Presentation|2023 Focus on the Spindle A New Wave of Business Opportunities in the Health Industry (Up)
With the breakthroughs in human science and the rapid development of technology, the concept of human beings towards diseases has shifted from disease treatment to disease prevention, and the medical treatment solutions have also shifted from closed and conservative to diversified and innovative, especially after the baptism of the COVID-19 virus pandemic, which has accelerated the development of breakthrough therapies such as mRNA vaccines or cellular therapies for application in medicine, and has prompted the rapid integration of ICT-enabled solutions into the scene of healthcare needs. This has also led to the rapid integration of ICT-enabled technologies into the healthcare landscape.
The biotechnology-pharmaceutical industry has always been one of the most important aspects of Taiwan's industries, and it is even regarded as the future economic lifeline of Taiwan, the new generation of the protector of the country. After many years of policy support and international integration, and after stumbling in the capital market and growing in the international market, a number of manufacturers have already obtained drug certificates overseas, and in the gold-mining game, whether it is good to mine gold (new drug development) or to sell mining tools or mining technology services (commissioned design and manufacturing services/clinical trial services), or to sell peripheral services (testing or research services), it depends on the core strengths and market strengths of manufacturers and the market. In the gold mining competition, whether it is better to mine gold (new drug development), sell mining tools or mining technology services (commissioned design and manufacturing services/clinical trial services), or sell peripheral services (testing or scientific research services) depends on the core strengths of the manufacturer and the opportunities and chances under the competition in the market. If the candidate drug obtains the marketing license, the results of the efficacy ranking competition, as well as the penetration rate of the drug in the market channel and market share in each country, will also be a choice under the management of opportunities and risks, and the only constant is that the hard truth is still the drug and the drug license will be the only thing that remains unchanged. The only thing that remains unchanged is that the drugs and medical technology services must be good enough to meet the medical needs of the customers.
In the post epidemic (Long COVID) era, the actual application of technology to the medical scene, technology, medical and health bundled together more closely, technology to participate in the future changes in health care, the integration of technology and wisdom empowerment is a necessary element, initiated by the biomedical data, translation (interpretation) of health information, to provide health knowledge to assist, the use of health wisdom interpretation, technology empowerment to health promotion, prevention, precision medicine and disease care services, combined with the introduction of medical products such as pharmaceuticals, medical devices, health supplies, nutritional foods and health aids, to enhance the quality of medical services, home care, health aids and other services, to enhance the quality of health care services, home care. The services of health promotion, preventive medicine, precision medicine and disease care, combined with the introduction of medical products such as pharmaceuticals, medical devices, healthcare products, nutritional food and healthcare aids, etc., to enhance the quality of medical services, home care and recreational services, leisure and fitness healthcare and healthcare consulting and management, which can be radiated to a wider range of dimensions of care and unsatisfied healthcare needs in different scenarios, how to select the topics for linking up with the healthcare service chain and how to participate in the healthcare services chain. How to choose the topic to connect the healthcare service chain and how to participate in the construction of the ecosystem of the healthcare industry will also be a major challenge for medical technology enterprises.
Looking ahead to 2023, Ji-Pu recommends that Taiwan's health industry trends and business opportunities can focus on the following points: 1. When will business opportunities open up as new medicines converge with the international market? 2. Technology companies are actively involved in the medical and biotechnology fields, how can they show results on the ground? And 3. How can emerging therapies turn the corner in the post-pandemic era? What can Taiwan do about cell therapy or gene therapy?
新藥接軌國際,何時開創商機呢?
