FirstWord Lists: Pharma's biggest pipeline drugs

Based on current consensus forecasts, pharma's 20 largest pipeline drugs will generate global sales of approximately $40 billion by 2020.

This figure is almost certain to undergo some revision as the end of the decade nears, but confidence in the commercial opportunity for many of these key pipeline assets continues to gain momentum.

Oncology drugs dominate the list, with immunotherapies in particular expected to make a notable commercial impact by 2020. The four PD-1/PD-L1 inhibitors currently in mid/late-stage development are all expected to generate blockbuster sales by the end of the decade, with Bristol-Myers Squibb's nivolumab and Merck & Co.'s pembrolizumab anticipated to be the two largest pipeline opportunities overall.

A number of yet un-launched cancer therapies outside of the immuno-oncology space are also expected to become rapidly established by 2020, including Pfizer's breast cancer treatment palbociclib (currently undergoing a rolling submission with the FDA based on positive Phase II data) and AbbVie/Roche's ABT-199, which is expected to emerge as another addition to the leukaemia treatment paradigm (following a succession of new approvals over the past 12 months).

The next five years is also expected to witness a race for market leadership between AstraZeneca and Clovis Oncology in EGFR-positive non-small-cell lung cancer (NSCLC), where both companies' new product offerings (AZD-9291 and CO-1686) are expected to become blockbusters. See Physician Views Poll Results: Oncologists eager for new targeted NSCLC therapies – incumbents will lose out if first-line data impresses.

The past few weeks have also seen analysts substantially increase their forecasts for Puma Biotechnology's neratinib – based on positive Phase III data in extended adjuvant HER2-positive breast cancer (see Physician Views Poll Results – Oncologists bullish on opportunity for Puma Biotechnology's neratinib in HER2-positive breast cancer extended-adjuvant setting). If confidence in these numbers is maintained as further data is published, Puma looks certain to gain interest as a potential takeout candidate.

The list above excludes Gilead Sciences' Sovaldi + ledipasvir combination in hepatitis C – due to launch in late 2014 – given the existing presence of Sovaldi in the marketplace. However, confidence remains high that despite Sovaldi's spectacular launch performance, the size of the hepatitis C market will support billion-dollar plus launches from both AbbVie and Merck (in the latter's instance boosted by its recent acquisition of Idenix Pharmaceuticals – see ViewPoints: Boehringer Ingelheim exits hep C market as Idenix reveals how much Merck & Co. initially bid.

The PCSK-9 inhibitors evolocumab (Amgen) and alirocumab (Regeneron Pharmaceuticals/Sanofi) both feature among pharma's biggest pipeline opportunities, although it remains to be seen if recent tactical manoeuvring in the regulatory space closes the current gap in consensus sales (see ViewPoints: But what is an FDA priority review voucher actually worth? BioMarin finally puts a price tag on it.

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