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市场调查报告书
商品编码
1642692
2025-2033 年按治疗领域、容器、配销通路和地区分類的仿製药注射剂市场报告Generic Injectables Market Report by Therapeutic Area, Container, Distribution Channel, and Region 2025-2033 |
2024年,全球仿製药注射剂市场规模达到510IMARC Group美元。品牌药物的专利到期日渐增多,以及政府机构监管支持的不断增加,主要推动了市场的发展。
仿製药注射剂是指注射入体内且在剂量、强度、品质和性能上与品牌药物相当的药物。它包括多种类型,例如疫苗、胰岛素和抗生素。仿製药注射剂广泛用于治疗一系列疾病,例如糖尿病、癌症、高血压和感染。它们也广泛应用于麻醉、荷尔蒙替代、免疫和紧急治疗。仿製药注射剂是安全且具成本效益的药物,可减少手术介入的需要,提供标靶治疗,且副作用较少。
药物配方和输送系统的最新技术进步提高了生产效率,从而降低了成本并提高了可用性,正在推动市场成长。此外,实施各种监管支援和倡议,透过简化审批流程为仿製药注射剂製造商创造有利的环境,也有助于市场成长。除此之外,不断增长的老年人口需要更多的医疗干预措施,包括针对各种与年龄相关的疾病的注射剂,这对市场成长产生了积极影响。此外,由于起效更快和生物利用度更高,患者对注射剂的偏好超过口服药物,这正在加强市场的成长。此外,供应链的快速改善使仿製药注射剂的分销更加精简,正在支持市场成长。
慢性病盛行率不断上升
慢性病盛行率不断上升是仿製药注射剂市场的主要驱动力。癌症、糖尿病和心血管疾病 (CVD) 等疾病的发生率不断上升,需要长期治疗和药物。治疗糖尿病的胰岛素、治疗癌症的化疗药物和治疗心血管问题的抗高血压药物等通用注射剂在这些疾病的治疗中是不可或缺的。此外,仿製药注射剂的可负担性使更多人能够使用它们,特别是在医疗基础设施可能有限或昂贵的低收入和中等收入国家。此外,医疗保健系统注重平衡品质和成本效益。与此一致的是,仿製药注射剂提供了一种可行的选择,因为它们以品牌注射剂的一小部分成本提供必要的治疗,从而促进更广泛的疾病管理和遏制。
全球医疗保健支出不断增加
不断增长的医疗费用是已开发国家和发展中国家都非常关心的问题。由于治疗费用飞涨,迫切需要负担得起的替代方案。与此一致的是,仿製药注射剂提供了一种具有成本效益的解决方案,且不影响功效或安全性。此外,它们可以大大减轻患者和家庭的经济负担。此外,它们还为预算有限的医疗保健系统提供了余地,以便更有效地分配资源,以改善医疗保健服务、研究或公共卫生措施。此外,患者还可以透过较低的自付费用直接受益,使治疗更容易获得。因此,不断上涨的医疗保健成本迫使医疗保健提供者和患者转向仿製药注射作为经济上可持续的替代方案。
品牌药的专利到期日渐增多
品牌注射剂的专利到期为仿製药注射剂市场提供了绝佳的机会。专利到期后,仿製药製造商可以生产和销售品牌药物的复製品。此外,他们可以生产同等的药物,而无需承担初始研发 (R&D) 成本,从而以较低的价格将节省的费用转嫁给消费者。此外,仿製药通常会获得更快的监管批准,因为它们与已批准的品牌药物具有生物等效性。这不仅加快了上市时间,也扩大了消费者获得基本药物的机会。此外,专利到期使得以前受智慧财产权 (IP) 法限制的药物得以大规模生产。因此,专利到期为仿製药注射剂市场的扩张创造了有利的环境,使製造商和消费者都受益。
The global generic injectables market size reached USD 51.0 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 99.2 Billion by 2033, exhibiting a growth rate (CAGR) of 6.88% during 2025-2033. The growing patent expiration of branded drugs, along with the increasing regulatory support from government bodies, is primarily driving the market.
