市场调查报告书
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1401844
到 2030 年无菌注射剂市场预测:按药物类型、分子类型、途径、给药配销通路、应用和地区进行的全球分析Sterile Injectable Market Forecasts to 2030 - Global Analysis By Drug Type, Molecule Type, Route of Administration, Distribution Channel, Application and By Geography |
根据 Stratistics MRC 的数据,2023 年全球无菌注射剂市场规模为 621 亿美元,预计在预测期内复合年增长率为 9.2%,到 2030 年将达到 1,150 亿美元。
需要去除活细菌(例如细菌或真菌)的静脉注射药物称为无菌注射剂。这些注射剂可以静脉注射(IV)、给药(IM)或给药(SC)。这些注射剂设计用于直接注射到循环系统或其他无菌身体组织中。它通常在严格的无菌加工条件下製备,以确保成品不受微生物污染。
根据美国国家卫生委员会的数据,2016 年,慢性病影响了约 1.33 亿美国人,占全国总人口的 40% 以上。到 2020 年,这一数字预计将增加到约 1.57 亿,其中 8,100 万人患有多种疾病。
对无菌注射剂的偏好日益增加
药品、生物製药和疫苗等无菌注射剂对于医疗保健至关重要,特别是对于疾病管理和紧急应变。医学研究的进步导致了新的注射治疗方法的发现和发展。这包括新的医疗干预措施,例如基因疗法和细胞疗法。这些方面将在整个预测期内推动市场成长。
污染风险
儘管尽可能保持无菌,但在製造、包装和给药过程中仍可能发生污染。对患者来说,污染物会导致严重的健康问题。此外,有些注射药物需要特殊的储存条件,例如冷藏,以保持稳定性。运输和储存方面的额外物流障碍限制了市场的成长,特别是在缺乏合适设施的地区。
提高生物利用度
无菌注射剂通常比口服药物具有更好的生物利用度,因为它们不易受到胃肠道吸收不可预测性的影响。注射药物通常比口服药物起效更快。对于治疗窗有限或需要固定给药才能获得最佳效果的药物来说,注射剂是有益的,因为可以将更高浓度的药物直接输送到循环中。预计这些因素将在预期期间推动市场扩张。
包装问题
无菌注射剂包装对于维持产品完整性至关重要。包装缺陷会导致污染和药物功效降低。此外,无菌注射剂的製造和品质保证程序可能昂贵且复杂。对人们、卫生系统和製药公司来说,这代价高昂。因此,这些事情都阻碍了市场的扩张。
疫情扰乱了全球供应链,导致原料、原料药成分和包装材料短缺。这影响了无菌注射剂的分销和製造。由于劳动力限制、社交距离措施和封锁,製造业活动受到干扰。劳动力短缺和旅行限制使一些製药公司难以维持生产水准。
胰岛素细分市场预计将成为预测期内最大的市场
预计胰岛素领域在预测期内将是最大的。无菌注射胰岛素对于糖尿病管理至关重要。透过协助血糖调节,它有助于避免低血糖和高血糖。注射胰岛素可以根据患者的特定要求、生活方式和血糖值精确且独特地调整给药。不同类型的胰岛素有不同的给药时间和给药,以客製化治疗。
预计癌症产业在预测期内将经历最高的复合年增长率。
预计癌症产业在预测期内将经历最高的复合年增长率。药物治疗可以透过无菌注射剂以精确和受控的方式进行。这很重要,因为癌症治疗需要精确的给药,以最大限度地提高治疗效果并减少副作用。这在癌症治疗中尤其重要,因为可能需要迅速采取行动来阻止癌细胞的生长和扩散。
由于人口中慢性病和残疾的盛行率不断上升,预计北美在预测期内将占据最大的市场占有率。该地区发达的医疗基础设施、知名企业、有吸引力的报销规则以及在肿瘤学领域的广泛应用是推动这一市场扩张的因素。此外,美国食品药物管理局(FDA) 等监管机构对于确保该地区无菌注射药物的安全性和品质至关重要。
由于人口中癌症患者数量不断增加以及政府加强医疗保健部门的投资大幅增加,预计亚太地区在预测期内将保持最高的复合年增长率。在医疗环境中,无菌注射剂对于实施各种治疗至关重要,包括特殊药物、疫苗接种和抗生素。大型製药企业经常在该地区生产和销售无菌注射药物。
According to Stratistics MRC, the Global Sterile Injectable Market is accounted for $62.1 billion in 2023 and is expected to reach $115.0 billion by 2030 growing at a CAGR of 9.2% during the forecast period. Pharmaceuticals that are given intravenously and must be devoid of live germs like bacteria or fungus are referred to as sterile injectables. These injectables can be given intravenously (IV), intramuscularly (IM), or subcutaneously (SC). They are designed to be directly injected into the circulation or other sterile bodily tissues. To guarantee that there is no microbiological contamination in the finished product, they are usually prepared under stringent aseptic processing conditions.
