Market research reports growing osteoporosis market, spurred by new products

Medical Marketing and Media, May 2000 by Liebman, Milton

The osteoporosis market will have a compound annual growth of 12.9 percent through year 2006, according to estimates by Frost & Sullivan. Last year the market generated $3.0 billion in revenue with a growth rate of 25.2 percent over 1998. By 2006, revenues should exceed $6.5 billion.

The market is being driven in large part by new products. But the medical profession and public health community are focusing on osteoporosis in an effort to improve diagnosis, in particular. A National Institutes of Health panel met in March to develop and issue a 34-page consensus statement on Osteoporosis Prevention, Diagnosis, and Therapy.

A Continuing Medical Education program on osteoporosis in men was prepared by Medical Information Services, sponsored by The Johns Hopkins University School of Medicine, and widely circulated. The Southern Medical Journal published a major teaching article on Osteoporosis: Epidemiology and Treatment. Both were published in full for CME credit on Medscape.

Continuing the opportunity for stateof the art learning by physicians, a World Congress on Osteoporosis 2000, sponsored by a prime mover in this field, the National Osteoporosis Foundation (NOF), will be held on the Navy Pier, Chicago, June 15-19.

Other factors influencing the market are a growing population of elderly people with increasing knowledge of osteoporosis higher rates of diagnosis, and improved preventive and therapeutic agents.

Frost & Sullivan explore use of approved prescription medication in the osteoporosis market in four therapeutic subsegments. Bisphosphonates are gaining an increasing share of the postmenopausal market with 1999 revenues reaching $600 million. The introduction of Fosamax for treatment of men and women in June 1999 led the growth of 63 percent. A once-weekly dosage form of Fosamax is now under FDA review.

Actonal (risedronate) has just been approved by the FDA for treatment and prevention of osteoporosis in women. Developed by Proctor & Gamble, and marketed along with Aventis, Actonal will compete with Fosamax.

The NOF commended the FDA for approving Actonal, pointing out that the condition threatens 28 million Americans, more than 80 percent of whom are women. Actonal had been marketed as a treatment for Padget's disease.

Evista (raloxifene) from Eli Lilly is the only currently available drug in the category of selective estrogen receptor modulator (SERM). Introduced in 1999 for postmenopausal osteoporosis, Evista has enjoyed great success. It passed the seven million prescription mark in April 2000 in the U.S. A large clinical trial has demonstrated the ability of Evista to reduce fracture risk, the currently desirable end point for osteoporosis therapy. The total 1999 revenues were $300 million, according to Frost & Sullivan research, and the compound annual growth rare is forecast to be 35.7 percent. Evista may face competition as Pfizer in association with Ligand has a SERM, droloxifene, in Phase III clinical trials.

There are two other therapeutic segments for osteoporosis. The 1999 revenue from calcitonin products was $119 million and the annual growth rate to 2006 is estimated at 7.4 percent. Early calcitonin products lost out to competition because they were injectables. Since the marketing of a nasal formulation, Miacalcin in 1996 by Novartis, sales have grown. Calcitonin provides an alternative for patients who find other therapy unacceptable or ineffective. Warner-Lambert has initiated early clinical trials with oral calcitonin, a natural hormone, that may prove more acceptable to patients. It is being developed with Unigene Laboratories.

The estrogen replacement therapy market last year was $1.9 billion with a growth rate forecast to be only 4.3 percent annually through 2006 by Frost & Sullivan. Competition from new, osteoporosis-specific drugs is slowing growth in the category. In addition, the ERT market will become more competitive with the introduction of new products.

Premarin from Wyeth-Ayerst is the category leader. Berlex is marketing Climara for prevention of postmenstrual osteoporosis, among other indications. It is an estradiol transdermal system for continuous delivery. The FDA has granted a postmenopausal osteoporosis indication to Activella (estradiol/norethindrone acetate) for women with an intact uterus. Approved April 11, it will be made available in tablet form by Novo Nordisk Pharmaceuticals.

Novartis has an estrodiol ERT named Vivelle in Phase III clinical trials. Johnson & Johnson has an oral contraceptive, norethindrone, in late clinical testing.

Overall, the osteoporosis market shows a pattern of continuous growth with new therapeutic entities and a growing patient base. However, the growth rate from 1999 through 2006 lessens annually from 25.5 percent to 7.1 percent. A particularly effective product is needed to make entry worthwhile for companies looking for blockbuster drug revenues.

Milton Liebman