Worldwide pharmaceutical sales are projected to exceed USD$1 trillion in 2020, according to an analysis by EvaluatePharma, a market intelligence company. Global sales in 2013 were $717 billion. Growth over the next seven years is projected to be about 5% per year despite a loss (-1.6%) in 2012 and minimal growth (+0.3%) in 2013. Higher growth is largely attributed to the development of biological agents, which are priced higher than pharmaceuticals and are less likely to be genericized.
In 2013, the top 5 companies by global sales were Novartis ($46.0 billion), Pfizer ($45.0 billion), Roche ($39.1 billion), Sanofi ($37.7 billion), and Merck ($37.6 billion). These companies also spent the most on R&D in 2013: Novartis ($9.4 billion), Roche ($8.3 billion), Merck ($7.1 billion), Pfizer ($6.6 billion), and Sanofi ($6.1 billion).
Sales growth over the next few years is expected to be fuelled largely by oncology products, which currently represent the largest segment of pharmaceutical sales (9.6%). However, in its list of most valuable R&D projects, three multiple sclerosis drugs make the Top 20 list: pegylated interferon-beta-1a (Plegridy, Biogen); ocrelizumab (Roche); and secukinumab (Novartis). Pegylated IFNb-1a is administered biweekly and received a favourable review by the European Medicines Agency in May 2014. It received FDA approval in August. Ocrelizumab, an anti-CD20 monoclonal antibody, is being studied in MS, systemic lupus erythematosus and rheumatoid arthritis. Secukinumab is an anti-IL17 MAb that is being studied in MS, psoriasis and rheumatoid arthritis.
The top-selling products in neurology and psychiatry in 2013 were Abilify (aripiprazole; $5.8 billion; ranked #11); Cymbalta (duloxetine; $5.2 billion; #12); Lyrica (pregabalin; $4.6 billion; #15); Copaxone (glatiramer acetate; $4.3 billion; #18); Avonex (IFNb-1a; $3.0 billion; #29); Plavix (clopidogrel; $2.6 billion; #34); Rebif (IFNb-1a; $2.5 billion; #37); and Botox (onabotulinumtoxinA; $2.2 billion; #42).
The three MS therapies making the Top 50 (Copaxone, Avonex, Rebif) contributed to the $16.2 billion in sales for the MS therapeutics market in 2013. This is expected to rise to $21.8 billion in 2020.
EvaluatePharma’s projected Top 50 list of therapies in 2020 includes five agents for use in neurology and psychiatry. The ones that made the list were Tecfidera (dimethyl fumarate), with projected annual sales of $6.3 billion; Gilenya (fingolimod; $2.8 billion); Tysabri (natalizumab; $2.5 billion); Vyvanse (dexamphetamine; $2.7 billion); and Botox (onabotulinumtoxinA; $2.2 billion).
Comment:
Dr. Daniel Selchen: If anyone doubted that multiple sclerosis is among other things a multibillion dollar industry – doubt no more!
It is interesting to note that all three MS drugs in the top 20 most valuable R&D projects are injectable. One is a beta interferon that appears (there are no head-to-head data) to have efficacy similar to the established agents but has much less frequent injections. Ocrelizumab was very efficacious in phase II trials and has large phase III trials in both RRMS and PPMS. Secukinumab has only limited early phase II data in MS but a more advanced program in psoriasis and rheumatoid arthritis.