2014年9月23日讯 /生物谷BIOON/ --根据全球领先的制药与医疗保健顾问公司Decision Resources日前发布的一份新报告，2型糖尿病发病率的不断升高、对能够长期有效控制病情药物的高度未满足需求、品牌疗法的持续市场接纳，将推动美国、日本、欧洲5大主要市场（法国、德国、意大利、西班牙、英国）2型糖尿病市场高速增长，从2013年的260亿美元增长至2023年的460亿美元。（关于中国2型糖尿病市场，请点击生物谷文章《中国2型糖尿病市场分析》）（本文系生物谷原创编译整理，欢迎转载！转载请注明来源并附原文链接http://news.bioon.com/article/6659290.html，谢谢！）
在预测期内，SGLT-2抑制剂类糖尿病新药的增长速度最快。不过，这些新药及其他新兴疗法也将面临重大挑战，包括报销障碍和日益严格的监管环境。然而，随着患者群体的不断扩大和依然存在的显著临床需求，2型糖尿病市场的商业机会仍将继续增长。
尽管纳税人和报销机构企图限制这些较昂贵药物的使用，但强劲的2型糖尿病管线持续不断地扩充了临床医生的治疗选择范围，而且目前，临床医生也正持续采取更加个性化方法用于患者的临床护理，因此，品牌2型糖尿病药物市场也将继续保持快速增长。
——SGLT-2抑制剂市场增速最快：2013-2023预测期内，SGLT-2抑制剂将成为增长最快的一类2型糖尿病药物。尽管口服降糖药SGLT-2抑制剂类新药与已知的生殖器霉菌和尿路感染相关，但在全球主要市场中，近期推出的SGLT-2抑制剂正被市场快速接纳，率先上市的SGLT-2抑制剂将实现重磅销售，如强生的Invokana（canagliflozin，卡格列净）和阿斯利康的Farxiga/Forxiga（dapagliflozin，达格列净）。强生Invokana是上市的首个SGLT-2抑制剂，阿斯利康Farxiga/Forxiga是第二个上市的SGLT-2抑制剂。SGLT-2(钠-葡萄糖协同转运蛋白2)抑制剂类新药，通过抑制肾脏对葡萄糖的重吸收，增加葡萄糖排泄，进而降低糖尿病患者已升高的血糖水平。
——GLP-1市场，礼来Trulicity将取代诺德Victoza：随着数个长效（每周注射一次）GLP-1受体激动剂新药在市场中的显著预期接纳，该类药物在预测期内也将经历快速增长。另外，由于礼来的新药Trulicity（dulaglutide，每周注射一次）疗效媲美诺和诺德Victoza（liraglutide，利拉鲁肽，每日注射一次）同等的疗效，Victoza年销20亿美元，在GLP-1市场傲视群雄，但Trulicity具有每周注射一次的优势，该药预计将迅速被市场接纳，并成为Victoza的替代者。
——报销、DPP-4用药限制将日益严格：针对不断增长的2型糖尿病临床治疗负担，纳税人和报销机构对于可报销药物的限制也已经越来越严格。纳税人正不断限制临床医生的用药选择，尤其针对具有多个治疗方案的药物类别，如DPP-4抑制剂类药物。默沙东Januvia（sitagliptin，西他列汀）是DPP-4抑制剂市场的领导者，2013年销售额高达40亿美元。
——胰岛素生物仿制药来袭，礼来仿制药屠杀来得时：预测期内，胰岛素生物仿制药的上市，尤其是礼来和勃林格糖尿病联盟的来得时（Lantus）仿制药Basaglar/Abasria（甘精胰岛素），将迅速抢滩市场，并注定将大肆瓜分来得时的市场份额。来得时是赛诺菲最畅销的基础胰岛素，年销80亿美元。这一点与纳税人对目前现有胰岛素制剂治疗成本不断上升的担忧相呼应。然而，与生物仿制药相关的成本节约，相对其他小分子糖尿病药物仿制药相关的成本节约要少。
——糖尿病市场首迎价格战，GLP-1药物类别最脆弱：由于不断涌现的新药中，大多数药物仍代表着“me-too类”治疗选择，与较早进入市场的药物相比，却鲜有真正突出的特征，因此，2型糖尿病市场注定将迎来首次价格战。GLP-1受体激动剂类药物是所有药物中最脆弱的药物类别，与GLP-1受体激动剂市场中领先的诺和诺德的Victoza（liraglutide）相比，葛兰素史克（GSK）的Tanzeum/Eperzan（albiglutide）预计将推出相当的定价优惠。（生物谷Bioon.com）
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英文原文：Continued Uptake of Branded Therapies Will Drive the Type 2 Diabetes Market to Increase from $26 Billion in 2013 to $47 Billion in 2023
SGLT-2 Inhibitors Will Be the Fastest-Growing Drug Class Over the 2013-2023 Forecast Period, According to Findings from Decision Resources Group
BURLINGTON, Mass., Sept. 17, 2014 /PRNewswire/ -- Decision Resources Group finds that as physicians continue to adopt a more individualized approach to patient care, branded type 2 diabetes therapies continue to experience increased use despite attempts by payer and reimbursement authorities to limit use of these more expensive drugs. As the robust type 2 diabetes pipeline increases the range of therapeutic options available to physicians, the overall type 2 diabetes market within the G7 (United States, France, Germany, Italy, Spain, United Kingdom and Japan) is set for rapid expansion, with growth from sales of over $26 billion in 2013 to $47 billion in 2023.
