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The generic injectables market is influenced by several key factors that contribute to its growth and dynamics. Firstly, the increasing demand for cost-effective healthcare solutions drives the adoption of generic injectables as affordable alternatives to brand-name drugs. With rising healthcare costs and budget constraints, healthcare providers, payers, and patients seek affordable treatment options without compromising quality or efficacy. Generic injectables offer significant cost savings compared to their branded counterparts, making them an attractive option for healthcare facilities, pharmacies, and patients seeking to reduce medication expenses while maintaining therapeutic outcomes. As a result, the demand for generic injectables continues to rise, particularly in emerging markets and healthcare systems with limited resources.
Secondly, patent expirations and market exclusivities create opportunities for generic manufacturers to enter the market and introduce generic versions of brand-name injectable drugs. When patents on branded drugs expire, generic manufacturers can obtain regulatory approval to produce and market bioequivalent versions of these drugs, typically at lower prices. This process, known as Abbreviated New Drug Application (ANDA) approval in the United States, enables generic injectable manufacturers to capitalize on the growing demand for affordable pharmaceuticals and expand their product portfolios with a wide range of generic injectables across various therapeutic categories, including oncology, anesthesia, antibiotics, and cardiovascular drugs.
Another significant factor driving the generic injectables market is the increasing prevalence of chronic diseases and age-related conditions that require long-term medication management and parenteral administration. Chronic conditions such as diabetes, hypertension, cancer, and autoimmune disorders often necessitate the use of injectable medications for disease control, symptom management, and disease modification. Generic injectables offer a cost-effective and convenient treatment option for patients requiring injectable therapies, enabling them to access essential medications without financial burden or adherence challenges. Moreover, the aging population and the rising incidence of age-related diseases contribute to the growing demand for injectable drugs, driving market expansion.
Moreover, regulatory reforms and initiatives aimed at promoting generic drug competition and market access drive growth in the generic injectables market. Regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO), have implemented measures to streamline the generic drug approval process, reduce regulatory barriers, and expedite market entry for generic injectables. These initiatives include priority review programs, expedited pathways for complex generics, and regulatory harmonization efforts to facilitate the development, assessment, and approval of generic injectable products, thereby promoting market competition, affordability, and accessibility.
Furthermore, the globalization of pharmaceutical manufacturing and the outsourcing of production to low-cost regions contribute to market growth by enabling generic manufacturers to achieve economies of scale, optimize production costs, and expand their global market presence. Contract manufacturing organizations (CMOs) play a crucial role in producing generic injectables on behalf of pharmaceutical companies, leveraging their expertise in manufacturing, quality control, and regulatory compliance to ensure the availability of high-quality and cost-effective injectable drugs. By outsourcing manufacturing operations to CMOs, generic manufacturers can focus on product development, regulatory affairs, and commercialization strategies, while benefiting from the scalability and flexibility offered by contract manufacturing partnerships.
Covered Aspects:
| Report Attribute/Metric | Details |
|---|---|
| Growth Rate | Â Â 14.5% (2022-2030 |
Generic Injectables Market Highlights:
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).
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
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
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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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