Generic injectables refer to pharmaceutical drugs that are injected into the body and are equivalent to their brand-name counterparts in dosage, strength, quality, and performance. It includes various types, such as vaccines, insulin, and antibiotics. Generic injectables are widely used for a range of medical conditions, such as diabetes, cancer, hypertension, and infections. They also find extensive applications in anesthesia, hormone replacement, immunization, and emergency treatments. Generic injectables are safe and cost-effective medications that reduce the need for surgical interventions, provide targeted therapy, and have fewer side effects.
The recent technological advancements in drug formulation and delivery systems that are making production more efficient, thereby lowering costs and boosting availability, are propelling the market growth. Additionally, the implementation of various regulatory support and initiatives to create a conducive environment for manufacturers of generic injectables by streamlining approval processes is contributing to the market growth. Apart from this, the growing geriatric population, which requires more healthcare interventions, including injectables for various age-related ailments, is positively influencing the market growth. Furthermore, the rising preference for injectables over oral medications among patients due to quicker onset of action and higher bioavailability is strengthening the market growth. In addition, the rapid improvement in the supply chain, which has made the distribution of generic injectables more streamlined, is supporting the market growth.
The escalating prevalence of chronic diseases
The escalating prevalence of chronic diseases is a primary driver of the generic injectables market. Conditions such as cancer, diabetes, and cardiovascular diseases (CVDs) are on a constant rise and require long-term treatments and medications. Generic injectables such as insulin for diabetes, chemotherapeutic agents for cancer, and antihypertensive medications for cardiovascular issues are indispensable in the management of these conditions. Furthermore, the affordability of generic injectables makes them accessible to a larger population, especially in low and middle-income countries where healthcare infrastructure may be limited or costly. Additionally, healthcare systems are focusing on balancing quality and cost-effectiveness. In line with this, generic injectables present a viable option, as they provide the necessary treatments at a fraction of the cost of their branded counterparts, thus facilitating more widespread disease management and containment.
The rising healthcare expenditure across the globe
The growing cost of healthcare is a significant concern for both developed and developing nations. There is an urgent need for affordable alternatives as treatment expenses are skyrocketing. In line with this, generic injectables offer a cost-effective solution without compromising on efficacy or safety. Furthermore, they can substantially lower the economic burden on patients and families. Additionally, they provide budget-constrained healthcare systems with the leeway to allocate resources more efficiently towards the improvement of healthcare services, research, or public health initiatives. Moreover, patients also benefit directly through lower out-of-pocket costs, making treatments more accessible. As a result, the rising cost of healthcare is compelling healthcare providers and patients to turn to generic injectables as a financially sustainable alternative.
The increasing patent expiration of branded drugs
Patent expirations of branded injectables present a golden opportunity for the generic injectables market. Expiry of the patent allows generic drug manufacturers to produce and sell copies of the branded medication. Furthermore, they can produce equivalent medications without incurring the initial research and development (R&D) costs, thereby passing on the savings to the consumers in the form of lower prices. Moreover, the generic versions usually receive faster regulatory approvals as they are bioequivalent to already-approved branded drugs. This not only speeds up the time-to-market but also broadens consumer access to essential medications. Additionally, patent expiry enables the mass production of medications that were previously restricted by intellectual property (IP) laws. As a result, patent expiration creates a conducive environment for the expansion of the generic injectables market, benefiting both manufacturers and consumers.
Oncology
Anaesthesia
Anti-infectives
Parenteral Nutrition
Cardiovascular
Oncology dominates the market
Oncology is dominating the market due to the high prevalence of cancer, which necessitates a consistent and accessible supply of medications for treatment. Furthermore, cancer treatments are highly expensive, often requiring combinations of drugs and long-term administration. In line with this, generic injectables offer a cost-effective alternative to branded drugs, alleviating some of the financial burdens on healthcare systems and patients. Besides this, the oncology sector has witnessed patent expirations for branded drugs, thus opening up opportunities for generic pharmaceutical companies to introduce their versions of these medications. Moreover, the complexity of cancer treatment protocols, which often call for targeted therapies, is facilitating the demand for generic injectables. In addition, oncology treatments frequently necessitate hospitalization or clinical administration of drugs, where injectables are more commonly used.
