In 2006, the FDA Approved Only 24 New Molecular Entities – 6 of Which Were Either Biologics or Biotechnology-Derived Products
Research and Markets (http://www.researchandmarkets.com/reports/c55853) has announced the addition of new Decision Resources report “Are Biologics the Wave of the Future?” to their offering.
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 record setting deals. However, drug pricing, reimbursement issues, and anticipated biogenerics erosion represent significant 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 first-generation 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 biotechnology derived 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 biogenericsn erosion.
Content Outline:
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
List of Tables
List of Figures
Companies Mentioned:
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
Pfizer
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
For more information visit http://www.researchandmarkets.com/reports/c55853