Industry Trend Report｜Global CDMO Industry Overview and Trends

Published On: 2022/09/23|Categories: 大健康(Healthcare)|

The full name of CDMO is Contract Development and Manufacturing Organization, which refers to the commissioned development and manufacturing service, i.e., the pharmaceutical company commissions the CDMO factory to carry out the development or manufacturing of the drug. This division of labor is similar to the OEM model in Taiwan's electronics industry, in that as the cost of manufacturing increases, the industry begins to seek outsourced manufacturing in order to efficiently allocate resources. The R&D process for a new drug can take as long as 10 to 15 years from the laboratory to the market, and consume 15 to 20 billion Taiwan dollars in capital. If you look at the whole R&D process in detail, it can go through three stages: drug discovery, preclinical testing, completion of Phase III clinical trials, and approval before the product is finally launched on the market.

Because the development of new drugs is too time-consuming, the division of labor in the pharmaceutical industry chain is becoming more and more refined (Figure 1As a result, specialized outsourcing has become an important strategic choice for pharmaceutical companies. The rise of CDMOs is due to two reasons: 1) the high cost and time-consuming development of new drugs, and the high risk for pharmaceutical companies; 2) the high cost of operating and maintaining pharmaceutical plants. In order to produce drugs, it is necessary to invest in equipment and plants, but owning a pharmaceutical plant makes it difficult for a pharmaceutical company to achieve economic scale, so pharmaceutical companies would rather focus more on new drug development, grab patents and get a license. CDMOs, on the other hand, focus on providing clinical trials and mass production for pharmaceutical companies, supplying a wide range of manufacturing needs, so that pharmaceutical companies can focus on drug development and patent licensing, after all, the licensing fees after the launch of a new drug is the real huge profits (Figure 2). More importantly, if manufacturing is left to CDMOs, it is more likely to ensure that each batch of drugs is as consistent as possible. In addition, since the composition of drugs comes from a variety of sources, CDMOs are specialized in assisting in the adjustment of formulations at different stages to test the most suitable dosage forms. Therefore, while large pharmaceutical companies still rely on CDMOs to ensure the quality of their drugs, small pharmaceutical companies are even more reliant on CDMOs for their services.

Figure 1 Outsourcing Services in the Pharmaceutical Industry

Organized by Ji-Pu Industrial Trend Research Institute 2022/9

圖二 CDMO服務項目

Organized by Ji-Pu Industrial Trend Research Institute 2022/9

還未壟斷生物藥前景可期

而從CDMO市場來說可分為兩大領域(Figure 3)：化學藥和生物藥。前者泛指各式小分子化學元素組成的藥物，包括普拿疼、阿斯匹林等可至藥局購買的成藥；其主要是以化學合成方式製造，因製程成熟代工比率超過六成，進入相對門檻較低。而後者則是由較複雜的大分子結構組成的藥物，例如蛋白質、核酸、幹細胞、基因等生物製劑；由於多用在慢性病、癌症等重大疾病上，因此相對技術門檻較高，目前代工比率僅兩成多，也因此解釋了為何生物藥的潛力相比化學藥要高。

圖三生物製劑與化學藥的差異

Organized by Ji-Pu Industrial Trend Research Institute 2022/9

目前國際市場上，雖仍以化學藥的整體規模和市值較大，但市場已明顯趨於飽和，反而是製作難度更高、成本更高的生物藥市場，正蓬勃發展中(Figure 4)。據研調機構GII統計，全球CDMO市場的年複合成長率是7％，其中生物藥為11.5%。另研究機構Frost & Sullivan也預估，生物藥全球市場規模可從2020年的180億元攀升至2025年的460億美元，足見其潛在商機備受看好。尤其生物藥涉及精密的細胞開發，流程上難複製，且需要投入臨床試驗，成本極高，但也因為進入門檻高，礙於轉單成本與研發時間長，生物藥一旦落地生產後，往往可以與藥廠建立長期合作關係，在生物藥的CDMO市場中找到重要戰略位置，因此生物藥CDMO也被視為台廠應該切入的領域。

圖四 2016~2025 生物藥和化學藥產值

資料來源： Forst&Sullivan；智璞產業趨勢研究所整理 2022/9

全球CDMO市場佈局概況

由於發展較早的優勢，目前全球CDMO市場主要份額還是為歐美地區佔據，許多大型的CDMO龍頭企業也均來自歐美，如Lonza、Catelent、Patheon等，前十大CDMO廠中就有七家總部在歐洲(Figure 5)。特別是當前生物藥CDMO商機備受期待，目前市場(尤其在亞洲地區)仍處於供不應求的狀態。根據研究機構Mordor Intelligence指出，生物藥CDMO雖然有一些主要玩家，但亞洲區整體市場仍處於「各自為政」的狀態，比起成熟的歐美地區，亞洲反而有許多機會。以目前亞洲市場來說，又以中國與韓國居於領先地位(圖六)，中國大陸由於內需市場大，目前中國政府投入大量資源扶植CDMO公司，其中以藥明生物為代表。而韓國同樣由政府加財團大力扶持投入銀彈，重金聘雇美國團隊協助培育韓國公司，近年來三星旗下的CDMO，無疑已是亞洲最具競爭力的公司之一。
值得一提的是，全球僅有前20大的CDMO公司營收超過5億美元，但仍有高達75%的CDMO公司營收低於5,000萬美元，顯示CDMO產業仍未飽和。而這些名列前茅的國際CDMO大廠，全球市占率共59%，其餘41%由中小型CDMO廠分占市場，因此包括台灣在內，各國皆將矛頭對準這41%的潛力市場。

圖五全球主要CDMO營收概況

註：Boehringer Ingelheim 僅計算DMO業務。

資料來源：vcbeat.top、各公司官網；智璞產業趨勢研究所整理 2022/9

國際市佔分散大廠併購不停

綜觀目前現況，營收前5%的公司就擁有15%的市場占有率，且皆為提供全方位服務的國際CDMO廠，因此市場也預期，CDMO將成為大者恆大的市場，整體產業的整併需求快速成長。保瑞董事長盛保熙也認為，併購會是全球CDMO產業的趨勢與成長策略，藉由私募股權基金的投入和精準併購，將可提升投資標的的技術質量與成長速度。