세계의 제네릭 의약품 시장 예측(-2032년) : 유형별, 투여 경로별, 유통 채널별, 용도별, 지역별 분석

According to Stratistics MRC, the Global Generic Pharmaceuticals Market is accounted for $485.37 billion in 2025 and is expected to reach $964.05 billion by 2032 growing at a CAGR of 10.3% during the forecast period. Generic drugs are cost-effective alternatives to branded medications, formulated with identical active components, dosage, and therapeutic purpose. Approved post-patent expiry, they must prove bioequivalence to ensure similar safety and efficacy. While packaging and non-active ingredients may vary, their clinical performance remains consistent. These drugs play a vital role in expanding access to treatment by reducing healthcare expenses without compromising quality.

According to the U.S. FDA's Generic Drugs Annual report, the number of ANDA approvals increased from 948 in 2020 to 776 in 2021.

Market Dynamics:

Driver:

Increasing prevalence of chronic diseases

The global rise in chronic conditions such as diabetes, cardiovascular disorders, and cancer is driving demand for affordable treatment options. As healthcare systems face mounting pressure, generic pharmaceuticals offer a cost-effective alternative to branded drugs. Aging populations and lifestyle-related illnesses are expanding the patient base across both developed and emerging markets. Governments and insurers are increasingly promoting generics to reduce healthcare expenditure. This shift is encouraging pharmaceutical companies to expand their generic portfolios and invest in scalable production. The growing burden of chronic diseases is thus a key catalyst for sustained market growth.

Restraint:

Intense price competition

Multiple players offering similar formulations lead to commoditization and downward price pressure. Regulatory mandates for cost containment further intensify competition among manufacturers. Companies struggle to differentiate products, making brand loyalty and premium pricing difficult to achieve. This environment discourages innovation and limits investment in advanced manufacturing technologies. As a result, firms must balance affordability with operational efficiency to remain viable.

Opportunity:

Technological advancements

Emerging technologies are transforming the generic drug landscape, enabling faster development and improved quality control. Automation, AI-driven formulation design, and continuous manufacturing are streamlining production processes. Advanced analytics and digital platforms are enhancing supply chain visibility and regulatory compliance. Innovations in bioequivalence testing and packaging are improving product reliability and shelf life. These advancements are helping manufacturers meet global standards while reducing time-to-market. As technology adoption accelerates, it opens new avenues for differentiation and scalability in generics.

Threat:

Quality and safety concerns

Inconsistent manufacturing practices and supply chain vulnerabilities can lead to product recalls and regulatory penalties. Cross-border production and outsourcing complicate oversight, raising concerns about contamination and efficacy. Negative publicity around substandard generics can erode public trust and hinder market acceptance. Regulatory bodies are tightening inspection protocols and demanding greater transparency from manufacturers. Without robust quality assurance, companies risk reputational damage and market exclusion.

Covid-19 Impact

The pandemic disrupted pharmaceutical supply chains, delaying production and distribution of generic drugs worldwide. Lockdowns and workforce shortages strained manufacturing capacities and logistics networks. Demand surged for certain generics, especially antivirals and respiratory treatments, creating temporary imbalances. Governments prioritized emergency approvals and stockpiling, reshaping procurement strategies. Post-COVID, the industry is focusing on supply chain resilience and digital transformation to mitigate future disruptions. The crisis underscored the critical role of generics in public health preparedness and affordability.

The simple generics segment is expected to be the largest during the forecast period

The simple generics segment is expected to account for the largest market share during the forecast period, due to its widespread adoption and regulatory ease. These drugs, being chemically identical to branded counterparts, are favoured for their affordability and therapeutic equivalence. Healthcare providers and insurers continue to promote their use to manage treatment costs. Manufacturing processes for simple generics are well-established, allowing for efficient scaling and distribution. Regulatory pathways are more streamlined compared to complex generics, facilitating faster approvals. As demand for cost-effective medication rises, this segment remains the cornerstone of the generics market.

The oncology segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the oncology segment is predicted to witness the highest growth rate, driven by rising cancer prevalence and high treatment costs. Generic oncology drugs offer significant savings compared to branded therapies, making them vital for healthcare systems. Advances in formulation and targeted delivery are improving efficacy and patient outcomes. Regulatory support for biosimilars and complex generics is accelerating market entry in oncology. Increasing awareness and early diagnosis are expanding the patient pool across regions.

