美國特種學名藥（注射劑）市場規模、佔有率和趨勢分析報告：2023-2030 年按類型、用途、配銷通路和細分市場預測

美國特種學名藥（注射劑）市場的成長與趨勢：

Grand View Research, Inc.最新報告顯示，2023年至2030年，美國特種學名藥（注射劑）市場預計將以8.33%的年複合成長率擴張，2030年達到3616萬美元。

美國主要製藥公司的強大影響力和慢性病盛行率的患病是成長的關鍵促進因素。此外，FDA 對特種學名藥（注射劑）的核准數量不斷增加、新的研發活動以及已建立的醫療基礎設施都有助於美國市場的成長。

在美國，癌症診斷和治療需求的不斷成長正在創造對特種學名藥（注射劑）的巨大需求。根據美國癌症協會預測，2022 年美國預計將新增 190 萬癌症病例，609,360 人死亡。這些要素促使公司專注於開發創新且有效的癌症治療方法方法。例如，2022 年 11 月，Amneal Pharmaceuticals, Inc. 收到了美國FDA 提交的Leuprolide Acetate的簡短新藥認證申請。這種注射液用於治療晚期攝護腺癌。

此外，藥物變得越來越重要，因為它們為消費者提供多種治療方法並改善患者的生活預後。因此，特種學名藥（注射劑）的技術創新持續不斷，使美國受益。例如，2022 年 6 月，Dr. Reddy's Laboratories Ltd. 從 Eton Pharmaceuticals, Inc.收購了品牌和學名藥注射劑產品組合。此次收購將支持 Dr. Reddy's 擴大並加速向患者提供藥物。此次收購將為雷迪博士在美國的機構業務增加競爭較弱的注射劑。

同樣，COVID-19大流行對特種學名藥（注射劑）市場產生了中等影響。疫情期間，對專用注射藥物的需求迅速成長。然而，生產和產品短缺，以及醫院和零售藥局的供應鏈中斷，造成了一些供應鏈中斷。公司面臨的關鍵問題之一是最終用戶的生產需求和產品供應。然而，由於生產和供應鏈的擴張，疫情後的市場正經歷快速成長。

此外，主要參與企業正在參與合作夥伴關係、協議、併購、聯盟和市場啟動等策略，以擴大其全球足跡和產品組合。例如，2023年1月，Glenmark 美國 Inc.推出了布美他尼注射液USP、1 mg/4 mL單劑量小瓶和2.5 mg/10劑量小瓶。這是 Validus Pharmaceuticals 生產的 Bumex 1 注射液 0.25mg/mL 的通用版本。同樣，2022 年 10 月，Akorn Operating Company LLC 在 2022 年美國生殖醫學會（加利福尼亞州）上推出了注射用醋酸西曲瑞克 0.25 毫克的學名藥（Cetrorelix）。

美國特種學名藥（注射劑）市場報告亮點

• 按類型分類，生技藥品領域在 2022 年佔據最大的銷售佔有率，由於其在慢性病治療中的廣泛採用，預計在預測期內將出現最快的成長速度。
• 2022年美國市場，腫瘤領域佔銷售量48.9%。這一成長是由癌症患者負擔的增加以及對乳腺癌、肺癌和其他癌症治療的強勁需求所推動的。
• 從配銷通路來看，由於醫院藥房的存在以及重症患者對注射劑的需求不斷增加，醫院藥房細分市場將在2022年佔據美國市場的主導地位。
• 該領域的主要企業不斷專注於產品發布和地理擴張，以維持其地位。

目錄

第1章 調查方法與範圍

第2章 執行摘要

第3章 市場變數、趨勢和範圍

• 市場體系預測
• 市場動態
• SWOT分析（要素因素）
• 產業分析-波特五力分析
• 消費行為分析
• 目標疾病族群
• 法規場景
• 贖回場景
• 分析未滿足的需求和機會
• 網紅回應

第4章 業務分析的類型

• 美國特種學名藥（注射劑）市場：類型變異分析
• 藥品
• 生技藥品

第5章 商業分析的用途

• 美國特種學名藥（注射劑）市場：用途變化分析
• 瘤
• 心血管
• 中樞神經系統
• 感染疾病
• 自體免疫疾病
• 其他

第6章 配銷通路業務分析

• 美國特種學名藥（注射劑）市場：配銷通路波動分析
• 醫院
• 零售藥房
• 其他

第7章 競爭形勢

• 公司分類
• 策略規劃
• 2022 年公司市場佔有率分析
• 公司簡介/名單

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