Abstract
Introduction
The osteoporosis market has traditionally been dominated by the bisphosphonate
drug class, championed by Merck' s once-weekly Fosamax (alendronate) and
Procter & Gamble[P&G]/Sanofi-Aventis' Actonel (risedronate). This will change
dramatically over the forecast period as smaller classes gain significant
share, new bisphosphonates enter the market, and Fosamax goes generic in the
US. Eli Lilly will emerge as the number one drug company in osteoporosis by
2011, largely by staying away from the increasingly competitive bisphosphonate
segment. Eli Lilly, which will comprise about 30% of the osteoporosis market
by the end of the forecast period, has two major brands in its osteoporosis
product portfolio-neither of which belongs to the dominant bisphosphonate drug
class: the selective estrogen-receptor modulator (SERM) Evista (raloxifene)
and a parathyroid hormone analogue (PTH) Forteo (teriparatide). In the
bisphosphonate market, the traditional stalwarts from Merck, P&G, and
Sanofi-Aventis are increasingly being challenged by new, less-frequently dosed
therapies while operating under the looming threat of new drug classes and the
genericization of the leading therapy, Fosamax.
Despite retaining the continental European patent for Fosamax, Merck' s
market-leading position in bisphosphonates--which generated over $2 billion in
osteoporosis revenues in 2006--will be decimated by generic versions of the
drug in the US, Japan, and the UK. Merck will see its market share drop from
nearly 40% in 2006 to 9% percent in 2011. Lilly is poised to fill the gap in
this newly competitive market along with a number of other companies including
Wyeth, Amgen, and Novartis, who will each more than double their market share
by 2011. Over 20% of physicians surveyed for this report predict that Wyeth
will be the most influential osteoporosis company over the next five years due
to the launch of Viviant and Aprela. Gynecologists, in particular, give the
company high marks on its sales force and physician and patient education.
Novartis and Amgen will also gain significant share due to a once-yearly
injectable bisphosphonate (Novartis' Reclast/Aclasta [zoledronate]) and a
twice-yearly first-in-class biologic (Amgen' s denosumab).
Questions Answered in This Report
- - Fosamax is widely considered the first-line therapy of choice for
osteoporosis treatment, however the drug loses patent protection in Japan and
the US in 2008, and already lost protection in the UK in 2005. However,
Merck' s drug will continue to be protected in continental Europe well past
2011. What effect will alendronate generics have on the osteoporosis market
in the US? How will Merck remain active in osteoporosis after losing its major
brand? How will continental European osteoporosis treatment diverge from the
US, UK, and Japan after the entry of alendronate generics?
- - The SERM Evista has long been part of the osteoporosis pharmacologic
armamentarium, but did not become the major bisphosphonate competitor that
many observers forecasted. In September 2007, the FDA approved a breast cancer
protection indication for the drug. How will Evista' s new labeling affect
its sales, and the sales of new SERMs? What do doctors think of Evista
relative to the oral bisphosphonates? How will emerging SERMs be positioned in
the osteoporosis market?
- - Bisphosphonates can cause severe gastrointestinal irritation in a
minority of patients, leading to noncompliance or even discontinuation.
Ever-more-tolerable and less-frequent formulations of bisphosphonates have
been pursued since this was first discovered, leading to the weekly
formulations of Fosamax and Actonel, stimulating the once-monthly Boniva, and
now the launch of Novartis' once-yearly Reclast (zoledronate). How
important is dosing frequency to physician prescribing habits? Will
less-frequent branded bisphosphonates that are largely undifferentiated from
alendronate succeed against the inexpensive generic agents after 2008?
- - While SERMs and bisphophonates are osteoporosis stalwarts, new classes
and drugs are being developed that will challenge these drug classes. Wyeth is
preparing a successor to its major HRT franchise, Premarin, with a combination
of SERM and HRT labeled Aprela (bazedoxifene/equine estrogens). This drug will
purportedly combine the beneficial effects of Premarin on menopause symptoms,
while providing the bone and breast tissue protection of SERMs. Meanwhile
Amgen, under siege from recent difficulties with its anemia franchise, is
preparing its next blockbuster, denosumab. Denosumab is a biologic member of
the RANKL-inhibitor class, and will represent the first biologic in
osteoporosis. How are the companies positioning emerging agents prior to
their launch? What conclusions can be drawn from clinical trial design, public
statements and other data sources regarding future development plans? What
features of emerging agents promise to challenge current therapies?
Scope
- Markets Covered: United States, France, Germany, Italy, Spain,
United Kingdom, and Japan.
- Competitive Analysis: Detailed discussion of major competitors
including Merck & Co., Eli Lilly, Procter & Gamble, Sanofi-Aventis, Novartis,
Wyeth, Roche, GlaxoSmithKline, Servier, and Amgen. Included is an analysis of
each company' s osteoporosis product portfolio, strategic positioning, and
development pipeline. The report features an in-depth discussion of leading
brands including approval history, sales and market position, SWOT analysis,
and on-going life cycle management initiatives.
- Physician Perception of Key Brands: Analysis of physician
perceptions in the psoriasis based on a custom survey of 30 US-based
gynecologists and 30 US-based PCPs. The survey is brand-focused and examines
physician perceptions of key competitors, brand attributes, and uptake of
emerging agents.
- Epidemiology: Total prevalent and diagnosed cases of both
osteoporosis and osteopenia (the precursor to osteoporosis) for each of the
major markets are presented in an annualized forecast from 2006 to 2011.
- Market Forecast: Annualized sales forecasts for branded agents
presented by region, drug class, molecule, and brand for 2006 to 2011,
including the uptake of new agents.
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