With 27 new approved drugs, 2013 was a return to normalcy after 2012 broke records with 39 approvals – with such large changes year-to-year, what can we anticipate for 2014? This three-part blog series will examine therapeutic trends, changes to FDA approval pathway, and potential tactical plans by pharmaceutical companies, all essential inputs to predict the future of the pharmaceutical industry. Part 1 examined the FDA approval pathways. This post (part 2) will look at therapeutic trends. 

Trends by therapeutic area are set in motion years in advance, well before clinical trials take place and end-points are determined, but pharma has swift power to reallocate investments and redefine focus. In 2013 one therapeutic area stood out from the rest. The breakthrough designations, breakthrough approvals, and overall approvals have been dominated by oncology with 30% of total approvals and 61% of expedited approvals (Exhibit 1), while novel Mechanism of Actions brought new hopes to patients (e.g. Anti-body Drug Conjugate, Peg-interferon free regimen).


Across therapeutic areas, we see a surprising drop of first-in-class approvals, down to 33% in 2013 compared to 51% in 2012 and 40% in 2011, while Orphan drug designations holds steady at 33% in 2012 and 2013, and 37% in 2011 (Exhibit 2).

 Looking at this data one may wonder if the industry’s “innovation” engine is stalling. Another hypothesis is that a new wave of “second generation” targeted therapies and novel MOAs enhancing current Standards of Care is underway (e.g. Kadcyla’s ADC structure magnifies current Hereceptin’s MAb approach in HER2 positive Breast Cancer). The trend might well persist in the future as pharma and biotech companies will also be eager to leverage innovation as a defense mechanism against generic competition, particularly in the biosimilar field, while taking advantage of new expedited processes.