Published Date: 04/08/2010
Category: Drug Delivery & Devices
Research Report Decription
This report gives in depth analysis of innovative drug delivery
technologies that are being applied to both innovative cancer therapies
and those that are currently in use. Innovative parenteral, oral and
transdermal delivery technologies are considered in the report and
forecasts given of the sales of products incorporating these
Key Questions Answered:
- Which companies are actively involved in developing mAbs & TPs?
- What are the key areas of therapeutic focus for biologics in the near- & long-term?
- What are the key manufacturing & production technologies utilized to cost-effectively supplybiologics on demand?
- what regulatory issues face companies in the development & commercialisation of novelmAbs & TPs?
- Which companies & products lead the field & why?
- What threats & opportunities may arise from the launch of biosimilars?
- What are the market trends & how will this influence the development of the nextgeneration of biologics?
- What size is the biologics market now & in the future?
Abbott Labs, Abgenix, Active Biotech, Agennix AG, Akebia Therapeutics, Amgen, Amylin, Baxter International, Bayer Schering Pharma, Biolex Therapeutics, Biogen Idec, Biosynexus, BioVitrum AB, Bio Products Lab, Bristol-Myers Squibb, Cambridge Antibody Technology, Celldex Therapeutics, Centocor, Cephalon Therapeutics, Chugai, CSL Behring, Cytheris SA, Dyax Corporation, Elan, Eli Lilly, Eisai, ERYetch Pharma, Genmab A/S, Genentech, Genzyme, GlaxoSmithKline, Glycotope GmbH, H. Lundbeck A/S, Helix BioPharma Corporation, Human Genome Sciences, ImClone Systems, Immutep AS, ImmunoGen, Immunomedics, Ipsen, Janssen-Cilag, Johnson & Johnson, Medarex, MedImmune, Merck Serono, Novo Nordisk, Octapharma AG, Pfizer, Phosphagenics, Proteon Therapeutics, Protalix Biotherapeutics, Roche, Sanofi Aventis, Seattle Genetics, Shire, Schering-Plough, Tanabe Seiyaku Co, Teva Pharmaceuticals, ThromboGenics NV, Tolerx, UCB, Wilex AG, Wyeth, ZymoGenetics
- From the 1990s onwards, growing insight into the biological processes responsible for disease led to a drive to develop treatments based on the biological contributors to the diseaseprocesses. Thus, began the biopharmaceutical era, and anaccompanying shift of focus to large-molecule compounds.
- The biopharmaceutical market is estimated to be worth over US$78 billion in 2009 growing by 15% per annum, focusing on two key areas, monoclonal antibodies and biological active proteins and driven by advances in biotechnology,manufacturing and delivery.
- mAbs have been widely used to treat cancer and immuno-inflammatory related diseases; promising new treatments are under development. Abbott Laboratories, Bristol-Myers Squibb, Johnson & Johnson and Biogen Idec and Genentech, dominate the market; several other companies have promising pipelines including: Amgen, BioInvent International AB, Celldex Therapeutics, Genmab A/S, Glycotope GmbH, ImmunoGen, Pfizer, Seattle Genetics, Tolerx and Wilex AG.
- TPs have been widely used to treat a range of diseases including: diabetes, growth hormone deficiencies, blood disorders, immuno-inflammatory related diseases. Numerous products are under development for these and other conditions, such as cancer and gastrointestinal disorders.
- The introduction of recombinant DNA technologies and genetic engineering has revolutionized the production of mAb and TPs. The modification of antibody mediated techniques (phage display) and the adoption of high throughput screening technologies has improved productivity and the reproducibility of complex proteins, which is central to discovery and characterisation of new TPs.
- Regulatory agencies from the US, Europe, and Japan are making efforts to collaborate and coordinate their requirements, in order to achieve global regulatory compliance.However, differences in government structures, cultural norms, and business environments has lead to differences interpreting and implementing international guidelines.Â
- The launch of biosimilars provides new challenges and threats for the biologics industry. Relatively few biosimilars have been launched to date due to high financial technical and regulatory barriers to entry; however those that have reached the market are available at between 20%-30% discount to branded products.
- Biologic manufacturers are already developing second generation products with improved efficacy, safety and/or pharmacokinetic profiles to keep one step ahead of the competition.
- The next phase of pharmaceutical medicine will be driven by fundamental scientific advances in the understanding of diseases and the development of personalised medicines. However, significant challenges remain to improve the cost-effective manufacture and production of biologics, and to enhance their delivery, pharmacokenetics and reduce immunogenicity.
- Despite these issues recent advances in mAbs and TPs technologies continue to drive innovation and meet the markets need to treat the right patient at the right time.