Other key findings from the Pharmacor advisory service entitled Type 2 Diabetes:
SGLT-2 inhibitors: The recently launched SGLT-2 inhibitors are experiencing rapid uptake in the major markets, despite known associations with genital mycotic and urinary tract infections; the first-to-market entrants canagliflozin (Johnson & Johnson's Invokana) and dapagliflozin (AstraZeneca's Farxiga/Forxiga) are set to garner significant sales.
GLP-1 receptor agonists: The GLP-1 receptor agonist class is also set for significant growth during the forecast period, with the emergence of a number of once-weekly agents set for considerable uptake. As the only once-weekly agent to thus far demonstrate non-inferiority to the market-leading liraglutide (Novo Nordisk's Victoza), dulaglutide (Eli Lilly's Trulicity) is set to garner significant uptake.
Increasingly stringent reimbursement: In response to the increasing cost burden of type 2 diabetes, payer and reimbursement agencies are becoming increasingly stringent with regard to reimbursable therapies. Payers are increasingly restricting the number of options available to physicians, particularly for drug classes with multiple therapy options, such as the DPP-IV inhibitors.
Biosimilar insulins: The emergence of biosimilar insulins during the forecast period, in particular Eli Lilly/Boehringer Ingelheim's biosimilar insulin glargine (Basaglar/Abasria), are set to enjoy considerable uptake in response to payer concerns over the escalating costs of existing insulin formulations. However, the cost-savings associated with biosimilars are less than those associated with generic small molecules.
Comments from Decision Resources Group Analyst Eamonn O'Connor, Ph.D.:
"Initial uptake of the SGLT-2 inhibitors has been stronger than previously anticipated, with uptake of first-to-market canagliflozin in the United States closely mirroring sales of sitagliptin (Merck's Januvia), the market-leading DPP-IV inhibitor with over $4 billion in annual sales in 2013."
"With the majority of emerging novel therapies representing 'me-too' therapeutic options with few truly distinguishing features from earlier-to-market entries, the type 2 diabetes market may be set to witness class-specific price wars for the first time. The GLP-1 receptor agonist class appears to be the most vulnerable, with albiglutide (GlaxoSmithKline's Tanzeum/Eperzan) launching at a considerable discount to the market-leading GLP-1 agonist liraglutide."
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