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Last Updated: December 27, 2024

Sterile water for injection - Generic Drug Details


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What are the generic drug sources for sterile water for injection and what is the scope of patent protection?

Sterile water for injection is the generic ingredient in three branded drugs marketed by Abraxis Pharm, Hospira, Am Regent, Fresenius Kabi Usa, Hikma, Medefil Inc, Nephron, Nexus, B Braun, Baxter Hlthcare, Icu Medical Inc, and Taro, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for sterile water for injection. Eighteen suppliers are listed for this compound.

Summary for sterile water for injection
Drug Prices for sterile water for injection

See drug prices for sterile water for injection

US Patents and Regulatory Information for sterile water for injection

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 217341-003 Feb 9, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 018801-005 Oct 27, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abraxis Pharm BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 089100-001 Dec 29, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medefil Inc STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 211188-003 Dec 2, 2019 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 018801-004 Oct 27, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Sterile water for injection Market Analysis and Financial Projection Experimental

Sterile Water for Injection Market Dynamics and Financial Trajectory

Market Overview

The Sterile Water for Injection market is a critical component of the pharmaceutical industry, particularly in the production and administration of parenteral drugs. This market has been experiencing significant growth driven by various factors, including the increasing demand for injectable medications and the expansion of healthcare facilities globally.

Market Size and Growth Projections

As of 2023, the global Sterile Water for Injection With Drugs Market was valued at approximately USD 1.385 billion. It is anticipated to reach USD 2.3215 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 8.3% during the forecast period from 2024 to 2030[3].

Segmentation

The market is segmented based on several key factors:

By Type

  • Vials and Ampoules: These are traditional forms of sterile water packaging and remain widely used.
  • Pre-filled Syringes: These are gaining popularity due to their convenience and reduced risk of contamination[1][3].

By Application

  • Vaccine: Sterile water is crucial for the reconstitution of vaccine formulations.
  • Biological Products: Used in the preparation of various biological products.
  • Bio-pharmaceutical: Essential for the production and administration of bio-pharmaceuticals[1][3].

By Region

  • North America: Expected to account for a significant share of the global market due to the high demand for biopharmaceuticals and advanced healthcare infrastructure.
  • Europe: Also a major market, driven by the presence of key pharmaceutical companies.
  • Asia-Pacific: Growing rapidly due to increasing healthcare access and the expansion of pharmaceutical manufacturing facilities[1][4].

Drivers of the Market

Increasing Demand for Injectable Medications

The rise in prevalence of diseases such as cancer, cardiovascular diseases, and diabetes has led to an increased demand for injectable medications. Most of these medications require sterile water for reconstitution, thereby driving the market growth[4].

Expansion of Healthcare Facilities

The growth in access to healthcare facilities in emerging economies is another significant driver. As more people gain access to healthcare, the demand for sterile water for injection increases[4].

New Drug Formulations

The development of new drug formulations, particularly in the biopharmaceutical sector, is boosting the demand for sterile water. Biologics, proteins, antibodies, and other biopharmaceutical products often require sterile water for their preparation and administration[4].

Challenges and Restraints

Supply Chain Disruptions

Historically, the market has faced challenges due to supply chain disruptions and manufacturing delays. For instance, in 2018, a shortage of sterile water for injection vials was reported due to limited production by major manufacturers like Pfizer and Fresenius Kabi[2].

Regulatory Compliance

Ensuring regulatory compliance is a significant challenge. The production, storage, and distribution of sterile water must adhere to strict guidelines to maintain quality and safety standards[4].

Key Players

The market is dominated by several key players, including:

  • Baxter Corporation
  • Hospira (ICU Medical)
  • Vetter
  • Otsuka
  • ROVI
  • Fresenius Kabi
  • Shijiazhuang No. 4 Pharmaceutical
  • Hikma
  • Kelun
  • Deo Gratias Parenteral[3].

These companies are investing in strategic expansions, improving manufacturing facilities, and developing new product lines to meet the growing demand.

Financial Trajectory

The financial trajectory of the Sterile Water for Injection market is robust, with a projected CAGR of 8.3% from 2024 to 2030. Here are some key financial highlights:

  • Market Size in 2023: USD 1.385 billion
  • Projected Market Size in 2030: USD 2.3215 billion
  • CAGR: 8.3%[3].

