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Generic sterile injectables market to reach $196.2B by 2029

A growing prevalence of chronic diseases has become a significant factor in target market growth, per a report from Prophecy Market Insights.

The generic sterile injectables market accounted for $ 68.7 billion in 2019 and is estimated to be $196.2 billion by 2029 and is anticipated to register a CAGR of 11.2%, per a report from Prophecy Market Insights.

An injectable compounded medication is a sterile drug to be administered into the body using a syringe and needle or an I.V. administration set and needle device.

The report notes that a growing prevalence of chronic diseases has become major factor in target market growth. In addition, a growing number of drug manufacturers focusing on the production of drugs to treat cancer and rapid Food and Drug Administration approval of sterile injectable drugs within a short period of time is expected to contribute to the demand for generic sterile injectables market growth.

[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]

The report also provided some recent approvals:

In August 2018, Apotex received FDA approval for its generic potassium chloride injection under FDA's Competitive Generic Therapy to treat and prevent low potassium blood levels such as hypokalemia;

In March 2023, Hikma announced the launch of four new sterile injectable medicines in Canada, providing important new treatment options for patients and healthcare providers and building on the company's growing presence in the Canadian market; and

  •  In March 2023, Milla Pharmaceuticals, a subsidiary of the Alter Pharma Group, announced that its partner, Athenex Pharmaceutical Division has just started to commercialize its abbreviated new drug application approval from FDA for its generic Magnesium Sulfate in Water for Injection, 2 g/50 ml (40 mg/ml), 4 g/100 ml (40 mg/ml) and 4 g/50 ml (80 mg/ml), in Non-PVC, Single-Patient.

The report cited the top key players operating in the generic sterile injectables market:

  •  Sun Pharmaceutical Industries
  •  Aspen Pharmacare Holding
  •  Lupin
  •  Cipla
  •  Fresenius Kabi
  •  AuroMedics Pharma
  •  Valeant
  •  Kay Pharma
  •  CSC Pharmaceuticals
  •  Reddy's Laboratories

The report addressed how COVID-19 impacted the generic sterile injectables market, noting that it caused disruptions in the global supply chain, resulting in delays in the production and distribution of generic sterile injectables and shortages of some products. However, the increased demand for critical care medications, including sterile injectables, due to the surge in COVID-19 cases created opportunities for manufacturers of generic sterile injectables. Delays in clinical trials for new drugs, including sterile injectables, and a growing focus on ensuring their safety and quality were also observed. The pandemic also led to changes in the prescribing and administration of sterile injectables due to pandemic-related restrictions on hospital visits and procedures.

[Read more: Sufficiently similar: What the FDA approval of the first interchangeable biosimilar product means for pharmacists]

What are the possibilities for the generic sterile injectables market?

Increasing Demand for Cost-Effective Treatment: With the rising cost of health care, patients and healthcare providers are looking for cost-effective treatment options. Generic sterile injectables offer a more affordable alternative to branded products, driving demand for these products.

Expanding Applications of Sterile Injectables: Sterile injectables are used in the treatment of a wide range of diseases and conditions, and the applications of these products continue to expand. This is creating new opportunities for manufacturers of generic sterile injectables.

Growing Number of Patent Expirations: Many patents for branded sterile injectables are set to expire in the coming years, creating opportunities for generic product manufacturers to enter the market. This is expected to increase competition and drive down prices, further boosting demand for generic sterile injectables.

Increasing Focus on Quality and Safety: As with all pharmaceutical products, quality and safety are critical concerns for sterile injectables. With growing awareness of these issues, there is an increasing focus on ensuring the quality and safety of generic sterile injectables. This is expected to further boost demand for these products.

Additionally, the report addresses the following drivers of the market:

  •  Increasing prevalence of chronic diseases such as cancer, diabetes and cardiovascular diseases;
  •  Rise in demand for cost-effective drugs due to the high cost of branded sterile injectables;
  •  Need for a reliable supply of drugs, particularly in critical care settings;
  •  Aging population is driving demand for sterile injectables; and
  • Advancements in drug delivery systems and new technologies create opportunities for innovation in the generic sterile injectables market.

Lastly, among the restraints in the market:

Regulatory challenges: Stringent regulations regarding quality control and safety standards for sterile injectables can make it difficult for manufacturers to launch new products.

Patent protection: The patent protection for some sterile injectables can limit the availability of generic alternatives, thereby reducing competition in the market.

High development costs: The development of sterile injectables requires significant investment in research and development, which can be a barrier for smaller manufacturers.

Supply chain challenges: Any disruptions in the global supply chain can lead to shortages of sterile injectables, resulting in reduced revenue and market growth.

Manufacturing complexities: Sterile injectables require specialized manufacturing facilities and processes, which can increase manufacturing costs and make it difficult for new entrants to compete in the market.

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