BioMedica’s Influence on Rare Medicine Availability in Emerging Regions

Medical advancements in biotechnology have made it possible to find treatments for many rare diseases.

However, despite these advancements, many emerging regions still lack access to these medicines due to pharmaceutical market entry barriers.

This has resulted in many deserving patients being unable to receive treatment and many biotech companies being unable to reach these markets.

Fortunately, Biomedica GMBH, a pharmaceutical company specializing in the commercialization of rare disease products for patients in underserved emerging markets, can help with this.

In this article, we’ll discuss BioMedica’s role in rare medicine access in emerging regions.

What Are Rare Medicines?

Rare medicines are specialized treatments designed for rare diseases or conditions that affect a small portion of the population. These medications are often tailored to address specific genetic, chronic, or life-threatening illnesses with limited or no existing remedies.

They’re characterized by their scarcity, developed through extensive research, and often requiring advanced technology or unique formulations.

Due to their targeted nature, production costs might be higher, and their availability can be limited, posing challenges in distribution and accessibility, especially in regions with smaller markets or limited healthcare infrastructure.

Emerging Regions for Rare Medicines

Here are some emerging markets for rare medicines:

1. CIS

Encompassing countries like Russia, Kazakhstan, and Uzbekistan, this region is growing due to improved healthcare focus and access to advanced treatments.

2. Ukraine

With over 40 million people, Ukraine is becoming significant for rare medicines due to a high prevalence of rare diseases affecting approximately 1.5 million individuals.

3. Eurasian Economic Union

Including Russia, Belarus, Armenia, Kazakhstan, and Kyrgyzstan, this evolving market collaborates to enhance healthcare and pharmaceutical access.

4. GCC

Consisting of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the UAE, these countries carry a notable burden of rare diseases, impacting around 1.2 million people.


Spanning from Morocco to Iran, MENA has a substantial rare disease burden, affecting 6-8% of the population across countries like Algeria, Egypt, Iran, and others.

6. LATAM (Latin America)

In nations like Brazil, Mexico, Argentina, and Colombia, challenges in healthcare infrastructure affect the accessibility of rare medicines.

7. CEE

Encompassing countries like Poland, Romania, and Serbia, this region faces a notable rare disease prevalence of 5-8% among its population.

Challenges of Making Rare Medicines Accessible in Emerging Regions

Making rare medicine accessible in emerging regions comes with several challenges:

1. Limited Infrastructure

Many emerging regions lack robust healthcare infrastructure, including proper storage facilities and distribution networks required for specialized medications.

2. Regulatory Hurdles

Stringent regulations and complex approval processes can delay or limit the entry of rare medicines into these markets, hindering timely access.

3. Financial Constraints

Affordability is a major hurdle. The high cost of producing and importing rare medicines often makes them unaffordable for individuals and healthcare systems in these regions.

4. Supply Chain Issues

Challenges in the supply chain, such as inadequate transportation and logistics systems, can lead to delays or shortages in the availability of these specialized treatments.

5. Lack of Awareness

Limited awareness among healthcare professionals and patients about these rare diseases and their specific treatments might delay diagnosis and access to appropriate medicines.

6. Market Fragmentation

Emerging regions often have fragmented healthcare markets, making it challenging for pharmaceutical companies to navigate and distribute their products effectively.

BioMedica’s Influence on Rare Medicine Availability in Emerging Regions

Here’s how BioMedica influences rare medicine access in emerging regions:

1. Specialization in Rare Diseases

BioMedica specializes in commercializing rare disease products specifically tailored for patients in underserved emerging markets. Their rapidly expanding portfolio covers various therapeutic areas (TAs), focusing on orphan drug pathways.

2. Market Expansion Support

With capabilities spanning over 25 emerging markets, BioMedica facilitates the expansion of biotech companies’ presence. They aim to create value while addressing unmet patient needs, managing risks, and ensuring competitive financial returns.

3.     Strategic Market Access Guidance

BioMedica’s team offers strategic guidance for effective pharmaceutical market entry pathways, ensuring compliance with regulations and expert-based solutions for both registered and non-registered products.

4.     Patient-Centric Solutions

BioMedica takes a unique approach, seeing every patient as an individual. They customize treatments, considering each person’s distinct needs, ensuring personalized attention and care for those requiring rare disease medications.

5.     Ethical Imperative in Healthcare Equity

BioMedica emphasizes the ethical imperative of providing access to essential medicines globally. They highlight the importance of extending reach to underserved regions, affirming health equity, strengthening global health security, and empowering economic growth.

6. Rapid Value Creation

Partnering with BioMedica allows for early entry into emerging markets, leading to substantial value creation for biotech companies in the long term while managing risks and complexity.

7. Management Team Expertise

The company’s management team, with over 20 years of experience in large pharma companies and direct work in target markets, is fully committed to bringing life-changing medicines to patients in the countries in which they operate.

8. Market Presence and Network

BioMedica’s extensive network covers more than 25 countries, offering offices in various locations (CIS, Ukraine, Eurasian Economic Union, GCC, MENA, LATAM, CEE, EE, and the Balkans) and providing access to additional populations totaling 730 million people.

9. Comprehensive Market Access Services

They provide a ‘one-stop-shop’ model, simplifying the process for over 25 countries and offering compliance, market assessments, reduced administrative burden, and transparent engagement models.

10. Regulatory Expertise and Compliance

The company ensures compliance with local regulations and partner rules. They focus on designated compliance officers, effective training, communication, internal audits, and upholding standards.

11. Transparent Engagement and Problem-Solving

BioMedica’s transparent engagement model involves openly communicating challenges. They also provide personalized attention to each patient, offering proactive problem-solving solutions and reducing time-to-market.

12. Early Engagement for Market Access

Partnering with BioMedica prior to FDA/EMA approval allows for the launch of certain markets immediately after approval. Thereby significantly reducing time-to-market and granting early patient access.


BioMedica emerges as a committed and strategic partner. It offers comprehensive solutions, compliance assurance, and patient-centric solutions to enhance the availability and accessibility of rare medicines in complex and underserved regions. It works as a bridge to connect biotech companies with emerging markets for the successful commercialization of rare disease medicines.