US and European first launch trends and implications for emerging biopharma

Emerging pharma first launches held steady in the U.S. last year, remained uncommon in Europe and showed improved performance against analyst forecasts compared with historical norms. The data offer critical insights for biotech and emerging biopharma leaders weighing their options ahead of a novel first launch. Specifically, our analysis clarifies key questions such as:

• How often does a U.S. first launch lead to European entry, and through which type of commercialization model?
• How likely are novel first launches to meet consensus analyst forecast, and what factors drive under- and overperformance?
• What postlaunch paths do first-time launchers take, and how common is it to scale, get acquired or stall out?

But first…

What defines a novel first launch?

ZS defines a novel first launch as any instance where a company commercializes a new, innovative product—either on its own or through a copromotion, where one partner is a first-time launcher. Launches of generics or 505(b)(2) products are not considered in this analysis.

Considering the U.S. and Europe together, novel first launches for 2024 were at the higher end of normal, based on our analysis stretching back to 2011. This masks a significant gap between the two geographies, with 15 first launches occurring in the U.S. in 2024 compared with just one in the EU (Figure 1).

Of the 141 novel drugs launched in the U.S. by first-timers between 2011 and 2024, fewer than half (66) had followed with a launch in Europe as of February of 2025 (Figure 2). Another 33 were still in active development for the EU, meaning either they’ve received a special designation or conditional approval, or have initiated regulator discussions.

Of the remainder, 13 have been withdrawn from the European launch pathway, while 16 were acquired before they could move forward with a European launch. The final 12 showed no signs of EU activity to date. This represents a significant number of innovative, high-value therapies that are not available to patients in the EU.

Despite fewer than half of all U.S. novel first launch products also launching in Europe, the data show that the majority of first-time launchers do take at least initial steps to enter the EU market as well. For those that do not enter, the most common reasons cited are the bloc’s lower pricing and reimbursement levels, its more fragmented commercialization landscape and country-specific requirements that add launch complexity.

Of the 66 novel U.S. first launch biotech and pharma products that subsequently entered Europe, 42% (28) launched solo, three entered copromotion partnerships and 31 out-licensed their product to another company for a European launch. Four were withdrawn from the market.

Notably, unlike in the U.S., copromotion is exceptionally rare in Europe.

For biopharma companies based outside the EU, Switzerland and the U.K. have historically been the most common choices for establishing European headquarters. However, the U.K.’s appeal has waned in the wake of Brexit and the growing concerns over its declining investment climate for innovative medicines. Switzerland, by contrast, has emerged as the clear winner—despite higher labor costs—thanks to its favorable tax policies, regulatory stability and deep talent pool.

So, how have U.S. novel first launches performed relative to consensus analyst forecasts? Underperformers dropped significantly in 2023 and 2024 compared with both 2018 and the COVID 19-era years of 2020-2022 (Figure 3). Overperformers also were less common in 2023 and 2024—although the drop was less dramatic than for underperformers.

How much the improvement in performance relative to expectations reflects more accurate consensus forecasts, stronger launch execution or both is hard to say. (Performance data relative to expectations for European first launchers was not available.)

To better understand common drivers of launch performance, ZS reviewed analyst reports, earnings call transcripts and company reports for each U.S. novel first launch between 2018 and 2024.

Launches that exceeded expectations typically benefitted from multiple success factors working in concert. Common traits include strong product differentiation that addresses an unmet need and effective early engagement with healthcare providers, patients and payers across channels. Greater use of advanced analytics, cloud solutions and applications that increasingly use AI are helping first launchers more efficiently improve launch performance, patient and provider experience, and address barriers to appropriate use. In contrast, one or two dominant issues, such as complex administration or insufficient differentiation relative to existing treatment options, could be a primary driver of underperformance.

The data suggests it’s rare for first launchers to graduate into the ranks of midsize pharma. ZS analysis has found that fewer than 5% of global first launchers that debuted in the U.S. or EU since 2011 have entered the ranks of midsize players while remaining independent.

While each company’s journey is unique, the data points to four patterns consistently shaping the trajectory of first launchers:

1. Launching solo or with a copromote partner in the U.S. is a proven, scalable path to market for emerging biopharma.
2. Most first launchers pursue Europe—but the road is longer, more fragmented and often more complex.
3. Successful launches hinge on two factors: meaningful product differentiation and flawless cross-functional execution.
4. Very few first launchers make the leap to midsize pharma while staying independent.

Remember: The goal isn’t just to launch—it’s to last.