A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes

The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.

开始日期2025-01-28

申办/合作机构

Novo Nordisk A/S

NCT06547619

/ Recruiting早期临床1期IIT

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.

开始日期2024-10-01

申办/合作机构

University of Iowa

NCT06532461

/ RecruitingN/AIIT

A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes

More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog

开始日期2024-07-20

申办/合作机构

Steno Diabetes Center A/S

100 项与门冬胰岛素相关的临床结果

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100 项与门冬胰岛素相关的转化医学

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100 项与门冬胰岛素相关的专利（医药）

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689

项与门冬胰岛素相关的文献（医药）

2025-03-01·Endocrine Practice

Comparing Postprandial Glycemic Control Using Fiasp vs Insulin Aspart in Hospitalized Patients With Type 2 Diabetes

Article

作者: Reddy, Niyoti ; Steenkamp, Devin W ; Alexanian, Sara M ; Malik, Aamir ; Cheney, Michael C ; Murati, Jonila ; Spartano, Nicole L ; Bello-Ramos, Jenny C ; Wolpert, Howard A

OBJECTIVE:

Hyperglycemia in hospitalized patients is associated with increased morbidity and mortality. Basal-bolus insulin therapy is the treatment of choice for most patients. The efficacy of an ultrarapid vs rapid-acting insulin in hospitalized patients with diabetes has not been evaluated. We assessed noninferiority in efficacy and safety of Fiasp vs aspart (Novolog) as part of a basal-bolus insulin regimen in noncritically ill patients with type 2 diabetes in a safety-net hospital.

METHODS:

This prospective, open-label, randomized trial included 137 patients with diabetes admitted to a non-intensive care unit setting. Subjects were treated with glargine at bedtime and either Fiasp or Novolog for prandial and correction insulin. Subjects were enrolled for a minimum of 4 or maximum of 6 meal boluses. Capillary blood glucose was used for insulin adjustment and a blinded Dexcom G6 Pro captured data for study analysis. The primary endpoint was time spent in sensor glucose range 100-180 mg/dL in the 4-hour postprandial period (assessed among 106 participants with ≥ 4 meals with a 4-hour postprandial period). Time spent in hypoglycemic ranges (<70, <54, <40 mg/dL) was assessed for safety.

RESULTS:

Four-hour postprandial time in range 100-180 mg/dL was 45% in the Fiasp group vs 36% in the Novolog group (P = .012; meeting prespecified noninferiority criteria). Other glycemic metrics were similar between groups with no difference in time spent in hypoglycemic ranges.

CONCLUSION:

Fiasp provides noninferior postprandial glucose control in hospitalized patients with type 2 diabetes when compared to Novolog with no increase in rates of hypoglycemia.

2025-03-01·Indian journal of pediatrics

Effect of Postmeal Fast-Acting Insulin Aspart Injection on the Frequency of Hypoglycemia among Pre-School Children with Type 1 Diabetes: An Open-Label, Cross-Over, Randomized Control Trial

Article

作者: Kumar, Rakesh ; Dayal, Devi ; Pattanaik, Smita ; Yadav, Jaivinder ; Patil, Amol ; Yadav, Arti

OBJECTIVES:

To study the effect of postmeal Fast-acting insulin Aspart (Fiasp^®) on the frequency of hypoglycemia compared to premeal injection among preschool children with type 1 diabetes.

METHODS:

A single-center trial was conducted among 65 pre-school children (6 mo to 6 y) with Type 1 diabetes for at least 6 mo, on multiple daily insulin injections. Children were randomized to receive their meal bolus postmeal or premeal for the first 3 mo, followed by cross-over at 3 mo. The two groups were compared at the end of 6 mo for the change in frequency of hypoglycemia and hyperglycemia, HbA1c, glycemic variability, and parental satisfaction. Ten children (5 in each group) underwent pharmacokinetic studies. The trial was approved by Institutional Ethics Committee and registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.

RESULTS:

Fifty-four children completed the study, with 27 children in each group. There were no significant differences in the frequency of clinical (p = 0.921), severe (p = 0.167) or serious (p = 0.753) hypoglycemia in the two groups. There were no differences in secondary outcome parameters and pharmacokinetics.

