Graul A I, Navarro D, Dulsat C, Cruces E, Tracy M
Thomson Reuters, Barcelona, Spain.
Drugs Today (Barc). 2014 Feb;50(2):133-58. doi: 10.1358/dot.2014.50.2.2122810.
The demise of the pharmaceutical industry, so pessimistically predicted by many in recent years, has not come to pass and in fact the patient is alive and well. New programs enacted by drug regulators have been enthusiastically taken up by the industry, including the FDA's breakthrough therapy and qualified infectious disease product (QIDP) designations, as well as the now-consolidated orphan drug programs in many countries. Pharma companies pragmatically wean nonperformers from the pipeline in an efficient manner, resulting in somewhat leaner but higher-quality pipelines. Mergers and acquisitions also continue to drive consolidation and efficiency in the industry, a trend that continued during 2013. This article provides an updated review of these and other trends in the pharmaceutical industry in the year just passed.
近年来,许多人悲观地预测制药行业会走向衰落,但这并未成为现实,实际上该行业发展良好。制药行业积极采用了药品监管机构制定的新计划,包括美国食品药品监督管理局(FDA)的突破性疗法和合格传染病产品(QIDP)认定,以及许多国家现已整合的孤儿药计划。制药公司切实有效地淘汰了研发流程中的不良项目,从而使研发流程有所精简但质量更高。并购也继续推动着该行业的整合与效率提升,这一趋势在2013年仍在持续。本文对过去一年制药行业的这些及其他趋势进行了最新综述。