Some stats: - for those interested.
US Market - gross US2.3-2.7b - net sales for topical = c. 1.1b of which Axiron has c. 14% share
The U.S. testosterone replacement therapy (“TRT”) market in 2014 was approximately $2.8 billion according to a Symphony Health Solutions report, and declined approximately 9% compared to 2013.
Based on U.S. Census data, there are approximately 59.5 million men over the age of 45 with the number of those experience low testosterone estimated to be approximately 40%. We count the 74% of men who go to see a primary care physician each year as part of our target population, which equates to approximately 17.6 million men who would be eligible for TRT. Of these, only 10% or so are on TRT.
Canada: - second largest TRT market outside US
Prescriptions for testosterone products in Canada have increased by nearly 40% over the past 4 years, from 99,854 prescriptions dispensed in the last quarter of 2009 to 137,318 prescriptions dispensed by the first quarter of 2014. The majority of testosterone prescriptions in Canada were for topical formulations (46%) followed by oral (26%), injectable (26%) and transdermal (2%) formulations.
By the first quarter of 2014, a total of $14.2 million was spent on all testosterone products nationally, an increase of approximately 42.1% since Q4 2009 ($10 million). Among the total cost of testosterone prescriptions in Q1 2014, the majority was spent on topical formulations (69.4%; $9.8 million), followed by oral (17.5%; $2.5 million) injectable (10.8%; $1.5 million) and patch (2.3%; $322,220) formulations (data not shown)
So you could call the market in Canada a c, 40m market for topical formulations - if Axiron can get 14% share you could see sales of + 5.6m (less current position which is unknown)
http://www.odprn.ca/wp-content/uploads/2014/12/TRT-Pharmacoepi-final-report-CENSORED-04dec14.pdf
http://www.canjurol.com/html/free-articles/V21I3S1_09F_DrMiner.pdf
Other Markets - a little old but gives you a sense of relative sizes
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9 Column 10 Column 11 Column 12 Column 13 0 1 Testosterone use, 2000–2011, by country or region
Defined monthly doses (% transdermal)*1 Country/region 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2 Australia 9.6 11.5 12.5 12.2 12.2 13.1 13.6 16.5 3 (1%) (10%) (13%) (13%) (12%) (13%) (23%) (23%) (22%) (22%) (22%) (23%) 4 Canada 10.0 11.3 40.4 82.1 102.3 108.5 115.4 122.3 135.7 220.0 333.5 385.5 5 (0) (3%) (7%) (86%) (89%) (90%) (91%) (91%) (91%) (95%) (96%) (97%) 6 Ireland 7 (45%) (41%) (4%) (54%) (67%) (72%) (72%) (74%) (69%) (64%) (60%) (58%) 8 United Kingdom 3.6 9 (15%) (16%) (21%) (24%) (37%) (43%) (45%) (49%) (51%) (47%) (48%) (50%) 10 United States 10.3 15.3 19.4 19.0 19.3 24.2 26.0 32.6 39.7 46.5 52.9 98.5 11 (31%) (53%) (67%) (61%) (57%) (66%) (67%) (71%) (72%) (69%) (68%) (78%) 12 Mexico 3.0 2.0 13 (0) (0) (0) (0) (0) (0) (0) (2%) (6%) (7%) (8%) (11%) 14 Eastern Europe† 15 (0) (0) (0) (0) (0) (1%) (4%) (6%) (7%) (9%) (9%) (7%) 16 Middle Europe‡ 4.8 5.0 4.8 6.0 17 (7%) (6%) (6%) (17%) (27%) (23%) (24%) (26%) (27%) (28%) (29%) (28%) 18 Northern Europe§ 4.8 10.5 12.6 14.8 16.6 19.3 19 (14%) (14%) (14%) (14%) (26%) (32%) (47%) (52%) (56%) (57%) (60%) (62%) 20 Denmark 21 (7%) (3%) (0) (0) (7%) (9%) (9%) (10%) (13%) (15%) (20%) (21%) 22 Finland 5.5 6.0 6.3 6.8 10.1 11.6 13.5 14.4 23 (9%) (7%) (7%) (10%) (24%) (28%) (28%) (29%) (31%) (31%) (32%) (34%) 24 Norway 5.6 5.9 10.6 12.6 25 (10%) (9%) (10%) (10%) (20%) (24%) (2%) (23%) (23%) (23%) (24%) (25%) 26 Sweden 5.8 6.0 15.8 20.4 25.0 28.2 34.1 40.2 27 (20%) (21%) (22%) (21%) (34%) (44%) (67%) (72%) (75%) (76%) (77%) (78%) 28 Southern Europe¶ 5.6 5.5 5.8 29 (2%) (6%) (6%) (7%) (11%) (15%) (15%) (17%) (19%) (21%) (21%) (21%) 30 Asia** 0.4 0.4 0.4 0.3 0.3 31 (0) (0) (0) (0) (0) (0) (0) (0) (0) (0) 32 * Per year per 1000 population; proportion given via transdermal products (gel, patch). † Bulgaria, Croatia, Czechoslovakia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Slovenia. ‡ Austria, Belgium, France, Germany, Luxembourg, the Netherlands, Switzerland. § Denmark, Finland, Norway, Sweden. ¶ Greece, Italy, Spain. ** China (hospitals), Hong Kong, Indonesia, Japan, Malaysia, the Philippines, Singapore, Thailand, Vietnam. ◆
