The Immune/Inflammatory Pipeline: A Strategic Review

Decision Resources, Inc, May 2009, Pages: 37

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. Questions Answered in This Report 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? 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 Pfi zer; 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 fi rst-line therapies.

- Opportunities in immune/inflammatory diseases: Working to tap unmet needs; gaining access to niche indications.

Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
The Immune/Inflammatory Disease Pipeline
Emerging Agents Targeting Diseases with Unmet Needs
Companies Developing Immune/Inflammatory Disease Agents
Current Market-Leading Companies
Novartis
GlaxoSmithKline
Pfizer
Challenges and Opportunities in the Immune/Inflammatory Disease Market
Current Market-Leading Products Pose a High Hurdle for Emerging Therapies…
…But Also Leave Gaps That Provide Opportunities for Emerging Agents
Opportunities in Rheumatoid Arthritis
Opportunities in Chronic Obstructive Pulmonary Disease
Opportunities in Systemic Lupus Erythematosus
Outlook for Emerging Agents
Current Market Statistics
Pipelines and Companies
Will Mergers & Acquisitions Continue to Move the Market?
Will Market-Leading Companies Continue to Dominate?

Tables
1. Descriptions of Inflammatory and Autoimmune Disorders
2. Drug Classes Commonly Used to Treat Cardiovascular Diseases
3. Key Unmet Needs in Common Immune/Inflammatory Diseases
4. Immune/Inflammatory Market-Leading Companies, 2008
5. Top-Selling Immune/Inflammatory Drugs, 2008
6. Novartis’s Immune/Inflammatory Pipeline
7. GlaxoSmithKline’s Immune/Inflammatory Pipeline
8. Pfi zer’s Immune/Inflammatory Pipeline
9. Wyeth’s Immune/Inflammatory Pipeline

Figures
1. Percentage of Novel and Non-Novel Molecules in the Immune/Inflammatory Pipeline
2. Immune/Inflammatory Pipeline by Development Phase
3. Immune/Inflammatory Pipeline by Disease
4. Percentage of Immune/Inflammatory Pipeline Drugs by Type
5. Drugs Targets, by Number, of Immune/Inflammatory Pipeline Drugs
6. Development Activity by Company Size
7. Companies with Multiple Immune/Inflammatory Drugs in Development
8. Companies with Leading Immune/Inflammatory Pipelines, Number of Agents by Disease
9. GlaxoSmithKline’s Immune/Inflammatory Franchise Sales, 2008
10. Abbott Laboratories’ Immune/Inflammatory Franchise Sales, 2008
11. Immune/Inflammatory Sales by Therapy Area, 2003-2008
12. Immune/Inflammatory Disease Market Growth by Region, 2003-2008
13. Worldwide Sales of Immune/Inflammatory Drug Classes, 2008

- 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
- Pfi zer
- Roche
- Schering-Plough
- Takeda
- UCB
- Wyeth

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