Vials
Ampoules
Premix
Prefilled Syringes
Vials exhibit a clear dominance in the market
Vials offer a high degree of sterility and contamination protection, which is essential for injectable drugs. The integrity of the medication is better preserved in a vial, which is a critical factor when dealing with sensitive substances, such as biologics or chemotherapy agents. Furthermore, they are incredibly versatile and can accommodate a wide range of drug volumes, from small quantities for specialized treatments to larger volumes for widespread applications. Additionally, vials are highly cost-effective, especially when produced in bulk. This cost advantage aligns well with the overall appeal of generic injectables as cost-effective alternatives to branded drugs.
Ampoules offer high barrier properties, ensuring that the medication inside remains sterile and free from contamination. Additionally, the glass construction of ampoules allows for high visibility, enabling healthcare professionals to visually inspect the solution for any impurities before administration, thus adding an extra layer of safety. Besides this, they are usually single-dose containers, which eliminates the risks associated with multi-dose vials, such as cross-contamination and dosing errors.
Hospitals
Retail Pharmacy
Hospitals holds the largest share in the market
Hospitals are dominating the market as they allow the immediate and precise administration of injectables, which is especially critical in emergency situations or intensive care units (ICUs) where quick onset of action can be lifesaving. Furthermore, they handle a high volume of patients and a broad array of medical conditions, ranging from surgeries to chronic disease management. The versatility of generic injectables allows them to be used across various departments, making them a go-to option for multiple therapeutic applications. Besides this, hospitals have the necessary infrastructure, including temperature-controlled storage and trained medical staff, to manage the complexities of injectable drug administration. Moreover, the growing pressure to manage healthcare costs effectively makes generic injectables a preferred choice for hospitals.
Europe
North America
Asia
Latin America
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest generic injectables market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include Europe, North America, Asia, Latin America, and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America has a well-established healthcare system that readily adopts medical innovations, including generic injectables. Furthermore, the region has some of the highest per capita healthcare spending, allowing for the widespread use of both branded and generic pharmaceuticals. Additionally, the imposition of supportive policies by regional governments to streamline processes for the approval of generic medications, including injectables, is positively influencing the market growth. Besides this, the frequent expiry of branded medication patents in North America is creating opportunities for generic drug manufacturers to introduce their own, more affordable versions. Moreover, the escalating geriatric population, which requires more medical treatments, often leading to higher consumption of medications, including injectables, is acting as another growth-inducing factor. Along with this, the heightened awareness and acceptance among both healthcare providers and consumers regarding the efficacy and cost-effectiveness of generic medications is supporting the market growth.
Leading companies are consistently working to expand their range of generic injectable medications, including biosimilars, to cover a broader spectrum of therapeutic areas. Furthermore, they are investing in research and innovation to improve the formulation and stability of generic injectables, thereby enhancing their quality and market appeal. In addition, several key players are forming strategic partnerships with other industry stakeholders to enhance their capabilities, distribution networks, and product offerings. Besides this, companies are focusing on expanding their geographical reach through collaboration with local distributors or setting up manufacturing facilities. Additionally, they are working on optimizing their production processes to offer cost-effective solutions without compromising on quality. Moreover, major players are ensuring products meet the rigorous regulatory requirements, especially in highly regulated markets.
Baxter International Inc.
Fresenius Kabi AG
Hikma Pharmaceuticals plc
Pfizer Inc.
Sagent Pharmaceuticals Inc. (Nichi-Iko Pharmaceutical Co. Ltd.)
Sandoz International GmbH (Novartis International AG)
Sanofi S.A.