제네릭 주입제 시장 보고서 : 치료 영역, 용기, 유통 채널, 지역별(2025-2033년)

The global generic injectables market size reached USD 51.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 99.2 Billion by 2033, exhibiting a growth rate (CAGR) of 6.88% during 2025-2033. The growing patent expiration of branded drugs, along with the increasing regulatory support from government bodies, is primarily driving the market.

Generic injectables refer to pharmaceutical drugs that are injected into the body and are equivalent to their brand-name counterparts in dosage, strength, quality, and performance. It includes various types, such as vaccines, insulin, and antibiotics. Generic injectables are widely used for a range of medical conditions, such as diabetes, cancer, hypertension, and infections. They also find extensive applications in anesthesia, hormone replacement, immunization, and emergency treatments. Generic injectables are safe and cost-effective medications that reduce the need for surgical interventions, provide targeted therapy, and have fewer side effects.

The recent technological advancements in drug formulation and delivery systems that are making production more efficient, thereby lowering costs and boosting availability, are propelling the market growth. Additionally, the implementation of various regulatory support and initiatives to create a conducive environment for manufacturers of generic injectables by streamlining approval processes is contributing to the market growth. Apart from this, the growing geriatric population, which requires more healthcare interventions, including injectables for various age-related ailments, is positively influencing the market growth. Furthermore, the rising preference for injectables over oral medications among patients due to quicker onset of action and higher bioavailability is strengthening the market growth. In addition, the rapid improvement in the supply chain, which has made the distribution of generic injectables more streamlined, is supporting the market growth.

Generic Injectables Market Trends/Drivers:

The escalating prevalence of chronic diseases

The escalating prevalence of chronic diseases is a primary driver of the generic injectables market. Conditions such as cancer, diabetes, and cardiovascular diseases (CVDs) are on a constant rise and require long-term treatments and medications. Generic injectables such as insulin for diabetes, chemotherapeutic agents for cancer, and antihypertensive medications for cardiovascular issues are indispensable in the management of these conditions. Furthermore, the affordability of generic injectables makes them accessible to a larger population, especially in low and middle-income countries where healthcare infrastructure may be limited or costly. Additionally, healthcare systems are focusing on balancing quality and cost-effectiveness. In line with this, generic injectables present a viable option, as they provide the necessary treatments at a fraction of the cost of their branded counterparts, thus facilitating more widespread disease management and containment.

The rising healthcare expenditure across the globe

The growing cost of healthcare is a significant concern for both developed and developing nations. There is an urgent need for affordable alternatives as treatment expenses are skyrocketing. In line with this, generic injectables offer a cost-effective solution without compromising on efficacy or safety. Furthermore, they can substantially lower the economic burden on patients and families. Additionally, they provide budget-constrained healthcare systems with the leeway to allocate resources more efficiently towards the improvement of healthcare services, research, or public health initiatives. Moreover, patients also benefit directly through lower out-of-pocket costs, making treatments more accessible. As a result, the rising cost of healthcare is compelling healthcare providers and patients to turn to generic injectables as a financially sustainable alternative.

The increasing patent expiration of branded drugs

Patent expirations of branded injectables present a golden opportunity for the generic injectables market. Expiry of the patent allows generic drug manufacturers to produce and sell copies of the branded medication. Furthermore, they can produce equivalent medications without incurring the initial research and development (R&D) costs, thereby passing on the savings to the consumers in the form of lower prices. Moreover, the generic versions usually receive faster regulatory approvals as they are bioequivalent to already-approved branded drugs. This not only speeds up the time-to-market but also broadens consumer access to essential medications. Additionally, patent expiry enables the mass production of medications that were previously restricted by intellectual property (IP) laws. As a result, patent expiration creates a conducive environment for the expansion of the generic injectables market, benefiting both manufacturers and consumers.

Generic Injectables Industry Segmentation:

Breakup by Therapeutic Area:

Oncology

Anaesthesia

Anti-infectives

Parenteral Nutrition

Cardiovascular

Oncology dominates the market

Oncology is dominating the market due to the high prevalence of cancer, which necessitates a consistent and accessible supply of medications for treatment. Furthermore, cancer treatments are highly expensive, often requiring combinations of drugs and long-term administration. In line with this, generic injectables offer a cost-effective alternative to branded drugs, alleviating some of the financial burdens on healthcare systems and patients. Besides this, the oncology sector has witnessed patent expirations for branded drugs, thus opening up opportunities for generic pharmaceutical companies to introduce their versions of these medications. Moreover, the complexity of cancer treatment protocols, which often call for targeted therapies, is facilitating the demand for generic injectables. In addition, oncology treatments frequently necessitate hospitalization or clinical administration of drugs, where injectables are more commonly used.