CONCLUSIONS:

The premeal or postmeal injection of Fiasp^® does not affect the frequency of hypoglycemia or other glycemic control parameters among pre-school children with Type 1 diabetes.

TRIAL REGISTRATION:

The trial is registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.

2025-02-01·JOURNAL OF SEPARATION SCIENCE

First Dimension Trap‐and‐Elute Combined with Second Dimension Reversed‐Phase Liquid Chromatography Separation Using a Two‐Dimensional‐Liquid Chromatography‐Tandem Mass Spectrometry System for Sensitive Quantification of Human Insulin and Six Insulin Analogs in Plasma: Improved Chromatographic Resolution and Stability Testing

Article

作者: Stejskal, David ; Jurica, Jan ; Handlos, Petr ; Sistik, Pavel ; Handlosova, Klara ; Andelova, Katerina ; Urinovska, Romana

ABSTRACT:

Multidimensional chromatography coupled to tandem mass spectrometry (MS/MS), including simple sample preparation with protein precipitation, anion conversion with ammonium hydroxide, and solid‐phase extraction using mixed‐mode anion exchange in a 96‐well plate format, has been validated for rapid simultaneous analysis of human insulin and its six analogs (lispro, glulisine, glargine, degludec, detemir, and aspart) in human plasma. This method is critical for clinical diagnostics, forensic investigations, and anti‐doping efforts due to the widespread use of these substances. In the present study, improved chromatographic resolution was achieved using a first‐dimension trap‐and‐elute configuration with an XBridge C18 (2.1 × 20 mm, 3.5 µm) trap column combined with second dimension separation on a Cortecs Ultra‐High‐Performance Liquid Chromatography (UHPLC) C18+ (2.1 × 100 mm, 1.6 µm) analytical column implemented within a two‐dimensional‐LC‐MS/MS system. The total chromatographic run time was 11 min. This setup increases both the resolution and sensitivity of the method. A mobile phase consisting of 0.8% formic acid (FA) in water and 0.7% FA in acetonitrile was used for gradient elution. Bovine insulin was used as the internal standard. MS detection was performed in positive electrospray ionization mode, and the ion suppression due to matrix effects was evaluated. Validation criteria included linearity, precision, accuracy, recovery, lower limit of quantitation, matrix effect, and stability tests with and without protease inhibitor cocktail under different conditions (short‐term stability, long‐term stability, and freeze‐thaw stability). The concentration range for all insulins was 50–15 000 pg/mL, with limits of quantification below the therapeutic reference range for all analytes. Intra‐run precision ranged from 1.1% to 5.7%, inter‐run precision from 0.7% to 5.9%, and overall recovery from 96.9% to 114.3%. The validated method has been implemented successfully by the Department of Forensic Medicine at our hospital for the investigation of unexplained deaths.

203

项与门冬胰岛素相关的新闻（医药）

2025-03-06

·PRNewswire

Biocon Biologics and Civica, Inc. Collaborate to Expand Insulin Aspart Access in the United States

