Fibromyalgia - Decision Resources

What emerging drugs will be the first to be approved for fibromyalgia? Will such emerging drugs significantly expand this market? How will medical practice for fibromyalgia change once drug companies market these new therapies? Where does the greatest unmet need remain in this market?

Fibromyalgia is one of the most common diagnoses made in rheumatological practice, yet the causes of this condition remain unknown and the treatments remain largely ineffective. Indeed, no drugs are yet labeled to treat fibromyalgia in any of the seven major pharmaceutical markets we study. Such a grim situation has left the market wide open for new drugs that show even modest efficacy. While several pharmaceutical companies are now investigating their respective compounds in large-scale fibromyalgia trials, none has yet proven highly effective for such patients. Nevertheless, such agents are poised to grow the market from $300 million in 2004 to more than $1 billion in 2014 simply by offering physicians new treatment options that boast official regulatory agencies' stamp of approval. A greater understanding of the pathophysiological processes underlying fibromyalgia could expand this market beyond the projected $1 billion because it would allow physicians to make rational, mechanism-based treatment decisions. Such an understanding remains a major area of unmet need.

In 2004, the number of prevalent cases of fibromyalgia in the major markets exceeded 14 million, but less than 20% of these cases were diagnosed and drug-treated. Because of such poor diagnosis and a paucity of effective drugs for fibromyalgia, the prescription drug market for this condition is negligible. Considerable drug development activity in this relatively sleepy market over the forecast period will drive newfound growth, leading to fibromyalgia drug sales in excess of $1 billion in the seven pharmaceutical markets we cover.

Evidence-based treatment approaches are a major area of unmet need in fibromyalgia. Indeed, no drugs are currently approved to treat this condition, and those that have been studied in clinical trials for fibromyalgia have shown only very modest benefit. To make rational treatment decisions, physicians require much more robust data from well-controlled trials in this patient population.

Physicians prescribe a wide variety of drugs to treat fibromyalgia because individual drugs provide only minimal benefit in this decidedly heterogeneous patient population. While this trend will continue throughout our forecast period, new compounds that gain official labeling for fibromyalgia will increasingly replace older agents in physicians’ armamentarium of drugs to treat this condition. Nevertheless, although new compounds will ultimately dominate in terms of market share because of their relative cost, peak-year sales for such compounds in fibromyalgia will be limited by what thought leaders say is this patient populations’ universally poor response to drug therapy.

Uncover the market potential for drugs set to enter this highly untapped market over the next decade.

Discover what physicians are looking for in new drugs to treat fibromyalgia.

Examine the advantages and disadvantages of entering the fibromyalgia market over the next decade.