Strategic Overview of Spondyloarthropathies: Tapping the Market Opportunity of Niche Immune Diseases

Abstract

Introduction

A trio of niche immune diseases have gained drug developers' attention after a period of strong sales growth. Treatment of these diseases, the spondyloarthropathies (SpAs), was revolutionized by the availability of TNF-alpha inhibitors and in turn these diseases proved to be a source of additional sales for these blockbuster agents. The sales trend, and the limited competition and remaining unmet needs in these indications, has prompted drug developers to consider whether and how to pursue these markets.

• Although ankylosing spondylitis, psoriatic arthritis, and reactive arthritis are grouped together as SpAs, treatment approaches have varied. What are the current first-, second-, and third-line therapies for these indications? What are their unique etiological components and unmet needs? What kind of efficacy and uptake have biologics seen in each indication?
• The SpAs are underdiagnosed and undertreated. What are the symptoms of these diseases? How are they diagnosed? How many people in the United States and Europe have an SpA? How will this population grow over the next ten years?
• Because of the high cost and increased use of TNF-alpha inhibitors, the SpA market overall has experienced strong growth over the past few years. How large is the SpA market? Will this market continue to grow? What new agents are in the pipeline for these diseases, and how will these agents perform in the market?
• In April 2009, the FDA approved Simponi (Centocor/Schering-Plough/Janssen/Mitsubishi Tanabe' s golimumab) for RA, AS, and PsA. What are this agent' s advantages? How do surveyed rheumatologists expect to use it in their medical practice?

Scope

• Primary research: Three disease-specific surveys of more than 100 U.S. rheumatologists.
• Overview of SpAs: Etiology, symptoms, and diagnosis.
• Current treatments and medical practice: NSAIDs, DMARDs, TNF-α inhibitors, corticosteroids, bisphosphonates; SpA treatment goals; first, second, and third lines of therapy; therapy switching trends.
• Epidemiology: Decision Resources epidemiology, disease-specific patient populations, tenyear growth forecasts, epidemiology methodology.
• Emerging agents: Centocor/Schering-Plough/Janssen/Mitsubishi Tanabe' s golimumab, approved by the FDA in April 2009; and the following developmental agents: Novartis' s AIN-457, Pozen/AstraZeneca' s PN-200 and PN-400, Bristol-Myers Squibb' s Orencia, Centocor/Medarex' s Stelara, Array Biopharma' s ARRY-371797, Celgene' s apremilast
• Market overview: 2008 AS, PsA, ReA, and undifferentiated SpA markets; outlook for current and emerging agents.
• Geographic scope: Six major markets - United States, France, Germany, Italy, Spain, United Kingdom.

• Abbott
• Amgen
• Array BioPharma
• Astellas
• AstraZeneca
• Boehringer Ingelheim
• Bristol-Myers Squibb
• Celgene
• Centocor
• Daiichi Sankyo
• Dava Pharmaceuticals
• Eisai
• GlaxoSmithKline
• Janssen
• Johnson & Johnson
• Medarex
• Merck
• Mitsubishi Tanabe
• Novartis
• Ovation
• Pfizer
• Pozen
• Procter & Gamble
• Sanofi-Aventis
• Schering-Plough
• Takeda
• UCB
• Wyeth