South America Biosurgery Market Outlook, 2031

Market Drivers

• Expanding surgical volumes and healthcare access across the region: South America performs millions of surgical procedures annually, with Brazil alone accounting for 14.7 million elective surgeries through SUS in 2025 a record high. Colombia has achieved 99% healthcare coverage of its population with a basic set of medical services, expanding surgical access across the country. Brazil also recorded 367,100 oncological surgeries in 2025, a 36.6% increase from 2022. The breadth and depth of surgical activity across the region ensure that biosurgical products particularly hemostatic agents and sealants are utilized in virtually every operating room. The continued expansion of surgical capacity, driven by hospital modernization and healthcare infrastructure investment, further reinforces this demand driver.
• Demographic pressures from aging populations and rising chronic disease burden: The aging South American population represents a significant long-term demand driver. In 2025, the population aged 60 years and over in Latin America and the Caribbean exceeded 98 million people, representing 14.7% of the total population, and is projected to double to 183 million by 2050. In Brazil, the elderly population (60 years and older) reached 16.6% of the total population in 2025, up from 11.3% in 2012 a 5.3 percentage point increase. The population aged 65 years and older reached 11.6% of Brazil's total population in 2025. Colombia's population aged 65 and older is projected to increase significantly over the coming decades. The increasing prevalence of chronic diseases, including cardiovascular disorders, cancer, and orthopedic conditions, is leading to more surgical interventions and driving demand for biosurgical products across the region.
• Growing healthcare investment and regulatory modernization: South America is experiencing increasing healthcare investment and regulatory modernization across key markets. Argentina's health spending reached 10.36% of GDP in 2025, ranking 26th globally. Colombia's healthcare budget has grown at an average annual real rate of 6.5% between 2000 and 2025. In Brazil, ANVISA processed 10,639 new medical device registration records in 2025 the highest annual total in the agency's history and a 16.2% year-over-year increase. In September 2025, ANVISA published a new manual for medical device registration, updating requirements based on RDC 751/2022. These investments and regulatory developments provide the financial and institutional foundation for sustained surgical activity and biosurgical product utilization across the region.

Market Challenges

• Healthcare spending constraints and infrastructure gaps across the region: Despite significant investment, South America faces persistent healthcare financing challenges. Latin America and the Caribbean allocate just 6.9% of GDP to health, well below the 8.5% OECD average. Colombia spends USD 1,877 per capita on health, far below the OECD average of USD 5,967. Healthcare infrastructure varies widely across the region, with significant disparities between urban and rural areas. These financial and infrastructure constraints create pricing pressure on biosurgical products and may limit adoption of premium-priced advanced biologics in public healthcare sectors.
• Regulatory complexity and varying compliance standards: The South American regulatory landscape presents challenges for biosurgery manufacturers. Each country maintains distinct regulatory requirements, from Brazil's ANVISA to Argentina's ANMAT and Colombia's INVIMA. In Brazil, Class III and IV (high and maximum risk) medical devices are subject to full registration with ANVISA, with authorization valid for ten years. Navigating these varying requirements increases time-to-market and compliance costs, particularly for smaller manufacturers.
• Economic volatility and currency fluctuations: South American economies face persistent economic volatility that affects the biosurgery market. Currency fluctuations impact the cost of imported medical devices and biosurgical products, which are predominantly imported across the region. Economic instability in countries such as Argentina and Brazil can affect healthcare budgets and procurement decisions, creating uncertainty for manufacturers and healthcare providers alike.

Market Trends

• Accelerating regulatory modernization and harmonization: Regulatory authorities across South America are modernizing frameworks to facilitate faster market access for innovative medical devices. Brazil's ANVISA processed 10,639 new registration records in 2025 the highest annual total in the agency's history. In October 2025, ANVISA published a new manual for medical device and SaMD registration, updating requirements based on RDC 751/2022. Argentina's ANMAT continues to evolve its regulatory framework, while Colombia's INVIMA regulates medical devices under Decree 4725 of 2005. These regulatory reforms support continued innovation and market entry for advanced biosurgical products across the region.
• Growing adoption of minimally invasive surgical techniques: South American healthcare systems are gradually adopting minimally invasive surgical techniques. The region is witnessing a shift toward laparoscopic and endoscopic surgeries in major metropolitan areas. This shift toward advanced surgical platforms creates new opportunities for biosurgical products specifically designed for minimally invasive applications. Surgical sealants and adhesives that can be delivered through small incisions, hemostatic agents optimized for sprayable application, and staple-line reinforcement products are increasingly in demand.
• Domestic manufacturing and import substitution initiatives: South American countries are increasingly focusing on domestic manufacturing of medical devices to reduce import dependence. Brazil's medical device market is among the top 15 globally, with local manufacturers gaining share. Colombia recorded 148 companies engaged in hospital equipment exports, with external sales of USD 81 million in 2025. These initiatives create opportunities for domestic biosurgery manufacturers while also presenting competitive challenges for international players.