Wednesday, April 16, 2014

Clinical Trial - Outsourcing trend to China, India, and South America

The motivation of out sourcing in clinical trial:

1)生物医药研发外包的部分主要是化学合成部分,在整个新药研发产业链中,这是人力资源需求最大的部分,所以,人力成本很重要。

2)外包公司在中国不断涌现的原因是,医药研发需要各种各样的试剂和原料,由于价格便宜,大量外包的兴起,使得北美和欧洲生产试剂和化学原料的很多工厂都关掉了,出现了产能空缺。而在上海的张江,几乎一个电话就可以买到需要的各种试剂和化学原料。而这恰恰是中国发展外包业无法取代的优势

3)大量的美国欧洲学历的中国印度生物医药博士人才回国创业

4)中国政府政策对医药外包的倾斜支持、人力、材料成本低廉

5)2009~2010年,大的制药公司面临市值达880多亿美元的专利过期,利润率预期的急剧下降使大的制药公司出现了裁员潮和兼并潮,先灵葆雅被默克兼并即是案例

6)种经营规模的药品开发商和生产商常常将以前被视为内部核心竞争力的许多任务和功能外包出去。随着成本管理和流程效率成为自身生存的关键所在,制药行业的基本性质发生了变化。外包已经成为行业的一个常态,它涵盖了制药活动的全过程,从筛选和先导化合物的确定,到毒理学和其他临床前研究、临床试验、市场营销,以及各种规模的生产等等。

7)外包被证明能有效降低运营和基础设施成本。在此期间,制药行业会明显降低其研发力度,减少新品的研发数量。这也促使许多制药公司进一步实施降本节支举措,增加外包业务,以作为减少工资支出和资本费用支出的一个途径。从某些方面来说,这种经济利益驱动型的外包业务的增加将会削弱行业的长期生产力。由于产品研发线萎缩和品牌药陆续失去专利保护,对于必须适应利润逐渐走低的制药公司来说,外包是可供它们的唯一选择。

8)发展中国家(中国印度)拥有快速发展的国内医药市场和制药行业。许多跨国制药公司在这些国家投巨资建立自己的研发中心,并将业务外包给当地的CROs/CMOs。这些活动促进了当地外包市场的快速发展。

9)CRO向发展中国家进军并不全是为了节省经费,也存在自然资源、地方病和伦理、留学人员回国问题

近年来,归国留学人员以每年29%的速度在增长,特别是金融危机后,增速更是惊人。医药行业的海归应该积极引进,凭借成本、人才、疾病谱三大优势抢夺市场制高点,分到满意的一杯羹

Industry drivers

Faced with stagnating sales, an array of upcoming patent losses, and rising research and development costs, concerns have arisen about research and development productivity at leading pharmaceutical companies in recent years. This has resulted in major bids to reduce research and development expenditure. It is widely expected that such resources will further contract.
The industry overall has also been downsizing. In 2010, approximately 80,000 job cuts in the pharmaceutical and healthcare sector were announced in the US alone, according to one recent article. The trend for outsourcing key activities is compounding these losses. Meanwhile, strategic business planning, bio-statistical analysis, laboratory services, and clinical operations have been growing business sectors for CROs. Many of these jobs are being created across the Asia-Pacific region.

Trend in China
1. 人口老龄化导致老龄医药实验(老年病、慢性病)需求增加
2. 城市化导致人口集中、环境恶化,带来呼吸系统疾病增加
3. 计划生育导致年轻人比例下降,老人比例增大,进而导致老人医疗护理需求增加

Foreign companies action in China
http://www.bioplanassociates.com/publications/articles/contrpharma_clintrialschina_may07.pdf

Clinical Trial in Asia: Opportunities and Challenges
http://www.zuelligpharma.com/news/clinical-trial-asia-opportunities-and-challenges


Clinical Trial trend in U.S: (2007)
1. from Northeast to Sourth and global
2. go e-Trail, Paperless
http://www.workforcesolutionsalamo.org/pdf/NCEE%20Clinical%20Research%20Industry%20Report.pdf

Clinical Trial in Ontario 2012-2017
1. 2/3 of clinical trial sites did not met patient recruitment expectations
2. decrease share by 12%
3. clinical trial is not big share for Ontario economy, as compared with education, manufacture, insurance, banking
4. Ontario facing difficulties in attraction of major clinical trial players
5. Small population, could not afford larger investor on clinical trial 靠山山不在,靠水水无源
6. Med-tech advance make Ontario lose commutativity : personalized medicine  by  way  of  genetics,  genomics  and  proteomics, such  evidence  is  increasingly  conducted in the context of global trials largely carried out by multinational pharmaceutical and device companies.
http://www.ctontario.ca/wp-content/uploads/2012/07/CTO-Strategic-Plan-June-2012.pdf

Canada's clinical trial infrastructure:
http://www.parl.gc.ca/Content/SEN/Committee/411/soci/rep/rep14nov12-e.pdf


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