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Report Overview

2024

Base Year

2018-2024

Historical Year

2025-2034

Forecast Year

North America Generic Injectables Market Size

The North America generic injectables market was valued at USD 33 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, with the values likely to rise from USD 35.6 billion in 2025 to USD 64 billion by 2034. 

North America Generic Injectables Market Outlook

  • The American Cancer Society’s annual cancer statistics report estimated that new cancer cases will surpass 2 million in the United States in 2024. The increasing burden of cancer and other chronic diseases along with the growing geriatric population are a significant growth driver for this market.
  • One of the major North America generic injectables market trends is the surge in drug approvals of generic injectables by the health regulatory bodies. For instance, in May 2024, the FDA approved Gland Pharma Limited’s generic Edaravone injection indicated for amyotrophic lateral sclerosis.
  • Several branded injectables are facing patent expiration which allows the entry of generic versions. The market share is also influenced by the rising advancements in the manufacturing processes of generic injectables.

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 Categories
Product Type Large Molecule Injectables (Monoclonal Antibodies (mAbs), Insulin, Others), Small Molecule Injectables
Container Type Vials, Premix, Prefilled Syringes, Ampoules, Others
Application Oncology, Cardiovascular, CNS, Infectious Diseases, Autoimmune Disorders, Others
Route of Administration Intravenous, Intramuscular, Subcutaneous, Others
Distribution Channel Hospital, Retail Pharmacy, Others
Country 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.

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2018-2024
Forecast Period 2025-2034
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product Type
  • Container Type
  • Application
  • Route of Administration
  • Distribution Channel
  • Region
Breakup by Product Type
  • Large Molecule Injectables
  • Small Molecule Injectables
Breakup by Container Type
  • Vials
  • Premix
  • Prefilled Syringes
  • Ampoules
  • Others
Breakup by Application
  • Oncology
  • Cardiovascular
  • CNS
  • Infectious Diseases
  • Autoimmune Disorders
  • Others
Breakup by Route of Administration
  • Intravenous
  • Intramuscular
  • Subcutaneous
  • Others
Breakup by Distribution Channel
  • Hospital Pharmacy
  • Retail Pharmacy
  • Others
Breakup by Region
  • United States of America
  • Canada
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Pfizer Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Baxter
  • Novartis Pharmaceuticals Corporation
  • Fresenius SE & Co. KGaA
  • Endo, Inc.
  • Hikma Pharmaceuticals PLC
  • Dr.Reddy’s Laboratories Ltd.
  • Sagent Pharmaceuticals
  • Viatris Inc.
  • Biocon
  • Sanofi
  • Lupin
  • Aurobindo Pharma Limited

North America Generic Injectables Market Report Snapshots

North America Generic Injectables Market Size

North America Generic Injectables Market Analysis

North America Generic Injectables Companies

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Key Questions Answered in the Report

The market attained a value of about USD 33 billion in 2024 driven by the rising prevalence of chronic diseases in the region.

The market is anticipated to grow at a CAGR of 7.60% during the forecast period of 2025-2034, likely to reach a market value of USD 64 billion by 2034. 

The increasing healthcare needs and the growing geriatric population are fuelling the demand for the market.

One of the significant trends in the market is the surge in drug approvals of generic injectables. For instance, in May 2024, the FDA approved Gland Pharma Limited’s generic Edaravone injection indicated for amyotrophic lateral sclerosis.

Based on the product type, the market is broadly segmented into large molecule injectables and small molecule injectables. Large molecule injectables are divided into monoclonal antibodies (mAbs), and insulin among others)

Container types available in the market include vials, premix, prefilled syringes, and ampoules, among others.

Major applications of the generic injectables include oncology, cardiovascular, CNS, infectious diseases, and autoimmune disorders, among others.

The market breakup by route of administration includes intravenous, intramuscular, and subcutaneous, among others.

Distribution channels of the market are hospitals and retail pharmacies, among others.

The market segmentation by countries includes the United States of America and Canada.

The key players in the market are Pfizer Inc., Teva Pharmaceutical Industries Ltd., Baxter, Novartis Pharmaceuticals Corporation, 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. 

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