非專利無菌注射劑市場（依藥品類型、治療用途、通路及地區分類）

2025 年全球非專利無菌注射劑市場規模估計為 464.3 億美元，預計到 2032 年將達到 933.9 億美元，2025 年至 2032 年的年複合成長率（CAGR）為 10.5%。

數字。 2025 年各地區非專利無菌注射劑市場佔有率（%）

非專利無菌注射是美國FDA核准的生技藥品，用於治療醫療保健產業廣泛領域的許多疾病和病症。非專利無菌注射劑比這些藥物的品牌版本便宜得多，但效果一樣好。因此，這些注射劑一直需求量很大，並被世界各地的大多數醫院和診所使用。然而，由於 FDA 對這些注射劑生產的嚴格規定，滿足對這些注射劑的嚴格需求一直是全球非專利無菌注射劑市場的主要參與者面臨的挑戰。

隨著無菌注射劑擴大應用於各種疾病和醫療狀況，非專利無菌注射劑市場預計將在可預見的未來獲得穩定的發展動力。製造商正致力於增加非專利無菌注射劑的產量，以滿足日益成長的需求，同時又不影響注射劑的品質。

市場動態

市場參與者正致力於推出新的非專利無菌注射劑產品，預計這將在預測期內促進全球非專利無菌注射劑的成長。例如，2017 年 6 月，百特國際公司宣布美國 FDA 核准並推出即用型鹽酸克林黴素注射液，有三種商業性核准劑型：300 mg/50 美國 、600 mg/50 mL 和 900 mg/50 mL。克林黴素是一種抗生素，當青黴素不適合患者時，廣泛用於治療敏感鏈球菌引起的嚴重感染疾病。

主要企業正專注於夥伴關係等無機活動，預計這將在預測期內促進全球非專利無菌注射劑市場的成長。例如，2017年，諾華公司的非專利部門山德士擴建了其在斯洛維尼亞的抗生素工廠，投資超過3,354萬美元用於開發和現代化該工廠。第一條生產線計劃於 2020 年投入使用，新生產線將分階段投入使用，直至 2024 年。

該公司專注於採用包括收購在內的無機成長策略，以擴大其全球影響力並改善其國際商機。例如，2016年8月，Teva Pharmaceutical Industries Inc.完成對Allergan學名藥業務的收購。艾爾建公司 (Allergan Plc) 是一家總部位於愛爾蘭的美國製藥公司。

本研究的主要特點

• 本報告對全球非專利無菌注射劑市場進行了詳細分析，並提供了預測期（2025-2032 年）的市場規模，以 2024 年為基準年。
• 它還強調了各個領域的潛在商機，並說明了該市場的有吸引力的投資提案矩陣。
• 它還提供了有關市場促進因素、限制因素、機會、新產品發布和核准、區域前景以及主要企業採用的競爭策略的重要見解。
• 全球非專利無菌注射劑市場的主要企業已根據公司概況、財務績效、產品系列、地理位置、分銷策略、關鍵發展和策略以及未來計劃等參數進行了分析。
• 本報告的見解將使負責人和企業經營團隊能夠就未來的產品發布、技術改進、市場擴張和行銷策略做出明智的決策。
• 全球非專利無菌注射劑市場報告針對該行業的各個相關人員，包括投資者、供應商、製造商、經銷商、新進業者和金融分析師。
• 相關人員可以透過用於分析全球非專利無菌注射劑市場的各種策略矩陣來簡化決策。

目錄

第1章 調查目的與前提條件

• 研究目標
• 先決條件
• 簡稱

第2章 市場概述

• 報告描述
  • 市場定義和範圍
• 執行摘要
• Coherent Opportunity Map（COM）

第3章市場動態、法規與趨勢分析

• 市場動態
  • 驅動程式
  • 限制因素
  • 市場機會
• 影響分析
• 監管情景
• PEST分析
• 最近的產品發布/核准
• 流行病學
• 合併與收購

