Market Report on TCM(E_cerpt)__国内外中药市场分析(摘要).doc

国内外中药市场分析摘要Excerpt ofAnalysis of TCM Market in China and the World2011年1月25日January 25, 2011目录一、中药产品简介3I. Brief introduction of TCM (traditional Chinese medicine) products3二、中国医药市场5II. Chinese pharmaceutical market5三、中国中药市场现状及其相关情况分析5III. Status quo of TCM Market in China51. 中国中药市场发展现状51. Status quo of TCM Market in China52. 中国中药市场态势分析（SWOT分析）72. Analysis of TCM Market in China (SWOT analysis)73. 中国中药出口情况113. Export of TCM114. 中国中药出口战略对策分析184. Strategies for TCM export18四、中国中药类产品发展趋势：19IV. Development trend of TCM products in China:191. 中药类产品发展趋势：191. Development trend of TCM products:192. 中药市场的新特点：202. New features of the TCM market:20五、未来中药产业将走向现代化21V. Modernization of TCM industry21六、中药国际化的主要策略22VI. Main strategies of TCM internationalization221. 规划中药产业政策，扩大产业规模221. Plan TCM industrial policies and expand the industrial scale222. 掌握各国的中草药法规及政策，制定中国中药出口的战略方针232. Master regulations about TCM in each country and develop strategic policy for TCM export233. 增强创新意识，加速科研进程233. Enhance the awareness of innovation and accelerate the research process234. 重视中药的知识产权保护244. Emphasize on IPR protection of TCM245. 因地制宜，多途径开拓中药国际市场245. Develop international market of TCM with local conditions246. 促进中医药现代化和国际化的进程，促进中药资源的发展246. Promote the modernization and internationalization of TCM24一、中药产品简介I. Brief introduction of TCM (traditional Chinese medicine) products中药是指在中医药理论指导下用以防治疾病的药物，其来源包括植物药、动物药和矿物药。植物药占绝大多数。中药产品是指上述药物的制成品。Traditional Chinese Medicine (TCM) refers to the drugs used to prevent disease under the guidance of TCM theory, whose sources include botanical drugs, animal drugs and mineral drugs. Botanical drugs account for the largest proportion. TCM products refer to patterned Chinese herbal products manufactured with above medicine.中药与西方植物药的比较Comparison between TCM and Western botanical drugs项目Project中药TCM西方植物药Western botanical drugs 理论Theory有系统理论，强调辨证施治，以性味归经理论原理指导临床用药With systematic theory, emphasizing on treatment based on different syndromes , guiding clinical medication with the theory of four properties, five tastes and channel distribution.虽有一定的用药经验，但未形成较系统的理论Having some clinical applications, but no systematic theory was formed.来源Sources植物、动物和矿物Plants, animals and minerals.以植物为主Most are plants.方剂Prescription强调配伍组方用药，即君臣佐使，七情和合，充分发挥药物之间的相互作用，多为复方用药Emphasizing on composition and seven conditions in making up prescription; fully leverage the interaction between drugs, and most drugs are compound medicine.大多为单方，少数为组合用药Most are single-ingredient medicine; compound medicine is rare.炮制加工Processing有系统和经过数千年实践的炮制经验和工艺Having systematic processing techniques based on thousand-year- practicing.无传统，无专门的炮制要求No traditional or special processing techniques.临床使用情况Clinical use1.丰富的实践，浩瀚文献，数千年实践考验；2.对慢性病、疑难杂症、老年病尤为擅长；3.对非器质性的功能性疾病有明显的疗效1. Having extensive practice, vast literature and improved by thousands of years practice; 2. Especially effective for chronic diseases, complicated diseases and senile diseases; 3. Having evident efficacy for functional diseases with non-organic damage.1.最长仅几百年历史；2.主要用于轻症，预防感冒、失眠、消化不良、食欲不佳、紧张，列入OTC药范围，被认为只是辅助作用1. Only with a history of a few hundred years for the most; 2. Mainly used for mild case, preventing cold, insomnia, indigestion, poor appetite and nervousness, which are included in the scope of OTC drugs and only have an adjunctive therapy role.临床前期慢毒、急毒及三致试验Pre-clinical chronic and acute toxicity test; carcinogenicity, teratogenicity and mutagenicity test.