We at Barrco Regulatory Solutions provide our clients with a unique range of Market Entry Healthcare Consulting Services in Strategy & Marketing, Establishing International Business, Licensing & M&A, Regulatory & Registration, Publications, Executive Searches, and more. Our key areas of expertise are within the Pharma, OTC, Medical Devices, Food Supplements, and Derma/Cosmetic segments, and most of our client projects take place in Latin America, Asia, US/Canada, Russia/CIS, Europe, and the Middle East.
The good old days of Pharma & Consumer Health businesses are irretrievably gone. To continue growing, the ability to quickly adjust to global market dynamics and needs is essential. In this fast-paced, challenging time, it is important to up the ante on international strategy to ensure that it can appropriately serve your company’s growth ambitions. Considering that Emerging Markets develop and grow much more quickly than mature markets, a shift in focus and investments to the growing international markets is something to be considered.
Shifting your focus from home market to international focus:
– Gain additional international sales with your existing products in additional countries
– Systematically identify your Products & Countries with best potential in Europe, Latin America, Asia, US/Canada, Middle East
– Be less depended on your home market and lower the risk
Leading international Pharma and Healthcare experts point out that to be successful in the long term, and to elevate your business to the next level, it cannot be confined to only a few countries. An international country portfolio is crucial to avoid dependence on a single market (home country), which can be very risky in the long-term. With a portfolio of 15-20 countries (7-10 countries to start with), a company can become more independent from any future crisis to come. Many leading experts point out that many companies have not realized the full potential of international Emerging Markets while competing on their home market. Because Emerging Markets develop and grow so quickly, companies should seriously consider switching their focus and investments to growing international countries.
Our Barrco Regulatory Solutions’ Experts understand that the future is global and recommend ‘letting go’ by developing, harvesting, or maintaining strategy in place for mature or home markets and investing in growing international markets. In the future, and even now, international markets are where additional revenues will come from.
To enter new international countries is a challenging and very time-consuming process that requires a great deal of local expertise, prior planning, and detailed analysis. In order to make this process more transparent, this article describes a systematic approach on how to enter the most promising Pharma and Consumer Health markets. The approach includes five fundamental steps:
- International Systematic Product Portfolio Analysis
The development of a solid and specific product portfolio as part of your international Pharma, OTC, and Medical Device Strategy is essential, as it creates the opportunity to launch the best fitting products with the best potential across different healthcare systems.
It is also imperative to analyse markets individually and look beyond market data alone (e.g. IMS, DSM, or Insight Health), as data can be quite misleading if it is not examined in context with local marketing knowledge. A market may show the rapid growth, but certain issues with respect to trademarks, registration rights, patents, high market entry costs, high regulatory cost, and long registration time issues can still be present. At this stage of international product strategy, your suggested patent, tenders, and consumer prices will be analyzed based on their competitiveness in the potential markets. Furthermore, new niche segments and off label indications will be assessed based on your own products.
The outcome of this first step is the identification of key products that can go international to gain further revenue.
- Systematic Country Selection
Two aspects should be considered in the selection of countries in Latin America, CIS/CEE, EU, USA, Middle East, or Asia. It is always necessary to identify the most suitable countries for your specific portfolio. Simply entering an emerging market does not automatically guarantee success. A new market entry also involves challenges apart from sales opportunities.
- Product & Country Matrix Analysis
After conducting the International Systematic Product Potential & Country Analysis, it is advisable to bring all those parameters in a matrix in order to identify the Top 3-5 products to launch in each region within the top 3-4 countries that show the most potential. This is a complex but very useful analysis to construct every 6-8 years for one of the geographical regions you are focused on e.g. Latin America, CIS/CEE, Middle East, Asia, or Europe.
- Registration of Focus Products in the identified Focus Countries
Since the regulatory situation has been analysed in previous steps, this stage is about conducting the individual registration successfully. The knowledge and understanding of each country’s regulatory entrance criteria is vital when trying to enter a new market, as there are notable national differences and your product is dependent on its status, e.g. Pharma, Consumer Health, Medical Devices, Food Supplements, Cosmetics, etc.
We identify the right registration category and strategy, options for fast track registrations and product labelling.
- Local Partner Company Identification and Selection Process
As with any international market success, more than 80% of success depends on finding a suitable local partner company or establishing your own office. Hence, a systematic search for the best fitting local partner company must be conducted as part of your global Pharma and Healthcare Strategy.
The above figure shows an overview of our approach in Systematic International Company Partner Identification.
The wrong choice of a partner can result in having to change local partners, which means that time, money, and energy would need to be reinvested. Thanks to our experience and network, we can save you valuable time and money by avoiding tedious “getting to know you meetings” throughout the partner selection process.
A screening of all available partners should be conducted to assess which company perfectly fits your requirements and product segments.
