The hormone replacement therapy market is a fragmented landscape with presence of few tier one companies and upcoming players. Top five companies involved in the hormone replacement therapy formulations account for a significant share of the overall hormone replacement therapy market. Top 5 players – Novo Nordisk, Pfizer Inc., Janssen NV (a Johnson & Johnson company), Novartis AG and Bayer AG collectively – collectively account for 35 percent revenue share of the hormone replacement therapy market from on the global front.
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Tier 1 hormone replacement therapy companies are focused on carrying out clinical trials for new product development (NPD). Moreover, these companies are adopting vertical, horizontal and backward integration in a bid to achieve rapid expansion and pace in technological development.
In addition, tier 1 hormone replacement therapy companies are forming alliances to co-develop and commercialize hormone replacement therapy drugs. For instance, Pfizer Inc., and Merck KGaA have formed a strategic alliance to develop avelumab (BAVENCIO) to manage hypothyroidism and other thyroid disorders.
Food and Drug Administration (FDA) has signed an agreement with NASEM (National Academies of Science, Engineering & Medicine) and is carrying out expanded agreements with University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation. Main focus behind this initiative was to conduct research and inform consumers regarding compounded drugs.
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NASEM is examining the utility of treating individuals with compounded BHRT (Bioidentical Hormone Replacement Therapy) products. Compounded Bioidentical hormone replacement therapy products such as testosterone and progesterone are used instead of FDA approved hormone replacement therapy drugs as BHRT drugs are considered more safe and natural for patients. This factor is likely to impact the clinical trials of new hormone replacement therapy products in turn challenging the growth of hormone replacement therapy market.
Affordability has always remained a major challenge for any pharmaceutical drug or formulation. Moreover, insufficient healthcare reimbursements have resulted in individuals opting for cheaper drugs with unclear drug effectiveness. This prompted manufactures of hormone replacement therapy drugs to produce generic versions of the formulations in a bid to bridge the gap between purchasing power of people and hormone replacement therapy drug pricing. Companies developing generic hormone replacement therapy drugs are also acquiring FDA approvals, which is direct inference apropos to drug effectiveness. For instance, Teva pharmaceuticals has introduced generic version of Estrace cream and estradiol vaginal cream in 2018. The trend is expected to auger well for the overall growth of the hormone replacement therapy market.
Growing life expectancy is closely associated with degeneration that further translates into osteoporotic fractures. In addition, this condition further results in an increase in gap between spine bones during menopause with diminishing estrogen levels. According to the International Osteoporosis Foundation, osteoporosis causes over 8.9 million fractures annually on the global front and is likely to grow in the coming years. Rising prevalence of osteoporosis among women is expected to trigger the demand for hormone replacement therapy.
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