美国非专利药注射药品契约製造市场规模、份额和趋势分析报告：按分子、应用和细分市场预测，2025-2030年

美国非专利药注射剂契约製造市场的成长和趋势：

Grand View Research, Inc. 的最新报告显示，到 2030 年，美国非专利药注射契约製造市场预计将达到 55.9 亿美元。

预计2025年至2030年美国市场将以10.8%的复合年增长率扩张。推动该市场成长的关键因素是重磅药物专利到期的频率增加、监管途径的简化、学名药成本的降低以及 CDMO 在非专利注射剂领域的渗透率不断提高。

COVID-19 大流行对供应链市场及其管理产生了重大影响，包括美国的非专利药注射契约製造製造业。由于安全问题和与大流行相关的限制，新非专利注射剂的临床试验已被修改或推迟，这可能会影响开发进度。此外，多家製药公司将产能转向生产 COVID-19 疫苗，这极大地影响了其他药品（包括非专利注射剂）的生产计划和产能。

生物製药专利到期数量的增加是促进该国非专利注射剂市场成长的关键因素。例如，据美国FDA 称，艾伯维 (AbbVie) 开发的一款治疗克隆氏症、关节炎、斑块型干癣和僵直性脊椎炎症状的重磅注射药物修Humira) 的专利将于2023 年到期。该专利到期为Adalimumab学名药的推出铺平了道路。由于成本效益的原因，对学名药的需求不断增长，也大大促进了美国非专利注射契约製造市场的成长。

美国非专利药注射契约製造市场报告亮点

• 依分子细分，市场分为小分子和聚合物。到2024年，聚合物细分市场将以58.02%的销售份额主导市场。
• 预计小分子领域在预测期内的复合年增长率为 10.40%。小分子注射药物在癌症、血液感染疾病和心血管疾病等多种疾病的治疗中继续发挥重要作用。
• 根据应用，市场分为癌症、免疫学、抗糖尿病、神经学、循环系统、呼吸系统等。 2024年，肿瘤学将以29.42%的销售份额占据市场主导地位。
• 神经病学领域预计在预测期内复合年增长率为 11.64%。

目录

第一章调查方法与范围

第 2 章执行摘要

第 3 章美国非专利药注射合约契约製造市场的变数、趋势和范围

• 市场体系展望
  • 母市场展望
  • 相关/附随市场展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• 美国非专利药注射剂契约製造市场分析工具
  • 产业分析-波特五力分析
  • PESTEL分析
  • COVID-19 影响分析

第四章美国注射非专利药契约製造市场：分子估计及趋势分析

• 美国非专利药注射药物契约製造市场（按分子）：细分仪表板
• 美国註射非专利药契约製造市场（按分子）：波动分析
• 分子，2018-2030
  • 低分子
  • 大分子

第五章美国非专利药注射剂契约製造市场：应用估计和趋势分析

• 美国非专利药注射剂契约製造市场（按应用）：细分仪表板
• 美国註射非专利药契约製造市场（按应用）：波动分析
• 按申请，2018-2030
  • 肿瘤学
  • 免疫学
  • 抗糖尿病药
  • 神经病学
  • 心血管
  • 呼吸系统
  • 其他的

第六章 竞争状况

• 市场参与企业分类
  • 创新者
  • 市场领导者
  • 新兴玩家
  • 2024 年企业市场占有率分析
• 公司简介
  • Charles River Laboratories International, Inc.
  • Hikma Pharmaceuticals PLC
  • Pfizer Inc.
  • Fresenius Kabi
  • Sandoz AG
  • Jubilant Pharma Limited
  • Baxter
  • PCI Pharma Services.
  • Gland Pharma Limited（USA）
  • Dr.Reddy's Laboratories Ltd.
  • Grand River Aseptic Manufacturing

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Growth & Trends:

The U.S. generic injectables pharmaceutical contract manufacturing market size is expected to reach USD 5.59 billion by 2030, according to a new report by Grand View Research, Inc. The U.S. market is expected to expand at a CAGR of 10.8% from 2025 to 2030. Key factors driving the growth of this market are the rising frequency of patent expirations for blockbuster drugs, streamlined regulatory pathways, low cost of generics, and increasing penetration of CDMOs in the generic injectables space.

