Are Biologics the Wave of the Future?

Published by: Decision Resources

Published: Mar. 30, 2007 - 29 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Still Time to Jump On the Bandwagon

The Worldwide Biologics Landscape

Few Biologics Players Dominate

Amgen’s Reign as Biologics King

Genentech’s Very Successful Ride with Roche

Johnson & Johnson’s Profi ts from Early Biologics Acquisition

Novo Nordisk

Big Pharma’s Lack of Early Interest

Biologics Are Booming—Especially MAbs

New Molecular Entities

Specialized and Niche Markets

MAbs Are Driving Extraordinary Growth

Biologics Development Pipelines

Deal Mania—Ante Up

Recent Biologics Converts

AstraZeneca

Novartis

Pfizer

Anything MAb Is on the Auction Block

Big Buyouts Through Mergers and Acquisitions

Bayer Schering Pharma

Merck Serono

GlaxoSmithKline Acquires Domantis

Amgen Acquires Abgenix

AstraZeneca Acquires Cambridge Antibody Technology

Merck & Co. Acquires Abmaxis

Glycoengineering Is Really Hot

Biologics Pricing and Cost-Effectiveness

Price Comparisons

The Cost of Developing Biologics

Cost-Effectiveness and Drug Reimbursement

Biogenerics

Regulatory Environment

Biogenerics Pricing

Biogenerics Market Dynamics

Outlook

Tables:

1. Major Biologics Companies: 2005 Sales and Projected 2012 Sales of Key Biologic Products

2. Select Biologics Under Development, March 2007

3. Acquisitions and License Agreements for Late-Stage Biologics, 2005 and 2006

4. Recent Acquisitions of Biotechnology Companies with Biologics Optimization Technologies

5. Cost-Effectiveness of Select Biologics

Figures:

1. The 100 Best-Selling Pharmaceutical Products Worldwide, By Technology, 2006

2. Best-Selling Biologics Worldwide, 2006

3. Approvals of New Biopharmaceutical Products in the United States, 1990 Through October 2006

4. Projected Growth in Biologics Sales, 2001-2010

5. Average Prices of Leading Biologics, Small-Molecule Drugs, and Pharmaceuticals Overall in the Major Markets as a Percentage of U.S. Prices

6. Total Capitalized Cost per Approved Biopharmaceutical, 2006

7. Biogenerics Market Dynamics, 2005-2015

Abstract

• In 2006, the FDA approved only 24 new molecular entities—6 of which were either biologics or biotechnology-derived products. Which of these new biologics are predicted to become blockbusters? What lessons does the rate of FDA approval for biologics hold for companies interested in developing new biologics?
• In recent years, the number of monoclonal antibodies (MAbs) under development has far outpaced the growth of other types of drugs, in part because of the premium prices MAbs command. Which companies currently have promising MAbs in late-stage development? What commercial and clinical limitations of fi rstgeneration MAbs is the new generation of MAbs, currently in development, hoping to overcome? What does GlaxoSmithKline’s 2006, record-breaking acquisition of Genmab indicate about the future market for MAbs?
• Only a few players dominate the biologics market; however, big pharma is now on a rampage to acquire early-to late-stage biologic products and smaller biologics companies. Which big pharma companies are recent converts to the promise of biologics? How are acquisitions enabling these companies to refocus their pipelines?
• Biologics are steadily being improved by new therapeutic protein optimization technologies. What does Merck’s acquisition of GlycoFi in May 2006 indicate about the potential value of glycoengineering?
• The market success of biologics is directly related to the premium prices biologics command. New legislation limiting the pricing of biologics is on the horizon, however. What strategies should the biologics industry employ to ensure that a mutually acceptable pricing agreement is reached with physicians, legislators, and the public at large? How will the imminent threat of biogenerics affect biologics pricing?

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