美国特种仿製药（注射剂）市场规模、份额和趋势分析报告：2023-2030 年按类型、用途、配销通路和细分市场预测

美国特种仿製药（注射剂）市场的成长与趋势：

Grand View Research, Inc.最新报告显示，2023年至2030年，美国特种仿製药（注射剂）市场预计将以8.33%的年复合成长率扩张，2030年达到3616万美元。

美国主要製药公司的强大影响力和慢性病盛行率的患病是成长的关键促进因素。此外，FDA 对特种仿製药（注射剂）的核准数量不断增加、新的研发活动以及已建立的医疗基础设施都有助于美国市场的成长。

在美国，癌症诊断和治疗需求的不断增长正在创造对特种仿製药（注射剂）的巨大需求。根据美国癌症协会预测，2022 年美国预计将新增 190 万癌症病例，609,360 人死亡。这些要素促使公司专注于开发创新且有效的癌症治疗方法方法。例如，2022 年 11 月，Amneal Pharmaceuticals, Inc. 收到了美国FDA 提交的Leuprolide Acetate的简短新药认证申请。这种注射液用于治疗晚期摄护腺癌。

此外，药物变得越来越重要，因为它们为消费者提供多种治疗方法并改善患者的生活预后。因此，特种仿製药（注射剂）的技术创新持续不断，使美国受益。例如，2022 年 6 月，Dr. Reddy's Laboratories Ltd. 从 Eton Pharmaceuticals, Inc.收购了品牌和仿製药注射剂产品组合。此次收购将支持 Dr. Reddy's 扩大并加速向患者提供药物。此次收购将为雷迪博士在美国的机构业务增加竞争较弱的注射剂。

同样，COVID-19大流行对特种仿製药（注射剂）市场产生了中等影响。疫情期间，对专用注射药物的需求迅速成长。然而，生产和产品短缺，以及医院和零售药局的供应链中断，造成了一些供应链中断。公司面临的关键问题之一是最终用户的生产需求和产品供应。然而，由于生产和供应链的扩张，疫情后的市场正经历快速成长。

此外，主要参与企业正在参与合作伙伴关係、协议、併购、联盟和市场启动等策略，以扩大其全球足迹和产品组合。例如，2023年1月，Glenmark 美国 Inc.推出了布美他尼注射液USP、1 mg/4 mL单剂量小瓶和2.5 mg/10剂量小瓶。这是 Validus Pharmaceuticals 生产的 Bumex 1 注射液 0.25mg/mL 的通用版本。同样，2022 年 10 月，Akorn Operating Company LLC 在 2022 年美国生殖医学会（加利福尼亚州）上推出了注射用醋酸西曲瑞克 0.25 毫克的仿製药（Cetrorelix）。

美国特种仿製药（注射剂）市场报告亮点

• 按类型划分，生技药品领域在 2022 年占据最大的销售份额，由于其在慢性病治疗中的广泛采用，预计在预测期内将出现最快的增长速度。
• 2022年美国市场，肿瘤领域占销售量48.9%。这一增长是由癌症患者负担的增加以及对乳腺癌、肺癌和其他癌症治疗的强劲需求所推动的。
• 从配销通路来看，由于医院药房的存在以及重症患者对注射剂的需求不断增加，医院药房细分市场将在2022年占据美国市场的主导地位。
• 该领域的主要企业不断专注于产品发布和地理扩张，以维持其地位。

目录

第1章调查方法与范围

第2章执行摘要

第3章市场变数、趋势和范围

• 市场体系预测
• 市场动态
• SWOT分析（要素因素）
• 产业分析-波特五力分析
• 消费行为分析
• 目标疾病族群
• 法规场景
• 赎回场景
• 分析未满足的需求和机会
• 网红回应

