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| Title: | 新興醫療產業的關鍵經營決策分析
Analysis of Critical Business Decisions in the Emerging Medical Industry |
| Authors: | 王佳蕙
Wang, Chia-Hui |
| Contributors: | 宋皇志
Sung, Huang-Chih
王佳蕙
Wang, Chia-Hui |
| Keywords: | 商業模式
開發策略
產業聯盟
動態競爭
細胞治療
再生醫學
Business model
Strategies
Industry Alliance
Competitive Dynamics
Cell Therapy
Regenerative Medicine |
| Date: | 2024 |
| Issue Date: | 2024-09-04 13:49:27 (UTC+8) |
| Abstract: | 隨著新興醫療產業的快速萌芽與發展，企業也將面臨各項挑戰。本研究旨在探討這些產業如何制定經營策略以應對挑戰，通過深入分析生物醫藥產業中不同規模企業的策略和發展趨勢。本研究選取九家具有代表性的企業，詳細探討了它們在創新技術推動、市場競爭和策略聯盟等方面的行動與決策過程，特別是免疫細胞和再生醫學療法的市場趨勢、技術發展、專利競爭及市場結構變化。
研究涉及五大產業情境：創新企業競爭、行業巨頭策略、競爭與聯盟變化、競爭與合作制約以及企業轉型。這些情境展示了不同規模企業如何把握市場機遇並應對挑戰，提升競爭力。
本文特別強調企業如何通過整合基礎資源來強化產品線和價值，以提高市場競爭力，尤其是在高風險的創新醫療領域如再生醫學和細胞治療。研究探討了新創企業如何立足、大型企業如何透過投資或戰略聯盟進入創新醫療領域，以及老企業如何成功轉型並建立穩固市場地位。此外，研究還探討了企業如何通過合作共同應對市場不確定性。
總結而言，本研究揭示了生物醫藥產業中企業經營策略的多樣性和挑戰。研究結果顯示，創新力和合作精神是驅動行業前進的核心要素，並探討了企業確立有效行動以實現目標的策略。這些深入分析為企業洞悉行業趨勢、制定未來策略提供了重要參考，有助於在激烈競爭中尋找增長突破點。
As the emerging healthcare industry rapidly sprouts and develops, companies will also face various challenges. This study explores how companies in the biopharmaceutical industry are developing business strategies to tackle these challenges. It conducts an in-depth analysis of the strategies and development trends of companies of different sizes within the industry. The study focuses on areas such as innovation technology promotion, market competition, and strategic alliances, with a special emphasis on market trends, technological development, patent competition, and market structure changes in immunotherapy and regenerative medicine.
The research examines five major industrial scenarios: competition among innovative companies, the strategies of industry giants, changes in competition and alliances, constraints of competition and cooperation, and enterprise transformation. These scenarios demonstrate how companies of varying scales take advantage of market opportunities and address challenges to improve their competitiveness.
The paper particularly emphasizes how companies can improve their product lines and value by integrating fundamental resources to enhance their market competitiveness, especially in high-risk innovative medical fields such as regenerative medicine and cell therapy. It explores how startups establish themselves, how large enterprises enter the innovative medical field through investment or strategic alliances, and how established companies successfully transform and secure a solid market position. Additionally, the research explores how companies collaborate to deal with market uncertainties.
In summary, this study reveals the diversity and challenges of business strategies within the biopharmaceutical industry. The findings suggest that innovation and cooperation are core elements driving the industry forward, and the strategies companies establish to achieve their goals are discussed. These in-depth analyses offer valuable insights for companies to understand industry trends and develop future strategies, helping them find growth opportunities in a highly competitive market. |
| Reference: | Abbasalizadeh S, Pakzad M, Cabral JMS, Baharvand H. 2017. Allogeneic cell therapy manufacturing: process development technologies and facility design options. Expert Opin Biol Ther 17: 1201-19
2. Alessandrini M, Preynat-Seauve O, De Bruin K, Pepper MS. 2019. Stem cell therapy for neurological disorders. S Afr Med J 109: 70-77
3. AmgenNews. 2015. Amgen and Kite Pharma Announce Strategic Cancer Immunotherapy Collaboration to Advance the Application of Novel Chimeric Antigen Receptor (CAR) T Cell Therapies.
