Latin America Generic Drugs Market

Latin America Generic Drugs Market Size

The generic drugs market size in Latin America was valued at USD 37.14 billion in 2023 and is predicted to be worth USD 53.92 billion by 2029 from USD 39.52 billion in 2024, growing at a CAGR of 6.41% during the forecast period.

MARKET DRIVERS

The pharmaceutical industry plays a vital role in the growth of generic drugs. The primary driver of the Latin American generic drugs market is patent expiration, which helps initial developers produce lower-cost generic variants and introduce them. Generic drugs are of the same quality, and there may be some changes in flavor, size, and color, but the efficacy of the drug remains the same as that of branded drugs. People prefer most generic drugs as they are cost-efficient and affordable. In addition, an increase in the rates of rising chronic illness is boosting the sales of generic drugs, advances in the formulation of drugs, and market players are also driving market growth.

The escalating prevalence of chronic diseases and the growing geriatric population across the region are other significant factors contributing to the expansion of the Latin American generic drugs market. The most significant burden of disease in the region is the non-communicable diseases, which are widely prone among the older population, where cardiovascular diseases represented the highest rate of deaths followed by cancer, diabetes, and kidneys, which propels the market growth rate.

• For Instance, the population above 65 years old has reached 58 million in Latin America and the Caribbean region, and the count is estimated to reach 145 million or almost 19% of the total population by 2030.  

MARKET RESTRAINTS

However, patients' preferences and assumptions make them less likely to choose generic drugs because they believe generic therapies are inferior to branded treatments. Doctors rarely prescribe generic drugs, and chemists only supply medicines that are written on the prescription. In addition, the FDA's strict guidelines and rules for the approval and side effects of the drugs due to some variation during formulation, color, or flavor are restraining the market growth. Doctor preference towards brands and their brand loyalty towards the branded drugs may impede the market growth. The cases of new adverse effects caused by switching between branded and generic drugs and the limited adoption of drugs with narrow therapeutic indexes are estimated to hinder the market growth in the region. Other factors, such as low absorption rate, impurities, and potency variations, hamper the regional market revenue growth.  

MARKET OPPORTUNITIES

The growing government support initiatives and the escalating investments by the market players in research activities in developing generic drugs are significant factors creating market growth opportunities. The increasing number of product launches and the favorable regulatory framework across the region propel regional market growth. The rising awareness among the people regarding the benefits of generic drugs, and the expanding geographical reach is providing generic drugs market growth opportunities across the Latin American region.

MARKET CHALLENGES

The major challenges with expanding generic drugs are the risk of sensitivity and intolerance, as the manufacturers may change the composition by adding other preservatives or fillers. Some generic drugs are not similar to branded drugs as they may vary regarding efficacy or safety, and changes in the release dosage may inhibit the adoption rate among people, leading to restricted market growth. The presence of limited awareness among the emerging population and the stringent regulations in certain countries may challenge market expansion.

REPORT COVERAGE

SEGMENTAL INSIGHTS

The branded generics segment dominated the generic drugs market in Latin America in 2023.

The domination of the branded generics segment is primarily due to their affordability compared to branded drugs. Most people can quickly learn about branded generics due to the brand name rather than the chemical name, which fuels the segment growth rate. The branded generics also undergo various regulatory processes and approvals from the United States Food and Drug Administration (USFDA). Branded generics can be marketed by both innovators and generic companies, which boo, boosting growth.

The pure generic drugs segment is anticipated to have notable growth during the forecast period. Pure generic drugs are the ones known by the chemical name where the API is similar and may differ in shape, size, color, and inactive ingredients.

The CNS segment held the most significant share of the regional market in 2023.

The domination of the CNS segment is expected to continue during the forecast period. The growing prevalence of spinal and brain disorders worldwide enhances the demand for CNS therapeutics, escalating the segment revenue expansion. The number of treatments, surgeries, and rehabilitation is enlarging the introduction of generic drugs, leading to segment growth.

The oncology segment is projected to have considerable growth during the forecast period with a notable growth rate. Various generic drugs are being adopted in oncology owing to their affordability and similar efficacy as branded drugs. These drugs do not require additional research and trials, which are the primary factors contributing to the segment growth opportunities. Generic cancer drugs provide prominent cost savings compared to branded drugs, boosting the segment's expansion.

Country-Level Analysis

Mexico held the most dominant share across the Latin American generic drugs market in 2023.

The rising incidence of chronic diseases across the country, growing healthcare costs, and increasing demand for cost-effective therapeutics are boosting the generic drugs market nationwide.

• According to the data provided by the Generics and Biosimilars Initiative in 2023, the acceptance of generic drugs across Mexico is about 65%, which is higher compared to Brazil, which is only 35.44%.

The Brazil generic drugs market is anticipated to increase during the forecast period. The Brazilian pharmaceutical market has revolutionized since the introduction of generic drug legislation in 1999. The increased number of generic drugs prescribed in the country is augmenting the country's market share growth.

• For Instance, among the topmost prescribed drugs in the country, the generic drugs held the largest share, being 15 out of 20 drugs; moreover, over 96 pharmaceutical companies market generics, which plays a significant role in treating the most prevalent diseases among the Brazilian population.  

LIST OF KEY PLAYERS IN THE LATIN AMERICA GENERIC DRUGS MARKET

Companies playing a notable role in the Latin American generic drugs market include

• Ranbaxy Laboratories, Ltd
• Actavis
• Mylan, Inc.
• Industries, Ltd.
• Dr. Reddy’s Laboratories
• Par Pharmaceutical, Inc.
• Sandoz International GmbH
• Hospira, Inc.
• Apotex, Inc.
• Watson Pharmaceuticals, Ltd.
• Teva Pharmaceuticals.

RECENT HAPPENINGS IN THE LATIN AMERICAN MARKET

• In March 2024, Brazil Fiocruz, a national public health foundation, announced its legal agreement with Boehringer Ingelheim. The agreement holds the deal with Fiocruz for manufacturing generic empagliflozin used to treat diabetes in Brazil's public health system.
• In 2024, Mexico's Federal Commission for Protection against Health Risks (COFEPRIS) announced the approval of its authorization for 12 new clinical trials in recent weeks, including a Phase 1 study of pediatric pneumonia treatment.