Outsourcing

Southern Hemisphere First: An Alternative to the Asia-Pacific Region

Outsourcing

12:00, May 16 2017

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Guillaume Trusz puts his case forward for running trials in Australia, Brazil, and South Africa

There does not seem to be a day that goes by where I do not hear or read about Asia-Pac.

When it comes to conducting clinical trials, numerous individuals stress the importance, potential, and strength of the Asia-Pacific markets. Japan and South Korea boast having some of the best pharmaceutical and biotech companies in the world, and with strong government backing along with a robust contract research organization (CRO) industry, their presence is easily felt.

China and India, being the top countries in the world in terms of population size, are extremely attractive in terms of market potential alone. But is Asia-Pac really the best option for conducting clinical trials? Or is it the right model for only a select few?

The Pros and Cons of Asia-Pac

Strong government involvement has helped Japan and South Korea become the biopharma giants they are today. Nevertheless, with recent reports predicting “population decline” (or even “population collapse”) due to an aging population and low fertility rates, the CRO availability as well as patient accessibility will become a real challenge. Some experts have mentioned that the unification of Korea could help solve their future population crisis.

However, the strong financial burden that would incur from unification between the two countries could destabilize everything. Strong patriotic feelings in both Japan and South Korea will most likely lead to domestic biopharma companies being favored for running clinical trials, and the competition between international companies will do nothing but increase.

India and China offer very attractive markets (close to 2.7 billion people combined) but reports from major journals mention that up to 80 percent of clinical trial data in China are fraudulent. In addition, unethical patient recruitment as well as the exaggeration of claims made by Indian physicians makes these markets very convoluted. Some experts have stressed the possibility of going through two of the Asian Tigers (Hong Kong or Taiwan) in order to make clinical trials in China easier.

However, just like Singapore, a relatively small population size as well as a strong currency could prevent numerous companies from gaining access and outsourcing to those locations. Moreover, increasing political tensions among several East Asian countries can only complicate matters in the long run.

Southern Hemisphere First – Australia, Brazil, and South Africa

This is why I would like to offer an alternative to the Asia-Pac model, something I like to call Southern Hemisphere First (SHF), which consists of three countries: Australia, Brazil, and South Africa. One of the main advantages to keep in mind is that according to several sources, patient recruitment takes place much more quickly and easily during the winter months.

When summer begins and patient recruitment drops in the northern hemisphere (primarily due to vacationing), outsourcing to the winter-struck southern hemisphere countries could be a wonderful option. In doing so, clinical trials would be completed much more rapidly, saving pharmaceutical and biotech companies a lot of valuabletime and capital.

Being only one of two first-world countries located below the equator, a lot of people tend to forget about Australia. One could argue that Australia’s main weakness is its population size (which is well below that of Japan and South Korea), but according to a locally based CRO, Australians tend to be very well informed, and there is a high level of research participation and commitment among the Aussie population.

In addition, the lack of a language barrier between Australia and English-speaking countrieshelps make business run much smoother and decent research and development tax offsetsoffered by the Australian governmentcan only be a stronger incentive.

Industry Big Hitters already stamping their imprint

Over in Latin America, Brazil offers a strong market potential as well. Their hosting of the 2014 FIFA World Cup and the 2016 Summer Olympic Games has helped strengthen and expand their economy. Moreover, having one of the world’s largest populations (fifth largest, right behind the United States and Indonesia) could make matters easier when it comes to patient recruitment.

Several of the pharma giants such as Pfizer, Merck, and Sanofi have recognized the potential of Brazil and are making their mark through acquisitions and partnerships. With the Brazilian pharmaceutical and biotech industry booming, it would be a shame not to take advantage of such an opportunity while it still presents itself.

On the other side of the Atlantic, South Africa offers another hidden gem. South Africa is the only African country to be part of the G20, and holds the continent’s largest GDP. Africa as a whole is slowly transitioning from communicable diseases such as tuberculosis and HIV to non-communicable ones such as diabetes and cardiovascular disease, which affect a significant portion of the first-world population.

Although South Africa has one of the continent’s slowest growing populations, a high unemployment rate could be key when it comes to patient recruitment. Furthermore, South Africa’s National Infrastructure Plan has helped make its infrastructure the best in Africa, easing participant access.

Is adopting an SHF strategy the way forward?

All three countries (Australia, Brazil, and South Africa) offer very appealing possibilities. Decent population numbers and predicted population increases, weakening currencies (the Australian Dollar, the Brazilian Real, and the South African Rand have all significantly decreased in strength over the last couple of years), as well as the seasonal advantages make this market trio an attractive alternative to conducting clinical trials in Asia-Pac. Now, with all of this being said, Asia-Pac is still a market that cannot be ignored, but with such high competition the SHF model (despite its own independent issues and limitations) could be a new solution for some.

 

References

Buente M., Danner S., Weissbäcker S., Rammé C. (2013). Pharma Emerging Markets 2.0 & How Emerging Markets are Driving the Transformation of the Pharmaceutical Industry.PwC

Deloitte (2011). The Next Phase: Opportunities in China’s Pharmaceutical Market.

Deloitte (2015).Winning with Biosimilars, Opportunities in Global Markets.

George Clinical (2016). Case Study: The Benefits of Conducting Clinical Trials in Australia.

Ministry of Science, ICT and Future Planning (2013).Biotechnology in Korea 2013.

Mondal S., Abrol D. (2015). Clinical Trials Industry in India: A Systematic Review.ISID Working Paper 179.

Rymzo B., Dowden N., Salvat R., Lee T. (2016) The Modern Merits of South Korea’s Biopharmaceutical Industry.Int J Drug Dev & Res 8: 001-006

United Nations, Department of Economic and Social Affairs, Population Division (2015). World Population Prospects: The 2015 Revision, Key Findings and AdvanceTables. Working Paper No. ESA/P/WP.241.

Woodhead, M. (2016). 80% of China’s Clinical Trial Data are Fraudulent, Investigation Finds. BMJ 2016;355:i5396doi: 10.1136/bmj.i5396.

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