Breakup by Container:

Vials

Ampoules

Premix

Prefilled Syringes

Vials exhibit a clear dominance in the market

Vials offer a high degree of sterility and contamination protection, which is essential for injectable drugs. The integrity of the medication is better preserved in a vial, which is a critical factor when dealing with sensitive substances, such as biologics or chemotherapy agents. Furthermore, they are incredibly versatile and can accommodate a wide range of drug volumes, from small quantities for specialized treatments to larger volumes for widespread applications. Additionally, vials are highly cost-effective, especially when produced in bulk. This cost advantage aligns well with the overall appeal of generic injectables as cost-effective alternatives to branded drugs.

Ampoules offer high barrier properties, ensuring that the medication inside remains sterile and free from contamination. Additionally, the glass construction of ampoules allows for high visibility, enabling healthcare professionals to visually inspect the solution for any impurities before administration, thus adding an extra layer of safety. Besides this, they are usually single-dose containers, which eliminates the risks associated with multi-dose vials, such as cross-contamination and dosing errors.

Breakup by Distribution Channel:

Hospitals

Retail Pharmacy

Hospitals holds the largest share in the market

Hospitals are dominating the market as they allow the immediate and precise administration of injectables, which is especially critical in emergency situations or intensive care units (ICUs) where quick onset of action can be lifesaving. Furthermore, they handle a high volume of patients and a broad array of medical conditions, ranging from surgeries to chronic disease management. The versatility of generic injectables allows them to be used across various departments, making them a go-to option for multiple therapeutic applications. Besides this, hospitals have the necessary infrastructure, including temperature-controlled storage and trained medical staff, to manage the complexities of injectable drug administration. Moreover, the growing pressure to manage healthcare costs effectively makes generic injectables a preferred choice for hospitals.

Breakup by Region:

Europe

North America

Asia

Latin America

Middle East and Africa

North America exhibits a clear dominance, accounting for the largest generic injectables market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include Europe, North America, Asia, Latin America, and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America has a well-established healthcare system that readily adopts medical innovations, including generic injectables. Furthermore, the region has some of the highest per capita healthcare spending, allowing for the widespread use of both branded and generic pharmaceuticals. Additionally, the imposition of supportive policies by regional governments to streamline processes for the approval of generic medications, including injectables, is positively influencing the market growth. Besides this, the frequent expiry of branded medication patents in North America is creating opportunities for generic drug manufacturers to introduce their own, more affordable versions. Moreover, the escalating geriatric population, which requires more medical treatments, often leading to higher consumption of medications, including injectables, is acting as another growth-inducing factor. Along with this, the heightened awareness and acceptance among both healthcare providers and consumers regarding the efficacy and cost-effectiveness of generic medications is supporting the market growth.

Competitive Landscape:

Leading companies are consistently working to expand their range of generic injectable medications, including biosimilars, to cover a broader spectrum of therapeutic areas. Furthermore, they are investing in research and innovation to improve the formulation and stability of generic injectables, thereby enhancing their quality and market appeal. In addition, several key players are forming strategic partnerships with other industry stakeholders to enhance their capabilities, distribution networks, and product offerings. Besides this, companies are focusing on expanding their geographical reach through collaboration with local distributors or setting up manufacturing facilities. Additionally, they are working on optimizing their production processes to offer cost-effective solutions without compromising on quality. Moreover, major players are ensuring products meet the rigorous regulatory requirements, especially in highly regulated markets.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Baxter International Inc.

Fresenius Kabi AG

Hikma Pharmaceuticals plc

Pfizer Inc.

Sagent Pharmaceuticals Inc. (Nichi-Iko Pharmaceutical Co. Ltd.)

Sandoz International GmbH (Novartis International AG)

Sanofi S.A.

Key Questions Answered in This Report

• 1. What was the size of the global generic injectables market in 2024?
• 2. What is the expected growth rate of the global generic injectables market during 2025-2033?
• 3. What has been the impact of COVID-19 on the global generic injectables market?
• 4. What are the key factors driving the global generic injectables market?
• 5. What is the breakup of the global generic injectables market based on the therapeutic area?
• 6. What is the breakup of the global generic injectables market based on the distribution channel?
• 7. What are the key regions in the global generic injectables market?
• 8. Who are the key players/companies in the global generic injectables market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Generic Drug Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Market Breakup by Region
• 5.4 Market Forecast
• 5.5 Major Players

6 Global Generic Drug Delivery Market

• 6.1 Oral
• 6.2 Injectables
• 6.3 Dermal/Topical
• 6.4 Inhalers

7 Global Generic Injectables Market

• 7.1 Market Overview
• 7.2 Market Performance
• 7.3 Impact of COVID-19
• 7.4 Market Breakup by Region
• 7.5 Market Breakup by Therapeutic Area
• 7.6 Market Breakup by Container
• 7.7 Market Breakup by Distribution Channel
• 7.8 Market Forecast
• 7.9 SWOT Analysis
  • 7.9.1 Overview
  • 7.9.2 Strengths
  • 7.9.3 Weaknesses
  • 7.9.4 Opportunities
  • 7.9.5 Threats
• 7.10 Value Chain Analysis
• 7.11 Porter's Five Forces Analysis
  • 7.11.1 Overview
  • 7.11.2 Bargaining Power of Buyers
  • 7.11.3 Bargaining Power of Suppliers
  • 7.11.4 Degree of Competition
  • 7.11.5 Threat of New Entrants
  • 7.11.6 Threat of Substitutes
• 7.12 Key Market Drivers and Success Factors

