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Novel Antibodies & Therapeutic Proteins: Technology Challenges & Future Prospects

PharmaVision
August 1, 2010
170 Pages - SKU: PBA2751095

Abstract Table of Contents Search inside this report Related Reports

This innovative & analytical report can be used to assess market trends & appraise the potential of new antibodies & therapeutic proteins. It provides perspective to:

gain an in-depth understanding of the marketplace, players, products & leading technologies driving the field;
evaluate the unmet clinical needs, product pipelines & technological challenges for the next generation of mAbs & TPs;
identify the key regulatory, IP & reimbursement issues which face biopharmaceutical companies;
assess the therapeutic potential of new mAbs & TPs targeting cancer, immuno-inflammatory related disorders, CNS disorders & others;
identify the potential threat of biosimilars & examine their impact on the prescription & development of new biologics now & in the future;
analyze the market trends & highlight future market opportunities.

Key Findings: Introduction: Historical Milestones & Impact on the Pharma Industry; Monoclonal Antibodies: Market Segmentation, Size & Trends; Therapeutic Proteins: Market Segmentation, Size & Trends; Challenges & Advances in Discovery, Development & Commercialization of TPs; Regulation, IP & Reimbursement Issues; Industry Perspective & Future Prospects
Chapter 1 Introduction: Historical Milestones & Impact on the Pharma Industry: Key Findings; Overview, definitions, and historical milestones; Monoclonal antibodies; Therapeutic Uses of mAbs; Therapeutic proteins; Impact of biopharmacy on the pharma industry; R&D; Product formulation & marketing; Pharma-biopharma alliances; Pharma majors; Overall Conclusions; Report Structure
Chapter 2 Monoclonal Antibodies: Market Segmentation, Size & Trends: Key Findings; Monoclonal Antibodies: Types; Murine; Chimeric & humanized antibodies; Chimeric; Humanized; Fully human; Antibody fragments; Monoclonal Antibodies: Uses; Cancer; Naked antibodies; Conjugated antibodies; Radiolabelled antibodies; Chemolabelled antibodies; Immunotoxins; Anti-TNF; Other indications; Autoimmune diseases; Bacterial infections; Bone disorders; Cardiovascular disease; CNS disorders; Pain; Monoclonal Antibodies: The Market; Front Runners: Products; Front Runners: Companies; Abbott Laboratories; Biogen Idec; Bristol-Myers Squibb; Genentech; Johnson & Johnson; Other mAbs; Monoclonal Antibodies: The Future; Ones to Watch: Pipeline Products; Oncology; Head and Neck; Ovarian; Melanoma; Renal cell; Immuno-inflammatory diseases; Rheumatoid arthritis; Eosinophilic esophagitis; Other Indications; Autoimmune diseases; Systemic lupus erythematosus; Type 1 diabetes; CNS disorders; Alzheimer’s disease; Infectious diseases; Bacterial infections; Pain; Ones to Watch: Companies; Amgen; Bioinvent International AB; Celdex Therapeutics Inc; Genmab A/S; Glycotope GmbH; ImmunoGen; Pfizer; Seattle Genetics; Tolerx; Wilex AG; Conclusions
Chapter 3 Therapeutic Proteins: Market Segmentation, Size & Trends: Key Findings; Therapeutic Proteins; Therapeutic Proteins: Classes; Insulin; Growth hormone; Haemopoietic growth factors; Erythropoietin; Colony-stimulating factors; Cytokines; Interleukins; Coagulation factors; Therapeutic Proteins: The Market; Front Runners: Products; Insulin products; EPO products; Coagulation factor products; Ones to Watch: Pipeline Products; Early stage; Cytokines; Haemopoietic growth factors; Late stage; Front Runners: Companies; Specialist companies; Amgen; Biogen Idec; Genentech; Major pharmaceutical companies; Baxter International; CSL Behring; Eli Lilly; Ipsen; Merck Serono; Novo Nordisk; Sanofi Aventis; M&A Activity; Ones to Watch: Companies; Agennix AG; Akebia Therapeutics, Inc.; Biovitrum AB; Cytheris SA; Dyax; ERYtech; H. Lundbeck A/S; Helix BioPharma; Human Genome Sciences; Immutep SA; Octapharma AG; Phosphagenics; Proteon Therapeutics; Shire; Teva Pharmaceuticals; ThromboGenics NV; ZymoGenetics; Conclusions
