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Latin America

Latin America is quickly expanding as a key growth area for the pharmaceutical industry. Improving economies and growing use of public and private insurance programs are giving patients across the region access to new drugs, which is driving up sales and increasing demand for new products. This is translating into substantial revenue opportunities for biopharma and device developers.

By the end of 2017, Brazil will become the fourth largest pharma market, behind the U.S., China and Japan according to data from an Americas Market Intelligence report. Also, the IMS Pharmerging Markets report named Chile, Peru and Ecuador among the current “frontier markets” for pharma sales, with total expected increases reaching $2.5 billion from 2012-2017.

Part of this growth stems from the shifting regulatory environment. Many regulators have begun adopting Good Clinical Practice (GCP) guidelines established by the International Conference on Harmonization (ICH) in an effort to align their standards with the US, Europe and Japan.

The growth in sales and maturing regulatory environment is drawing the attention of global biopharma developers who are beginning to view Latin America as an important player in their long-term market strategies. It’s also changing the way they do business in this region. In the past, biopharma companies often entered the region as a second line strategy, after developing and marketing products for larger target markets in Europe, the US and Asia. More recently though, we’ve seen many companies target Latin America for their primary launch plans.

Time to move

These changes are giving pharma companies an opportunity to rapidly expand their market reach in the region and to optimize regulatory affairs related to maintenance of marketed products — but they need to be thoughtful about their approach. To avoid mistakes and mitigate risk, companies need expertise on their team to adapt clinical research plans to accommodate new rules and evolving market demand.

With the changes in local regulations — in addition to more ICH-aligned requirements introduced for biologics and biosimilars — local companies are developing programs that may enable them to launch products in central markets like US and Europe. And while many Latin American regulatory bodies are working together to standardize regulations across the region, there are still gaps between countries that need to be addressed in the launch of new products and management of existing marketed products. Companies that want to take full advantage of the growing business opportunities in Latin America need the guidance of experts who understand the marketplace and have their finger on the pulse of regulatory change in the region.

Many of these organizations are choosing to work with global partners who can help them navigate the regulatory environment and enhance their strategies for product launch and management. Through these partnerships, companies are able to fast-track their development plans, and avoid mistakes that could delay product launches and add risk to their business model. Such partnerships are especially valuable for smaller and mid-sized biopharma companies that lack the resources and expertise to go it alone.

New and existing product management

Launching a drug in any unfamiliar market is fraught with risk, particularly when the regulatory environment is in flux. Along with adapting to new rules, developers may lack an existing sales network, and be unfamiliar with marketplace mechanics, local laws and IP protection. All of which can thwart their ability to successfully break into that market.

By partnering with a global expert like QuintilesIMS, companies are able to leverage the extensive local knowledge as well as the existing infrastructure, technology and salesforce who have well-established relationships with payers, providers, pharma, and patient communities in the countries. These resources can be utilized to support the new product market strategy, which can dramatically shorten the time it takes to bring a product to market.

Biopharma companies can also use these partnerships to improve their regulatory affairs work, which requires localization and can create a significant financial and human capital burden for companies with limited resources that need to manage marketed products in these countries.

At QuintilesIMS, we are able to manage these tasks more efficiently and at less cost and overhead for our clients through our ‘Hub and Spoke model’, which leverages staff in key Latin American countries who oversee all regulatory submissions. These staff have the expertise, language fluency and technology to easily adapt filings for every regulatory body from a centralized locale. Work on the core dossier for each product is done in an off-shore site, where basic files are produced and published. It is then made available electronically, using secure portals for each hub to tailor for their countries. This partnership model for global regulatory affairs management can eliminate a company’s need for in-country personnel and free up resources to focus on more strategic related efforts.

Planning for the future

As more biopharma and device companies view Latin America as a key market for long-term growth, they need to determine how best to navigate the regulatory environment for new and existing products. By partnering with companies that have deep expertise in these areas, they can access the knowledge, resources and technology to confidently establish themselves and their products, without investing in massive infrastructure and resources in the region.