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Using Historical Analogues to Forecast New Product Launches
The Importance of Indication
Oct 29, 2021
A common approach to forecasting new drug launches is to use historical analogues as benchmarks. These analogues are typically selected based on properties that are identical or similar to those of the pipeline drug under investigation, and the analogue uptake is used as a proxy for the new drug forecast. A question commonly asked during this process, is whether analogues should be limited to the disease / therapy area into which the new product is to be launched. There are clearly advantages of looking at uptake within the same disease environment, but where other launch criteria are complex or unusual, opening up other disease areas can release a much richer pool of analogues.
In this blog, we used IQVIA’s Analogue Planner New Product (APNP) to investigate the impact of disease in more detail. We first used the APNP database to select all new product launches from 2011 to 2020 across eight developed markets (Canada, France, Germany, Italy, Japan, Spain, UK and USA). Note that the database considers new chemical entities and new combination products; but excludes generics and biosimilars. Using this cohort, we selected the 10 indications* that had seen the highest number of product launches:
Based on this group of diseases, we used APNP to look at volume uptake (in standard units**) of each of the 813 product launches and used this data to determine each product’s time to peak volume.***Any products that had yet to reach peak volume were excluded from the study. Times to peak were then averaged by disease (across the eight countries) to investigate the impact of indication on speed of new product uptake.
The average time to peak across the 10 diseases was 13.3 quarters (approximately 3.5 years). Hepatitis C clearly stands out as showing the fastest time to peak, driven by the exceptionally rapid uptake of a new generation of hepatitis C treatments, such as sofosbuvir and combinations, from 2014. Although less dramatic than hepatitis C, there is variation in uptake amongst the remaining 9 diseases. This is likely to be driven by a range of factors, such as innovation / advantages of new drugs, unmet needs, and the overall number of drug launches / crowding of market. The hypertension and diabetic areas, for example, have fewer unmet needs than the other diseases, especially at the beginning of the analysis period. Diabetes and HIV have also seen the greatest number of product launches.
Whilst product uptake does vary by disease, this does not mean that analogues should always be limited to the same disease area. It is important to recognise that a disease area evolves over time, so even when selecting analogues from the same indication, there is a risk that the launch environment may have significantly changed. For example, early launches into an indication with few existing products and high unmet need will perform differently to later launches arriving into a more satisfied market. In such a situation, it may make sense to broaden the search and focus on properties such as order of entry and unmet need.
However, any analogues selected from a broader disease base should be carefully reviewed to ensure there are not fundamental differences in indication compared to the investigational drug. The scope of diseases can also be narrowed indirectly by using other selection criteria that are specific to the launch environment, such as chronic vs acute therapies, market satisfaction, and market genericization – all available as selection criteria within APNP. This can help ensure that analogues selected across broader therapies are still good benchmarks for the pipeline drug under study.
IQVIA’s Analogue Planner New Product is a tool that supports new product forecasting by enabling rapid and systematic identification of analogues. It contains a database of over 9,500 historical product launches, with each one categorized against 26 key launch criteria. In September 2021, disease selection criteria were added to the database.
To learn more about Analogue Planner New Product, contact us here.
*Based on IQVIA Analytics Link disease assignments.
**Standard units are used as a measure of volume. They are defined as the smallest dose of a product, equivalent to one tablet or capsule for an oral solid, one teaspoon, i.e. 5 mL, for a liquid or syrup, and one ampoule or vial for an injectable product.
***Time to peak is defined as time from IQVIA MIDAS launch date to the period immediately prior to two periods of zero or negative growth, where at least 80% of maximum volume has been attained.