Region with largest share:

During the forecast period, the Asia Pacific region is expected to hold the largest market share supported by large populations and expanding healthcare access. Countries like India and China are major producers and exporters of generics, benefiting from cost-efficient manufacturing. Government initiatives to promote generics and reduce healthcare costs are driving domestic consumption. Rising chronic disease incidence and urbanization are increasing demand for affordable treatments. Regulatory reforms and infrastructure investments are enhancing market transparency and quality standards.

Region with highest CAGR:

Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, fueled by rising healthcare costs and policy shifts favoring generics. The U.S. and Canada are expanding reimbursement coverage and streamlining approval processes for generic drugs. Technological innovation in manufacturing and distribution is enhancing efficiency and compliance. Growing demand for biosimilars and specialty generics is reshaping the competitive landscape. Public awareness and physician acceptance of generics are improving, boosting market penetration. With strong regulatory frameworks and investment in R&D, North America is set to lead in generics innovation and adoption.

Key players in the market

Some of the key players profiled in the Generic Pharmaceuticals Market include Sandoz, Aurobindo Pharma, Teva Pharmaceuticals, Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, STADA Arzneimittel, Viatris, Towa Pharmaceutical, Fresenius Kabi, KRKA, Cipla, Zydus Lifesciences, Dr. Reddy's Laboratories, Aspen Pharmacare, and Lupin.

Key Developments:

In August 2025, Sandoz announced the signing of a 10-year virtual Power Purchase Agreement (PPA) with Elawan Energy, a global player in the renewable energy sector, for new-build solar projects in Valladolid, Castilla y Leon, Spain. This agreement marks a concrete step in the company's decarbonization strategy, reinforcing its commitment to climate action and sustainable operations.

In June 2025, Teva Pharmaceutical Industries Ltd. and Shanghai Fosun Pharmaceutical Co., Ltd. announced that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy. Teva's internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications.

Types Covered:

• Simple Generics
• Specialty Generics
• Biosimilars
• Other Types

Route of Administrations Covered:

• Oral
• Topical
• Injectable
• Other Route of Administrations

Distribution Channels Covered:

• Hospital Pharmacies
• Online Pharmacies
• Retail Pharmacies

Applications Covered:

• Cardiovascular
• Central Nervous System (CNS)
• Anti-infectives
• Respiratory
• Oncology
• Dermatology
• Diabetes
• Other Applications

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 Emerging Markets
• 3.8 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Generic Pharmaceuticals Market, By Type

• 5.1 Introduction
• 5.2 Simple Generics
• 5.3 Specialty Generics
• 5.4 Biosimilars
• 5.5 Other Types

6 Global Generic Pharmaceuticals Market, By Route of Administration

• 6.1 Introduction
• 6.2 Oral
• 6.3 Topical
• 6.4 Injectable
• 6.5 Other Route of Administrations

7 Global Generic Pharmaceuticals Market, By Distribution Channel

• 7.1 Introduction
• 7.2 Hospital Pharmacies
• 7.3 Online Pharmacies
• 7.4 Retail Pharmacies

8 Global Generic Pharmaceuticals Market, By Application

• 8.1 Introduction
• 8.2 Cardiovascular
• 8.3 Central Nervous System (CNS)
• 8.4 Anti-infectives
• 8.5 Respiratory
• 8.6 Oncology
• 8.7 Dermatology
• 8.8 Diabetes
• 8.9 Other Applications

9 Global Generic Pharmaceuticals Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Sandoz
• 11.2 Aurobindo Pharma
• 11.3 Teva Pharmaceuticals
• 11.4 Glenmark Pharmaceuticals
• 11.5 Sun Pharmaceutical Industries
• 11.6 STADA Arzneimittel
• 11.7 Viatris
• 11.8 Towa Pharmaceutical
• 11.9 Fresenius Kabi
• 11.10 KRKA
• 11.11 Cipla
• 11.12 Zydus Lifesciences
• 11.13 Dr. Reddy's Laboratories
• 11.14 Aspen Pharmacare
• 11.15 Lupin