Postmenopausal osteoporosis is a condition affecting millions of women worldwide. It is characterised by decreased bone density in women of postmenopausal age which in turn increases the fragility of bones and making them susceptible to increased risk of sudden and unexpected bone fractures. The cause of postmenopausal osteoporosis is not clearly identified, however, the decrease in bone density is directly linked to deficiency of estrogen, a natural consequence of menopause in women. Since, menopause is an inevitable part of a women’s life, postmenopausal women are at high risk of being affected with osteoporosis. Other risk factors include family history, body weight and bone structure. In osteoporosis, bone mineral density (BMD) drops down to levels below normal range, which can be measured by a bone density scan. The treatment of postmenopausal osteoporosis includes medications to treat osteoporosis specifically such as selective estrogen receptor modulator (SERM), bisphosphonates, monoclonal antibodies, calcium, Vitamin D analogues and hormone replacement therapy (HRT). In addition to the existing classes of drugs, many new drugs are under development for the treatment of postmenopausal osteoporosis.
The main growth drivers for the pipeline of postmenopausal osteoporosis therapeutics include increasing ageing women population, innovations in the osteoporosis drug development market, increasing investment on healthcare infrastructure, rising awareness and consciousness among women about the risk of postmenopausal osteoporosis.
In 2017, Radius Health, Inc. submitted a marketing authorisation application (MAA) for Abaloparatide-SC to the European Medicines Agency (EMA) for the treatment of postmenopausal women with osteoporosis. Abaloparatide is a novel synthetic peptide analog of the PTH receptor binding domain of parathyroid hormone-related protein (PTHrP), a natural hormone that can increase bone mineral density by stimulating new bone formation. In November 2016, Amgen Inc. and UCB Pharmaceuticals announced results from a Phase III study that demonstrated that romosozumab treatment in men with osteoporosis, resulted in significant bone mineral density (BMD) gains at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months. In June 2011, Synthes, Inc. and Eli Lilly and Company entered into a collaboration agreement in the domain of osteoporosis. As part of the agreement, the companies agreed to develop and license early stage molecules from Eli Lilly and Company to Synthes Inc. for use within orthopedic areas. The agreement allowed for joint development of site-specific osteoinductive products with the help of on Synthes' biomaterials combined with Eli Lilly's biologics or pharmaceuticals.
The key market players having a pipeline for postmenopausal osteoporosis include Eli Lilly and Company, Pfizer, Inc., F. Hoffman La Roche, Shire plc, Merck Sharp & Dohme Corp., GlaxoSmithKline plc, Chiesi Farmaceutici S.p.A., Novartis AG, Amgen Inc., Eisai Co., Ltd., Sanofi S.A., Procter & Gamble Co., Radius Health, Inc., Tarsa Therapeutics, Inc., Zosano Pharma Inc., Ligand Pharmaceuticals, Alvogen Korea Co.Ltd, Nordic Bioscience A/S, CMX Research Inc., PhytoHealth Corporation, TransPharma Medical, Yuyu Pharma, Inc., Bayer AG, Deltanoid Pharmaceuticals, Hanlim Pharm. Co., Ltd., Takeda Pharmaceutical Company Ltd., Asahi Kasei Pharma Corporation, Ono Pharma USA Inc., Nastech Pharmaceutical Company, Inc., Azelon Pharmaceuticals, Bionovo, and Zelos Therapeutics.