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市場調查報告書
商品編碼
1363507

美國學名藥注射藥物合約製造的市場規模、佔有率和趨勢分析報告：按分子類型、用途和細分市場預測，2023-2030 年

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Size, Share & Trends Analysis Report By Molecule Type (Small Molecule, Large Molecule), By Application, And Segment Forecasts, 2023 - 2030
出版日期: | 出版商: Grand View Research | 英文 100 Pages | 商品交期: 2-10個工作天內

價格

美國學名藥注射藥物合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，美國注射學名藥合約製造市場預計將達到53.9億美元。

預計2023年至2030年美國市場將以10.7%的年複合成長率擴張。推動該市場成長的關鍵要素是重磅藥物專利到期的頻率增加、法規途徑的簡化、學名藥價格的降低以及 CDMO 在學名藥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，包括美國的學名藥注射藥品合約部門。由於安全問題和與大流行相關的限制，新學名藥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移到生產 COVID-19 疫苗，這嚴重影響了其他藥品（包括學名藥注射劑）的生產計劃和產能。

注射生物製藥專利到期數量的增加是促進該國學名藥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美樂(Humira) 的專利將於2023 年到期。該專利到期為阿達木單抗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增加，也大大促進了美國學名藥注射藥物合約製造市場的成長。

美國學名藥注射藥品合約製造市場報告亮點

  • 根據分子類型，美國市場分為小分子和聚合物，其中聚合物的銷售佔有率最高，2022年將達到61.3%。這主要是由於美國各地生物相似藥的上市速度不斷增加。
  • 預計神經病學領域在預測期內將以 11.3% 的年複合成長率成長最快。這是由於神經系統疾病日益流行，需要創新且具有成本效益的治療方法，導致對治療多種疾病的學名藥注射劑的需求增加。
  • 由於合約製造商的大量存在以及近年來製藥和生物製藥外包的顯著增加，預計美國市場在分析期間將實現 10.7% 的良好成長率。

目錄

第1章 調查方法和範圍

第2章 執行摘要

第3章 美國學名藥注射藥品合約製造市場的變數、趨勢和範圍

  • 市場體系預測
    • 母市場預測
    • 相關/附隨市場預測
  • 市場動態
    • 市場促進因素分析
    • 市場抑制因素分析
  • 美國學名藥注射劑合約製造市場分析工具
    • 市場分析-波特五力分析
    • PESTEL分析
    • COVID-19感染疾病的影響分析

第4章 美國學名藥注射劑合約製造市場：按分子類型估計和趨勢分析

  • 按分子類型分類的美國學名藥注射藥物合約製造市場：細分儀表板
  • 美國注射用學名藥合約製造市場，依分子類型：變異分析

第5章 美國學名藥注射劑合約製造市場：按用途估計和趨勢分析

  • 美國學名藥注射藥物合約製造市場，按用途：細分儀表板
  • 美國注射用學名藥合約製造市場（按用途）：波動分析

第6章 美國學名藥注射劑合約製造市場：國家估計和趨勢分析

  • 美國

第7章 競爭形勢

  • 市場參與企業分類
    • 創新者
    • 市場領導
    • 新興企業
    • 2022 年公司市場佔有率分析
  • 公司簡介
    • 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說明/建議

Product Code: GVR-4-68040-125-2

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)