This blog is part of an ongoing series, A Brave New World: Finding life science success in modern markets.

The life sciences industry currently stands at an inflection point. Medical innovation continues to thrive, but the environment for launching and sustaining new therapies is becoming more challenging. The combination of policy-driven economic compression and shifting dynamics across stakeholders demands a fundamental rethinking of lifecycle strategy, most importantly at launch. New pressures are shaping the path to success, making it more elusive than ever. Companies that adapt by optimizing promotion in real time, engaging a broader and evolving provider base, using evidence in a strategic and convincing fashion, and supporting patients will be the best-positioned for success in the coming decade.

More than ever, life sciences success hinges on a strong and well—executed launch.

Why is launch more important than ever? The modern market answer starts at the end of a brand’s lifecycle. The Inflation Reduction Act (IRA) ushered in price negotiation pressures that effectively shortened the economic life to 9 years for small molecules and 13 years for biologics. Consider Enbrel, one of the first drugs selected for Maximum Fair Price (MFP) negotiations and which launched in the U.S. in May 1999. Had the MFP provisions been in place when Enbrel initially entered the market, it would have been first eligible for negotiation in 2012, much earlier than the patent expiry, which is set for 2029. Adjusting for the percentage of business in the Medicare channel (~25%), that means there will be a minimum of a 4-year impact on the economic lifespan of the drug. However, that could range as far out as the full 17 years if the markets see Commercial payer spillover from Medicare negotiated prices. The resulting change in economic value reverberates throughout the drug lifecycle all the way to pre-launch when decisions on indication strategy first emerge.

Product Lifecycle: Economic Compression

Launch Outcomes Under Pressure

Even before the IRA, U.S. launches were facing headwinds. Average sales for new products have dropped off significantly compared to pre-pandemic norms. Compared to the average product launched between 2018-2020, after excluding vaccines, COVID treatments, and GLP-1s, recently launched products now have gross sales close to 30% lower in their first year in the market, and the gap only widens in years two and three. This revenue gap exists for both retail and specialty products and can be seen in many therapeutic areas. Questions remain as to whether products catch up later in their lifecycle as markets mature, payer contracting decreases net prices, and evidence catches up to brand positioning.

Average gross sales by launch year

The reasons for the declines are multifaceted and extend across the product lifecycle:

• Promotional Inefficiency: While brand awareness is crucial for both providers and patients for driving new product uptake, particularly during the first 6 months of launch, current launches are spending more on promotion while activating fewer prescribers and acquiring fewer patients. One facet of this can be direct-to-consumer (DTC) promotion, which remains a significant catalyst for adoption. However, it is a high-risk/high-reward tactic. DTC influence on product uptake has diminished over time as competition proliferates the airwaves and costs have increased.
• Patient Leakage: Patient drop-off throughout the first year of therapy is one of the most overlooked drivers of poor brand performance and a common reason for missed launch forecasts. For example, for one specialty brand that launched in 2022, by the end of the first year on market, only 4% of new-to-brand patients who attempted therapy remained adherent to treatment. The 96% loss in demand was due to a cascade of challenges from payer rejections, abandoned prescriptions, and poor adherence. The brand drove demand; however, patient leakage eroded efficiency and significantly undermined promotional ROI.
• Changing Provider Dynamics: As the physician shortage is projected to get worse, the rise in nurse practitioners and physician assistants (NP/PAs) is expected to grow. With over 440,000 NP/PAs writing prescriptions in the U.S. in 2024, the specialty accounts for one in four filled prescriptions for branded drugs. Their share of prescribing is growing across therapeutic areas, from retail products such as diabetes or respiratory agents, to specialty products like immunology, and include many rare and orphan drugs such as those prescribed in oncology. Yet, manufacturers continue to overlook their impact, making it essential to tailor launch strategies to this expanding prescriber base. Whether NP/PAs act as primary or secondary prescribers, the influence continues to grow as the numbers surge at the same time that other specialties slow.
• Payer Dynamics: Payers are exerting historically high control at launch. Utilization management tools, such as prior authorizations and step edits, are applied more aggressively, and first year access can be observed deteriorating over time rather than improving. Rejection rates for new launches are rising, shifting the market from one where most brands were filled to one where most are denied.

