NEWARK, Del, Jan. 30, 2025 (GLOBE NEWSWIRE) -- The global generic injectable market is on a strong growth trajectory, with sales projected to surge from USD 135.4 billion in 2025 to an impressive USD 401.8 billion by 2035, registering a robust CAGR of 11.5% during the forecast period.
The market’s expansion is fueled by increasing demand for cost-effective therapeutics, rising prevalence of chronic diseases, and the growing adoption of biosimilars. In 2024, the global generic injectable market generated USD 120.7 billion in revenue, highlighting its substantial contribution to the pharmaceutical industry.
The increasing prevalence of chronic diseases has resulted in investments in innovations in the field of generic injectables. The demand for immediate treatment options has resulted in the growing popularity of intravenous (IV) or intramuscular (IM) routes of drug administration. For example, IM administration of insulin provides better patient outcomes. Generic injectable products offer multiple advantages, such as faster approvals, improved availability of biologic drugs in development pipelines, and a higher preference for injectable drug delivery.
Factors such as cost-effectiveness, and better patient outcomes are bolstering sales prospects for products, including vaccines, monoclonal antibodies, peptides, immunoglobulins, and antibodies.
Generic injectables are also increasingly recognized as cost-effective treatments as compared with branded alternatives. These factors are driving up adoption rates in the generic injectable market.
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Surge in the Investment in the Pharmaceutical Sector in India to Push Sales of Generic Injectable
The growth of government spending in the pharmaceutical sector is a key factor generating opportunities in India. High levels of capital investment as continuous support to keep up with United States FDA cGMP generic clean injectable plants are projected to positively influence market developments.
The lapse of patents for branded items and the reduction in new item launches have brought about an increase in generic injectable deals in India. As a result, the generic sterile injectables market is flourishing in the country. Comparatively, relaxed standards of regulatory approval of generic injectables have contributed to high investments in production to ensure high-quality levels.
The usual time for regulatory approval for sterile medications in the country is more than three to four years. A huge gap between demand and supply adds to deficiencies and creates value-building incentives. Practical medication for the working class populace is projected to also contribute to the market growth.
Market Growth Drivers:
1. Patent Expirations and Biosimilars Expansion
The expiration of patents on major branded injectables opens the door for generic alternatives, allowing pharmaceutical companies to introduce cost-effective versions of essential drugs. Additionally, the rise of biosimilars—generic versions of biologics will contribute significantly to the market's expansion.
2. Rising Prevalence of Chronic Diseases
The increasing incidence of cancer, diabetes, cardiovascular diseases, and autoimmune disorders is driving the demand for injectable medications. Generic injectables provide an economical alternative to branded drugs, ensuring broader patient access to life-saving treatments.
3. Advancements in Drug Delivery Technologies
Innovations in pre-filled syringes, auto-injectors, and lyophilized formulations are enhancing the safety and efficiency of injectable therapies. These advancements are improving patient compliance while reducing medication errors in hospitals and homecare settings.
4. Government and Regulatory Support
Healthcare authorities worldwide are promoting generic drug adoption to curb healthcare costs. Favorable regulations, coupled with faster FDA and EMA approvals, are facilitating market growth and encouraging new players to enter the sector.
"The rapid growth of the generic injectable market underscores the critical role of affordability and accessibility in modern healthcare, with increasing regulatory support and a strong push towards generic alternatives, we anticipate sustained momentum in the coming years." says Sabyasachi Ghosh Associate Vice President at Future Market Insights (FMI) analyst.
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Branded Versions Contributing to the Sales of Generic Injectables
The expiry of patents of branded items and the reduction in new launches have positively influenced generic medications. These have also contributed to the development of generic injectable market players and product sales.
Generic injectable costs are relatively low when compared with the costs of branded products providing significant impetus to market growth while also expanding net sales. Generic drugs are resulting in losses for pharmaceutical companies with support from government incentives for participants in the market.
Across economies, there has been a rising trend in healthcare expenditure in the last decade. Factors responsible include inflation rates that contribute significantly towards drug price spirals.
Utilization of capacities and rates have remained stagnant since 2000 and only prices that are driving growth. In this regard, close focus on both pricing and healthcare access are key aspects that need to be considered while containing medical costs.
Pipeline Drug Approvals and Sterile Injectables Gaining Importance
Medications in the drug development pipelines with parenteral applications have risen from 56% to 58%, between 2020 and 2021. This can be attributed to the scaling of biologics. Expansion of generic injectables in the pipeline results in the expansion, and research and development efforts involved in the conventional injectable market.
Generic injectables were affirmed as new molecule entities (NMEs) by the United States Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), which estimated a peak of 57% in 2020 and has since dropped to 40% in recent months.
