남미의 의약품 수탁제조 시장 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the South America pharmaceutical contract manufacturing market size is projected to expand from USD 3.69 billion in 2025 and USD 3.92 billion in 2026 to USD 5.37 billion by 2031, registering a CAGR of 6.52% between 2026 and 2031.

South America Pharmaceutical Contract Manufacturing Market Trends and Insights

Outsourcing by Domestic and Multinational Pharmaceutical Companies

Outsourcing became a strategic requirement for domestic laboratories and multinational sponsors operating in the region. Large Brazilian drug makers faced capacity constraints as production volumes increased, which spurred demand for external manufacturing partners. Blau Farmaceutica completed 2 new lines at its Sao Paulo complex in late 2025, and the lines entered ANVISA validation before commercial operations began in 2026. Multinational companies launching biosimilars and specialized injectable medicines also have stronger reasons to select regional partners rather than import finished products by air. Local-content preferences in public tenders and ANVISA's evolving reliance framework make qualified regional capacity more useful for market entry. The South America pharmaceutical contract manufacturing market, therefore, draws demand from domestic companies seeking sterile biologics, lyophilization, and high-potency API capabilities, as well as from multinational sponsors.

Demand for Generics, Biosimilars, and Chronic-Disease Therapies

Demand for generic drugs and biosimilars is broadening the work available to contract manufacturers. Brazil resumed domestic insulin production in July 2025 after a 20-year hiatus, through a Productive Development Partnership among Biomm, Wockhardt, and Fundacao Ezequiel Dias. This program demonstrated how technology transfer can support domestic production of a critical medicine for chronic diseases. PAHO urged countries in February 2025 to improve access to essential cancer medicines and encouraged regional approaches that can support biosimilar adoption. Contract manufacturers can therefore receive both finished-product fill-finish work for biosimilars and API batch work for lower-cost generic medicines. This combination favors providers that can offer multiple services instead of a single production step.

GMP Compliance, Inspection, and Remediation Costs

GMP compliance is a major cost barrier for contract manufacturers in South America. ANVISA's RDC 982/2025 introduced a health risk-based model for GMP and good distribution practice certification renewal in July 2025. The framework may modernize the process, but it requires manufacturers to maintain stronger documentation and quality systems. An FDA inspection at mAbxience's Garin facility in April 2025 identified issues involving bioburden control, environmental monitoring, and validation activities. Findings at a regional site can delay technology-transfer work and lead sponsors to maintain secondary suppliers. Clean-room upgrades, equipment requalification, and repeat inspections can restrict a mid-sized facility's ability to invest in capacity expansion. Colombia's GMP requirements under Decree 335 also require rigorous process-validation records, which can challenge smaller facilities.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Biologics and Injectable Localization
2. Regional Supply-Chain Resilience and Import Substitution
3. Currency Volatility and Imported API Dependence

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

API manufacturing held 42.73% of the South America pharmaceutical contract manufacturing market share in 2025. The segment was supported by Brazil's large base of generic-drug production sites and Argentina's expanding biosimilar API capacity. Long batch runs for established molecules create predictable production schedules and cash flow for manufacturers. This helps explain why established domestic laboratories retain API capabilities while outsourcing selected dosage-form activities. Finished dosage form development and manufacturing serve companies that need formulation support, registration batches, and finished products for regional clinical programs. It also serves virtual biotechnology companies that need a supply without building their own plants.

Secondary packaging is projected to expand at a 7.98% CAGR through 2031, the highest rate within this segmentation. Serialization, tamper evidence, and country-specific labeling requirements make local packaging capacity more important to sponsors. These requirements can make centralized packaging in Europe or North America less suitable for products intended for several South American countries. Unither Pharmaceuticals operates 2 GMP-certified facilities in Brazil and holds authorizations from ANVISA, INVIMA, and DIGEMID. Its footprint illustrates why multi-country packaging and regulatory capabilities can create an advantage. The South America pharmaceutical contract manufacturing market gives packaging providers a larger role when sponsors need market-ready, locally compliant units.

Small molecules accounted for 56.83% of the South America pharmaceutical contract manufacturing market size in 2025. Their position reflected the established generics base and chemistry infrastructure across Sao Paulo's pharmaceutical corridor. Public procurement through Brazil's Unified Health System supports high-volume demand for off-patent medicines. The manufacturing chain serving this demand remains largely focused on small-molecule products. Providers with validated chemistry processes and efficient batch operations can continue to serve this broad volume base. The segment also gives manufacturers a foundation for investments in more complex product classes.

Advanced therapies are projected to expand at a 7.78% CAGR through 2031, making them the fastest-growing molecule category. Cell and gene therapies started from a narrower base than conventional molecules, so individual capacity decisions can materially shape development in the category. Biologics also have a growing role, as regional production of biosimilar monoclonal antibodies and recombinant proteins can support both local and export supply. ITC-CDMO offers GMP-compliant services for cell-based therapies and has supported clinical-phase projects. This activity shows that the South America pharmaceutical contract manufacturing market has early-stage capacity for advanced modalities. Sponsors can consider regional providers for clinical manufacturing when their quality and technical requirements are met.