BRIDGEWATER, N.J. and PETERSBURG, Va. and BENGALURU, India, March 6, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), and Civica, Inc. (Civica), a not-for-profit generic drug and pharmaceutical company founded in 2018 to address and resolve life-saving drug shortages and affordability, today announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the United States. Continue Reading Under the terms of the agreement, Biocon Biologics will supply Insulin Aspart drug substance to Civica, Inc., who will use the drug substance to produce Insulin Aspart drug product, a rapid-acting insulin analog, at its manufacturing facility in Petersburg, Virginia. Civica will commercialize the medicine for patients in the United States, after completion of development work and clinical trials. No technology transfer is involved in the agreement. Biocon Biologics and Civica announce agreement to expand access and affordability of Insulin Aspart in the U.S. Post this Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "As a fully integrated global biologics company, Biocon Biologics is uniquely positioned to drive commercial success through tailored go-to-market strategies that create lasting value for all stakeholders. Our collaboration with Civica reflects this commitment, enabling us to expand patient access to Insulin Aspart in the United States while reinforcing our dedication to serving the growing needs of people living with diabetes. Together, we are working to ensure more patients have access to high-quality, affordable insulin." Ned McCoy, President and Chief Executive Officer, Civica, Inc., said: "Civica's mission is to help people who need access to necessary generic and biosimilar medicines at affordable prices. This includes people living with diabetes, one in five of whom have skipped, delayed, or used less insulin than was needed to save money. Our partnership with Biocon Biologics for Aspart drug substance supply will allow us to deliver on our important mission and help people who need access to Insulin Aspart. Civica will utilize our U.S.-based manufacturing operations in Petersburg, Virginia to produce prefilled pens and vials of insulin." This collaboration is in addition to Biocon Biologics' own Insulin Aspart Drug Product for the United States which is currently under U.S. Food and Drug Administration (FDA) review. There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.1 1 U.S. Department of Health & Human Services, Centers for Disease Control and Prevention. "National Diabetes Statistics Report." Accessed: January 28, 2025. Last Reviewed: May 15, 2024. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. About Civica, Inc.: Civica is a non-profit generic pharmaceutical company established in 2018 to address drug shortages. It was founded by a group of U.S. health systems and philanthropies who, after more than a decade of chronic shortages, recognized that the market was not self-correcting and that a different approach is required. Civica works to deliver a safe, stable, and affordable supply of essential medicines to U.S. patients. Civica has built a sterile injectable manufacturing plant in Petersburg, Virginia capable of producing prefilled pens and vials of insulin. Website: Follow us on X (formerly Twitter) @civicarx and LinkedIn: CivicaRx for company updates Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd. 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引进/卖出

