How biopharma can get the right mix of people and tech for launch success

Facing a challenging commercial environment, biopharma companies need to embrace an end-to-end, AI-driven strategy to succeed. 

In brief

• Effective biopharma launches need to leverage real-world evidence and AI from early clinical development through to follow-on actions.
• Most biopharma launches miss revenue forecasts, underscoring the need for better launch strategy adaptation.
• Life Sciences CEOs face major challenges due to workforce and critical skill shortages, affecting resource allocation and new product launch pace.

For life sciences companies focused on the future, getting new product launches right is a critical priority. With more products predicted to launch in the next five years than in the previous decade, an increasingly competitive environment and budget-constrained payers pushing back harder on pricing and reimbursement, maximizing the commercial potential of new products has become a vastly more demanding challenge.

Rather than a series of tactical decisions to be made once the product is ready to go, commercial launch now requires an end-to-end integrated strategy. This strategy needs to begin while the product is still in early clinical development and extend through the initial launch to include follow-on actions. It needs to draw on real-world evidence and, increasingly, AI capabilities, to amplify, sustain and extend the value narrative and supporting evidence the company builds around its assets. As launches become more complex, product marketers must also become more sophisticated and develop a deeper understanding of local market conditions, novel technologies, and patient treatment pathways.

Right now, biopharma companies are coming up short on these challenges. EY analysis suggests that in four key therapeutic areas most new biopharma launches are missing their projected revenue targets – ranging from 56% of launches in the oncology therapeutic area up to 67% in infectious diseases (see Figure 1). The growing complexity of launch strategy, and companies’ failure to adapt to this, is a key issue, leading to several recognizable shortcomings in recent launches (Figure 2).

The impact of regulatory changes ushering in more pricing control, including the Inflation Reduction Act in the US and wider impact of international reference pricing has only added to this sink-or-swim urgency, with peak revenue times potentially eroding under the impact of pricing shifts (Figure 4). All of this means that companies need to accelerate the product launch cycle to hit those peak revenue points. Doing this means having stakeholders prepared and ready for the new launch and ready to embrace it as soon as the new product is rolled out. 

Stakeholders must gain a comprehensive understanding of the disease that the drug is intended to treat and must recognize the signs and symptoms associated with the disease. It is incumbent upon the company to demonstrate to the ecosystem the existing unmet need and how the drug addresses this need. In the case of rare diseases, this may necessitate detailed education on diagnostic criteria. For new oncology drugs, it might involve ensuring that physicians are testing for specific biomarkers. Drugs intended for a broader market may require differentiation in other areas.

Awareness amongst the clinical community, payers and policy makers is critical to driving early diagnosis and treatment, and therefore driving commercial success. Particularly for ATMPs where awareness and education are often pivotal. Progressing from awareness to treatment requires strong relationships with the academic community, as well as potential key prescribers.

In the future, market shaping might also involve aligning with government priorities and finding the win: wins and common areas that benefit both the corporate pharmaceutical agenda and government policymakers in various regions. This requires a deep understanding of healthcare systems, their evolving priorities and how to enable and facilitate effective partnership across stakeholders in the ecosystem to ultimately benefit patients and society. Third-party providers can help connect stakeholders, managing risk exposure and facilitating outcomes-based contracts.

What legal considerations are involved in a successful launch?

Patents are the primary tool for securing market exclusivity in a launch to protect new drug formulations, delivery systems, and manufacturing processes. Companies must ensure that their IP rights are recognized and enforceable in all markets where they intend to sell their drugs.

Licensing agreements are also critical to launch in certain geographies and relationships with external partners, academic institutions, or other pharmaceutical companies need to be clearly defined. Contracts should cover the scope of collaboration, IP ownership, responsibilities, and financial arrangements. Market exclusivity periods may also come into play, where a drug is granted protection from competition for a limited time, enhancing its profitability and market position.

The potential for product liability claims is a significant risk once a drug hits the market.  In the case of adverse events, companies must be prepared to respond to regulatory authorities and manage claims effectively. Insurance coverage, including product liability insurance, is essential to protect against potential financial exposure from lawsuits.

Legal professionals with expertise in these areas, whether in-house or from a third-party, are essential to ensure that the drug development process is legally sound, compliant with applicable regulations, and positioned for commercial success. A strategic approach will not only mitigate risks but also maximize the innovation's potential to reach patients and improve global healthcare.

What do you need to do to keep your product relevant as markets evolve?

A successful commercial launch doesn’t end after the initial launch period or even after the first year but requires an evolving strategy that will keep the product relevant throughout its lifecycle as the market and competitive environment continues to evolve. To maintain a strong strategy post launch requires continuous engagement with stakeholders and flexible data-driven operating models.

