GENERIC STERILE INJECTABLES MARKET ANALYSIS

The generic sterile injectables drugs refers to biologics that are used for the treatment of various drugs and has same active ingredients to that of the branded versions of it. The process of manufacturing generic sterile injectable is mostly equal to the U.S FDA regulations to that of the branded counterparts. The chronic diseases are one of the major causes of mortality as these diseases cannot easily be cured by vaccines and healthcare medication. According to the World Health Organization (WHO) in 2017, the non- communicable chronic diseases attributed to over 38 million death per year. These diseases include arthritis, diabetes, asthma, cardiovascular diseases, cancer, and also the viral diseases such as hepatitis C and HIV/AIDS. According to the Center for Disease Control and Prevention: 2017, around half of the U.S. population, i.e. 47% people have at least one major risk factor for cardiovascular disease, which mainly includes uncontrolled low-density lipoproteins (LDL) cholesterol, high blood pressure, and smoking habits. The high prevalence rates of these diseases will inadvertently drive growth of the global generic sterile injectables market.

Global Generic Sterile Injectables Market - Impact of the Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic is expected to drive the growth of the global generic sterile injectable market, owing to the expansion of the manufacturing facility for the production of generic products. For instance, in the year 2021, Civica Rx, manufacturer of generic sterile injectables, collaborated with Phlow Corp., a pharmaceutical company to build a US$ 124.5 million manufacturing facility (120,000-square-foot plant), specific for generic sterile injectables. The construction of the new manufacturing site will be completed by the year 2023.

Moreover, many market players are producing generic sterile injectables for the treatment of COVID-19, this is expected to drive the growth of the global generic sterile injectable market, during the forecast period. For instance, in 2020, Hetero Healthcare Ltd, a pharmaceutical company, was supplying 60,000 vials of Covifor, generic version of Remdesivir injection in India from July 13 to 20, 2020. Covifor is the first generic brand of Remdesivir, which is meant for treatment of COVID-19 patients that are adults and children, hospitalized with severe symptoms of the disease. The drug is available in 100 mg vial (Injectable).

Global generic sterile injectables market is estimated to be valued at USD 46.33 Bn in 2024 and is expected to exhibit a CAGR of 10.3% during the forecast period (2024-2031).

Figure 1. Global Generic Sterile Injectables Market Value (US$ Bn), by Region, 2024

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Market players are engaged in receiving approvals from the regulatory authorities, in order to expand their product portfolio. This is expected to drive growth of the global generic sterile injectables market over the forecast period.

Key players are focused on receiving approvals from the regulatory authorities and this is expected to drive growth of the global generic sterile injectables market over the forecast period. For instance, in 2022, Sandoz, a unit of Novartis AG, announced the approval from the U.S. Food and Drug Administration (FDA) for the generic version of Copaxone which is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Moreover, for instance, in 2019, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ZIRABEV (bevacizumab-bvzr), a biosimilars to Avastin (bevacizumab), 1 for the treatment of five types of cancer: metastatic colorectal cancer; unrespectable locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.

Increasing inorganic activities such as acquisitions, in order to increase the product portfolio is expected to drive the growth of the global generic sterile injectables market over the forecast period

Market players are focused on inorganic activities such as acquisitions and is expected to drive growth of the global generic sterile injectables market over the forecast period. For instance, in March 2020, Baxter International Inc., expects sales to grow approximately 4% on a compounded annual basis at constant currency rates from 2016 to 2020 by focusing on cost optimization and portfolio management. The company is expected to generate free cash flow of approximately US$ 1.75 Bn in 2020.

Moreover, in 2017, Fresenius Kabi AG, healthcare company, acquired Akorn, Inc., manufacturer of over the- counter pharmaceuticals products, for approximately US$ 4.3 billion. This acquisition represents a potential innovative growth opportunity for its sterile injectables business portfolio.

