Novel Antibodies & Therapeutic Proteins: Technological Challenges & Future Prospects

Publisher: Select Biosciences
Published: July 2010
Pages: 183

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:

• 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 in disease processes. Thus, began the biopharmaceutical era, and an accompanying shift of focus to large-molecule compounds.
• The biopharmaceutical market is now 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 wide 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 still lead to differences in interpreting and implementing international guidelines.
• 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 marker 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.

Report Table of Contents (TOC) [Click Here to Download PDF File]

Sample Pages from the Market Report [Downloadable PDF File]

For enquiries about this market report, please contact Kathy Gray at Kathy.Gray@Selectbiosciences.com