The COVID-19 pandemic significantly impacted the supply chain market and its management, including the U.S. generic injectables pharmaceutical contract manufacturing sector. The conduction of clinical trials for new generic injectables has been modified or delayed due to pandemic-related safety concerns and restrictions, potentially impacting the development timeline. Furthermore, several pharmaceutical companies pivoted their production capacities to manufacture COVID-19 vaccines, significantly impacting the production timelines and capacity for other pharmaceuticals, including generic injectables.

The increasing number of patent expirations for biologic injectables is a key factor contributing to the growth of the generic injectables market in the country. For instance, as per the U.S. FDA, the blockbuster injectable drug Humira, developed by AbbVie Inc. that treats the symptoms of Crohn's disease, arthritis, plaque psoriasis, and Ankylosing Spondylitis, has lost its patent in 2023. This expiration has paved the way for introducing its generic counterpart, adalimumab. The rising demand for generics owing to their cost-effectiveness is another significant factor contributing to the growth of the U.S. market for generic injectables pharmaceutical contract manufacturing.

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Report Highlights:

• On the basis of molecule segment, the market is segregated into small molecule, and large molecule. In 2024, the large molecule segment dominated the market, accounting for a revenue share of 58.02%.
• The small molecule segment is anticipated to register the CAGR of 10.40% during the forecast period. Small molecule-based injectable drugs continue to hold an essential position in the treatment of a wide range of illnesses, including cancer, blood disorders, infectious diseases, and cardiovascular ailments.
• On the basis of application segment, the market is segregated into oncology, immunology, antidiabetic, neurology, cardiovascular, respiratory, and others. In 2024, the oncology segment dominated the market, accounting for a revenue share of 29.42%.
• The neurology segment is anticipated to register the fastest CAGR of 11.64% during the forecast period.

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Molecule
  • 1.2.2. Application
• 1.3. Regional Scope
• 1.4. Estimates And Forecast Timeline
• 1.5. Research Methodology
• 1.6. Information Procurement
  • 1.6.1. Purchased Database
  • 1.6.2. GVR's Internal Database
  • 1.6.3. Secondary Sources
  • 1.6.4. Primary Research
• 1.7. Information Or Data Analysis
  • 1.7.1. Data Analysis Models
• 1.8. Market Formulation & Validation
• 1.9. Model Details
  • 1.9.1. Commodity Flow Analysis
  • 1.9.2. Parent Market Analysis
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Rising frequency of patent expirations for blockbuster drugs
    • 3.2.1.2. Streamlined regulatory pathway and low cost of generics
    • 3.2.1.3. Increasing penetration of CDMOs in the generic injectables space
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Presence of substitute therapies
    • 3.2.2.2. Compliance issues while outsourcing
• 3.3. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Molecule Estimates & Trend Analysis

• 4.1. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market, By Molecule: Segment Dashboard
• 4.2. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market, By Molecule: Movement Analysis
• 4.3. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Estimates & Forecasts, By Molecule, 2018 - 2030
  • 4.3.1. Small Molecule
    • 4.3.1.1. Small Molecule Market, 2018 to 2030 (USD Million)
  • 4.3.2. Large Molecule
    • 4.3.2.1. Large Molecule Market, 2018 to 2030 (USD Million)

Chapter 5. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Application Estimates & Trend Analysis

