세계의 제네릭 주입제 시장 규모는 2024년에 510억 달러에 달했습니다. IMARC Group은 2025-2033년의 성장률(CAGR)이 6.88%로, 2033년에는 992억 달러에 달할 것으로 예측하고 있습니다. 브랜드 의약품의 특허 만료가 진행되고 있는 것과 함께 정부기관에 의한 규제 지원이 증가하고 있는 것이 주로 시장을 촉진하고 있습니다.
제네릭 주사제란 체내에 주입하는 의약품으로 용량, 강도, 품질, 성능 면에서 오리지널 의약품과 동등한 의약품을 말합니다. 백신, 인슐린, 항생제 등 다양한 유형이 있습니다. 제네릭 주사제는 당뇨병, 암, 고혈압, 감염성 질환 등 다양한 질환에 널리 사용되고 있습니다. 또한 마취, 호르몬 보충, 예방접종, 응급치료 등에도 광범위하게 사용되고 있습니다. 제네릭 주사제는 외과적 개입의 필요성을 줄이고, 표적화된 치료를 제공하며, 부작용이 적고, 안전하고 비용 효율적인 약제입니다.
최근 약물 제제 및 약물전달 시스템의 기술 발전으로 인해 생산 효율성이 향상되어 비용이 절감되고 가용성이 향상되어 시장 성장에 기여하고 있습니다. 또한 승인 절차를 간소화하여 제네릭 주사제 제조업체에게 유리한 환경을 조성하기 위한 다양한 규제 지원 및 구상의 시행은 시장 성장에 기여하고 있습니다. 이와는 별도로, 다양한 노화 관련 질환으로 인해 주사제를 포함한 더 많은 의료 개입을 필요로 하는 노인 인구 증가는 시장 성장에 긍정적인 영향을 미치고 있습니다. 또한 빠른 효과와 높은 생체 이용률로 인해 경구용 의약품보다 주사제에 대한 환자들의 선호도가 높아지면서 시장 성장에 힘을 실어주고 있습니다. 또한 공급망의 급속한 개선으로 제네릭 주사제의 유통이 더욱 간소화되면서 시장 성장을 지원하고 있습니다.
만성질환 증가
만성질환의 확산은 제네릭 주사제 시장의 주요 촉진요인입니다. 암, 당뇨병, 심혈관 질환(CVDs) 등의 치료는 지속적으로 증가하고 있으며, 장기적인 치료 및 투약이 필요합니다. 당뇨병의 인슐린, 암의 화학요법제, 심혈관질환의 강압제 등 제네릭 주사제는 이들 질환의 관리에 필수적입니다. 또한 제네릭 주사제는 가격이 저렴하므로 특히 의료 인프라가 제한적이거나 비용이 높은 중저소득 국가에서 더 많은 사람들이 쉽게 접근할 수 있습니다. 또한 의료 시스템은 품질과 비용 효율성의 균형을 중요시하고 있습니다. 이에 따라 제네릭 주사제는 필요한 치료를 오리지널 의약품에 비해 몇 분의 일의 일의 비용으로 제공할 수 있으므로 실행 가능한 대안이 되어 보다 광범위한 질병 관리와 통제를 촉진할 수 있습니다.
전 세계에서 증가하는 의료비 지출
의료비 증가는 선진국과 개발도상국 모두에게 심각한 문제입니다. 치료비가 치솟고 있으므로 합리적인 가격의 대체품이 절실히 요구되고 있습니다. 이에 따라 제네릭 주사제는 효과와 안전성을 손상시키지 않으면서도 비용 효율적인 솔루션을 제공합니다. 또한 환자와 가족의 경제적 부담을 크게 줄일 수 있습니다. 또한 제네릭 의약품은 예산이 한정된 의료 시스템에 여유를 제공하여 의료 서비스 개선, 연구 또는 공중 보건 노력에 보다 효율적으로 자원을 배분할 수 있도록 합니다. 또한 환자들은 본인 부담금 감소로 인해 직접적으로 혜택을 받을 수 있으며, 치료의 접근성을 높일 수 있습니다. 결과적으로, 의료비 상승으로 인해 의료 프로바이더와 환자들은 재정적으로 지속가능한 대안으로 제네릭 주사제에 눈을 돌릴 수밖에 없는 상황입니다.
브랜드 의약품의 특허 만료 증가
브랜드 주사제의 특허 만료는 제네릭 주사제 시장에 좋은 기회입니다. 특허만료로 인해 제네릭 의약품 제조업체는 브랜드 의약품의 카피를 제조 및 판매할 수 있습니다. 또한 제네릭 제약사들은 초기 R&D 비용 없이도 동등한 의약품을 생산할 수 있으므로 절감된 비용을 소비자에게 저렴한 가격으로 돌려줄 수 있습니다. 또한 제네릭 의약품은 이미 승인된 오리지널 의약품과 생물학적으로 동등하므로 일반적으로 규제 당국의 승인을 더 빨리 받을 수 있습니다. 이는 시장 출시 시간을 단축할 뿐만 아니라, 소비자가 필요한 의약품을 더 쉽게 구할 수 있는 기회를 넓혀줍니다. 또한 특허가 만료되면 이전에는 지적재산권(IP) 법에 의해 제한되었던 의약품의 대량 생산이 가능해집니다. 결과적으로 특허 만료는 제네릭 주사제 시장 확대를 위한 환경을 조성하여 제조업체와 소비자 모두에게 이익을 가져다 줄 것입니다.
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.