4. Amirazad H, Baradar Khoshfetrat A, Zarghami N. 2023. A dual synergistic effect of titanium and curcumin co-embedded on extracellular matrix hydrogels of decellularized bone: Potential application in osteoblastic differentiation of adipose-derived mesenchymal stem cells. J Biomater Sci Polym Ed 34: 372-97
5. Amirazad H, Dadashpour M, Zarghami N. 2022. Application of decellularized bone matrix as a bioscaffold in bone tissue engineering. J Biol Eng 16: 1
6. Atilla E, Kilic P, Gurman G. 2018. Cellular therapies: Day by day, all the way. Transfus Apher Sci 57: 187-96
7. Bayer M. 2023. Bayer-bought BlueRock cuts 12% of workforce across 3 sites as pipeline contracts. fiercebiotech.com
8. Beetler DJ, Di Florio DN, Law EW, Groen CM, Windebank AJ, et al. 2023. The evolving regulatory landscape in regenerative medicine. Mol Aspects Med 91: 101138
9. BioProcessInternational. 2020. Transforming Personalized Medicine into Off-the-Shelf Cell Therapies.
10. Bohrer LR, Stone NE, Mullin NK, Voigt AP, Anfinson KR, et al. 2023. Automating iPSC generation to enable autologous photoreceptor cell replacement therapy. J Transl Med 21: 161
11. Bose D, Ortolan D, Farnoodian M, Sharma R, Bharti K. 2023. Considerations for Developing an Autologous Induced Pluripotent Stem Cell (iPSC)-Derived Retinal Pigment Epithelium (RPE) Replacement Therapy. Cold Spring Harb Perspect Med
12. Caldwell KJ, Gottschalk S, Talleur AC. 2020. Allogeneic CAR Cell Therapy-More Than a Pipe Dream. Front Immunol 11: 618427
13. Caplan H, Olson SD, Kumar A, George M, Prabhakara KS, et al. 2019. Mesenchymal Stromal Cell Therapeutic Delivery: Translational Challenges to Clinical Application. Front Immunol 10: 1645
14. Century. 2022. Century Therapeutics Reports Full Year 2022 Financial Results and Provides Business Updates.
15. Century. 2023. Century Therapeutics Reports Full Year 2023 Financial Results and Provides Business Updates.
16. Cheever MA, Higano CS. 2011. PROVENGE (Sipuleucel-T) in prostate cancer: the first FDA-approved therapeutic cancer vaccine. Clin Cancer Res 17: 3520-6
17. Chen R, Li L, Feng L, Luo Y, Xu M, et al. 2020. Biomaterial-assisted scalable cell production for cell therapy. Biomaterials 230: 119627
18. Chisholm ME, Hopkins DJ. 2014. Process modeling and optimization of a cell therapy manufacturing operation. Regen Med 9: 427-30
19. Costandi M. 2013. Kite and NCI partner on T cells. Nature Biotechnology 31: 10
20. Couto SCF, Kowes A, Aurabi CS, Oliveira TGM, Klinger P, Rocha V. 2023. Autologous, allogeneic hematopoietic cell transplantation and CAR-T/NK therapy: what is their real importance in PTCL? Front Oncol 13: 1195759
21. David FR. 2009. Strategic management: concepts and cases Francis Marion University, Florence, South Carolina
22. Davis RJ, Alam NM, Zhao C, Muller C, Saini JS, et al. 2017. The Developmental Stage of Adult Human Stem Cell-Derived Retinal Pigment Epithelium Cells Influences Transplant Efficacy for Vision Rescue. Stem Cell Reports 9: 42-49
