The South American drug delivery market is evaluated at US$27.033 billion in 2020 and is expected to grow at a CAGR of 8.94% to reach the market size of US$56.550 billion by 2027.
South America Drug Delivery Market Key Highlights
The South American drug delivery market is undergoing a transition driven by the integration of advanced delivery technologies into public and private healthcare systems. The shift is largely motivated by the need to address a growing chronic disease burden while promoting cost-effective outpatient treatment models. Regulatory harmonization with international standards, such as those recommended by the International Medical Device Regulators Forum (IMDRF), is expected to reduce barriers for high-technology delivery systems, allowing broader adoption of advanced therapeutics.
Current market dynamics are influenced by a “regulatory reliance” strategy, where approvals from agencies such as the FDA or EMA support faster local market authorization. Additionally, an emphasis on technovigilance, the monitoring of device safety post-market, encourages manufacturers to prioritize safe and effective delivery solutions. As a result, the market is shifting from conventional consumables toward sophisticated systems that improve dosing accuracy and patient adherence in homecare settings.
South America Drug Delivery Market Analysis
Growth Drivers
Regulatory modernization, including ANVISA and COFEPRIS reliance pathways, is facilitating faster market entry for novel delivery systems. The increasing prevalence of chronic diseases such as diabetes and rheumatoid arthritis is driving demand for long-term self-administration devices. The shift toward biologics (medicines derived from living organisms) and biosimilars (biologic drugs highly similar to approved reference biologics) further increases demand for specialized delivery systems that maintain product stability and efficacy.
Challenges and Opportunities
Inconsistent reimbursement policies and high import taxes may limit the adoption of premium delivery systems in some countries. However, the growth of homecare services, supported by Brazilian regulations, presents opportunities for self-injection devices and wearable pumps. Localization of manufacturing by global players can improve supply chain resilience and capture price-sensitive market segments.
Raw Material and Pricing Analysis
Device production in South America is sensitive to the cost of medical-grade polymers (e.g., polypropylene, cyclic olefin polymers) and stainless steel. Currency fluctuations and global trade dynamics may affect raw material costs. Manufacturers are adopting High-Value Product (HVP) components, such as specialized elastomer stoppers and glass vials, to maintain profitability and ensure device quality.
Supply Chain Analysis
The regional supply chain relies on a combination of imported high-technology components and local manufacturing of consumables. Key challenges include navigating customs within the Mercosur trade bloc and managing cold-chain requirements for biologics. Companies are optimizing distribution networks to ensure timely delivery to healthcare facilities.
Government Regulations
| Jurisdiction | Key Regulation / Agency | Market Impact Analysis |
|---|---|---|
| Brazil | ANVISA RDC 812/2023 | Allows home delivery of controlled medications, expected to increase demand for home-use delivery devices and digital tracking systems. |
| Mexico | COFEPRIS Abbreviated Pathway (2025) | Reduces registration timelines for devices with prior foreign approvals, expected to accelerate adoption of innovative delivery technologies. |
| Argentina | ANMAT Disposition 727/2013 | Requires risk-based device classification and post-market safety monitoring, increasing demand for compliant delivery hardware. |
| Brazil | ANVISA RDC 913/2024 | Introduces regulatory reliance model for biologics, expected to facilitate introduction of advanced therapeutic delivery systems. |
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In-Depth Segment Analysis
By Formulation Type: Novel Drug Delivery
Novel Drug Delivery Systems (NDDS) improve therapeutic effectiveness and patient adherence through controlled-release formulations, targeted delivery, and pre-filled devices. NDDS adoption is growing in oncology and autoimmune therapy, as well as in biosimilars markets.
By End-User: Homecare Settings
Homecare is the fastest-growing segment due to decentralization of healthcare services. The need for self-injection devices, ambulatory infusion pumps, and portable nebulizers is increasing. Devices with simplified interfaces, integrated safety mechanisms, and remote monitoring features are increasingly preferred.
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Geographical Analysis
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Competitive Environment and Analysis
The competitive landscape of the South American drug delivery market is defined by a mix of global medical technology conglomerates and specialized delivery system manufacturers. Competition is increasingly focused on digital integration and patient-centric design rather than just device cost. Companies are leveraging their global scale to navigate regional regulatory complexities while establishing local distribution partnerships to ensure market penetration.
Becton, Dickinson and Company (BD)
BD has an extensive portfolio of safety-engineered injection systems and vascular access devices. The company has planned investments in manufacturing capacity to support South American supply chains and promote healthcare-associated infection prevention.
Baxter International
Baxter focuses on infusion therapy and injectable product delivery. The company has announced plans for new injectable launches designed to reduce preparation complexity and improve patient safety.
West Pharmaceutical Services, Inc.
West Pharmaceutical provides packaging and delivery components for injectable drugs. Its HVP strategy, including specialized elastomer stoppers, supports the growing biologics and biosimilars market.
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Recent Market Developments
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South America Drug Delivery Market Segmentation