Pharmaceutical market-2010
Forecast: drugs and groups – leaders of 2010
"Weekly Pharmacy" based on the materials of Pharmaceutical executive and FDAIn 2010, pharmaceutical companies will shift the point of application of their main forces from the markets of the EU member states, the USA and Japan to the markets of developing countries.
This is the assumption of analysts of the agency "Thomson Reuters". Its editor-in-chief, Alexandra Kibble, in an article published by Pharmaceutical executive, also predicts a slowdown in the growth of the global pharmaceutical market, which in 2009 for the first time reached $800 billion. Among the new factors that will influence the situation, the large-scale healthcare reform in the United States and the deployment of the influenza A (H1N1) pandemic are named. The legacy of the past years remains the economic crisis, the small innovative activity of pharmaceutical manufacturers, the massive loss of patent protection by drugs and measures to save health care costs.
In 2010, Aricept/Aricept (donepezil, Pfizer), Flomax/Omnik (tamsulosin hydrochloride, Astellas, Boehringer Ingelheim), Taxotere will lose patent protection/Taxotere (docetaxel, Aventis Pharma), Effexor XR/Effexor XR (venlafaxine, Wyeth Pharmaceuticals), Cozaar/Kozaar (losartan, Merck Sharp&Dohme) and Arimidex/Arimidex (anastrozole, AstraZeneca Pharmaceuticals). In general, the generic threat in 2010 will become relevant for the first time for drugs with a total sales of $ 15.7 billion.
Lipitor will remain unavailable for generic competition in the coming year/Liprimar (atorvastatin, Pfizer) and Plavix/Plavix (clopidogrel, "Bristol-Myers Squibb"/"Sanofi-aventis"). The leaders will retain their positions, and the leading classes of medicines in terms of sales will continue to be used in the pathology of the cardiovascular system, antineoplastic and antimicrobial.
Thanks to the appearance of new drugs on the market, sales growth will be demonstrated by such classes as drugs used for pathology of the central nervous system and sugar-lowering drugs.
Agents acting on the cardiovascular systemThe appearance of interesting new drugs is expected in the group of hypolipidemic agents.
So, for the first quarter of 2010, a launch of the drug Certriad (calcium rosuvastatin, fenofibrate) is scheduled, which, according to the results of phase III clinical trials, proved to be more effective than monotherapy with its components. Among other products of this group that are in the late stages of development, A. Kibble advises in 2010 to pay attention to darapladib (GlaxoSmithKline), an inhibitor of lipoprotein-associated phospholipase (Lp-PLA2), as well as mipomersen (Isis, Genzyme), an inhibitor of apolipoprotein B100. The final stages of clinical trials are also anacetrapib (Merck & Co.) and dalcetrapib (Roche).
Of the antihypertensive agents, angiotensin receptor blockers will remain the most prescribed in 2010, but the sales volume of the latter will decrease sharply after the loss of patent protection by the drug Cozaar in April this year. The appearance of innovative drugs in the class of antihypertensive agents is not expected.
Sales volumes of the first-in-class (direct renin inhibitors) drug Tekturna (aliskiren, Novartis) will not grow significantly this year, the analyst believes, since the results of the ASPIRE HIGHER research program have not yet appeared.
Xarelto (rivaroxaban, Bayer, Johnson & Johnson) can make a breakthrough from anticoagulants in 2010, but subject to obtaining marketing permission in the USA for use in the postoperative period after knee replacement (the European Commission gave permission back in 2008). Having received approval in the USA, rivaroxaban will be the first a new oral anticoagulant for 40 years. However, this drug "in the project" has another indication for use – to prevent thromboembolic complications in patients with atrial fibrillation. In this regard, analysts from Thomson Pharma Partnering Forecast assume that the peak growth in sales of the drug replacing warfarin will occur in 2011-2012.
The competition of Plavix in 2010 will be Effient/Effient (prazugrel, "Eli Lilly"), which, according to the results of clinical studies, is more effective in preventing death, myocardial infarction and stroke, but also causes bleeding more often. 2011 promises to be even more significant for Effient, since by this time new information should appear regarding the adverse reactions of the drug, and the patent protection of Plavix will end.
