Androgen Replacement Therapy Market Analysis (2020-2027)

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2. ANDROGEN REPLACEMENT THERAPY MARKET ANALYSIS (2020-2027) • Androgen Replacement Therapy Market, By Product Type (Creams/Gels, Patches, Injections, Implants, and Oral Tablets/Capsules/Gums), By Active Ingredient Type (Testosterone, Methyl Testosterone, Testosterone Undecanoate, Testosterone Enanthate, and Testosterone Cypionate), By Distribution Channel (Hospitals Pharmacies, Retail Pharmacies, and Online Pharmacies), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027

3. Androgen Replacement Therapy or low testosterone therapy is commonly called hormone replacement therapy for men. It is designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is a clinical syndrome which results in the failure of the testes to produce physiological levels of testosterone. The primary reason for hypogonadism may be a problem with the testes. The secondary reason is a problem with the hypothalamus or pituitary gland or both primary and secondary. Primary hypogonadism is caused due to genetic abnormalities, testicular trauma, orchitis, radiation treatment or chemotherapy, while secondary hypogonadism is caused due to genetic abnormalities of pituitary gland and hypothalamus. Testosterone injections, implants, gels, creams and oral medications are used for treatment of hypogonadism. Patients can use the medication as per their convenience. • The androgen replacement therapy market is estimated to be valued at US$ 1,736.9 million in 2020 and is expected to exhibit a CAGR of 3.7% during the forecast period (2020-2027).

4. Fig. 1. Androgen Replacement Therapy Market Share (%) Analysis in Terms of value, By Product Type, 2020

5. The increasing prevalence of hypogonadism and product launches are expected to drive growth of the androgen replacement therapy market • The growing prevalence of hypogonadism in adult men worldwide is expected to drive growth of the androgen replacement therapy market. According to the European Association of Urology: 2016 report, among middle-aged men, the incidence of hypogonadism varies from 2.1% to 12.8%. In Europe, the incidence of low testosterone and symptoms of hypogonadism in men in the age group of 40 to 79 varies from 2.1% to 5.7%. Hypogonadism is more prevalent in older men, in men with obesity, those with co-morbidities, and in men with a poor health status. Furthermore, according to the Therapeutics Advances of Urology Journal: 2016, testosterone was one of the most widely prescribed medications in the U.S. in 2011. This has resulted in growth of androgen replacement therapy from US$ 18 million in 1980 to US$ 1.6 billion in 2011 which was a five-fold increase. • Moreover, products launches by market players are expected to accelerate the androgen replacement therapy market growth in the near future. For instance, in April 2019, Israeli generics company, Teva Pharmaceutical Industries (Teva), announced the launch of generic versions of AndroGel (testosterone gel) 1.62% CIII and VESIcare (solifenacin succinate) tablets, 5 mg and 10 mg, in the U.S. Testosterone gel 1.62% CIII is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, which include congenital or acquired primary hypogonadism and congenital or acquired hypogonadotropic hypogonadism.

6. Androgen Replacement Therapy Market - Restraints • However, growth of the androgen replacement therapy market may be hampered owing to the increasing product recalls of testosterone products in the market. For instance, in August 2018, the U.S. subsidiary of Sun Pharmaceutical Industries Ltd recalled more than 5,215 units of 10 ml vials of testosterone cypionate injections, in the strength of 200 mg/ml from the U.S. market, the latest enforcement report of recall was ordered by the U.S. Food and Drug Administration (US FDA). According to the U.S.FDA report, the ongoing voluntary nationwide recall is a Class II recall, initiated in a situation. The product was recalled due to the possibility of it causing temporary or medically reversible adverse health consequences.

7. Androgen Replacement Therapy Market – Regional Analysis • North America accounted for the largest share in the androgen replacement therapy market, in 2019 owing to the increasing number of product launches in the U.S. For instance, in October 2018, the Perrigo Company Plc. announced the launch of an AB-rated generic version of Androgel Topical Gel, 1.62% (20.25mg testosterone/1.25g packet, 40.5mg testosterone/2.5g packet, and 20.25mg/1.25g actuation pump). At generic market formation, an unrelated third party has launched an authorized generic version. Androgel Topical Gel, 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

8. Furthermore, major companies in the market are focusing on acquiring license agreements to gain commercial rights for a particular country which is expected to drive growth of the androgen replacement therapy market in Asia Pacific. For instance, in December 2016, Acerus Pharmaceuticals Corporation announced the signing of an agreement granting exclusive right to market NATESTO in South Korea to Hyundai Pharm Co. Ltd., a South Korean pharmaceutical company. NATESTO is the first and only testosterone nasal gel for androgen replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

10. Fig.2 Androgen Replacement Therapy Market Value (US$ Mn) & Y-o-Y Growth (%), 2017-2027

11. Androgen Replacement Therapy Market - Competitive Landscape • Key players operating in the androgen replacement therapy market are AbbVie, Inc., Allergan Plc, Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International Plc, Mylan N.V., Novartis International AG, Pfizer, Inc., Clarus Therapeutics, Ferring Holding SA, Perrigo Company Plc, Acerus Pharmaceuticals Corporation, Upsher-Smith Laboratories, LLC, Dr. Reddy's Laboratories, Bausch Health Companies Inc., Sun Pharmaceutical Industries Ltd., and Par Pharmaceutical.

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