最新CMO产业的形成及市场概况.pptVIP

製劑及劑型代工生產―健亞生技 ? 第一家獲得行政院開發資金投資的藥廠 ? 目前為大藥廠代工生產藥品 ? 以新藥研發為發展方向 * hhjkl 生物晶片代工―台灣基因 於2000年接受PE Biosystems的技術轉移取得基因引子（primer）的技術 提供生物晶片製造，生物晶片委託設計、製造、分析的服務 * hhjkl 臨床試驗級生技藥品生產―永昕 第一家專業CMO公司 生技藥品製造、檢驗試劑製造、穩定性測試、法規諮詢 臨床生技藥品臨床門檻高，獲利較可觀 * hhjkl 全球產業現況及展望 * hhjkl 全球CMO產業現況 全球蛋白質藥物產品供不應求 新產品消耗量高於舊產品，均造成產能嚴重失衡 新生產設備設計建造認證耗時耗資 * hhjkl 契機 The biotech market today and the ”capacity crunch” Why outsource and factors in choosing a CMO Sound process development Increasing regulatory requirements * hhjkl Capacity crunch “We estimate that demand for manufacturing capacity will exceed current capacity by a factor of four by 2005” J. P. Morgan. The State of Biologics Manufacturing, 2001 ”...the expected needs for increased capacity would be almost fourfold for fermentation and monoclonal antibodies and ten fold for mammalian cell culture. Given that Contract biomanufacturers only have an increase of one to two fold planned, this shortfall in capacity could become significantly painful” High Tech Business Decisions, 2001 * hhjkl Capacity crunch today and tomorrow Is the crunch as crunchy today? A significant increase in demand for additional capacity when new products go into clinical trials and market Avastin (genentech) and Erbitux (imclone/bms) will have impact on capacity The crunch depends very much on success of products in the clinical trials and improvements in yields The crunch may not be evenly spread but will most likely remain scarcity re competent specialists with PRACTICAL experience Scarcity re capacity at small scale UBS assumptions: Runs per year practically constant Protein expression level 0.5 (2003), 0.6 (2004), 0.75 (2005), 0.95(2006), Recovery yield 35% (2003), 38% (2004), 40% (2005), 45% (2006), Probability of success 80% throughout UBS 2003 * hhjkl Solutions for meeting capacity demands Long term Expanding capacity or building new facilities Short term Improving process development Increasing staff and adding shifts Develop better expression system