23. DealForma. 2023. 2023 Annual Biopharma Licensing and Venture Report. J.P. Morgan
24. Deloitte. 2021. Distribution and Supply Chain Models in the Cell & Gene Therapy Landscape.
25. El-Kadiry AE, Rafei M, Shammaa R. 2021. Cell Therapy: Types, Regulation, and Clinical Benefits. Front Med (Lausanne) 8: 756029
26. Elmhirst E, Brown A. 2022. Pharma Market Drivers Part One: Hey! Big (Pharma) Spender. Evaluate Vantage
27. EMA. 2006-2009. Guidelines relevant for advanced therapy medicinal products: Cell-therapy and tissue engineering.
28. FDA US. 2016. FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee.
29. FDA US. 2017. FDA announces comprehensive regenerative medicine policy framework.
30. FDA US. 2019. Framework for the Regulation of Regenerative Medicine Products.
31. FDA US. 2022. FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma.
32. FDA US. 2023. FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes.
33. FierceBiotech. 2011. Fibrocell Science, Inc. Announces FDA Approval for laViv(R) (azficel-T).
34. Fritsche E, Volk HD, Reinke P, Abou-El-Enein M. 2020. Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy. Trends Biotechnol 38: 1099-112
35. Garcia Delgado AB, de la Cerda B, Alba Amador J, Valdes Sanchez ML, Fernandez-Munoz B, et al. 2019. Subretinal Transplant of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium on Nanostructured Fibrin-Agarose. Tissue Eng Part A 25: 799-808
36. Garcia Jareno P, Bartley OJM, Precious SV, Rosser AE, Lelos MJ. 2022. Challenges in progressing cell therapies to the clinic for Huntington's disease: A review of the progress made with pluripotent stem cell derived medium spiny neurons. Int Rev Neurobiol 166: 1-48
37. Gardenswartz A, Mehta B, El-Mallawany NK, van de Ven C, Hochberg J, et al. 2023. Safety and efficacy of combinatorial therapy utilizing myeloablative conditioning and autologous stem cell transplantation, targeted immunotherapy, and reduced intensity conditioning and allogeneic stem cell transplantation in children, adolescents, and young adults with relapsed/refractory mature B-cell non-Hodgkin lymphoma. Leuk Lymphoma 64: 234-37
38. Genengnews. 2023. Cell Therapy Industry Looks for Ways to Sustain Growth.
39. Glotzbach JP, Wong VW, Gurtner GC, Longaker MT. 2011. Regenerative medicine. Curr Probl Surg 48: 148-212
40. GrandViewResearch. 2019. Asia Pacific Cell Therapy Market Size, Share & Trends Analysis Report By Use-type (Clinical-use, Research-use), By Therapy Type (Autologous, Allogeneic), And Segment Forecasts, 2021 - 2028.
