History and development of vacuum blood collection tube industry

Product introduction period (Prior to 1995)

Vacuum blood collection tube was invented in 1937, and began to circulate in the Occident. Subsequently, with increasing clinical practices, it has been continually improved and become more mature. In 1964, it was introduced into Japan and formally used in 1971. After reform and opening-up policies were carried out in China, vacuum blood collection tube was introduced into our country and it was adopted by parts of hospitals in 1990s’. 

Initial stage of the industry (1995—2000)

(1) Most existing enterprises on the Chinese market were established and started their business to produce and promote vacuum blood collection tube at this period; besides, part established medical device industries also began to produce the product.    

Several medical device companies such as Guangdong Yangpu Co., (1996) Hunan Sanli Co., (1997) Hubei Jin Xing Technology Development Co., Ltd, (1997) Chengdu Ruiqi Inc (1998) were established at this stage. Besides, in 1985, Zhejiang Gongdong Medical Device Co. was founded and began to produce vacuum blood collection tube. 

(2) At this stage, some international monopolists such as BD, Austria Greiner Co., Japan Terumo Co., came to China and invested vacuum blood collection tube.

In 1994, BD formally dispatched personnel to China to register and establish representative offices so as to conduct its business with China. Besides, Aug, 1995, the company invested 25 million dollars to establish its production enterprise namely Suzhou Becton Dickinson Medical Devices, Co., Ltd in Suzhou Industrial Park, it covers 20,000 square meters and 10,000 square meters for factory area; class-106 clean rooms cover 2,200 square meters. Jun and Dec in 1998, Becton Dickinson passed the international quality certification ISO9002, ISO13488 and obtained CE mark respectively, which offered passport for their products to enter into European markets.

In 1985, with the advantages in plastic industry, Greiner Co. invented plastic vacuum blood collection tube series product whose registered trade mark is VACUETTE; subsequently, it has become the most innovative product in the field of blood-taking industry. Patent double blood-layer coagulation tube developed by the company in 1996 can ensure coagulation test to avoid interference of various factors, and thus provide more accurate test results. In 1999, Beijing Jianfeng Biotechnology Company was accredited by Greiner Co as its general agent in China to sell its products which mainly include Vacuette series products such as vacuum blood collection system and ESR instrument etc.  
      
In 1995, Japanese Terumo Co planned to establish its subsidiary in Hangzhou and it was completed and put into production in 1997. Vacuum blood collection tube, one of series products of Terumo Hangzhou Co, launched in 2004 and it occupied China’s high-end market and resold back to Japan.     

Turning point of the industry (2001—2002)

On the one hand, production of vacuum industry in China has been preliminarily mature and its production management has become preliminarily standardized.  

On the other hand, Chinese Ministry of Health promulgated administrative regulations to promote disposable vacuum blood collection tube must be adopted by clinical laboratory tests. Two points mentioned above impelled the startup of subdivided industry-vacuum blood collection tube; it is a turning point at which the industry steps towards the growth period. 

In 2001, Guangdong Yangpu Corporation from China Vacuum Blood Collection System industry has passed firstly ISO quality certifications ofISO9001:2000 and EU EN46002:1994 of German TV SD (Now renamed German TV SD Co.) respectively, which indicated homemade vacuum blood collection tubes can freely enter into European markets and other countries which recognize European standards. Chinese Ministry of Health, in 2002, released two health industry standards namely “WS/T 225-2002 Collection and Management of Blood Samples for Clinical-chemical Test” and “WS/T 224£­2002 vacuum blood collection tube and its additives”, it prescribed that disposable vacuum blood collection tubes must be adopted by the collection of blood samples for clinical-chemical test.  

Growth period of the industry (From 2003 to now)

After the industry stepped into growth period, it is characterized with three facets below: 

(1) Diversified investors: it includes foreign medical device industry giants and state-owned enterprises, which has changed private enterprises-based investment model. For instance, in 2003, Sekisui Inc established Sekisui Chuangge Joint Venture Company in Beijing and the annual output of it reached 200 million sets; Sichuan Pushi Co, invested by Sichuan Wuliangye Group in 2006, invested 120 million yuan to develop its medical devices division project which mainly includes vacuum blood collection tube. Up to the end of 2008, there were more than 20 vacuum blood collection tube enterprises in China.  