常缺乏GLP实验室水准的实验数据 Lack the experimental data at the level of GLP laboratory.部分具有Some of them have the experimental data at the level of GLP laboratory.临床试验Clinical trials常缺乏双盲法等临床数据Often lack of clinical data of double blind and other studies. 现代研究强调用双盲法Double blind method is emphasized in modern studies.发现新药Development of new drugs因为有规律及丰富经验积累，是开发新药的重要途径Because of its regularity and rich experience in practice, it is an important way to develop new drugs. 有生命力，但无法与中药相比Vigorous; but inferior to TCM二、中国医药市场II. Chinese pharmaceutical market医药工业是国民经济的重要组成部分，2003年全国医药产品销售收入完成2961亿元，其中化学药品原料药产量为80.35万吨，中成药产量为60.29万吨。据国家食品药品监督管理局（SFDA）南方医药经济研究所统计，2008年全年医药工业生产总值（现价）基本达到7080亿元，同比增长约18%。Pharmaceutical industry sector is an important part of the economy in China. Sales of pharmaceutical products nationwide were RMB 296.1 billion in 2003, of which bulk pharmaceutical chemicals were 803,500 tons and TCM drugs were 602,900 tons. According to the data of Southern Medical Economic Research Institute of the State Food and Drug Administration (SFDA), the total output value (current prices) of pharmaceutical sector basically reached RMB 708 billion in 2008, up by about 18% year on year.三、中国中药市场现状及其相关情况分析III. Status quo of TCM Market in China1. 中国中药市场发展现状1. Status quo of TCM Market in China中药行业是医药行业的子行业，由中药材生产、中药工业（含中药饮片加工、中成药生产、中药机械制造）和中药商业组成。经过长期发展，中国已形成了以中药材生产为基础，中药工业为主体，中药商业为纽带的中药生产流通体系。到2001年年底，全国拥有中成药企业1208家，能生产35大类、43种剂型、5000多种中成药，另有生产中药的西药企业近1000家，中药饮片和保健品企业近3000家。根据国家经贸委（现发改委）经济运行局统计数据，2002年中国中药企业（包括中成药工业企业和中药饮片工业企业）纳入统计口径的总计1150家。中药行业的工业总产值及中药行业年销售收入呈逐年上升趋势。TCM is an industry within the pharmaceutical industry sector, consisting of raw TCM herbs production, TCM manufacturing (including processing of prepared TCM herbs, production of Chinese patent drugs and manufacturing of TCM equipment) and TCM business. After a long-term development, a production and distribution system has formed in China, with Raw TCM herbs manufacturing as the basis, TCM manufacturing as the main body and TCM business circulation as a link. By the end of 2001, there were 1,208 Chinese patent drug enterprises, which could produce Chinese patent drugs in 35 categories, 43 types of dosage forms and 5,000 types. In addition, there were nearly 1,000 Western medicine enterprises producing TCM and 3,000 enterprises producing prepared TCM herbs and health-care products. According to the statistic data of Bureau of Economic Operation of State Economic and Trade Commission (now National Development and Reform Commission), a total of 1,150 TCM manufacturing enterprises were included in the statistic caliber (including TCM drug enterprises and prepared TCM herbs enterprises) in 2002. The output value and annual sales of TCM industry are increasing year by year.2005年2007年中药行业的工业总产值及增速Total Output Value and Growth Rates of TCM Industry, 2005 -2007年份Year工业生产总值（亿元）Total output value(100 million RMB)比上年同期增长（%）Year-on-year Growth(%)20051183.2223.2120061444.2822.0620071728.5719.68（数据来源：国家发改委经济运行局）(Source: Bureau of Economic Operation of National Development and Reform Commission)2006年2007年中国中药行业年销售收入及增速Sales and Growth Rates of TCM Industry, 2006 -2007年份Year年销售收入（亿元）Annual sales (100 million RMB)比上年同期增长（%）the Year-on-year Growth (%)20061330.3412.0420071424.487.08（数据来源：国家发改委经济运行局）(Source: Bureau of Economic Operation of National Development and Reform Commission)2. 中国中药市场态势分析（SWOT分析）2. Analysis of TCM Market in China (SWOT analysis)1). 