May_New Drugs｜GLP-1 weight-loss drugs: second wave of gold rush
GLP-1New weight-loss drugs are popular all over the world, and the shortage of goods and production capacity continues to burn.
How popular are the new GLP-1 weight loss drugs? At present, the only two new GLP-1 weight loss drugs approved for marketing in the world are Semaglutide (trade name Wegovy), which will be approved by the U.S. FDA in June 2021 by Novo Nordisk.®), and Eli Lilly's November 2023 U.S. FDA approval of Tirzepatide (trade name Zepbound®). Judging from the recent strong sales figures of the two pharmaceutical companies, Lilly Zepbound®175 million in revenue in less than two months since IPO, and Novo Nordisk's 2023 Wegovy®Under the premise of insufficient production capacity and focusing on the market in 8 countries, the company has sold US$4.5 billion, which is a good result if the sales of two other drugs with the same ingredient, Semaglutide (trade name Ozempic), are taken into account.®and Rybelsus®In the past, Novo Nordisk's Semaglutide was approved for hypoglycemia, and may be used off-label. Novo Nordisk's Semaglutide ingredient alone generated about US$21.2 billion, while Eli Lilly's Tirzepatide also had a production value of about US$5.3 billion. Under the smoke and mirrors of tight supply and competition for market share, Novo Nordisk and Eli Lilly are coincidentally expanding their production capacity with large sums of money. Novo Nordisk has acquired the OEM drugmaker Catalent with US$16.5 billion and invested in the expansion of its plant in Denmark with US$6 billion, while Eli Lilly has spent US$2.5 billion on the construction of a new plant in Germany and US$1.6 billion on expansion of its plant in the U.S. It is easy to find out that there is a huge opportunity for the new drug GLP-1 to reduce the weight of the population under this circumstance. In view of this, GLP-1 weight loss drug is also regarded as an opportunity for competition to seize the market.
Remarks: Off-label use: This refers to the use of a medication prescribed by a physician that is not in accordance with the indications in the generic version of the medication.
the (whole) worldGLP-1減肥新藥成長率高達20.6%Market Size6Year after year growth7.1times (multiplier)
根據Azoth Analytics (2024)報告指出2023 年全球GLP-1減肥新藥市場規模187.5億美元，預估到2030年可成長約7.12倍，達到 1335億美元，年複合成長率為20.6%。從市場增長的角度來看，受惠於GLP-1減肥新藥減重療效良好、安全性優於過往減肥藥，並具備降血糖和降心血管疾病風險等優勢，在醫療保險報銷障礙掃除下，預期在全球6.5億肥胖人口基數、先進國家兒童肥胖問題，以及愛美人士減重或體重控制需求大等因素，未來將帶動更多人使用GLP-1減肥新藥，而愛美人士減重或體重控制更將會是GLP-1減肥新藥最強勁的巿場。
GLP-1減肥新藥大賣，只是開端!? 國際藥廠競爭加速，打響第二波GLP-1新藥開發爭奪戰，如何保持領先?或瓜分諾和諾德和禮來打下的領先地位是市場關注的焦點之一，GLP-1減肥藥淘金熱點燃戰火，國際大藥廠蓄勢待發，搶進第二波減肥新藥開發，是基於GLP-1R/ GLP-1或多靶點(GIPR/ GCGR/ INS)藥理機制的可行性外，新一代減肥新藥的競爭更著重於拚減重療效、拚新適應症、拚停藥後體重維持效益、拚減脂增肌、拚長效使用，拚成本價格優勢等方面。國際大藥廠蜂擁而至看好GLP-1減肥新藥市場的理由主要有三點，分別為一、GLP-1減肥藥銷售業績明燈指路，得益於現行GLP-1減肥藥Semaglutide和Tirzepatide的銷售成功，市場需求持續快速成長; 二、GLP-1減肥藥新的延伸適應症，受惠於GLP-1R/ GLP-1明確地藥理機制，GLP-1減肥藥已被美國FDA核准降血糖、減重和降低心血管疾病風險等適應症療效，目前其他藥廠轉而探索GLP-1類藥物在脂肪性肝炎、慢性腎病、失智症、癌症、憂鬱症或成癮、阻塞性睡眠呼吸中止症、膝骨關節炎等臨床療效的應用，若成功開發則有望創造出彎道超車或另闢蹊徑的商業契機，如默沙東(MSD)開發的efinopegdutide，在臨床2a數據肝脂肪降72.7%，試圖在脂肪性肝炎治療領域彎道超車; 三、現行GLP-1減肥藥仍有更好的改善空間，如更好的減重療效; 或停藥後體重難維持，體重容易反彈; 或體重減輕但伴隨約佔減重比例30~40%的大量肌肉流失; 或劑型優化方便藥物使用，或減少施打次數的不舒適性，或療程價格仍偏高(Wegovy®約每年1.5萬美元)，開發經濟實惠版本等。除此之外，近期國際藥廠除禮來加碼以19.3億美元收購減肥藥物製造商Versanis主攻減少脂肪且增肌的大分子抗體藥bimagrumab，強化未來減肥藥領先趨勢外，尚有羅氏(Roche)斥資近30億美元收購Carmot Therapeutics的三種藥物分子新藥CT-388、新藥CT-996和新藥CT-868、3個，全面試圖搶攻更好減重療效(短期>15~20%)，以及阿斯特捷利康(AstraZeneca)砸超20億美元與中國誠益生物(Eccogene)簽訂小分子口服減肥藥(ECC5004)的合作協議，切入低成本方案，都可看出國際藥廠砸數10億美元，以併購策略快速搶進GLP-1減肥新藥開發且不落人後的企圖心。
台廠以胜肽藥物技術和注射部件，切入GLP-1新藥和局部減肥新藥開發契機
GLP-1減肥千億商機指路，引發國際減肥藥淘金熱持續發燒，台廠佈局不落人後，卡位第二波減肥新藥商機。北極星藥業收購霖揚，取得多胜肽合成技術及預充卡式注射器製造能力，搶攻合成GLP-1減肥藥;免疫功坊以超長效胜肽脂肪酸束修飾技術平台開發效益更佳的GLP-1候選新藥;以及康霈開發促進脂肪細胞凋亡的局部減脂新藥，或宇隆提供諾和諾德關鍵藥物注射部件等，在全球減肥顯學下也將有望帶動台廠新成長動能。
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