US emerging pharma and biotech first launches: A story of over- and underperformance

In recent years we’ve seen a significant increase in first launches by emerging pharmaceutical and biotech companies—either as part of co-promotions or solo ventures. To understand which launches succeeded and some factors explaining why, we analyzed performance for pharma first launches in the U.S. from 2019 through 2021. We compared actual launch-year sales to pre-launch forecasts and then placed each drug into one of three categories: met expectations (achieved between 80% and 120% of analyst expectations), overperformed (surpassed 120% of analyst expectations) and underperformed (achieved less than 80% of analyst expectations). 

As with any drug launch, it is impossible to say with precision which factors contributed in what proportion to a launch’s success or failure. But our analysis here highlights some key factors.

Among the 36 U.S. novel pharma first launches between 2019 and 2021, we had sufficient data to analyze 30 of them. (Of the six excluded, two companies were acquired within six months of launch, two launched too recently to draw conclusions, and two were launched by private companies and therefore lacked sufficient publicly available data.)

Even with a generous 20% band around the average forecast defining our “met expectations” category, this was by far the least common outcome. Of the 30 pharma launches we analyzed, 13 underperformed (43%), 13 overperformed and only four met expectations (13%).

While the 2019 sample size is small, our analysis shows that the peak COVID-19 years of 2020 and 2021 reflect significantly higher levels of commercial underperformance. If we look only at these years, slightly more than half of pharma first launches (12 of 23) underperformed. While it would be irresponsible to draw decisive conclusions about COVID-19 leading to underperformance by only comparing to 2019 results, we can speculate that the combination of reduced pharma and biotech field team access to healthcare practitioners and an overall decrease in doctor’s visits dampened uptake of new drugs.

While performance issues cut across therapeutic areas, drugs targeting the central nervous system and gastrointestinal indications were the most likely to underperform—with three in four falling short of expectations. Oncology and immunomodulators performed better, with more than 60% beating estimates. Among the remaining, more than three-quarters either met or exceeded expectations.

To better understand why first launches succeeded or failed, we started by grouping drugs into three categories: pioneers (13), innovators in established markets (13) and “bandwagoners” (4). We also looked at launch tactics, market access, and orphan and priority review status.

Of 26 pioneers and established market innovators, more than 60% (16) either met or exceeded expectations. Bandwagoners, on the other hand, fared much worse, with three of four underperforming.

Of the first launches we analyzed, 70% (21 of 30) have either an orphan or priority review designation, which helps companies with a combination of financial incentives, application fee waivers and expedited approvals. These designations are often associated with products deemed to have the potential to address unmet patient needs.

First launches that underperformed did so for myriad reasons. Take Sage’s Zulresso, which, despite becoming the first drug approved for postpartum depression, underperformed analyst expectations thanks to a host of factors including price, unfavorable payer coverage, Risk Evaluation and Mitigation Strategies (REMS) designation and administration complexity (a one-time, 60-hour continuous IV infusion). 

We can group performance barriers into five categories:

• Entry into a competitive market with limited differentiation or profile superiority
• Long, inconvenient administration or treatment
• Restrictions on use of the product by payers, for example through step therapies or prior authorizations
• Lack of sufficient promotional investment and COVID-19 restrictions curtailing promotional activities
• High price for target audience relative to perceived benefit

For our synthesis of analysts’ takeaways on the 13 underperforming launches, download figure 4.

Meanwhile, drugs that met or exceeded analyst expectations did so thanks to a variety of factors. Evolus’s Jeuveau exceeded analyst forecasts by more than 200%, despite its late entry into the medical aesthetics market. Analysts attributed its success to its perceived superior clinical profile and lower price than incumbent Botox. 

Drugs that met or exceeded analyst expectations often benefit from a combination of factors, including:

• Significant unmet needs of a readily identified patient population addressed, compared with other options
• Superior treatment efficacy and administration convenience 
• Effective promotion via sales and marketing efforts
• Favorable payer coverage and patient support programs

For our synthesis of analysts’ takeaways on the four drugs that met expectations and the 13 that overperformed, download figures 5 and 6. 

Our look at the past three years of novel U.S. first launches suggests an equal likelihood of overperformance and underperformance. A successful pharma launch depends on many variables, which reflect choices made over the course of years, from early development through launch, including: the indication and patient pool that stands to benefit from treatment, the level of unmet need a drug addresses, the treatment’s differentiation and strength of profile and evidence, payer coverage, and launch strategy and execution. We have also found that success tracks back to the pharma company’s focus in its portfolio-level investment strategy. Of course, the extent to which the average pre-launch forecasts (our comparator here) were realistic and robust may also be a key factor in the gap between expected and actual launch performance.