市場調查報告書
商品編碼
1401844
到 2030 年無菌注射劑市場預測:按藥物類型、分子類型、途徑、給藥配銷通路、應用和地區進行的全球分析Sterile Injectable Market Forecasts to 2030 - Global Analysis By Drug Type, Molecule Type, Route of Administration, Distribution Channel, Application and By Geography |
根據 Stratistics MRC 的數據,2023 年全球無菌注射劑市場規模為 621 億美元,預計在預測期內複合年成長率為 9.2%,到 2030 年將達到 1,150 億美元。
需要去除活細菌(例如細菌或真菌)的靜脈注射藥物稱為無菌注射劑。這些注射劑可以靜脈注射(IV)、給藥(IM)或給藥(SC)。這些注射劑設計用於直接注射到循環系統或其他無菌身體組織中。它通常在嚴格的無菌加工條件下製備,以確保成品不受微生物污染。
根據美國國家衛生委員會的數據,2016 年,慢性病影響了約 1.33 億美國人,佔全國總人口的 40% 以上。到 2020 年,這一數字預計將增加到約 1.57 億,其中 8,100 萬人患有多種疾病。
對無菌注射劑的偏好日益增加
藥品、生物製藥和疫苗等無菌注射劑對於醫療保健至關重要,特別是對於疾病管理和緊急應變。醫學研究的進步導致了新的注射治療方法的發現和發展。這包括新的醫療干預措施,例如基因療法和細胞療法。這些方面將在整個預測期內推動市場成長。
污染風險
儘管盡可能保持無菌,但在製造、包裝和給藥過程中仍可能發生污染。對患者來說,污染物會導致嚴重的健康問題。此外,有些注射藥物需要特殊的儲存條件,例如冷藏,以保持穩定性。運輸和儲存方面的額外物流障礙限制了市場的成長,特別是在缺乏合適設施的地區。
提高生物利用度
無菌注射劑通常比口服藥物具有更好的生物利用度,因為它們不易受到胃腸道吸收不可預測性的影響。注射藥物通常比口服藥物起效更快。對於治療窗有限或需要固定給藥才能獲得最佳效果的藥物來說,注射劑是有益的,因為可以將更高濃度的藥物直接輸送到循環中。預計這些因素將在預期期間推動市場擴張。
包裝問題
無菌注射劑包裝對於維持產品完整性至關重要。包裝缺陷會導致污染和藥物功效降低。此外,無菌注射劑的製造和品質保證程序可能昂貴且複雜。對人們、衛生系統和製藥公司來說,這代價高昂。因此,這些事情都阻礙了市場的擴張。
疫情擾亂了全球供應鏈,導致原料、原料藥成分和包裝材料短缺。這影響了無菌注射劑的分銷和製造。由於勞動力限制、社交距離措施和封鎖,製造業活動受到干擾。勞動力短缺和旅行限制使一些製藥公司難以維持生產水準。
胰島素細分市場預計將成為預測期內最大的市場
預計胰島素領域在預測期內將是最大的。無菌注射胰島素對於糖尿病管理至關重要。透過協助血糖調節,它有助於避免低血糖和高血糖。注射胰島素可以根據患者的特定要求、生活方式和血糖值精確且獨特地調整給藥。不同類型的胰島素有不同的給藥時間和給藥,以客製化治療。
預計癌症產業在預測期內將經歷最高的複合年成長率。
預計癌症產業在預測期內將經歷最高的複合年成長率。藥物治療可以透過無菌注射劑以精確和受控的方式進行。這很重要,因為癌症治療需要精確的給藥,以最大限度地提高治療效果並減少副作用。這在癌症治療中尤其重要,因為可能需要迅速採取行動來阻止癌細胞的生長和擴散。
由於人口中慢性病和殘疾的盛行率不斷上升,預計北美在預測期內將佔據最大的市場佔有率。該地區發達的醫療基礎設施、知名企業、有吸引力的報銷規則以及在腫瘤學領域的廣泛應用是推動這一市場擴張的因素。此外,美國食品藥物管理局(FDA) 等監管機構對於確保該地區無菌注射藥物的安全性和品質至關重要。
由於人口中癌症患者數量不斷增加以及政府加強醫療保健部門的投資大幅增加,預計亞太地區在預測期內將保持最高的複合年成長率。在醫療環境中,無菌注射劑對於實施各種治療至關重要,包括特殊藥物、疫苗接種和抗生素。大型製藥企業經常在該地區生產和銷售無菌注射藥物。
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.