第4章业务分析的类型

• 美国特种仿製药（注射剂）市场：类型变异分析
• 药品
• 生技药品

第5章商业分析的用途

• 美国特种仿製药（注射剂）市场：用途变化分析
• 瘤
• 心血管
• 中枢神经系统
• 感染疾病
• 自体免疫疾病
• 其他的

第6章配销通路业务分析

• 美国特种仿製药（注射剂）市场：配销通路波动分析
• 医院
• 零售药房
• 其他的

第7章竞争形势

• 公司分类
• 策略规划
• 2022 年公司市场占有率分析
• 公司简介/名单

U.S. Specialty Injectable Generics Market Growth & Trends:

The U.S. specialty injectable generics market is expected to reach USD 36.16 million by 2030, expanding at a CAGR of 8.33% from 2023 to 2030, according to a new report by Grand View Research, Inc.. High presence of key pharmaceutical players in the U.S. and the rising prevalence of chronic diseases are among the key drivers for the growth. Furthermore, the growing number of FDA approvals for specialty injectable generics, emerging research & development activities, and well-established healthcare infrastructure contribute to U.S. space growth.

In the U.S., the increasing cancer diagnosis and treatment demand has created immense demand for specialty injectable generics. According to the American Cancer Society, in 2022, it is expected that 1.9 million new oncology cases are anticipated to diagnose and 609,360 cancer deaths in the U.S. This factor has led companies to increase their focus on the development of innovative and effective treatments for oncology cases. For instance, in November 2022, Amneal Pharmaceuticals, Inc. received abbreviated new drug application approval from the U.S. FDA for leuprolide acetate. The injection is used for advanced prostatic cancer treatment.

Furthermore, pharmaceutical drug products have become increasingly important as they provide consumers with an array of treatments and life expectancy-enhancing patient lives. Thereby, continued specialty injectable generics innovation has benefited the U.S. space. For instance, in June 2022, Dr. Reddy's Laboratories Ltd. acquired branded & generic injectable products portfolio from Eton Pharmaceuticals, Inc. The acquisition will support Dr. Reddy's company to expand & accelerate affordable medications for patients. The acquisition will add Dr. Reddy's U.S. institutional business with limited competition injectable products.

Likewise, the COVID-19 pandemic has moderately impacted the specialty injectable generics market. During the pandemic, there was a rapid demand for specialty injections. However, shortage of production and products, and supply chain disruptions in hospitals, retail pharmacy had hampered the supply chain to some extent. One of the key issues faced by companies was production demand and delivery of products to end users. However, post-pandemic the market has witnessed rapid growth with increased production and supply chain.

Furthermore, the key participants are engaged in strategies such as partnerships, agreements, mergers & acquisitions, collaborations, and launches, among others, to expand their global footprints and portfolios. For instance, in January 2023, Glenmark Pharmaceuticals Inc., USA launched Bumetanide Injection USP, 1 mg/4 mL Single-Dose Vials & 2.5 mg/10 Multi-Dose Vials which is Validus Pharmaceuticals, Inc's generic version of Bumex1 Injection, 0.25 mg/mL. Similarly, in October 2022, Akorn Operating Company LLC launched the generic Cetrorelix Acetate for Injection 0.25 mg (Cetrorelix) at the 2022 American Society for Reproductive Medicine Conference, California.

U.S. Specialty Injectable Generics Market Report Highlights:

