CROs in Modern-day China
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Keywords

CRO
China
outsourcing
R&D
IPO
M&A
IP
SFDA

Abstract

Contract research organization (CRO) outsourcing has become a critical strategy for multinational biopharmaceutical companies looking to reduce costs, time-to-market and expanding their pipelines as blockbuster patents expire. Much of the growth in the CRO industry is coming from emerging markets, such as China and India. China's CRO industry began in 1996 and is still relatively young and fragmented. However, it is growing quickly at an annual rate of 30%. Global CRO giants such as Quintiles, PPD, Covance, Parexel and ICON have invested in facilities in China and some Chinese CROs have grown to become global players. This paper will provide a detailed analysis on CROs in China, including the characterization of companies and services provided, recent IPO/M&A deal activity, trends in the sector, and intellectual property and regulatory issues to consider. Readers will be able to obtain a clear picture of China's CRO landscape. This paper should serve as a guide for companies considering outsourcing R&D to China and investors looking for opportunities in China's CRO industry.

 

https://doi.org/10.5912/jcb548
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References

CIA (2012) China: The World Factbook, https://www.cia.gov/library/publications/the-world-factbook/geos/ch.html#, accessed 1 April, 2012.

UNDP (2012) China Country Profile: Human Development Indicators, http://hdrstats.undp.org/en/countries/profiles/CHN.html, accessed 1 April, 2012.

Frew, S.E., Sammut, S.M., Shore, A.F., Ramjist, J.K., Al-Bader, S., Rezaie, R., Daar, A.S. and Singer, P.A. (2008) Chinese health biotech and the billion-patient market. Nature Biotechnology 26, 37-53.

Li, Z., Wen, K. and Chen, G. (2005) Developing innovative capacity in China to meet health needs. In: Pefile, S., Li, Z., Ke, W., Guang, C., Chamas, C. and Bhojawani, H. and Hering, I (eds.) Innovation in Developing Countries to Meet Health Needs: Experiences of China, Brazil, South Africa and India. CIPIH Study 10d. Commission on Intellectual Property Rights, Innovation and Public Health, Geneva, 2005: 37-74.

Wang, Y. and Xiang, L. (2011) Nation placing priority on biotechnology. China Daily, 28 June: p14.

Reymond, E., (2007) CRO market to reach $24bn by 2010. Outsourcing-Pharma.com, 30 Jul, http://www.outsourcing-pharma.com/Clinical-Development/CRO-market-to-reach-24bn-by-2010, accessed 5 April, 2012.

PricewaterhouseCoopers (2008) The changing dynamics of pharma outsourcing in Asia: Are you readjusting your sights?

Ng, I., (2009) China's drug contractors on a fast-growth track. Reuters, 3 Sep, http://www.reuters.com/article/2009/09/03/cro-china-idUSN0347982120090903?pageNumber=2&virtualBrandChannel=0, accessed 4/11/12.

KPMG (2011) China's pharmaceutical industry - Poised for the giant leap.

Daverman, R. (2011) China Life Science 2010: A Giant Leap Forward. ChinaBio, 8 April, http://www.chinabiotoday.com/articles/20110406, accessed 1 April, 2012.

Engardio, P., Rissing, B., (2008) Big Pharma's R&D Booster Shot, 11 Jun, http://www.businessweek.com/technology/content/jun2008/tc20080610_071365.htm, accessed 4/11/12.

Bloomberg News (2012) WuXi's Margins Dwarfing U.S. Lead China's Drug Targets: Real M&A. Bloomberg, 2 Feb, http://www.bloomberg.com/news/2012-02-01/wuxi-profit-margins-dwarfing-u-s-lead-china-s-drug-deal-targets-real-m-a.html, accessed 1 April, 2012.

PricewaterhouseCoopers (2009) Investing in China's Pharmaceutical Industry-2nd Edition.

Hughes, B. (2010) China spurs pharma innovation. Nature Reviews Drug Discovery 9, 581-582.

GBI Research (2011) Emerging Pharmaceutical Market in China - Forecast to Become the World's Third-Largest Pharmaceutical Market by 2013. Research and Markets, Sep.

Jackson, R. (2011) Can an Aging China Be a Rising China? the China Business Review, https://www.chinabusinessreview.com/public/1104/jackson.html.

Zhou, Y. (2006) Contract Research Drives China's Pharma Sector, PharmaManufactoring.com, http://www.bioplanassociates.com/publications/Pharma_Mfg_CRO_Drives_China.pdf, accessed 1 April, 2012.