4. 全球非專利無菌注射劑市場-冠狀病毒（COVID-19）大流行的影響

• 對供應鏈的影響
• 對研發的影響
• 政府舉措

5. 2020 年至 2032 年全球非專利無菌注射劑市場（依藥品類型）

• 單株抗體
• 細胞激素
• 胰島素
• 肽激素
• 疫苗
• 免疫球蛋白
• 血液因素
• 抗生素
• 其他

6. 2020 年至 2032 年全球非專利無菌注射劑市場（依治療應用）

• 癌症
• 代謝疾病
• 心血管疾病
• 中樞神經系統疾病
• 感染疾病
• 肌肉骨骼疾病
• 其他

7. 2020 年至 2032 年全球非專利無菌注射劑市場（依通路）

• 醫院藥房
• 零售藥局
• 網路藥局

8. 全球非專利無菌注射劑市場（按地區分類），2020 年至 2032 年

• 北美洲
• 拉丁美洲
• 歐洲
• 亞太地區
• 中東
• 非洲

第9章 競爭態勢

• 公司簡介
  • Baxter International Inc.
  • AstraZeneca plc
  • Merck &Co., Inc.
  • Pfizer Inc.
  • Fresenius Kabi
  • Novartis International AG
  • Teva Pharmaceuticals
  • Hikma Pharmaceuticals
  • Reddy's Laboratory
  • Mylan NV
  • Sun Pharmaceutical Industries Ltd.

第 10 章分析師建議

• 命運之輪
• 分析師觀點
• 一致的機會圖

第 11 章 章節

• 參考
• 調查方法

Global Generic Sterile Injectables Market is estimated to be valued at USD 46.43 Bn in 2025 and is expected to reach USD 93.39 Bn by 2032, growing at a compound annual growth rate (CAGR) of 10.5% from 2025 to 2032.

Figure. Generic Sterile Injectables Market Share (%), By Region 2025

The generic sterile injectable are U.S. FDA approved biologics that are used for the treatment of many diseases and disorders in the vast arena of the healthcare industry. The generic sterile injectable are very inexpensive as compared to that of their branded counterparts of these drugs and performs equally well. Thus, these Injectables are heavily in demand all the time and are used in majority of hospitals and clinics across the globe. However, due to the stringent FDA regulations for the production of these injectable, the rigorous demand satisfaction of these injectable has always been a constant challenge for the key players in the global generic sterile injectable market.

The generic sterile injectable market is expected to gain steady traction in the foreseeable future as the sterile injectable products find its application across a wide number of diseases and medical condition. Manufacturers are focused on increasing the production of generic sterile injectable to meet the rising demands without compromising on the quality of the injectable.

Market Dynamics

Market players are engaged in launching new products for generic sterile injectables, this is expected to increase the growth of the global generic sterile injectables, over the forecast period. For instance, in June 2017, Baxter International Inc. announced the U.S. FDA approval and commercial launch of ready-to-use clindamycin injection in saline in three commonly prescribed formulations (300mg/50mL, 600mg/50mL, and 900mg/50mL). Clindamycin is a widely prescribed antibiotic for serious infections which is caused by susceptible anaerobic bacteria and strains of streptococci, pneumococci and staphylococci, when penicillin is inappropriate for a patient.

Key players are focusing on inorganic activities such as partnerships, this is expected to increase the growth of the global generic sterile injectables market, over the forecast period. For instance, in 2017, Novartis' generic arm Sandoz expanded its antibiotic facility in Slovenia, with an investment of over US$ 33.54 million aimed at the development and modernization of facilities. The first production lines started in 2020, after which new lines will be gradually phased in by 2024.

The company is focused on adopting inorganic growth strategies such as acquisitions to expand its global presence and improve international commercial opportunities. For instance, in August 2016, Teva Pharmaceutical Industries Ltd. completed the acquisition of Allergan's generics business. Allergan plc.is an American, Irish-domiciled pharmaceutical company.

Key features of the study:

• This report provides an in-depth analysis of the global generic sterile injectables market, provides market size (US$ Billion), and compound annual growth rate (CAGR %) for the forecast period (2025-2032), considering 2024 as the base year
• It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrix for this market
• This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategies adopted by the leading players
• It profiles leading players in the global generic sterile injectables market based on the following parameters - company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies, and future plans
• Key companies covered as a part of this study include Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Pfizer Inc., Fresenius Kabi, Novartis International AG, Teva Pharmaceuticals, Hikma Pharmaceuticals, Dr. Reddy's Laboratory, Mylan N.V., and Sun Pharmaceutical Industries Ltd.
• Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launch, technology up-gradation, market expansion, and marketing tactics
• The global generic sterile injectables market report caters to various stakeholders in this industry including investors, suppliers, manufacturers, distributors, new entrants, and financial analysts
• Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global generic sterile injectables market

Detailed Segmentation:

