台灣發展生物科技CDMO產業競爭優勢策略研究 – 借鑑晶圓代工產業發展策略

Abstract

本研究主要為探討台灣生物科技 CDMO(Contract Development and Manufacturing Organization，委託開發與製造組織)產業的競爭優勢策略，並從半導體晶圓代工產業的發展 經驗中借鑑。生物科技與醫藥產業被視為台灣政府的國家發展策略重點，尤其是在疫情期間， 生物技術產業鏈的重要性更加凸顯。台灣的半導體晶圓代工產業透過技術創新、有效的供應 鏈管理及積極的市場擴張策略，在全球市場中取得領先地位，這些成功經驗對於發展生物科 技 CDMO 產業具有重要的借鑑意義。

本研究首先回顧全球與台灣生物科技 CDMO 產業的現狀與發展趨勢。全球生物科技 CDMO 市場在近年來呈現快速增長，這一產業逐漸成為製藥產業中不可或缺的一環。台灣的 生物科技 CDMO 產業雖然起步較晚，但在政府政策支持和本土企業積極投入下，也取得了 一定的成績。

其次，本研究進行了 PESTEL 分析，以了解台灣生物科技 CDMO 產業所面臨的外部環 境。分析結果顯示，台灣在政策法規、科技研發和市場需求方面具有一定優勢，但也面臨資 金投入不足和國際競爭激烈的挑戰。接著，本研究運用波特五力分析探討產業競爭態勢。分 析結果顯示，供應商議價能力較強，因為生物科技原材料和設備供應商掌握核心技術;買方 議價能力也較高，因為製藥委託公司對 CDMO 企業有較高的品質和成本要求。此外，新進 入者威脅相對較低，主要因為進入門檻較高，需要大量資本、技術以及法規認證投入。而在 價值鏈分析方面，本研究發現，CDMO 企業在不同發展階段的核心競爭力存在顯著差異。初 創期的企業應該重視製程技術開發和市場拓展，而成長期的企業則應該加強生產效率和品質 控制。成熟期的企業則應該關注品牌建設和全球市場擴展，以提升競爭力和市場佔有率。

透過對比台灣半導體晶圓代工與生物科技 CDMO 產業的策略，本研究發現兩者在技術 創新、供應鏈管理和市場擴張方面存在顯著相似之處。半導體產業的成功經驗，如技術創新 驅動下的持續研發投入、充分整合的供應鏈協作和靈活的市場應對策略，對於生物科技 CDMO 產業有重要的啟示。兩個產業在初期發展階段均依賴於技術突破和市場需求的驅動， 且都需要政府政策的支持和資金的投入。然而，兩者也存在一些差異。半導體產業的技術發 展週期較短，需要不斷更新和升級，而生物科技 CDMO 產業的研發周期較長，產品上市需 要經過多個臨床試驗階段。此外，半導體產業在全球市場中的競爭更加激烈且集中，而生物 科技 CDMO 產業的市場相對分散，且受各國醫療法規的影響較大。

基於以上分析，本研究提出了台灣生物科技 CDMO 產業的發展建議。首先，應重視技 術創新，增加製程開發投入，特別是在關鍵製程和產線效率的精進。其次，加強產學研合作， 促進技術轉移和創新資源共享，以提升產業整體技術水準。此外，政府應完善政策法規支持， 提供資金和稅收優惠，營造有利於產業發展的環境。最後，應積極開拓國際市場，加強與國 際製藥企業的合作，提升全球競爭力。

總結來說，台灣在發展生物科技 CDMO 產業方面，應充分利用半導體產業的成功經驗， 結合在地自身優勢特點和市場需求，提出相對規模優勢的生產發展策略，才能在全球生技 CDMO 市場中創造新的價值，提升國際競爭力。

This study primarily investigates the competitive advantage strategies of Taiwan's biotechnology CDMO (Contract Development and Manufacturing Organization) industry, drawing lessons from the development experience of the semiconductor wafer foundry industry. The biotechnology and pharmaceutical industries are considered key national development strategies by the Taiwanese government, especially during the pandemic, when the importance of the biotechnology industry chain has become more prominent. Taiwan's semiconductor wafer foundry industry has achieved a leading position in the global market through technological innovation, effective supply chain management, and proactive market expansion strategies. These successful experiences are of significant reference value for the development of the biotechnology CDMO industry.

This study first reviews the current status and development trends of the global and Taiwanese biotechnology CDMO industries. The global biotechnology CDMO market has shown rapid growth in recent years, becoming an indispensable part of the pharmaceutical industry. Although Taiwan's biotechnology CDMO industry started later, it has achieved some success with government policy support and active investment from local enterprises.

Next, this study conducts a PESTEL analysis to understand the external environment faced by Taiwan's biotechnology CDMO industry. The analysis results show that Taiwan has certain advantages in policy regulations, technological research and development, and market demand, but also faces challenges such as insufficient capital investment and intense international competition. Subsequently, this study uses Porter's Five Forces analysis to explore the competitive landscape of the industry. The analysis results indicate that the bargaining power of suppliers is strong because suppliers of biotechnology raw materials and equipment possess core technologies; the bargaining power of buyers is also high, as pharmaceutical companies have high-quality and cost requirements for CDMO enterprises. Additionally, the threat of new entrants is relatively low, mainly due to high entry barriers requiring significant capital, technology, and regulatory approvals.

In terms of value chain analysis, this study finds that the core competencies of CDMO companies vary significantly at different stages of development. Start-up companies should focus on process technology development and market expansion, while growth-stage companies should enhance production efficiency and quality control. Mature companies should focus on brand building and global market expansion to improve competitiveness and market share.

By comparing the strategies of Taiwan's semiconductor wafer foundry and biotechnology CDMO industries, this study finds significant similarities in technological innovation, supply chain management, and market expansion. The successful experiences of the semiconductor industry, such as continuous R&D investment driven by technological innovation, well-integrated supply chain collaboration, and flexible market response strategies, provide important insights for the biotechnology CDMO industry. Both industries rely on technological breakthroughs and market demand during their early development stages, and both require government policy support and capital investment.

However, there are also some differences. The technology development cycle of the semiconductor industry is relatively short, requiring constant updates and upgrades, while the R&D cycle of the biotechnology CDMO industry is longer, with products needing to undergo multiple clinical trial stages before reaching the market. Additionally, the semiconductor industry faces more intense and concentrated global competition, whereas the biotechnology CDMO industry has a more fragmented market and is significantly affected by the medical regulations of various countries.

Based on the above analysis, this study proposes development recommendations for Taiwan's biotechnology CDMO industry. Firstly, it should focus on technological innovation, increasing investment in process development, especially in key processes and production line efficiency improvements. Secondly, it should strengthen industry-academia-research collaboration to promote technology transfer and the sharing of innovative resources, thereby enhancing the overall technological level of the industry. Furthermore, the government should improve policy and regulatory support, providing funding and tax incentives to create a favorable environment for industry development. Finally, it should actively explore international markets, strengthening cooperation with international pharmaceutical companies to enhance global competitiveness.

In conclusion, Taiwan should fully utilize the successful experiences of the semiconductor industry in developing the biotechnology CDMO industry, combining its local advantages and market demand to propose production development strategies with relative scale advantages. This approach will enable Taiwan to create new value in the global biotechnology CDMO market and enhance its international competitiveness.