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PUBLISHER: Grand View Research | PRODUCT CODE: 1363507

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PUBLISHER: Grand View Research | PRODUCT CODE: 1363507

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

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

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

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

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)
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