2025-03-05

·摩熵医药

价格暴跌超50%！140亿胰岛素市场，甘李药业等国产企业借势崛起……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近年来，随着GLP-1受体激动剂、SGLT-2抑制剂等新型糖尿病治疗药物的涌现，糖尿病治疗选择日益丰富。然而，胰岛素凭借其独特的作用机制和广泛的适用人群，依然在糖尿病治疗市场中占据核心地位。在医疗技术进步和患者需求多样化的推动下，胰岛素市场正经历深刻变革。对于医药企业而言，理解市场竞争格局、把握市场趋势，不仅是生存的关键，更是实现可持续发展的必由之路。摩熵咨询的《胰岛素市场研究专题报告》揭示了胰岛素市场的现状，并前瞻性地指出了行业发展方向。本文基于该报告部分内容，聚焦甘精胰岛素等产品的发展现状与竞争态势，并展望胰岛素市场的未来走向，旨在为相关各方把握市场机遇、应对挑战提供有力参考。 01 甘精胰岛素市场竞争格局 1.甘精胰岛素2023年全国销售额约42亿元，原研占据过半市场甘精胰岛素为第三代基础胰岛素类似物，是全球首个每日一次的长效胰岛素类似物，原研企业为法国赛诺菲公司，商品名为来得时。甘精胰岛素分别于2000年4月获得美国FDA批准上市，用于治疗1型和2型糖尿病，2004年进入中国市场，目前国内生产企业包括甘李药业、珠海联邦制药、通化东宝药业等。在国内销售额方面，据摩熵医药数据库统计，甘精胰岛素注射液于2021年达到销售峰值84.79亿元，2021年纳入胰岛素专项集采后销售额急剧下滑，目前销售额仅约41.77亿元。数据来源：摩熵医药销售数据库在竞争格局方面，赛诺菲作为原研企业，凭借其品牌优势和技术实力，稳居市场第一，市场份额约52%。而本土企业甘李药业等则通过仿制药的研发和生产，逐渐占据了三成的市场份额。 2.专项集采五家企业中标，国产产品院内销售额/量小幅提升 2021年专项集采中，甘精胰岛素注射液总采购量为3125万支，采购金额约19.03亿元，为采购量/金额第三大品种，中标企业包括原研赛诺菲和四家国产厂商，包括甘李药业、通化东宝、东阳光、联邦制药。专项集采后，赛诺菲院内销售额占比从57.02%略微下滑至53.38%，销售量占比从52.99%下滑至45.25%，国产仿制产品销售额/量均有所提升，2023年销售额/量占比分别达46.67%、54.75%。数据来源：摩熵医药药品集中采购数据库 3.甘精胰岛素注射液各级医院市场分析（以海南省为例）据摩熵医药药物流向数据显示，以海南省为例，甘精胰岛素注射液2023年各季度销售量和销售额如下图：甘精胰岛素注射液2023年销售额TOP3医院（海南省为例）分别为海南省人民医院、海南医学院第二附属医院、海南医学院第一附属医院。数据来源：摩熵医药药物流向数据甘精胰岛素注射液2023年销售市场在各级医院均有分布，其中三级医院为主要销售市场，各季度三级医院销售额占比均达到63%以上。 02 精蛋白重组人胰岛素市场竞争格局 1.精蛋白重组人胰岛素2023年全国销售额约47亿元，预混30R为主要品种精蛋白重组人胰岛素为第二代产品，属于中效胰岛素，目前我国已上市的制剂按照速效胰岛素加入的比例，包括常规、30R、40R、50R四个品种。精蛋白重组人胰岛素混合注射液（30R）峰值持续时间较长，2-8小时可达最大效应，作用持续时间为12-24小时，能够较好地模拟人体胰岛素的自然分泌模式，该品种为目前国内市场精蛋白重组人胰岛素主要品种。受集采影响，精蛋白重组人胰岛素销售额从2020年开始连续下滑，常规、30R、40R、50R四个品种2023年合计销售额为47.10亿元，其中30R销售额最大，超过40亿元。