India and Europe Generic Injectable Market, By Therapeutic Application (Oncology, Cardiovascular Disorders, Infectious Diseases, Pain Management, Metabolic Disorder (Diabetes), and Immunology Disorders), Biosimilar Drugs (Semaglutide, Ibutidlide Fumarate, Evolocumab, Alirocumab, Anidulafungin, Dulaglutide, Lixisenatide, Exenatide, Liraglutide, and Adalimumab), End User (Direct Sales Distributors, Pharmaceutical Wholesalers, Drug Stores, Pharmacy, Group Purchasing Organizations (GPOs), and Others), Distribution Channel (Pharmaceutical Wholesalers, Contract Manufacturers, Pharmacy Chains, Group Purchasing Organizations (GPOs), and Others) - Industry Trends and Forecast to 2035.
India and Europe Generic Injectable Market Analysis and Size
Generic injectable, being more economical than their branded counterparts, offer an attractive solution for healthcare systems aiming to manage costs without compromising quality is driving the market growth. The ascendance of market growth through increased emphasis on contract research manufacturing is expected to create an opportunity for market growth.
Data Bridge Market Research analyzes that the India and Europe generic injectable market is growing at a CAGR of 9.0% in the forecast period of 2024 to 2035 and is expected to reach USD 119,063.77 million by 2031 from USD 43,499.40 million in 2023. Escalating the incidence of chronic diseases and a surge in the development and production of generic injectable is expected to drive the market's expansion.
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Report Metric
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Details
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Forecast Period
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2024 to 2035
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Base Year
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2023
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Historic Year
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2022 (Customizable 2016-2021)
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Quantitative Units
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Revenue in USD Million
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Segments Covered
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Therapeutic Application (Oncology, Cardiovascular Disorders, Infectious Diseases, Pain Management, Metabolic Disorder (Diabetes), and Immunology Disorders), Biosimilar Drugs (Semaglutide, Ibutidlide Fumarate, Evolocumab, Alirocumab, Anidulafungin, Dulaglutide, Lixisenatide, Exenatide, Liraglutide, and Adalimumab), End User (Direct Sales Distributors, Pharmaceutical Wholesalers, Drug Stores, Pharmacy, Group Purchasing Organizations (GPOs), and Others), Distribution Channel (Pharmaceutical Wholesalers, Contract Manufacturers, Pharmacy Chains, Group Purchasing Organizations (GPOs), and Others)
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Country/Region Covered
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India and Europe
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Market Players Covered
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Cipla Inc., Dr. Reddy’s Laboratories Ltd, Sanofi, Viatris Inc., Fresenius Kabi AG, Sandoz Group AG, GLENMARK PHARMACEUTICALS LTD, Gland Pharma Limited, Par Pharmaceutical, and Sun Pharmaceutical Industries Ltd., among others
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Market Definition
The term "generic injectable" describes the injectable administration of pharmaceuticals using generic drugs. The drug delivery method is preferred due to its effectiveness in providing accurate dosage management and serving as a backup when oral administration is not feasible or is not as effective. Generic injectable medication administration is essential to healthcare because it offers reasonably priced substitutes without sacrificing therapeutic requirements.
India and Europe Generic Injectable Market Dynamics
This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:
Drivers
- Surge in Development and Production of Generic Injectable
The market is experiencing a noteworthy boost due to the escalating development and production of generic injectable. Several factors, including the growing emphasis on cost-effectiveness in healthcare, propel this surge.
Generic injectable, being more economical than their branded counterparts, offer an attractive solution for healthcare systems aiming to manage costs without compromising quality.
The expiration of patents for various branded injectable drugs has further opened avenues for generic alternatives, fostering healthy competition and expanding choices for healthcare providers. Regulatory support and favorable environments in Europe play a pivotal role encouraging generic injectable approval and market entry. In addition, the rising demand for biosimilar, especially generic versions of complex biologic injectable, contributes significantly to the increasing landscape of generic injectable drug development.