According to the National Health Council, in 2016, chronic diseases affect approximately 133 million Americans, representing more than 40% of the total population of the country. By 2020, that number is projected to grow to an estimated 157 million, with 81 million having multiple conditions.
Rise in inclination towards sterile injectables
Sterile injectables, such as medicines, biologics, and vaccinations, are essential to healthcare, particularly for managing diseases and in emergency circumstances. New treatment methods, many of which are injected, have been discovered and developed as a result of advancements in medical research. This covers novel medical interventions such as gene and cell therapy. These are the aspects driving market growth throughout the predicted period.
Risk of contamination
Although sterility is maintained to the best of our ability, contamination can still occur during production, packing, or administration. For patients, contaminants can result in major health problems. Additionally, in order to preserve stability, some injectable medications may need special storage conditions, such refrigeration. Creating additional logistical hurdles for transportation and storage, particularly in areas with poor access to adequate facilities restrains the market growth.
Increased bioavailability
Sterile injectables frequently offer better bioavailability than oral drugs because they are not susceptible to the unpredictability of gastrointestinal absorption. Medications that are injectable frequently start working faster than those that are oral. For drugs with a limited therapeutic window or those needing a certain dosage for best efficacy, they are beneficial since they deliver larger drug concentrations straight into the circulation. During the anticipated time, these factors will be propelling market expansion.
Packaging concerns
Sterilized injectable packaging is essential to preserving the integrity of the product. A breach in the package may result in contamination or a reduction in the medication's effectiveness. Furthermore, the production and quality assurance procedures for sterile injectables can be expensive and complicated. Higher expenses follow for people, healthcare systems, and pharmaceutical corporations alike. Thus, these are the things impeding the market's expansion.
The pandemic caused supply chain disruptions on a worldwide scale, resulting in shortages of raw materials, active pharmaceutical ingredients (APIs), and packaging supplies. This has an impact on the distribution and manufacturing of sterile injectables. Manufacturing activities were disrupted by personnel constraints, social distancing measures, and lockdowns. Due to workforce shortages and mobility constraints, several pharmaceutical businesses found it difficult to sustain production levels.
The insulin segment is expected to be the largest during the forecast period
The insulin segment is expected to be the largest during the forecast period. Insulin that is sterile for injection is an essential part of managing diabetes. By assisting in blood glucose regulation, it helps avoid hypo- and hyperglycemia. With injectable insulin, dosage may be precisely and uniquely adjusted for each patient depending on their unique requirements, lifestyle, and blood glucose levels. To customize therapy, a variety of insulin types with different onset and duration characteristics are available.
The cancer segment is expected to have the highest CAGR during the forecast period
The cancer segment is expected to have the highest CAGR during the forecast period. Medication may be administered precisely and under control to sterile injectables. This is important because, in the treatment of cancer, precise dosage is necessary to maximize therapeutic efficacy and reduce adverse effects. This can be especially crucial for cancer therapy, as it may be required to act quickly to stop the growth and spread of cancer cells.
North America is projected to hold the largest market share during the forecast period due to the rise in prevalence of chronic diseases and disorders among population. The region's well-developed healthcare infrastructure, well-known companies, attractive reimbursement rules, and strong use in the cancer sector are all credited with this expansion. Furthermore, regulating organizations like the Food and Drug Administration (FDA) of the United States are essential in guaranteeing the security and caliber of sterile injectable medications in the area.
Asia Pacific is projected to hold the highest CAGR over the forecast period due to the increasing prevalence of cancer cases among people and surging investment by government with the purpose of enhancing healthcare sector. In healthcare settings, sterile injectables are essential for administering a range of treatments, such as specialized medications, vaccinations, and antibiotics. Sterile injectable medications are often manufactured and distributed in the region by major pharmaceutical businesses, both domestic and foreign.
Some of the key players in Sterile Injectable market include Novartis AG, Baxter International Inc., Merck & Co., Inc, AstraZeneca plc, Johnson & Johnson Services, Inc, Gilead Sciences, Inc., JHP Pharmaceuticals, Pfizer Inc., Fresenius Kabi Ag, CordenPharma, Hikma Pharmaceuticals PLC, Bryllon LLC, Aenova Holding GmbH, Vetter Pharma-Fertigung GmbH & Co. KG and Catalent Pharma Solutions.
In November 2023, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases.
In January 2022, Johnson & Johnson Medical Devices Companies announced that it will collaborate with Microsoft to further enable and expand JJMDC's secure and compliant digital surgery ecosystem.
In January 2021, Novartis announced collaboration with Alnylam to leverage Alnylam's proven, proprietary siRNA technology to inhibit a target discovered at the Novartis Institutes for BioMedical Research, potentially leading to development of a treatment designed to promote the regrowth of functional liver cells and to provide an alternative to transplantation for patients with liver failure.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.