GLOBAL COMPETITIONS AMONGCROS IN OUTSOURCING WEI & FABIO GAROFOLO

The competition in CRO business is increasingtoo. This competition has resulted in severaladvantages for pharmaceutical companiesin the short term. Certainly, they are getting

lower prices, better quality and more aggressivetimelines. Hence, the CROs are suffering

lower and lower revenues and, in the long term,we can probably say that only the ‘best’ CROswill be able to survive the increasing shrinkage

of profitability.

There are also competitions in outsourcingbusiness from outside the USA and Europe.

India has become an opportunity for pharmaceuticalcompanies for drug development due to the cost

effectiveness. In fact, India is the4th largest producer of drugs and biologics [7].A total of 12 major pharmaceutical companies

are located there. It has 74 FDA-approved manufacturingfacilities – more than in any othercountry outside the USA [2,101].

There are manyadvantages besides low cost when outsourcingto India. For many Western companies, the fact

that English is widely spoken in India is a bigpositive. India also has a very good IT infrastructure,

strong patent protection in place and largenumbers of qualified scientists.

There are evenmore advantages when running Phase II and III

clinical trials in India, as it has 5 million clinicians,including a high number of clinical investigators

signing on to conduct FDA-regulatedclinical trials and over 700,000 specialty hospital

beds [2,7, 101]. In fact, the clinical market inIndia is expected to grow to US$1.5 billion by

2010 [2,101].

There are certain shortcomings when outsourcingto India. First, India’s government is

very concerned about pharmaceutical companiesusing poor people [2,7]. There are also culturalissues regarding abusing animals for scientificresearch. In addition, high turnover in India is

a serious issue. Emigration to more developedcountries is very common among the highly

educated workforce.

China is another country emerging very fast inthe life science industry. A lot of pharmaceutical

companies view China as a huge market. ForPhase II and III clinical trials, China has access

to large patient populations, such as for cardiovascularand diabetes diseases. China also has

well-equipped hospitals, a relatively inexpensivetechnical workforce and highly-educated clinical

investigators. Finally, like India, China is costeffective; the cost of Phase III trials is 20–40%

of the cost of the same trials in the USA [2,102].

There are also drawbacks for outsourcing toChina: intellectual property is not protected

enough there yet. There is no clear understandingof the way China treats disclosures of

confidential information and of how the Chinesecourt system works for offshore complaints.

What is more, metabolic differences betweenAsian and Caucasian patients must also be

considered when carrying out clinical trials [8].

To read the entire publication, please visit WeiGarofolo's website below:

https://sites.google.com/site/globalcrocouncil//weigarofolobio