Frost & Sullivan (2010) The Rising Dominance of the Asian CRO Market.

Indigo Research (2008) Global Contract Research Organization (CRO) Industry: Overview and Trends, 2008. Cipher, Apr.

Li, Y., Zhang, Y. (2009) 36 Billion CRO market, the rise of Chinese CROs, ChinaVenture, 9 Apr, http://news.chinaventure.com.cn/3/20090409/22880.shtml, accessed 4/12/12.

Ernst & Young (2007) Beyond Borders: Global Biotechnology Report 2007.

Ernst & Young (2008) Beyond Borders: Global Biotechnology Report 2008.

VenturePharm (2007) Raising HK$ 97 million VPS-CRO, A Chinese Leader in Preclinical & Clinical Service is Ready to Run, 27 Jul, http://www.venturepharm.com/News_en/new_info.asp?News_ID=799, accessed 4/12/12.

Ernst & Young (2011) Beyond Borders: Global Biotechnology Report 2011.

Chan, C., Pettypiece, S. (2008) Wuxi Will Acquire AppTec Laboratory for $151 Million (Update3), Bloomberg, 4 Jan, http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a2B6r10kMxTQ&refer=asia, accessed 4/12/12.

WuXi AppTec (2011) WuXi PharmaTech Acquires China-Based Clinical Research Services Companies, 24 Oct, http://ir.wuxipharmatech.com/phoenix.zhtml?c=212698&p=irol-newsArticle&ID=1620275, accessed 4/12/12.

ChinaBio Today (2009) PPD Continues Rapid China Growth with Another CRO Acquisition, Seeking Alpha, 19 Nov, http://seekingalpha.com/article/174239-ppd-continues-rapid-china-growth-with-another-cro-acquisition, accessed 4/12/12.

Macdonald G. (2010) ShangPharma beats IPO forecast and plans Fengxian facility, Outsourcing-Pharma.com, 19 Oct, http://www.outsourcing-pharma.com/Clinical-Development/ShangPharma-beats-IPO-forecast-and-plans-Fengxian-facility, accessed 4/12/12.

Sundia (2008) European Company NovaSecta Joins First Chinese CRO Service Alliance for Drug Discovery Solutions, 18 Feb, http://www.sundia.com/news/full.asp?ClassID=144959613005987840&ID=124, accessed 4/12/12.

Taylor, N. (2011) Strong R&D spending in China continues despite economic dip. Outsourcing-Pharma.com, 21 Sep, www.outsourcing-pharma.com/Preclinical-Research/Strong-R-D-spending-in-China-continues-despite-economic-dip, accessed 4/12/12.

ChinaBio Today (2010) Convance Increases Emerging Markets Focus: Building Pre-Clinical Facility in China, Seeking Alpha, 31 Jan, http://seekingalpha.com/article/185650-covance-increases-emerging-markets-focus-building-pre-clinical-facility-in-china, accessed 4/12/12.

ChinaBio Today (2010) PPD Adds to Its Presence in China, Seeking Alpha, 28 Apr, http://seekingalpha.com/article/201320-ppd-adds-to-its-presence-in-china, accessed 4/12/12.

Goodall, S., Janseens, B., Wagner, K., Wong, J., Woods, W., Yeh, M. (2006) The promise of the East: India and China as R&D options, Nature Biotechnology, 25 Jul, www.nature.com/bioent/2006/060701/full/bioent910.html, accessed 4/12/12.

Langer, E.S. (2007) China as a Biopharmaceutical Powerhouse: Just a Matter of Time. BioPharm International 20, 12.

Qi, J., Wang Q., Yu Z., Chen, X., Wang, F. (2011) Innovative drug R&D in China. Nature Reviews Drug Discovery, 10, 333-334.

Jia H. (2009) China tightens IP protection, but concerns linger. Nature Biotechnology, 27, 787-788.

Jia H. (2004) IP litigation in China could drive innovation. Nature Biotechnology 22, 368.

Hopkins, H. (2011) On Human Resources in China's CROs, ChinaSourcing, 17 Aug, http://en.chinasourcing.org.cn/content2.jsp?id=6705, accessed 4/12/12.

Jia H. (2009) CROs expand business to fight crisis, RSC, Jun, http://www.rsc.org/chemistryworld/Issues/2009/June/CROsExpandBusinessToFightCrisis.asp, accessed 4/12/12.

Ke, R. (2011) Where is the way out for Clinic CROs with Presence in China, ChinaSourcing, 26 May, http://en.chinasourcing.org.cn/content2.jsp?id=6294, accessed 4/12/12.

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