Therapeutic focus - Genito-Urinary keeps up its sex drive

Analysis

The potential US approval of UCB’s Toviaz for overactive bladder is unlikely, punning aside, to make as much of a splash when the drug goes up before the FDA in the next couple of months. Similarly Johnson & Johnson’s long wait for European regulatory clearance for its premature ejaculation drug, dapoxetine, which could be over by the end of this month, is also unlikely to be a headline grabber.

What they both have in common is that they are drugs that address the kind of conditions that are either not talked about in polite society or ones that are the butt of jokes. But while Genito-Urinary may not be the most exciting therapy area when compared to oncology, the sector is set for solid if not massive growth over the next seven years. According to consensus analyst forecasts from EvaluatePharma, genito-urinary drugs are predicted to have compound annual growth of 3%, reaching sales of $28.9bn by 2014; a 4% share of the $806.9bn worldwide pharmaceutical market.
 

WW Rx & OTC Sales By Therapy Area ($m)    
  2007 2014 CAGR (07 - 14) Market share
      Oncology & Immunomodulators  57,677  109,202  10%  14%
      Systemic Anti-Infectives  63,807  100,422  7%  12%
      Central Nervous System  87,628  89,821  0%  11%
      Cardiovascular  77,812  67,903  (2%)  8%
      Musculoskeletal  35,943  62,274  8%  8%
      Endocrine  29,729  51,415  8%  6%
      Blood  37,915  49,653  4%  6%
      Respiratory  40,682  46,266  2%  6%
      Gastro-Intestinal  31,400  29,211  (1%)  4%
Genito-Urinary   22,851 28,849 3% 4%
      Dermatology  9,310  14,473  7%  2%
      Sensory Organs  10,196  14,213  5%  2%
      Various  10,560  18,436  8%  2%
      Other Rx & OTC Pharma  76,237  124,743  7%  15%
Total WW Rx & OTC Sales 591,747  806,882  5%  

Although this is significantly below the 10% growth expected in oncology and the 8% relating to diabetes, it is still higher than the sluggish growth in the much larger respiratory market and the fall in overall sales to be experienced by cardiovascular and gastro-intestinal drugs.

While GU may not be sexy, its sales are definitely driven by sex. The drug set to dominate the therapy area, with 2014 sales forecasts of $2.2bn, is Eli Lilly’s erectile dysfunction treatment, Cialis. Erectile dysfunction was also top of the charts in 2007, with Pfizer’s Viagra notching up the highest sales of all drugs in the category with $1.76bn worth of the little blue pill still flying off the shelves.

Market Status  Rank  Product Company Therapeutic Subcategory WW sales in 2014 ($m)
Marketed 1 Cialis Eli Lilly Sexual dysfunction 2,161
  2 Yasmin/YAZ Bayer AG Hormonal contraceptives 1,491
  3 Vesicare Astellas Pharma Other genito-urinary agents 1,374
  4 Crinone/Prochieve Columbia Laboratories Fertility agents 1,137
  5 Premarin Wyeth Female sex hormones 1,069
           
R&D (current status)          
Filed 1 Dapoxetine Johnson & Johnson Sexual dysfunction 514
Phase III 2 Aprela Wyeth Female sex hormones 429
Phase III 3 Org 36286 (FSH-CTP) Schering-Plough Fertility agents 270
Filed 4 Nebido Indevus Pharmaceuticals Male sex hormones 218
Phase III 5 NOMAC/E2 (EMM 310066) Schering-Plough Hormonal contraceptives 174

Drugs addressing sexual dysfunction are currently the fourth biggest sub-division within the sector, but are expected to jump to second position with total sales of $4bn in six years time, thanks in part to Cialis. But the increase in sexual dysfunction drugs, in line with an aging but still sexually active population, is unlikely to ever leapfrog hormonal contraceptives, the biggest division in the therapy area.

 WW Rx & OTC Sales: Genito-urinary ($m)  
  2007 2014 CAGR (07 - 14)
     Hormonal contraceptives 6,501 7,739 3%
     Sexual dysfunction 3,384 4,036 3%
     Female sex hormones 2,841 3,582 3%
     Prostatic therapies 3,890 3,218 (3%)
     Fertility agents 1,369 3,057 12%
     Male sex hormones 639 1,259 10%
     Genito-urinary anti-infectives 379 533 5%
     Other genito-urinary 3,847 5,425 5%
Total Genito-urinary 22,851 28,849 3%

As the owner of oral contraceptive Yasmin, Bayer AG is the largest player in the sector, helped by its acquisition of Schering AG in 2006, commanding an impressive 17.7% of the market. The German group has also cleverly protected its pole position with a deal it struck earlier this year with US group Barr to produce an authorised generic version of Yasmin after it lost a patent dispute in March. As part of the agreement Bayer will supply Barr with the drug, which Barr will market in the US.

The relatively little deal activity in the sector, only 26 since January 2007 compared with the 139 deals struck in oncology, mean that it is unlikely that Bayer’s lead in sales will be overtaken any time soon. However, Schering-Plough managed to push itself up the rankings to second place with its $14.4bn purchase of Akzo Nobel’s Organon in 2007.

  Product Deals - since Jan 07
Oncology & Immunomodulators 139
Central Nervous System 137
Systemic Anti-infectives 92
Respiratory 48
Musculoskeletal 46
Gastro-Intestinal 45
Cardiovascular 44
Endocrine 40
Dermatology 32
Blood 30
Genito-Urinary 26
Sensory Organs 22
Various 19
Total product deals 720

Before the acquisition, Schering Plough had almost no presence in the field with sales in 2007 amounting to only $203m. Now revenues are expected to reach $2.65bn in 2014, making the buy look like a wise one.

  WW Rx & OTC Sales: Genito-urinary ranked by company ($m)
Rank Company 2007 2014 CAGR (07 - 14) Market Share in 2014
1      Bayer AG 3,868  5,118  4% 17.7%
2      Schering-Plough 203 2,648 44% 9.2%
3      Eli Lilly 1,166 2,197 9% 7.6%
4      Wyeth 1,496 1,978 4% 6.9%
5      Astellas Pharma 1,193 1,819 6% 6.3%

The addition of Organon has also meant that of the significant new treatments on the horizon in the sector, Schering-Plough owns two of them, contraceptive NOMAC/E2 (EMM 310066) and female infertility drug Org 36286 (FSH-CTP). As fertility agents are forecast to grow at above industry rates, due to the later stage at which women in developing countries are having children, Schering-Plough again looks to have done well with its strategy to boost its women's healthcare unit.

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