知識密集服務業群聚之形成 -以生技服務業為例

The Clustering Formation of Knowledge-Intensive Services -A Case Study on Bio-services

鄭秋欽(Cheu-Chin Jeng)

指導教授 ： 曾盛恕

元智大學/管理學院/管理研究所/碩士(2005年)

摘要

生技製藥產業已是政府決心發展，並視為本世紀台灣繼資訊產業之後，另一個有能力帶動台灣生命力的重點產業，生物科技領域相當龐大且價值體系複雜，從人用藥物、生態環境保護以至農業應用無所不包，新藥研發是生技製藥產業中最引人注目的領域，因為新藥研發代表著高獲利、高科技、高風險、高投資等與其他產業相當不一樣的特點，新藥研發原本多屬於全球性大藥廠的專精項目，近二十年來，整個生技製藥產業正進行不斷的解構與重組，在價值體系內出現了許多專精在某一環節具特異能力的公司，透過彼此連結委外或聯盟方式參與生技製藥產業活動，其中以提供技術、服務為主的生技服務業，包含委託研究服務機構（CRO）、委託製造服務機構（CMO）與委託銷售服務機構（CSO），因為具備知識密集的特性，且實際參與藥物研發活動中，從臨床前試驗、臨床試驗、製造、行銷、銷售、服務等價值體系上中下游之重要活動，也是最具附加價值的領域。
本研究以Michael Porter著名鑽石模型與群聚形成觀點，依生產要素、需求條件、企業策略結構與競爭及相關與支援產業等四大決定性因子，探索分析台灣生技服務業現狀，本研究發現，基本上台灣已具備充分發展生技服務業的生產要素，其中以台灣領先全球病床數超過1000床以上諸多大型醫學中心與區域醫院最具特色，這些醫院大部分集中分佈於台灣人口密集的都會地區、醫院內為數眾多水準以上可執行被其他國家認可臨床試驗數據的醫療團隊，加上許多召集容易的不同病源患者，對於以執行BA/BE試驗、臨床試驗為主的CRO是一大發展利基。在衛生署持續不斷提升國資藥廠製藥水準的政策下，一般藥廠均需通過cGMP規範，產品才能取得許可證上市，部分藥廠亦已通過FDA查廠，產品將可銷售至美國，或可接受全球訂單委外生產，如有更多國資藥廠依此模式發展，台灣製藥工業接受委託生產模式一旦成形將具無窮爆發力。資訊順暢流通是產業良性發展重要的一環，財團法人醫藥品查驗中心無疑是近年來對生技製藥產業發展具關鍵性影響的機構，查驗中心在提升新藥審查之品質及效率，協助研擬諸多臨床試驗相關法案，並大幅提高新藥審查水準與時效，輔導政府補助之國資藥廠研發新藥計劃，經常舉辦各類型研討會提升產業水準等作為，查驗中心對生技服務業發展將有極大助益。而隨著全球法規的統一，台灣生技服務業本身也積極強化海外佈局及爭取國際機構認證，並尋求與此領域之知名公司形塑策略聯盟關係，事實上來自於市場適度的需求，也有製藥廠把原屬內部部門獨立出來成立服務公司的例子。
台灣生技服務業在上述四個決定性因子彼此交互影響下，台灣主要CRO、CMO及CSO積極向外以各種方式結合，整體生技服務業已見基本架構，而台灣獨持的市場交易方式，促使CRO積極與國外知名公司合作，引進大型研究計劃或參與大藥廠新產品上市前臨床試驗有關東方人種病患之收集研究，CMO有關委託製造部分，特別是製劑學更是台灣傳統之強項；CSO負責承接整合國內各通路市場之銷售網並提供相關行銷訓練服務，CSO更是在某些特殊服務市場上具有相當大的發揮空間。
台灣生技服務業起源於整個生技製藥產業價值體系的解構與重組，而這種情況仍在進行之中，在探討生技服務業是否具備群聚條件之餘，本國已具規模的醫療機構與醫事服務人員，與許多召集容易的不同病源患者，似乎扮演著產業加速器的角色，因為有這種在國外真正少有的特質，影響了企業策略，業者相形之下更具有條件與國外相關業者合作結盟，引進真正具附加價值的案源，當經由實際執行所累積的經驗提升進度效率，對正在進行人體試驗的新藥之藥廠，不只可節省成本更重要的是提早讓產品上市，這仍是大多數全球性大藥廠最重視的價值所在。

