The Globalization of Pharma
According to the World Health Organization (WHO), "a measure of the globalization of a health system would include its degree of openness to foreign goods, services, ideas and policies, and people."1 Extending this measurement to the global pharmaceutical market, then, requires U.S. pharma to explore the relative openness of worldwide markets by evaluating a couple of key questions.
How is global R&D changing?
Financial pressures throughout healthcare mean more and more stakeholders are exploring ways to do more with less. For manufacturers, that often means looking for more cost-effective ways to conduct clinical trials while also increasing the complexity of their research. The shrinking majority of trials that are conducted in the U.S. and Europe indicates a shift toward areas with more "treatment value" patients - patient populations that are ripe for the wide-spectrum data sets that emerge from successful studies. Areas with dense populations of varying health and socioeconomic conditions also present opportunities for cost savings, especially as many global markets make investments in their infrastructures to accommodate trials.
With many countries now requiring that trials be conducted within their borders prior to a product's availability in the country, conducting global trials doesn't just present cost savings; it also makes strategic sense. In addition, running trials in locations where ideal patient populations exist means a manufacturer's commercial market will likely follow suit.
What are the challenges associated with global markets?
Despite the opportunities, regulatory challenges exist that can impact clinical trials and commercialization in most emerging markets. In the "BRIC" nations (Brazil, Russia, India and China) that represent more than $248 billion in projected pharma sales by 20162, success can be slowed by regulatory complexities. India, for example, has a slow trial approval process that recently stopped altogether, turning a 12- to 16-week long approval into one of indefinite length. Brazil has import license and other regulatory requirements that are difficult to navigate, as do Russia and China. These challenges mean that shipping products and samples to emerging markets for clinical or commercial purposes can be a wholly complicated process that varies by shipment.
What trends impact local decision-making?
For U.S.-based manufacturers looking to explore emerging markets, factors beyond regulations also impact decisions about logistics, shipping and outcomes data. The newest specialty drugs have unique and varying temperature-control needs that can range from body-temp specimens to frozen finished product, raising concerns around expertise in handling and innovation in packaging. In addition, global commercialization efforts command local, region- or market-specific expertise.
When it comes to patient data, registries are often unconsolidated, meaning manufacturers must mine through disparate data instead of accessing standardized banks of data that cover their initiatives across the globe. And though global storage and transport regulations are constantly improving, there's much progress to be made in terms of standardized compliance training for every stakeholder - from airlines to internal manufacturer personnel. These issues demonstrate a marked need for manufacturers to collaborate with expert partners and jointly work toward standardization and shared strategies.
How can manufacturers shape their global strategies?
Up-to-date insight on emerging markets - from where ideal trial patients exist to the logistics and regulatory challenges present in those areas - can significantly impact trial timing and speed to market. Equally critical is access to the expertise of experienced, versatile partners. As such, manufacturers are increasingly looking at partners that offer a combination of skills - for example, regulatory and packaging expertise - as well as technology solutions that extend the manufacturer's business intelligence and inform strategic decisions. The most consistent formula for success in emerging markets comes down to harnessing global reach in concert with in-market, local resources.
Learn more about shipping to emerging markets. Read World Courier's field guide.