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North America Generic Injectables Market Size and Share - Outlook Report, Forecast Trends and Growth Analysis (2025-2034)

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    Report

  • 250 Pages
  • July 2025
  • Region: North America
  • Expert Market Research
  • ID: 6162960
The North America generic injectables market was valued at USD 33.00 Billion in 2024, driven by the increasing prevalence of chronic diseases and the rising approval of generic injectables in the region. The market is expected to grow at a CAGR of 7.60% during the forecast period of 2025-2034, reaching a value of USD 68.65 Billion by 2034 .

North America Generic Injectables Market Analysis

Generic injectables are drugs that are administered generally through intramuscular or intravenous routes. They are manufactured to meet the safety and efficacy profile of the brand-name drugs. Generic injectables are comparatively cheaper and are widely used by patients who need injections frequently. Several branded injectables are facing patent expiration which allows the entry of generic versions, contributing to the expansion of the global generic injectables market. Moreover, the rising advancements in the manufacturing processes of these generic drugs such as lyophilization and aseptic processing are enabling generic manufacturers to produce high-quality products, thereby driving the North America generic injectables market growth.

Injectable drugs are known for their faster therapeutic effects as compared to oral drugs due to their higher bioavailability and thus are highly critical for emergency situations. The increasing burden of chronic diseases along with the growing geriatric population are a significant growth driver for this market. The American Cancer Society's annual cancer statistics report released in January 2024 estimated that new cancer cases will surpass 2 million in the United States in 2024, which translates to around 5,500 cancer diagnoses in a single day. The increasing prevalence of such diseases will fuel the need for effective medications including injectables, which are poised to augment the North America generic injectables market demand.

One of the major market trends is the surge in drug approvals of generic injectables by the health regulatory bodies. For instance, in May 2024, Indian-based generic injectable manufacturer Gland Pharma Limited announced the approval for its generic Edaravone injection of strengths 30mg/100ml and 60mg/100ml single-dose bags indicated for amyotrophic lateral sclerosis from the United States Food and Drug Administration (FDA). The injectable product, expected to be launched in 2025, is a generic equivalent of Mitsubishi Tanabe Pharma Corporation's Radicava injection, 30 mg/100 ml and 60 mg/100 ml. The rising introduction of such high-quality generic injectables, supported by the presence of a favorable regulatory environment, is anticipated to boost the market share.

North America Generic Injectables Market Segmentation

The report offers a detailed analysis of the market based on the following segments:

Market Breakup by Product Type

  • Large Molecule Injectables
  • Small Molecule Injectables

Market Breakup by Container Type

  • Vials
  • Premix
  • Prefilled Syringes
  • Ampoules
  • Others

Market Breakup by Application

  • Oncology
  • Cardiovascular
  • CNS
  • Infectious Diseases
  • Autoimmune Disorders
  • Others

Market Breakup by Route of Administration

  • Intravenous
  • Intramuscular
  • Subcutaneous
  • Others

Market Breakup by Distribution Channel

  • Hospital Pharmacy
  • Retail Pharmacy
  • Others

Market Breakup by Region

  • United States of America
  • Canada

Leading Players in the North America Generic Injectables Market

The key features of the market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

Pfizer Inc.

The global pharmaceutical giant Pfizer has a strong presence in the market through its subsidiary, Hospira. Hospira specializes in injectable drugs and infusion technologies and was acquired by Pfizer in 2015.

Teva Pharmaceutical Industries Ltd.

Headquartered in Israel, Teva is one of the largest generic drug manufacturers in the world. The company is leveraging strategic acquisitions and its considerable manufacturing capacity to expand its presence in the generic injectables market.

Baxter

Baxter International Inc. is a global leader in generic injectables, primarily serving areas such as anesthesia and critical care.

Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation, through its spin-off Sandoz, is a key player in the generic injectables market, focusing on therapeutic areas such as oncology, immunology, and endocrinology.

Other players in the market include Fresenius SE & Co. KGaA, Endo, Inc., Hikma Pharmaceuticals PLC, Dr. Reddy's Laboratories Ltd., Sagent Pharmaceuticals, Viatris Inc. (Mylan N.V.), Biocon, Sanofi, Lupin, and Aurobindo Pharma Limited, among others.