41. Hernandez R. 2015. Novartis and Juno Settle Over CAR-T Therapy Technology. pharmtech.com
42. Hesterly JBBWS. 2018. Publisher of Strategic Management and Competitive Advantage: Concepts and Cases. Pearson.
43. Hoang DM, Pham PT, Bach TQ, Ngo ATL, Nguyen QT, et al. 2022. Stem cell-based therapy for human diseases. Signal Transduct Target Ther 7: 272
44. Holman CM. 2021. In Juno v. Kite the Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation in CAR T-Cell Therapy. Biotechnology Law Report 40: 372
45. Hong SG, Winkler T, Wu C, Guo V, Pittaluga S, et al. 2014. Path to the clinic: assessment of iPSC-based cell therapies in vivo in a nonhuman primate model. Cell Rep 7: 1298-309
46. Jean A. 2021. CAR-T in the Courts. Genetic Engineering and Biotechnology News
47. June CH. 2023. The Unlikely Development of CAR T Cells: a Brief History and Prospects for the Future. Keio J Med 72: 26
48. Keymeulen B, De Groot K, Jacobs-Tulleneers-Thevissen D, Thompson DM, Bellin MD, et al. 2023. Encapsulated stem cell-derived beta cells exert glucose control in patients with type 1 diabetes. Nat Biotechnol
49. Kim KM, Thaqi M, Peterson DA, Marr RA. 2021. Induced Neurons for Disease Modeling and Repair: A Focus on Non-fibroblastic Cell Sources in Direct Reprogramming. Front Bioeng Biotechnol 9: 658498
50. Kojima H, Raut B, Chen LJ, Nagai N, Abe T, Kaji H. 2020. A 3D Printed Self-Sustainable Cell-Encapsulation Drug Delivery Device for Periocular Transplant-Based Treatment of Retinal Degenerative Diseases. Micromachines (Basel) 11
51. KPMG. 2023. Biopharma deal trends outlook for 2023.
52. Krampera M, Le Blanc K. 2021. Mesenchymal stromal cells: Putative microenvironmental modulators become cell therapy. Cell Stem Cell 28: 1708-25
53. Kroger N, Wulf G, Hegenbart U, Burchert A, Stelljes M, et al. 2023. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients less than 60 years of age: a prospective phase II study. Haematologica
54. Lim WA, June CH. 2017. The Principles of Engineering Immune Cells to Treat Cancer. Cell 168: 724-40
55. Liu S, Deng B, Yin Z, Lin Y, An L, et al. 2021. Combination of CD19 and CD22 CAR-T cell therapy in relapsed B-cell acute lymphoblastic leukemia after allogeneic transplantation. Am J Hematol 96: 671-79
56. MacDonald KN, Ivison S, Hippen KL, Hoeppli RE, Hall M, et al. 2019. Cryopreservation timing is a critical process parameter in a thymic regulatory T-cell therapy manufacturing protocol. Cytotherapy 21: 1216-33
57. Marangon M, Visco C, Barbui AM, Chiappella A, Fabbri A, et al. 2021. Allogeneic Stem Cell Transplantation in Mantle Cell Lymphoma in the Era of New Drugs and CAR-T Cell Therapy. Cancers (Basel) 13
58. Matovic IM. 2020. PESTEL Analysis of External Environment as a Success Factor of Startup Business. CONSCIENS CONFERENCE ON SCIENCE AND SOCIETY 96-101
59. Mitra A, Barua A, Huang L, Ganguly S, Feng Q, He B. 2023. From bench to bedside: the history and progress of CAR T cell therapy. Front Immunol 14: 1188049
60. Mousaei Ghasroldasht M, Seok J, Park HS, Liakath Ali FB, Al-Hendy A. 2022. Stem Cell Therapy: From Idea to Clinical Practice. Int J Mol Sci 23
61. Neumayer G, Torkelson JL, Li S, McCarthy K, Zhen HH, et al. 2023. A scalable, GMP-compatible, autologous organotypic cell therapy for Dystrophic Epidermolysis Bullosa. bioRxiv
62. Nguyen H, Zarriello S, Coats A, Nelson C, Kingsbury C, et al. 2019. Stem cell therapy for neurological disorders: A focus on aging. Neurobiol Dis 126: 85-104
63. Osterwalder A, Pigneur Y, Bernarda G, Smith A, Papadakos T. 2014. Value Proposition Design： How to Create Products and Services Customers Want. Wiley
64. Osterwalder A, Pigneur Y, Tucci CL. 2005. Clarifying business models: Origins, present, and future of the concept. Communications of the Association for Information Systems 16
65. Panagiotou G. 2003. Bringing SWOT into focus. Business Strategy Review 14: 3-10
66. Piercy N, Giles W. 1989. Making SWOT analysis work. Marketing Intelligence & Planning 7: 5-7
67. Pigeau GM, Csaszar E, Dulgar-Tulloch A. 2018. Commercial Scale Manufacturing of Allogeneic Cell Therapy. Front Med (Lausanne) 5: 233
68. Porter ME. 2008. The Five Competitive Forces That Shape Strategy. Harvard Business Review 24-41
69. PrecedenceResearch. 2023. Cell Therapy Market (By Use Type: Clinical use, Research use; By Therapy Type: Autologous Therapies, Allogenic Therapies; By End User: Hospitals & Clinics, Academic & Research Institutes; By Technology) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023 – 2032.
