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Delivering New Biopharmaceutical Therapies: Challenges & OpportunitiesPublished by: PharmaVision Published: Jan. 19, 2009 - 150 Pages Table of Contents
Abstract“Over the last decade, biotech antibodies have provided some of the biggest breakthroughs in medicine. The list includes Avastin, Herceptin, Rituxan and Erbitux for cancer and Enbrel, Humira, and Remicade for immune and inflammatory disorders.”Sidney Taurel, Chairman and Chief Executive Officer Eli Lilly and Company A biopharmaceutical is defined as a medical drug (proteins including antibodies, nucleic acids, DNA, RNA or antisense oligonucleotides) which is produced using biotechnology. In the late 1990s advances in manufacturing and processing revolutionized the production of biopharmaceuticals such as recombinant DNA technology and hybridoma technology. These technological advances have enabled the market place to open up and for smaller players to enter and capitalize on the growing need for targeted, personalized medicine. During the 1960s and 1970s formulation began to assume greater importance. More recently still, the inconvenience of parenteral administration became a focus for attempts to minimize the burden and optimize treatment. Nowadays, any development programme for a new drug will include consideration of the optimal dosage form from the conception of a drug development project. A plethora of delivery platforms have evolved to meet market demands and overcome solubility and pharmacokinetic issues, and will have an important role to play in determining the dosage form that ultimately appears on the market. The biopharm field represents a major opportunity for generic manufacturers with sufficient resources to withstand the relatively high development costs and the technological demand. It is estimated that biosimilars, targeting the six leading biopharm products, could generate revenues in excess of $2 billion within 2-3 years. However, there are considerable challenges facing companies developing and marketing biopharm products. Manufacturing problems will remain a significant hurdle for companies entering this field; the regulation of innovator biopharm products continues to evolve and the harmonization of regulatory processes among the three main national regulatory agencies (the EU, the US and Japan) should make life simpler for biopharm companies seeking to establish a global presence for their products. Biotherapeutics represent 7.5 percent of all drugs on the market; they account for approximately 10 percent of the total expenditure for marketed drugs and their use is growing at more than 20 percent per year. Biotechnology drug candidates account for around 32 percent of all pipeline research programs. In addition, biological drugs are administered in life-saving or end-stage applications, 74 percent more than chemically derived pharmaceuticals. The biopharmaceutical market was estimated to be worth over $79 billion in 2007 with antibodies representing around $27 billion sales and protein products generating almost $52 billion. The biopharma market is growing at an annual rate of around 15% - far higher than pharmaceuticals (c. 6-7% per annum). By 2020 the market is forecast to be worth over $200 billion driven by a shift in usage from conventional drugs to biopharma products, the relatively high cost of biopharma products, the launch of biosimilars and a new generation of biotherapeutics. Get Full Details About This Report >> |
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