Special Report: Acute and Chronic Gout—New Agents Target Refractory Patients and Tap Market Opportunity

We forecast a tenfold sales increase in the chronic gout sector and a tripling in sales of acute gout therapies-this robust outlook reflects major change in the long-dormant gout marketplace driven by recent approvals of novel, and pricy, therapies. Gout remains an active focus of R&D and market competition-good news for the large patient population experiencing chronic gout and its acute flares. For the first time in more than 40 years, novel chronic gout agents have launched. Takeda's Uloric/Ipsen's Adenuric (febuxostat) presents a new challenge to well-established therapies, and Savient Pharmaceuticals' Krystexxa (pegloticase) seeks to address the specific needs of patients who experience refractory and tophaceous gout as well as extreme, chronic, inflammatory gout attacks. Uptake of these novel agents will significantly increase the value of the chronic gout market. Nonetheless, significant unmet need remains for therapies that can better lower urates and address the pain of acute gout, and do so while offering a superior safety profile.

Questions Answered

• Gout is a common reason for outpatient visits. How many cases of diagnosed chronic gout exist in the major pharmaceutical markets we cover? How often do patients experience acute episodes?
• Most gout patients present to and are managed by primary care physicians/general practitioners (PCPs/GPs), and Decision Resources' primary research on gout focuses on these physicians for the purpose of this report. What do they tell us about their current approaches? How will they incorporate new agents into their practices? What unmet needs do they identify?
• Takeda's Uloric/Ipsen's Adenuric was launched in the United States in 2009 and in Europe in 2008; Savient's Krystexxa (pegloticase) received FDA approval in September 2010. How will these new contenders perform against existing established agents such as Prometheus Laboratories' Zyloprim/GlaxoSmithKline's Zyloric (allopurinol; also available generically)? How do interviewed physicians envisage Uloric/Adenuric and Krystexxa fitting into patterns of treatment for chronic gout? What market share will they capture?
• In September 2010, the FDA indicated its intention to ban all unapproved oral colchicine products for the treatment of gout. What does this move mean for URL Pharma, which recently secured approval for a branded colchicine, Colcrys? What is the likely impact on treatment patterns?
• With a series of new agents being launched, the gout market is at its most active in several decades. What opportunities remain for novel therapies for the treatment of acute and chronic gout? What do physicians desire from novel therapies?
• Savient has made clear that, upon approval of Krystexxa, it will seek a buyer for the company. What are the expectations of other contenders in this space? What drivers and constraints must they heed?

Scope

• Markets covered: The major pharmaceutical markets: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
• Primary research: More than a dozen country-specific interviews with both thought leaders and PCPs/GPs.
• Epidemiology: Diagnosed prevalent cases of chronic gout and number of acute gout flare events in the major markets over 2009-2019.
• Emerging therapies: Phase II and III drug development for acute and chronic gout.
• Market forecast features: Acute and chronic gout markets, 2009-2019; market drivers and constraints.

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