8 Global Generic Injectables Market: Performance of Key Regions

• 8.1 North America
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Europe
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Asia
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast
• 8.4 Latin America
  • 8.4.1 Market Trends
  • 8.4.2 Market Forecast
• 8.5 Middle East and Africa
  • 8.5.1 Market Trends
  • 8.5.2 Market Forecast

9 Market by Therapeutic Area

• 9.1 Oncology
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Anaesthesia
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast
• 9.3 Anti-infectives
  • 9.3.1 Market Trends
  • 9.3.2 Market Forecast
• 9.4 Parenteral Nutrition
  • 9.4.1 Market Trends
  • 9.4.2 Market Forecast
• 9.5 Cardiovascular
  • 9.5.1 Market Trends
  • 9.5.2 Market Forecast

10 Market by Container

• 10.1 Vials
  • 10.1.1 Market Trends
  • 10.1.2 Market Forecast
• 10.2 Ampoules
  • 10.2.1 Market Trends
  • 10.2.2 Market Forecast
• 10.3 Premix
  • 10.3.1 Market Trends
  • 10.3.2 Market Forecast
• 10.4 Prefilled Syringes
  • 10.4.1 Market Trends
  • 10.4.2 Market Forecast

11 Market by Distribution Channel

• 11.1 Hospitals
  • 11.1.1 Market Trends
  • 11.1.2 Market Forecast
• 11.2 Retail Pharmacy
  • 11.2.1 Market Trends
  • 11.2.2 Market Forecast

12 Global Generic Injectables Market: Competitive Landscape

• 12.1 Market Structure
• 12.2 Market Breakup by Key Players

13 Generic Injectables Manufacturing Process

• 13.1 Product Overview
• 13.2 Detailed Process Flow (Injectables)
• 13.3 Various Types of Unit Operations Involved
• 13.4 Mass Balance and Raw Material Requirements

14 Project Details, Requirements and Costs Involved

• 14.1 Land Requirements and Expenditures
• 14.2 Construction Requirements and Expenditures
• 14.3 Plant Machinery
• 14.4 Machinery Pictures
• 14.5 Raw Material Requirements and Expenditures
• 14.6 Packaging Requirements and Expenditures
• 14.7 Transportation Requirements and Expenditures
• 14.8 Utility Requirements and Expenditures
• 14.9 Manpower Requirements and Expenditures
• 14.10 Other Capital Investments

15 Loans and Financial Assistance

16 Project Economics

• 16.1 Capital Cost of the Project
• 16.2 Techno-Economic Parameters
• 16.3 Product Pricing and Margins Across Various Levels of the Supply Chain
• 16.4 Taxation and Depreciation
• 16.5 Income Projections
• 16.6 Expenditure Projections
• 16.7 Financial Analysis
• 16.8 Profit Analysis

17 Key Player Profiles

• 17.1 Baxter International Inc.
  • 17.1.1 Company Overview
  • 17.1.2 Product Portfolio
  • 17.1.3 Financials
  • 17.1.4 SWOT Analysis
• 17.2 Fresenius Kabi AG
  • 17.2.1 Company Overview
  • 17.2.2 Product Portfolio
  • 17.2.3 Financials
  • 17.2.4 SWOT Analysis
• 17.3 Hikma Pharmaceuticals plc
  • 17.3.1 Company Overview
  • 17.3.2 Product Portfolio
  • 17.3.3 Financials
  • 17.3.4 SWOT Analysis
• 17.4 Pfizer Inc.
  • 17.4.1 Company Overview
  • 17.4.2 Product Portfolio
  • 17.4.3 Financials
  • 17.4.4 SWOT Analysis
• 17.5 Sagent Pharmaceuticals Inc. (Nichi-Iko Pharmaceutical Co. Ltd.)
  • 17.5.1 Company Overview
  • 17.5.2 Product Portfolio
  • 17.5.3 Financials
  • 17.5.4 SWOT Analysis
• 17.6 Sandoz International GmbH (Novartis International AG)
  • 17.6.1 Company Overview
  • 17.6.2 Product Portfolio
  • 17.6.3 Financials
  • 17.6.4 SWOT Analysis
• 17.7 Sanofi S.A.
  • 17.7.1 Company Overview
  • 17.7.2 Product Portfolio
  • 17.7.3 Financials
  • 17.7.4 SWOT Analysis