Chapter 4 Challenges & Advances in Discovery, Development & Commercialization of TPs: Key Findings; Phage display; High-throughput screening; New Classes of Therapeutic Proteins; Major histocompatibility complex proteins; Phage display of MHCs; Yeast cell surface display of MHCs; T cell receptors; Protein fusions & rational design; Phage display of TCRs; Yeast surface display of TCRs; TCR -like antibodies; Targets for New Monoclonal Antibodies; Production Challenges; Making New Therapeutic Proteins “Fit For Purpose”; Improving Pharmacokinetics; Fusion; Glycosylation; Pegylation; Reducing Immunogenicity; Genetic Engineering; Display technologies; Phage display; Cell surface display; Cell free display; Commercial Production; Manufacturing capabilities; Mammalian cell culture—still the most widely-used system; Therapeutic Proteins: Production Challenges; PTM glycosylation; PTM misfolded proteins; Protein aggregation; Oxidation; Deamidation; Plant-based Protein Production; Case Study: Protalix ProCellEx™ plant cell system; Case Study: Biolex Therapeutics LEX system; Non-invasive Protein Delivery; Proteins & peptides: nature vs. pharmaceuticals; Advanced Injection Technologies; Conclusions
Chapter 5 Regulation, IP & Reimbursement Issues: Key Findings; Towards regulatory harmonisation; Data requirements; Local partners; GMP compliance; Inspections; Suppliers’ compliance; Communicating with the regulators; Regulation of biosimilars; Intellectual Property Issues; Recombinant DNA technology; Monoclonal antibody technology; Evolution of mAb technology; Current status of technology; Cost & Reimbursement Issues; Conclusions
Chapter 6 Industry Perspective & Future Prospects: Key Findings; Market size; Product trends; Industry trends; Market Trends; Production & manufacturing; R&D & product development; Monoclonal antibodies; Cancers; Immuno-inflammatory diseases; CNS diseases; Infectious diseases; Therapeutic proteins; Trends in personalised medicine; Commercial relevance; Delivery trends; Inhalation; Transdermals; Therapeutic Growth; Patient & disease demographics; Personalised medicine; Companion diagnostics; The Biosimilar Market; Opportunities & threats; The US market: the ‘biggest biosimilar prize’; Future Prospects
List of Figures: Figure 1: Schematic of mAb; Figure 2: Molecular structure of Campath; Figure 3: Production Strategies for antibody fragment therapeutics; Figure 4: Schematic of a bacteriophage structure; Figure 5: Production of a phage library; Figure 6: HTS microtitre plates; Figure 7: Rational design of fusion proteins; Figure 8: Biologics today & the future; Figure 9: New cancer therapeutics and vaccine entering clinical study 1993-2006
List of Tables: Table 1: Leading monoclonal antibody products in 2009; Table 2: Leading marketed antibodies; Table 3: Leading marketed therapeutic proteins; Table 4: Leading cytokine products; Table 5: Leading coagulation factor products; Table 6: Leading insulin products; Table 7: Leading EPO products; Table 8: Leading coagulation factor products; Table 9: Late stage therapeutic proteins; Table 10: Specialist companies; Table 11: Molecular targets of leading mAbs; Table 12: Molecular targets of developmental mAbs; Table 13: Cost biosimlars vs. brands

Novel Antibodies & Therapeutic Proteins: Technology Challenges & Future Prospects

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