This growth is driven by the increasing demand for biopharmaceuticals, the expansion of healthcare facilities, and the development of new drug formulations.

Regional Market Dynamics

North America

North America is expected to account for a major share of the global market. The region is witnessing significant growth due to the rise in development of plasma fractionation and specialty enzymes, as well as strategic investments by key players[4].

Europe

Europe is another significant market, driven by the presence of major pharmaceutical companies and a well-established healthcare infrastructure.

Asia-Pacific

The Asia-Pacific region is growing rapidly due to increasing healthcare access and the expansion of pharmaceutical manufacturing facilities. This region is expected to play a crucial role in the future growth of the market[1][4].

Use and Importance in Healthcare

Sterile Water for Injection is essential in healthcare for several reasons:

  • Reconstitution of Medications: It is used to reconstitute medications available as lyophilized powders. Without a consistent supply, healthcare personnel face significant challenges in treating patients effectively[2].
  • Fluid Replacement: It can be used for fluid replacement after suitable additives are introduced to approximate isotonicity[5].

Safety and Quality Considerations

The use of Sterile Water for Injection must adhere to strict safety and quality guidelines. For example, it must be administered intravenously only after rendering it approximately isotonic with a suitable solute to avoid hemolysis and other adverse reactions[5].

Managing Shortages

Given the critical nature of Sterile Water for Injection, managing shortages is paramount. Strategies include conserving supplies, using alternative products like commercially available premixes, and batching the preparation of medications to minimize waste[2].

Conclusion

The Sterile Water for Injection market is poised for significant growth, driven by increasing demand for injectable medications, expansion of healthcare facilities, and new drug formulations. Despite challenges such as supply chain disruptions and regulatory compliance, the market's financial trajectory is robust, with a projected CAGR of 8.3% from 2024 to 2030.

Key Takeaways

  • Market Growth: The market is expected to grow from USD 1.385 billion in 2023 to USD 2.3215 billion by 2030.
  • CAGR: The market will grow at a CAGR of 8.3% during the forecast period.
  • Key Drivers: Increasing demand for injectable medications, expansion of healthcare facilities, and new drug formulations.
  • Challenges: Supply chain disruptions, regulatory compliance, and managing shortages.
  • Regional Dynamics: North America, Europe, and Asia-Pacific are key regions driving market growth.

FAQs

Q: What is the primary use of Sterile Water for Injection in healthcare?

A: Sterile Water for Injection is primarily used to reconstitute medications available as lyophilized powders and for fluid replacement after suitable additives are introduced to approximate isotonicity[2][5].

Q: Which regions are expected to drive the growth of the Sterile Water for Injection market?

A: North America, Europe, and the Asia-Pacific region are expected to drive the growth of the market due to their advanced healthcare infrastructure and increasing demand for biopharmaceuticals[1][4].

Q: What are the key challenges facing the Sterile Water for Injection market?

A: The market faces challenges such as supply chain disruptions, regulatory compliance, and managing shortages. Historically, shortages have been a significant issue, affecting the availability of sterile water for injection vials[2][4].

Q: Who are the major players in the Sterile Water for Injection market?

A: Major players include Baxter Corporation, Hospira (ICU Medical), Vetter, Otsuka, ROVI, Fresenius Kabi, Shijiazhuang No. 4 Pharmaceutical, Hikma, Kelun, and Deo Gratias Parenteral[3].

Q: What is the projected CAGR of the Sterile Water for Injection market from 2024 to 2030?

A: The market is projected to grow at a CAGR of 8.3% from 2024 to 2030[3].

Sources

  1. Market Research Intellect: Global Sterile Water For Injection With Drugs Market Size, Scope ...
  2. ASHP: Sterile Water for Injection Shortage FAQ
  3. Valuates Reports: Sterile Water for Injection With Drugs Market Size
  4. Transparency Market Research: Water for Injection Market Insight and Trends 2031
  5. DailyMed: Sterile Water for Injection, USP in VIAFLEX Plastic Container For ...

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