查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
封面
市场调查报告书
商品编码
1818078

2032 年学名药市场预测：按类型、给药途径、分销管道、应用和地区进行的全球分析

Generic Pharmaceuticals Market Forecasts to 2032 - Global Analysis By Type (Simple Generics, Specialty Generics, Biosimilars, and Other Types), Route of Administration, Distribution Channel, Application, and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3个工作天内

价格

根据 Stratistics MRC 的数据，全球学名药市场预计到 2025 年将达到 4,853.7 亿美元，到 2032 年将达到 9,640.5 亿美元，预测期内的复合年增长率为 10.3%。

学名药是品牌药的经济高效的替代品，具有相同的活性成分、剂量和治疗目的。由于仿製药在专利到期后才核准，因此必须证明其生物等效性，以确保相似的安全性和有效性。虽然包装和非活性成分可能有所不同，但临床表现保持一致。这些药物在降低医疗成本、扩大治疗可近性且不影响品质方面发挥关键作用。

慢性病增多

在全球范围内，糖尿病、心血管疾病和癌症等慢性疾病的发生率不断上升，推动了对可负担治疗方案的需求。在医疗保健系统面临压力之际，学名药提供了比品牌药更具成本效益的替代方案。人口老化和文明病正在扩大已开发市场和新兴市场的患者群体。各国政府和保险公司正在推广使用学名药以降低医疗成本。这种转变正鼓励製药公司扩大其学名药组合併投资于可扩展生产。因此，日益加重的慢性病负担是市场持续成长的关键驱动力。

激烈的价格竞争

由于多家製药公司提供类似的配方，商品化程度不断提高，对价格造成了下行压力。成本控制法规进一步加剧了製造商之间的竞争。各公司难以实现产品差异化，难以获得品牌忠诚度与溢价。这种环境扼杀了创新，并限制了对先进製造技术的投资。因此，企业必须在价格承受能力和营运效率之间取得平衡才能生存。

技术进步

开发技术的进步正在改变学名药的格局，使其能够加快开发速度并改善品管。自动化、人工智慧配方和连续生产正在简化製造流程。先进的分析和数位平台正在增强供应链的可视性和法规遵循。生物等效性测试和包装方面的创新正在提高产品的可靠性和保质期。这些进步正在帮助製造商满足全球标准，同时缩短产品上市时间。技术的加速应用为学名药的差异化和扩充性开闢了新的途径。

品质和安全问题

生产规范不一致和供应链漏洞可能导致产品召回和监管处罚。跨境生产和外包使监管更加复杂，并引发对污染和疗效的担忧。围绕不合格学名药的负面宣传可能会损害公众信任，阻碍市场接受。监管机构正在加强测试通讯协定，并要求製造商提高透明度。如果没有强而有力的品质保证，企业将面临声誉受损甚至被市场淘汰的风险。

COVID-19的影响

疫情扰乱了医药供应链，减缓了全球学名药的生产和分销。封锁和劳动力短缺给生产能力和物流网络带来了压力。某些学名药的需求激增，尤其是抗病毒和呼吸道药物，造成了暂时的供不应求。各国政府优先考虑紧急核准和储备，并调整了筹资策略。在后疫情时代，该产业正专注于供应链的韧性和数位转型，以减轻未来的中断风险​​。这场危机凸显了学名药在公共卫生防范和可负担性的关键作用。

简单非专利市场预计将成为预测期内最大的市场

由于学名药的广泛可用性和监管的便利性，预计简单非专利领域将在预测期内占据最大的市场份额。这些药物的化学成分与品牌药相同，有利于降低价格并实现治疗等效性。医疗保健提供者和保险公司继续推广使用学名药来控制治疗成本。简单非专利成熟的生产流程可实现高效的可扩展性和分销。与复杂学名药相比，简化的监管途径可以加快核准。随着对经济实惠药物的需求不断增长，这一领域仍然是学名药市场的关键参与者。

预测期内，肿瘤学领域预计将以最高复合年增长率成长

受癌症发病率上升和高昂治疗费用的推动，预计肿瘤学领域将在预测期内实现最高增长率。与品牌药相比，非专利抗癌药可显着节省成本，使其成为医疗保健体係不可或缺的一部分。製剂和标靶给药技术的进步正在提升疗效和改善患者预后。监管部门对生物相似药和复杂学名药的支持正在加速肿瘤学领域的市场准入。认知度的提高和早期诊断正在扩大各地区患者群体。

比最大的地区

预计亚太地区将在预测期内占据最大的市场份额，这得益于其庞大的人口和不断扩大的医疗保健覆盖率。印度和中国等国家是学名药的主要生产国和出口国，得益于其成本效益高的生产方式。政府推广学名药和降低医疗成本的措施正在推动国内消费。慢性病盛行率的上升和都市化正在推动对可负担治疗的需求。监管改革和基础设施投资正在提高市场透明度和品质标准。