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

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Table of Contents

1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage - Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 North America Generic Injectables Market Overview
3.1 North America Generic Injectables Market Historical Value (2018-2024)
3.2 North America Generic Injectables Market Forecast Value (2025-2034)
4 North America Generic Injectables Market Landscape*
4.1 North America Generic Injectables Market: Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 North America Generic Injectables Market: Product Landscape
4.2.1 Analysis by Product Type
4.2.2 Analysis by Cell
4.2.3 Analysis by Molecule
5 North America Generic Injectables Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.2.1 Strengths
5.2.2 Weaknesses
5.2.3 Opportunities
5.2.4 Threats
5.3 Porter’s Five Forces Model
5.3.1 Bargaining Power of Suppliers
5.3.2 Bargaining Power of Buyers
5.3.3 Threat of New Entrants
5.3.4 Threat of Substitutes
5.3.5 Degree of Rivalry
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 North America Generic Injectables Market (2018-2034)
6.1 North America Generic Injectables Market (2018-2034) by Product Type
6.1.1 Market Overview
6.1.2 Large Molecule Injectables
6.1.2.1 Monoclonal Antibodies (mAbs)
6.1.2.2 Insulin
6.1.2.3 Others
6.1.3 Small Molecule Injectables
6.2 North America Generic Injectables Market (2018-2034) by Container Type
6.2.1 Market Overview
6.2.2 Vials
6.2.3 Premix
6.2.4 Prefilled Syringes
6.2.5 Ampoules
6.2.6 Others
6.3 North America Generic Injectables Market (2018-2034) by Application
6.3.1 Market Overview
6.3.2 Oncology
6.3.3 Cardiovascular
6.3.4 CNS
6.3.5 Infectious Diseases
6.3.6 Autoimmune Disorders
6.3.7 Others
6.4 North America Generic Injectables Market (2018-2034) by Route of Administration
6.4.1 Market Overview
6.4.2 Intravenous
6.4.3 Intramuscular
6.4.4 Subcutaneous
6.4.5 Others
6.5 North America Generic Injectables Market (2018-2034) by Distribution Channel
6.5.1 Market Overview
6.5.2 Hospital Pharmacy
6.5.3 Retail Pharmacy
6.5.4 Others
6.6 North America Generic Injectables Market (2018-2034) by Country
6.6.1 Market Overview
6.6.2 United States of America
6.6.3 Canada
7 United States of America Generic Injectables Market (2018-2034)
7.1 United States of America Generic Injectables Market (2018-2034) by Product Type
7.1.1 Market Overview
7.1.2 Large Molecule Injectables
7.1.2.1 Monoclonal Antibodies (mAbs)
7.1.2.2 Insulin
7.1.2.3 Others
7.1.3 Small Molecule Injectables
7.2 United States of America Generic Injectables Market (2018-2034) by Container Type
7.2.1 Market Overview
7.2.2 Vials
7.2.3 Premix
7.2.4 Prefilled Syringes
7.2.5 Ampoules
7.2.6 Others
7.3 United States of America Generic Injectables Market (2018-2034) by Application
7.3.1 Market Overview
7.3.2 Oncology
7.3.3 Cardiovascular
7.3.4 CNS
7.3.5 Infectious Diseases
7.3.6 Autoimmune Disorders
7.3.7 Others
7.4 United States of America Generic Injectables Market (2018-2034) by Route of Administration
7.4.1 Market Overview
7.4.2 Intravenous
7.4.3 Intramuscular
7.4.4 Subcutaneous
7.4.5 Others
7.5 United States of America Generic Injectables Market (2018-2034) by Distribution Channel
7.5.1 Market Overview
7.5.2 Hospital Pharmacy
7.5.3 Retail Pharmacy
7.5.4 Others
7.6 Canada Generic Injectables Market (2018-2034)
7.7 Canada Generic Injectables Market (2018-2034) by Product Type
7.7.1 Market Overview
7.7.2 Large Molecule Injectables
7.7.2.1 Monoclonal Antibodies (mAbs)
7.7.2.2 Insulin
7.7.2.3 Others
7.7.3 Small Molecule Injectables
7.8 Canada Generic Injectables Market (2018-2034) by Container Type
7.8.1 Market Overview
7.8.2 Vials
7.8.3 Premix
7.8.4 Prefilled Syringes
7.8.5 Ampoules
7.8.6 Others
7.9 Canada Generic Injectables Market (2018-2034) by Application
7.9.1 Market Overview
7.9.2 Oncology
7.9.3 Cardiovascular
7.9.4 CNS
7.9.5 Infectious Diseases
7.9.6 Autoimmune Disorders
7.9.7 Others
7.10 Canada Generic Injectables Market (2018-2034) by Route of Administration
7.10.1 Market Overview
7.10.2 Intravenous
7.10.3 Intramuscular
7.10.4 Subcutaneous
7.10.5 Others
7.11 Canada Generic Injectables Market (2018-2034) by Distribution Channel
