台灣製藥CDMO產業生態系:價值活動分析與發展策略探討

Abstract

生技醫藥產業已逐漸轉向透過委託開發與製造CDMO的專業服務以促使藥物加速上市時程以及有效降低營運成本。在政府政策利多、學研機構的技術支持下，台灣想藉此在全球藥物市場需求高速成長的時機卡位，多數人均認為台灣發展CDMO後市可期，也將CDMO視為台灣在半導體產業後的下一個護國神山。 本研究採取質性研究的多個案整理設計，以台灣從事CDMO的醫藥公司為研究對象，分析其產業現況與發展策略。主要採用商業生態系、策略群組、價值共創以及服務主導邏輯作為理論框架。藉由台灣24家公發與上市櫃CDMO公司的年報次級資料、並深度訪談6家被委託方CDMO公司、4家委託方新藥研發公司主要負責評估決策的營運主管，瞭解台灣醫藥公司與CDMO公司在委託開發製造的各種價值行為的實務現況，並比對委託雙方決策CDMO各關鍵評估要素。 本研究發現，在經過策略群組S-C-P分析其績效、近三年財務報酬表現後，多數台灣CDMO公司尚處於初期發展階段，在專家訪談中也發現委託雙方對於CDMO提供之價值活動、所得營運績效，以及提供之服務是否滿足彼此原始預期的諸多看法上存在落差，要跨入國際市場除品質合規、技術領先外，更需關注顧客有感之服務活動。 現今歐美中日韓在醫藥CDMO的發展與投入規模已領先台灣十年以上。新興療法的興起、原廠藥物與生物相似藥近期更將陸續上市，台灣欲積極搶佔此成長的委託代工未飽和市場領域，宜切入高技術附加價值之利基市場，透過CDMO產業生態系發揮成長綜效，並形成特色化的優質服務價值鏈才能形成差異化優勢。本研究結論並針對突破現狀提出的發展建議，期待台灣CDMO產業能明確定位、用勢佈局，靈活策略，創造差異化競爭優勢進而立足於國際醫藥市場。

Biopharmaceutical industry has gradually shifted to deliver value through the contract development & manufacturing organization (CDMO) to accelerate the time-to-market of drugs and reduce operating costs more effectively. With support of academic and research institutions and favorable government policies, more and more biopharmaceutical companies entering the CDMO field within last 5 years while the market demand is growing rapidly. This study adopts a multi-case design of qualitative research, through literature review and takes Taiwan CDMO companies as the research object to analyze their industry status and development strategies. Mainly adopts business ecosystems, strategic groups, value co-creation and service-dominant logic as the theoretical framework and evaluates the performance of various business activities through secondary data analysis and expert interviews with both parties between CDMOs & their clients. This also leads us to the key elements for Taiwan CDMOs to enter the global market. Through the secondary information of 24 CDMO companies with TWSE listed financial information and annual reports, as well as interviews with experts from 6 CDMOs and 4 entrusted MAH companies, it was found that the CDMO industry is still in the early stage of industry lifecycle, and some of the service of CDMOs provides is beyond their client’s expectations. Most people regard CDMOs as Taiwan's “Bio-shield”, same strategic position as “Silicon Shield” in Taiwan. However, worldwide market are now dominant by EU, USA, China, Japan and South Korea companies. Taiwan CDMOs needs to identify the success factors of the biopharmaceutical industry by advanced Bio & ICT technology, well-operated industry ecosystem and better quality of service which performs higher value to enter the global biopharma supply chain. This study also states the opinion of industry KOLs and experts about the way to create the competitive advantage and expand the service value for Taiwan CDMOs. And the CDMOs need to shift their business models and mindset in response to a fast-changing environment as well.