Compare an average launch brand in 2018 to an average launch brand in 2023. In just over 5 years, the fill rate has declined from just over half of patients successfully filling a new-to-brand prescription to just over one-third. Translating that to demand generation, it took 1,000 patients in 2018 to capture ~500. To capture those same 500 patients in 2023, that would have meant demand generation of 1,432 patients or a 43% increase from an analog only five years old. For 2024 launches, albeit without a full year to perform the analysis, payer control continues to pressure performance, with only 1 out of 5 patients able to navigate controls successfully to get onto treatment within the Commercial channel.

NBRx Durable Claims Status Within 12Months Post-Launch

Strategic Imperatives for the Next Decade

Difficulties abound, and the path to success is becoming a steeper climb with each passing year. Coupled with declining first-year sales, rising rejection rates, and evolving stakeholder dynamics, the traditional launch state of play has changed.

Yet, opportunity still exists for manufacturers who are willing to adapt. To meet this moment, life sciences companies must reimagine how they engage across the product lifecycle, from clinical development through commercialization, to build strategies that reflect the realities of payer control, provider fragmentation, and patient leakage.

To thrive in modern launch, life science companies must embrace a new set of principles:

• Manage the Lifecycle Within a Compressed Timeframe: With economic pressures and policy constraints shortening the commercial runway, manufacturers must rethink how they maximize value early. Lifecycle management must now begin even prior to launch with earlier investments in integrated evidence strategies that combine clinical, economic, and real-world data to prove value. For multi-indication or high-value assets, stacking indications earlier in the lifecycle instead of sequencing them over time results in major changes to the cost of research and development.
• Update Launch Strategy for a Competitive Environment: The current market is crowded and intensely competitive. Manufacturers must begin looking beyond the drug or therapeutic class they are competing in and understand the totality of the launch landscape. Many indications for both retail and specialty drugs have multiple competitors. In modern markets, that means prescribers and patients are navigating more promotion across specialties. Success now requires an extended launch window with an optimized strategy tailored to the unique differentiators of the brand. The first six months on the market remain important, but it must be bolstered by effective pre-launch tactics that cut through the noise and use the latest in behavioral based targeting.
• Modernize the Patient Experience: Today’s patients are increasingly engaged, empowered, and self-directed in their treatment decisions. They also expect the same seamless, technology-driven experiences in healthcare that they encounter with many other purchasing decisions. Patient engagement strategies need to reflect these expectations and, where appropriate, be paired with direct-to-patient strategies or transitional assistance initially as coverage is improved over time. These changes will yield increased returns in the access, brand awareness, and patient support needed today.
• Align Promotional Investment with Impact: With promotional ROI under pressure, brands need to deploy resources more intelligently. This means leveraging direct, indirect, and consumer-driven promotional strategies. A strong digital strategy to identify high-value, promotionally sensitive prescribers (including NP/PAs) while personalizing engagement is now table stakes for brand success. With more information available than ever before, the industry needs to build next generation strategies and tools to accelerate progress from market event, to market insight, to tactical execution.
• Optimize Access and Adherence: Market access strategies must go beyond formulary placement. Addressing patient leakage requires end-to-end support including benefits verification, transition assistance, prior authorization assistance, adherence programs, and digital engagement. Measuring success solely by filled prescriptions misses the nuances and challenges of the patient journey.

The Bottom Line

With tightening policy constraints, economic pressure, and shifting stakeholder dynamics, the life sciences industry faces a critical juncture that calls for a reimagining of lifecycle approaches, particularly at launch. Companies that adapt by optimizing promotion, engaging a broader and evolving provider base, and supporting patients will be those most likely to find success.

The next decade will reward those who plan early, execute with precision, and measure success across the full patient journey. For those who cling to the old playbook, the cost will be measured not just in lost revenue, but in missed opportunities to deliver innovation to patients who need it most. Please contact your IQVIA representative for more information.