Asian countries can offer great value as locations for clinical study sites. This introductory article will be followed by a more detailed piece on the ins and outs of getting the best out of your Southeast Asia clinical trial strategy.
Say you are a proto-typical biotech company with one lead clinical drug candidate and several others in either pre-clinical or discovery. Chances are high that your development strategy will be to out-license your lead program to a big pharma company or be acquired. Given the exponentially rising costs of late-stage development through commercialization, this is not an unreasonable expectation on the part of your investors, particularly venture capitalists. And it's certainly justifiable, if your plan to get to your next clinical development milestone is based on getting it done in the US or Europe.
Would your investors' exit strategy be different if you could add value to your enterprise by achieving your clinical milestone faster and at less cost? Enter Asia.
According to a recent report from Global Data, the number of clinical trials conducted in the Asia-Pacific region has almost quadrupled from 1,364 in year 2010 to 4,316 in 2015. The Asia-Pacific region comprises the so-called "Tier One" countries: Australia, New Zealand and Japan, followed by "Tier Two" countries: Taiwan, Singapore, Hong Kong and (South) Korea, and the "Tier Three" countries: India, China, Malaysia, Thailand, Phillippines, Indonesia and Vietnam. These classifications, albeit somewhat arbitrary, are based on broad criteria of quality and accountability, using as the gold standard the robust implementation of Good Clinical Practices (GCP) as seen in the US and Europe. As we shall see later, they are also borne out by real data on the number of multicenter clinical trial sites located in these countries.
So, what is the main attraction to Asia? Time – as in money. The single biggest contributing factor to escalating costs of clinical trials is the time it takes to accrue patients. Asian countries have large, genetically diverse populations, many of whom are drug-naïve. This can reduce accrual times dramatically for the right indication. There are also other factors that contribute to cost reduction, including the lower cost of health care in general, and potentially lower patient and physician compensation, compared to the US and Europe. Although, we won't delve too deeply into costs, as they can vary substantially depending on the particular situation, it would not be an exaggeration to state that in the aggregate, overall cost savings upwards of 50percent may be achieved by opening up clinical trial sites in Asian countries.
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Among Asian countries, Japan is the one and only country in Tier One, and it is also the exception to the time and money savings rule. You have nothing to gain by opening up a study site in Japan, if you do not intend to market and sell your drug product in that country.
So, let's focus on Tier Two and Three countries in Asia. When we look at data from a registry, such as ClinicalTrials.gov, and search for multicenter trials in various Asian countries that are either "open" or have an "unknown status," we find that there is a huge difference in the number of clinical studies normalized for population size. For example, China (a Tier Three country) has the highest number of open clinical studies at 827, which is 0.60 per 1 million population. Compare that with 611 studies for Korea (a Tier Two country), which is 11.9 per 1 million population – almost 20 times higher per capita. In general, Tier Two Asian countries garner far more clinical study sites per capita compared to Tier Three countries.
Clearly, with established GCP, sophisticated facilities, well-trained medical professionals, and strong Government backing, Tier Two Asian countries have become the clinical trial destination of choice for Western companies. However, these countries are getting crowded and their clinical trial infrastructures are being stretched.
This gives an opportunity for Tier Three countries to step up their game, and for Western companies to give serious consideration to those countries as alternative study sites.
Within the Tier Three group, Malaysia and Thailand stand out above the rest, and are showing strong capabilities to move up into Tier Two. Both countries have implemented GCP since year 2000. They have built state-of-the-art facilities and have a large cadre of highly qualified US – or Europe – trained medical professionals.
China continues to be the sleeping giant, albeit with formidable regulatory hurdles. China is hard to ignore because of its potential market size. Companies wishing to sell their products in China need to conduct trials there anyway. Therefore, they might as well plan ahead of time to include multicenter clinical study sites in China and endure the regulatory marathon.
In the next article in this series, we will focus exclusively on all Tier Three Asian countries and highlight the kinds of challenges companies might encounter as you navigate the regulatory and infrastructure landscape in these countries.
*Ramani A. Aiyer, PhD, MBA is the Principal at Shasta BioVentures, San Jose, California, USA. To post comments to the author, Ramani can be reached at: ramani@shasta-bioventures.com
