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Generic Sterile Injectable Market Size, Cost & Supply Chain

Generic Sterile Injectable Market to Scale $119.82 Bn by 2034

The global generic sterile injectable market was estimated at US$ 51.23 billion in 2025 and is projected to grow to US$ 82.14 billion by 2030. In 2023, North America led the market with a 40% share. Monoclonal antibodies dominated the market accounting for 34% of the share. The cancer therapeutic application held the largest segment, with a 26% share, and hospital pharmacies were the primary distribution channel, representing 52% of the market.

Generic Sterile Injectable Market Size, Shares & Achievements

The global generic sterile injectable market was estimated at US$ 42.42 billion in 2023 and is projected to grow to US$ 119.82 billion by 2034, rising at a compound annual growth rate (CAGR) of 9.9% from 2024 to 2034. For people who belong to the poor class or in underdeveloped countries where branded medicines are very expensive, the market for generic medicines grows strongly due to their affordability.

Generic Sterile Injectable Market Revenue 2023 to 2034 (USD Billion)

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Major Key Insights of the Generic Sterile Injectable Market

  • North America dominated the market share by 40% in 2023.
  • Asia Pacific is expected to grow at the fastest rate during the forecast period.
  • By drug type, the monoclonal antibodies segment poised its dominance over the generic sterile injectable market share by 34% in 2023.
  • By therapeutic application, the cancer segment held the largest market share by 26% in 2023.
  • By distribution channel, the hospital pharmacies segment held the dominant share of the market by 52% in 2023.

Generic Sterile Injectable Market: Cost-Effective

Generic sterile injectables are the same as branded injectables when it comes to strength, dosage form, quality, route of administration, intended use, and performance characteristics. However, generic medicines have different looks and contain different non-active ingredients compared to brand-name medicines. Generic alternatives are cheaper than branded medicines because manufacturers do not invest in development and marketing. The generic sterile injectable market deals with the production of injectable medicines that come in vials, pre-filled syringes, and ampoules. Generic injectables are used to treat various conditions, including pain, inflammation, infections, and others. With the growing demand for pharmaceutical products, generic medicines might need high production in the future.

How can AI Improve the Generic Sterile Injectable Market?

There are various aspects in the development of generic drugs in which AI can play a useful role. First of all, AI can be used for finding drug biosimilars with the help of natural language processing and predictive analysis. Predictive analysis can also be used in conducting research associated with the crystal structures of drug compounds. Machine learning can also be used in generic drug development by implementing it in salt and polymorph screening. As generic medicines have different non-active compounds, AI can be used for data analysis to find different ingredients that can be used as replacements. Apart from this, AI can also be used in supply chain management, manufacturing, transportation, inventory management, and sorting tasks that can decrease labor costs and increase efficiency and productivity.

For instance,

  • In December 2023, the first software-as-a-service platform that connects the application programming interface (API) of SynthiaTM retrosynthesis software to bridge the gap between virtual molecule design and real-world manufacturability is AIDDISONTM drug discovery software, which MilliporeSigma, the Life Science division of Merck KGaA in the United States and Canada, introduced. It integrates computer-aided drug design, machine learning, and generative AI to expedite medication development. The program finds chemicals with a profitable medication's essential qualities, such as stability, solubility, and non-toxicity, out of over 60 billion potential combinations.

Top Companies in the Generic Sterile Injectable Market

  • Fresenius Kabi
  • Novartis International
  • Merck & Co., Inc.
  • AstraZeneca
  • 3M
  • Sun Pharmaceutical Industries Ltd.
  • Pfizer
  • Hikma
  • Nichi-Iko
  • Teva Pharmaceuticals
  • Mylan N.V.
  • Sandoz
  • Civica
  • Dr. Reddy’s Laboratory
  • Baxter
  • Others

Teva’s Contribution to the Generic Sterile Injectable Market 

Company Name Teva Pharmaceuticals
Headquarters Israel, Middle East
Recent Development The company is a leading provider of generic medicines in the U.S., and its market is approximately 500 generic prescription products. The company’s pre-approved global pipeline consists of 1,100 generic products. In 2023, the company’s revenue in generic medicine was US$ 8,734 million, of which North America’s share was US$ 3,475 million, Europe’s share was US$ 3,664 million, and others’ share was US$ 1,594 million. As of 2024, the global generic market share of Teva is US$ 43 billion.

Hikma’s Contribution to the Generic Sterile Injectable Market

Company Name Hikma Pharmaceuticals
Headquarters London, UK, Europe
Recent Development

In May 2024, announced the founding of HIKMA ESPAÑA, S.L.U. (Hikma Spain), Hikma Pharmaceuticals PLC (Hikma) is an international pharmaceutical firm. Spain has a generic injectable market worth around $860 million, and this is Hikma's formal debut in that country. 25 goods have been introduced by Hikma in Spain so far this year, and the company has approved 36 products.

