美國非專利藥注射藥品契約製造市場規模、佔有率和趨勢分析報告：按分子、應用和細分市場預測，2025-2030年

美國非專利藥注射劑契約製造市場的成長和趨勢：

Grand View Research, Inc. 的最新報告顯示，到 2030 年，美國非專利藥注射契約製造市場預計將達到 55.9 億美元。

預計2025年至2030年美國市場將以10.8%的複合年成長率擴張。推動該市場成長的關鍵因素是重磅藥物專利到期的頻率增加、監管途徑的簡化、學名藥成本的降低以及 CDMO 在非專利注射劑領域的滲透率不斷提高。

COVID-19 大流行對供應鏈市場及其管理產生了重大影響，包括美國的非專利藥注射契約製造製造業。由於安全問題和與大流行相關的限制，新非專利注射劑的臨床試驗已被修改或推遲，這可能會影響開發進度。此外，多家製藥公司將產能轉向生產 COVID-19 疫苗，這極大地影響了其他藥品（包括非專利注射劑）的生產計劃和產能。

生物製藥專利到期數量的增加是促進該國非專利注射劑市場成長的關鍵因素。例如，據美國FDA 稱，艾伯維 (AbbVie) 開發的一款治療克隆氏症、關節炎、斑塊型乾癬和僵直性脊椎炎症狀的重磅注射藥物修Humira) 的專利將於2023 年到期。該專利到期為Adalimumab學名藥的推出鋪平了道路。由於成本效益的原因，對學名藥的需求不斷成長，也大大促進了美國非專利注射契約製造市場的成長。

美國非專利藥注射契約製造市場報告亮點

• 依分子細分，市場分為小分子和聚合物。到2024年，聚合物細分市場將以58.02%的銷售佔有率主導市場。
• 預計小分子領域在預測期內的複合年成長率為 10.40%。小分子注射藥物在癌症、血液感染疾病和心血管疾病等多種疾病的治療中繼續發揮重要作用。
• 根據應用，市場分為癌症、免疫學、抗糖尿病、神經學、循環系統、呼吸系統等。 2024年，腫瘤學將以29.42%的銷售佔有率佔據市場主導地位。
• 神經病學領域預計在預測期內複合年成長率為 11.64%。

目錄

第1章調查方法與範圍

第 2 章執行摘要

第 3 章美國非專利藥注射合約契約製造市場的變數、趨勢和範圍

• 市場體系展望
  • 母市場展望
  • 相關/附隨市場展望
• 市場動態
  • 市場促進因素分析
  • 市場限制因素分析
• 美國非專利藥注射劑契約製造市場分析工具
  • 產業分析-波特五力分析
  • PESTEL分析
  • COVID-19 影響分析

第4章美國注射非專利藥契約製造市場：分子估計及趨勢分析

• 美國非專利藥注射藥物契約製造市場（按分子）：細分儀表板
• 美國注射非專利藥契約製造市場（按分子）：波動分析
• 分子，2018-2030
  • 低分子
  • 大分子

第5章美國非專利藥注射劑契約製造市場：應用估計和趨勢分析

• 美國非專利藥注射劑契約製造市場（按應用）：細分儀表板
• 美國注射非專利藥契約製造市場（按應用）：波動分析
• 按申請，2018-2030
  • 腫瘤學
  • 免疫學
  • 抗糖尿病藥
  • 神經病學
  • 心血管
  • 呼吸系統
  • 其他

第6章 競爭狀況

• 市場參與企業分類
  • 創新者
  • 市場領導者
  • 新興玩家
  • 2024 年企業市場佔有率分析
• 公司簡介
  • 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