The most significant development in the global pharmaceutical market in 2012 is the displacement of Lipitor of Pfizer from its number one pharmaceutical product by Humira of Abbott. Lipitor, the cholesterol drug of Pfizer has been the top blockbuster for several years with its sales touching a peak of $13 billion just three years ago. Expiry of its patent in 2011 brought Lipitor to 17th position in blockbuster ranking with worldwide sales plummeting to $3.9 billion in 2012. Humira, the top drug now reported a sales of $9.2 billion.
The year 2012 has been marked by several ups and downs in ranking of blockbuster (sales above US$ one billion) products on account of loss of patent exclusivity in international markets. The sales of leading products like Lipitor, Plavix, Seroquel IR & XR, Singulair, Zyprexa, Nexium, Xalatan/ Xalacom, Taxotere, Geodon/ Zeldox, CellCept, Nexaver, etc., declined significantly due to stiff competition from generic version for blockbusters after loss of patent exclusivity.
The revenue of Pharmabiz sample of leading 100 pharma products from 15 major international pharma players in the world market declined by 2.6 per cent to $232 billion during the year 2012 from $238 billion in the previous year. There were 92 blockbuster products during 2012 as against 85 in the previous year. The worldwide sales of 35 major products declined during 2012 and 25 products managed to registered single digit growth. However, nine products registered growth of over 25 per cent. Two products lost blockbuster status in the year 2012. The pharmaceutical sales, including vaccines, of these 15 companies declined to $433 billion from $439 billion in the previous year.
The Pharmabiz sample of 15 leading pharmaceutical companies with year ending in December 2012 and 2011 viz., Novartis, Pfizer, Sanofi, Merck & Co, Roche, GlaxoSmithKline (GSK), AstraZeneca, Johnson & Johnson (J&J), Abbott Laboratories, Eli Lilly Co, Teva Pharma, Bristol-Myers Squibb Co (Bristol), Amgen, Bayer and Baxter International incurred research and development expenditure of $86 billion during 2012 as compared to $84 billion in the previous year, registering a growth of 3.5 per cent. However, the huge R&D expenditure failed to launch fair number of new blockbusters in 2012.
The competition and loss of exclusivity put pressure on revenues of several products during 2012 and these product lost blockbuster status. Roche's CellCept sales declined to $995 million in 2012 from $1,054 million and Bayer's Nexaver sales moved down to $958 million from $1,026 million. Few important products which lost blockbuster status during 2012 includes Pfizer's Xalatan/Xalacom as its sales went down to $806 million from $1,250 million, Sanofi's Taxotere for treatment of cancer declined to $744 million from $1,194 million and Pfizer's Geodon/ Zeldox sales dip sharply to $353 million from $1,027 million in the previous year.
The study has not included Boehringer Ingelheim as it has not announced its working results for the year 2012. During 2011, Boehringer's two products i.e. Spiriva and Micardis achieved revenues of $4,083 million and $2,063 million respectively. Further, the study has taken constant exchange rates while converting Euros, Pounds and Swiss Franc into US Dollar as at the end of 2012 and 2011.
Among the 15 companies, the sales of major products of AstraZeneca, Bristol-Myers, Eli Lilly, Merck and Co, Pfizer declined during the 2012 and that of Amgen, Bayer, GSK, Novartis and Sanofi improved marginally. However, Abbott, J&J, Roche and Teva registered double digit growth in sales of blockbusters. GSK and Merck has 11 products each in the Pharmabiz study, followed by Pfizer 10 products, Novartis nine products, Eli Lilly, J&J and Roche have eight products each and AstraZeneca, Bristol-Myers, Sanofi reported seven products each. Other 14 products were reported by Abbott, Amgen, Bayer and Teva Pharma. Baxter International does not have any major product in the Pharmabiz list.
The sales of Pfizer's leading product Lipitor declined sharply by 58.8 per cent to $3,948 million in 2012 with ranking at 17th spot from $9,577 million in the previous year. Lipitor sales declined continuously during the last five years from $12,401 million in 2008 to present level of $3,948 million. Similarly, Bristol- Myers Squibb Co's Plavix lost its fourth rank in 2011 and went down to 29 rank in 2012 as Plavix's sales declined sharply by 64.1 per cent to $2,547 million from $7,087 million. The sales of AstraZeneca's Seroquel IR & XR went down by 51.9 per cent to $2,803 million in 2012 from $5,828 million in 2011. Seroquel IR & XR was ranked at 7 spot in 2011 as against 24 in the 2012.
GlaxoSmithKline's (GSK) Seretide/Advair moved up to second spot among the 100 leading product during 2012 as its sales increased to $8,146 million from $7,821 million, a growth of 4.2 per cent. Roche's MabThera/ Rituxan climbed up to third spot from sixth in the previous year and its sales increased to $7,338 million from $6,390 million in the previous year. Sanofi's blockbuster Lantus jumped to fourth place from 14th in the previous year. Its sales increased by 29.3 per cent to $6,555 million from $5,071 million. Roche's two products viz., Herceptin and Avastin moved up to fifth and sixth place from 10th and 9th spot respectively.
Novartis' Gilenya registered strong growth in sales of 142 per cent during 2012 and its sales moved up to $1,195 million from $494 million in 2011. The sales of nine major products viz., AndroGel (Abbott), Orencia (Bristol), Forteo (Eli Lilly) Epzicom/Kivexa (GSK) Synagis (AstraZeneca), Stelara (J&J), Sprycel (Bristol) and Ventolin (GSK) improved significantly during 2012 and entered in to Blockbuster list of Pharmabiz. Similarly, J&J's Zytiga brand posted sharp growth in sales of 219 per cent to $961 million from $301 million in the last year.
The oncology segment with 14 products remained top sales contributor in the Pharmabiz sample during 2012 followed by respiratory, diabetes, cardiovascular, vaccine, HIV and hypertension. The sales from 14 oncology products increased by 10 per cent to $38,535 million from $35,040 million in the previous year. oncology products like Herceptin and Avastin of Roche registered sales of $6,444 million and $6,307 million during 2012. Novartis Gleevec/Glivec notched up sales of $4,575 million. Novartis Tasigna oncology product registered sales of $998 million as against $716 million in the previous year. J&J's Zytiga moved up to $961 million from $301 million. However, Bayer's Nexaver sales declined to $958 million from $1,026 million.
The sales of seven products from respiratory segment declined to $20,814 million from 22,587 million in the previous year. The diabetes sales from five major products went up to $15,935 million from $13,375 million. The cardiovascular segment registered sales of $13,833 million from six products during 2012 and vaccine sales from 8 products increased to $13,455 million. This was followed by sales of HIV and hypertension segment at $9,028 million from seven products and $8,639 million from four products respectively.
Thus, the loss patent exclusivity and slow outcome of R&D to find new drugs will put pressure on highly research investment based companies in the coming years. The competition from generics will put additional burden in the coming years. Further, economic slowdown in the European region will cut down healthcare cost under austerity measures and generic products are likely to move on with greater strength.
Sales of 100 major products