70. Price J. 2020. Cell therapy approaches to autism: a review of clinical trial data. Mol Autism 11: 37
71. PWC. 2023. How to Manage Supply Chains.
72. Qiu B, de Vries RJ, Caiazzo M. 2021. Direct Cell Reprogramming of Mouse Fibroblasts into Functional Astrocytes Using Lentiviral Overexpression of the Transcription Factors NFIA, NFIB, and SOX9. Methods Mol Biol 2352: 31-43
73. Rai B, Shukla J, Henry TD, Quesada O. 2021. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells 10
74. Ramdani B, Binsaif A, Boukrami E. 2019. Business model innovation: a review and research agenda. New England Journal of Entrepreneurship: 89-108
75. Rana J, Biswas M. 2020. Regulatory T cell therapy: Current and future design perspectives. Cell Immunol 356: 104193
76. Rath JA, Arber C. 2020. Engineering Strategies to Enhance TCR-Based Adoptive T Cell Therapy. Cells 9
77. Sharkis SJ, Jones RJ, Civin C, Jang YY. 2012. Pluripotent stem cell-based cancer therapy: promise and challenges. Sci Transl Med 4: 127ps9
78. SimplyWallSt. 2024. Century Therapeutics (NASDAQ:IPSC) Will Have To Spend Its Cash Wisely. finance.yahoo.com
79. Simpson DJ, Olova NN, Chandra T. 2021. Cellular reprogramming and epigenetic rejuvenation. Clin Epigenetics 13: 170
80. Song F, Hu Y, Zhang Y, Zhang M, Yang T, et al. 2023. Safety and efficacy of autologous and allogeneic humanized CD19-targeted CAR-T cell therapy for patients with relapsed/refractory B-ALL. J Immunother Cancer 11
81. SphericalInsights. 2022. Global Stem Cell Therapy Market Size, Share, and COVID-19 Impact Analysis, By Type (Autologous and Allogeneic), By Cell Source (Adipose Tissue-Derived, MSC, Bone Marrow, and Placenta/Umbilical Cord), By Therapeutic Application (Musculoskeletal, Wounds, Surgeries, Cardiovascular, and Neurological), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East and Africa), Analysis and Forecast 2021 – 2030.
82. SupplyChainBrain. 2023. Cell and Gene Therapy: An Industry in Need of Supply Chain Visibility.
83. Takahashi K, Yamanaka S. 2006. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126: 663-76
84. Takayama K, Yamanaka S. 2023. Pluripotent stem cell-based therapies and their path to the clinic. Stem Cell Reports 18: 1547-48
85. Thakur V. 2021. Framework for PESTEL dimensions of sustainable healthcare waste management: Learnings from COVID-19 outbreak. J Clean Prod 287: 125562
86. Turk OM, Woodall RC, Gutova M, Brown CE, Rockne RC, Munson JM. 2021. Delivery strategies for cell-based therapies in the brain: overcoming multiple barriers. Drug Deliv Transl Res 11: 2448-67
87. Van Norman GA. 2016a. Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs. JACC Basic Transl Sci 1: 170-79
88. Van Norman GA. 2016b. Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices. JACC Basic Transl Sci 1: 277-87
89. Verbarendse M, Snyder R, Lakshmipathy U. 2023. Mini-review: Equipment evaluation for process scalability and readiness for current Good Manufacturing Practices in cell therapy workflows. Cytotherapy 25: 1107-12
