BioPharma licensing and M&A trends
BioPharma licensing and M&A trends
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生物制药许可和 M
DOI：
10.1038/nrd1697
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发表时间：
2005
期刊：
影响因子：
--
通讯作者：
M. Belsey
中科院分区：
文献类型：
--
作者：
Alex K. Pavlou;M. Belsey
制药业面临一系列挑战，包括更加严格的监管和报销环境，一系列即将到来的重磅炸弹专利到期，以及处方药市场日益增长的仿制药渗透率。因此，通过强有力的渠道创新和生产率实现增长是一个关键问题。美国这一领域的总研发支出已经从1983年的32亿美元增长到2003年的330亿美元，增长了10倍。1)。虽然该行业在1990年代初经历了一波创新浪潮，在1996年达到顶峰，当时提交了131项新药申请，批准了53项新分子实体2，但研发生产率几乎每年都在下降。2003年，提交了72份国家发展援助申请，批准了21份国家海洋生态系统3，自1996年以来分别减少了45%和60%。因此，管理良好或定位明智的许可或收购交易增加了研发的生物技术多样性，是制药公司提高生产率的战略途径，既是内部开发的替代方案，也是有机研发创新的补充。
The pharmaceutical industry faces a number of challenges, including a more rigid regulatory and reimbursement environment, a series of imminent blockbuster patent expiries and increasing generic penetration of the prescription drug market. Generating growth through strong pipeline innovation and productivity is therefore a key issue. Total R&D spending of this sector in the US has grown tenfold from US $3.2 billion in 1983 to US $33 billion in 2003 (REF. 1). Although the industry enjoyed a wave of innovation during the early 1990s, peaking in 1996 when 131 New Drug Applications (NDAs) were filed and 53 New Molecular Entities (NMEs) were approved2, R&D productivity has declined on almost a year-onyear basis. In 2003, 72 NDAs were filed and 21 NMEs approved3, which represents a 45% and 60% decline, respectively, since 1996. Therefore, well-managed or wisely-positioned licensing or acquisition deals that increase the biotechnological diversity of R&D represent strategic paths by which pharma companies can boost productivity, both as an alternative to in-house development, and to complement organic R&D innovation.