established healthcare systems have seen the greatest benefits. But according to the International Monetary Fund, 85 percent of the world’s population – 6 billion people – live in developing or emerging markets, with limited or no options for safe and effective drug products to properly treat medical disorders.
Here is our 6 steps guide to achieve success in those emerging markets.
But according to the International Monetary Fund, 85 percent of the world’s population – 6 billion people – live in developing or emerging markets, with limited or no options for safe and effective drug products to properly treat medical disorders.
In recent years, while patents have expired and growth has slowed in mature markets, pharmaceutical companies have reinforced the ways to better serve emerging markets. Many “emerging markets” have growing economies and regulatory agencies that are being created or upgraded to institute tighter quality controls. With higher populations able to access medicines, there is an ongoing shift from acute to chronic treatments similar to those in mature markets, like diabetes, obesity and cardiovascular disease. Top-tier emerging markets include Brazil, Russia, India and China (referred to as the BRIC countries) followed by Southeast Asia, Latin America and Africa. While all are categorized as “emerging,” they are far from the same. Each has widely differing demographics, government infrastructure, healthcare availability and affordability, cultural diversity, and industry regulations.
Go-to-market strategies used in mature markets have often proved ineffective in emerging ones. Pharmaceutical companies entering these markets have learned that in order to succeed, they need to adopt an entirely new approach customized for each country.
Market expansion is a challenging and complex process – mainly from regulatory perspective
One of the biggest challenges for companies entering emerging markets is learning how to successfully navigate the different requirements in each country’s regulatory process. Teva api devotes a significant amount of resources adjusting to market-specific requirements. For example, the Brazilian ANVISA has instituted new regulations that require drug products to meet stability standards for tropical zones (IVb). In mature markets, most drugs are required to meet standards for temperature controlled, air conditioned environments. But in Brazil, APIs and drug products distributed there have to maintain stability and efficacy in high heat and humidity. A similar challenge exists in India, where companies are now required to adopt the local pharmacopoeia to attain local registration.
Markets also require different processes for registering Drug Master Files (DMFs). In some cases, Teva api submits the DMF to the Ministry of Health and it grants access to our customer; in other countries, Teva api ’s customer is the one required to submit the DMF for Ministry review. Teva api ’s Regulatory Affairs team often works closely with customers on the submission process. They have many years of experience successfully handling regulatory submissions and stay up-to-date on the requirements in each country, so our customers can go to market as quickly as possible.
Getting started and achieving success in emerging markets – our main 6 steps
Based on Teva api’s experience, there are several steps pharmaceutical companies might want to consider before entering or expanding in an emerging market, including:
Creating a targeted strategy. Companies should seek to identify and focus on consumer segments within emerging markets and pinpoint drug products that meet their needs. It is important to learn how consumers access and pay for healthcare, and determine the most effective way to manufacture and distribute medicines. For Teva api, therefore, selection of the correct portfolio is critical for supporting its customers in specific therapeutic areas.
Being first to market. This has perhaps been the number one challenge for many pharmaceutical companies in recent years. Experts have concluded that drug manufacturers will be more likely to succeed in markets with such early access in a fairly developed healthcare system, but It is also essential in growth markets for companies to determine the benefits of early market entry: whether consumers will have access to their medicines and whether there are local incentives for being the first to market. Teva api seeks to meet the needs of its customers to help them where possible be the first to gain market access.
Understanding the regulatory and IP environment. Companies should acquire in-depth knowledge of the market’s regulatory standards and be able to keep pace with changes. It is essential to develop good working relationships and having open and transparent communication with regulatory authorities and local public bodies. In order to secure their IP position, companies need to develop the right strategy that aligns with the local market.
Establishing a local presence. A local presence in an emerging market can lead to stronger relationships and more effective operations. While a local sales office may be sufficient, some companies might decide to add R&D and manufacturing facilities, or find a reliable partner with operations based in the market or region.
Quality. Quality. Quality!. Patients all around the world deserve the highest product quality standards. Our ultimate goal reaches beyond just supplying products that meet compliance standards. We want to help all consumers, no matter where they are, live better lives.
Investing for the long term. Success does not happen quickly. Companies entering or enlarging their footprint in emerging markets need to be prepared to commit time and resources, possibly for several years. Relationships with partners with experience in a market or region may help a company to improve competitiveness and leapfrog other companies for market entry.
Teva api to provide exceptional support to customers in emerging markets
We are currently developing full service capabilities across our entire organization to support customers worldwide who would like to enter new emerging markets. We are establishing local sales offices staffed by local teams to provide one-on-one customer attention, and in some growth countries we operate R&D centers and state-of-the-art manufacturing plants. As regions evolve and customer needs change, marketing designs product portfolios specifically for each market. R&D develops product adaptations for each, and Quality Assurance makes sure specific quality and stability requirements are being met. Regulatory Affairs creates and updates detailed documentation and Supply Chain and Operations ensures products are produced and delivered to the customer.
Because we already have a presence and a proven track record in developing and emerging countries, we use our knowledge and expertise to support customers who are pursuing new market opportunities there.
The future looks promising for the pharmaceutical industry’s growth in emerging markets, and strengthening Teva api’s leadership in those countries will be long-term process. With planning, collaboration and game-changing innovation, we are confident our work will help contribute to our customers’ efforts to enter markets more quickly and improve patient health and wellbeing around the world.
To learn how Teva api can help support your efforts to enter or expand in emerging markets, please contact us