查看購物車
  • Simplified Chinese
  • English
  • Japanese
  • Korean
封面
市場調查報告書
商品編碼
1818078

2032 年學名藥市場預測：按類型、給藥途徑、分銷管道、應用和地區進行的全球分析

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個工作天內

價格

根據 Stratistics MRC 的數據，全球學名藥市場預計到 2025 年將達到 4,853.7 億美元，到 2032 年將達到 9,640.5 億美元，預測期內的複合年成長率為 10.3%。

學名藥是品牌藥的經濟高效的替代品，具有相同的活性成分、劑量和治療目的。由於學名藥在專利到期後才核准，因此必須證明其生物等效性，以確保相似的安全性和有效性。雖然包裝和非活性成分可能有所不同，但臨床表現保持一致。這些藥物在降低醫療成本、擴大治療可近性且不影響品質方面發揮關鍵作用。

慢性病增多

在全球範圍內，糖尿病、心血管疾病和癌症等慢性疾病的發生率不斷上升，推動了對可負擔治療方案的需求。在醫療保健系統面臨壓力之際，學名藥提供了比品牌藥更具成本效益的替代方案。人口老化和文明病正在擴大已開發市場和新興市場的患者群體。各國政府和保險公司正在推廣使用學名藥以降低醫療成本。這種轉變正鼓勵製藥公司擴大其學名藥組合併投資於可擴展生產。因此，日益加重的慢性病負擔是市場持續成長的關鍵驅動力。

激烈的價格競爭

由於多家製藥公司提供類似的配方，商品化程度不斷提高，對價格造成了下行壓力。成本控制法規進一步加劇了製造商之間的競爭。各公司難以實現產品差異化，難以獲得品牌忠誠度與溢價。這種環境扼殺了創新，並限制了對先進製造技術的投資。因此，企業必須在價格承受能力和營運效率之間取得平衡才能生存。

技術進步

開發技術的進步正在改變學名藥的格局，使其能夠加快開發速度並改善品管。自動化、人工智慧配方和連續生產正在簡化製造流程。先進的分析和數位平台正在增強供應鏈的可視性和法規遵循。生物等效性測試和包裝方面的創新正在提高產品的可靠性和保存期限。這些進步正在幫助製造商滿足全球標準，同時縮短產品上市時間。技術的加速應用為學名藥的差異化和擴充性開闢了新的途徑。

品質和安全問題

生產規範不一致和供應鏈漏洞可能導致產品召回和監管處罰。跨境生產和外包使監管更加複雜，並引發對污染和療效的擔憂。圍繞不合格學名藥的負面宣傳可能會損害公眾信任，阻礙市場接受。監管機構正在加強測試通訊協定，並要求製造商提高透明度。如果沒有強而有力的品質保證，企業將面臨聲譽受損甚至被市場淘汰的風險。

COVID-19的影響

疫情擾亂了醫藥供應鏈，減緩了全球學名藥的生產和分銷。封鎖和勞動力短缺給生產能力和物流網路帶來了壓力。某些學名藥的需求激增，尤其是抗病毒和呼吸道藥物，造成了暫時的供不應求。各國政府優先考慮緊急核准和儲備，並調整了籌資策略。在後疫情時代，該產業正專注於供應鏈的韌性和數位轉型，以減輕未來的中斷風險​​。這場危機凸顯了學名藥在公共衛生防範和可負擔性的關鍵作用。

簡單非專利市場預計將成為預測期內最大的市場

由於學名藥的廣泛可用性和監管的便利性，預計簡單非專利領域將在預測期內佔據最大的市場佔有率。這些藥物的化學成分與品牌藥相同，有利於降低價格並實現治療等效性。醫療保健提供者和保險公司繼續推廣使用學名藥來控制治療成本。簡單非專利成熟的生產流程可實現高效的可擴展性和分銷。與複雜學名藥相比，簡化的監管途徑可以加快核准。隨著對經濟實惠藥物的需求不斷成長，這一領域仍然是學名藥市場的關鍵參與者。

預測期內，腫瘤學領域預計將以最高複合年成長率成長

受癌症發病率上升和高昂治療費用的推動，預計腫瘤學領域將在預測期內實現最高成長率。與品牌藥相比，非專利抗癌藥可顯著節省成本，使其成為醫療保健體係不可或缺的一部分。製劑和標靶給藥技術的進步正在提升療效和改善患者預後。監管部門對生物相似藥和複雜學名藥的支持正在加速腫瘤學領域的市場准入。認知度的提高和早期診斷正在擴大各地區患者群體。

比最大的地區

預計亞太地區將在預測期內佔據最大的市場佔有率，這得益於其龐大的人口和不斷擴大的醫療保健覆蓋率。印度和中國等國家是學名藥的主要生產國和出口國，得益於其成本效益高的生產方式。政府推廣學名藥和降低醫療成本的措施正在推動國內消費。慢性病盛行率的上升和都市化正在推動對可負擔治療的需求。監管改革和基礎設施投資正在提高市場透明度和品質標準。

複合年成長率最高的地區

受醫療成本上漲和政策轉向支持學名藥的推動，北美地區預計將在預測期內呈現最高的複合年成長率。美國和加拿大正在擴大報銷範圍，並簡化學名藥核准流程。製造和分銷領域的技術創新正在提高效率和合規性。對生物相似藥和特種學名藥日益成長的需求正在重塑競爭格局。公眾意識的提高和醫生對學名藥的接受度不斷提高，正在推動市場滲透。憑藉強大的法律規範和研發投入，北美很可能在學名藥創新和應用方面引領潮流。

免費客製化服務

此報告的訂閱者可以選擇以下免費自訂選項之一：

  • 公司簡介
    • 全面分析其他市場參與者（最多 3 家公司）
    • 主要企業的SWOT分析（最多3家公司）
  • 區域細分
    • 根據客戶興趣對主要國家進行的市場估計、預測和複合年成長率（註：基於可行性檢查）
  • 競爭基準化分析
    • 根據產品系列、地理分佈和策略聯盟對主要企業基準化分析

目錄

第1章執行摘要

第2章 前言

  • 概述
  • 相關利益者
  • 調查範圍
  • 調查方法
    • 資料探勘
    • 數據分析
    • 數據檢驗
    • 研究途徑
  • 研究材料
    • 主要研究資料
    • 次級研究資訊來源
    • 先決條件

第3章市場走勢分析

  • 驅動程式
  • 抑制因素
  • 機會
  • 威脅
  • 應用分析
  • 新興市場
  • COVID-19的影響

第4章 波特五力分析

  • 供應商的議價能力
  • 買方的議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 競爭對手之間的競爭

第5章全球學名藥市場類型

  • 簡單非專利
  • 專業非專利
  • 生物相似藥
  • 其他

6. 全球學名藥市場（依給藥途徑）

  • 口服
  • 局部的
  • 注射
  • 其他

7. 全球學名藥市場（按分銷管道）

  • 醫院藥房
  • 網路藥局
  • 零售藥局

第8章全球學名藥市場（按應用）

  • 心血管系統
  • 中樞神經系統（CNS）
  • 抗感染藥物
  • 呼吸系統
  • 腫瘤學
  • 皮膚科
  • 糖尿病
  • 其他

9. 全球學名藥市場（按地區）

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太地區
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地區
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 卡達
    • 南非
    • 其他中東和非洲地區

第10章：重大進展

  • 協議、夥伴關係、合作和合資企業
  • 收購與合併
  • 新產品發布
  • 業務擴展
  • 其他關鍵策略

第11章 公司概況

  • 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.