R&D innovations to drive growth in osteoporosis market

With key R&D trends in the field of osteoporosis treatments focusing on novel dosing regimens and expanded indications, the market is set for strong growth driven by new product entrants. A flurry of launch activity is expected between 2004-8 and six key products should reach the market in this time. Research from Datamonitor analyzes the products and trends likely to spur this growth.

In 'Pipeline Insight: Osteoporosis', Datamonitor analyzes the main pharmacologic approaches to preventing and treating osteoporotic bone loss and benchmarks the key drugs in development in a number of drug classes: bisphosphonates, SERMs, parathyroid hormones, calcitonins, and others. Innovations in the pipeline are further investigated with a summary of projects in the early stages of development to give an indication of future treatment directions.

Antiresorptives challenge established brands

Antiresorptive agents, drugs that slow down or halt the rapid loss of bone characteristic in osteoporosis, dominate current treatment. Key marketed products with this kind of activity include the bisphosphonates, such as the Merck & Co.'s market-leading Fosamax and second-in-class Actonel (P&G/Aventis), as well as another top selling drug, Eli Lilly's Evista (raloxifene), a selective estrogen receptor modulator (SERM).

The pipeline holds two new drugs in each of these classes with the potential to oust established brands from their market position. New bisphosphonates Boniva and Zometa could offer benefits over older drugs such as Fosamax and Actonel, although therapeutic efficacy is not expected to differ greatly between these products. 

The primary benefits of the new bisphosphonates are their longer dosing intervals; whereby monthly, quarterly and yearly doses are in development, versus the weekly regimens currently available. These novel regimens could offer patients greater convenience by lowering the number of tablets or doses they have to take, and help improve poor compliance rates by reducing the likelihood of missed or inaccurately administered doses.

Potential blockbusters in development

Datamonitor believes Zometa's yearly dose, currently in phase III trials, could garner blockbuster sales by 2011, while positive trial results for monthly or quarterly Boniva could drive sales of up to $800 million over the same period.

Novel SERMs (selective estrogen receptor modulators) are taking a different tack in the R&D stakes. In this class, Pfizer's lasofoxifene is in trials investigating potential beneficial effects on breast cancer prevention and heart disease, as well as osteoporosis. Positive results in these areas would make the drug very attractive to patients at-risk for those conditions and postmenopausal bone loss, vastly extending the drug's patient potential.

Wyeth's approach to its SERM bazedoxifene targets the range of menopausal symptoms. The drug is in trials with Premarin as a potential new hormone therapy product. However, with the aftermath of the WHI still negatively affecting HRT sales, the clinical data on this combination product will likely undergo close scrutiny and commercialization could be difficult.

Forteo under pressure

Osteoporosis is a progressive bone deterioration disease and novel bone-forming drugs are one of the most promising approaches to improving bone density and preventing fractures. Lilly's PTH drug, Forteo, launched in December 2002, is currently the only drug on the market capable of building new bone. However, new anabolic agents are set to hit the market by 2005, opening it up to direct competition and widening the treatment choices.

Key anabolic agents in the pipeline are NPS Pharmaceutical's Preos, a full length recombinant version of the PTH hormone from which Forteo is also derived, and Servier's Protos (strontium ranelate), a salt reported to have both an anti-resorptive and anabolic effect on bone. Both these drugs have recently reported results from their pivotal phase III trials detailing fracture reduction efficacy, and are expected to file for approval later in 2004.

Preos in particular could achieve sales of over $430 million by 2011, and is expected to drive class sales growth by over 40%. The drug will be Forteo's first direct competitor, but will be at a disadvantage both in terms of NPS's marketing power, currently without a commercial partner for the drug, and Lilly's three years detailing experience with their product by the time Preos is launched.

Pipeline drugs to drive growth

The early stage pipeline (phase II or lower) is bursting with potential candidates for osteoporosis treatments. The focus on innovation is clear among these drugs, an approach distinct from products in the later stage pipeline where the candidates are second-third to market, or me-too drugs. Successful development of the early pipeline could see the introduction of five entirely new therapeutic classes to the market.

Antiresorptives nevertheless look set to dominate therapy, although there should be room for various treatments with market sales forecast to reach $10.4 billion by 2011, from approximately $5.0 billion in 2003 (excluding HRT sales).

"The impending launch of six new osteoporosis drugs over the next four years will shake up the market and offer patients and physicians an unprecedented choice of treatment options," comments Victoria Williams, Women's Health analyst at Datamonitor.

"Crucial to the success of pipeline drugs will be clinical equivalence or improvements in vertebral and non-vertebral fracture reduction compared to established products, as well as clear benefits in side effects, delivery, dosing and cost-effectiveness. However, the patent expiry of market-leader Fosamax in 2008, and entry of generic equivalents, could limit the sales potential of some of the newer anti-resorptives."

Related research:

• Pipeline Insight: Osteoporosis - Intermittent Dosing and Multiple Indications Drive Market Growth - $10,200.00

• Disease Modifying Osteoarthritis Drugs - The Search for the 'Holy Grail' Continues - $1,600.00

• Commercial Insight: Osteoporosis & HRT - HRT is down for the count, but can osteoporosis players pick up the pieces? - $12,800.00

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