美国仿製药注射药物合约製造的市场规模、份额和趋势分析报告：按分子类型、用途和细分市场预测，2023-2030 年

美国仿製药注射药物合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，美国注射仿製药合约製造市场预计将达到53.9亿美元。

预计2023年至2030年美国市场将以10.7%的年复合成长率扩张。推动该市场成长的关键要素是重磅药物专利到期的频率增加、法规途径的简化、仿製药价格的降低以及 CDMO 在仿製药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，包括美国的仿製药注射药品合约部门。由于安全问题和与大流行相关的限制，新仿製药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移到生产 COVID-19 疫苗，这严重影响了其他药品（包括仿製药注射剂）的生产计划和产能。

注射生物製药专利到期数量的增加是促进该国仿製药注射剂市场成长的关键因素。例如，据美国FDA 称，艾伯维 (AbbVie) 开发的一款治疗克罗恩病、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美乐(Humira) 的专利将于2023 年到期。该专利到期为阿达木单抗仿製药的推出铺平了道路。由于成本效益的原因，对仿製药的需求不断增加，也大大促进了美国仿製药注射药物合约製造市场的成长。

美国仿製药注射药品合约製造市场报告亮点

• 根据分子类型，美国市场分为小分子和聚合物，其中聚合物的销售份额最高，2022年将达到61.3%。这主要是由于美国各地生物相似药的上市速度不断增加。
• 预计神经病学领域在预测期内将以 11.3% 的年复合成长率增长最快。这是由于神经系统疾病日益流行，需要创新且具有成本效益的治疗方法，导致对治疗多种疾病的仿製药注射剂的需求增加。我是。
• 由于合约製造商的大量存在以及近年来製药和生物製药外包的显着增加，预计美国市场在分析期间将实现 10.7% 的良好成长率。

目录

第1章调查方法和范围

第2章执行摘要

第3章美国仿製药注射药品合约製造市场的变数、趋势和范围

• 市场体系预测
  • 母市场预测
  • 相关/附随市场预测
• 市场动态
  • 市场促进因素分析
  • 市场抑制因素分析
• 美国仿製药注射剂合约製造市场分析工具
  • 市场分析-波特五力分析
  • PESTEL分析
  • COVID-19感染疾病的影响分析

第4章美国仿製药注射剂合约製造市场：按分子类型估计和趋势分析

• 按分子类型分類的美国仿製药注射药物合约製造市场：细分仪表板
• 美国注射用仿製药合约製造市场，依分子类型：变异分析

第5章美国仿製药注射剂合约製造市场：按用途估计和趋势分析

• 美国仿製药注射药物合约製造市场，按用途：细分仪表板
• 美国註射用仿製药合约製造市场（按用途）：波动分析

第6章美国仿製药注射剂合约製造市场：国家估计和趋势分析

• 美国

第7章竞争形势

• 市场参与企业分类
  • 创新者
  • 市场领导
  • 新兴企业
  • 2022 年公司市场占有率分析
• 公司简介
  • 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

第8章Kol说明/建议

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 5.39 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 10.7% from 2023 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:

• Based on molecule type, the U.S. market is segmented into small molecule and large molecule, with the large molecule segment accounting for the higher revenue share of 61.3% in 2022. This is majorly due to the increasing launch rate of biosimilars across the U.S.
• The neurology segment is anticipated to advance at the fastest CAGR of 11.3% during the forecast period. This is due to the growing prevalence of neurological conditions requiring innovative and cost-effective therapeutics, thereby boosting demand for generic injectables to treat several types of disorders
• The U.S. market is anticipated to witness a lucrative growth rate of 10.7% during the analysis timeframe due to the significant presence of contract manufacturers and a notable increase in the outsourcing of pharmaceutical and biopharmaceutical products in the U.S. market in recent years

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Segment Definitions
  • 1.1.2. Molecule Type
  • 1.1.3. Application
• 1.2. Regional Scope
• 1.3. Estimates And Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective-1
  • 1.4.2. Objective-2
  • 1.4.3. Objective-3
• 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. List Of Secondary Sources
• 1.11. List Of Abbreviations

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

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. The rising frequency of patent expirations for blockbuster drugs is expected to strengthen the market for generic injectables
    • 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. Market Analysis - Porter's Five Forces
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat Of New Entrant
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

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

• 4.1. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market, By Molecule Type: Segment Dashboard
• 4.2. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market, By Molecule Type: Movement Analysis
• 4.3. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Estimates & Forecasts, By Molecule Type, 2018 - 2030
  • 4.3.1. Small Molecules
    • 4.3.1.1. Small Molecule U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 4.3.2. Large Molecules
    • 4.3.2.1. Large Molecule U.S. Generic Injectables Pharmaceutical Contract Manufacturing 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 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 5.3.2. Immunology
    • 5.3.2.1. Immunology U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 5.3.3. Antidiabetic
    • 5.3.3.1. Antidiabetic U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 5.3.4. Neurology
    • 5.3.4.1. Neurology U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 5.3.5. Cardiovascular
    • 5.3.5.1. Cardiovascular U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 5.3.6. Respiratory
    • 5.3.6.1. Respiratory U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 5.3.7. Others
    • 5.3.7.1. Others U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market 2018 to 2030 (USD Million)

