data filing package submission.”

The investigators further noted the importance of gaining the confidence of HCPs, which has become a greater challenge in recent years for field sales representatives. This is because reaching HCP targets via traditional communication channels has become more difficult in the post-COVID world.

“As a result, it is essential for manufacturers of biopharma products to seek and address gaps in their HCP engagement strategy and move away from relying on face-to-face as the primary means to engage, educate and activate HCPs,” they added. “In addition to earning the confidence of HCPs, launch success also hinges on engaging with and educating patients—and providing much-needed product support and assistance programs based on the complexity of the product and the disease area.”

To overcome these challenges, the experts suggest identifying the preferred channel of engagement for HCPs; developing reliable and meaningful content that provides education via a targeted and customized method; and prioritizing access for payers and patient support programs.

4. Field force effectiveness and efficiency challenges

Only 7% of experts ranked field force effectiveness and efficiency as having a high impact on missed launch forecasts; however, more than half ranked it as having medium impact. Although the COVID-19 pandemic has mostly passed, the study explains that HCPs are still largely demanding immediate, digital information and are still unable to meet reps face-to-face. To address this area, the study suggests finding a balanced strategy for deployment that emphasizes field force and digital tools to optimize promotional efforts, while improving efficiency.

5. Patient engagement and adoption issues

Rounding out the top five challenges is patient engagement and adoption issues. Sixty percent of the experts ranked this area as having a medium impact on missing launch forecasts. While patients will typically follow the advice of their physicians, rare disease areas require a greater emphasis on engagement.

“To successfully reach the desired patient population, manufacturers must comprehend the patient’s journey and their requirements, mapping out the path to diagnosis, reimbursement scenarios, and physician-referral dynamics,” the study authors wrote.

For this challenge, the experts suggest developing a cohesive patient engagement plan that includes HCPs and other key decision-makers, as well as using appropriate technology to engage patients through preferred channels.

The study concludes by stressing the importance of proactive planning and effective execution. It presents a plan that follows a “people, process, and capability” perspective for each key impact area that accounts for the viewpoints of the major stakeholders involved in the launch process.1

“On a broad level, biopharma companies must craft a comprehensive launch strategy that addresses the top obstacles that affect achieving a company’s revenue goals,” the study authors wrote. “Despite falling under discrete categories, these obstacles are consistently best addressed in prior phases of clinical and commercial development.”

For more information, visit www.indegene.com.


1. “Achieving product launch success in the biopharma industry,” Indegene, 2023

2. “Ready for launch: Reshaping pharma’s strategy in the next normal”, McKinsey, 2020

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