Emerging pharma/biotech companies, having achieved their first two- or five-year plan milestones, often look to expand internationally. However, before making any moves, company CEOs should do their research and consult with an expert.

Optimizing Growth through Globalization

For emerging US-based pharma and biotech companies that have reached their initial milestones, business growth can best be achieved by expanding internationally. Emerging markets are particularly attractive, because they represent more than half of the world’s population and a significant percentage of the global pharma market.

Start with a Market of Interest

While many companies are eager to establish a global footprint, the first step in a successful international strategy is to establish a strong presence in an initial — typically, domestic — market. Success in an initial market allows companies to overcome barriers to entry in secondary markets. Establishing internal processes, building an expert team, and generating cash flow in an initial market will increase the likelihood of a successful expansion abroad.

Many Ways to Expand

A successful global expansion strategy must focus on the competitive advantages of the company and the value proposition of the products or services in foreign markets.

There are numerous mechanisms for global expansion. Some companies choose to build brick-and-mortar edifices in a new market, while others choose to establish partnerships with domestic firms. The correct approach depends on the risk profile of the biopharma company, the regulatory environment in markets of interest, and the competitive landscape within the product category.

Four Key Considerations

When developing an appropriate globalization strategy, there are four key concepts to consider:

• Culture
• Quality and regulatory requirements
• Government policies
• The business plan

Regardless of whether you are a pharmaceutical company, biotech firm, contract research organization, contract development and manufacturing organization or testing lab — and whether you are partnering or going it alone — the results will depend on how you manage these four factors. Appropriate planning and proper execution with the right people drive success.

Understand the Culture

It is essential ­— but often undervalued — to understand the cultures of the markets you are considering. Cultural differences impact buying habits and, in the case of pharmaceuticals, prescription volume. Time and resources must be invested to ensure that the target market is appropriate for your products or services.

For American firms, Western European markets tend to offer the easiest entry, as there are many cultural similarities. Asian countries, on the other hand, present an entirely different cultural landscape. We recommend leveraging experienced professionals to navigate cultural complexities in foreign markets. Having a key influencer on the ground with a detailed implementation plan — regardless of the mechanism used for expansion — is essential.

Be Familiar with Regulatory Requirements

Every region/country has its own regulatory agencies and compliance requirements. There has been some degree of harmonization among U.S., European, and Japanese pharma regulations, and while many emerging markets are rapidly closing the gap, important differences remain. It is necessary to understand, in detail, the regulatory pathway of the target market. The most effective way to achieve this goal is to invest in human resources — consultants or external hires who have appropriate experience early in the process.

Build Government Relationships

Government policy can heavily influence the operations of foreign companies. It is necessary to understand those policies that impact foreign companies, especially those that protect the domestic biopharma industry to determine the best strategy for expansion. In addition to government finance programs, exchange rates, and permitting issues, there may also be standards that promote hiring domestically and discourage expatriates from establishing businesses. Building robust relationships with government representatives should begin at the earliest possible stage.

Have a Solid Business Foundation

If the proper cultural considerations are made, the regulatory pathway is understood, and government policies are supportive, the target market may still not be suitable for your product or service without a well-devised business plan. An understanding of market size, growth rate, penetration rate, intellectual property and trademark protection establishes the foundation of the business plan. There must be a clear sales benefit before making your international move.