Outsourcing Clinical-Trial Materials Heats Up - Pharmaceutical Technology

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Outsourcing Clinical-Trial Materials Heats Up
The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.


Pharmaceutical Technology
Volume 32, Issue 1

Meeks says that Azopharma made four major acquisitions during 2007. The company gained facilities for preclinical services, inhalation development, synthetic chemistry, and manufacturing during the year. "These added capabilities, coupled with our existing expertise, enable Azopharma to truly offer total product development, from discovery to manufacturing, with all the development activities in between."

In June 2007, Metrics (Greenville, NC) initiated a 47,000-ft2 expansion of its clinical-batch manufacturing and commercial-production capabilities. The expanded facility is scheduled for completion in April 2008 and will contain approximately 9000 ft2 of warehouse space, 17,000 ft2 of pharmaceutical manufacturing space, and approximately 7800 ft2 of analytical support laboratories.

West moves East

CMOs in India, China, and Singapore are gaining prominence as globalization plays an increasingly important role in the pharmaceutical industry. "More and more pharmaceutical and biotechnology companies are doing their trials in those countries," Bhatt explains. Conducting a clinical trial in China, India, or other parts of Asia, for example, requires a company "to have a storage facility, a manufacturing facility, logistics, or project-management capability in that region," he adds.

As drugmakers conduct more clinical trials in Asia, CMOs are responding to meet clients' needs. Some Asian CTM providers that previously served only their local markets now work for multinational pharmaceutical companies, Bhatt notes. These CMOs are familiar with the local infrastructure and supply chain, and they have the local expertise that companies from outside the region require. Increased demand also has "pushed companies such as Thermo Fisher to move into Singapore, India, or China in an aggressive manner," notes Bhatt.

For example, in October 2007, Thermo Fisher Scientific (Waltham, MA) broke ground on a $17-million facility in Ahmadabad, India. The facility will package and oversee the global distribution and logistics management of pharmaceutical samples for clinical-trial patients around the world. Thermo plans to open the facility in spring 2008.

Several other companies are building or improving plants in Asia. In June 2007, Aptuit teamed with Laurus Labs (Hyderabad, India), a provider of contract research and manufacturing services, to form Aptuit Laurus. The new company is headquartered in Hyderabad, India. Aptuit plans to invest roughly $100 million during the next several years to increase Aptuit Laurus's development, manufacturing, and informatics capabilities. The expansion includes the addition of development services such as formulation and analytical-testing services and clinical GMP packaging and logistics. "Our expansion into India, combined with our new packaging facilities currently under development in the US and Europe, will nearly double our capacity over the next 18 months," Houlton says.

Development activities are a large part of Aptuit Laurus's work, according to Houlton. "We expect to further our growth in India with expanded CTM services at Aptuit Laurus." In addition, Aptuit will also produce large commercial volumes of APIs and finished product in India.

Aptuit has also been active elsewhere in Asia. "Our clinical packaging and logistics operation in Singapore doubled over the past two years," remarks Houlton. Aptuit's expansions in Asia will continue. "We are looking to grow into a new facility in Singapore that will allow us to double or triple our CTM supplies business again," he says.

According to Bhatt, China, India, and Singapore are the main countries to benefit from the globalization of outsourcing. Because companies can raise or borrow money relatively cheaply in those countries, he explains, "it's become very attractive to grow inorganically through mergers, acquisitions, and joint ventures and to provide services to global companies on the value propositions of convenience, cost, and certainly quality products or quality service. And that's happening more and more."

Referring to the growing number of clinical trials that pharmaceutical companies are conducting overseas, Bhatt says, "The fact that India, China, Russia, and other countries are being exploited requires clinical-trial supplies to be [available] in a global marketplace. Why would Fisher go and invest $17 million in India if none of their customers were conducting any trials in India or China?"


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