2010 Products and Therapy Areas to Watch

Pharmaceutical product sales are expected to exceed $800 billion for the first time in 2009⁽¹⁾, despite a general decline in the industry's annual growth rate. Notwithstanding improving sales, change was the only certainty as the reality of an economic downturn took hold.

Forecasts are now turning to the year ahead. Even if we experience thawing in worldwide economies, there will likely be several factors further limiting drug sales growth in 2010, including patent loss, payers seeking to limit price increases, and increased use of generics. A number of events could also have a longer-term effect on the pharmaceutical market, including the passage of comprehensive healthcare reform in the US, and the magnitude of the H1N1 pandemic. FDA approval activity also remains low.

Nevertheless, the pharma sector is expected to grow through 2010, albeit at reduced levels, given the rising rates of chronic diseases alongside aging populations, and a boost in per-capita medical spending. Companies are also beginning to shift their focus away from North American, European and Japanese markets - where growth is softening - to emerging markets.

Key therapy areas
The Thomson Reuters pharmaceutical forecasting tool Thomson Pharma PartneringForecast indicates that several blockbusters could face a fight to hold on to their top spots in 2010 as new drugs enter the market. However, the key therapeutic areas of cardiovascular, oncology, and anti-infectives should hold their positions. Indeed, the statin Lipitor and the platelet inhibitor Plavix will likely remain the top two largest-selling drugs in 2010.

The situation will likely change in the next couple of years as many of the current top drugs begin to go off patent, and although many of the new drugs expected to hit the market in 2010 will inevitably be priced at a premium, the introduction of key generics will offset these gains. Over $15.7 billion of prescription drugs will be subject to generic competition in 2010 as a number of significant products come off patent. These include patent expiries for Aricept, Flomax, Taxotere, Effexor XR, Cozaar and Arimidex.

As well as the established key therapy areas, pipeline therapeutics to watch in 2010 include candidates for central nervous system disorders and diabetes, both of which will see increasing sales.

Cardiovascular
In cholesterol management, Lipitor will almost certainly remain the top statin in 2010, but the availability of generic simvastatin has resulted in increased therapeutic substitution and declining franchise share. Interest remains in drugs that raise HDL cholesterol. Certriad, expected to be launched in the first quarter, offers greater benefit across multiple lipid parameters than monotherapy comparators, according to phase III data.

Potential new products to watch for in 2010 include GlaxoSmithKline's darapladib, a lipoprotein-associated phospholipase (Lp-PLA2) inhibitor, and Isis and Genzyme's mipomersen, an apolipoprotein B100 antisense inhibitor designed to reduce lipids in high-risk patients. Two new CETP inhibitors, Merck's anacetrapib and Roche's dalcetrapib, are also in late-stage trials.

In hypertension, angiotensin receptor blockers are expected to remain the most prescribed drugs in 2010, although one major player, Merck's Cozaar, goes off patent in April. This expiry has the potential to alter the structure of the hypertension market dramatically, and will clip sales for the whole category towards the end of the year. Other drug classes in hypertension, such as ACE inhibitors and calcium inhibitors, will continue to decline in 2010, with no new category entrants.

Novartis's Tekturna, a first-in-class direct renin inhibitor, provides prescribers with the next advance in the treatment of hypertension, although sales will not gain pace markedly in 2010. Physicians may be awaiting outcomes data from the company's ASPIRE HIGHER program.

In the antiplatelets arena, there is greater activity following efforts to develop more effective products. Bayer and Johnson & Johnson's rivaroxaban will go before the FDA once again in early 2010, seeking approval for the treatment of venous thromboembolism post-surgery. This follows an approvable letter in May 2009. If approved, the drug will be the first new oral anticoagulant to reach the market in 40 years. However, ThomsonPharmaPartneringForecast suggests that the drug's greatest growth will be seen in 2011 and 2012, once it gains approval for the prevention of stroke in atrial fibrillation, which presents a larger opportunity as a replacement for warfarin.

Another important antiplatelet drug is Effient, which was launched in the US in August 2009 with a competitive label, and which could rival Plavix as it gains market in 2010. Clinical data demonstrated that Effient may be more effective than Plavix in preventing death, myocardial infarction and stroke, but it may also cause more serious bleeding. The Plavix patent expiry in 2011 will present a further opportunity for Effient, should additional bleeding data become available in 2010.

Schering Plough's SCH-530348, an oral antiplatelet drug, is expected to be filed in 2010. If approved, it will be the first in a new class of thrombin receptor antagonists. Another new antiplatelet agent, AstraZeneca's Brilinta, is the first reversible oral ADP receptor antagonist, and is also expected to go before the FDA in 2010.

Oncology
Despite varied therapeutic development, it is still cancer which grabs the lion's share of the industry's attention. Our forecast confirms that the two major anticancer categories are expected to post further significant increases in 2010. In particular, monoclonal antibodies are gaining market share, with six antibodies now appearing in the top 15 drugs of 2010 by sales.