诺和诺德、通化东宝、珠海联邦制药为主要玩家，合计占据80%以上市场。 2.预混30R专项集采中选企业达8家，最高降幅超70% 2021年专项集采中，常规、30R、40R、50R四个品种平均降幅约43.85%、48.27%、42.08%、41.92%，中选企业数分别有6、8、1、4家。精蛋白重组人胰岛素混合注射液（30R）采购量为6745万支，为采购量最大品种，采购金额约19.63亿元。甘李药业旗下3ml:300iu（笔芯）规格中选价格低至17.89元，而江苏万邦降幅最高，达70.17%。图片来源：摩熵咨询的《胰岛素市场研究专题报告》 03 门冬胰岛素市场竞争格局 1.门冬胰岛素2023年全国销售额约53亿元，原研占据主导地位门冬胰岛素为第三代胰岛素类似物，属于速效胰岛素，原研企业为诺和诺德，于1999年首次在欧洲上市，2000年在美国上市，2005年进入国内市场，此后，诺和诺德分别在2005年、2012年推出预混30、预混50产品。近五年，门冬胰岛素全国销售额受第六批集采影响较大，从2021年峰值96.26亿元下滑至53.42亿元，预混30是销售额最大的品种，2023年销售额约33.98亿元。竞争格局方面，原研企业诺和诺德处于绝对优势地位，目前市场份额近90%。 2.第六批集采平均降幅约50.24%，预混30产品采购量/金额位居第二 2021年专项集采中，门冬胰岛素常规、预混30、预混50三个品种平均降幅约52.71%、49.52%、40.00%，中选企业数分别有5、3、1家，整体平均降幅约50.24%。门冬胰岛素30注射液采购量约4478万支，采购金额约19.27亿元，为采购量/金额第二位的大品种。甘李药业3ml:300iu（笔芯）规格降幅高达65.89%，中选单价低至24.56元。 04 胰岛素市场趋势分析趋势1：三代胰岛素替代加速，新型胰岛素制剂蓄势待发未来第三代胰岛素将逐步替代二代产品。我国历年胰岛素市场结构呈现明显的变化趋势，受到新一代产品的冲击，二代胰岛素市场份额逐年下降，2023年二代胰岛素整体份额下滑至19%，而第三代胰岛素（胰岛素类似物）因其更接近生理性的作用机制和更少的副作用，2023年占据了六成胰岛素市场，未来也将继续保持主导地位。新型胰岛素制剂开启糖尿病治疗新纪元。诺和诺德旗下伊柯胰岛素为全球首款胰岛素周制剂，每周仅需注射一次，在人体内半衰期约196小时，注射频率降低可提高患者治疗接受度和依从性；赛诺菲甘精胰岛素利司那肽注射液为甘精胰岛素与利司那肽的固定比例复方制剂，可兼顾降糖疗效、低血糖风险和体重获益；未来新型胰岛素制剂将为糖尿病患者提供更多治疗选择。趋势2：国产胰岛素全球竞争力显著提升，出海正成为大势所趋市场规模方面，2023年全球胰岛素市场规模约367亿美元，而北美、欧洲仍是主要的市场，合计市场份额超过80%，为国产胰岛素产品出海提供了广阔的市场空间；产品价格方面，在美国市场占据主导地位的赛诺菲、诺和诺德、礼来三家企业旗下胰岛素产品价格显著高于国内，高定价为国产胰岛素全球化发展提供了机遇。出海正成为全行业共识，甘李药业、通化东宝两家企业率先开启胰岛素出海，多款产品海外研发及申报顺利推进，未来更多国产胰岛素产品将登上国际舞台，参与全球化竞争。结语胰岛素专项集采重塑了国内市场格局，加速国产替代与价格理性回归；而三代胰岛素迭代与新型制剂研发则为行业注入长期增长动力。未来，具备创新研发能力与全球化视野的企业将主导市场竞争。 END 本文为原创文章，转载请留言获取授权市场研究专题报告二十四----胰岛素完整报告领取方式近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准带量采购医药出海核酸药物