Chapter 6. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Country Estimates & Trend Analysis

• 6.1. U.S.
  • 6.1.1. Key Country Dynamics
  • 6.1.2. Competitive Scenario
  • 6.1.3. Regulatory Framework
  • 6.1.4. U.S. Market Estimates and Forecasts, 2018 - 2030

Chapter 7. Competitive Landscape

• 7.1. Market Participant Categorization
  • 7.1.1. Innovators
  • 7.1.2. Market Leaders
  • 7.1.3. Emerging Players
  • 7.1.4. Company Market Share Analysis, 2022
• 7.2. Company Profiles
  • 7.2.1. Hikma Pharmaceuticals plc
    • 7.2.1.1. Company Overview
    • 7.2.1.2. Financial Performance
    • 7.2.1.3. Service Benchmarking
    • 7.2.1.4. Strategic Initiatives
  • 7.2.2. Pfizer Inc.
    • 7.2.2.1. Company Overview
    • 7.2.2.2. Financial Performance
    • 7.2.2.3. Service Benchmarking
    • 7.2.2.4. Strategic Initiatives
  • 7.2.3. Fresenius Kabi
    • 7.2.3.1. Company Overview
    • 7.2.3.2. Financial Performance
    • 7.2.3.3. Service Benchmarking
    • 7.2.3.4. Strategic Initiatives
  • 7.2.4. Sandoz AG
    • 7.2.4.1. Company Overview
    • 7.2.4.2. Financial Performance
    • 7.2.4.3. Service Benchmarking
    • 7.2.4.4. Strategic Initiatives
  • 7.2.5. Jubilant Pharma Limited
    • 7.2.5.1. Company Overview
    • 7.2.5.2. Financial Performance
    • 7.2.5.3. Service Benchmarking
    • 7.2.5.4. Strategic Initiatives
  • 7.2.6. Baxter
    • 7.2.6.1. Company Overview
    • 7.2.6.2. Financial Performance
    • 7.2.6.3. Service Benchmarking
    • 7.2.6.4. Strategic Initiatives
  • 7.2.7. PCI Pharma Services
    • 7.2.7.1. Company Overview
    • 7.2.7.2. Financial Performance
    • 7.2.7.3. Service Benchmarking
    • 7.2.7.4. Strategic Initiatives
  • 7.2.8. Gland Pharma Limited (USA)
    • 7.2.8.1. Company Overview
    • 7.2.8.2. Financial Performance
    • 7.2.8.3. Service Benchmarking
    • 7.2.8.4. Strategic Initiatives
  • 7.2.9. Dr. Reddy's Laboratories Ltd.
    • 7.2.9.1. Company Overview
    • 7.2.9.2. Financial Performance
    • 7.2.9.3. Service Benchmarking
    • 7.2.9.4. Strategic Initiatives
  • 7.2.10. Grand River Aseptic Manufacturing
    • 7.2.10.1. Company Overview
    • 7.2.10.2. Financial Performance
    • 7.2.10.3. Service Benchmarking
    • 7.2.10.4. Strategic Initiatives

Chapter 8. Kol Commentary/Recommendations

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 Type, 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 research process
• Fig. 2 Information procurement
• Fig. 3 Market research approaches
• Fig. 4 QFD modelling for market share assessment
• Fig. 5 Market formulation & validation
• Fig. 6 Commodity flow analysis
• Fig. 7 Primary interviews in U.S.
• Fig. 8 Market Snapshot
• Fig. 9 Segment Snapshot
• Fig. 10 Segment Snapshot
• Fig. 11 Competitive Landscape Snapshot
• Fig. 12 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Segmentation
• Fig. 13 Parent market outlook (2022)
• Fig. 14 Related/ancillary market outlook (2022)
• Fig. 15 Market driver relevance analysis (Current & future impact)
• Fig. 16 Market restraint relevance analysis (Current & future impact)
• Fig. 17 Porter's Five Forces analysis
• Fig. 18 SWOT analysis, by factor (political & legal, economic and technological)
• Fig. 19 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Molecule Type outlook: Segment dashboard
• Fig. 20 U.S. Generic Injectables Pharmaceutical Contract Manufacturing: Molecule Type movement analysis
• Fig. 21 Small Molecule market, 2018 - 2030 (USD Million)
• Fig. 22 Large Molecule market, 2018 - 2030 (USD Million)
• Fig. 23 U.S. Generic Injectables Pharmaceutical Contract Manufacturing market Application outlook: Segment dashboard
• Fig. 24 U.S. Generic Injectables Pharmaceutical Contract Manufacturing market: Application movement analysis
• Fig. 25 Oncology market, 2018 - 2030 (USD Million)
• Fig. 26 Immunology market, 2018 - 2030 (USD Million)
• Fig. 27 Antidiabetic market, 2018 - 2030 (USD Million)
• Fig. 28 Neurology market, 2018 - 2030 (USD Million)
• Fig. 29 Cardiovascular market, 2018 - 2030 (USD Million)
• Fig. 30 Respiratory market, 2018 - 2030 (USD Million)
• Fig. 31 Others market, 2018 - 2030 (USD Million)
• Fig. 32 U.S. market, 2018 - 2030 (USD Million)