Complete Report Scope:

• By Service Type
  • API Manufacturing
  • FDF Development and Manufacturing
  • Secondary Packaging
• By Drug Molecule Type
  • Small Molecule
  • Biologics
  • Advanced Therapies, Cell and Gene
• By Scale of Operation
  • Clinical-Phase Manufacturing
  • Commercial-Scale Manufacturing
• By End User
  • Big Pharma
  • Generic Pharma
  • Emerging and Virtual Biotech
  • Specialty Pharma
• By Therapeutic Area
  • Oncology
  • Cardiovascular
  • Central Nervous System (CNS)
  • Infectious Disease
  • Other Therapeutic Areas
• By Country
  • Brazil
  • Argentina
  • Chile
  • Colombia
  • Peru
  • Rest of South America

List of Companies Covered in this Report:

1. Catalent Inc.
2. Thermo Fisher Scientific Inc.
3. Lonza Group Ltd.
4. Recipharm AB
5. Unither Pharmaceuticals
6. mAbxience S.L.
7. Insud Pharma S.L.
8. Eurofarma Laboratorios S.A.
9. Laboratorio Cristalia S.A.
10. Grupo Centroflora
11. TRIQUIM S.A.
12. Laboratorios LASCA S.A.
13. Sinergium Biotech S.A.
14. Altea Farmaceutica S.A.
15. Zambon Laboratorios Farmaceuticos Ltda.
16. Myralis Industria Farmaceutica Ltda.
17. Biosidus S.A.
18. Laboratorio Pablo Cassara S.R.L.
19. Laboratorios Richmond S.A.C.I.F.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Outsourcing by Domestic and Multinational Pharmaceutical Companies
  • 4.2.2 Demand for Generics, Biosimilars, and Chronic-Disease Therapies
  • 4.2.3 Rising Biologics and Injectable Localization
  • 4.2.4 Regional Supply-Chain Resilience and Import Substitution
  • 4.2.5 Cross-Border Regulatory and Export-Platform Specialization
  • 4.2.6 Modular and Continuous-Flow Manufacturing Under Capital Constraints
• 4.3 Market Restraints
  • 4.3.1 GMP Compliance, Inspection, and Remediation Costs
  • 4.3.2 Currency Volatility and Imported API Dependence
  • 4.3.3 Regulatory Fragmentation Across National Markets
  • 4.3.4 Utility Reliability, Cold-Chain Gaps, and Specialized Talent Shortages
• 4.4 Industry Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Intensity of Competitive Rivalry
  • 4.7.5 Threat of Substitute Products
• 4.8 Impact of Macroeconomic Factors on the Market
• 4.9 Investment Analysis

5 MARKET SIZE AND GROWTH FORECASTS (VALUE)

• 5.1 By Service Type
  • 5.1.1 API Manufacturing
  • 5.1.2 FDF Development and Manufacturing
  • 5.1.3 Secondary Packaging
• 5.2 By Drug Molecule Type
  • 5.2.1 Small Molecule
  • 5.2.2 Biologics
  • 5.2.3 Advanced Therapies, Cell and Gene
• 5.3 By Scale of Operation
  • 5.3.1 Clinical-Phase Manufacturing
  • 5.3.2 Commercial-Scale Manufacturing
• 5.4 By End User
  • 5.4.1 Big Pharma
  • 5.4.2 Generic Pharma
  • 5.4.3 Emerging and Virtual Biotech
  • 5.4.4 Specialty Pharma
• 5.5 By Therapeutic Area
  • 5.5.1 Oncology
  • 5.5.2 Cardiovascular
  • 5.5.3 Central Nervous System (CNS)
  • 5.5.4 Infectious Disease
  • 5.5.5 Other Therapeutic Areas
• 5.6 By Country
  • 5.6.1 Brazil
  • 5.6.2 Argentina
  • 5.6.3 Chile
  • 5.6.4 Colombia
  • 5.6.5 Peru
  • 5.6.6 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Strategic Moves
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.4.1 Catalent Inc.
  • 6.4.2 Thermo Fisher Scientific Inc.
  • 6.4.3 Lonza Group Ltd.
  • 6.4.4 Recipharm AB
  • 6.4.5 Unither Pharmaceuticals
  • 6.4.6 mAbxience S.L.
  • 6.4.7 Insud Pharma S.L.
  • 6.4.8 Eurofarma Laboratorios S.A.
  • 6.4.9 Laboratorio Cristalia S.A.
  • 6.4.10 Grupo Centroflora
  • 6.4.11 TRIQUIM S.A.
  • 6.4.12 Laboratorios LASCA S.A.
  • 6.4.13 Sinergium Biotech S.A.
  • 6.4.14 Altea Farmaceutica S.A.
  • 6.4.15 Zambon Laboratorios Farmaceuticos Ltda.
  • 6.4.16 Myralis Industria Farmaceutica Ltda.
  • 6.4.17 Biosidus S.A.
  • 6.4.18 Laboratorio Pablo Cassara S.R.L.
  • 6.4.19 Laboratorios Richmond S.A.C.I.F.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment