仿製药市场 - 全球行业规模、份额、趋势、机会和预测，按类型、按应用、按药物输送、按形式、按来源、按配销通路、按地区和竞争进行细分，2020-2030 年

2024 年全球仿製药市场价值为 4,434.4 亿美元，预计在预测期内将稳定成长，到 2030 年的复合年增长率为 6.27%。全球仿製药市场主要受几个关键因素驱动，包括慢性病盛行率上升、医疗保健成本增加以及对负担得起的治疗方案的需求。仿製药提供了一种比品牌药更具成本效益的替代品，使其更易于被更多人使用。品牌药的专利到期为仿製药製造商进入市场创造了机会，从而加剧了竞争并降低了价格。政府提倡使用仿製药以降低医疗保健支出的措施进一步推动了市场成长。对仿製药的需求不断增长以及新兴市场仿製药生产能力的扩张也促进了市场的扩张。在可负担性、可近性和市场竞争的推动下，全球仿製药市场可望持续成长。仿製药和生物相似药仅占美国医疗保健总支出的 1.2%，凸显了它们的成本效益。

关键市场驱动因素

成本效益和可负担性

主要市场挑战

监管障碍和审批流程

主要市场趋势

仿製生物製剂（生物相似药）的进展

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：顾客之声

第五章：全球仿製药市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按类型（小分子仿製药和生物仿製药）
  • 按应用（心血管疾病、糖尿病、神经病学、肿瘤学、抗发炎疾病、其他）
  • 透过药物输送（口服、外用、肠外、其他）
  • 按剂型（片剂、胶囊、注射剂、其他）
  • 按来源（内部和合约製造组织）
  • 按配销通路（医院药房、零售药房、网路药房、其他）
  • 按地区
  • 按公司分类（2024）
• 市场地图

第六章：北美仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 美国
  • 加拿大
  • 墨西哥

第七章：欧洲仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 德国
  • 英国
  • 义大利
  • 法国
  • 西班牙

第八章：亚太仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：南美洲仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第十章：中东和非洲仿製药市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 合併与收购（如有）
• 产品发布（如有）
• 最新动态

第 13 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 14 章：竞争格局

• Teva Pharmaceutical Industries Ltd.
• Sandoz International GmbH
• Viatris Inc.
• Sun Pharmaceutical Industries Ltd.
• Fresenius Kabi AG
• STADA Arzneimittel AG
• Aurobindo Pharma Limited
• Dr Reddy's Laboratories Ltd.
• Cipla Ltd.
• Novo Nordisk A/S
• Abbott Laboratories Inc.
• Endo International plc
• Sanofi SA
• Aspen Pharmacare Holdings Limited
• Lupin Limited

第 15 章：策略建议

第16章调查会社について・免责事项

Global Generic Drugs Market was valued at USD 443.44 Billion in 2024 and is anticipated to project steady growth in the forecast period with a CAGR of 6.27% through 2030. The Global Generic Drugs Market is primarily driven by several key factors, including the rising prevalence of chronic diseases, increasing healthcare costs, and the need for affordable treatment options. Generic drugs offer a cost-effective alternative to brand-name medications, making them accessible to a broader population. Patent expirations of branded drugs create opportunities for generic manufacturers to enter the market, leading to increased competition and lower prices. Government initiatives promoting the use of generic drugs to reduce healthcare expenditures further fuel market growth. The growing demand for generic versions of biologic drugs and the expansion of generic drug manufacturing capabilities in emerging markets also contribute to the market's expansion. The Global Generic Drugs Market is poised for sustained growth driven by affordability, accessibility, and market competition. Generics and biosimilars represent just 1.2% of total U.S. healthcare spending, underscoring their cost-effectiveness.

Key Market Drivers

Cost-effectiveness and Affordability

The affordability and accessibility of generic drugs compared to their brand-name counterparts constitute a pivotal factor driving their widespread adoption and market expansion on a global scale. Generic medications, renowned for their lower price points, serve as indispensable alternatives for patients and healthcare systems grappling with constrained budgets or exorbitant out-of-pocket expenses associated with branded pharmaceuticals. In regions where healthcare resources are scarce or where patients bear a substantial burden of medication costs, the cost-effectiveness of generic drugs emerges as a cornerstone of healthcare provision. The considerable price differentials between generic and brand-name medications facilitate broader access to essential treatments, ensuring that individuals can afford the medications they need to manage their health conditions effectively.

A fundamental driver of the cost-effectiveness of generic drugs lies in the expiration of patents on brand-name medications. Upon patent expiry, generic manufacturers gain the legal right to produce and distribute equivalent versions of the drug, igniting competition within the pharmaceutical market. This competitive landscape fosters price reductions as generic manufacturers leverage economies of scale, streamlined production processes, and reduced research and development costs to offer their products at significantly lower prices.

Key Market Challenges

Regulatory Hurdles and Approval Processes

One of the primary challenges confronting the Global Generic Drugs Market is navigating the complex regulatory landscape governing generic drug approval processes. Regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others, enforce stringent standards and requirements for the approval of generic medications. Generic manufacturers must demonstrate bioequivalence, pharmaceutical equivalence, and therapeutic equivalence to the reference brand-name drug through comprehensive analytical and clinical studies. The regulatory pathway for generic drug approval often entails navigating intricate legal frameworks, conducting extensive pharmacokinetic and pharmacodynamic studies, and adhering to stringent quality assurance standards, all of which pose formidable barriers to entry for manufacturers. Disparities in regulatory requirements between different regions and countries necessitate meticulous compliance with diverse regulatory mandates, adding complexity and uncertainty to the generic drug approval process.

Key Market Trends

Advancements in Generic Biologics (Biosimilars)

The emergence of biosimilars heralds a transformative paradigm shift within the pharmaceutical landscape, ushering in a new era of accessibility, affordability, and innovation in biologic drug therapy. Biosimilars, colloquially referred to as generic versions of biologic drugs, constitute a rapidly burgeoning segment of the generic drugs market, poised to revolutionize the treatment landscape across a diverse array of therapeutic domains. This paradigmatic evolution is underpinned by significant advancements in biotechnology and regulatory frameworks governing biosimilar approval, which collectively catalyze the development, commercialization, and widespread adoption of biosimilar therapies as compelling alternatives to their costly brand-name counterparts. In 2023, the average out-of-pocket cost for a generic drug was USD 7.05, compared to $27.10 for a brand-name drug.

The ascendancy of biosimilars as a burgeoning force within the generic drugs market is predicated upon the intricate interplay between scientific innovation and regulatory harmonization. Pioneering breakthroughs in biotechnological methodologies have empowered manufacturers to elucidate the complex structural and functional attributes of biologic drugs with unparalleled precision and fidelity, thereby facilitating the rational design and engineering of biosimilar formulations that closely mimic the reference biologic products. Leveraging state-of-the-art analytical techniques, manufacturers can meticulously characterize the physicochemical properties, pharmacokinetic profiles, and immunogenicity profiles of biosimilars, ensuring their comparability to the reference biologic drugs with utmost rigor and scientific rigor.

Key Market Players

• Teva Pharmaceutical Industries Ltd.
• Sandoz International GmbH
• Viatris Inc.
• Sun Pharmaceutical Industries Ltd.
• Fresenius Kabi AG
• STADA Arzneimittel AG
• Aurobindo Pharma Limited
• Dr Reddy's Laboratories Ltd.
• Cipla Ltd.
• Novo Nordisk A/S
• Abbott Laboratories Inc.
• Endo International plc
• Sanofi S.A.
• Aspen Pharmacare Holdings Limited
• Lupin Limited

Report Scope:

In this report, the Global Generic Drugs Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Generic Drugs Market, By Type:

• Small Molecule Generics
• Biosimilars

Generic Drugs Market, By Application:

• Cardiovascular Diseases
• Diabetes
• Neurology
• Oncology
• Anti-Inflammatory Diseases
• Others

Generic Drugs Market, By Drug Delivery:

• Oral
• Topical
• Parenteral
• Others

Generic Drugs Market, By Form:

• Tablet
• Capsule
• Injection
• Others

Generic Drugs Market, By Source:

• In House
• Contract Manufacturing Organizations

Generic Drugs Market, By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Others

Generic Drugs Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Generic Drugs Market.

Available Customizations:

Global Generic Drugs market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validations
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Generic Drugs Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Type (Small Molecule Generics and Biosimilars)
  • 5.2.2. By Application (Cardiovascular Diseases, Diabetes, Neurology, Oncology, Anti-Inflammatory Diseases, Others)
  • 5.2.3. By Drug Delivery (Oral, Topical, Parenteral, Others)
  • 5.2.4. By Form (Tablet, Capsule, Injection, Others)
  • 5.2.5. By Source (In House and Contract Manufacturing Organizations)
  • 5.2.6. By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Others)
  • 5.2.7. By Region
  • 5.2.8. By Company (2024)
• 5.3. Market Map

6. North America Generic Drugs Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Type
  • 6.2.2. By Application
  • 6.2.3. By Drug Delivery
  • 6.2.4. By Form
  • 6.2.5. By Source
  • 6.2.6. By Distribution Channel
  • 6.2.7. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Generic Drugs Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Type
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By Drug Delivery
      • 6.3.1.2.4. By Form
      • 6.3.1.2.5. By Source
      • 6.3.1.2.6. By Distribution Channel
  • 6.3.2. Canada Generic Drugs Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Type
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By Drug Delivery
      • 6.3.2.2.4. By Form
      • 6.3.2.2.5. By Source
      • 6.3.2.2.6. By Distribution Channel
  • 6.3.3. Mexico Generic Drugs Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Type
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By Drug Delivery
      • 6.3.3.2.4. By Form
      • 6.3.3.2.5. By Source
      • 6.3.3.2.6. By Distribution Channel

