Although Bisphosphonates Will Continue to Dominate Osteoporosis Treatment Through 2020, Patent Expiries of Risedronate, Re

The Overall Osteoporosis Drug Market Will Be Mostly Flat, With Sales Remaining Just Over $6.2 Billion from 2010 to 2020, According to Findings from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that although bisphosphonates will continue to dominate the osteoporosis drug market, the patent expiries of risedronate (Sanofi/Warner Chilcott/Eisai’s Actonel/Atelvia, Takeda’s Benet, generics), Novartis’s Reclast/Aclasta (zoledronate) and Roche/GlaxoSmithKline’s Boniva/Bonviva (ibandronate) will trigger a decline in sales for this drug class over the next decade.

The findings from the Pharmacor topic entitled Osteoporosis reveal that the overall market for this indication will be mostly flat over the next decade, with sales remaining just over $6.2 billion from 2010 to 2020 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Ongoing concerns regarding the long-term safety profiles of the bisphosphonates will allow premium-priced agents such as Amgen/GlaxoSmithKline/Daiichi Sankyo’s Prolia (denosumab) and Merck’s emerging cathepsin K inhibitor odanacatib to capture patient share, despite generic competition. In the world’s major pharmaceutical markets, Prolia and odanacatib will generate combined sales of more than $960 million in 2020.

Additionally, physician enthusiasm for novel anabolic agents such as Amgen/UCB’s AMG-785/CDP-7851 remains undiminished. Although these agents are likely to command high prices if they demonstrate strong efficacy, particularly in reducing the risk of nonvertebral fractures, use even in only those patients at highest risk of fracture could still translate into robust sales.

Sales of selective estrogen receptor modulators (SERMs) will decline owing to the launch of generic raloxifene (Eli Lilly/Daiichi Sankyo's Evista, generics) in Europe and its patent expiry in the United States in 2014. The most recent SERM to enter the market, bazedoxifene (Pfizer’s Conbriza/Viviant) did not launch until September 2010 despite being approved in Europe in April 2009. In addition to competition from generic raloxifene, sales of bazedoxifene will be constrained by a label limiting use to postmenopausal women at increased risk of fracture. This contrasts with raloxifene’s label which indicates a broader use for the prevention and treatment of osteoporosis in postmenopausal women. Furthermore, the launch of bazedoxifene has been restricted to Spain, Italy and Japan.

“The loss of patent protection for the majority of antiresorptive therapies used for the treatment of osteoporosis and osteopenia in the next four years will ensure that opportunity remains highest in this market for novel anabolic agents with a demonstrated bone-building effect and proven anti-fracture protection,” said Decision Resources Analyst Matthew Scutcher, Ph.D.

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