The Immune/Inflammatory Pipeline: A Strategic Review

Abstract

Introduction

The current immune/inflammatory pipeline is over 375 drugs strong, with approximately 250 companies involved in these agents' development. Yet, despite this robust pipeline size, Decision Resources analysts do not believe that any one agent in development will significantly alter the way physicians treat their patients with immune/inflammatory disorders. Nonetheless, opportunities exist for companies that develop treatments for specific unmet needs in this therapeutic area. While these opportunities will not yield the kind of cross-indication blockbuster returns previously seen in this therapeutic area, investing R&D money in the immune/inflammatory area still seems worthwhile.

• The immune/inflammatory market experienced steady growth from 2003 through 2008. What drug classes contributed most to this steady increase in sales? What other factors play a role in market growth in this therapeutic area?
• The failure rate of current biologics for rheumatoid arthritis (RA) and similar indications is high enough to justify the need for more-efficacious treatments. Does the pipeline feature novel agents with potential for higher efficacy than current agents? Which indications within this therapeutic area are drawing the most interest from developers?
• The immune/inflammatory therapeutic area is lucrative and will likely continue to be so in the future. Which companies are the current market leaders? Which companies are attempting to enter, grow, or defend their position in this market?
• Replicating the success of today' s immune/inflammatory agents presents a challenge to developers of novel treatments. How do regulatory requirements complicate R&D efforts? How can drug developers working in this area maximize their chances of success?

Scope

• 2008 market: 2008 sales; leading drug classes; market-leading companies; commercial position of leading agents.
• The immune/inflammatory disease pipeline: Number of agents in development; disease focus; active companies; profiles of Novartis, GlaxoSmithKline, and Pfizer; mechanisms of action; company type; phase analysis; novel formulations versus reformulations; smallmolecule drugs versus biologics.
• Immune/inflammatory diseases focused on in this report: Ankylosing spondylitis; asthma; chronic obstructive pulmonary disease (COPD); Crohn' s disease (CD); psoriasis; psoriatic arthritis; rheumatoid arthritis (RA); Sjogren' s syndrome; systemic lupus erythematosus (SLE); ulcerative colitis (UC).
• Challenges in immune/inflammatory diseases: Regulatory issues; challenging first-line therapies.
• Opportunities in immune/inflammatory diseases: Working to tap unmet needs; gaining access to niche indications.

• Abbott Laboratories
• Amgen
• Array BioPharma
• AstraZeneca
• Boehringer Ingelheim
• Centocor
• CombinatoRx
• Dong-A Pharmaceutical
• Eisai
• Eli Lilly
• Genentech
• GlaxoSmithKline
• Johnson & Johnson
• Medimmune
• Merck & Co.
• Merck Serono
• Mitsubishi Tanabe Pharma
• Novartis
• Pfizer
• Roche
• Schering-Plough
• Takeda
• UCB
• Wyeth