2025-03-04

·摩熵医药

最高降价74%！集采之下，胰岛素市场国产双雄通化东宝、甘李崛起

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。糖尿病作为一种高发且严重影响人们健康的慢性疾病，其治疗药物市场一直备受关注。胰岛素作为糖尿病治疗的关键药物，在降糖药物领域中占据着举足轻重的地位。摩熵咨询发布的《胰岛素市场研究专题报告》，深度剖析了胰岛素流行病学数据、胰岛素市场竞争格局以及胰岛素市场趋势等多个关键方面，为医药企业制定战略规划、研发决策和市场推广提供有力的数据支撑。本文将基于报告的部分精选内容，将对我国胰岛素市场的竞争格局进行分析。 01 胰岛素市场概览集采冲击下，我国胰岛素市场规模下滑至190亿元，占据一半降糖药市场。近年来，受集采政策的显著影响，我国胰岛素市场规模发生了明显变化。据摩熵医药销售数据库的数据，近五年我国胰岛素市场规模走势呈现出先升后降的态势。2019年市场规模为296亿元，随后增长至2021年的峰值339亿元。然而，由于2021年全国第六批集采（胰岛素专项集采）的实施，市场规模迅速下滑，到2023年已降至192亿元。其中，医院端的销售额为166亿元，约占总销售额的86%。数据来源：摩熵医药销售数据库在全球及中国降糖药物市场的大格局中，胰岛素依旧占据着半壁江山。我国胰岛素市场份额占比约为48%，紧随其后的是GLP-1RA（13%）、SGLT-2i（12%）、DPP-4i（10%）以及其他口服降糖药（17%）。 02 胰岛素市场竞争格局诺和诺德、赛诺菲、礼来合计占据68%市场，通化东宝、甘李为国产胰岛素双雄。从企业竞争层面来看，在2023年我国胰岛素销售额企业排行榜中，排名前五的企业外资占据三席，内资占据两席。外资企业中，诺和诺德以94.31亿元的销售额位居榜首；赛诺菲销售额约为22.27亿元，礼来销售额约为14.23亿元。在内资企业中，通化东宝和甘李药业被誉为国产胰岛素双雄，2023年销售额分别约为21.56亿元和18.09亿元。综合来看，诺和诺德、赛诺菲、礼来三家外资企业合计占据我国近七成的胰岛素市场份额，而本土代表企业通化东宝和甘李药业的市场份额仍然较低，两者合计约为21%。在胰岛素品种方面，甘精胰岛素作为第三代基础胰岛素，在市场上表现突出。2023年，其全国销售额约为41.77亿元，市场份额约为22%，成为我国销售额排名第一的胰岛素品种。销售排名第二的品种是精蛋白重组人胰岛素混合注射液（30R），属于第二代预混胰岛素，2023年销售额为40.09亿元，市场份额约为20.84%。数据来源：摩熵医药销售数据库在排名前十的品种中，第三代产品有7个，第二代产品有3个，这显示出第三代胰岛素产品在市场上的受欢迎程度逐渐提高，市场份额也在不断扩大。 03 胰岛素集采 01 集采概况全国两轮胰岛素集采全面覆盖二、三代产品，接续集采药品价格稳中有降。为了降低患者的用药成本，提高胰岛素的可及性，我国针对胰岛素先后开展了两轮集采工作，即2021年11月开始的专项集采和2024年3月开始的接续集采。 2021年11月26日，全国第六批国家药品集中采购（胰岛素专项）在上海开标，共纳入二代和三代胰岛素，包括六大类、16个胰岛素品种、42个胰岛素产品，药品平均降价47.67%，最高降幅达74%。 2024年3月29日，胰岛素接续集采工作启动，主要涉及全国第六批集采品种的接续，包括六大类、15个胰岛素品种，13家企业的49个产品完成集中采购，药品平均降价43.87%，在专项集采基础上再降3.8%。图片来源：摩熵咨询《胰岛素市场研究专题报告》 02 需求量与采购金额接续集采整体需求量、采购金额均有所提升，预混胰岛素（类似物）为采购大类。全国第六批集采需求量为2.15亿支，品种单价约38.59元/支，采购金额总计82.98亿元；而接续集采需求量为2.41亿支，品种单价约38.76元/支，整体来看，接续集采需求量和采购金额在全国第六批集采基础上均有所提升。两次集采均覆盖人胰岛素产品（第二代）和胰岛素类似物产品（第三代），每代产品又包括餐食、基础、预混三大类。从需求量来看，两次集采的第二代产品以预混胰岛素为主，第三代产品以预混胰岛素类似物为主，基础胰岛素类似物次之。数据来源：摩熵医药药品集中采购数据库 03 品种采购集中度前四位品种采购量占总量的74%，采购金额占比约75%。门冬胰岛素30注射液和精蛋白人胰岛素混合注射液（30R）采购量排在前两位，采购量前4位的品种需求量在首次采购中占总量的76.17%，在接续采购中占总量的74.26%。前四的品种采购金额首次采购占总量的80.32%，接续采购占总量的75.49%。 04 企业集采表现诺和诺德两次集采采购金额均居首位，甘李药业接续集采量价齐升。诺和诺德两次集采的采购金额均居首位，其中专项集采43.10亿元、接续集采30.65亿元，约占总采购金额的51.93%和32.86%。中选品种数分别为9、8个，包括人胰岛素、精蛋白人胰岛素、精蛋白人胰岛素混合液30R、精蛋白人胰岛素混合液50R、门冬胰岛素、德谷胰岛素、地特胰岛素（接续未中选）、门冬胰岛素30、门冬胰岛素50。甘李药业采购量和采购金额在接续集采时大幅提升，采购量从16.64亿支提升至41.77亿支，采购金额从7.24亿元增至17.91亿元，中选价格方面，接续集采较上一次专项集采上涨31%。前后两次集采中选品种数均为6个，包括精蛋白人胰岛素混合液30R、门冬胰岛素、赖脯胰岛素、甘精胰岛素、精蛋白锌重组赖脯胰岛素混合液25R、门冬胰岛素30。结语胰岛素市场竞争格局在集采政策的影响下呈现出新的特点和发展趋势。未来，企业需要密切关注市场动态和政策变化，加强技术创新和产品研发，提升市场竞争力，以应对日益激烈的市场竞争和不断变化的市场需求。摩熵咨询该报告为药企制定集采应对策略、投资机构评估行业潜力提供了关键数据支撑，尤其在集采常态化与创新转型背景下，具有重要决策参考意义。 END 本文为原创文章，转载请留言获取授权市场研究专题报告二十四----胰岛素下期内容预告目录一、诺和诺德、赛诺菲、礼来瓜分80%市场，国产胰岛素出海抢滩全球市场近期将持续更新，敬请期待近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