Research into new treatment and routes of administration options for chronic diseases has increased. This is projected to drive development in the generic injectable market.
The leading drug production organizations have reported their expectations to invest in manufacturing facilities to improve manufacturing limits, cut down corporate expense rates, and build their international presence. These organizations are planning to extend their geographic presence in emerging economies like India and China, where manufacturing cost is relatively low as compared to Europe and North America.
The new duty changes in the United States, have resulted in low corporate tax rates, and have boosted biopharmaceutical organizations to bolster production capacities.
For Instance, in July 2020, Pfizer reported an arrangement to contribute around USD 465 million to fabricate a sterile injectable plant in Portage, Michigan. This development is a part of the company’s plan to invest around USD 5 billion for every United States-based capital task in line with corporate assessment changes in the country.
Key Players of Generic Injectable Industry:
- Samsung Biologics Co Ltd
- Aurobindo Pharma Limited
- Sun Pharmaceutical Industries Ltd.
- Novartis AG
- Merck &
- Cipla Ltd
- Pfizer Inc
- Fresenius Kabi
- Sanofi S.A
- AstraZeneca Plc
- Teva Pharmaceuticals.
- Mylan N.A
- Baxter International
- Dr. Reddy’s Laboratories
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Key Segments of Generic Injectable Industry:
By Product Type:
In terms of product type, the industry is divided into monoclonal antibodies, immunoglobulin, cytokines, insulin, peptide hormones, blood factors, peptide antibiotics, vaccines, small molecule antibiotics, chemotherapy agents, and others.
By Molecule:
In terms of molecule, the industry is divided into small molecule, large molecule
By Application:
In terms of application, the industry is divided into oncology, infectious diseases, diabetes, blood disorders, hormonal disorders, musculoskeletal disorders, CNS diseases, pain management, cardiovascular diseases
By Route of Administration:
In terms of technology, the industry is divided into single wavelength generic injectable devices and multiple wavelength generic injectable devices
By Distribution Channel:
In terms of distribution channel, the industry is segregated into intravenous (IV), intramuscular (IM), subcutaneous (SC), homecare settings.
By Region:
Key countries of North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe, and Middle East and Africa (MEA) have been covered in the report.
French Translation:
Le marché mondial des génériques injectables est sur une trajectoire de forte croissance, avec des ventes qui devraient passer de 135,4 milliards USD en 2025 à un impressionnant 401,8 milliards USD d’ici 2035, enregistrant un TCAC robuste de 11,5 % au cours de la période de prévision.
L’expansion du marché est alimentée par la demande croissante de traitements rentables, la prévalence croissante des maladies chroniques et l’adoption croissante des biosimilaires. En 2024, le marché mondial des injectables génériques a généré un chiffre d’affaires de 120,7 milliards USD, soulignant sa contribution substantielle à l’industrie pharmaceutique.
Avec l’intérêt croissant pour les solutions de soins de santé abordables et l’expiration des principaux brevets de médicaments de marque, le secteur des injectables génériques devrait connaître d’importants investissements, innovations et approbations réglementaires dans le monde entier.
Alors que les entreprises pharmaceutiques continuent d’améliorer leurs capacités de production et de rationaliser leurs chaînes d’approvisionnement, l’accessibilité des injectables génériques de haute qualité devrait s’améliorer, répondant ainsi aux besoins médicaux critiques dans divers systèmes de santé.
Le marché mondial des injectables génériques est sur le point de connaître une croissance substantielle entre 2025 et 2035, stimulé par la demande croissante de médicaments rentables, l’expiration des brevets des médicaments de marque et les progrès des produits biologiques. Alors que les systèmes de santé du monde entier continuent de rechercher des options de traitement abordables et de haute qualité, les injectables génériques deviennent un élément clé pour répondre aux besoins des patients et des prestataires de soins de santé.
Moteurs de croissance du marché :
1. Expiration des brevets et expansion des biosimilaires
L’expiration des brevets sur les injectables de grande marque ouvre la porte à des alternatives génériques, permettant aux sociétés pharmaceutiques d’introduire des versions rentables de médicaments essentiels. De plus, l’essor des biosimilaires, c’est-à-dire des versions génériques de produits biologiques, contribuera de manière significative à l’expansion du marché.
2. Prévalence croissante des maladies chroniques
L’incidence croissante du cancer, du diabète, des maladies cardiovasculaires et des troubles auto-immuns stimule la demande de médicaments injectables. Les injectables génériques offrent une alternative économique aux médicaments de marque, assurant un accès plus large aux patients aux traitements vitaux.