關鍵字：知識密集服務業，群聚，委外，生物技術，生技服務業，鑽石模型

關鍵字

知識密集服務業、群聚、委外、生物技術、生技服務業、鑽石模型

並列摘要

The Biopharmaceutical industry is one of the most important fields next by Information Technology industry which the government has been determined to develop, and took it into Taiwanese government political views to foresight and sagacity in the 21st century. The Biopharmaceutical industry is quite huge with a complicate value system, it include medicine for human, appliances for environment protection also agricultural applications. There are the most noticeable field on the new medicines research and development in Biopharmaceutical industry. Because that on behalf of high making profit, high-tech, risky with high investment etc. With quite different characteristic of the overwhelming majority industries, the new medicines research and development formerly to be part of precise project of global pharmaceutical company. In the past 20 years, it is carrying on a reconstruction and reorganization process in industries; there are a lot of companies with unique ability to participate activities link through each other with connect the outsourcing or strategic alliance in the pharmaceutical value system, among them in order to provide technology and service are called Bio-services which includes Contract Research Organization（CRO）, Contract Manufacturing Organization（CMO）and Contract Sales Organization（CSO）, because possess the knowledge-intensive characteristic cultivation and participate in the process of research and development, such as pre-clinical trial, clinical trial, manufacture, marketing, selling and services from the upstream till downstream of pharmaceutical industries value system, it is a field that has valuable.
The study forms a point-of-view with Michael Porter famous Diamond model and Clustering, such four determinants separate by production factor, demand condition, enterprise’s strategy structure and competition and relevant and support industry to discover and analyze the current situation of Bio-services in Taiwan. The study indicate that Bio-services in Taiwan is catch factor of production especially many medical centers and regional hospitals among them lead the global that wards scope exceed 1000’s also located at mass population territory, a numerous ingenious medical personnel are executable clinical trials that result is approved by global regulation, augment a lot of easy convene patients with different disease type, it is a great development niche to CRO which principle in carrying out BA/BE study and clinical trial. Prolonged improve the level of manufacturing capability of pharmaceutical companies has a fixed policy in government health administration, the products eventually could obtain license and on market unless the pharmaceutical factory should take through cGMP stipulation, some pharmaceutical factory extremely approved the FDA examination that indicate the products production in Taiwan also can export to US and may accept global outsourcing order to produce medicines, if there are more pharmaceutical factories come into being a scale model of contract manufacturing, it will have infinite explosive force for pharmaceutical industry in Taiwan. It is an important status of industry’s development that information circulates smoothly, the CDE play a role of key influence of industry’s development in recent years that constant upgrade quality and efficiency in new medicine regulation process, help to grind and draft many regulations of relevant act of clinical trials and give assistance to pharmaceutical factories for their new product development project, hold many kind issues seminar and training program to improve industry level, the CDE will have benefit to Bio-services development in the future. Followed suit the harmonization of the global regulation, Taiwan Bio-services industry as well as strengthen the overseas overall arrangement and strive for authentication of international organization. In fact, come from the appropriate service demand of the market, a pharmaceutical company separates the inside service division originally and establishes an autonomy service company.
The four determinants sustained affect to Bio-services industry in Taiwan, the main company of Bio-services integrates by various kinds’ way that construct the basic scope yet, and the particular business transactions way which Taiwan hold alone had been impelled CRO to collaborate with global well-known company to introduce large-scale project or planned participates a clinical trial of eastern ethnic group collecting within develop process of global pharmaceutical company. To produce a unique dosage form preparations of medicine is the traditional advantage field of CMO in Taiwan. CSO is responsible for integrate pharmaceutical distribution and providing marketing and training service in relevant market.
Bio-services industry grows due to reconstruction and reorganization from whole value system of Biotechnology and Pharmaceutical industry, the circumstance still to evolve, after probing into that clustering formation of Bio-services that many medical centers and regional hospitals with a lot of easy convene patients with different disease type appears that a role with accelerator, the entrepreneur can introduce effective and valuable project possess more advantage to take shape collaboration with global relevant company which improve progress efficiency via carrying out accumulate experience that not merely save cost but the most important issues is make product on market to advance launch schedule.

Key words：Knowledge-Intensive Services, Clustering, Outsourcing, Biotechnology, Bio-services, Diamond model.

並列關鍵字

Knowledge-Intensive Services, Clustering, Outsourcing, Biotechnology, Bio-services,Diamond model

參考文獻

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