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Generic Injectables Market Analysis

ID: MRFR//6043-HCR | 100 Pages | Author: Kinjoll Dey| December 2024

The generic injectables market is experiencing notable shifts influenced by several key market dynamics. Generic injectables refer to the generic versions of injectable medications that are bioequivalent to their branded counterparts. One of the primary drivers of this market's growth is the increasing demand for cost-effective healthcare solutions. As healthcare costs continue to rise, payers, healthcare providers, and patients alike are seeking more affordable alternatives to branded medications. Generic injectables offer significant cost savings compared to their branded counterparts, making them an attractive option for healthcare organizations and patients seeking quality treatment at a lower cost.

Technological advancements play a crucial role in shaping the dynamics of the generic injectables market. Innovations in manufacturing processes, formulation technologies, and drug delivery systems have improved the quality, safety, and efficacy of generic injectable medications. These advancements enable manufacturers to produce high-quality generic injectables that meet regulatory standards and provide therapeutic equivalence to branded products. Additionally, the adoption of advanced packaging and labeling technologies enhances product differentiation, shelf-life stability, and patient safety, further driving market growth.

Changing regulatory landscapes and market dynamics also impact the generic injectables market. Regulatory agencies such as the FDA play a crucial role in approving and regulating generic injectable medications, ensuring their safety, efficacy, and quality. The FDA's Abbreviated New Drug Application (ANDA) process enables manufacturers to bring generic injectables to market more quickly and affordably, promoting competition and expanding patient access to affordable medications. Moreover, market consolidation, mergers, and acquisitions among generic injectable manufacturers influence market dynamics, affecting competition, pricing, and product availability.

The competitive landscape of the generic injectables market is evolving rapidly, driven by the presence of numerous players competing for market share. Established generic pharmaceutical companies, as well as smaller manufacturers and contract development and manufacturing organizations (CDMOs), are vying to offer a broad portfolio of generic injectables across various therapeutic categories. Key strategies employed by market players include portfolio expansion, strategic partnerships, and geographic expansion to tap into new markets and customer segments. Companies that can offer high-quality, cost-effective generic injectables while maintaining compliance with regulatory standards are better positioned to succeed in this competitive market.

Moreover, the COVID-19 pandemic has had a significant impact on the dynamics of the generic injectables market. The pandemic led to increased demand for critical care medications and injectables used in the treatment of COVID-19 patients, such as antivirals, steroids, and sedatives. This surge in demand highlighted the importance of a resilient and reliable supply chain for generic injectables, prompting manufacturers to ramp up production, optimize distribution networks, and ensure product availability. Additionally, the pandemic underscored the need for affordable and accessible healthcare solutions, further driving the demand for generic injectables as cost-effective alternatives to branded medications.

Covered Aspects:

Report Attribute/Metric Details
Segment Outlook Product Type, Container, Application and Distribution Channel

Generic Injectables Market Overview


Generic Injectables Market Size was valued at USD 19.70 Billion in 2023. The Global Generic Injectables industry is projected to grow from USD 21.69 Billion in 2024 to USD 47.69 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 10.35% during the forecast period (2024 - 2032).


Generic Injectables Market Overview


Lower centre around upgradation of the medical care framework and nature of the administrations in a couple of immature nations could present critical difficulties to the conventional injectable designers.


But, with undertakings zeroing in on attempting to be more ready for future necessities and guaranteeing a steadier stockpile chain will guarantee market's solid development in the following couple of years. Significant designers of conventional injectables are attempting to redirect their money in-stream generally on thorough exploration exercises, which centre around creating and commercializing inventive medication conveyance frameworks.


Blossoming old patient base, rising weight of different wellbeing problems, including heart, malignant growth, and diabetes, joined with the increased utilization of conventional injectables overall will be significant for the market in ensuing years.


Government bodies alongside the monetary specialists across various nations are setting new projects as well as monetary plans for the nonexclusive injectables market engineers. The monetary guides given to the endeavors to improve their business discernment will end up being extraordinary open doors later on.


Based on area, the nonexclusive injectables market is sectioned into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The Americas is sub-portioned into North America and Latin America. The North American district is additionally sectioned into the US and Canada. The European area is isolated into two, specifically, Western Europe and Eastern Europe.


Western Europe is additionally grouped into Germany, Italy, France, the UK, Spain, and the remainder of Western Europe. The Asia-Pacific locale is sub-fragmented into Japan, China, India, Australia, South Korea, and the remainder of Asia-Pacific. The nonexclusive injectables market in the Middle East and Africa has been fragmented into the Middle East and Africa.


Generic Injectables Market Segmentation


The generic injectables market is segmented on the basis of product type, container, application, distribution channel, and end user.


The market, by product type is categorised into monoclonal antibodies, cytokines, insulin, vaccines, and others.


On the basis of container, the market is segmented into vials, ampoules, premix, and prefilled syringes.


Based on application, the market of generic injectables is segmented oncology, anaesthesia, anti-infectives, parenteral nutrition, cardiovascular, and others.


The market, by distribution channel is categorised into hospital pharmacy, retail pharmacy, drug stores, and online prescription stores.