根據市調機構Statista(2022/10)推估,全球生技醫藥產業市場規模將持續增長,2023年全球藥品市場規模將達1.5兆美元,預估2025年可達到1.6兆美元,主要來自仍有許多疾病人類尚未攻克(治癒)、癌症死亡人數逐年攀高且有年輕化趨勢、遺傳疾病(罕見疾病)、失智症、慢性病管理,或複雜因子高風險族群仍是影響人類健康的挑戰。細部來看各類疾病用藥市場,在2023年仍是以癌症用藥市場規模最大,推估市場規模約為1,666億美元、其次是自體免疫疾病用藥推估市場規模約為1,339億美元,以及糖尿病用藥推估市場規模可達1,280億美元,預估在2023~2025年間全球各疾病類別用藥市場年複合年成長率,以疫苗(包含COVID-19疫苗)最高約為12~15%、其次是癌症用藥和自體免疫疾病用藥約為9~12%。
從臨床中開發新藥和USFDA核准藥物數據來看國際間藥廠選題策略,在技術發展態勢、技術成熟度和適應症開發方面,不難發現mRNA疫苗與CAR-T細胞療法是市場追逐的技術焦點,mRNA技術平台除了病毒疫苗應用外,已逐步朝向癌症疫苗的應用發展,而CAR-T技術平台則由過去治療癌細胞如血癌、淋巴癌或多發性骨髓瘤,朝向實體腫瘤的治療發展。在適應症方面,國際市場適應症開發重點在COVID-19 新藥、罕見疾病和癌症藥物,在COVID-19 新藥的治療重點除預防病毒感染外,則放在治療病毒感染後的症狀和治療病毒感染後產生相關併發症的治療,在罕見疾病方面,細胞與基因治療對於罕見疾病的治癒存在相當大的機會點,根據美國NIH研究發現人類目前已知罕見疾病約有7,000多種,其中5,600種是與基因遺傳問題引起,透過基因檢測,找出基因遺傳缺失和表現問題,以及採用特定細胞與基因治療,將能有效地治癒罕見疾病。在癌症方面,除了肺癌、乳腺癌和大腸癌患病率不斷上升外,許多癌症如胰腺癌、肝癌、肺癌、食道癌、腦癌、胃癌、卵巢癌、骨髓瘤和血癌目前仍處於5年存活率低於50%的狀態,治癒率偏低狀態是推動全球抗癌新藥研發的動力,臨床中開發癌症候選藥物也呈現逐年攀高的趨勢約佔總臨床中開發候選藥物的39%,而從國際大藥廠適應症開發佈局態勢中,輝瑞聚焦 COVID-19 新藥、諾華引領罕見病,而癌症則是各大藥廠兵家必爭之地。
面對現在極豐富且開創的新藥開發和醫療科技應用,在醫療領域的商業競爭,商機關鍵點就著重在: 『選題』+『商業發展策略』,其中『選題』包含技術選題和疾病適應症選題,即疾病問題和解決方案間的配對問題,底層關係在於藥物實體(涵蓋藥物本身特性、藥物作用機制(Mechanism of action, MOA)和藥物傳輸技術)的有效性和廣用性(整體效益),對解決攻克人類疾病問題的難易程度如緩解、減輕和治癒,就能決定其有多少的市場價值,有多少人願意買單,在『商業發展策略』則包含取證策略,如臨床試驗設計和法規審批策略,以及上市後銷售海外通路佈局策略,綜觀整體醫藥領域產品開發具有開發時間長、成本高、技術門檻高和法規監管嚴格等特性,需要大量專業積累及長期策略規劃才有機會成功,醫藥領域投資屬於長期投資且需要長期關注技術領域的應用和突破,生醫產業發展時間長,在企業端重點就要觀測在研發週期長軸下短時間軸內的細部變化,整體要看長期發展(策略)和短期變化(戰術),而短期變化往往會決定公司資源運用(排兵佈陣)的後續走向。
全球新藥開發的挑戰賽,臺灣新藥公司在選題佈局接軌國際,並且對標國際大廠的選題如癌症用藥和罕病用藥,關鍵是誰能勝出? 如圖一,近年來多家臺廠已取得藥證,取得藥證(入圍)後的關鍵是藥物治療適應症的排名賽,也就是治療用藥所屬的醫療選用位階,如一線用藥、或二三線用藥,以及合併治療的機會等,然後才是進入國際市場佈局銷售,帶動藥品出貨和業績增長。智璞觀測近年已有多家新藥公司陸續取得US FDA審批藥證,且未來2-3年將陸續會有其他新藥公司取得海外藥證,表示臺灣新藥公司已逐漸熟悉新藥開發和臨床試驗審批規範,漸漸朝向藥物國際上市海外通路佈局銷售發展,就治療用藥適應症排名而言,僅藥華藥干擾素新藥Besremi®(Ropeginterferon alfa-2b)取得一線用藥資格,目前治療市場對於該藥物潛在銷售額看法呈現樂觀可期,此外帶動藥華藥新建廠投資預估未來5年內將創造400億台幣產值,而其他臺廠新藥多核准為二、三線或輔助治療,因此對於相關新藥的潛在銷售額期待多處於審慎保守,此外部分臺廠已邁入新的延伸適應症賽道和新臨床數據亮點賽道,如藥華藥新藥Besremi®開發延伸適應症原發性血小板增多症(Essential thombocythemia, ET)、逸達CAMCEVI® (leuprolide mesylate) 開發延伸適應症兒童中樞性性早熟,或智擎挑戰胰臟癌一線用藥及開發延伸適應症非小細胞肺癌等,短期可看延伸適應症和新臨床數據亮點,都將有望擴大該藥物在臨床治療市場的使用機會,中長期仍是要看實質業績增長率,預估未來2-3年是多家新藥公司在臨床數據推進、業績增長率和營收關鍵的重要觀察指標。
Figure 1.歷年臺灣新藥公司取證和海外上市狀況分析圖

Source of information: Organized by Ji-Pu Industrial Trend Research Institute
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