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| Title: | 台灣細胞治療公司之商業模式與經營策略分析-以領先者X公司為例
Analysis of the business model and strategy of Taiwan's cell therapy companies - Taking the leader X company as an example |
| Authors: | 潘仕軒
Pan, Shih-Hsuan |
| Contributors: | 馮震宇
彭朱如
Fong, Jerry G.
Peng, Tzu-Ju
潘仕軒
Pan, Shih-Hsuan |
| Keywords: | 細胞治療
特管辦法
商業模式
策略
Cell therapy
Regulations of Special Medical Techniques
Business model
Strategy |
| Date: | 2025 |
| Issue Date: | 2025-03-03 13:33:03 (UTC+8) |
| Abstract: | 本研究首先在文獻探討中，分析全球與台灣細胞治療產業的現況、發展趨勢及各國法規，並運用商業模式九宮格、SWOT分析、波特五力分析、BCG矩陣、Ansoff矩陣及策略矩陣等管理學理論，結合公開資料與訪談資料，深入分析台灣細胞治療領導廠商X公司的商業模式及經營策略。研究發現X公司的成功有5個關鍵:
1. 透過長期與學術機構合作，以授權方式持續取得學研界有潛力的研發成果，並在授權前參與研發的討論，有效縮短研發時程及縮小產學落差。
2. 透過長期與醫療機構合作，掌握CDMO的通路，建立規模經濟及品牌優勢，創造豐沛的現金流+轉投資獲利，進而支持細胞新藥臨床試驗。
3. 有自己的細胞製造工廠，建立規模經濟，降低製造成本，取得CDMO優勢；製造經驗同時可支持臨床試驗的申請與進行。
4. 具有細胞治療經驗且長期合作的CRO協助，加上執行臨床試驗的醫師先期參與，提高IND的成功率及臨床試驗的可行性。
5. 內部具有專業的研發、製造、臨床及專案管理人才，讓以上4點能夠運作順利。
另外，根據五力分析發現，X公司之新藥臨床試驗的議價能力較高，而特管辦法CDMO的議價能力較低。根據BCG矩陣分析顯示，X公司只要在製造與業務部門持續投入適當資源，可持續維持CDMO的市場優勢；但最重要的是，需投入公司大部份資源推動新藥上市或授權，成為明星商品。根據Ansoff矩陣分析，需思考如何在CDMO市場維持領先地位，可利用品牌優勢及規模經濟，降低成本；有足夠病人數據回饋給醫師與病人，讓兩者有意願使用X公司的細胞產品；思考如何進軍有類似台灣特管辦法的國家，或讓更多國外病人到台灣進行特管的細胞治療；思考完成臨床一期的新藥，是否有治療其他適應症的可能，可大幅縮短上市時程；而不同適應症也可分開對外授權。這些建議亦適用於其他同時投入新藥研發與CDMO的細胞治療廠商。
本研究歸納出台灣細胞治療產業的成功因素及潛在風險，並提出相關建議，期能為學術界、產業界及政府的決策者提供未來細胞治療產業發展的參考。
First of all, this study analyzed the status, trends, and regulations of the global and Taiwan cell therapy industry through literature review. Subsequently, this study employed management theories such as the Business Model Canvas, SWOT analysis, Porter's Five Forces, BCG matrix, Ansoff matrix, and Strategy matrix to assess the business model and strategy of Company X, a leading cell therapy firm in Taiwan, utilizing public information and interview data. The study found five key factors contributing to Company X's success:
1. Long-term collaboration with academic institutions enabled Company X to acquire potential technologies through licensing-in, facilitating discussions on technology development to shorten development time and bridge the gap between academia and industry.
2. Long-term partnership with hospitals allowed Company X to navigate the Regulations of Special Medical Techniques effectively, establishing economies of scale and brand recognition while generating substantial cash flow, and together with the return of investment, to support clinical trials.
3. Owing cell manufacturing factory led to reduced production costs and to support clinical trial applications.
4. Collaboration with experienced CROs and early involvement of physicians conducting clinical trials to improve IND success rates and clinical trial feasibility.
5. Professional employees in R&D, manufacturing, clinical operations, and project management ensured the smooth execution of these strategies.
In addition, according to the Porter's five forces analysis, Company X has a high bargaining power in new drugs, while the bargaining power of the CDMO is lower. According to the BCG matrix analysis, Company X can maintain the leading in CDMO market as long as it continues to invest appropriate resources. However, it needs to invest most resources in developing new drugs to market or licensing out, so that they become star products. Based on the Ansoff matrix analysis, X company may use brand advantages and economies of scale to reduce costs; have sufficient patient data to feed back to physicians and patients so that both are willing to use Company X's cell products to maintain leading position in CDMO market. Think about how to enter countries with cell regulation similar to Taiwan, or how to bring more foreign patients to Taiwan for cell therapy; considering whether new drugs that have completed Phase I clinical trials have the potential to treat other indications, which can shorten the time to approval; and different indications can be licensed out separately.
These recommendations also apply to other cell therapy companies that are simultaneously developing in new drug and CDMO. |
| Reference: | 中文部分:
張慧潔、鄭宇婷、王意婷、呂雅蕙、林建邦、范盛軍、許毓真、陳思豪、楊子平、劉曉君、蔡維原，2022。2022年醫藥展業年鑑。財團法人生物技術開發中心(DCB)。
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網路資料:
數位時代，2021。全球12％臨床案來自台灣！生技界「怪物新人」細胞治療，兩大趨勢接軌國際。https://www.bnext.com.tw/article/65916/cellulartherapy。搜尋日期: 2024年12月3日。
衛生福利部網站 https://celltherapy.mohw.gov.tw/announcement_page.htm?id=97。搜尋日期: 2024年12月5日。
吳培安，2021/12/28。細胞治療「特管辦法」上路三年破百件，成效分析仍難產?! 環球生技月刊。https://news.gbimonthly.com/tw/article/show.php?num=45563。搜尋日期: 2024年12月14日。
經濟部產業技術司網站https://www.moea.gov.tw/MNS/doit/industrytech/IndustryTech.aspx?menu_id=13545&it_id=528。搜尋日期: 2024年12月16日。
再生製劑條例 https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030142。搜尋日期: 2024 年 12 月18日。
Alliance for Regenerative Medicine website. https://alliancerm.org/。搜尋日期: 2024 年12 月15日。
Boston Consulting Group Website. https://www.bcg.com/about/overview/our-history/growth
share-matrix。搜尋日期: 2024 年 12 月 13 日。
BPS Bioscience Website. https://bpsbioscience.com/custom-car-t-cell-development。搜尋日期: 2025 年 1 月20日。
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Rooster Bio Website. https://www.roosterbio.com/blog/hucpvcs-the-champagne-of-human-umbilical-cord-cells/。搜尋日期: 2024 年 12 月 15 日。 |
| Description: | 碩士
國立政治大學
經營管理碩士學程(EMBA)
109932168 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0109932168 |
| Data Type: | thesis |
| Appears in Collections: | [經營管理碩士學程EMBA] 學位論文
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