Generic Injectables For Infectious Diseases Market Size, Share, Opportunities, And Trends By Product Type (Monoclonal Antibodies, Immunoglobulin, Cytokines, Insulin, Peptide Hormones, Blood Factors, Vaccines, Small Molecule Antibiotics, Chemotherapy Agents, Others), By Molecule Type (Small Molecule, Large Molecule), By Route Of Administration (Intramuscular, Intravenous, Subcutaneous), By Distribution Channel (Hospital Pharmacy, Online Pharmacy, Retail Pharmacy), And By Geography - Forecasts From 2024 To 2029

The Generic Injectables for Infectious Diseases Market is anticipated to rise steadily throughout the projected period.

Generic injectables for infectious diseases are non-branded, injectable medications used to manage and treat infections caused by various pathogens. These drugs are bioequivalent to the original, brand-name drugs used in treating infectious diseases, administered via injection and containing the same active ingredients, dosage forms, strengths, and indications as their branded counterparts. Key aspects to consider when defining generic injectables for infectious diseases include bioequivalence, active ingredients, dosage forms and strengths, indications, quality and safety, cost savings, regulatory approval, market competition, and interchangeability. Generic injectables are typically more affordable than their brand-name counterparts, promoting accessibility to treatment. They must undergo rigorous regulatory scrutiny to ensure they meet the same quality and safety standards as their branded counterparts. Increased competition often leads to lower prices, benefiting healthcare systems and patients. In many healthcare systems, generic injectables are considered interchangeable with their branded counterparts, allowing healthcare providers to substitute a generic version for a brand-name drug if it meets bioequivalence and regulatory criteria.

Market Drivers

• High infectious disease prevalence is anticipated to drive the generic injectables for infectious diseases market growth

The need for effective treatments is fueled by the persistently high global incidence of infectious diseases. Healthcare systems offer more affordable options to treat and control infectious diseases using generic injectables. The high prevalence of infectious diseases like HIV, tuberculosis, malaria, and bacterial infections necessitates the use of injectable medications for cost-effective treatments, thereby boosting demand. For instance, in April 2023, the National Library of Medicine (NLH) published an article that infectious diseases are a major cause of morbidity and mortality, causing over 52 million annual deaths worldwide. Half of the population is at risk of emerging and re-emerging diseases. Recent figures show 14 million global deaths in children under 5, 70% from vaccine-preventable diseases, and 99% in developing countries.

• Expanding access to essential medicines bolsters the generic injectables for infectious diseases market growth.

Global healthcare expenditures and the need for cost-effective solutions are driving the demand for generic medications, including injectables for infectious diseases. To improve access to essential medicines, increased spending may be needed to distribute and make these medications more accessible to a broader population as populations expand and age. For instance, in June 2022, Hikma Pharmaceuticals PLC established Hikma France S.A.S., marking its official entry into France, the second-largest pharmaceutical market in Europe and a $2 billion generic injectables hospital market. With approval and a new commercial office outside Paris, Hikma will now supply medicines directly to hospitals in anti-infective, cardiovascular, and central nervous system therapeutic areas. With manufacturing plants in Portugal, Italy, and Germany, Hikma supplies injectable products to North America, the Middle East, North Africa, and Europe.

• Expedited approvals and regulatory support are expected for the generic injectables for infectious diseases market growth.

Regulatory bodies have put initiatives into effect to accelerate the licensing procedure for generic injectables, including particular treatment pathways. Due to the possibility of rapid approvals, this encourages market players to invest in research and development. Regulatory agencies frequently aid in the creation and approval of generic medications to boost competition and healthcare accessibility. The expedited approvals for generic injectables can significantly enhance market entry. In October 2021, NLH published an online article regarding the FDA making significant efforts to improve harmonization and clarity in regulating complex generic drug products through regular publication of product-specific guidance documents, pre-ANDA meetings, and international initiatives.

North American region is predicted to grow significantly.

The North American market for generic injectables, particularly for infectious diseases, is predicted to grow due to high prevalence, demographic factors, government initiatives, and a well-established regulatory environment. The aging population in North America is more susceptible to infectious diseases, driving the need for treatments. Government initiatives and public health programs often involve the procurement and distribution of medications, contributing to market growth. The increasing acceptance and trust in generic medications have increased utilization and market growth. Patent expirations of branded medications create opportunities for generic alternatives, leading to increased competition among manufacturers. Strategic collaborations between generic drug manufacturers, healthcare providers, and government agencies can enhance the accessibility and availability of generic injectables. Advancements in biotechnology, including biosimilars, and pandemic preparedness support market growth.

Market Restraints

• Biosimilars and Biological Complexity

The development of biosimilars and generic biologics for infectious diseases presents unique challenges due to their biological complexity. The process of achieving similarity to the reference product is challenging, and the regulatory pathways for biosimilars may differ from those for small-molecule generics.

Market Developments

• March 2023- Hikma Pharmaceuticals PLC, a top US supplier of generic injectable medicines, has launched Cefazolin for Injection in 2g and 3g doses. The drug is used to treat various infections caused by bacteria, including skin, bone, joint, genital, blood, heart chamber lining, respiratory tract, biliary tract, and urinary tract infections. The product has been approved for US FDA marketing.
• March 2021- Fresenius Kabi has introduced the first-ever generic for Foscavir® (Foscarnet Sodium) Injection in the United States, available in a 6000 mg/250 mL bottle. This drug is indicated for treating CMV retinitis in AIDS patients and can be combined with ganciclovir for relapsed patients. However, safety and efficacy have not been established for other CMV infections, congenital or neonatal CMV disease, or non-immunocompromised individuals. It is also used for acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.

Company Products

• Zyvox® (linezolid) Injection- Teva Pharmaceuticals has introduced the generic version of Zyvox® (linezolid) Injection, which is used to treat infections caused by Gram-positive bacteria. It is indicated for treating nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections, and Vancomycin-resistant Enterococcus faecium infections. However, it is not suitable for treating Gram-negative infections, and immediate treatment is needed for concomitant Gram-negative pathogens.
• Ceftaz (Ceftazidime) 1gm Injection - Ceftaz 1gm Injection is an antibiotic medicine by Cipla used to treat bacterial infections in various body parts, including the brain, lungs, ear, urinary tract, skin, bones, joints, blood, and heart. It is effective against a broad spectrum of bacteria and can be given as a drip or injection under healthcare supervision. Ceftazidime, a third-generation cephalosporin antibiotic, is commonly used to treat infections caused by susceptible bacteria and is used in the respiratory tract, urinary tract, skin, soft tissue, and intra-abdominal infections.

Segmentation

• By Product Type
  • Monoclonal Antibodies
  • Immunoglobulin
  • Cytokines
  • Insulin
  • Peptide Hormones
  • Blood Factors
  • Vaccines
  • Small Molecule Antibiotics
  • Chemotherapy Agents
  • Others
• By Molecule Type
  • Small Molecule
  • Large Molecule
• By Route of Administration
  • Intramuscular
  • Intravenous
  • Subcutaneous
• By Distribution Channel
  • Hospital Pharmacy
  • Online Pharmacy
  • Retail Pharmacy
• By Geography
  • North America
    • USA
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Others
  • Asia Pacific
    • China
    • Japan
    • South Korea
    • India
    • Indonesia
    • Others