(2) Rapid expansion of production: rapid expansion of total production capacity came from high starting points of investment of foreign giants and state-owned enterprises combining with expanded production capacity of original enterprises. According to the statistics, planned annual total production capacity of vacuum blood collection tube has reached 2.76 billion, which already satisfied the current demands.

(3) With the overall development of disposable sterile medical device industry, vacuum blood collection tube began to account for a large proportion of export share. For instance, since 2005, the exports share of Guangdong Yangpu Co accounted for more than 50% of sale.

Characteristics of the current development of vacuum blood collection tube industry

A good industrial base

Conventional medical device such as ordinary syringe and infusion set etc have already entered into the mature market period and it has overproduced and the development of it has been explicitly restricted in some provinces. However, in this context, as a new member of medical device family, the development of vacuum blood collection tube gained a good industrial base, which is manifested in following aspects: (1) Nowadays, in China, main production machinery used to produce vacuum blood collection tube such as mold, injection molding machine, assembly machine, packaging machine already had a good production capacity, comparing with the equipments from Germany, Japan and Taiwan, Chinese products had the price advantages and provided relevant supports for it; (2) the production of supporting parts is also very mature, including rubber stopper, blood collection needle and needle holder etc; the production of rubber stopper in Chinese markets has become saturated and overproduced; at the same time, the production technology of blood collection needle is also very mature in China. 

A good basis for the international market

(1) Some Chinese companies are commissioned by several major international medical device companies to produce their products and these products are mainly sold to the three countries namely the United States, Germany and Japan; these homemade products have obtained a certain degree of international recognition, for example, Shanghai Candeley Co has been commissioned by BD and NIPRO to produce syringe and Australia OMI Co commissioned Zhejiang Double-Dove Group to produce safe syringe. (2) Enormous value of export of medical device products: in 2008, China’s total import and export of medical equipment reached 16.28 billion U.S. dollars which increased by 28.21% when it compared with the same period of last year, in which value of export and import reached 11.067 and 52.16 billion U.S. dollars respectively, which increased by 31.46% and 21.81% respectively comparing with the same period of last year. Foreign trade of medical equipment continuously maintained a favorable balance and its surplus reached 5.851billion U.S. dollars, 1.718 billion U.S. dollars of increase comparing with the same period of last year; (3) “Package Procurement” of medical devices was beneficial for the sale of vacuum blood collection tube and made it to be a “free-rider”; during the distribution of medical devices, buyers always purchased various whole set of medical equipment instead of a single product such as syringe, infusion set, injection needle, gauze, surgical glove and surgical clothe etc. mature international market of other medical devices has laid a good foundation for the foreign trade of vacuum blood collection tube; (4) commanding basic operations of international marketing: china’s manufactures of medical devices have generally participated in Dusseldorf Fair (Germany), established Ministry of Foreign Trade and invested online marketing etc. 
    
Low Industry threshold

For medical device enterprise whose annual production capacity of vacuum blood collection tube can reach 100 million, its total investment should be no more than 50 million yuan, including the investments of land, workshops, purification plants etc; it can be reduced by half if manufacture planned to rent workshops. A lower investment will be necessary for existing medical device manufacturers if they restructure or establish new vacuum blood collection tube lines in that universally applied injection molding machine, and thus possible crowded investors will follow easily.

A serious external competition

U.S. BD Co, Sekisui Chemical Co., Ltd., and Austria Greiner Co, industry leaders, were founded in 1897, 1947 and 1968 respectively, the histories of them are between 50 to 110 years and they have become the monopolists among sub-sectors; these enterprises hold the industry standards, key technologies and relevant patents, besides, they are also the forerunners in the Chinese markets and control high-end customers. 
     
China has no industry giant and has not yet entered into industry integration phase

At present, China has no listed company which mainly focuses on the production of vacuum blood collection tube and few companies invested this product only include two enterprises namely Kehua Bio-Engineering Co., Ltd and Sichuan Wuliangye Group. The existing enterprises with relatively high planned production capability namely Guangzhou Yangpu Co and Weihai Hongyu Medical Devices Co., Ltd can produce 500 million of vacuum blood collection tubes each year, which is far less than actual annual yield and sale of Austria Greiner Co (1.4billion tubes).