Big breakthroughs in non-small cell lung cancer have eluded pharma and small drug developers alike for years, which is why each wave of oncology drugs seems to give the condition a try. A new generation of targeted therapies and immuno-oncology projects is no different, making the disease the fastest-growing indication for projects in R&D, according to an analysis of EvaluatePharma data.
Congestive heart failure and hyperlipidaemia join NSCLC in rapid growth, led by new entries that promise to improve significantly on pills that have already gone generic. On the other hand, R&D assets are reckoned to have an impact in disorders – multiple sclerosis for example – where patent-protected products still hold sway (see table).
This analysis is drawn from the sales by indication module in EvaluatePharma, which develops separate consensus forecasts for indication sales where analysts have broken them out. Certain products have efficacy in only a single indication, such as antivirals; on the other hand, oncology drugs can work on multiple tumour types and therefore an analysis by indication gives a clearer picture of the potential.
Only true R&D assets are covered by this analysis, so in the PD-1/PD-L1 class only Roche’s MPDL3280A is represented in the non-small-cell lung cancer tally. The inclusion of Opdivo and Keytruda, approved in other indications but yet to get regulatory blessing for NSCLC, would drive the total higher.
|Biggest growing indications in the next five years|
|Rank||Indication||New sales in 2020 from drugs currently in R&D ($bn)||Total indication sales in 2020 ($bn)|
|1||Non-small cell lung cancer||10.4||24.3|
|2||Congestive heart failure||8.1||8.8|
|6||Diabetes, type II||3.5||57.4|
Some other indications might arguably belong in this analysis based on pipeline promise – hepatitis C and HIV treatments have a number of candidates still to work through. However, much of the value in these indications is based on combination with already approved molecules – sofosbuvir in hepatitis C, and tenofovir, elvitegravir and emtricitabine in HIV.
Caveats aside, the analysis by R&D indication sales is a glimpse into where the pharma sector has been focusing money. After NSCLC comes congestive heart failure, an indication that will clearly be dominated by one product: Novartis’s LCZ696. This pill has been filed in the US and Europe and should be launched later this year.
Ranking third is hyperlipidaemia, which would be a surprise with the genericisation of the statins if not for the expected entry of the biological agents evolocumab from Amgen and alirocumab from Regeneron and Sanofi. Those two projects also are forecast to be launched later this year. Bullish, if high-risk, forecasts on Merck & Co’s anacetrapib and Isis Pharmaceuticals’ antisense project also help to prop up this category.
If not for approval of Pfizer’s Ibrance (palbociclib) last week, breast cancer would have ranked third in this tally. But with $4.9bn in sales from R&D projects, this category will not be an insignificant one. The $2.6bn forecast for Puma Biotechnology’s PB272, itself a Pfizer cast-off, figures heavily here.
In cystic fibrosis, one project looms large: Vertex Pharmaceuticals’ combination of VX-809 + ivacaftor, the latter being the already marketed Kalydeco. This will account for $4.7bn of the $4.8bn in growth. Unlike with the hep C or HIV combinations, however, the combo is expected to outsell the already marketed component heavily.
It is rather a surprise to see Alzheimer’s disease in the table. Analysts’ continued bullishness on Lilly’s solanezumab, which already failed phase III trials, accounts for about $1bn of the $4.3bn in forecast 2020 sales. Diabetes can look forward to the entry of lifecycle extensions and insulin biosimilars, but true novel agents are not significant contributors to R&D growth.
Both of these disease areas remain attractive targets for pharma, nevertheless, as the population ages.