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Dan Pan

Osteoporosis a disease characterized by decreased bone mineral density (BMD), which causes brittle bones and increases the risk of fracture. The disease affects 10 million Americans, with 34 million more estimated to have a low bone mass and increased risk of the disease. Since bone mineral density naturally decreases with age, osteoporosis most commonly affects those over 50. As the baby boomer generation ages and people continue to live longer, the incidence of osteoporosis is expected to increase.

In women over 45, osteoporosis is responsible for more hospital stays than many other diseases such as diabetes, heart attack, or breast cancer.^[1]. An estimated $18 billion is spent annually on direct health care services related to osteoporotic fractures, making it an attractive market for pharmaceutical companies that produce drugs to help manage the disease.

Drugmakers win from expanding market

The osteoporosis market is currently $7 billion and is projected to reach $10.4 billion by 2011. ^[2] Some major players are:

• Merck (MRK) - Fosamax is the dominant player in osteoporosis drugs. With sales of more than $3.1 billion in 2006, the drug represents nearly half of the market. Fosamax is also Merck's third most important drug in terms of revenue. However, the drug's U.S. patent will expire in February 2008, after which generics will enter the market and put significant pressure on sales. Fosamax is a bisphosphonate drug, and competes with other drugs in the bisphosphonate family including Novartis AG (NVS)'s Zometa, Roche Pharmaceuticals (RHHBY) / GlaxoSmithKline (GSK)'s Boniva, and Procter & Gamble / Sanofi-Aventis's Actonel.

• Novartis AG (NVS) - Zometa differs from its competitors in that it is marketed primarily as a cancer drug, rather than an osteoporosis drug. Patients with certain types of cancers are more susceptible to bone fractures, and Zometa is used to lower the risk of these fractures by increasing bone mineral density. The drug belongs to the same family as its largest competitor, Fosamax.

• Eli Lilly and Company (LLY) - Evista is the third major osteoporosis drug, with sales of $664 million in 2006. However, it is only available for women. The sharp decline of estrogen levels in post-menopausal women is a major risk factor for osteoporosis, and Evista works by slowing the decline of estrogen. Eli Lilly also markets Forteo, which is prescribed to patients who cannot tolerate bisphosphonates are have especially low BMDs. Unlike bisphosphonate drugs, not only does Forteo increase bone mineral density by inhibiting the reabsorbtion of bone, it also promotes new bone formation. This relatively new drug is currently only approved for use in post-menopausal women.

• Amgen (AMGN) - Denosumab is a new osteoporosis drug developed by Amgen. The drug is currently undergoing Phase III trials, and may be the company's next major blockbuster drug, with potential sales of up to $2 billion if approved.^[3] Unlike current treatments, it only requires injections twice a year, which is more convenient for patients. Results from a large scale Phase II study have so far been positive. Postmenopausal women with osteoporosis given the drug saw a sustained increase in bone mineral density over four years. Denosumab's potential competitive advantage centers around compliance. Currently, treatments for osteoporosis require patients take a pill daily or weekly, fast the night before doing so, and remain standing for several hours after they take the pill. Most patients stop taking their medicine within a few months. When patients stop taking their osteoporosis medication, they are at increased risk of hip fractures. Hip fractures are both dangerous and expensive to treat. As a result, payors are willing to cover more expensive treatments for osteoporosis if patient compliance is likely to improve.

Health insurance companies lose from reimbursements

Health insurance companies such as Aetna (AET), UnitedHealth Group (UNH), WellPoint Health Networks (WLP), and AFLAC (AFL) may be hurt by the increased incidence of osteoporosis because reimbursement costs will increase.

Medicare, which covers most health costs for those over 65, has a particularly large impact on the osteoporosis market due to the overlapping demographics of the patient population. While Medicare currently covers most osteoporosis treatments, changes in osteoporosis coverage will affect both pharmaceutical and health insurance companies.

What is osteoporosis?

Osteoporosis is caused by decreased bone mineral density (BMD), and leads to brittle bones and increased the risk of fracture. The condition is defined in medicine as having a BMD of 2.5 standard deviations below a person's expected peak bone mass. Osteoporosis affects 10 million Americans, with 34 million more estimated to have a low bone mass and increased risk of the disease.

Disease risk factors and drivers

• Age - Bone mineral density naturally decreases with age, so advanced age is one of the most important risk factors for osteoporosis. This decline in bone strength is usually not visible until a fracture occurs. 75% of hip, spine, and forearm fractures occur in patients over 65 years old.^[4]. As the baby boomer generation ages and as people are living longer in general, the incidence of osteoporosis is increasing.

• Gender and hormonal changes - Eighty percent of those with osteoporosis are women, and one in four women over the age of 50 has the disease. ^[5]Post-menopausal women are especially susceptible to osteoporosis because the decline in estrogen levels is strongly correlated with a decline in bone mineral density. On average, men have a higher bone mineral density, so they are less at risk.

• Ancestry - Osteoporosis is a heritable disease, so those with a family history of the disease are at an increased risk. In particular, those of European and Asian ancestries have increased risks of osteoporosis.

• Sedentary lifestyle - Exercise helps to build stronger bones and muscle, especially during the adolescent years, which is correlated with a lower risk of osteoporosis. The trend of an increasing sedentary lifestyle and obesity contribute to the increased incidence of osteoporosis.

• Smoking and alcoholism have both been shown to increase the risk of osteoporosis.

References

1. ↑ http://www.iofbonehealth.org/facts-and-statistics.html
2. ↑ Chu, Wai Lang. "Osteoporosis sees new wave of treatment options." April 28, 2007. http://www.drugresearcher.com/news/ng.asp?id=51696-osteoporosis-sees-new
3. ↑ Chase, Marylin. "Osteoporosis Drug Is Amgen's Hope For a Strong Future." The Wall Street Journal, December 14, 2007.
4. ↑ http://www.iofbonehealth.org/facts-and-statistics.html
5. ↑ Liebman, Milton. "Awakening the Silent Osteoporosis Market." Medical Marketing & Media. April, 2002.