ジェネリック注射剤医薬品受託製造の米国市場規模、シェア、動向分析レポート：分子タイプ別、用途別、セグメント別予測、2023年～2030年

米国のジェネリック注射剤医薬品受託製造市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、米国のジェネリック注射剤医薬品受託製造市場規模は2030年までに53億9,000万米ドルに達する見込みです。

米国市場は2023年から2030年にかけてCAGR 10.7％で拡大すると予測されます。この市場の成長を促進する主な要因は、ブロックバスター医薬品の特許切れの頻度の上昇、規制経路の合理化、ジェネリック医薬品の低価格化、ジェネリック注射剤領域におけるCDMOの浸透の拡大です。

COVID-19の大流行は、米国のジェネリック注射剤医薬品受託製造部門を含むサプライチェーン市場とその管理に大きな影響を与えました。新しいジェネリック注射剤の臨床試験の実施は、パンデミックに関連した安全性への懸念や制限のために変更されたり延期されたりしており、開発スケジュールに影響を与える可能性があります。さらに、複数の製薬会社がCOVID-19ワクチンの製造に生産能力を振り向けたため、ジェネリック注射剤を含む他の医薬品の生産スケジュールや生産能力に大きな影響を与えました。

生物学的製剤の注射剤の特許切れ件数が増加していることは、同国のジェネリック注射剤市場の成長に寄与する主要因です。例えば、米国FDAによると、クローン病、関節炎、尋常性乾癬、強直性脊椎炎の症状を治療するアッヴィ社が開発した大ヒット注射薬ヒュミラは、2023年に特許が切れました。この特許切れにより、アダリムマブのジェネリック医薬品導入の道が開かれました。費用対効果の高さからジェネリック医薬品への需要が高まっていることも、米国のジェネリック注射剤医薬品受託製造市場の成長に大きく寄与しています。

米国のジェネリック注射剤医薬品受託製造市場レポート・ハイライト

• 分子タイプに基づき、米国市場は低分子と高分子に区分され、2022年の売上高シェアは高分子が61.3%と高いです。これは主に、米国全体でバイオシミラーの上市率が高まっているためです。
• 神経分野は、予測期間中に11.3%のCAGRで最も急速に成長すると予測されています。これは、革新的で費用対効果の高い治療薬を必要とする神経疾患の流行が拡大しているためであり、その結果、複数の種類の疾患を治療するためのジェネリック注射剤の需要が高まっています。
• 米国市場は、近年、受託製造業者の存在感が大きく、医薬品・バイオ医薬品のアウトソーシングが顕著に増加していることから、分析期間中に10.7%という有利な成長率を記録すると予測されています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国のジェネリック注射剤医薬品受託製造市場の変数、動向、範囲

• 市場系統の見通し
  • 親市場の見通し
  • 関連/付随市場の見通し
• 市場力学
  • 市場促進要因の分析
  • 市場抑制要因分析
• 米国のジェネリック注射剤医薬品受託製造市場分析ツール
  • 市場分析- ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19感染症の影響分析

第4章 米国のジェネリック注射剤医薬品受託製造市場：分子タイプ別推定・動向分析

• 米国のジェネリック注射剤医薬品受託製造市場、分子タイプ別：セグメントダッシュボード
• 米国のジェネリック注射剤医薬品受託製造市場、分子タイプ別：変動分析

第5章 米国のジェネリック注射剤医薬品受託製造市場：用途別推定・動向分析

• 米国のジェネリック注射剤医薬品受託製造市場、用途別：セグメントダッシュボード
• 米国のジェネリック注射剤医薬品受託製造市場、用途別：変動分析

第6章 米国のジェネリック注射剤医薬品受託製造市場：国別推定・動向分析

• 米国

第7章 競合情勢

• 市場参入企業の分類
  • イノベーター
  • 市場リーダー
  • 新興企業
  • 企業の市場シェア分析、2022年
• 企業プロファイル
  • 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の解説/推奨事項

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)

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