Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017

13 Aug 2010 • by Natalie Aster
GlobalData, the industry analysis specialist, has released a new report, “Hormone Replacement Therapy in Menopause - Pipeline Assessment and Market Forecasts to 2017”. The report is an essential source of information and analysis on the global menopause hormone therapy market. The report identifies the key trends shaping and driving the global menopause hormone therapy market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the existing market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global menopause hormone therapy sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts. GlobalData estimated the global hormone therapy (HT) market to be worth $2.4 billion in 2009, indicating a Compound Annual Growth Rate (CAGR) of -5.9% between 2001 and 2009. This decline in the market is mainly attributed to poor patient compliance as a result of the serious safety concerns associated with hormones. By 2017, the market is forecast to be worth $2.8 billion, with a CAGR of 2.2% between 2009 and 2017. The market is restrained by factors such as the poor acceptance of hormone therapies in patients and physicians. Increased interest in low-dose and ultra-low dose hormone therapies are expected to lead to marginal growth of the HT market.

The Hormone Therapy Market is Forecast to Show Marginal Growth Between 2009 and 2017

GlobalData estimated the global hormone therapy (HT) market to be worth $2.4 billion in 2009, indicating a Compound Annual Growth Rate (CAGR) of -5.9% between 2001 and 2009. This decline in the market is mainly attributed to poor patient compliance as a result of the serious safety concerns associated with hormones. By 2017, the market is forecast to be worth $2.8 billion, with a CAGR of 2.2% between 2009 and 2017. The market is restrained by factors such as the poor acceptance of hormone therapies in patients and physicians. Increased interest in low-dose and ultra-low dose hormone therapies are expected to lead to marginal growth of the HT market.

The Current Competition in the Hormone Therapy Market is Weak

GlobalData found that the current competition in the hormone therapy market is weak. Several products are currently available in different dosage forms such as oral tablets, vaginal creams, rings and tablets, transdermal patches, sprays, syringes, intrauterine systems and combination products. Hormone therapy has been the treatment of choice since the 1960s. But, HT is associated with serious safety concerns such as increased breast cancer (26%) and cardiovascular disease risk (41%). Also, the widespread media coverage of the Women’s Health Initiative (WHI) study results has caused consternation among women and physicians. Low dose and ultra-low dose versions of hormones used for a short time have gone some way in meeting the unmet need but there has been no good data to prove the safety of these minimized doses of HT. Thus, the current market still awaits a highly safe and efficacious drug.

Few Promising Hormonal Products In Late Stage Development: Stability of the HT Market at Stake?

GlobalData found that the HT pipeline is weak with few promising hormonal products under development, let alone first-in-class hormonal products. Low-dose hormone drugs such as Angeliq low-low and combination hormonal drugs are being developed but a major share of the pipeline is of non-hormonal molecules. The HT market has been rapidly declining and researcher’s quest for treatments for postmenopausal symptoms is continuing.

Low-dose hormone drugs were successful in stabilizing the market to a certain extent but not all women desire or are candidates for HT. Should a hormonal drug with better safety and efficacy be approved, it might increase the size of the HT market. Aprela is the only promising Phase III molecule and its launch is expected to restore the HT market. LibiGel is another promising Phase III molecule for the treatment of female sexual dysfunction in post-menopausal women. Otherwise, non-hormonal treatments make up the majority of the pipeline and, if approved by the US FDA, are predicted to hamper the postmenopausal hormone therapy market.

Unmet Need Exists in terms of Safety and Patient Compliance

Hormone therapy is the only approved treatment and was considered to be one of the most efficacious pharmacological interventions for treating menopausal symptoms and osteoporosis. However, it is associated with serious side effects such as increased cancer risks and coronary heart disease. The WHI study in 2002 significantly hampered the HT market and led to increased concerns among HT patients. Although the WHI reanalysis in 2007 suggested that HT is not as harmful as suggested by the original WHI study results, postmenopausal women are still worried about using HT. The major unmet need in the HT market is the safety of hormonal drugs which has resulted in poor patient compliance. Thus, high unmet need exists in the menopause market in terms of safety and patient compliance.

To target this unmet need, low dose therapies for shorter periods and non-hormonal treatments are being developed. Non-hormones claim to offer better safety and efficacy and are not associated with safety concerns such as increased breast cancer risk. Several non-hormonal products in the late stage pipeline such as Pristiq, Ophena, Serada, Menerba and Odanacatib have shown promising results for the treatment of postmenopausal symptoms such as hot flashes, vaginal atrophy and osteoporosis.

Approval of Pristiq, Aprela, Denosumab and Odanacatib to Significantly Enhance the Sales of Postmenopausal Therapies

Pfizer’s Pristiq is currently under review by the US FDA for the treatment of moderate to severe vasomotor symptoms. Its expected launch in 2012 is estimated to generate sales of $2 billion. Amgen’s Prolia has recently been approved by the FDA for postmenopausal women with osteoporosis. Prolia (Denosumab) is considered to be the most promising drug for the treatment of postmenopausal osteoporosis and is estimated to generate revenues of approximately $1 billion. Aprela, a Phase III molecule developed by Wyeth (Pfizer), is a combination of conjugated estrogens and Bazedoxifene. It is indicated for postmenopausal symptoms and osteoporosis and is estimated to generate revenues of $870 million in 2012. BioSante’s LibiGel, currently in Phase III, is a transdermal testosterone gel to treat female sexual dysfunction in postmenopausal women. An NDA for LibiGel will be filed in mid-2011. Menerba, currently in Phase III, is estimated to generate revenues close to $1 billion with its probable approval in or before 2015. Odanacatib, a drug being developed by Merck for the treatment of osteoporosis, is estimated to generate revenues of $0.5 billion to $1 billion and is expected to be launched in 2013. Thus, these strong drugs in late stage development and regulatory filing will drive the market. It should be noted that except for Aprela and Libigel, the other molecules are non-hormonal.