Targeted therapies are changing the cancer market and are expected to be used in most cancer patients within five years. Indeed, cancer monoclonal antibody sales could reach over $20 billion in 2010.

Rituxan, used widely in haematological malignancies, is likely to remain the world's best selling cancer drug with forecast sales reaching $7 billion. Genentech/Roche's Avastin (approved for colorectal, lung and breast cancer), has validated anti-angiogenesis as a therapeutic strategy, and follows closely behind with expected sales of $6.9 billion.

Sales of supportive care drugs for anemia (Amgen's Aranesp and J&J's Procrit) are being decimated by safety issues, but the market for white blood cell support (Amgen's Neupogen/Neulasta) is expected to remain strong, approaching $5 billion in 2010.

Central nervous system
SSRIs should continue to be the mainstay treatment for depression and anxiety, despite concerns over suicide, but sales of the class are declining due to generics, as well as issues of efficacy. Patent expiry for Effexor XR in 2010 will bring further generic erosion to the sector.

The potential of newer treatment modalities in the category, such as NK antagonists, beta3-adrenoreceptor agonists and CRF antagonists, remains unclear. Dual-acting agents impacting both serotonin and norepinephrine systems should continue to gain prescription market share from the SSRIs in 2010, driven primarily by Lilly's Cymbalta.

Melatonin receptor agonists are also in the pipeline for depression, with one of the lead compounds, agomelatine (from Novartis), now entering the market in Europe and expected to gain ground in 2010. Compared with existing antidepressants, agomelatine is the first melatonergic agent to demonstrate favorable data in its effect on sleep, weight and sexual function.

The migraine market is unlikely to grow significantly in 2010, given the little differentiation between Imitrex generics. However, the antipsychotics market may begin to change in 2010 as a third generation of antipsychotics reach the market, which may provide broader efficacy, reduced side effects and improved tolerability. Among them is sertindole (from Lundbeck), associated with less sedation when used to treat schizophrenia, and asenapine (from Schering-Plough), a new 5-HT_2A/D₂ receptor antagonist.

Diabetes
Many patients with diabetes remain undertreated as the incidence of the disease assumes epidemic proportions. Insulin will remain the cornerstone of treatment in 2010, for which sales will be driven by increased penetration of insulin analogs. Lantus appears poised to retain its position as the leading basal insulin. In the short-acting market, Lilly's Humalog and Novo Nordisk's Novolog share the market and new competitors are expected to have little impact.

Oral DPP-IV inhibitors are shaping up to be the next oral diabetes blockbusters. The launch of Merck's Januvia has been positive, but the drug faces new competition from BMS/AstraZeneca's Onglyza. Januvia has recently been linked to a possible association with pancreatitism, and although further data are required to confirm the link, it appears the association may be limiting forecasts into 2010. Novartis's Galvus has been delayed indefinitely in the US on safety concerns.

In the GLP analog sector, Lilly/Amylin's Byetta forecasts have slowed since the launch of Januvia, although Byetta LAR, a long-acting formulation, is expected to hit the US market in 2010. Other GLP-1 analogs which look promising include Novo Nordisk's liraglutide, which has demonstrated a lower risk of hypoglycemia than existing drugs. Liraglutide is also expected to be launched in the US in 2010

Finally, in a field of failed attempts to market inhaled insulin, MannKind could gain approval for a delivery system that administers an inhaled dry-powder insulin formulation.

Infectious disease
GlaxoSmithKline will almost certainly maintain its pole position in the antibiotic/antiviral drug category in 2010, although Merck's share should increase, driven by its vaccine franchise (Gardasil, Zostavax).

Quinolones and macrolides have been impacted by generics, and sales forecasts are declining, but a number of new anti-MRSA antibiotics are in late-stage development and could make significant advances in 2010. These include telavancin, dalbavancin and iclaprim.

HIV, hepatitis and influenza also offer large market opportunities for new drugs in the sector. Merck's Isentress had a strong launch in 2008, and its sales are expected to top $1 billion in 2010. H1N1 will be a particularly significant boost in 2009/2010 for vaccine manufacturers GlaxoSmithKline, sanofi-aventis, Novartis, AstraZeneca and CSL. Roche/Gilead and GSK will also benefit from significant Tamiflu and Relenza demand respectively, both of which are expected to double sales from 2008 levels.

Reference
1. Thomson Reuters, CMR International 2009 Pharmaceutical R&D Factbook.

Thomson Pharma Partnering Forecast contains a consensus of analyst forecasts for strategic drugs across the major pharma therapy areas, and combines these forecasts with patient-based revenue models for drugs in over 100 indications.  The models include transparent assumptions on incidence and prevalence, eligible numbers of patients, estimated timing of approval, pricing, and market share within the indication.