复合年增长率最高的地区

受医疗成本上涨和政策转向支持学名药的推动，北美地区预计将在预测期内呈现最高的复合年增长率。美国和加拿大正在扩大报销范围，并简化学名药核准流程。製造和分销领域的技术创新正在提高效率和合规性。对生物相似药和特种学名药日益增长的需求正在重塑竞争格局。公众意识的提高和医生对学名药的接受度不断提高，正在推动市场渗透。凭藉强大的法律规范和研发投入，北美很可能在学名药创新和应用方面引领潮流。

免费客製化服务

此报告的订阅者可以选择以下免费自订选项之一：

  • 公司简介
    • 全面分析其他市场参与者（最多 3 家公司）
    • 主要企业的SWOT分析（最多3家公司）
  • 区域细分
    • 根据客户兴趣对主要国家进行的市场估计、预测和复合年增长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第一章执行摘要

第二章 前言

  • 概述
  • 相关利益者
  • 调查范围
  • 调查方法
    • 资料探勘
    • 数据分析
    • 数据检验
    • 研究途径
  • 研究材料
    • 主要研究资料
    • 次级研究资讯来源
    • 先决条件

第三章市场走势分析

  • 驱动程式
  • 抑制因素
  • 机会
  • 威胁
  • 应用分析
  • 新兴市场
  • COVID-19的影响

第四章 波特五力分析

  • 供应商的议价能力
  • 买方的议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 竞争对手之间的竞争

第五章全球学名药市场类型

  • 简单非专利
  • 专业非专利
  • 生物相似药
  • 其他的

6. 全球学名药市场（依给药途径）

  • 口服
  • 局部的
  • 注射
  • 其他的

7. 全球学名药市场（按分销管道）

  • 医院药房
  • 网路药局
  • 零售药局

第八章全球学名药市场（按应用）

  • 心血管系统
  • 中枢神经系统（CNS）
  • 抗感染药物
  • 呼吸系统
  • 肿瘤学
  • 皮肤科
  • 糖尿病
  • 其他的

9. 全球学名药市场（按地区）

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲地区

第十章：重大进展

  • 协议、伙伴关係、合作和合资企业
  • 收购与合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第十一章 公司概况

  • 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
  • Lupin
Product Code: SMRC31041

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

List of Tables

  • Table 1 Global Generic Pharmaceuticals Market Outlook, By Region (2024-2032) ($MN)
  • Table 2 Global Generic Pharmaceuticals Market Outlook, By Type (2024-2032) ($MN)
  • Table 3 Global Generic Pharmaceuticals Market Outlook, By Simple Generics (2024-2032) ($MN)
  • Table 4 Global Generic Pharmaceuticals Market Outlook, By Specialty Generics (2024-2032) ($MN)
  • Table 5 Global Generic Pharmaceuticals Market Outlook, By Biosimilars (2024-2032) ($MN)
  • Table 6 Global Generic Pharmaceuticals Market Outlook, By Other Types (2024-2032) ($MN)
  • Table 7 Global Generic Pharmaceuticals Market Outlook, By Route of Administration (2024-2032) ($MN)
  • Table 8 Global Generic Pharmaceuticals Market Outlook, By Oral (2024-2032) ($MN)
  • Table 9 Global Generic Pharmaceuticals Market Outlook, By Topical (2024-2032) ($MN)
  • Table 10 Global Generic Pharmaceuticals Market Outlook, By Injectable (2024-2032) ($MN)
  • Table 11 Global Generic Pharmaceuticals Market Outlook, By Other Route of Administrations (2024-2032) ($MN)
  • Table 12 Global Generic Pharmaceuticals Market Outlook, By Distribution Channel (2024-2032) ($MN)
  • Table 13 Global Generic Pharmaceuticals Market Outlook, By Hospital Pharmacies (2024-2032) ($MN)
  • Table 14 Global Generic Pharmaceuticals Market Outlook, By Online Pharmacies (2024-2032) ($MN)
  • Table 15 Global Generic Pharmaceuticals Market Outlook, By Retail Pharmacies (2024-2032) ($MN)
  • Table 16 Global Generic Pharmaceuticals Market Outlook, By Application (2024-2032) ($MN)
  • Table 17 Global Generic Pharmaceuticals Market Outlook, By Cardiovascular (2024-2032) ($MN)
  • Table 18 Global Generic Pharmaceuticals Market Outlook, By Central Nervous System (CNS) (2024-2032) ($MN)
  • Table 19 Global Generic Pharmaceuticals Market Outlook, By Anti-infectives (2024-2032) ($MN)
  • Table 20 Global Generic Pharmaceuticals Market Outlook, By Respiratory (2024-2032) ($MN)
  • Table 21 Global Generic Pharmaceuticals Market Outlook, By Oncology (2024-2032) ($MN)
  • Table 22 Global Generic Pharmaceuticals Market Outlook, By Dermatology (2024-2032) ($MN)
  • Table 23 Global Generic Pharmaceuticals Market Outlook, By Diabetes (2024-2032) ($MN)
  • Table 24 Global Generic Pharmaceuticals Market Outlook, By Other Applications (2024-2032) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.