For healthcare industry stakeholders, the current environment is perhaps more dynamic, more volatile and, in many ways, more challenging than ever before. Emerging Biological Disability Companies (EBPS) are no exception. Essentially, EBP lacks the weight to affect complexity and external forces of change. Just like weather, these dynamics are uncontrollable, but it is important to stay informed of environmental forecasts.
With that in mind, consider this blog as a “weather report” for industry trends in 2025. This highlights some of the most important policy, regulation and market changes and sets the IQVIA Insight Brief stage on how EBPS can adapt and thrive.
First: $500 Billion Questions
To understand why policy conversations are so relevant now, consider these statistics from the IQVIA Institute's latest understanding of drug use reports. In 2024, drug product sales exceeded $1 trillion in the US. Less than $487 billion.
In other words, over $500 billion has vanished to spread the economy in a total. At IQVIA, this is called the spread economy and is huge. If $500 billion is the country's gross domestic product, it ranks as the 30th largest economy in the world, along with Austria and Thailand. This is a complex dollar flow that goes through rebates to suit the offsets of the Pharmacy Benefits Manager (PBMS) and Employers (estimated at $315 billion), Hospital 340B discounts (estimated at $80 billion), Group Purchase Organization Fees (estimated at $50 billion), and various other other industrial pay offsets.
Key Trend 1: Rapid Fire Policy and Regulation Changes
In the first 120 days, the Trump administration issued more than 120 executive orders. This is an unprecedented pace of restructuring healthcare policy in real time. Much of the Trump administration's healthcare policy covers $500 billion flowing through populist policies aimed at reducing list prices, PBM reforms for transparency, or raising prices elsewhere.
Key Trend 2: Benefits of redesigning game rules changes
Another dramatic change is underway with the redesign of the benefits of Medicare Part D.
As an example, consider a specialist product of $22,000 per month (i.e. a $264,000 prescription per year for fully adhesion patients). Just two years ago, patients faced a 5% co-insurance at a devastating stage. However, by 2024, patients will fall to zero, and by 2025, they will face an out-of-pocket (OOP) of just $2,000. Once the patient's financial exposure effectively vanished, payer liability tripled from $55,000 in 2024 to $160,000 in 2025.
The ripple effects are profound as patient behavior changes as patient behavior changes as patient behavior increases and payer behavior increases simultaneously with responsibility. And markets change as economic trade-offs become more complicated across the spread economy.
Key Trend 3: Lower the OOP cap that drives a surge in usage
Sometimes a gentle breeze will become a tailwind to continue the weather's relative phorification. If 5% catastrophic coinsurance was eliminated in January 2024, oncology prescription volumes under Medicare Part D exploded virtually 53% overnight.
What causes such a dramatic staircase step in use? It was not that there was an influx of cancer diagnoses. Rather, many patients were “stored” with patient assistance programs, charity care, and basic support. Many in the industry were blinded to the impact of how important this shift in out-of-pocket exposure was to the industry.
When OOP costs dropped to zero, patients were flooded into visible markets. This trend continues in 2025 with a $2,000 out-of-pocket cap affecting not only oncology but all products.
EBP organizations need to be aware of what is happening with all the drugs they use, not just the patients sell. To think more about the brand dynamics mentioned above, you need access to data that many people don't own.
Key Trend 4: “Pil Penalty” Wild Card
This potential policy change could be a game changer for small molecule development.
Currently, small molecules are subject to Medicare's highest fair price negotiations nine years after launch. In contrast, biology enjoys it 13 years before negotiations. This is a major advantage, as industry analysis shows that approximately half of the lifetime value of a product comes from years 9 to 13.
Proposals to close or reduce the “pill penalty” gap could double the lifetime value of small molecule assets and fundamentally shift R&D investment incentives. For EBPS, which focuses on small molecule development, this represents a large-scale potential assessment shift that could reconstruct the entire business model.
Key Trend 5: Boom or Bust launch environment
In addition to complex policy and regulatory changes, the launch environment is increasingly biased between booms and busts.
Think of just five drugs (GLP-1 and RSV vaccines) earning 80% of first year sales in 2022 and 2023, while the other 84 launches shared the remaining 20%. Additionally, between 2015 and 2019, one in five drugs achieved $100 million in one year sales. From 2020 to 2024, it fell by 1/10.
Of the 23 products that achieved more than $100 million in sales a year ago since 2020, half came from emerging biological oil companies compared to 13 from large pharmaceutical companies. This suggests that while the overall environment is becoming more challenging, lighter EBP may benefit more than larger competitors.
When faced with an asymmetric launch strategy for large players, knowledge is key to success. Understanding the impact of precision sales targeting, early adoption of physicians and practices, promotional sensitivity, and how initiating patient and transition assistance programs impact commercial breakeven are just some of the insights needed to find success in modern markets.
Key Trend 6: Hidden Challenges in Demand Capture
Finally, demand capture efficiency has become an important yet often overlooked component of modern launch dynamics. It is the challenge best illustrated through real-world examples. It is a specialized brand that created critical physician demand, but lost 96% between initial prescription trials and 12 months of patient adherence.
Here's how brand demand erosion has turned out to be:
44% lost in refusal of compensation, prior approval was lost, 13% lost in ration and planning restrictions 15.5% lost in patient abandonment after approval, 5% lost in one treatment discontinuation
As most companies measure prescriptions only, there is no chance of intervention with 80% of patient journeys.
EBP: Ready to adjust the sail?
From policies to changing launch dynamics, industry trends create both headwinds and tailwinds for emerging biopharma companies. Although EBPS cannot control market forces or have a significant impact on policy decisions, it can adapt strategies to navigate strategies more effectively.
Iqvia is here to help you navigate the brave new world
Asymmetric launch strategies work, but they require deep analysis to support them. Getting an accurate “weather forecast” means maximizing the profits of your efforts beyond traditional market strategies. The industry is packed with examples of companies that spend hundreds of millions of dollars and launch products just to return a small portion of their investment.
Future insights overview highlights specific strategies that can be used to coordinate EBP sails in this changing environment. This involves rethinking everything from display sequences and pricing strategies to manufacturing partnerships. In the meantime, we will turn the trends of Brave New World: 2025 into a reshaping of healthcare and explore how IQVIA can help the EBP market.
