Patent expiration of several blockbusters and limited success in launching new molecules during the last few years are the two critical factors that  impacted the revenues of the top international pharmaceutical companies during the period 2007-2013. The patent expiration leading to escalated competition from generics and reduction in healthcare spending by several governments thus created a challenging situation for major players.

With limited success from R&D and longer gestation period to develop new drugs, the product pipelines dried up significantly. Additionally, stringent approval norms adopted by regulatory bodies put pressure on investments and development of new products. Next few years are going to be still worse for these companies as some more patents are set to expire. These products will face stiff competition from generics. As against this situation, the successful launch of new blockbusters seems difficult.

As per the Pharmabiz study of 150 major products of 15 leading players between 2007 and 2013 revealed that 96 products improved sales during this period and 54 products lost growth in sales. Further, 26 products lost blockbuster status during 2007-2013. There were 35 products with negligible or zero sales in 2007 and these products entered the list during 2007-2013. The Pharmabiz study has taken the period of 7 years as the Pfizer's Lipitor, which was the largest selling drug for treating LDL cholesterol, registered a decline for the first time during 2007 to $12,675 million from its highest sales of $12,886 million in 2006. Lipitor's sales for the year ended December 2013 declined sharply to $2,315 million due to loss of patent exclusivity and competition.

The major products like Avandia and Valtrex (GlaxoSmithKline), Eloxatin, Taxotere and Stilnox/Ambien/Myslee (Sanofi), Lipitor and Geodon/Zeldox (Pfizer), Fosamax and Cozaar/Hyzaar (Merck & Co), Avapro/Avalide and Plavix (Bristol-Myers), Arimidex (AstraZeneca), TriCor/Trilipix(AbbVie - separated entity from Abbott Laboratories), Zyprexa (Eli Lilly & Co) and NeoRecormon/Epogin (Roche) lost over 70 per cent of there sales between 2007 and 2013. Few products viz. Gemzar (Eli Lilly), Merrem (AstraZeneca) and Relenza (GSK) lost completely.

Despite challenging situation, the international pharmaceutical majors successfully launched several new products like Prevnar family (Pfizer), Zetia, Vytorin and Nasonex (Merck), Prezista, Velcade and Invega Sustenna/Xeplion (Johnson & Johnson), Exforge, Gilenya, Tasigna, Afinitor/Votubia and Galvus (Novartis), Actemra/RoActemra, Zytiga and Stelara (Roche), Ventolin (GSK), AndroGel (AbbVie), NovoRapid/NovoLog, Victoza, Levemir and NovoMix (Novo Nordisk), Xgeva/Prolia, Xgeva and Sensipar/Mimpara (Amgen), Xarelto (Bayer), Renagel & Renvela (Sanofi) during 2007-2013 and these products crossed sales of US$1 billion.

The sales of several products notched up strong growth of over 200 per cent during 2013 as compared to 2007. Activase/TNKase of Roche and Sprycel of Bristol-Myers sales went up sharply by over 700 per cent. Bristol-Myers' Orencia product for treatment in rheumatoid arthritis also registered strong growth of over 525 per cent during 2007-2013 and its sales reached at $1,444 million as at the end of December 2013 from $231 million in 2007. The sales of Lucentis for neuroscience/ophthalmics of Novartis and Roche's also clocked stronger growth of 524 per cent to $4,280 million during 2013 from $817 million in 2007. The sales of Januvia (Merck), Baraclude (Bristol-Myers), Copaxone (Teva Pharma), Isentress (Merck), Humira (AbbVie),  Alimta (Eli Lilly) notched up growth of over 200 per cent during 2007-2013. Humira for Rheumatoid arthritis of AbbVie remained on top with sales of $10,659 million during 2013.

Other major products such as Nexavar (Bayer), Avastin and Tarceva (Roche), Lantus (Sanofi), Lucentis (Sanofi & Novartis) Lyrica and Sutent (Pfizer), Avodart (GSK), Cymbalta (Eli Lilly), Symbicort and Crestor (AstraZeneca), and Remicade (Johnson & Johnson and Merck) registered strong growth of over 100 per cent between 2007 and 2013.

During the  2007-2013 period, the total R&D expenditure incurred by the 15 companies touched to $559 billion with Roche spending over $66 billion (including R&D spending on other than pharmaceutical segment also), followed by Novartis $58, Pfizer $57 billion, Johnson & Johnson $53 billion, Merck $51 billion, Sonofi $45 billion and GlaxoSmithKline $44 billion. The R&D expenditure growth of these 15 companies declined continuously from the year 2007 to 2012, except for the year 2010 on account of merger of Schering-Plough with Merck & Co. The R&D expenditure improved marginally by 0.1 per cent during 2013 to $84,664 billion from $83,860 million.

Despite overall reduction in R&D expenditure, these companies launched several new products during this period for various therapies and currently holding several products in pipeline. The long-term growth of these R&D based products is supported by emerging markets like Brazil, China, India, Russia, South Korea and Turkey.




Ups & Down in ranking of Blockbuster 2007-2013