带量采购医药出海上市批准核酸药物

100 项与门冬胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04475	门冬胰岛素	A10AD05 A10AB05	DB01306

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	日本	Novo Nordisk A/S	2019-09-20
糖尿病	欧盟	Novo Nordisk A/S	1999-09-07
糖尿病	冰岛	Novo Nordisk A/S	1999-09-07
糖尿病	列支敦士登	Novo Nordisk A/S	1999-09-07
糖尿病	挪威	Novo Nordisk A/S	1999-09-07

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肥胖	临床3期	西班牙	Novo Nordisk A/S	2005-04-01
急性淋巴细胞白血病	临床3期	美国	Novo Nordisk A/S	2004-04-01
淋巴母细胞淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
伯基特淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
低血糖	临床3期	澳大利亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	克罗地亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	丹麦	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	意大利	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	南非	Novo Nordisk A/S	2001-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03659799 (Pubmed)	临床4期	1型糖尿病	40	insulin type (ultra-rapid vs rapid insulin) (Rapid aspart)	鹹築糧壓選艱廠襯觸願(願鑰獵窪壓廠膚壓糧網) = 繭選鹽製艱鏇鏇壓淵繭鬱窪膚膚廠鏇簾壓鏇範 (願選願夢鏇蓋夢淵觸壓 )	积极	2024-07-29
				insulin type (ultra-rapid vs rapid insulin) (Exercise at 60 min post meal)	選窪積夢顧齋齋鑰築遞(顧築蓋築遞鑰壓醖襯網) = 餘壓鑰艱構鏇顧觸鬱艱選糧遞構膚觸獵鹹鏇範 (築淵襯憲構積壓蓋夢鏇, 1.2 ~ 100%)
NCT04538352 (TRANSITION-T2D, CTgov)	临床4期	2型糖尿病	60	Insulin Degludec+semaglutide+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	構廠醖襯積願簾衊簾鬱(壓鏇膚糧獵製遞網觸鬱) = 鏇艱獵鑰積願夢願窪艱衊糧醖餘襯餘範鏇壓鹹 (鬱蓋簾餘憲襯簾簾願糧, 築簾憲觸鑰築襯襯廠壓 ~ 淵醖遞網夢顧廠築鬱觸) 更多	-	2024-07-29
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	構廠醖襯積願簾衊簾鬱(壓鏇膚糧獵製遞網觸鬱) = 夢鹹製窪鏇鹽鹽糧積築衊糧醖餘襯餘範鏇壓鹹 (鬱蓋簾餘憲襯簾簾願糧, 願廠憲獵繭壓餘憲構淵 ~ 鹽廠鹹範鑰鏇簾範顧淵) 更多
820-P (ADA2024)	N/A	1型糖尿病	-	Faster-Acting Insulin Aspart (Fiasp)	製獵構醖鬱鏇遞壓憲選(憲壓鬱積選鑰淵醖醖願) = 壓製鹹糧選觸糧襯鹹遞艱齋夢鹽鹹範憲鑰積夢 (製夢鬱遞壓簾鏇繭遞遞, 12.3) 更多	积极	2024-06-14
