Latin America Orphan Drugs Market

Latin America Orphan Drugs Market Size (2023 to 2028)

The size of the Latin America Orphan Drugs Market was worth USD 15.21 billion in 2023 and estimated to be growing at a CAGR of 7.38%, to reach USD 21.72 billion by 2028.

Orphan drug access in Latin America will continue to rise over the long term, propelled by the need to promote the marketing and state procurement of these high-value drugs. Multinational drugmakers will profit from the growing patient demand, which will create further commercial prospects in years to come. However, access will remain limited over the short term as the region's broader economic slump confines overall spending capabilities.

Rising support from the government through investments in the development of specified drugs for rare diseases with high quality and Y-O-Y growth in the incidence of rare diseases are propelling the Latin America orphan drugs market. Furthermore, these drugs are explicitly manufactured according to rare diseases, which also multiply the shares of the market. Besides, growing prevalence to have effective treatment procedures at any cost, awareness over the availability of different treatment procedures for every disease through campaigns and digital advertisements and early diagnosis of a disease by most of the people are further expected to fuel the growth rate of the Latin American Orphan drugs market.

Advanced technology plays a crucial part in introducing innovative products in the medical sector, which is lucrative to improve growth opportunities for the market. In addition, the rising geriatric population, growing knowledge over the combination therapy approaches, and the increasing need to increase the production of orphan drugs, along with an increasing number of patients with various diseases, are broadening the demand of the market. Furthermore, changes in the schemes by the government in concern towards people’s health are leveling up the growth rate of this market.

However, the shortage of skilled professionals in manufacturing the latest drugs with a specific formula is slowly hindering the market's growth rate. Orphan drugs are a bit expensive compared with normal medicines, which remains a challenging factor for the market players. In addition, strict rules by the government over pharmaceutical companies to release high-quality products impede the demand of the market. Lack of standardization is also restricting the need of the market.

This research report on the Latin American orphan drugs market is segmented and sub-segmented into the following categories:

By Type: 

• Biological
• Non-biological

By Therapeutic: 

• Hematology
• Neurology
• Oncology
• Others

By Region: 

• Brazil
• Mexico
• Argentina
• Chile
• Rest of Latin America

Regional Analysis:

There are around 13 million people in Brazil, according to the ministry of health data. Brazil’s National Health Surveillance Agency (ANVISA) has approved 21 orphan drugs in 2019. The advanced therapy products have great potential benefit to the patients with rare diseases for which there is no other alternative treatment available. The government has passed a new resolution for the research of rare diseases treatment and clinical trials. Besides, a rise in the number of people with various chronic diseases prompts the demand for the orphan drugs market in Brazil. 

In Mexico, the market size is to have the fastest growth in the coming years. Mexico’s General Health Law has now created a federal law for the regulation of orphan drugs. Increasing support from the government authorities to invest more in the development of orphan drugs is escalating the market demand. In Mexico, around 6 million people suffer from rare diseases, of which 80% are genetic diseases, and 20% are caused by immune deficiency. Growing awareness over the availability of different treatment procedures is fuelling the demand of the market.

Key market participants:

A few promising companies operating in the LATAM Orphan Drugs Market profiled in this report are Novartis, GlaxoSmithKline, Roche, Alexion, Sanofi, Bristol Myers Squibb, Pfizer, Vertex, Celgene, and Merck.