Market pull-through may also involve continual capture and deployment of real-world evidence (RWE) to support the launch narrative in-market across the product lifecycle. Companies may need a cross functionally aligned global integrated evidence strategy across the product lifecycle, bringing together RWE with clinical and health economic data. This is done to encourage a continuous evolving and market stakeholder specific narrative through all types of media and communication, whether it be emails, advertising, signage, blogs, social media updates, or scientific publications.

Products often don’t perform the same way in real world settings as they do in clinical trials, where all variables are accounted for and patients are closely monitored. It is crucial to the physician and payer relationship to observe how products perform outside the clinic to further strengthen the efficacy, safety and economic narrative. RWE will become an increasingly significant part of the equation moving forward. However, current health ecosystems in many markets lack the necessary infrastructure to efficiently, accurately, and systematically capture this data and evidence globally.

As a result, manufacturers often seek strategic partnerships within the ecosystem to address these challenges. For instance, they might propose to build data infrastructure for rare diseases and registries in exchange for support with product funding and value-based payments. These partnerships aim to enhance data tracking and understanding, as well as to optimize the positioning and utilization of treatments.

How can technology help achieve your launch goals?

The rapidly shifting technology landscape offers a wealth of possibilities for companies to develop leading edge capabilities in commercial and medical insights and analytics, leveraging GenAI to deliver faster insight into action. If companies set off on the right launch trajectory, a comprehensive suite of launch support tools will enable them to consolidate that success. From digital control towers to track key launch metrics, through data-to-insights engines to allow agile adaptation of strategy, and operational tools to orchestrate and co-ordinate messaging in the market, deploying the right technology platforms gives companies the greatest chance of succeeding from the start - and of adapting and recovering if they hit unforeseen launch obstacles.

Currently, most life sciences companies take a reactive approach to business needs, leveraging analytics on a request basis. This creates a disconnect and misalignment across different franchises, brands, and campaigns, resulting in KPI reports that have limited actionable insights. According to an EY survey, only 38% of life sciences companies are using marketing automation platforms, which can be crucial for data analytics and optimization.

From data collection to market shaping and pull-through, each of these areas has the potential to harness new GenAI technology to help make communications more streamlined, cohesive, and efficient. According to EY research, over 20% of life sciences investment into AI technologies is targeting commercial applications, from optimizing pricing strategies to building and curating platforms for engagement and education (Figure 5). Creating an ethical AI framework for your commercial organization will be a key consideration for life sciences companies. 

Yet, this technology is only as good as the people behind it. Companies need to consider their future operating models and invest in a highly skilled workforce that can help consider the business needs and deploy technology and AI capabilities in the right way to meet those needs.

Bringing together the right capabilities for launch confidence

Delivering launch excellence means companies need to think across the lifecycle from pre-launch to post-launch rather than seeing launch as a single event, particularly as many therapeutics have multiple therapeutic indication expansions. Moreover, it needs companies to work across multiple dimensions and bring together a range of different capabilities.

The ability to flawlessly execute commercial launch itself needs companies to unite several differentiated skillsets to capture, interpret, integrate and communicate the key data needed to present the value proposition. Yet, to truly excel in this space companies need to layer on top of these skillsets the human-centered capability to personalize the way they communicate both internally and externally. Connecting more effectively with each of the multiple groups of stakeholders can mean the difference between success and failure. Meantime, companies should be optimizing the workforce to drive better interactions and earlier and deeper cross functional engagement with each of these groups.

Finally, success requires companies to build in the cutting-edge AI capabilities needed to stay on top of the rising wave of data generated by new products in both the clinic, clinical trial environment and also in the real world.  Companies need to continuously transform these data into new actionable insights that feed back into the process of defining the optimal strategy and differentiating the product in an ongoing cycle of evolution of the value narrative and positioning strategy. True launch excellence means working at the interface of these different domains of specialized expertise and building a better partnering strategy to allow the company to access all the tools needed to unlock success.

Not only partnering better with the different stakeholders in the health ecosystem to allow companies to understand and meet their needs and common goals, but partnering with the right players to shape and execute a human-centered strategy and a gameplan built on up-to-the-minute implementation of integrated data and AI analytics.

Launch excellence is not a single problem needing a simple toolkit, but a set of intertwined opportunities, challenges and risks which companies can unlock with the right strategy built on the right data, technology, people and partnerships. Companies that can get this mix right will be in the best position to shape their future commercial strategies with confidence. 

James Evans, EY Global Life Sciences Lead Analyst and Lisa LaMotta, Global Life Sciences Senior Analyst, contributed to this article.