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
|
Related Report
|
View Cart
