米国のジェネリック注射薬受託製造の市場規模、シェア、動向分析レポート：分子別、用途別、セグメント別予測、2025年～2030年

米国のジェネリック注射薬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薬受託製造市場規模は2030年までに55億9,000万米ドルに達する見込みです。

米国市場は2025年から2030年にかけてCAGR 10.8％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コスト化、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薬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薬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薬受託製造市場レポート・ハイライト

• 分子セグメント別では、市場は低分子と高分子に分類されます。2024年には、高分子セグメントが58.02%の売上シェアを占め、市場を独占します。
• 低分子セグメントは予測期間中に10.40％のCAGRを記録すると予測されています。低分子ベースの注射薬は、がん、血液疾患、感染症、心血管疾患など、幅広い疾患の治療において重要な位置を占め続けています。
• 用途別では、市場はがん、免疫、抗糖尿病、神経、循環器、呼吸器、その他に分類されます。2024年には、がん領域が29.42%の売上シェアを占め、市場を独占しています。
• 神経分野は予測期間中に11.64％のCAGR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薬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/付随市場見通し
• 市場力学
  • 市場 促進要因分析
  • 市場抑制要因分析
• 米国のジェネリック注射薬受託製造市場分析ツール
  • 業界分析- ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19の影響分析

第4章 米国のジェネリック注射薬受託製造市場：分子の推定・動向分析

• 米国のジェネリック注射薬受託製造市場、分子別：セグメントダッシュボード
• 米国のジェネリック注射薬受託製造市場、分子別：変動分析
• 分子、2018年-2030年
  • 低分子
  • 大分子

第5章 米国のジェネリック注射薬受託製造市場：用途の推定・動向分析

• 米国のジェネリック注射薬受託製造市場、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薬受託製造市場、用途別：変動分析
• 用途別、2018年-2030年
  • 腫瘍学
  • 免疫学
  • 抗糖尿病薬
  • 神経学
  • 心臓血管
  • 呼吸器
  • その他

第6章 競合情勢

• 市場参入企業の分類
  • イノベーター
  • マーケットリーダー
  • 新興プレーヤー
  • 企業市場シェア分析、2024年
• 企業プロファイル
  • Charles River Laboratories International, Inc.
  • 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

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, 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 segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value chain-based sizing & forecasting
• Fig. 7 QFD modelling for market share assessment
• Fig. 8 Market formulation & validation
• Fig. 9 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market revenue, 2018 - 2030 (USD Million)
• Fig. 10 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market snapshot
• Fig. 11 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market driver impact
• Fig. 12 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market restraint impact
• Fig. 13 U.S. Generic Injectables Pharmaceutical Contract Manufacturing molecule key takeaways (USD Million)
• Fig. 14 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Molecule movement analysis
• Fig. 15 Small molecule market, 2018 - 2030 (USD Million)
• Fig. 16 Large molecule market, 2018 - 2030 (USD Million)
• Fig. 17 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Application key takeaways (USD Million)
• Fig. 18 U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Application movement analysis
• Fig. 19 Oncology market, 2018 - 2030 (USD Million)
• Fig. 20 Immunology market, 2018 - 2030 (USD Million)
• Fig. 21 Antidiabetic market, 2018 - 2030 (USD Million)
• Fig. 22 Neurology market, 2018 - 2030 (USD Million)
• Fig. 23 Cardiovascular market, 2018 - 2030 (USD Million)
• Fig. 24 Respiratory market, 2018 - 2030 (USD Million)
• Fig. 25 Others market, 2018 - 2030 (USD Million)
• Fig. 26 Market participant categorization

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 5.59 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 10.8% from 2025 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:

• On the basis of molecule segment, the market is segregated into small molecule, and large molecule. In 2024, the large molecule segment dominated the market, accounting for a revenue share of 58.02%.
• The small molecule segment is anticipated to register the CAGR of 10.40% during the forecast period. Small molecule-based injectable drugs continue to hold an essential position in the treatment of a wide range of illnesses, including cancer, blood disorders, infectious diseases, and cardiovascular ailments.
• On the basis of application segment, the market is segregated into oncology, immunology, antidiabetic, neurology, cardiovascular, respiratory, and others. In 2024, the oncology segment dominated the market, accounting for a revenue share of 29.42%.
• The neurology segment is anticipated to register the fastest CAGR of 11.64% during the forecast period.

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Molecule
  • 1.2.2. Application
• 1.3. Regional Scope
• 1.4. Estimates And Forecast Timeline
• 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. Objectives

Chapter 2. Executive Summary

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

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. Rising frequency of patent expirations for blockbuster drugs
    • 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. Industry Analysis - Porter's
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

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

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

Chapter 6. Competitive Landscape

• 6.1. Market Participant Categorization
  • 6.1.1. Innovators
  • 6.1.2. Market Leaders
  • 6.1.3. Emerging Players
  • 6.1.4. Company Market Share Analysis, 2024
• 6.2. Company Profiles
  • 6.2.1. Charles River Laboratories International, Inc.
    • 6.2.1.1. Company Overview
    • 6.2.1.2. Financial Performance
    • 6.2.1.3. Service Benchmarking
    • 6.2.1.4. Strategic Initiatives
  • 6.2.2. Hikma Pharmaceuticals PLC
    • 6.2.2.1. Company Overview
    • 6.2.2.2. Financial Performance
    • 6.2.2.3. Service Benchmarking
    • 6.2.2.4. Strategic Initiatives
  • 6.2.3. Pfizer Inc.
    • 6.2.3.1. Company Overview
    • 6.2.3.2. Financial Performance
    • 6.2.3.3. Service Benchmarking
    • 6.2.3.4. Strategic Initiatives
  • 6.2.4. Fresenius Kabi
    • 6.2.4.1. Company Overview
    • 6.2.4.2. Financial Performance
    • 6.2.4.3. Service Benchmarking
    • 6.2.4.4. Strategic Initiatives
  • 6.2.5. Sandoz AG
    • 6.2.5.1. Company Overview
    • 6.2.5.2. Financial Performance
    • 6.2.5.3. Service Benchmarking
    • 6.2.5.4. Strategic Initiatives
  • 6.2.6. Jubilant Pharma Limited
    • 6.2.6.1. Company Overview
    • 6.2.6.2. Financial Performance
    • 6.2.6.3. Service Benchmarking
    • 6.2.6.4. Strategic Initiatives
  • 6.2.7. Baxter
    • 6.2.7.1. Company Overview
    • 6.2.7.2. Financial Performance
    • 6.2.7.3. Service Benchmarking
    • 6.2.7.4. Strategic Initiatives
  • 6.2.8. PCI Pharma Services.
    • 6.2.8.1. Company Overview
    • 6.2.8.2. Financial Performance
    • 6.2.8.3. Service Benchmarking
    • 6.2.8.4. Strategic Initiatives
  • 6.2.9. Gland Pharma Limited (USA)
    • 6.2.9.1. Company Overview
    • 6.2.9.2. Financial Performance
    • 6.2.9.3. Service Benchmarking
    • 6.2.9.4. Strategic Initiatives
  • 6.2.10. Dr.Reddy's Laboratories Ltd.
    • 6.2.10.1. Company Overview
    • 6.2.10.2. Financial Performance
    • 6.2.10.3. Service Benchmarking
    • 6.2.10.4. Strategic Initiatives
  • 6.2.11. Grand River Aseptic Manufacturing
    • 6.2.11.1. Company Overview
    • 6.2.11.2. Financial Performance
    • 6.2.11.3. Service Benchmarking
    • 6.2.11.4. Strategic Initiatives