Pharmaceutical outsourcing
In a recent PricewaterhouseCoopers (PwC) analysis, Taiwan ranked fourth as a destination for pharmaceutical outsourcing in
Asia, trailing only China and India, which respectively ranked number one and two, and Korea, which was rated third (1, 2).
The ranking was based on a weighted index that factored in costs (compensation, infrastructure, tax, and regulatory), risks
(geopolitical, human capital, economic risks, legal, and infrastructure), and market opportunity (current and future needs
of the aging population, pharmaceutical market size and growth).
Taiwan's positive ranking is a result of government policy to develop its biotechnology industry, drug-development activities,
and broaden the use of contract research organizations (CROs). In 2000, the country replaced local registration requirements
for clinical trials with bridging evaluations that followed international standards, according to the PwC report (1). This
action provided the framework for multinational companies to consider Taiwan in its clinical research activities, but also
provided opportunity for domestic CROs. The government also introduced tax incentives to encourage Taiwanese pharmaceutical
companies to employ CROs. CROs were also given the right to represent sponsor companies in applying for investigational new
drug applications under a new drug approval system, which was introduced in 2007, as a means to make the drug-approval process
more transparent and efficient (1).
These efforts have made some inroads. Taiwan is competitive with other Asian countries in its clinical-trials activities based
on a review of open clinical trials from ClinicalTrials.gov/, a registry of federally and privately supported clinical trials in the United States and globally. Taiwan had 772 open clinical
trials as of Apr. 13, 2009, compared with 607 in Korea, 573 in China, and 398 in India, according to ClinicalTrials.gov/ (3). Big Pharma, however, is a lead sponsor in only a handful of these trials. A review of the top 20 pharmaceutical companies
shows Pfizer with the greatest number of open clinical trials (26 trials) conducted in Taiwan in which a Big Pharma company
is a lead sponsor. GlaxoSmithKline and Bristol-Myers Squibb have the next highest totals, each with 18, followed by Roche
(Basel, Switzerland) with 14, and Boehringer-Ingelheim with 12 (3, 4).
Multinational and domestic CROs are building their presence in Taiwan. In 2007, Parexel International (Boston) acquired the
Taiwanese CRO Apex International Clinical Research for NT$1.7 billion ($50.9 million). Parexel, with annual sales of approximately
$1.3 billion, is one of the largest global CROs, and Apex was one of Taiwan's largest CROs at the time of the acquisition.
The Japanese CRO EPS (Tokyo) opened a branch in Taiwan in 2007 and the CRO CMIC (Tokyo) also has operations in Taiwan.
Table I: Select contract research and manufacturing organizations in Taiwan.
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The number of suppliers of pharmaceutical raw materials and intermediates and contract manufacturing organizations (CMOs)
in Taiwan is still small compared with the number in China and India, which are more established in the pharmaceutical supply
chain. One measure of this difference is the number of exhibitors from these respective countries at CPhI Worldwide, the large
international trade show of pharmaceutical ingredient suppliers, which includes pharmaceutical and chemical suppliers and
manufacturers. At the 2008 show, which was held in Frankfurt, approximately 430 exhibitors were from China, 200 from India,
and only 13 from Taiwan. Table 1 lists select CMOs from Taiwan.
ScinoPharm Taiwan (Shan-Hua, Tainan Country) is a leading Taiwanese CMO providing process R&D, custom synthesis of early-phase
materials, and manufacturing of generic APIs. It was founded in 1997 by two former executives at Syntex, a pharmaceutical
company acquired by Roche in 1994. Jo Shen, president and CEO of ScinoPharm, was formerly corporate vice-president for pharmaceutical
technology and operations at Syntex. Hardy W. Chan, executive vice-president of ScinoPharm Taiwan, was formerly Syntex's vice-president
of research and director of biotechnology.
The Taiwanese government holds a 16% stake in ScinoPharm, and the US generic-drug manufacturer Watson Pharmaceuticals (Corona,
CA) hold 31%. Watson invested nearly $47 million between 2004 and 2006 to increase its equity position in Scinopharm, according
to Watson's 2007 annual filing. In addition to its primary API manufacturing facility (which operates under good manufacturing
practices [GMP]) in Tainan City, ScinoPharm operates facilities in China. These facilities include process R&D laboratories
and a kilo-scale laboratory in Kunshan, Jiangsu Province, and a manufacturing facility in Taicang, Jiangus Province. Its Chinese
operations provide process R&D of API intermediates, scale-up, and nonGMP manufacturing.
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