2010 should also be marked by the filing of applications for marketing permits in the USA for the anticoagulants SCH-530348 (Schering Plough) and Brilinta (ticagrelor, AstraZeneca), the first reversible oral antagonists of adenosine diphosphate.
Antineoplastic agents
Among antineoplastic agents, monoclonal antibodies are the fastest growing group in all respects. According to A. Kibble, in the world top-15 medicines in 2010 there will be 6 drugs of this group, the total sales volume of which may exceed $ 20 billion Rituxan/Mabthera (rituximab, "Roche") will remain the best-selling antineoplastic agent in the world with sales of about $ 7 billion. Avastin will not be far behind him/Avastin (bevacizumab, "Roche"), which will bring the company about $ 6.9 billion. Due to safety reasons, sales of erythropoietins will decrease, while sales of Neupogen/Neulasta/Neupogen (filgrastim) will remain high (about $ 5 billion).
Drugs acting on the central nervous systemSince Effexor XR will lose patent protection in 2010, the volume of sales of drugs of the serotonin reuptake receptor antagonist group will decrease.
On the contrary, sales of drugs acting simultaneously on the capture of serotonin and norepinephrine will grow (mainly due to Cymbalta/Simbalta (duloxetine, "Eli Lilly")). The melatonin receptor agonist, agomelatin (Novartis), which has already been introduced to the European market, is expected to have a good sales dynamics. According to A. Kibble, the potential of such innovative drugs under development as neurokinin receptor antagonists, beta3-adrenergic receptor agonists and corticotropin-releasing factor antagonists remains unclear.
Hypoglycemic agentsA. Kibble does not expect the arrival in 2010 of serious competitors to the existing leaders: among the basal – Lantus (insulin glargine, "Sanofi-aventis"), and among the short–acting - Humalog (insulin lispro, "Eli Lilly") and Novolog (insulin aspart, "Novo Nordisk").
Dipeptidyl peptidase-IV inhibitors have a chance to become blockbusters, but the sales forecast is very restrained, since the drug Januvia/Januvia (sitagliptin, Merck & Co.) almost immediately after the successful launch, another newcomer from this group, Onglyza, began to step on the heels/Onglyza (saxagliptin). Sales may also be affected by ambiguities regarding the safety profile of drugs (the likelihood of developing pancreatitis when taking Januvia requires further research). Also, due to safety, the marketing authorization for the Galvus drug in the USA has been postponed indefinitely, although it is present on the EU market.
In the group of glucagon-like peptide analogues, the sales volume of the Byetta drug has increased/Baeta (exenatide, "Eli Lilly"/"Amylin") slowed down with the Januvia patch, although Byetta LAR, a delayed-release form, promises to shake up the US market in 2010. After the termination of marketing support for the only commercialized insulin for inhalation administration, the prospects of such drugs remain questionable, nevertheless, MannKind has received approval of its system for the inhalation administration of insulin in powder form.
Antimicrobial agentsThe leading company in this segment, GlaxoSmithKline, will be slightly pushed by Merck & Co. in 2010 thanks to its Gardasil/Zostavax vaccine.
Due to the increased presence of generics, sales of quinolones and macrolides will decrease. The emergence of new products that are currently in the late stages of development (telavancin, dalbavancin and iclaprim) will lead to an increase in sales of drugs active against methicillin-resistant strains of Staphylococcus aureus.
Groups of drugs used in the treatment of influenza, HIV infection and viral hepatitis are also promising. It is predicted that the sales volume of Isentress /Isentress (raltegravir) in 2010 will reach $ 1 billion. Growth is also expected in the group of influenza vaccines, which should be felt by their manufacturers – GlaxoSmithKline, Sanofi-aventis, Novartis, AstraZeneca and CSL. The enviable situation is also with Tamiflu/Tamiflu (oseltamivir, "Roche") and Relenza (zanamivir, "GlaxoSmithKline"), whose sales volume will double compared to 2010.
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