Rapidly Growing Latin American Pharmaceutical Market... K-Pharma Also Throws Its Hat in the Ring

Still at a scale of 72 trillion won
Annual growth rate around 13%

From gastroesophageal reflux disease treatments
to autoimmune diseases, anticancer drugs, and vaccines

The Latin American pharmaceutical market is rapidly expanding, boasting the highest growth rate in the world. As domestic pharmaceutical companies swiftly introduce new drugs, local efforts to establish a foundation for industry development are ongoing, raising expectations for further growth.

[Image source=Pixabay]

According to IQVIA, a pharmaceutical market research firm, the Latin American pharmaceutical market size reached $56.2 billion (approximately 72 trillion KRW) last year. Considering that the U.S., the largest single-country market, has a market size of $586.1 billion (about 750 trillion KRW), Latin America’s market is roughly 10% of that, making it relatively small in comparison.

However, it is a rapidly growing market driven by ongoing economic development. According to the global statistics platform Statista, the annual growth rate of the Latin American pharmaceutical market was 13% in 2021. This is the highest growth rate worldwide, surpassing the global average (10.5%), the European Union (EU) at 11.8%, and North America at 8.1%. Furthermore, it is projected to maintain an average annual growth rate of 12.6% from 2021 to 2025.

In response, domestic companies are making efforts to pioneer the market early. HK Innoen ('K-CAB') and Daewoong Pharmaceutical ('Pexuclu'), which developed gastroesophageal reflux disease treatments based on a new mechanism called potassium-competitive acid blocker (P-CAB), are representative examples. In 2018, HK Innoen signed an export contract with Latin America’s major pharmaceutical company Laboratorios Carnot for 17 Latin American countries and launched K-CAB in Mexico under the name 'K-CAB.' It also received approval in Peru on the 21st of last month. Pexuclu obtained approval in Ecuador and Chile earlier this year and plans to launch soon. In February, Daewoong Pharmaceutical also exported its diabetes drug 'Envlo' to local pharmaceutical company Moksha8 for up to $84.36 million (approximately 110 billion KRW). The goal is to launch in Brazil and Mexico in the second half of next year.

Celltrion Group, which has established a direct sales system extending to Latin America, further strengthened its portfolio by launching the autoimmune disease treatment 'Remsima SC' in Brazil last May. It already sells the intravenous (IV) version of 'Remsima' and the anticancer drug 'Truxima,' with Remsima commanding an 84% market share. Celltrion Healthcare also has local subsidiaries in Chile, Peru, Ecuador, Costa Rica, and Colombia, in addition to Brazil.

Given the characteristics of Latin America, where many countries are low- to middle-income, vaccine business with high demand is also actively expanding. GC Green Cross secured a contract worth $44.38 million (approximately 57 billion KRW) for influenza vaccines in the southern hemisphere under the Pan American Health Organization (PAHO), a WHO agency, in March this year. SK Bioscience also began continuous supply by shipping the initial batch of the varicella vaccine 'Sky Varicella,' contracted with PAHO, in May.

Flags of Cuba, Mexico, and Colombia displayed in the meeting room for the establishment of the Latin American and Caribbean Medicines Agency (AMLAC)
Photo by Mexican Government

Buoyed by the market’s growth, moves to establish an 'integrated regulatory agency' are becoming visible. This system, already implemented through the European Medicines Agency (EMA) in the European Union (EU), is expected to strengthen regulatory capabilities.

According to the Korea Bio Association’s Bioeconomy Research Center, on the 16th of last month, heads of pharmaceutical regulatory agencies from Argentina, Brazil, Chile, Colombia, Cuba, and Mexico gathered in Bogot?, Colombia, and agreed to establish the 'Latin America and Caribbean Medicines Agency (AMLAC).' This follows the 'Acapulco Declaration' signed in April by health officials from Colombia, Cuba, and Mexico, with the initiative gradually expanding. AMLAC aims to support effective and high-quality manufacturing of medicines and medical devices and to enhance flexibility regarding intellectual property, with the goal of strengthening self-sufficiency in medicines and medical devices.

If this plan materializes, it is expected to resolve the inconvenience of having to obtain product approvals separately by country. An industry insider said, "If AMLAC succeeds in becoming an integrated regulatory agency like EMA, the hurdles compared to individual country approvals may be somewhat higher," but added, "If integrated approval becomes possible, overseas market entry will be easier and faster."

Currently, EMA operates various integrated certification systems. These include the 'centralized procedure,' where EMA directly reviews and grants a single marketing authorization, and the 'mutual recognition procedure,' where approval is first obtained in one member state and then recognized by others. Both significantly reduce the workload compared to individual country approvals. Similarly, in Africa, where many countries are low- to middle-income, 15 countries have decided to establish the 'African Medicines Agency (AMA),' with Kigali, Rwanda, designated as the AMA headquarters, reflecting a global acceleration of such initiatives.

This content was produced with the assistance of AI translation services.