生物製剤の将来動向

Abstract

Introduction:

Biologics have been good to the pharmaceutical industry- a trend that will continue for the foreseeable future as a raft of new and improved biologics comes to market. Some companies rode the crest of the biologics wave that began 25 years ago while others were left behind. Big pharma, in particular, has taken a long time to recognize the vital importance of biologics in today' s marketplace. Big pharma is now on a rampage, entering the extraordinarily "hot" biologics licensing and acquisitions game, which is characterized by recent recordsetting deals. However, drug pricing, reimbursement issues, and anticipated biogenerics erosion represent signifi cant challenges to the status quo, and 2007 will be a pivotal year for legislative action.

Get the Answers You Need to Shape Your Strategy:

• 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 earlyto 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?

Scope

• The worldwide biologics landscape: the dominant companies; blockbusters, mega-blockbusters, and specialized markets.
• The current boom in biologics: monoclonal antibodies, recombinant proteins, and biotechnologyderived vaccines; specialized markets; and biologics pipelines.
• Deal mania: licensing agreements, product acquisitions, and M&A activity.
• Pricing and cost-effectiveness: price comparisons, cost of developing an approved biologics drug, drug reimbursement, and harmonization standards in Europe.
• Biogenerics: regulatory environment, pricing, and market dynamics.
• Outlook: challenges to current pricing and reimbursement structures and the threat of biogenerics erosion.

Companies Mentioned in This Spectrum Report

• Abbott Laboratories
• Abgenix
• Abmaxis
• Alexion
• Alkermes
• Amgen
• Applied Molecular
• Evolution
• AstraZeneca
• Baxter International
• Bayer AG
• Bayer Healthcare
• Bayer Schering Pharma
• Bioceuticals Arzneimittel
• Biogen Idec
• Bioren
• BioRexis
• Bristol-Myers Squibb
• Cambridge Antibody
• Technology
• Celtic Pharmaceutical
• Centocor
• Corixa
• CureTech
• Daiichi Sankyo
• Danisco
• Domantis
• Eisai
• Elan
• Eli Lilly
• Genentech
• Genmab
• Genzyme
• GlaxoSmithKline
• Glycart Biotechnology
• GlycoFi
• Hoffman-La Roche
• Hospira
• Human Genome Sciences
• ImaRx Therapeutics
• ImClone Systems
• Immunex
• Immunomedics
• InterMune
• Johnson & Johnson
• Ligand Pharmaceuticals
• Lundbeck
• Medarex
• MedImmune
• Merck & Co.
• Merck KGaA
• Merck Serono
• Millennium
• Pharmaceuticals
• Neurobiological
• Technologies
• Novo Nordisk
• Novartis
• Ortho Biotech
• Paion
• PDL BioPharma
• PDL Pharmaceuticals
• Pfi zer
• Protherics
• Regeneron Pharmaceuticals
• Rinat Neuroscience
• Roche
• Sandoz
• Sanofi -Aventis
• Savient Pharmaceuticals
• Schering AG
• Schering-Plough
• Seattle Genetics
• Serono
• Shire Human Genetic
• Therapies
• Takeda
• Talecris Biotherapeutics
• Tanabe Seiyaku
• Teva
• Transkaryotic Therapies
• UCB
• Valeant Pharmaceuticals
• Valera Pharmaceuticals
• Wyeth
• ZymoGenetics

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
    • GlaxoSmithKline
    • 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