The Competitors:
Androgel® (AbbVie Inc.): A gel form of testosterone that is applied to the skin. The product is available as either a 1% or 1.62% formulation and is supplied in a metered dosage pump or a single use packet, with the gel applied to the upper arms and shoulders. A clinical study of 274 men with low testosterone showed that 82% of Androgel® users had their testosterone levels return to normal, versus 37% of placebo users. This product is the market leader, with sales totaling $1.03 billion in 2013.
Axiron® (Eli Lilly & Co): A gel form of testosterone that is applied to the armpits approved by the FDA in 2010. A clinical study of 155 hypogonadal men showed that within two weeks of beginning treatment with Axiron®, 76% of subjects had normal testosterone levels, and that after 120 days of treatment that number increased to 84%. The product generated total revenues of $178 million in 2013.
Testim® (Auxilium Pharmaceuticals Inc.): A testosterone gel that is supplied in unit-dose tubes that is applied to the shoulders and upper back. Clinical data showed that 74% of hypogonadal patients receiving Testim® had an average serum testosterone concentration within the normal range on treatment day 90. Total revenues for Testim® in 2013 were $211 million.
Fortesta® (Endo Internationals plc): A 2% testosterone topical gel that is supplied in a metered pump and applied to the front and inner thighs. In a clinical study of 149 hypogonadal males, 77.5% of patients treated with Fortesta® had normal testosterone levels after 90 days of treatment. Sales of Fortesta® totaled $66 million in 2013.
Delatestryl® (Endo Internationals plc): An injectable form of testosterone supplied as testosterone enanthate that is administered every two to four weeks. Total sales of Delatestryl® are not disclosed. Androderm® (Actavis plc): A 2 mg or 4 mg testosterone patch that is applied once per day. This product was initially formulated as a 2.5 mg or 5 mg patch, but was changed to the lower dosages in 2011. In a clinical trial of 35 hypogonadal patients, 97% had serum testosterone levels within the normal range after 28 days of treatment using Androderm® 2 mg or 4 mg patches. Total revenues for Androderm® were $95 million in 2013.
Aveed® (Endo Internationals plc): An injectable form of testosterone that is administered at initiation, at 4 weeks, and every 10 weeks thereafter. A clinical trial of 117 hypogonadal men showed that at week 24, 94% of patients maintained a normal testosterone level. Aveed® was approved by the FDA in March 2014.
Striant® and Testopel® (Auxilium Pharmaceuticals Inc): Striant® is a testosterone buccal system applied to the gum region twice daily. A clinical trial of 82 hypogonadal patients found that 86% had a normal testosterone level after 12 weeks of treatment with Striant®. Testopel® is an implantable testosterone pellet that is designed to deliver testosterone for 3 to 4 months per implantation. Sales of Testopel® totaled $60 million in 2013 while total sales of Striant® were not disclosed.
Natesto (Trimel Pharmaceuticals Corp.): An intranasal formulation of testosterone that was approved by the FDA in May 2014. A clinical trial of 78 hypogonadal patients showed that 90% of those treated with Natesto had normal testosterone levels after 90 days of treatment.
Other angles... Transdermal Drug Delivery is big - ACR ARE YOU LISTENING!!!!!!
http://www.kellyscipub.com/wp-content/uploads/2014/12/Sample-Pages-TDDM.pdf
Axiron research, page-2
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