Latam Pharma Entry Into the EU: Quality, Regulatory, and Strategy

The European Union represents one of the world’s most attractive pharmaceutical markets: still expanding, driven by aging populations, high purchasing power, universal drug coverage, mature regulatory frameworks, and strong demand for innovative and high-quality medicines. For Latin-American pharmaceutical companies, entering Europe offers a strategic opportunity to scale globally, diversify revenues, and enhance brand credibility.

However, EU entry is also a top demanding process in one of the most regulated and competitive environments worldwide, requiring a holistic assessment process, regulatory discipline, quality excellence, and a long-term commercial strategy.

This article outlines the key opportunities, challenges, and some strategic recommendations for Latin-American pharmaceutical leaders considering expansion into the EU.

1. The European Union: A High-Value Pharmaceutical Market

According to IQVIA MIDAS data included in a 2025 report by European Federation of Pharmaceutical Industries and Associations (EFPIA), the European market accounts for 22.7% (US$347 billion) of the World Pharmaceutical prescription market estimated at US$1.5 trillion at ex-factory prices in 2024.

Rx Spending in Europe is expected to increase by US$85 billion through 2029, driven by new and existing brands, while the impact of exclusivity losses will reach US$25 billion over five years, with most due to small molecules.

Western Europe has had four straight years of 8% spending growth through 2024 and is expected to slow to 4.5–7.5% through 2029 as a combination of expiry events and payer pressure partly offset by the wider use of novel medicines.

2. Strategic Opportunities for Latin-American Manufacturers

Demand for High-Quality, Cost-Competitive Products

Europe’s commitment to reducing healthcare spending creates openings for areas where Latin American firms can excel:

• Generics and biosimilars: cost containment pressures across EU healthcare systems create demand for high quality, affordable alternatives.
• High-value niche therapeutics (orphan, hospital-only, specialty products): These segments have less competition, rapid uptake in reference hospitals, and high willingness-to-pay if clinical value is proven. Small and midsize companies can enter Europe with fewer barriers than large mass-market products.
• Consumer healthcare products: With aging demographics and higher health-awareness, there’s more demand for self-care and preventive healthcare, wellness, aesthetic, supplements, mobility, chronic condition support outside the clinic.

Leveraging Latin-American Capabilities

Regions like Mexico, Colombia, Brazil, and Argentina have:

• Competitive manufacturing costs
• Strong formulations and bioequivalence expertise
• Growing R&D clusters

These capabilities can support EU market penetration when paired with compliance upgrades.

3. The Challenges: What Executives Must Prepare For

Although we have already reviewed the potential of the European market and the opportunities it offers to Latin American companies, it is necessary to highlight that the European pharmaceutical market poses a great challenge for new entrants from other geographies.

These challenges can be grouped into four categories: regulatory environment, operational and quality requirements, pricing strategy and market access, and finally, commercial and competitive complexity.

Regulatory Barriers

The EU pharmaceutical regulatory framework is a comprehensive system balancing patient safety, innovation, and market access. It is anchored in EU directives and regulations, enforced by EMA (European Medicines Agency) and NCAs (National competent authorities), and continuously updated to respond to challenges like medicine shortages, affordability, and global competitiveness.

The centralized authorization via EMA provides a single approval valid across all EU Member States, simplifying market entry and reducing duplication. Despite harmonization, regulatory approval can be slower compared to other regions, delaying patient access to innovative therapies.

Additionally, while EMA provides centralized approval, pricing and reimbursement decisions remain national, leading to unequal access across member states.

Quality and Operational Requirements

Meeting EU standards requires significant resources, which can be burdensome for smaller Latin American companies.

Key challenges:

• Obtaining EU-GMP certification
• Meeting strict requirements for bioequivalence, stability, impurities, and traceability
• Implementing serialization and anti-falsification systems
• Managing long approval timelines
• To compete, manufacturers must adopt:
• ICH-aligned quality management systems
• Highly detailed technical documentation (CTD)
• Robust pharmacovigilance systems
• Continuous audit readiness

Market Access and Pricing Constraints

Each EU country has its own system for:

• Pricing
• Reimbursement
• Health Technology Assessment (HTA)
• For executives, the fragmentation increases:
• Time to market
• Administrative burden
• Need for local expertise

Commercialization Complexity

EU commercialization requires:

• Local presence or strong distributors
• Multilingual packaging and labeling
• Country-specific dossiers
• Investment in marketing, medical affairs, and tender processes

4. Strategic Recommendations for Latin-American Pharma Leaders

Start with a Holistic (and Critical) Assessment

Executives should evaluate:

• Which products are best suited for EU entry
• Competitive landscape in target countries
• Price expectations and reimbursement potential
• Total cost of regulatory compliance
• How internal resources and capabilities are aligned and prepared for a European landing.

Strengthen Regulatory & Quality Infrastructure

Consider:

• Achieving EU-GMP for key manufacturing plants
• Upgrading quality management to EU/ICH standards
• Investing in robust pharmacovigilance teams

Enter Through Strategic Partnerships

Different strategies and alternatives must be considered:

Licensing products to experienced EU distributors: It’s the mostly used strategy because companies minimize investments and risks. But it’s adding fewest value because the control remains in the distributor who owns the key assets: market and clients.

Co-development agreements: Specially indicated for innovative companies with New Chemical Entities or real innovations to be adapted to the European market.

Building own network of subsidiaries: Maximize the value for the pharmaco but the investment is high and the risks are the highest when top executives have little knowledge about the market trends and real business.

Strategic alliances with European partners: It’s an intermediate alternative with lower risks and investment needs that setting up proprietary subsidiaries but maximize the long-term value with a real presence in Europe. Partners can help the foreigner company to sail into the regional and local regulatory complexity, offer a reliable logistic and distribution network, access to key markets and payers plus commercial expertise. Icon Group, as part of Global Alliances for Pharmaceutical Solutions, is offering commercial solutions for Latin American companies across Europe working together with top partners leaders in the German, French, British, Italian, Nordics (Sweden, Norway, Denmark & Finnish), Belgian, Spanish and Portuguese pharmaceutical markets.

Build a Phased Expansion Plan

Start with:

• One or two EU priority markets with high generic penetration and predictable pricing (Spain, Portugal, Belgium, Nordics, and so on).
• Expand to top markets once brand credibility is established.

Conclusion: Europe Is a Growth Frontier Worth the Effort

Entering the European Union market is a great opportunity for Latin American pharmaceutical companies to maximize the value of their portfolios. But….

As one of the most complex and mature pharma market in the world, a professional and deep opportunity analysis is needed to ensure that internal capabilities and assets are aligned with the available spaces and quality and regulatory requirements.

Betting on a reliable network of partners can be a suitable decision to minimize risks and investments while a long-term proprietary structure is created.