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Taking Advantage of Protein-Based Therapy Opportunities
Decision Resources, Inc, March 2011, Pages: 32
“The next decade will be about access and cost as much as it is about innovation” - a prophetic statement made in January 2011 by Biogen Idec CEO George Scangos. Innovation will always be the bedrock of the pharmaceutical industry, but expanding the commercial value of existing drugs generates the resources needed to fund that innovation. Biological therapies continue to excite Big Pharma. Premium pricing, high sales potential, and rapidly evolving protein-engineering technologies that make biologics even better (biobetters) are driving the industry’s fascination with exploiting new biologics opportunities.
Corporate goals in this arena increasingly focus on five major strategies: (1) increasing the proportion of biologics in R&D pipelines, (2) exploring biobetter opportunities, (3) further penetrating emerging markets with protein therapy brands, (4) exploring biosimilar opportunities, and (5) investigating opportunities for rare-disease therapies. This report examines recombinant protein therapies that are not monoclonal-antibody-based therapies.
Questions answered in this report:
- Therapeutic proteins are one of the more lucrative sectors of drug development and commercialization. What is the market size and projected growth of the different protein therapy market segments? What are the leading protein therapy (non-monoclonal antibody) companies in 2010, and which companies will lead in 2016? What are the blockbuster recombinant protein therapies?
- The branded generics component of emerging markets is very attractive to multinational companies (MNCs). How are these markets established? What has Pfizer been doing to establish a presence in these markets?
- By March 2008, Enbrel had been approved in more than 70 countries. What is Enbrel’s position in the BRIC markets? What MNC rheumatoid arthritis brands compete or will soon launch in the BRIC markets? What is the financial burden for patients seeking branded RA drugs in these markets?
- Many generics, pharmaceutical, and biotechnology companies are expressing an interest in biosimilars. What are CEOs from Biogen Idec and Amgen saying about entering biosimilar markets? Which companies are developing biosimilar therapies for RA, including biosimilar Enbrel?
- Numerous opportunities exist to tweak the structure of a protein therapy to make it better. What is the key to commercial success? Which companies are using pegylation and different fusion technologies to develop drugs? Which of these modified protein therapies are on the market or in late-stage development?
Scope of the report:
- Geographies: BRIC countries (Brazil, Russia, India, and China), emerging markets, United States, Canada, Western Europe, Scandinavian countries, Australia, New Zealand, South Korea, Latin America, Middle East, Africa, Central and Eastern Europe, Turkey, Japan, Europe, major pharmaceutical markets in Europe (France, Germany, Italy, Spain, and the United Kingdom).
- Pharmaceutical market sectors: Monoclonal antibodies (MAbs), synthetic peptides, small-molecule drugs, vaccines, other polymers, recombinant proteins (i.e., protein therapies), market sizes, growth, major companies marketing protein and peptide therapies, complex markets, brands, branded generics.
- Protein therapies: Polymers and peptide therapies, top-selling drugs, blockbusters, rheumatoid arthritis (RA) protein therapies, GLP-1 analogue therapies, biologics, biosimilars, modified protein therapies, biobetters, duration of action, long-acting therapies, enzyme replacement therapies (ERTs).
- BRIC market penetration: Enbrel (etanercept) in mature and BRIC markets; regulatory approvals; branded generics; RA brands and sales; RA market sizes; multinational companies (MNCs); pricing constraints; BRIC market characteristics; RA biosimilars; potential market entry dates in the United States, Europe, and Japan.
- Protein modification technologies: Pegylation, protein engineering, Fc immunoglobulin fusions, albumin fusions, CTP fusions, transferrin fusions, antibody fusions, glycopegylation, amino acid substitutions, C-terminal lysine residues, antibody fusions, specialized drug delivery formulations, acylation, a-aminoisobutyric substitutions, biodegradable polymer polylactide co-glycolide (PLG).
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