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Business Strategies for Different Types of Biogenerics

Published by: Decision Resources

Published: Nov. 27, 2007 - 32 Pages


Table of Contents


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Abstract

The rush to develop and market biogenerics has begun. While the United States dragged its feet drafting legislationto codify issues surrounding biogenerics, biogenerics companies have successfully brought products to severalother markets around the world. Looking forward, developers of biogenerics must monitor not only the nuancesof specifi c biologics markets but also the long-term commitment they will be required to make when developingbiogenerics and the signifi cant capital investment that will be required to achieve success. On the other side ofthe coin, originator companies have much to lose from the uptake of biogenerics. Second-generation productsdesigned to extend the half-lives of biologics and to protect brand franchises have never been more important inorder to fend off the challenge of a new category of drugs that will have more impact on biologic markets over thenext ten years than any other single factor. Above all else, however, innovative new products are needed to expandpharmaceutical markets, not just to replace market share lost to biogeneric erosion.

Get the Answers You Need to Shape Your Strategy:
  • Companies developing biogenerics must gauge the likelihood that a more innovative product may supersede •the originator biologic product they are targeting. In which area of U.S. and European biologics marketshave innovative, modifi ed products almost completely replaced unmodifi ed versions?
  • To date, the European market is the most complex market for erythropoiesis-stimulating proteins (ESPs) •and encompasses all three types of competing ESPs (brands, biogenerics, and modifi ed brands). Whichcompanies have ESPs on the market in Europe, and how successful are these companies’ drugs?
  • Adherence to strategies that guide the development of biogenerics can optimize a company’s chances of •success in today’s morphing biologics marketplace. What strategies should companies consider whendeveloping biogenerics?
  • Oncologists and endocrinologists in the United States, France, and Germany have nuanced, product-specifi c •perspectives regarding the adoption of specifi c biogeneric products (including biogeneric ESPs, granulocyteG-CSF, insulin, and hGH). How robust will clinical studies of these biogeneric products need to be for amajority of these physicians to become comfortable prescribing biogeneric agents?
Scope
  • Understanding the markets: • contending with originator brands, second-generation brandedbiologics, other biogeneric entrants, and other branded biologics.
  • How the process defi nes the product: • the fundamental differences between traditional small-moleculepharmaceuticals and biologic agents; the pivotal role of companies’ trade secrets; manufacturingvariabilities and the Ebrex disaster; assessing therapeutic equivalence for biologic products.
  • Selecting the right comparator: • how selection determines the amount of preclinical and clinicalstudies required; legal impediments; commercial considerations.
  • Establishing a manufacturing process: • the role regulators play in biomanufacturing protocol; therole of development efforts and costs associated with standardizing and optimizing biologic productmanufacture; the advantages of de novo manufacturing processes.
  • Establishing comparability: • preclinical studies; clinical development; pharmacodynamic markersand safety databases; target indications; minimum trial requirements.
  • Anticipating long-term studies of immunogenicity: • pharmacovigilance and postmarketing commitments.
  • Pricing strategies: • the role of market competition; principal drivers of biogenerics adoption; thepricing strategies of Omnitrope and Genotropin.
  • Promotion strategies: • nuanced, product-specifi c perspectives of physicians in the United States,France, and Germany.
  • Outlook: • the major drivers behind the push for biogenerics; requirements for success in thebiogenerics market; the unique competitive environment lying ahead.


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