- Escalating Incidence of Chronic Diseases
This rise in chronic illnesses has created an unprecedented demand for targeted and efficient therapeutic interventions. Injectable drug delivery systems have emerged as indispensable tools in addressing the complexities of managing these persistent health challenges. The inherent nature of chronic diseases often demands precise dosage control and continuous medication administration, areas in which injectable drug delivery excels. The market gains prominence by offering solutions that lead to enhanced treatment outcomes, improved patient management, and increased therapeutic efficacy as healthcare systems globally grapple with the escalating burden of chronic conditions.
In conclusion, the market's direction is intricately tied to its capability to address the complex healthcare demands arising from the escalating prevalence of chronic diseases. The market solidifies its pivotal role as a
Opportunity
- Ascendance of Market Growth Through Increased Emphasis on Contract Research Manufacturing
Contract Research and Manufacturing Organizations (CRMOs) are becoming increasingly popular among pharmaceutical businesses, especially those engaged in developing generic drugs. Contract manufacturing is utilizing specialized expertise, improving procedures, and increasing the output of generic drugs. Pharmaceutical businesses can concentrate on their primary skills, which include marketing, research, and regulatory compliance by using CRMOs to handle production. The pharmaceutical sector is changing, and with it, the need for efficiency, economy, and flexibility in drug discovery and production is rising. CRMOs, or contract research and manufacturing organizations, are essential in helping generic drug producers satisfy these expectations since they provide specialized services. Pharmaceutical businesses are outsourcing different stages of their operations due to restricted regulatory requirements, the increasing complexity of drug research procedures, and the necessity for innovative manufacturing technology.
Restraints/Challenges
- Ensuring and Maintaining High-Quality Standards
The stringent quality control processes inherent in injectable manufacturing demand meticulous attention to detail at every stage. Meeting these standards necessitates substantial investments in technology, infrastructure, and skilled personnel, which can contribute to elevated production costs. In addition, the rigorous compliance requirements may also extend the time-to-market for new injectable drugs. Despite these challenges, the commitment to maintaining high quality is imperative to safeguard patient safety and uphold the integrity of healthcare practices.
Despite the challenges posed by quality assurance constraints, it stands out as a pivotal aspect that underscores the industry's unwavering commitment to providing injectable drugs that are both safe and effective. This commitment plays a fundamental role in securing the trust and well-being of patients on a global scale.
- Logistics Arising from Specialized Storage and Transportation Requirements
Generic drugs are frequently made by several manufacturers, resulting in different formulations and packaging. Although generic medications come in various formulations, they may be more vulnerable to changes in humidity and temperature while being stored and transported. The problem arises from the possibility that some generic drugs, particularly those with specific stability requirements, may require specific storage settings to preserve their effectiveness and safety.
Certain complex formulations and generic drugs may be susceptible to changes in temperature and exposure to light. The integrity of these medications may be compromised by inadequate storage, which could result in decreased therapeutic efficacy or even safety issues when administered. Furthermore, wholesalers and distributors are just two of the numerous intermediaries frequently involved in the worldwide distribution networks for generic medications. Exposure to unfavorable storage conditions poses a risk at every stage of the supply chain. This becomes especially important in areas with less developed infrastructure or uneven transportation temperature regulation.
