Obesity, Abdominal

A case study on how DelveInsight helped a pharma client navigate the evolving metabolic dysfunction-associated steatohepatitis (MASH) landscape with actionable market intelligence LAS VEGAS, March 13, 2025 /PRNewswire/ -- DelveInsight recently conducted an in-depth MASH Market Size and Share Assessment to help a pharmaceutical client understand the evolving Metabolic Dysfunction-Associated Steatohepatitis (MASH) market in key Asian countries. Formerly known as Non-Alcoholic Steatohepatitis (NASH), MASH was officially renamed in 2023 by leading liver disease authorities, including the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), to reflect its metabolic origins better. The client sought to evaluate MASH prevalence, MASH patient burden, existing and emerging therapies for MASH, and market entry feasibility in China, India, Japan, South Korea, and Southeast Asian nations. Understanding MASH grade- and severity-specific patient pools, treatment adoption, and competitive dynamics was crucial to shaping their market entry and product positioning strategy. With decades of expertise in Pharma Market Assessments, DelveInsight employed rigorous epidemiological research, competitive intelligence, and strategic forecasting to equip the client with actionable insights. Our comprehensive analysis provided a clear picture of MASH treatment trends, market gaps, and the potential opportunities for innovative therapies. MASH is a rising global health concern, particularly in Asia, where factors such as ethnicity, obesity, and metabolic syndrome contribute to high prevalence rates. According to DelveInsight, there were approximately 42 million prevalent cases of MASH in the 7MM (US, EU5, and Japan) in 2023, with 15 million diagnosed cases, a figure projected to increase significantly by 2034. In Asia, MASH prevalence varies significantly between rural and urban populations. Japan accounted for 2.5 million diagnosed cases in 2023, while India exhibited a higher prevalence in urban areas (17–25%) compared to rural regions (10%). Other Southeast Asian countries, such as Sri Lanka, Malaysia, and Singapore, show prevalence rates ranging from 5% to 35%. Additionally, in South Korea, obesity and abdominal obesity rates reached 36% and 24%, respectively, highlighting a growing risk factor for MASH. Currently, only one drug is approved for MASH treatment . On March 14, 2024, the FDA approved REZDIFFRA for NASH patients with moderate to severe fibrosis (F2-F3), setting a new benchmark for efficacy and safety. Its acceptance is expected to accelerate future NASH treatments, with clinical trials likely expanding to Southeast Asia. Beyond Rezdiffra, several companies are advancing therapies in the pipeline, including I nventiva Pharma, Novo Nordisk, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim/Zealand Pharma, Galectin Therapeutics, Viking Therapeutics, Eli Lilly, Pfizer, Merck & Co./Hanmi Pharmaceutical, Gilead Sciences, and others. For the latest insights, explore DelveInsight's updated MASH Market Report . A data-driven Market Size and Share Assessment is vital for strategic decision-making in today's competitive pharmaceutical landscape. DelveInsight's market analysis helps companies identify target patient populations, assess treatment landscapes, and analyze emerging therapies to uncover growth opportunities. DelveInsight enables pharmaceutical firms to make informed decisions, optimize strategies, and secure a strong market presence by providing market forecasting, adoption trends, and competitive positioning insights. With MASH gaining attention as a high-burden disease with significant unmet needs, understanding market dynamics is critical for companies looking to make a meaningful impact. DelveInsight's Data-Driven Market Assessment Methodology for Unlocking MASH Opportunities To help our client navigate the MASH market, DelveInsight employed a multifaceted research and strategic analysis approach, combining epidemiological insights, competitive intelligence, and market forecasting. Our methodology included the following key steps: Market Dynamics Evaluation – The current MASH treatment landscape was analyzed across each target country, assessing market share data for existing therapies and forecasting the adoption of treatments in development. Competitor Analysis & Market Entry Assessment – An in-depth competitor landscape study was conducted, identifying key companies developing MASH drugs and evaluating the feasibility of market entry in each region. Strategic Product Positioning – To differentiate the client's product in a symptom-management-dominated market, a treatment-based approach was emphasized, ensuring better alignment with healthcare providers and patient needs. Grade-Specific Patient Focus – Based on the client's request, research was