Global Generic Sterile Injectables Market – Restraints

Shortage of sterile injectable is expected to decrease the growth of the global generic sterile injectables market, over the forecast period. Sterile injectables shortage has increased by 200X over the last few years. This is primarily attributed to increasing demand from emerging economies – Asia Pacific and Latin America and limited production capacity of the plants. Supply side factors include physical constraints due to remarkably high standards in the chain of production and in the distribution of the products which are potentially very dangerous.

For instance, according to the Bloomberg Data published in August 2016, the top three manufacturers of generic sterile injectables including Pfizer, Sagent, and Hikma accounted for nearly 70% of the global volume as per the analysis of prescription data from Symphony Health. The shortages faced in the industry are primarily due to increased manufacturing issues, delay in supply, and shortage of API. There have been an exponential rise in the number of warnings to manufacturing faculties by the U.S. FDA, especially in India, which is among the largest generic manufacturers globally. This has led to shortage of generic sterile injectables in the global market.

Global Generic Sterile Injectables Market – Regional Analysis

On the basis of region, global generic sterile injectables market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa

Among regions, North America generic sterile injectables market is expected to hold a dominant position during the forecast period, owing to the launching of the new generic injectables in the region. For instance, in February 2022, Dr Reddy's Laboratories Ltd announced the launch of vasopressin injection, which is used to control frequent urination, increased thirst, and loss of water caused by diabetes, in the U.S. market. It is a generic version of Par Pharmaceuticals' Vasostrict. Par Pharmaceuticals is a company that develops generic pharmaceutical and branded injectable products.

Furthermore, Europe is also estimated to witness significant growth in the global generic sterile injectables market, owing to increasing prevalence of chronic conditions such as cardiovascular diseases, Alzheimer’s diseases and hypertension. For instance, according to the data provided by the National Health Service, Scotland as of May 2021, it is estimated that Alzheimer's disease affects around 850,000 people in the U.K.

Figure 2. Global Generic Sterile Injectables Market Share, By Drug Type, 2024

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Recent Developments

• In March 2023, Hikma Pharmaceuticals PLC, a multinational pharmaceutical company, announced the launch of four new sterile injectable medicines in Canada, providing crucial new treatment options for patients and healthcare professionals while also expanding the company's presence in the Canadian market. All of the drugs are the first or second generic versions of their compounds on the Canadian market, and these treat illnesses in a wide range of therapeutic areas, representing a significant increase in access to medicines for Canadian patients.
• In May 2022, Endo International plc, a generics and specialty branded pharmaceutical company, announced that its subsidiary Endo Ventures Limited (EVL) had acquired six development-stage, ready-to-use injectable product candidates from Nevakar Injectables Inc., a subsidiary of Nevakar, Inc. The product candidates are in various phases of development, with the first launch anticipated for 2025. Endo now has control over all remaining development, approval, launch, and commercialization efforts for these pharmaceutical candidates following the acquisition.
• In March 2022, Nevakar Injectables Inc., a biopharmaceutical company developing multiple sterile injectable products, announced the launch of its ready-to-use Ephedrine Sulfate Injection (“Ephedrine”), a formulation pre-diluted to a 5mg/mL concentration and supplied in a 10mL vial. The product will be marketed and sold in the U.S. by the Par Sterile Products (“Par”) business of Endo International plc., a generics and specialty branded pharmaceutical company. Ephedrine is a widely used injectable vasopressor agent that is indicated for the treatment of clinically important hypotension occurring during surgery.
• In September 2020, Strides Pharma Science Limited, a global pharmaceutical company, announced an investment in SteriScience Pharma Private Limited to establish the company's dedicated arm for the global sterile injectables market. Furthermore, SteriScience Pharma Private Limited has formed a joint venture ('JV') with Brooks Laboratories Limited ('Brooks') to establish a strong carbapenem company with integrated production capabilities.

Global Generic Sterile Injectables Market – Competitive Landscape

Major players operating in the global generic sterile injectables market include Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Pfizer Inc., Fresenius Kabi, Novartis International AG, Teva Pharmaceuticals, Hikma Pharmaceuticals, Dr. Reddy’s Laboratory, Mylan N.V. and Sun Pharmaceutical Industries Ltd.