Low-Cost Drives the Generic Sterile Injectable Market

U.S. Manufacturer Gross Precripstion Drug Prices as a % of Prices Comparison, All Drugs, 2022

Branded products are high in cost due to patents, intense research, investment while approval by the FDA, marketing, and other factors. Due to this, brand-name injectables become unaffordable for people who belong to the poor class. In many cases, even middle-class people are unable to afford injectables. For people who live in countries like the U.S., affording healthcare becomes very expensive without insurance. Therefore, due to the lower cost of generic injectables, they are in high demand, especially in underdeveloped countries. Not only are they cheaper, but they also have the same medicinal effect as the brand-name injectables. Due to their cost-effectiveness, generic injectables become an attractive alternative for healthcare providers and patients.

Shortage of Generic Sterile Injectable Restrain the Market

The generic sterile injectable market is facing a shortage of drugs, which is a leading issue impacting the market’s growth. According to the Drug Shortage Report published by USP in 2024, there was a 91% shortage of generic sterile injectables in 2023, out of which 58% were injectable drugs that newly went into shortage in 2023. This shortage usually occurs due to supply chain disruptions. It is highly essential for the generic medicine industry to bolster its supply chain resilience. Apart from this, sterile injectable drugs have high manufacturing complexity, which leads to shortages. There have been quality concerns related to generic drugs, which have caused manufacturers to recall the products back to inventory, causing a shortage of generic sterile injectables in the market.

Opportunity: Increasing Development of Biosimilars

With growing research and development in biosimilars, the generic sterile injectable market can get a boost in the future. The market for generic sterile injectables is seeing an increase in the use of biosimilars, which are generic copies of monoclonal antibodies. When it comes to safety and efficacy, biosimilars are a more cost-effective option than branded monoclonal antibodies. The market for generic sterile injectables containing monoclonal antibodies is predicted to continue growing as a result of the increasing development and approval of biosimilars for these drugs, which include rituximab, trastuzumab, and adalimumab.

For instance,

  • In September 2024, to increase the company, generic medication manufacturer Aurobindo Pharma will improve the supply chain, grow operations in emerging regions, and develop its specialty business. It is also speeding up the development of biosimilar products. In a statement on the strategic efforts it is pursuing, the Hyderabad-based company stated that it has filed 14 peptide API drug master files (DMFs) in the United States and that 14 biosimilar drugs are in various phases of development.

The Monoclonal Antibodies Segment Dominated in 2023

Generic Sterile Injectable Market Share, By Drug Type, 2023 (%)

By drug type, the monoclonal antibodies segment poised its dominance over the generic sterile injectable market share by 34% in 2023. When it comes to therapeutics, monoclonal antibodies dominate in treating different diseases or conditions. Monoclonal antibodies are used in diagnostics, infectious disease treatment, radio immunodetection, radioimmunotherapy, cancer treatment, cardiovascular disease treatment, autoimmune disease therapy, viral disease treatment, pathogen identification, cell & their function tracing, and so on. Though monoclonal antibodies hold great therapeutic potential, the high cost reduces usage, which is why developing biosimilar or generic monoclonal antibodies becomes a crucial step for developing cost-effective monoclonal therapeutics.

For instance,

  • In July 2024, 3 further monoclonal antibody biosimilars—rituximab, trastuzumab, and ranibizumab—are recommended to be granted marketing authorization by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in a favorable opinion that was accepted.

The Cancer Segment Dominated the Market in 2023

Generic Sterile Injectable Market Share, By Therapeutic Application, 2023 (%)

By therapeutic application, the cancer segment held the largest generic sterile injectable market share by 26% in 2023. The cases of cancer are growing exponentially, and cancer is becoming a leading cause of death globally. There were 20 million new cases of cancer, and it is estimated that there will be 30 million new cases by 2040, according to the WHO. A large population is not able to afford cancer treatment due to the cost of therapies and drugs. The development of generic sterile injectables can significantly reduce the overall cost of cancer treatment. With growing R&D in cancer, researchers have been working on developing biosimilars, biosimilar monoclonal antibodies, and other injectable drugs.

For instance,

  • In April 2024, the U.S. Food and Drug Administration (U.S. FDA) approved Eribulin Mesylate Injection, a 0.5 mg/mL single-dose vial, for use by generic injectable manufacturer Gland Pharma. It is anticipated that the medication will be the first generic approved for sale, with indications for treating metastatic breast cancer. Gland Pharma anticipates launching it soon with the help of its marketing partner. The product's U.S. sales for the twelve months that ended in February 2024 were around $92 million, according to the firm, which cited IQVIA data.

The Hospital Pharmacies Segment Held the Largest Share

Generic Sterile Injectable Market Share, By Distribution Channel, 2023 (%)

By distribution channel, the hospital pharmacies segment held the dominant share of the generic sterile injectable market share by 52% in 2023. Hospital pharmacies are attached to hospitals, and most patients purchase medicines from hospital pharmacies, which is why this segment holds the dominant share. Apart from this, hospital pharmacies have access to a wide range of generic medicines. Hospital pharmacies are also involved in testing, procurement, compounding, dispensing, packaging, storage, manufacturing, distribution, and research of drugs, which gives hospital pharmacies more opportunities for growth and development. With a growing number of communicable and non-communicable diseases, the number of hospital admissions has increased and is going to increase even further in the future, which will increase the demand for hospital pharmacies.

