Humira to assume Lipitor¹s crown as Pfizer feels the heat from Sanofi and Novartis

Lipitor's patent expiry this year precipitates the steepest decline in the industry's patent cliff, with $139bn predicted to be lost from sales of branded drugs between 2011 and 2016, equal to 20% of the global pharmaceutical market last year. Meanwhile the race for the pharmaceutical sales top spot is going to be close, with Sanofi and Novartis breathing down Pfizer's neck - all three companies are expected to have prescription drug sales in the region of $50bn by 2016, the EvaluatePharma report shows.

Clinging on

Despite predictions that sales of its prescription drugs are set to decline from $54.1bn last year to $51.2bn by 2016, Pfizer is expected to just cling on to the industry's top spot - but Sanofi and Novartis are catching up fast.

Sanofi's $20bn acquisition of Genzyme, predicted growth in emerging markets and its vaccines business have significantly boosted the outlook for the French group's pharmaceutical revenues - forecast sales in 2016 of $50.2bn are $11.2bn higher than in the same analysis conducted in April 2010.

Prospects for Novartis' pharmaceutical business have been boosted by key regulatory approvals for oral MS pill Gilenya and Tasigna, a follow-on product to leukaemia blockbuster Glivec.

WW Prescription (Rx) Sales WW Annual Sales ($bn) 2016 vs. Apr-2010 WW Market Share Change in Market Rank (10-16)
Rank Company 2010 2016 Growth (10-16) 2010 2016
1 Pfizer 54.1 51.2 -1% +4.0 8.0% 6.0% -
2 Sanofi 36.6 50.2 +5% +11.2 5.4% 5.9% +2
3 Novartis 41.4 49.7 +3% +2.6 6.1% 5.8% -1
4 GlaxoSmithKline 35.6 45.0 +4% +6.3 5.3% 5.3% +2
5 Roche 35.6 43.6 +3% -0.3 5.3% 5.1% -
6 Merck & Co 40.4 42.3 +1% -4.0 6.0% 5.0% -3
7 AstraZeneca 32.1 27.0 -3% +4.9 4.7% 3.2% -
8 Abbott Laboratories 19.9 24.4 +3% -1.7 2.9% 2.9% +2
9 Teva Pharmaceutical 14.5 23.9 +9% +3.1 2.1% 2.8% +4
10 Johnson & Johnson 20.7 21.9 +1% -2.9 3.1% 2.6% -1

Once again the fastest growing company in the top ten in terms of prescription revenues is expected to be Israeli company Teva. The generics firm is rapidly becoming a big pharma player through an aggressive M&A strategy which increasingly spans the industry spectrum from generics to innovative technologies. The EvaluatePharma report shows that Teva increased its share of the global generics market to 18% in 2010 and the company is well placed to benefit the most from the blockbuster patent cliff.

In contrast, the outlook for Merck & Co has been tempered somewhat, hit hardest by the phase III failure of novel anti-coagulant, vorapaxar. A year ago Merck was seen as Pfizer's closest rival for the top spot in 2016, but the company now sits outside the top five.

Humira reigns supreme

Estimated global sales of Lipitor of $10.6bn means 2011 will be the last year the cholesterol-lowering agent tops the rankings, with Humira expected to be the biggest selling medicine in 2012 with sales of $8.7bn. Humira is forecast to grow 5% annually to reach $9.7bn by 2016, almost $2bn higher than its nearest challenger, Roche's Avastin. The cancer antibody was once regarded as Lipitor's heir apparent before a number of clinical and regulatory setbacks in the last 18 months.

Biotech products targeting cancer and rheumatic disorders are seen accounting for six of the top ten products in 2016. Of the three small molecule drugs, AstraZeneca's cholesterol drug Crestor has been boosted by a successful legal defence of its patent until 2016. A receding generic threat in the US is benefitting Glaxo's respiratory medicine Advair, while Merck & Co's Januvia franchise goes from strength to strength and is expected to dominate the non-insulin market for diabetes agents.

Top Ten Selling Products in 2016 WW Product Sales ($bn) 2016 Change vs Apr-10
Rank Product Company(s) Target Technology 2010 2016 % Growth
1 Humira Abbott + Eisai Arthritis Biotech (monoclonal antibody) 6.7 9.7 +5% -405 -4%
2 Avastin Roche Cancer Biotech (monoclonal antibody) 6.2 7.8 +3% -1078 -12%
3 Rituxan Roche + Biogen Idec Cancer Biotech (monoclonal antibody) 6.1 7.7 +3% +897 +13%
4 Crestor AstraZeneca + Shionogi + Chiesi Cholesterol Conventional (small molecule) 6.1 7.5 +3% +1242 +20%
5 Enbrel Amgen + Pfizer + Takeda Arthritis Biotech (recombinant product) 7.3 7.2 -0% -119 -2%
6 Seretide / Advair GSK + Almirall + Faes Asthma / COPD Conventional (small molecule) 8.1 7.0 -2% +1768 +34%
7 Januvia / Janumet Merck + Ono + Almirall Diabetes Conventional (small molecule) 3.5 6.8 +10% +791 +13%
8 Herceptin Roche Cancer Biotech (monoclonal antibody) 5.2 6.5 +3% +300 +5%
9 Remicade J&J + Merck + Mitsubishi Tanabe Arthritis Biotech (monoclonal antibody) 6.5 6.1 -1% +380 +7%
10 Prevnar 13 Pfizer Pneumococcal disease Biotech (bioengineered vaccine) 2.4 5.8 +13% +4081 +237%

Commenting on the launch of the report, Jonathan de Pass, founder and chief executive of EvaluatePharma, said: "Our revised outlook for 2016 shows how competitive the landscape will be for the big pharma players - key pipeline successes or failures, or the outcome of courtroom patent battles, could dramatically change the current picture".

"Our World Preview report provides valuable insight into life beyond the patent cliff and who the likely winners and losers will be".

EvaluatePharma launched the report today at BIO 2011 in Washington DC, United States.