Recent Developments
- In January 2024, Sun Pharmaceutical Industries Limited and Taro Pharmaceutical Industries Ltd. officially entered into a definitive merger agreement. Under this agreement, Sun Pharma, as the controlling shareholder of Taro, will acquire all outstanding ordinary shares of Taro, excluding those already held by Sun Pharma or its affiliates. The acquisition will be at a cash price of USD 43.00 per share without interest. This merger is anticipated to create a more robust and competitive entity, driving potential benefits such as increased market presence, operational efficiency, and expanded capabilities for Sun Pharma and Taro Pharmaceutical Industries Ltd
- In November 2023, Fresenius Kabi introduced Tyenne, its biosimilar of tocilizumab referencing RoActemra (tocilizumab), in the European Union. Tyenne marks the inaugural tocilizumab biosimilar in Europe for addressing various inflammatory and immune diseases. It will expand its product range
- In August 2023, Aurobindo Pharma secured final approval from the U.S. Food and Drug Administration (USFDA) for the production and commercialization of Vancomycin Hydrochloride for Injection USP in Single-Dose Vials with strengths of 1.25 g/vial and 1.5 g/vial. These formulations are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vancomycin Hydrochloride for Injection USP, manufactured by Mylan Laboratories Ltd
- In June 2023, Dr. Reddy's Laboratories Ltd. announced the opening of its new, dedicated division "RGenX," marking its entry into the Indian commercial generics market. Dr. Reddy believes this will give patients more affordable and more access to a greater selection of products. The new venture will advance the company's objective of serving more than 1.5 billion patients by 2030. This has helped the company to expand its business with product availability
- In December 2023, Hikma Pharmaceuticals PLC introduced Phenylephrine HCl Injection, USP, available in 500mcg/5mL and 1,000mcg/10mL doses. This product is now available in the United States in ready-to-use vials. Its intended use is to elevate blood pressure in adults experiencing clinically significant hypotension primarily caused by vasodilation during anesthesia. This helped the company to expand its market.
India and Europe Generic Injectable Market Scope
The India and Europe generic injectable market is segmented into three notable segments, which are based on therapeutic application, end user, biosimilar drugs and distribution channel. The growth amongst these segments will help you analyze meager growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.
Therapeutic Application
- Oncology
- Cardiovascular Disorders
- Infectious Diseases
- Pain Management
- Metabolic Disorder (Diabetes)
- Immunology Disorders
On the basis of therapeutic application, the market is segmented into oncology, cardiovascular disorders, infectious diseases, pain management, metabolic disorder (diabetes), and immunology disorders.
Biosimilar Drugs
- Semaglutide
- Ibutidlide Fumarate
- Evolocumab
- Alirocumab
- Anidulafungin
- Exenatide
- Lixisenatide
- Dulaglutide
- Adalimumab
On the basis of biosimilar drugs, the market is segmented into semaglutide, ibutilide fumarate, evolocumab, alirocumab, anidulafungin, exenatide, lixisenatide, dulaglutide, and adalimumab.
End User
- Direct Sales Distributors
- Pharmaceutical Wholesalers
- Drug Stores
- Pharmacy
- Group Purchasing Organizations (GPOs)
- Others
On the basis of end user, the market is segmented into direct sales distributors, pharmaceutical wholesalers, drug stores, pharmacy, group purchasing organizations (GPOs), and others.
Distribution Channel
- Pharmaceutical Wholesalers
- Contract Manufacturers
- Pharmacy Chains
- Group Purchasing Organizations (GPOs)
- Others
On the basis of distribution channel, the market is segmented into pharmaceutical wholesalers, contract manufacturers, pharmacy chains, Group Purchasing Organizations (GPOs), and others.
The India and Europe Generic Injectable Market Regional Analysis/Insights
The India and Europe generic injectable market is analyzed and market size insights and trends are provided by therapeutic application, end user, biosimilar drugs and distribution channel.
The country/region covered in this market report are India and Europe.
Europe is expected to dominate the India and Europe generic injectable market owing to technological advancements in injectable generic drug molecules in the region
The country section of the report also provides individual market-impacting factors and changes in market regulation that impact the current and future trends of the market. Data points like downstream and upstream value chain analysis, technical trends, porter's five forces analysis, and case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of regional/country brands and their challenges faced due to large or scarce competition from local and domestic brands, the impact of domestic tariffs, and trade routes are considered while providing forecast analysis of the country data.
India and Europe Generic Injectable Market: Competitive Landscape and Share Analysis
The India and Europe generic injectable market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, regional presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus on the market.
Some of the major players operating in the India and Europe generic injectable market are Cipla Inc., Dr. Reddy’s Laboratories Ltd, Sanofi, Viatris Inc., Fresenius Kabi AG, Sandoz Group AG, GLENMARK PHARMACEUTICALS LTD, Gland Pharma Limited, Par Pharmaceutical, and Sun Pharmaceutical Industries Ltd., among others.
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