May_CDMO Topics|Asia CDMOs are back with new opportunities
Commentator: Shin Chung-chul, Director of Health Center, Ji-Pu Industrial Trend Research Institute
The global biopharmaceutical CDMO (Contract Development and Manufacturing Organization) foundry business is mainly concentrated in Europe and the U.S. because Europe and the U.S. is not only one of the world's largest pharmaceutical sales markets, but also an important industrial cluster for biopharmaceutical R&D. The types of biopharmaceutical CDMO business can be briefly divided into two categories, as shown in Table 1, which are CDMO mass production foundry manufacturing with commercial scale and CDMO clinical candidate new drug manufacturing. The types of business of biopharmaceutical CDMOs, as shown in Table 1, can be briefly categorized into two main types, namely, CDMO mass-production foundry manufacturing with commercial scale, and CDMO pilot-production foundry manufacturing for new drugs on clinical waiting list. It is estimated that there are currently more than 300 CDMO manufacturers in the market, and the CDMO market is still relatively fragmented, with the total revenue of the top 5 CDMO manufacturers accounting for 15% of the overall market size. The CDMO supply chain continues to thrive in the midst of consolidation, and in addition to cross-domain integration of the value chain of biotechnology-based R&D of new medicines, it provides services for raw material drug development (chemical, biological, or cellular genetics), drug formulation, and drug delivery system (drug formulation and drug delivery). In addition to the cross-domain integration of the biotechnology R&D value chain to provide API development (chemical, biopharmaceutical or cytogenetic drugs), drug delivery system, clinical trial solutions (contract research organization), filling and packaging, and cold-chain logistics to support drug development and manufacturing services, another focus of attention is the development trend of vertical integration of the supply chain of manufacturing equipment, with the acquisition of Thermo Fisher Scientific by the U.S. company Thermo Fisher Scientific. Another focus of attention is the development trend of vertical integration in the manufacturing equipment supply chain, represented by the acquisition of Patheon by Thermo Fisher Scientific, the acquisition of Mirus Bio by Millipore Sigma, and the acquisition of Biovectra by Agilent, which are manufacturing equipment suppliers that have entered the CDMO industry.
表一、國際生技製藥CDMO業務類型

Source: Organized by Ji-Pu Industrial Trend Research Institute.
隨著川普關稅政策不排除未來對全球進口至美國的生技醫藥品加徵關稅,加上近期大國博奕間地緣政治的不確定性,美中或美歐關稅貿易爭端不斷,以及美國鞏固生技製藥霸權,降低對中國過度依賴,推動生技製藥產業回流美國等趨勢下,除了推升美國境外的國家生產、進口至美國的醫藥品風險外,雖然多家跨國藥廠已表態重返美國投資設廠,但美國本土建廠重塑供應鏈動輒耗時五年以上,不僅過程曠日廢時且為供應鏈穩定性埋下隱憂,面對生技製藥供應鏈的脆弱性,生技製藥CDMO產業多元供應鏈佈局的可擴展性,在藥物開發製程靈活性,以及新技術導入速度,讓CDMO角色愈發關鍵,生技製藥CDMO業者就成為全球製藥公司因應地緣政治風險、分散供應鏈風險的關鍵解方之一。
看準全球製藥公司尋求供應鏈多元化韌性、降低製藥成本的壓力,以及降低過度依賴中國風險帶來的巨大成長機會下,CDMO產業迎來格局轉變的契機,亞洲CDMO業者憑藉聚焦核心技術能力、高效生産模式、以及研發生産環節的成本管理能力和成本優勢,逐漸吸引原本倚重歐美CDMO的國際製藥公司,轉向日本、韓國、印度和台灣CDMO廠商的合作,如已多年卡位佈局美國的日本富士軟片(Fujifilm Diosynth)獲美Regeneron約30億美元代工生產抗體藥物大單; 或韓國三星生物(Samsung BioLogics) 延續去年 CDMO 交易勢頭,再獲美國製藥公司(未公開)簽署 5.18 億美元生產合同; 或印度最大生技製藥CDMO業者Syngene以3,650萬美元收購美國生物製劑廠,首次正式插旗美國,以及台廠保瑞(Bora)攜手泰福(Tanvex)擴大美國CDMO業務,都顯示全球生技製藥產能正加速向亞太地區轉移。除牽動亞洲CDMO供應鏈版圖的變化外,也加速全球對亞洲CDMO的需求擴張,使得日、韓、印和台成為今年CDMO產業關注的焦點。此外,國際私募股權投資(private equity, PE)的布局也成為推動CDMO產業成長的另一項重要動能,如貝恩資本(Bain Capital)正洽談以100億美元收購美國PCI(PCI Pharma Services),黑石(Blackstone)收購日本CRO公司CMIC的60%股權,或KKR以12億美元收購瑞典生命科學公司Biotage,其原因來自於策略性買家和全球生命科學製造商加強其供應鏈,提高其彈性製造能力,以避免受地緣政洽緊張局勢的影響,並看好CDMO產業具備產業整併潛力,規模經濟優勢、穩定的經常性收入與強勁現金流,再加上可協助藥廠加快藥品上市時程與控制成本等的未來成長性。
CDMO競爭白熱化,全球化、聯盟化、跨國合作為關鍵解方
生技製藥CDMO已成為全球高階製造的兵家競爭之地,創新先進製造技術能力、規模化成本和速度優勢,以及供應鏈信任合作關係將是生技製藥CDMO取勝的三大關鍵,面對日本、韓國和印度等亞洲CDMO業者,以及藥明系、凱萊英和康龍化成等中資CDMO廠商的強勢競爭,台廠CDMO正需要尋求全球化市場和技術規模化發展,來延伸覆蓋多類型CDMO具備綜合性服務優勢,借鏡國際CDMO供應鏈整合所帶來綜效的趨勢,無論是自主併購打造美台雙基地,建立精簡且彈性的海外佈局,或是以產業聯盟帶動供應鏈協作擴張生產接單,或聯合日本CDMO業者或印度CDMO業者進行業者間跨國合作,以擴大客戶群,建立跨洲供應鏈無縫接軌,提供客戶靈活解決方案,都是可能的選項。
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