• Global Generic Sterile Injectables Market, By Drug Type:
  • Monoclonal Antibodies
  • Cytokines
  • Insulin
  • Peptide Hormones
  • Vaccines
  • Immunoglobulins
  • Blood Factors
  • Antibiotics
  • Others
• Global Generic Sterile Injectables Market, By Therapeutic Application:
  • Cancer
  • Metabolic Diseases
  • Cardiovascular Diseases
  • Central Nervous System Disease
  • Infectious Disorders
  • Musculoskeletal Disorders
  • Others
• Global Generic Sterile Injectables Market, By Distribution Channel:
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Global Generic Sterile Injectables Market, By Region:
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
  • Africa
• Company Profiles
  • Baxter International Inc.
  • AstraZeneca plc
  • Merck & Co., Inc.
  • Pfizer Inc.
  • Fresenius Kabi
  • Novartis International AG
  • Teva Pharmaceuticals
  • Hikma Pharmaceuticals
  • Reddy's Laboratory
  • Mylan N.V.
  • Sun Pharmaceutical Industries Ltd.

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Overview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Market Snippet, By Drug Type
  • Market Snippet, By Therapeutic Application
  • Market Snippet, By Distribution Channel
  • Market Snippet, By Region
• Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Drivers
  • Restraints
  • Market Opportunities
• Impact Analysis
• Regulatory Scenario
• PEST Analysis
• Recent Product Launch/Approval
• Epidemiology
• Mergers and Acquisitions

4. Global Generic Sterile Injectables Market - Impact of Coronavirus (Covid-19) Pandemic

• Impact on Supply Chain
• Impact on Research and Development
• Government Initiatives

5. Global Generic Sterile Injectables Market, By Drug Type, 2020-2032, (USD Bn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Monoclonal Antibodies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Cytokines
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Insulin
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Peptide Hormones
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Vaccines
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Immunoglobulins
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Blood Factors
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Antibiotics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)

6. Global Generic Sterile Injectables Market, By Therapeutic Application, 2020 - 2032, (USD Bn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Cancer
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Metabolic Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Cardiovascular Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Central Nervous System Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Infectious Disorders
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Musculoskeletal Disorders
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)

7. Global Generic Sterile Injectables Market, By Distribution Channel, 2020 - 2032 (USD Bn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Hospital Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Retail Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)
• Online Pharmacies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020 - 2032, (USD Bn)

8. Global Generic Sterile Injectables Market, By Region, 2020 - 2032 (USD Bn)

• Introduction
  • Market Share Analysis, By Region, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, For Regions, 2020 - 2032
  • Regional Trends
• North America
  • Market Size and Forecast, By Drug Type, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Therapeutic Application, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Country, 2020 - 2032 (US$ Bn)
    • U.S.
    • Canada
• Latin America
  • Market Size and Forecast, By Drug Type, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Therapeutic Application, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Country, 2020 - 2032 (US$ Bn)
    • Brazil
    • Mexico
    • Argentina
    • Rest of Latin America
• Europe
  • Market Size and Forecast, By Drug Type, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Therapeutic Application, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Country, 2020 - 2032 (US$ Bn)
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
• Asia Pacific
  • Market Size and Forecast, By Drug Type, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Therapeutic Application, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Country, 2020 - 2032 (US$ Bn)
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
• Middle East
  • Market Size and Forecast, By Drug Type, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Therapeutic Application, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Country, 2020 - 2032 (US$ Bn)
    • GCC
    • Israel
    • Rest of Middle East
• Africa
  • Market Size and Forecast, By Drug Type, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Therapeutic Application, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Distribution Channel, 2020 - 2032 (US$ Bn)
  • Market Size and Forecast, By Country, 2020 - 2032 (US$ Bn)
    • South Africa
    • Central Africa
    • North Africa

9. Competitive Landscape

• Company Profiles
  • Baxter International Inc.
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • AstraZeneca plc
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Merck & Co., Inc.
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Pfizer Inc.
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Fresenius Kabi
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Novartis International AG
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Teva Pharmaceuticals
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Hikma Pharmaceuticals
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Reddy's Laboratory
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Mylan N.V.
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies
  • Sun Pharmaceutical Industries Ltd.
    • Company Overview
    • Drug Portfolio
    • Financial Performance
    • Recent Developments/Updates
    • Strategies

10. Analyst Recommendation

• Wheel of Fortune
• Analyst View
• Coherent Opportunity Map

11. Section

• References
• Research Methodology
• About Us and Sales Contact