• 5.1. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market, By Application: Segment Dashboard
• 5.2. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market, By Application: Movement Analysis
• 5.3. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Estimates & Forecasts, By Application, 2018 - 2030
  • 5.3.1. Oncology
    • 5.3.1.1. Oncology Market, 2018 to 2030 (USD Million)
  • 5.3.2. Immunology
    • 5.3.2.1. Immunology Market, 2018 to 2030 (USD Million)
  • 5.3.3. Antidiabetic
    • 5.3.3.1. Antidiabetic Market, 2018 to 2030 (USD Million)
  • 5.3.4. Neurology
    • 5.3.4.1. Neurology Market, 2018 to 2030 (USD Million)
  • 5.3.5. Cardiovascular
    • 5.3.5.1. Cardiovascular Market, 2018 to 2030 (USD Million)
  • 5.3.6. Respiratory
    • 5.3.6.1. Respiratory Market, 2018 to 2030 (USD Million)
  • 5.3.7. Others
    • 5.3.7.1. Others Market, 2018 to 2030 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Market Participant Categorization
  • 6.1.1. Innovators
  • 6.1.2. Market Leaders
  • 6.1.3. Emerging Players
  • 6.1.4. Company Market Share Analysis, 2024
• 6.2. Company Profiles
  • 6.2.1. Charles River Laboratories International, Inc.
    • 6.2.1.1. Company Overview
    • 6.2.1.2. Financial Performance
    • 6.2.1.3. Service Benchmarking
    • 6.2.1.4. Strategic Initiatives
  • 6.2.2. Hikma Pharmaceuticals PLC
    • 6.2.2.1. Company Overview
    • 6.2.2.2. Financial Performance
    • 6.2.2.3. Service Benchmarking
    • 6.2.2.4. Strategic Initiatives
  • 6.2.3. Pfizer Inc.
    • 6.2.3.1. Company Overview
    • 6.2.3.2. Financial Performance
    • 6.2.3.3. Service Benchmarking
    • 6.2.3.4. Strategic Initiatives
  • 6.2.4. Fresenius Kabi
    • 6.2.4.1. Company Overview
    • 6.2.4.2. Financial Performance
    • 6.2.4.3. Service Benchmarking
    • 6.2.4.4. Strategic Initiatives
  • 6.2.5. Sandoz AG
    • 6.2.5.1. Company Overview
    • 6.2.5.2. Financial Performance
    • 6.2.5.3. Service Benchmarking
    • 6.2.5.4. Strategic Initiatives
  • 6.2.6. Jubilant Pharma Limited
    • 6.2.6.1. Company Overview
    • 6.2.6.2. Financial Performance
    • 6.2.6.3. Service Benchmarking
    • 6.2.6.4. Strategic Initiatives
  • 6.2.7. Baxter
    • 6.2.7.1. Company Overview
    • 6.2.7.2. Financial Performance
    • 6.2.7.3. Service Benchmarking
    • 6.2.7.4. Strategic Initiatives
  • 6.2.8. PCI Pharma Services.
    • 6.2.8.1. Company Overview
    • 6.2.8.2. Financial Performance
    • 6.2.8.3. Service Benchmarking
    • 6.2.8.4. Strategic Initiatives
  • 6.2.9. Gland Pharma Limited (USA)
    • 6.2.9.1. Company Overview
    • 6.2.9.2. Financial Performance
    • 6.2.9.3. Service Benchmarking
    • 6.2.9.4. Strategic Initiatives
  • 6.2.10. Dr.Reddy's Laboratories Ltd.
    • 6.2.10.1. Company Overview
    • 6.2.10.2. Financial Performance
    • 6.2.10.3. Service Benchmarking
    • 6.2.10.4. Strategic Initiatives
  • 6.2.11. Grand River Aseptic Manufacturing
    • 6.2.11.1. Company Overview
    • 6.2.11.2. Financial Performance
    • 6.2.11.3. Service Benchmarking
    • 6.2.11.4. Strategic Initiatives

List of Tables

• Table 1 List of secondary sources
• Table 2 List of Abbreviations
• Table 3 U.S. Generic Injectables Pharmaceutical Contract Manufacturing market, by Molecule, 2018 - 2030 (USD Million)
• Table 4 U.S. Generic Injectables Pharmaceutical Contract Manufacturing market, by Application, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value chain-based sizing & forecasting
• Fig. 7 QFD modelling for market share assessment
• Fig. 8 Market formulation & validation
• Fig. 9 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market revenue, 2018 - 2030 (USD Million)
• Fig. 10 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market snapshot
• Fig. 11 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market driver impact
• Fig. 12 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market restraint impact
• Fig. 13 U.S. Generic Injectables Pharmaceutical Contract Manufacturing molecule key takeaways (USD Million)
• Fig. 14 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Molecule movement analysis
• Fig. 15 Small molecule market, 2018 - 2030 (USD Million)
• Fig. 16 Large molecule market, 2018 - 2030 (USD Million)
• Fig. 17 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Application key takeaways (USD Million)
• Fig. 18 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Application movement analysis
• Fig. 19 Oncology market, 2018 - 2030 (USD Million)
• Fig. 20 Immunology market, 2018 - 2030 (USD Million)
• Fig. 21 Antidiabetic market, 2018 - 2030 (USD Million)
• Fig. 22 Neurology market, 2018 - 2030 (USD Million)
• Fig. 23 Cardiovascular market, 2018 - 2030 (USD Million)
• Fig. 24 Respiratory market, 2018 - 2030 (USD Million)
• Fig. 25 Others market, 2018 - 2030 (USD Million)
• Fig. 26 Market participant categorization