				Insulin Aspart (Iasp)	製獵構醖鬱鏇遞壓憲選(憲壓鬱積選鑰淵醖醖願) = 醖憲餘壓繭齋簾鑰網繭艱齋夢鹽鹹範憲鑰積夢 (製夢鬱遞壓簾鏇繭遞遞, 12.1) 更多
NCT04588259 (CTgov)	临床3期	1型糖尿病 \| 2型糖尿病	331	Insulin degludec+Faster aspart	遞繭夢觸顧選網構衊製(鏇範醖獵鏇淵窪遞鹹衊) = 淵遞簾範選夢網遞構壓襯築膚選積壓鏇廠願壓 (窪構願遞壓顧簾繭衊願, 0.63) 更多	-	2024-03-20
NCT04460326 (In-FI, CTgov)	临床3期	2型糖尿病	137	Insulin Glargine+NovoLog (Group 1 Insulin Glargine and Novolog)	憲鑰襯範製範窪蓋蓋範(積繭廠壓構顧簾襯鏇廠) = 齋窪獵製膚網廠蓋廠蓋構積廠憲遞顧遞築壓築 (膚網齋願艱憲鹹夢願蓋, 29.78) 更多	-	2024-03-19
				Insulin Glargine+Insulin Fiasp (Group 2 Insulin Glargine and Fiasp)	憲鑰襯範製範窪蓋蓋範(積繭廠壓構顧簾襯鏇廠) = 糧襯築範構構餘憲簾繭構積廠憲遞顧遞築壓築 (膚網齋願艱憲鹹夢願蓋, 32.63) 更多
NCT00913497 (CTgov)	临床4期	1型糖尿病	16	insulin glulisine (Insulin Glulisine)	構網築蓋觸簾衊遞鏇鏇(蓋鹽憲淵選獵餘築艱夢) = 窪窪淵遞構淵範顧襯鹹範鏇繭鏇獵簾鏇艱獵網 (簾製壓製齋蓋獵襯鹹獵, 15.7) 更多	-	2023-09-18
				Insulin Aspart (Insulin Aspart)	構網築蓋觸簾衊遞鏇鏇(蓋鹽憲淵選獵餘築艱夢) = 範鹹膚餘餘廠願夢艱窪範鏇繭鏇獵簾鏇艱獵網 (簾製壓製齋蓋獵襯鹹獵, 14.7) 更多
NCT04853030 (Pubmed \| Diabetes Technol Ther)	N/A	1型糖尿病	30	Faster Insulin Aspart	願餘襯壓憲鬱願窪鹽積(鹽鹹醖齋鹹鑰壓憲齋廠) = 窪廠鹹糧繭糧鏇醖淵餘蓋窪夢膚餘餘壓齋餘鬱 (網積獵簾淵憲製顧願壓 ) 更多	不佳	2023-09-01
				Standard Insulin Aspart	願餘襯壓憲鬱願窪鹽積(鹽鹹醖齋鹹鑰壓憲齋廠) = 簾顧製顧夢網襯壓窪艱蓋窪夢膚餘餘壓齋餘鬱 (網積獵簾淵憲製顧願壓 ) 更多
NCT03895515 (Pubmed \| Diabetes Ther)	N/A	1型糖尿病	178	Fast-Acting Insulin Aspart	築鹹願壓繭艱鹹鏇獵選(積獵窪觸鹽憲觸獵憲襯) = 網齋窪網遞蓋獵範積範網廠壓膚衊艱選遞選艱 (構夢憲蓋艱鹹選廠觸鹽 )	积极	2023-07-14
ADA2023	N/A	-	29	AT247	夢廠餘構範繭網壓範鹽(窪繭壓齋獵選壓壓網廠) = 壓壓壓鹽壓齋蓋遞簾鹹鏇齋糧鏇襯廠積艱構膚 (鹽鬱蓋壓鹽獵積選獵齋 )	-	2023-06-20
				NovoLog	夢廠餘構範繭網壓範鹽(窪繭壓齋獵選壓壓網廠) = 製壓範範鹽鑰構壓衊艱鏇齋糧鏇襯廠積艱構膚 (鹽鬱蓋壓鹽獵積選獵齋, *)
CopenFast Trial (ADA2023)	N/A	1型糖尿病	216	Faster-acting insulin aspart	鬱鬱築鏇鹹壓繭觸淵範(鹹憲簾積鏇糧製襯築淵) = 夢繭觸醖願醖鑰蓋壓鏇製蓋構鹽鹽窪窪齋鹽繭 (艱餘網選膚艱鬱醖壓蓋, 38 ~ 46) 更多	-	2023-06-20
				Insulin aspart	鬱鬱築鏇鹹壓繭觸淵範(鹹憲簾積鏇糧製襯築淵) = 鬱壓選襯構壓憲願壓願製蓋構鹽鹽窪窪齋鹽繭 (艱餘網選膚艱鬱醖壓蓋, 39 ~ 46) 更多