Androgen replacement therapy or low testosterone therapy is commonly called as 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.
Global Androgen Replacement Therapy Market - Impact of the Coronavirus (COVID-19) Pandemic
Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19 as pandemic on March 11, 2020.
According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 148,329,348 cases and 3,128,962 deaths due to Coronavirus disease (COVID-19) were reported on April 28, 2021, across the globe.
General guidance on medicines management for endocrinology conditions during COVID-19 is available at Society for Endocrinology. This list of guidelines are issued by the National Health Service (NHS), England.
The objective is to advise on the administration and monitoring of testosterone injections during COVID-19 for androgen deficiency in adults, to protect patients from unnecessary health care visits, to help preserve NHS capacity, and to provide options for the management of patients who are self-isolating or have symptoms of COVID-19.
The most commonly prescribed testosterone injections for androgen deficiency in the U.K. include either a long acting intramuscular depot testosterone, Nebido, or short-acting mixed testosterone esters, and Sustanon.
Administration: During the COVID-19 pandemic, options to manage administration include:
1) Temporarily interrupt administration – For most testosterone formulations and most patients, a temporary interruption in the testosterone replacement therapy (TRT) is unlikely to cause harm. It is unlikely that bone or muscle mass will be affected by a 3-4 month interruption of treatment.
2) Switching to testosterone based gel – Empirical dose (Tostran 50 mg daily; Testogel Pump 40.5 mg daily; or Testovance 46 mg daily). The testosterone gel should be commenced from the date the next injection would have been due. The intramuscular preparation could be recommenced, once non-urgent services resume.
The global androgen replacement therapy market is estimated to be valued at US$ 1,965.5 Mn in 2021 and is expected to exhibit a CAGR of 7.8% over the forecast period (2021-2028).
Androgen Replacement Therapy Market Report Coverage
||Market Size in 2021:
||US$ 1,965.5 Mn
|Historical Data for:
||2017 to 2020
||2021 to 2028
|Forecast Period 2021 to 2028 CAGR:
||2027 Value Projection:
||US$ 3,317.6 Mn
- North America: U.S. and Canada
- Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
- Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
- Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
- Middle East: GCC, Israel, and Rest of Middle East
- Africa: South Africa, North Africa, and Central Africa
- By Product Type: Testosterone Creams/Gels, Testosterone Patches, Testosterone Injections, Testosterone Implants, Testosterone Tablets/Capsules/Gums
- By Active Ingredient Type: Testosterone, Methyl Testosterone, Testosterone Undecanoate, Testosterone Enanthate, Testosterone Cypionate
- By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Plc., Eli Lilly and Company, Kyowa Kirin International Plc., Novartis International AG, Pfizer Inc., Clarus Therapeutics, Inc., Perrigo Company Plc, Acerus Pharmaceuticals Corporation, Sawai pharmaceutical Co., Ltd., Reddy's Laboratories, Sun Pharmaceutical Industries Ltd., and Simple Pharma.
- Robust pipeline drugs for treatment of hypogonadism
- Increasing product approvals and launches
- Increasing prevalence of hypogonadism
|Restraints & Challenges:
- Stringent regulations and drug recalls
- Side effects and lack of awareness regarding androgen replacement treatment
Figure 1: Global Androgen Replacement Therapy Market Share (%) Analysis, By Distribution Channel, 2021
The increasing prevalence of hypogonadism and product launches are the major factors that are expected to drive the market growth over the forecast period.
The growing prevalence of hypogonadism in adult men worldwide is expected to drive growth of androgen replacement therapy market over the forecast period. For instance, according to the European Association of Urology: 2016 report, among middle-aged men, 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 elderly men, men with obesity, those with co-morbidities, and men with a poor health status.
Moreover, products launches by market players are expected to fuel the androgen replacement therapy market growth in the near future. For instance, in April 2019, Israel-based generics company, Teva Pharmaceutical Industries (Teva), launched generic versions of AndroGel (testosterone gel) 1.62% CIII and VESIcare (solifenacin succinate) tablets of 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.
Global 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 over 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 instructed by the U.S. Food and Drug Administration (U.S. FDA). According to the U.S. FDA report, the ongoing voluntary nationwide recall is a Class II recall, initiated in a situation. The testosterone cypionate injections was recalled due to the possibility of it causing temporary or medically reversible adverse health consequences.
Global Androgen Replacement Therapy Market – Regional Analysis
On the basis of region, the global androgen replacement therapy market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
North America region is expected to hold dominant position in the global androgen replacement therapy market over the forecast period, owing to increasing number of product launches and approvals associated with androgen replacement therapy by regulatory bodies. For instance, in February 2019, Innovus Pharmaceuticals, Inc., a commercial-stage pharmaceutical company, received approval from the Health Canada for BH Testosterone Booster capsules, indicated to maintain the testosterone levels and production in adult males.
Furthermore, Asia Pacific is also estimated to witness significant growth in the androgen replacement therapy market, owing to increasing number of agreements by market players, over the forecast period. For instance, in August, 2020, Antares Pharma, Inc., a pharmaceutical technology company, entered into an exclusive distribution agreement with Lunatus Global Medical Supplies (‘Lunatus’) for the distribution and promotion of XYOSTED, a testosterone enanthate injection, in Saudi Arabia and the United Arab Emirates (UAE).
Figure 2: Global Androgen Replacement Therapy Market Value (US$ Mn), by Region, 2020
Global Androgen Replacement Therapy Market – Competitive Landscape
Major players operating in the global androgen replacement therapy market include AbbVie, Inc., Bayer AG, Endo International plc, Eli Lilly and Company, Kyowa Kirin International Plc., Novartis International AG, Pfizer Inc., Clarus Therapeutics, Inc., Perrigo Company Plc, Acerus Pharmaceuticals Corporation, Sawai pharmaceutical Co., Ltd., Reddy's Laboratories, Sun Pharmaceutical Industries Ltd., and Simple Pharma.