• Based on type, the Biologics segment held the largest revenue share in 2022 and is anticipated to grow at the fastest growth rate over the forecast period owing to the wide adoption of the biologics in the treatment of chronic diseases
• The oncology segment dominated the U.S. market with a revenue share of 48.9% in 2022. The growth is attributed to the growing burden of cancer cases and strong demand for breast and lung cancer therapies, among other types.
• On the basis of distribution channels, the hospital pharmacy segment dominated the U.S. market in 2022 due to the presence of hospital pharmacies and increased injectable demand among critical patients.
• Key players operating in the space are constantly focusing on product launches and geographical expansion to maintain their presence.
• A few of the key players include Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Baxter International, Novartis AG, Fresenius SE & Co. KGaA, Par Pharmaceutical, Hikma Pharmaceuticals PLC, Dr. Reddy's Laboratories, Sagent Pharmaceuticals, Inc., Mylan N.V.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
  • 1.2.1. Segment 1
  • 1.2.2. Segment 2
  • 1.2.3. Segment 3
• 1.3. Research Methodology
  • 1.3.1. Information Analysis
  • 1.3.2. Market Formulation & Data Visualization
  • 1.3.3. Data Validation & Publishing
• 1.4. Research Assumptions
• 1.5. Information Procurement
  • 1.5.1. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
• 1.9. Global Market: CAGR Calculation
• 1.10. Objective
  • 1.10.1. Objective 1
  • 1.10.2. Objective 2

Chapter 2. Executive Summary

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

Chapter 3. 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. Emerging chronic diseases patients
    • 3.2.1.2. Increasing number of new FDA injectable generics drugs approvals
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. High cost of injectable
• 3.3. SWOT Analysis, by Factor
• 3.4. Industry Analysis- Porter's
• 3.5. Consumer Behavior Analysis
• 3.6. Target Disease Population
• 3.7. Regulatory Scenario
• 3.8. Reimbursement Scenario
• 3.9. Unmet Needs and Opportunity Analysis
• 3.10. KOL Responses

Chapter 4. Type Business Analysis

• 4.1. U.S. Specialty Injectable Generics Market: Type Movement Analysis
• 4.2. Drugs
  • 4.2.1. Drugs Market, 2018 - 2030 (USD Million)
• 4.3. Biologics
  • 4.3.1. Biologics Market, 2018 - 2030 (USD Million)

Chapter 5. Application Business Analysis

• 5.1. U.S. Specialty Injectable Generics Market: Application Movement Analysis
• 5.2. Oncology
  • 5.2.1. Oncology Market, 2018 - 2030 (USD Million)
• 5.3. Cardiovascular
  • 5.3.1. Cardiovascular Market, 2018 - 2030 (USD Million)
• 5.4. CNS
  • 5.4.1. CNS Market, 2018 - 2030 (USD Million)
• 5.5. Infectious Diseases
  • 5.5.1. Infectious Diseases Market, 2018 - 2030 (USD Million)
• 5.6. Autoimmune Disorders
  • 5.6.1. Autoimmune Disorders Market, 2018 - 2030 (USD Million)
• 5.7. Others
  • 5.7.1. Others Market, 2018 - 2030 (USD Million)

Chapter 6. Distribution Channel Business Analysis

• 6.1. U.S. Specialty Injectable Generics Market: Distribution Channel Movement Analysis
• 6.2. Hospital
  • 6.2.1. Hospital Market, 2018 - 2030 (USD Million)
• 6.3. Retail Pharmacy
  • 6.3.1. Retail Pharmacy Market, 2018 - 2030 (USD Million)
• 6.4. Others
  • 6.4.1. Others Market, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Company Categorization
• 7.2. Strategy Mapping
• 7.3. Company Market Share Analysis, 2022
• 7.4. Company Profiles/Listing
  • 7.4.1. Pfizer, Inc.
    • 7.4.1.1. Overview
    • 7.4.1.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.1.3. Product Benchmarking
    • 7.4.1.4. Strategic Initiatives
  • 7.4.2. Teva Pharmaceutical Industries Ltd.
    • 7.4.2.1. Overview
    • 7.4.2.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.2.3. Product Benchmarking
    • 7.4.2.4. Strategic Initiatives
  • 7.4.3. Baxter International
    • 7.4.3.1. Overview
    • 7.4.3.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.3.3. Product Benchmarking
    • 7.4.3.4. Strategic Initiatives
  • 7.4.4. Novartis AG
    • 7.4.4.1. Overview
    • 7.4.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.4.3. Product Benchmarking
    • 7.4.4.4. Strategic Initiatives
  • 7.4.5. Fresenius SE & Co. KGaA
    • 7.4.5.1. Overview
    • 7.4.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.5.3. Product Benchmarking
    • 7.4.5.4. Strategic Initiatives
  • 7.4.6. Par Pharmaceutical
    • 7.4.6.1. Overview
    • 7.4.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.6.3. Product Benchmarking
    • 7.4.6.4. Strategic Initiatives
  • 7.4.7. Hikma Pharmaceuticals PLC
    • 7.4.7.1. Overview
    • 7.4.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.7.3. Product Benchmarking
    • 7.4.7.4. Strategic Initiatives
  • 7.4.8. Dr. Reddy's Laboratories
    • 7.4.8.1. Overview
    • 7.4.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.8.3. Product Benchmarking
    • 7.4.8.4. Strategic Initiatives
  • 7.4.9. Sagent Pharmaceuticals, Inc.
    • 7.4.9.1. Overview
    • 7.4.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.9.3. Product Benchmarking
    • 7.4.9.4. Strategic Initiatives
  • 7.4.10. Mylan N.V.
    • 7.4.10.1. Overview
    • 7.4.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.4.10.3. Product Benchmarking
    • 7.4.10.4. Strategic Initiatives