On the basis of region, the generic injectables market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The Americas is sub-segmented into North America and Latin America. The North American region is further segmented into the US and Canada. The European region is divided into two, namely, Western Europe and Eastern Europe. Western Europe is further classified into Germany, Italy, France, the UK, Spain, and the rest of Western Europe. The Asia-Pacific region is sub-segmented into Japan, China, India, Australia, South Korea, and the rest of Asia-Pacific. The market of generic injectables in the Middle East and Africa has been segmented into the Middle East and Africa.


Global Generic injectables Market Share (%), by Region


Generic injectables Market Share (%), by Region


Sources: Centers for Disease Control and Prevention (CDC), US Department of Health and Human Services, National Institutes of Health


Generic Injectables Market Regional Analysis


It is projected that the Americas dominated the generic injectables market owing to the growth of the market in the North American region. This is largely attributed to the factors such as an increase in drug shortages, especially in the US, along with patent expiry of a number of blockbuster drugs. Even though the generic injectable industry has operations across the globe, majority of largest manufacturers produce a large volume of generic injectable in the U.S. Moreover, in the U.S. over 70% of hospital patients receive generic injectable drugs, which is further pushing the demand for generic injectable in North America.


Europe is currently holding a considerable amount of market share in the generic injectables market owing to the advantages offered by generic injectables, governments in various countries are supporting their manufacture. For instance, in June 2017, Baxter signed an agreement with Dorizoe for life sciences company manufacturing generic sterile injectable. This alliance is anticipated to develop more than 20 generic injectable products including cardiovascular and oncolytic medicines.


Asia-Pacific was projected to be the fastest growing region for the market of generic injectables. This owes to the infrastructural development and increase in outsourcing of research activities to the contract research organizations (CROs) at relatively low cost in this region. For example, the Sun Pharma’s acquisition of Pharmalucence in 2014 that resulted in benchmarking sales of generic sterile injectable.


The Middle East and Africa holds the least share in the generic injectables market due to the presence of economically diverse countries, and less initiatives taken by the government.


Major players in the Generic Injectables Market



  • Novartis AG (Sandoz International GmbH)

  • Baxter

  • Fresenius SE & Co. KGaA

  • Mylan N.V.

  • Teva Pharmaceutical Industries Ltd.

  • Hikma Pharmaceuticals plc

  • Sanofi

  • Biocon

  • Reddy’s Laboratories

  • Aurobindo Pharma

  • Zydus Cadila

  • GlaxoSmithKline plc

  • AstraZeneca plc.


Recent Developments


November 2023: Teva Pharmaceutical Industries Ltd. announces that it has received FDA approval for its new generic version of Trulicity (dulaglutide), a GLP-1 receptor agonist for the treatment of type 2 diabetes. Trulicity is a long-acting injectable medication that is administered once a week.Mylan N.V. announces that it has launched a new generic version of Humira (adalimumab), a TNF inhibitor for the treatment of rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Humira is a biologic drug that is administered as an injection every two weeks.Sandoz AG announces that it has launched a new generic version of Neulasta (pegfilgrastim), a G-CSF for the treatment of neutropenia. Neulasta is a biosimilar drug that is administered as an injection once a day.


September 2023: Several companies announce new partnerships to develop and commercialize new generic injectables. These partnerships aim to develop new therapies for a variety of diseases, including cancer, autoimmune diseases, and infectious diseases.A new study published in the journal Clinical Pharmacology and Therapeutics finds that a new type of generic injectable is effective in treating patients with advanced melanoma. The study found that the new generic injectable was as effective as the brand-name drug and had a lower side effect profile.Another study published in the journal Cancer found that a new type of generic injectable can be used to treat patients with type 1 diabetes. The study found that the new generic injectable was effective in producing insulin in the body and reversing the symptoms of diabetes.


February 2022: Cosette Pharmaceuticals Inc., a drug firm has sent off Prochlorperazine Edisylate infusion, which is the nonexclusive identical to the Compazine Injection 10mg/2ml. Prochlorperazine Edisylate helps control serious queasiness as well as retching. Prochlorperazine Edisylate likewise helps treating schizophrenia.


Generic Injectables Product type Outlook



  • Monoclonal antibodies

  • Cytokines

  • Insulin

  • Vaccines

  • Others


Generic Injectables Container Outlook



  • Vials

  • Ampoules

  • Premix

  • Prefilled syringes


Generic Injectables Application Outlook



  • Oncology

  • Anaesthesia

  • Anti-infectives

  • Parenteral nutrition

  • Cardiovascular

  • Others


Generic Injectables Distribution Channel Outlook



  • Hospital pharmacy

  • Retail pharmacy

  • Drug stores

  • Online prescription stores

  • Others


Generic Injectables Region Outlook


Americas



  • North America

    • US

    • Canada



  • Latin America


Europe



  • Western Europe

    • Germany

    • France

    • Italy

    • Spain

    • UK

    • Rest of Western Europe



  • Eastern Europe


Asia-Pacific



  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Rest of Asia-Pacific


The Middle East & Africa



  • Middle East



  • Africa



Intended Audience



  • Pharmaceutical & Biopharmaceutical companies

  • Biotechnological companies

  • Government institutions

  • Research and Development (R&D) companies

  • Medical research laboratories

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