Biogenerics & Therapeutic Proteins Overview The consolidation process in the biogenerics industry has commenced after first approvals of biogeneric human growth hormone products in the US and the EU and first filings of biogeneric erythropoietin and insulin in the EU. Smaller biogeneric companies have been taken over by generic players from India and Eastern Europe . Large generic and hospital specialist companies have entered the field by acquisition and licensing deals. Apart from biogenerics, the US$ 42 bln market of the major therapeutic proteins (EPO, insulin, coagulation factors, interferons, G-CSF, hGH, enzyme replacement and FSH) is being challenged by competitor projects arising from various technologies. Oral small molecules or oral delivery of packaged or engineered proteins can bypass conventional next generation solutions such as pegylation, fusion proteins or non-invasive drug delivery technologies. Manufacturing of biopharmaceuticals is getting a commodity in non-regulated countries as local investors paid for technology transfer and infrastructure. Countries such as Egypt , Tunisia and Iran are joining pioneer countries such as Argentina , Cuba , India , South Korea and China which so far service domestic and other non-regulated and less developed countries. Indian companies such as Biocon now are on the move to the European Union with biogeneric proteins and are favored by a less costly local, yet GMP approved infrastructure. Biogeneric proteins not only may directly compete with first generation therapeutic proteins, but also serve for drug delivery solutions requiring larger amounts of protein. Cost-efficient manufacture by an advantageous infrastructure or less expensive expression systems may become crucial in future market competition. The major therapeutic proteins are not only being challenged by biogeneric developments in the Western countries, but also by innovative investigational new drugs. A state of the art approach is pegylation or glycopegylation of the parent protein, but protein engineering technologies may lead to the same effect of a longer half-life and also result in improved pharmacodynamic properties. Oral delivery approaches for hGH, insulin, and interferon are currently being evaluated while oral small molecules stimulating thrombopoiesis or erythropoiesis are already in advanced clinical testing. The use of clinical stage peptide agonist or peptibody molecules are an alternative to proteins such as EPO or TPO. Progress in protein engineering and expression made available recombinant plasmin becoming an attractive alternative to plasminogen activators because it directly degrades fibrin, but yet is readily neutralized. This Competitor Analysis provides a stakeholder evaluation in the US$ 42 bln markets of 10 major proteins: - Erythropoietin (EPO);
- Human growth hormone (hGH);
- Interferon;
- Insulin;
- G-CSF and GM-CSF;
- Follicle stimulating hormone (FSH);
- Thrombopoietin (TPO) agonists;
- Thrombolytics;
- Coagulation Factors;
- Enzyme Replacement Therapies.
Players in these markets are: - first generation product innovator companies;
- biogeneric companies in regulated markets;
- biogeneric companies in non-regulated or off-patent countries;
- drug delivery companies;
- device companies;
- next generation innovator companies of proteins, peptides and small molecules.
The competitor and pipeline analysis in the field of these major protein products as of April 2007 is structured in a tabular format. The products and projects are listed on 128 pages in ten chapters, one chapter for each protein. Information in the tables is provided on: - Drug Codes,
- Target / Mechanism of Action,
- Class of Compound,
- Company,
- Therapeutic Area, Drug Delivery Technology, Territory or Product Category;
- Indication,
- R&D Stage and
- additional comments with a hyperlink leading to the source of information.
Index - EPO
- EPO Market: Sales 2006
- First Generation Epoetins
- Second Generation Epoetins
- EPO Biosimilars
- First generation EPO in off-patent countries
- Next generation Erythropoiesis Stimulating Agents
- Next generation ESAs
- G-CSF & GM-CSF
- Branded G-CSF Products
- Biosimilar G-CSF products
- Next generation G-CSF products
- Off-patent G-CSF products
- Off-patent Pegylated G-CSF products
- Branded GM-CSF Products
- Off-patent and follow-up GM-CSF products
- hGH (Human Growth Hormone)
- hGH Market Sales 2006
- 1st generation hGH products in regulated markets
- 1st generation biosimilar hGH in regulated markets
- 2nd generation injectable hGH products in regulated markets
- 2nd generation hGH products in regulated markets
- Drug Delivery Activities for Hgh
- Low-cost manufacturing systems for hGH
- 1st generation hGH in "off-paten" countries
- 2nd generation hGH in "off-paten" countries
- Interferon
- Interferon Market: Sales 2006
- Interferon alfa
- 1st and 2nd generation biosimilar IFN alpha-2a
- 2nd generation interferon alpha-2a incl. improved manufacturing systems
- 1st generation IFN alpha-2a in "off-paten" countries
- 1st generation in "off-patent" countries
- 2nd generation IFN alpha-2b
- 1st generation IFN alpha-2b in "off-patent" countries
- Other rhu interferon alpha
- Purified interferon alpha
- Interferon beta
- Interferon gamma
- Other Interferons
- Interferon gene therapy
- Insulin
- Insulin Market: Sales 2006
- Insulin Market
- Inhaled Insulin
- Nasal Insulin
- Transdermal Insulin
- Oral Insulin
- Engineered Insulin
- Long-acting Insulin
- Follow-on Insulin
- FSH (Follicle stimulating hormone)
- FSH Market: Sales 2006
- First generation FSH
- Second generation FSH
- FSH in "off-patent" markets
- Delivery systems for FSH
- Third generation, glyco-engineered FSH
- Fourth generation of oral FSH receptor agonists
- Thrombolytics
- 1st generation (non-fibrin selective) fibrinolytics
- 2nd+ 3rd generation (fibrin-selective) fibrinolytics
- 4th generation fibrinolytics
- 5th generation fibrinolytics
- Fibrinolytics in non-regulated markets
- TPO (Thrombopoiesis-Stimulating Agents)
- Active projects
- Stand by or recently discontinued
- Coagulation Factors
- Sealants
- F. VIIa
- F. VIII
- F. IX
- F. XIII
- von Willebrand Factor
- ERT (Enzyme Replacement Therapies)
- Market of ERT
- Gaucher?s disease
- Fabry disease
- Pomp? disease
- Phenylketonuria
- CNS delivery
- Various Metabolic Diseases
- About La Merie Business Intelligence
About Competitor Analysis Series The Competitor Analysis Series delivers NO-FRILLS , but concise information about the pipeline of R&D projects for targets, diseases, technologies and companies at low prices. The information is provided in a tabular format and fully referenced. Competitor analysis reports can be purchased as individual products or obtained by subscribing to R&D Pipeline News. R&D Pipeline News is published weekly 50-times a year and each issue contains at least two competitor evaluations. Individual products from the Competitor Analysis Series and R&D Pipeline News are independently elaborated by analysts of La Merie Business Intelligence and distributed by PipelineReview.com.
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