7. Europe Generic Drugs Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Type
  • 7.2.2. By Application
  • 7.2.3. By Drug Delivery
  • 7.2.4. By Form
  • 7.2.5. By Source
  • 7.2.6. By Distribution Channel
  • 7.2.7. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Generic Drugs Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Type
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By Drug Delivery
      • 7.3.1.2.4. By Form
      • 7.3.1.2.5. By Source
      • 7.3.1.2.6. By Distribution Channel
  • 7.3.2. United Kingdom Generic Drugs Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Type
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By Drug Delivery
      • 7.3.2.2.4. By Form
      • 7.3.2.2.5. By Source
      • 7.3.2.2.6. By Distribution Channel
  • 7.3.3. Italy Generic Drugs Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecasty
      • 7.3.3.2.1. By Type
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By Drug Delivery
      • 7.3.3.2.4. By Form
      • 7.3.3.2.5. By Source
      • 7.3.3.2.6. By Distribution Channel
  • 7.3.4. France Generic Drugs Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Type
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By Drug Delivery
      • 7.3.4.2.4. By Form
      • 7.3.4.2.5. By Source
      • 7.3.4.2.6. By Distribution Channel
  • 7.3.5. Spain Generic Drugs Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Type
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By Drug Delivery
      • 7.3.5.2.4. By Form
      • 7.3.5.2.5. By Source
      • 7.3.5.2.6. By Distribution Channel

8. Asia-Pacific Generic Drugs Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Type
  • 8.2.2. By Application
  • 8.2.3. By Drug Delivery
  • 8.2.4. By Form
  • 8.2.5. By Source
  • 8.2.6. By Distribution Channel
  • 8.2.7. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Generic Drugs Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Type
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By Drug Delivery
      • 8.3.1.2.4. By Form
      • 8.3.1.2.5. By Source
      • 8.3.1.2.6. By Distribution Channel
  • 8.3.2. India Generic Drugs Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Type
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By Drug Delivery
      • 8.3.2.2.4. By Form
      • 8.3.2.2.5. By Source
      • 8.3.2.2.6. By Distribution Channel
  • 8.3.3. Japan Generic Drugs Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Type
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By Drug Delivery
      • 8.3.3.2.4. By Form
      • 8.3.3.2.5. By Source
      • 8.3.3.2.6. By Distribution Channel
  • 8.3.4. South Korea Generic Drugs Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Type
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By Drug Delivery
      • 8.3.4.2.4. By Form
      • 8.3.4.2.5. By Source
      • 8.3.4.2.6. By Distribution Channel
  • 8.3.5. Australia Generic Drugs Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Type
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By Drug Delivery
      • 8.3.5.2.4. By Form
      • 8.3.5.2.5. By Source
      • 8.3.5.2.6. By Distribution Channel

9. South America Generic Drugs Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Type
  • 9.2.2. By Application
  • 9.2.3. By Drug Delivery
  • 9.2.4. By Form
  • 9.2.5. By Source
  • 9.2.6. By Distribution Channel
  • 9.2.7. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Generic Drugs Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Type
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By Drug Delivery
      • 9.3.1.2.4. By Form
      • 9.3.1.2.5. By Source
      • 9.3.1.2.6. By Distribution Channel
  • 9.3.2. Argentina Generic Drugs Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Type
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By Drug Delivery
      • 9.3.2.2.4. By Form
      • 9.3.2.2.5. By Source
      • 9.3.2.2.6. By Distribution Channel
  • 9.3.3. Colombia Generic Drugs Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Type
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By Drug Delivery
      • 9.3.3.2.4. By Form
      • 9.3.3.2.5. By Source
      • 9.3.3.2.6. By Distribution Channel

10. Middle East and Africa Generic Drugs Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Type
  • 10.2.2. By Application
  • 10.2.3. By Drug Delivery
  • 10.2.4. By Form
  • 10.2.5. By Source
  • 10.2.6. By Distribution Channel
  • 10.2.7. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Generic Drugs Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Type
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By Drug Delivery
      • 10.3.1.2.4. By Form
      • 10.3.1.2.5. By Source
      • 10.3.1.2.6. By Distribution Channel
  • 10.3.2. Saudi Arabia Generic Drugs Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Type
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By Drug Delivery
      • 10.3.2.2.4. By Form
      • 10.3.2.2.5. By Source
      • 10.3.2.2.6. By Distribution Channel
  • 10.3.3. UAE Generic Drugs Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Type
      • 10.3.3.2.2. By Application
      • 10.3.3.2.3. By Drug Delivery
      • 10.3.3.2.4. By Form
      • 10.3.3.2.5. By Source
      • 10.3.3.2.6. By Distribution Channel

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Porter's Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Teva Pharmaceutical Industries Ltd.
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Sandoz International GmbH
• 14.3. Viatris Inc.
• 14.4. Sun Pharmaceutical Industries Ltd.
• 14.5. Fresenius Kabi AG
• 14.6. STADA Arzneimittel AG
• 14.7. Aurobindo Pharma Limited
• 14.8. Dr Reddy's Laboratories Ltd.
• 14.9. Cipla Ltd.
• 14.10. Novo Nordisk A/S
• 14.11. Abbott Laboratories Inc.
• 14.12. Endo International plc
• 14.13. Sanofi S.A.
• 14.14. Aspen Pharmacare Holdings Limited
• 14.15. Lupin Limited

15. Strategic Recommendations

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