3. Progrès dans les technologies d’administration de médicaments
Les innovations dans les seringues préremplies, les auto-injecteurs et les formulations lyophilisées améliorent la sécurité et l’efficacité des thérapies injectables. Ces progrès améliorent l’observance thérapeutique des patients tout en réduisant les erreurs de médication dans les hôpitaux et les soins à domicile.
4. Soutien gouvernemental et réglementaire
Les autorités sanitaires du monde entier encouragent l’adoption de médicaments génériques pour réduire les coûts des soins de santé. Des réglementations favorables, associées à des approbations plus rapides de la FDA et de l’EMA, facilitent la croissance du marché et encouragent de nouveaux acteurs à entrer dans le secteur.
« La croissance rapide du marché des injectables génériques souligne le rôle essentiel de l’abordabilité et de l’accessibilité dans les soins de santé modernes, avec un soutien réglementaire croissant et une forte poussée vers les alternatives génériques, nous prévoyons une dynamique soutenue dans les années à venir. » déclare Sabyasachi Ghosh, vice-président associé chez Future Market Insights (FMI), analyste.
Défis à l’expansion du marché :
Malgré la forte trajectoire de croissance, l’industrie est confrontée à certains défis, notamment :
- Obstacles réglementaires stricts : Le respect des normes de qualité et de sécurité reste un défi majeur pour les fabricants.
- Érosion des prix et concurrence : La présence de plusieurs acteurs sur le marché entraîne des pressions sur les prix, ce qui a un impact sur les marges bénéficiaires.
- Perturbations de la chaîne d’approvisionnement : La disponibilité des matières premières et l’uniformité de la fabrication sont des préoccupations cruciales, en particulier après la pandémie.
Principales tendances du marché (2025 à 2035) :
- Augmentation des investissements dans les médicaments génériques biologiques (biosimilaires)
- Essor des dispositifs auto-injectables à usage domestique
- Émergence de l’IA et de l’automatisation dans la fabrication de produits injectables
- Focus sur les emballages durables et écologiques
- Expansion des injectables génériques dans les marchés émergents
Perspectives d’avenir :
Le marché des injectables génériques est destiné à une croissance transformatrice, stimulée par les innovations technologiques, le soutien réglementaire et la demande croissante de solutions de traitement abordables. Alors que le secteur mondial de la santé met l’accent sur la réduction des coûts et l’accessibilité pour les patients, les injectables génériques resteront la pierre angulaire de la médecine moderne au cours de la prochaine décennie.
Alors que les acteurs de l’industrie se concentrent sur l’innovation, les partenariats stratégiques et l’efficacité de la fabrication, le marché connaîtra une expansion continue, garantissant que les patients du monde entier bénéficient de thérapies injectables sûres, efficaces et économiques.
Principaux acteurs de l’industrie des injectables génériques :
- Samsung Biologics Co Ltd
- Aurobindo Pharma Limited
- Sun Pharmaceutical Industries Ltd.
- Novartis AG
- Merck et
- Cipla Ltd
- Pfizer Inc
- Fresenius Kabi
- Sanofi S.A
- AstraZeneca Plc
- Teva Pharmaceuticals.
- Mylan N.A
- Baxter International
- Les laboratoires du Dr Reddy
Segments clés de l’industrie des injectables génériques :
Par type de produit :
En termes de type de produit, l’industrie est divisée en anticorps monoclonaux, immunoglobulines, cytokines, insuline, hormones peptidiques, facteurs sanguins, antibiotiques peptidiques, vaccins, antibiotiques à petites molécules, agents de chimiothérapie et autres.
Par molécule :
En termes de molécule, l’industrie est divisée en petite molécule, grande molécule
Par application :
En termes d’application, l’industrie est divisée en oncologie, maladies infectieuses, diabète, troubles sanguins, troubles hormonaux, troubles musculo-squelettiques, maladies du SNC, gestion de la douleur, maladies cardiovasculaires
Par voie d’administration :
En termes de technologie, l’industrie est divisée en dispositifs injectables génériques à longueur d’onde unique et dispositifs injectables génériques à longueurs d’onde multiples
Par canal de distribution :
En termes de canal de distribution, l’industrie est séparée en intraveineux (IV), intramusculaire (IM), sous-cutané (SC) et soins à domicile.
Par région :
Les principaux pays d’Amérique du Nord, d’Amérique latine, d’Asie de l’Est, d’Asie du Sud et du Pacifique, d’Europe de l’Ouest, d’Europe de l’Est et du Moyen-Orient et d’Afrique (MEA) ont été couverts dans le rapport.
Author By:
Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.
Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.
Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.
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