Market Players Drive the North America’s Market

Stacked Graph 0

By region, North America dominated the generic sterile injectable market share by 40% in 2023 due to the strong presence of key market players, government investments, government initiatives, technological advancements, advanced healthcare infrastructure, growing R&D in therapeutics, and the strong presence of pharma and biotech companies. Apart from this, the growing prevalence of chronic conditions and cancer is increasing the production of generic medicines in the region. The U.S. and Canada majorly contribute to the growth of the market.

The generic sterile injectable market has grown significantly in the U.S. According to the annual report 2023 of the Office of Generic Drugs, 956 generic drugs were approved, more than 21,000 stakeholders across the world participated in workshops and webinars, and US$ 20 million was invested in generic drug science and research projects.

FDA-Approved Generic Drugs in the U.S., 2023

Canada also significantly contributes to the growth of the generic sterile injectable market. According to CGPA, 2.2 million prescriptions are dispensed using generic medicines on an everyday basis. Out of the total perceptions, 75% of prescriptions are for generic medicines. Some of the companies that provide generic drugs in Canada are Apotex, Auropharma, Baxter, Fresenius Kabi, Juno Pharmaceuticals Canada, Mantra Pharma, Marcan Pharmaceuticals Inc., Mint Pharmaceuticals Inc., Pharma Science, Sandoz, Sterimax Inc, Taro, Teva, and Viatris.

Growing Demand for Generic Medicine Drives Asia Pacific

Generic Sterile Injectable Market Share By Region, 2023 (%)By region, Asia Pacific is expected to grow at the fastest rate during the forecast period. The growing number of health issues and the high cost of medicines are driving the generic sterile injectable market in the Asia Pacific. The major contributors to the market’s growth include India, China, Japan, and South Korea.

India contributes significantly to the generic sterile injectable market due to the strong presence of the generic medicine market. India hosts the third largest pharmaceutical sector globally and is known for generic medicines and low-cost vaccines. In the financial year 2021-22, the pharma sector’s revenue was INR 3,44,125 Crore. India produces the largest amount of generic medicines and 60,000 different generic brands in 60 therapeutic categories, which is equivalent to 20% of the global generic medicine supply. The Indian Government also launched ‘Janaushadhi Pariyojana’ with the objective to develop generic medicines that are more affordable. As of 2024, there are 12,616 facilities under this program across the country, and there are 2047 drugs.

Recent Developments in the Generic Sterile Injectable Market

  • In June 2024, an approved generic version of Victoza®1 (liraglutide injection 1.8 mg) was introduced in the US, according to Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. As of April 2024, Victoza® generated $1.656 billion in revenue annually.
  • In June 2024, in order to treat adult patients' acute episodes of hereditary angioedema, Alembic Pharmaceuticals Ltd. announced that it had obtained final clearance from the US health agency for its generic Icatibant injectable.
  • In May 2024, drug giant Cipla said on Wednesday that the US Health Department had given the company permission to commercialize a generic drug that treats acromegaly and other ailments. The medicine manufacturer located in Mumbai said in a statement that it had obtained final permission from the U.S. Food and Medicine Administration (USFDA) to offer Lanreotide injections in various strengths.

Segments Covered in the Report

By Drug Type

  • Monoclonal Antibodies
  • Insulin
  • Cytokines
  • Peptide Hormones
  • Vaccines
  • Immunoglobulin
  • Blood Factors
  • Antibiotics
  • Others

By Therapeutic Application

  • Cancer
  • Diabetes
  • Cardiovascular Disease
  • Central Nervous System
  • Infectious Disorders
  • Musculoskeletal System
  • Others

By Distribution Channel

  • Hospital Pharmacies
  • Online Pharmacies
  • Retail Pharmacies
  • Others

By Region

  • North America
    • U.S.
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Swede
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Insight Code: 5238
  • No. of Pages: 150+
  • Format: PDF/PPT/Excel
  • Published: September 2024
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2022
  • Base Year: 2023
  • Estimated Years: 2024-2033

Meet the Team

Kesiya Chacko is a healthcare market research expert with 4+ years of experience, specializing in analyzing industry trends, assessing market opportunities, and providing actionable insights for businesses in healthcare sectors.

Learn more about Kesiya Chacko

Aditi Shivarkar, with 14+ years in packaging market research, specializes in food, beverage, and eco-friendly packaging. She ensures accurate, actionable insights, driving Towards Packaging 's excellence in industry trends and sustainability.

Learn more about Aditi Shivarkar

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FAQ's

For getting FDA approval, certain points should be considered, which include generic medicines that have the same active ingredients, non-active ingredients that may vary, identical in strength, identical in dosage form, identical in route of administration, and bioequivalent.

No. Although both the products are the same when it comes to their properties and, in many cases, produced by the same company, generic medicines have different packaging from brand-name medicines due to FDA and patent-related guidelines.

World Health Organization, U.S. FDA, Department of Biotechnology, National Cancer Institute, National Institutes of Health, National Library of Medicine, Department of Pharmaceuticals, Association of Accessible Medicines.