South America Drug Delivery Market Size, Share, Opportunities, COVID-19 Impact, And Trends By Device Type (Self-Injection Devices, Conventional Devices), By Formulation Type (Conventional Drug Delivery, Novel Drug Delivery), By Therapeutic Use (Autoimmune Disorders, Hormonal Disorders, Oncology), By End-User (Hospitals, Homecare Settings, Research Institutes, Clinical Laboratories), And By Country- Forecasts From 2022 To 2027

Description

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 Brazilian Health Regulatory Agency (ANVISA) issued RDC 812/2023, allowing home delivery of controlled medications. This is expected to increase demand for specialized ambulatory and home-based drug delivery devices.
• Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) introduced an Abbreviated Regulatory Pathway in September 2025, which leverages international approvals to reduce device registration timelines. This pathway is expected to facilitate faster market entry for innovative delivery technologies.
• Rising prevalence of chronic conditions, including Type 2 Diabetes and Autoimmune Disorders, is shifting demand toward self-administration devices and patient-centric delivery formulations.
• Strategic expansions by global manufacturers, such as Becton, Dickinson and Company (BD) planning investments in safety-engineered injection lines, and Baxter International planning the launch of new injectable products, are anticipated to support supply chain stability for high-volume delivery components.

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

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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

• Brazil
  Brazil dominates the South American market due to its large public healthcare system (SUS) and local manufacturing capabilities. Demand is increasing for insulin delivery systems, oncology infusion sets, and biosimilars requiring high-quality primary packaging.
• Mexico
  Mexico’s drug delivery market is influenced by the 2025 COFEPRIS Abbreviated Pathway and high diabetes prevalence. Adoption is rising for specialty injectables, self-administration kits, and devices used in private healthcare.

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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

• January 2025: Becton, Dickinson and Company (BD) announced a capacity expansion for critical medical devices, including safety-engineered syringes and IV catheters, following a $10 million investment in 2024 to support global healthcare supply chain resilience and meet rising procedural demand.
• October 2024: Becton, Dickinson and Company (BD) entered a strategic collaboration with Ypsomed to advance self-injection systems for high-viscosity biologics, specifically targeting the growing demand for home-administered treatments in the autoimmune and oncology therapeutic areas.
• July 2024: Acino finalized the commercial rollout of Hyruan One in Brazil following an exclusive agreement with LG Chem. This single-injection intra-articular drug delivery system for osteoarthritis marks a shift toward long-acting, minimally invasive treatments, reducing the burden of frequent clinical visits for patients in the region.

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South America Drug Delivery Market Segmentation

• By Device Type
  • Self-injection Devices
  • Conventional Devices
• By Formulation Type
  • Conventional Drug Delivery
  • Novel Drug Delivery
• By Therapeutic Use
  • Autoimmune Disorders
  • Hormonal Disorders
  • Oncology
• By End-User
  • Hospitals
  • Homecare Settings
  • Research Institutes
  • Clinical Laboratories
• By Country
  • Mexico
  • Brazil
  • Argentina
  • Chile
  • Rest of Latin America

Table Of Contents

1. Introduction

1.1. Market Definition

1.2. Market Segmentation

2. Research Methodology

2.1. Research Data

2.2. Assumptions

3. Executive Summary

3.1. Research Highlights

4. Market Dynamics

4.1. Market Drivers

4.2. Market Restraints

4.3. Porters Five Forces Analysis

4.3.1. Bargaining Power of End-Users

4.3.2. Bargaining Power of Buyers

4.3.3. Threat of New Entrants

4.3.4. Threat of Substitutes

4.3.5. Competitive Rivalry in the Industry

4.4. Industry Value Chain Analysis

5. South America Drug Delivery Market Analysis, by Device Type

5.1. Introduction

5.2. Self-injection Devices

5.3. Conventional Devices

6. South America Drug Delivery Market Analysis, by Formulation Type

6.1. Introduction

6.2. Conventional Drug Delivery

6.3. Novel drug Delivery

7. South America Drug Delivery Market Analysis, by Therapeutic Use

7.1. Introduction

7.2. Autoimmune Disorders

7.3. Hormonal Disorders

7.4. Oncology

8. South America Drug Delivery Market Analysis, by End User

8.1. Introduction

8.2. Hospitals

8.3. Homecare settings

8.4. Research Institutes

8.5. Clinical Laboratories

9. South America Drug Delivery Market Analysis, by Country

9.1. Introduction

9.2. Mexico

9.3. Brazil

9.4. Argentina

9.5. Chile

9.6. Rest of Latin America

10. Competitive Environment and Analysis

10.1. Major Players and Strategy Analysis

10.2. Emerging Players and Market Lucrativeness

10.3. Mergers, Acquisitions, Agreements, and Collaborations

10.4. Vendor Competitiveness Matrix

11. Company Profiles

11.1. Antares Pharma Inc.

11.2. Baxter International

11.3. Becton Dickinson Company

11.4. Elcam Medical

11.5. Unilife Corporation

11.6. West Pharmaceutical Inc.

List of Figures

List of Tables

Companies Profiled

Antares Pharma Inc.

Baxter International

Becton Dickinson Company

Elcam Medical

Unilife Corporation

West Pharmaceutical Inc.

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