상품DB/베트남 뎅기열진단 KIT 시장동향(2014.4)/뒤편을 보강한 진단용ㆍ실험실용 시약과 조제된 진단용ㆍ실험실용 시약(뒤편을 보강한 것인지에 상관없으며 제3

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제목	베트남 뎅기열진단 KIT 시장동향(2014.4)
게시일	2016-03-15	국가	베트남	작성자	김주선(하노이무역관)
품목	뒤편을 보강한 진단용ㆍ실험실용 시약과 조제된 진단용ㆍ실험실용 시약(뒤편을 보강한 것인지에 상관없으며 제3002호ㆍ제3006호의 물품은 제외한다), 보증된 참조물질
품목코드	382200
작성일자: 2014.4.23 작성자: 하노이 무역관 La Hong Phuong(lh.phuong@kotra-hanoi.org.vn) 1. Over View of Vietnam Dengue Hemorrhagic Fever □ Vietnam Dengue Hemorrhagic Fever(DHF) Situation  ○ According to the World Health Organization, Dengue hemorrhagic fever is currently circulating in more than 100 countries of the tropics and subtropics. Each year there are approximately 50 million cases of dengue. In Vietnam, dengue is complicated movements, tend to increase, always potentially large outbreak, each year there are approximately 100,000 cases and over 100 deaths. Table 1: Average number of dengue cases in 30 most highly endemic countries/territories as reported to WHO, 2004-2010              Source: Global strategy for dengue control and prevention 2012–2020, WHO, page 5  ○ Dengue fever is one of the most important emerging infectious diseases in Vietnam which has the highest rates of infection and death among children. This has become a serious health problem. Statistics of the Vietnam Ministry of Health in 2012 showed that there were approximately 48,000 cases of dengue, rising 21% compared to 2011. According to statistics of the General Department of Preventive Medicine, cases of severe dengue hemorrhage fever accounted for approximately 7.6% and tends to increase in adults. Deaths by dengue fever in the country also increased by over 20% compared with the previous year.  ○ Dengue fever occurs throughout Vietnam, with the greatest number of cases in the southern part of the country. Dengue fever is characterized by acute onset of high fever, intense headache, and severe aches and pains in the muscles and joints lasting several days to a week or more. Fever may be accompanied by a rash. Fatigue may linger for weeks. The most severe clinical form is Dengue Hemorrhagic Fever (DHF). Although Dengue Fever occurs year-round in Vietnam, it peaks in the hot rainy months of July and August. Table2: Reported number of dengue cases in 2014 and 2013 (for the same time period), by country                         Note: * NA: Not applicable.                                  * Dengue reporting systems vary by country and any change in the                                  surveillance system over time is not reflected in the above figures. Number                                  of reported cases listed for 2014 and 2013 (or, if stated for 2013 and 2012)                                  are for the same time period for each year.                                  ** Recent trend is based on the 3 week moving average for countries                                  reporting by week and monthly comparisons for the last complete month for                                  countries reporting by month.                                  *** Australia: Aedesaegypti and Aedesalbopictus are present only in Northern.                         Source: WHO  ○ While Australia, Malaysia and Singapore have been experiencing a greater number of reported cases in 2014 compared to 2013 for the same time period, the recent trend continued to decrease in Cambodia, Lao PDR, New Caledonia, Philippines and Viet Nam. According to WHO, cumulative number reported cases of death in 2014 is 2,373 compared with 4,962 cases in 2013 during reporting period (January). □ Dengue Virus Detection  ○ Dengue virus infection is currently detected by tests such as virus isolation, reverse transcription polymerase chain reaction (RT-PCR), antigen detection ELISA, he hemagglutination inhibition (HI) test, capture ELISAs for IgM (MAC ELISA) and IgG (GAC ELISA), rapid immunoassay (immune chromatography). However, some tests require more expensive equipment, some do not detect the disease early since antibody response later when the patient has through the acute phase. Therefore, early and accurate diagnosis is an essential need for both doctors and patients. 2. Demand Trend in Vietnam  ○ Dengue hemorrhagic fever (DHF) is an infectious disease caused by Dengue virus. There are 4 types of Dengue viruses including DEN-1, DEN-2, DEN-3 and DEN-4. In the Southeast Asian countries like Vietnam, all four types of this virus have appeared. They are transmitted from person to person by mosquitoes. Aedesaegypti mosquitoes are the primary vectors.  ○ The challenge now for countries like Vietnam, caused by dengue 4 viruses, is 1, 2, 3, and 4. Four viruses without cross-resistance, that is, if you have a fever of virus 1by blood does not mean you will be immune to the remaining virus. Two years later, if you were infected by virus 2 then you probably will be seriously infected; sometimes the virus can lead to complications. So many countries including Vietnam are facing many challenges as they have severe cases due to both four types of virus appearing here. And it will affect more people; there will be people to get dengue fever up to two times. This will lead to severe cases and be difficult to treat. In 2011, Viet Nam reported 69,680 dengue cases (61 fatal). Laboratory testing occurs for a proportion of clinically suspected dengue cases (7% by serology and 3% by virus isolation). Among 7249 laboratory-tested cases, 3262 (45%) were confirmed by serology or virus isolation. Among the 674 serotyped cases, the predominant serotype was DEN-1 (284 [42%] DEN-1, 217 [32%] DEN-2, 118 [18%] DEN-4 and 55 [8%] DEN-3). Table 3: Reported number of dengue cases, and case fatality rates (CFRs) from Cambodia, Laos, Malaysia, Philippines, Singapore, Vietnam and Australia, 2007 to 2011  ○ In Vietnam, this disease happens throughout the year and tends to increases during rainy seasons. This disease is caught by both children and adults. Clinical symptoms of DHF are diverse and develop quickly. The disease strikes suddenly and goes through 03 phases: febrile phase, critical phase, and recovery phase. Therefore, early detection of this disease and understanding of clinical problems in each phase facilitate early diagnosis, correct and timely treatment to cure patients.  ○ Through the reports of the health sector from 1983 to now, approximately every 3-4 years will cause epidemic DHF; the last time that DHF epidemic happened was in 2010, according to a forecast by the NhaTrang Pastuer Institute, in 2013 or 2014 may be the year the epidemic DHF cycle.  ○ Updated guidelines 2009 by the World Health Organization, in order to overcome the limitations of previous guidelines, on February 16, 2011 the Minister of Healthissued Decision No. 458/QD-BYT "Guidelines for the diagnosis and treatment of dengue".  ○ According this Decision, Ministry of Health regulates the diagnosis of origins of dengue virus as following tests:  ○ Serological test   - Quick test:    · Find NS1 antigen within the first 5 days of the disease.    · Find IgM antibody from the 5th day.   - ELISA test:    · Find IgM antibody from the 5th day.    · Find IgG antibody: take the second blood sample one week after the first one to find antibody dynamics (4 times greater).  ○ PCR test, virus isolation: take blood samples during the febrile phase.   - Moreover, different testing techniques can be applied such as reactive prevent erythrocyte agglutination, complement fixation reaction, neutralization reaction (rarely used).  ○ In general, everyone can be infected by Dengue fever since there is now no vaccine for people to get immune by this disease. Thus, recently, detecting NS1 Dengue antigen in patients’ sera has been described as an alternative method for early diagnosis. 3. Competitive Trend  ○ Among the Dengue test kit, currently the SD Bioland Dengue test is the most common test which is widely promoted and used in Vietnam market. As many research among Dengue test made by pharmacists showed that SD Bioland NS1/IgM/IgG has the diagnosis accuracy which is higher than all the other immune chromatographic and ELISA tests. Through the interviews with buyers and experts, we can estimate that SD Bioline Dengue Duo has top market share in Vietnam and others share the rest of the market share.  ○ After searching the circulation registration permits by Drug Administration in Vietnam in recently year, there was no record about the Dengue test with brand name Humasis. 4. Imports Trend  ○ Dengue test kit in Vietnam is forecasted to be a fast-growing market in the next few years as Dengue fever is still a challenge for the medical industry and yet no preventive vaccine to prevent the disease. According to the statistics of UN Comtrade, import value of product HS Code 3822.00 in 2012 is about $50.8 million.  ○ As for Dengue test kit for a rapid diagnosis, Vietnam has not been able to produce this kind of products. Therefore, all of items used up to now has been imported. Foreign –produced kit test must be imported by medicine companies which have licenses given by the Ministry of Health of Vietnam. Also, the products must be approved by Drug Administration of Heath with an official circular number to be controlled.  ○ Following is imported value of products HS Code 3822.00(Composite diagnostic or laboratory reagents, nes) for reference.          Source: UN Comtrade  ○ As can be seen from the chart, imported value of products HS Code 3822.00 has experienced a gradual increase from 2008-2011. Compared with growth speed between 2010 and 2011, there was a decrease trend between 2011 and 2012. Dr. Babatunde Olowokure, Representative of the World Health Organization (WHO) in Vietnam, in 2012, Vietnam has reduced the mortality rate due to dengue fever cases to less than 1/1,000. Respectively in 2012, Korea possessed the fifth largest imported products HS Code 382200 with market shares of 7%, behind Singapore (21%), Germany (16%), France and USA (14%). 5. Regulation on Import and Trade  ○ The main regulatory authority in Vietnam is the Ministry of Health (MoH) and its Drug Administration of Vietnam (DAV), established in 1996.The MoH carries out the state’s public health functions. These include health protection and promotion, curative care, rehabilitation, traditional medicine, pharmaceutical supplies, food safety and medical equipment. In addition, the MoH has 70 subordinate institutions in three major areas: (1) hospitals; (2) preventive medicine and professional institutes; and (3) medical colleges and universities.  ○ Vietnam’s regulators are facing their greatest challenge due to the country’s entrance to the WTO, which was achieved in 2007. Foreign enterprises have been given the right to open branches in Vietnam and to import medical products directly. As part of membership application, Vietnam also set import duties at zero, only remain added value tax at 5%:         Source: Export–Import Tariff and VAT on Imports Book (Ministry of Finance)