Moorkens Evelien, Meuwissen Nicolas, Huys Isabelle, Declerck Paul, Vulto Arnold G, Simoens Steven
Department of Pharmaceutical and Pharmacological Sciences, KU LeuvenLeuven, Belgium.
Hospital Pharmacy, Erasmus University Medical CenterRotterdam, Netherlands.
Front Pharmacol. 2017 Jun 8;8:314. doi: 10.3389/fphar.2017.00314. eCollection 2017.
Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market. A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales. Strategies were documented by collecting data on manufacturing plans, development programs, acquisition and collaboration agreements, the portfolio and pipeline of biosimilar, originator and next-generation biopharmaceutical products. Data were extracted from publicly available sources. Various investment and development strategies can be identified in the global biopharmaceutical market: (a) development of originator biopharmaceuticals, (b) investment in biotechnology, (c) development of next-generation biopharmaceuticals, (d) development of biosimilars, (e) investment in emerging countries, and (f) collaboration between companies. In the top 25 pharmaceutical companies almost every company invests in originator biopharmaceuticals and in biotechnology in general, but only half of them develops next-generation biopharmaceuticals. Furthermore, only half of them invest in development of biosimilars. The companies' biosimilar pipeline is mainly focused on development of biosimilar monoclonal antibodies and to some extent on biosimilar insulins. A common strategy is collaboration between companies and investment in emerging countries. A snapshot of investment and development strategies used by industrial players in the global biopharmaceutical market shows that all top 25 pharmaceutical companies are engaged in the biopharmaceutical market and that this industrial landscape is diverse. Companies do not focus on a single strategy, but are involved in multiple investment and development strategies. A common strategy to market biopharmaceuticals is collaboration between companies. These collaborations can as well be used to gain access in regions the company has less experience with. With patents expiring for some of the highest selling monoclonal antibodies, this snapshot highlights the interest of companies to invest in the development of these molecules and/or enter into collaborations to create access to these molecules.
生物制药在全球药品市场中所占份额日益增长,并且由于许多此类生物制药产品面临专利到期的情况,生物类似药如今也可能进入生物制药市场。本研究旨在识别并记录全球生物制药市场中的企业采用了哪些投资与开发策略。根据2015年全球处方药销售额,对排名前25位的制药公司的投资与开发策略进行了描述性分析。通过收集有关生产计划、开发项目、收购与合作协议、生物类似药、原研药和下一代生物制药产品的产品组合及研发进程的数据,记录了相关策略。数据取自公开可用的来源。在全球生物制药市场中可以识别出各种投资与开发策略:(a)原研生物制药的开发;(b)对生物技术的投资;(c)下一代生物制药的开发;(d)生物类似药的开发;(e)对新兴国家的投资;以及(f)企业之间的合作。在排名前25位的制药公司中,几乎每家公司都投资于原研生物制药以及一般意义上的生物技术,但只有一半的公司开发下一代生物制药。此外,只有一半的公司投资于生物类似药的开发。这些公司的生物类似药研发进程主要集中在生物类似单克隆抗体的开发上,在一定程度上也涉及生物类似胰岛素的开发。企业之间的合作以及对新兴国家的投资是一种常见策略。全球生物制药市场中企业采用的投资与开发策略的概况表明,排名前25位的制药公司都涉足生物制药市场,并且这一产业格局是多样化的。企业并非专注于单一策略,而是参与多种投资与开发策略。生物制药市场化的一种常见策略是企业之间的合作。这些合作也可用于进入公司经验较少的地区。随着一些畅销单克隆抗体的专利到期,这一概况凸显了企业投资开发这些分子和/或开展合作以获取这些分子的兴趣。