90. Vericel. 2020. Vericel corp annual report.
91. Vericel. 2021. Vericel corp annual report.
92. Vericel. 2022. Vericel corp annual report.
93. Vericel. 2023. Vericel corp annual report.
94. Wang H, Yang Y, Liu J, Qian L. 2021a. Direct cell reprogramming: approaches, mechanisms and progress. Nat Rev Mol Cell Biol 22: 410-24
95. Wang LL, Janes ME, Kumbhojkar N, Kapate N, Clegg JR, et al. 2021b. Cell therapies in the clinic. Bioeng Transl Med 6: e10214
96. Wang Z, Cao YJ. 2020. Adoptive Cell Therapy Targeting Neoantigens: A Frontier for Cancer Research. Front Immunol 11: 176
97. Wu S, Chang KC, Nahmou M, Goldberg JL. 2018. Induced Pluripotent Stem Cells Promote Retinal Ganglion Cell Survival After Transplant. Invest Ophthalmol Vis Sci 59: 1571-76
98. Yükse İ. 2012. Developing a Multi-Criteria Decision Making Model for PESTEL Analysis. International Journal of Business and Management 7: 52-66
99. Yamanaka S. 2020. Pluripotent Stem Cell-Based Cell Therapy-Promise and Challenges. Cell Stem Cell 27: 523-31
100. Yoshida K, Uehara O, Kurashige Y, Paudel D, Onishi A, et al. 2021. Direct reprogramming of epithelial cell rests of malassez into mesenchymal-like cells by epigenetic agents. Sci Rep 11: 1852
101. Zhang X, Chen X, Hong H, Hu R, Liu J, Liu C. 2022. Decellularized extracellular matrix scaffolds: Recent trends and emerging strategies in tissue engineering. Bioact Mater 10: 15-31
102. Zhou T, Yuan Z, Weng J, Pei D, Du X, et al. 2021. Challenges and advances in clinical applications of mesenchymal stromal cells. J Hematol Oncol 14: 24
103. 工商時報. 2019. 台灣再生醫療 黃金紀元啟動.
104. 工商時報. 2022. 再生醫療三法 掀千億商機.
105. 中國大陸國家衛生健康委辦公廳. 2019. 體細胞治療臨床研究和轉化應用管理辦法（試行）.
106. 天下雜誌. 2023a. The Evolution of a Highly Anticipated Cancer-Fighting Weapon: Allogeneic Cell Therapy as the Key Technology for Democratizing Cell Therapy.
107. 天下雜誌. 2023b. 用別人捐的細胞抗癌，有望更便宜 再生醫療新時代降臨？.
108. 天下雜誌. 2023c. 萬眾矚目的抗癌利器再進化：「同種異體細胞治療」成為細胞治療普及化的關鍵技術.
109. 王佳蕙. 2022. 新興醫療藥品之發展策略與商業模式_以視網膜再生醫療產品為例. 碩士論文
110. 高尚志, 林致凡, 劉雅芳. 2020. 台灣特管辦法通過之免疫細胞治療. Taiwan Medical Journal 63: 26
111. 陳秋蘭, 劉宗榮. 2021. 淺談再生醫療製劑. 藥學雜誌 Journal of Taiwan Pharmacy 37
112. 楊青玲. 2016. 台、日、韓細胞治療產品法規概論. 財團法人醫藥品查驗中心 當代醫療法規月刊 71
113. 衛生福利部. 2022. 再生醫療施行管理條例草案總說明.
114. 顧曼芹. 2013. 掌握大藥廠開放性研發模式的合作商機. 當代醫藥法規 |
| Description: | 碩士
國立政治大學
經營管理碩士學程(EMBA)
109932161 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0109932161 |
| Data Type: | thesis |
| Appears in Collections: | [經營管理碩士學程EMBA] 學位論文
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