7.11.1 Market Overview
7.11.2 Hospital Pharmacy
7.11.3 Retail Pharmacy
7.11.4 Others
7.12 Regulatory Framework
7.13 Patent Analysis
7.14 Analysis by Component of Patent
7.15 Analysis by Publication year
7.16 Analysis by Issuing Authority
7.17 Analysis by Patent Age
7.18 Analysis by CPC Analysis
7.19 Analysis by Patent Valuation
7.20 Analysis by Key Players
7.21 Grants Analysis
7.22 Analysis by Year
7.23 Analysis by Amount Awarded
7.24 Analysis by Issuing Authority
7.25 Analysis by Grant Product
7.26 Analysis by Funding Institute
7.27 Analysis by Departments
7.28 Analysis by Recipient Organization
7.29 Funding and Investment Analysis
7.30 Analysis by Funding Instances
7.31 Analysis by Component of Funding
7.32 Analysis by Funding Amount
7.33 Analysis by Leading Players
7.34 Analysis by Leading Investors
7.35 Analysis by Geography
7.36 Partnership and Collaborations Analysis
7.37 Analysis by Partnership Instances
7.38 Analysis by Component of Partnership
7.39 Analysis by Leading Players
7.40 Analysis by Geography
7.41 Supplier Landscape
7.42 Market Share by Top 5 Companies
7.43 Pfizer Inc.
7.43.1 Financial Analysis
7.43.2 Product Portfolio
7.43.3 Demographic Reach and Achievements
7.43.4 Mergers and Acquisitions
7.43.5 Certifications
7.44 Teva Pharmaceutical Industries Ltd.
7.44.1 Financial Analysis
7.44.2 Product Portfolio
7.44.3 Demographic Reach and Achievements
7.44.4 Mergers and Acquisitions
7.44.5 Certifications
7.45 Baxter
7.45.1 Financial Analysis
7.45.2 Product Portfolio
7.45.3 Demographic Reach and Achievements
7.45.4 Mergers and Acquisitions
7.45.5 Certifications
7.46 Novartis Pharmaceuticals Corporation
7.46.1 Financial Analysis
7.46.2 Product Portfolio
7.46.3 Demographic Reach and Achievements
7.46.4 Mergers and Acquisitions
7.46.5 Certifications
7.47 Fresenius SE & Co. KGaA
7.47.1 Financial Analysis
7.47.2 Product Portfolio
7.47.3 Demographic Reach and Achievements
7.47.4 Mergers and Acquisitions
7.47.5 Certifications
7.48 Endo, Inc.
7.48.1 Financial Analysis
7.48.2 Product Portfolio
7.48.3 Demographic Reach and Achievements
7.48.4 Mergers and Acquisitions
7.48.5 Certifications
7.49 Hikma Pharmaceuticals PLC
7.49.1 Financial Analysis
7.49.2 Product Portfolio
7.49.3 Demographic Reach and Achievements
7.49.4 Mergers and Acquisitions
7.49.5 Certifications
7.50 Dr.Reddy’s Laboratories Ltd.
7.50.1 Financial Analysis
7.50.2 Product Portfolio
7.50.3 Demographic Reach and Achievements
7.50.4 Mergers and Acquisitions
7.50.5 Certifications
7.51 Sagent Pharmaceuticals
7.51.1 Financial Analysis
7.51.2 Product Portfolio
7.51.3 Demographic Reach and Achievements
7.51.4 Mergers and Acquisitions
7.51.5 Certifications
7.52 Viatris Inc.
7.52.1 Financial Analysis
7.52.2 Product Portfolio
7.52.3 Demographic Reach and Achievements
7.52.4 Mergers and Acquisitions
7.52.5 Certifications
7.53 Biocon
7.53.1 Financial Analysis
7.53.2 Product Portfolio
7.53.3 Demographic Reach and Achievements
7.53.4 Mergers and Acquisitions
7.53.5 Certifications
7.54 Sanofi
7.54.1 Financial Analysis
7.54.2 Product Portfolio
7.54.3 Demographic Reach and Achievements
7.54.4 Mergers and Acquisitions
7.54.5 Certifications
7.55 Lupin
7.55.1 Financial Analysis
7.55.2 Product Portfolio
7.55.3 Demographic Reach and Achievements
7.55.4 Mergers and Acquisitions
7.55.5 Certifications
7.56 Aurobindo Pharma Limited
7.56.1 Financial Analysis
7.56.2 Product Portfolio
7.56.3 Demographic Reach and Achievements
7.56.4 Mergers and Acquisitions
7.56.5 Certifications
7.57 North America Generic Injectables Market - Distribution Model (Additional Insight)
7.58 Overview
7.59 Potential Distributors
7.60 Key Parameters for Distribution Partner Assessment
7.61 Key Opinion Leaders (KOL) Insights (Additional Insight)
7.62 Company Competitiveness Analysis (Additional Insight)
7.63 Very Small Companies
7.64 Small Companies
7.65 Mid-Sized Companies
7.66 Large Companies
7.67 Very Large Companies
7.68 Payment Methods (Additional Insight)
7.69 Government Funded
7.70 Private Insurance
7.71 Out-of-Pocket

Companies Mentioned

  • Pfizer Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Baxter
  • Novartis Pharmaceuticals Corporation