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 U.S. Specialty Injectable Generics market revenue estimated and forecast, by type, 2018 - 2030 (USD million)
• Table 4 U.S. Specialty Injectable Generics market revenue estimated and forecast, by application, 2018 - 2030 (USD million)
• Table 5 U.S. Specialty Injectable Generics market revenue estimated and forecast, by distribution channel, 2018 - 2030 (USD million)
• Table 6 Company market share, 2022

List of Figures

• Fig. 1 Market Research Process
• Fig. 2 Information Procurement
• Fig. 3 Primary Research Pattern
• Fig. 4 Market Research Approaches
• Fig. 5 Value Chain-Based Sizing & Forecasting
• Fig. 6 Market Formulation & Validation
• Fig. 7 U.S. Specialty Injectable Generics Market Segmentation
• Fig. 8 Market Driver Relevance Analysis (Current & Future Impact)
• Fig. 9 Market Restraint Relevance Analysis (Current & Future Impact)
• Fig. 10 Market Challenge Relevance Analysis (Current & Future Impact)
• Fig. 11 Penetration & Growth Prospect Mapping
• Fig. 12 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
• Fig. 13 Porter's Five Forces Analysis
• Fig. 14 U.S. Specialty Injectable Generics market: Type outlook and key takeaways
• Fig. 15 U.S. Specialty Injectable Generics market: Type movement analysis & market share 2022 & 2030
• Fig. 16 Drugs market, 2018 - 2030 (USD Million)
• Fig. 17 Biologics market, 2018 - 2030 (USD Million)
• Fig. 18 U.S. Specialty Injectable Generics market: Application outlook and key takeaways
• Fig. 19 U.S. Specialty Injectable Generics market: Application movement analysis & market share 2022 & 2030
• Fig. 20 Oncology market, 2018 - 2030 (USD Million)
• Fig. 21 Cardiovascular market, 2018 - 2030 (USD Million)
• Fig. 22 CNS market, 2018 - 2030 (USD Million)
• Fig. 23 Infectious Diseases market, 2018 - 2030 (USD Million)
• Fig. 24 Autoimmune Disorders market, 2018 - 2030 (USD Million)
• Fig. 25 Others market, 2018 - 2030 (USD Million)
• Fig. 26 U.S. Specialty Injectable Generics market: Distribution channel outlook and key takeaways
• Fig. 27 U.S. Specialty Injectable Generics market: Distribution channel movement analysis & market share 2022 & 2030
• Fig. 28 Hospital market, 2018 - 2030 (USD Million)
• Fig. 29 Retail pharmacy market, 2018 - 2030 (USD Million)
• Fig. 30 Others market, 2018 - 2030 (USD Million)
• Fig. 31 Strategy Mapping