prioritized on grade-specific patient populations, offering targeted recommendations by understanding disease progression and unmet needs at different stages. Strategic Outcomes of DelveInsight's Market Size and Share Assessment for MASH By integrating rigorous data analysis with strategic insights, DelveInsight provided the client with a clear, actionable roadmap for market entry, competitive positioning, and long-term success in the evolving MASH market. DelveInsight's rigorous epidemiological research provided the client with a detailed assessment of the MASH (formerly NASH) burden across key Asian markets. By analyzing prevalence data across different disease grades and severity levels, we equipped the client with actionable insights into the target patient population, enabling informed strategic planning. Our market dynamics evaluation gave the client a comprehensive view of the existing treatment landscape, including market share insights and future adoption forecasts for emerging therapies. This allowed the client to identify growth opportunities, optimize product positioning, and make data-driven market entry decisions. Through competitive intelligence and feasibility assessments, we pinpointed key players and potential market entry barriers in each target country. These insights helped the client anticipate challenges, refine market penetration strategies, and gain a competitive edge. By prioritizing grade-specific patient segmentation, we provided tailored recommendations, helping the client better understand patient needs at various disease stages. This enabled them to align their strategy with real-world clinical and commercial dynamics, ultimately strengthening their position in the evolving MASH market. Curious about how the MASH landscape is evolving? Let DelveInsight be your guide . Get in touch today for expert insights and strategic solutions! Market Size and Share Assessment Services: DelveInsight provides a 360-degree market landscape analysis, delivering 10-year epidemiology-driven market forecasts. Our expertise offers precise insights into emerging therapies' current and projected market share, helping stakeholders navigate evolving treatment landscapes. By integrating epidemiology-based models, emerging trends, competitive dynamics, and unmet needs, we empower businesses to craft data-driven strategies and identify lucrative opportunities. Whether it's pipeline analysis, pricing strategies, epidemiology-driven forecasting, or competitive benchmarking, DelveInsight delivers actionable intelligence tailored to your strategic goals. Competitive Intelligence Services Tailored to Gastroenterology Domain: DelveInsight's competitive intelligence services deliver real-time, precise insights across therapeutic domains, with gastroenterology being one of our key areas of expertise. We provide in-depth analysis of advancements across both prevalent and rare conditions, including MASH, Primary Sclerosing Cholangitis, Ulcerative Colitis, and Barrett's Esophagus. Our services track competitor pipelines, clinical trial progress, regulatory shifts, and patent landscapes, offering a comprehensive view of the evolving gastroenterology market. By leveraging these insights, stakeholders can identify emerging threats, seize growth opportunities, and craft strategic moves to stay ahead in this dynamic space. Conference Coverage Services: DelveInsight's Conference Coverage Services offer a thorough analysis of outcomes from major gastroenterology events like WCOG, Euro-Global Gastroenterology Conference, ICGH, ICGDD, and ICCGVG. This detailed examination provides businesses with essential insights for competitive intelligence and market trend forecasting, supporting the formulation of future strategies. R&D Analysis: DelveInsight's skilled research and development analyst specializes in the complexities of different indications, offering essential insights and advice to clients aiming to advance in research and development. They utilize a methodical assessment approach, aligned with industry norms, to track the progress of each drug in both pre-clinical and clinical stages. DelveInsight's comprehensive reports are crafted to reduce uncertainties and highlight overlooked areas, providing organizations with timely and strategic intelligence. Why Choose DelveInsight? DelveInsight's Market Assessment Services provide data-driven insights and competitive intelligence to help pharmaceutical companies navigate evolving market landscapes. With 10-year forecasts, drug uptake analysis, competitive benchmarking, and customized market evaluations, we deliver precise projections for both emerging and established markets. Our expertise in epidemiology modeling, primary intelligence, and data analytics ensures clients gain a clear, strategic understanding of their therapy's potential and competitive positioning. Covering the 7MM region and beyond, DelveInsight equips stakeholders with actionable intelligence to drive informed decision-making and commercial success. Get in touch today to leverage our expertise and stay ahead in the competitive market! Contact us for a personalized consultation. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▎药明康德内容团队编辑 减肥的精髓离不开“管住嘴、迈开腿”，但是如何科学“管住嘴”，却是大有学问的。限时进食法（TRE，也称为轻断食）将每日进食时间控制在一定范围内（≤10小时），剩余时间则禁食（≥14小时），如我们熟知的16+8饮食法、14+10饮食法等。相关研究发现，采用TRE饮食法患者耐受性好、依从性高、不良反应少、体重可适当减轻、心脏代谢健康略有改善。不过，TRE饮食法也仍有需要明确的地方，比如TRE饮食法对特定部位，特别是内脏脂肪沉积的影响有无不同；不同进食时间窗效果是否存在差异等。 近日，Nature Medicine发表的一项研究，对3种不同进食时间窗的TRE饮食法进行了研究，结果显示相比于单独的地中海饮食，无论设定什么时间开始为期8小时的进食窗口期，TRE饮食在降低内脏脂肪组织方面并未带来额外的益处。但在减重、降低空腹血糖和夜间血糖水平方面，不同进食时间窗联合地中海饮食能够带来额外的益处。 截图来源：Nature Medicine 这是一项平行组、多中心随机临床试验，纳入年龄30~60岁、超重/肥胖[体重指数（BMI）在25~40 kg/m2]、腹部肥胖（男性腰围＞95 cm，女性腰围＞82 cm）、平常久坐不动、习惯性进食时间≥12小时、至少存在一个代谢综合征的心脏代谢风险因素的患者，共197例。 如下图所示，研究人员设计了3种不同8小时进食时间窗的TRE饮食法，以及地中海饮食的常规护理，整个干预为期12周。 地中海饮食的常规护理组（49例）； 早期TRE联合组（49例）：早上10点之前开始8小时的进食时间窗； 晚期TRE联合组（52例）：下午1点之后开始8小时的进食时间窗； 自定义TRE联合组（47例）：参与者自行决定何时开始8小时的进食时间窗。 图片来源：Nutrition Metabolism Cardiovascular Diseases 从结果来看，无论设定什么时间开始为期8小时的进食窗口期，内脏脂肪组织的变化并无显著差异（均P＞0.05），其中相比于地中海饮食的常规护理组，早期TRE联合组、晚期TRE联合组、自定义TRE联合组内脏脂肪组织分别多减少了4%、6%和3%。不同时间进食窗口期的联合组之间，内脏脂肪组织变化也无显著差异（P≥0.99）。 ▲地中海的常规护理组（白色）、早期TRE联合组（黄色）、晚期TRE联合组（蓝色）、自定义TRE联合组（紫色）内脏脂肪组织体积（图a）和百分比（图b）变化对比（图片来源：参考文献[1]） 在其他次要结局方面，研究人员观察到了部分差异： 皮下脂肪组织（SAT） 相比于地中海饮食的常规护理组，早期TRE联合组皮下脂肪组织（SAT）减少量多减少了5%（P=0.005），但晚期TRE联合组、自定义TRE联合组皮下脂肪组织变化与地中海饮食的常规护理组无明显差异。不同时间进食窗口期的联合组之间，皮下脂肪组织变化也无显著差异（P≥0.26）。 体重 相比于地中海饮食的常规护理组，其中早期TRE联合组、晚期TRE联合组、自定义TRE联合组体重分别多减少了2.9 kg、2.4 kg和3.1 kg（均P＜0.001），但不同时间进食窗口期的联合组之间，体重变化无显著差异（均P≥0.99）。 葡萄糖稳态 空腹血糖水平：相比于地中海饮食的常规护理组，早期TRE联合组、晚期TRE联合组、自定义TRE联合组空腹血糖水平分别多降低了6 mg/dl（0.33 mmol/l）、8 mg/dl（0.44 mmol/l）和5 mg/dl（0.27 mmol/l），差异均具有统计学意义，但不同时间进食窗口期的联合组之间，体重变化无显著差异； 夜间血糖水平：相比于地中海饮食的常规护理组，早期TRE联合组、晚期TRE联合组、自定义TRE联合组夜间血糖水平分别多降低了7 mg/dl（ 0.38 mmol/l）、13 mg/dl（0.72 mmol/l）和4 mg/dl（0.44 mmol/l），但不同时间进食窗口期的联合组之间，体重变化无显著差异； 不同组之间糖化血红蛋白（HbA1C）水平、24小时或日间平均血糖水平之间均不存在显著差异； 身体成分和血压 不同组之间身体成分和血压之间不存在显著差异。 安全性方面，所有组均未发生严重不良事件，有5例参与者报告了轻度不良事件。依从性方面，所有联合组的依从性均更高（85%~88%）。 总之，从本次研究结果来看，无论设定什么时间开始为期8小时的进食窗口期联合地中海饮食，均可带来减重、降低空腹血糖和夜间血糖水平方面的额外益处。因此，对于肥胖/超重的成人而言，限时进食法联合地中海饮食可能是一种安全、耐受性良好和可行性高的饮食模式。 点击文末“阅读原文/Read more”，即可访问Nature Medicine官网阅读完整论文。 推荐阅读 欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。 参考资料 [1] Dote-Montero, M., Clavero-Jimeno, A., Merchán-Ramírez, E. et al. Effects of early, late and self-selected time-restricted eating on visceral adipose tissue and cardiometabolic health in participants with overweight or obesity: a randomized controlled trial. Nat Med (2025). https://doi.org/10.1038/s41591-024-03375-y [2]Dote-Montero, M. et al. Efficacy of different 8 h time-restrictedeating schedules on visceral adipose tissue and cardiometabolic health: a study protocol. Nutr., Metab. Cardiovasc. Dis. 34, 177–187(2024). 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。 如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知

REDWOOD CITY, CA, USA I December 30, 2024 I Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushing’s syndrome). Corcept’s NDA is based on positive results from the pivotal GRACE trial and confirmatory evidence from the Phase 3 GRADIENT and long-term extension studies and a Phase 2 study in hypercortisolism. Patients in these studies who received relacorilant experienced improvements in a wide array of hypercortisolism’s signs and symptoms, with an acceptable safety burden. Notably, there were no instances of drug-induced adrenal insufficiency, hypokalemia or QT prolongation – serious adverse events that can arise in patients taking currently approved medications – and no adverse events associated with activity at the progesterone receptor, such as endometrial thickening or vaginal bleeding. “Relacorilant’s combination of efficacy and safety give it the potential to become the standard of care for the medical treatment of patients with hypercortisolism,” said Joseph Belanoff, MD, Corcept’s Chief Executive Officer. “Our commitment to the health of patients with hypercortisolism is unwavering. We are optimistic that relacorilant will be of great benefit to them.” About Relacorilant Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to endogenous hypercortisolism (Cushing’s syndrome), including ovarian, adrenal and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. Relacorilant has orphan drug designation in the United States and the European Union for the treatment of Cushing’s syndrome. About Hypercortisolism (Cushing’s Syndrome) Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. About Corcept Therapeutics For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym ® , the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com. SOURCE: Corcept Therapeutics