优势分析：中国药用资源极为丰富，全国药用资源共12807种，其中药用植物11146种，药用动物1500种，药用矿物80种；用量较大的药材均能人工栽培，是世界上最大的药材生产国；中国中药目前出口到130多个国家或地区，年出口创汇总额超过6亿美元；中药复方在应用上品种繁多，为新药、保健食品的开发提供了得天独厚的来源；特别是中药在临床上表现出的相应毒副反应小或无毒副反应、无耐药性，对一些疑难病、慢性病和老年病有独特的疗效等优势引起了世界许多国家的重视，这些国家纷纷把目光转向中药的研究上来。目前中国有1141种中药新药通过注册，其中一类新药占11.5%，二类占6.5%，三类占40%，四类占40%，五类占2%。国家对中药的科学研究逐年加大经费投入。中国政府已经制定了“中药现代化科技产业行动计划”，提出了四大中国科技先导性中药产业；推进中国中药进入国际医药市场；出巨资，建设药材GAP（中药材质量管理规范）生产基地，研究开发符合国际需求的现代药材。批准建立第一个国家级中药现代科技产业基地（四川基地），启动几十种常用中药材GAP规范的制定，并有几十家中药企业已通过国家GMP的认证1). Strength: China is the largest producer of medicinal materials in the world, which is very rich in medicinal resources. There are 12,807 kinds of medicinal resources in total, including 11,146 kinds of medicinal plants, 1,500 kinds of medicinal animals and 80 kinds of medicinal minerals; all medicinal materials are widely used and can be artificially cultivated. TCM is currently exported to over 130 countries or regions from China, bringing over USD600 million of foreign exchange every year for the country. TCM compounds are numerous in variety and are unique sources for development of new drugs and health food. TCM is demonstrated to have few toxic side-effects and drug resistances in clinical practices, and unique efficacy for some complicated diseases, chronic diseases and senile diseases, attracting more and more attention from many countries in the world, which begin to research and develop TCM. Currently, there are 1,141 kinds of new TCM drugs that have been registered, of which class new drugs account for 11.5%, class 6.5%, class 40%, class 40% and class 2%. Year by year, China increases the investment in scientific research of TCM. The Chinese government has formulated Plan for Modernization of TCM Industry, which proposes four TCM sub-industries at the pioneering position of science and technology in China; promotes Chinese medicine into the international pharmaceutical market; invests heavily to build the TCM GAP (Good Agriculture Practice, a TCM quality management qualification) production bases and develop modern Raw TCM herbs in line with international demands. China has approved of establishment of the first national modern technology industrial base of TCM (Sichuan base) and started to formulate the GAP qualification for dozens of common-used Raw TCM herbs. Dozens of TCM enterprises have obtained the national GMP certification.2). 劣势分析：目前中药出口主要为中药材（占65%左右）和保健药，这与中国作为中药发源地的地位极不相称。中国中药的加工程度及附加值低，中成药中具有“三效”（速效、长效、高效）、“三小”（毒性小、副作用小、用量小）和“三便”（储存方便、携带方便、服用方便）的品种较少。中国中药大多包装简陋，包装上的使用说明缺乏规范，给人以劣质产品的错觉，因此在国际竞争中处于不利地位。由于中药材来自农副产品，加工手段较简单，再加上生产工艺不合理，导致许多产品技术含量低，有些产品不但无法定量甚至连定性都困难，所以难以保证产品质量的稳定性，且各种药材的有效成分不能相对稳定，临床疗效不一致，难以有好销路及高利润。目前，中国在中药种植、生产、有效成分测定、毒理药效检测、质量检测、包装储存等方面尚缺乏统一的标准。此外，在种植药材过程中，因滥用农药而造成农药残留过多及重金属含量超标（高于FAO/WHO规定的标准），严重影响中药的安全性。国际上医药生产要求符合GMP标准，非临床安全性研究要求符合GLP标准，临床安全性研究要求符合GAP、GMP、GLP、GCP，不达标无法取得市场准入资格。中国中药企业通过GMP认证的不足3%，不少企业存在简陋，车间布局不合理，设备陈旧等软、硬件不足。2). Weakness: At present, the main exported TCM products are raw TCM herbs (accounting for about 65%) and health-care drugs, which is disproportional to Chinas status as the birthplace of TCM. The processing degree and added value of exported TCM are very low. Among all Chinese patent drugs there are few products that can be honored as “three efficient” (quick, long-lasting, highly efficient), “three low” (low toxicity, few side effects and low amount of dosage) and “three convenient” (convenient to store, convenient to carry, convenient to take). Most of the exported TCM are packaged simply and the instructions on the packages lack specifications, producing an impression of inferior products to customers, and therefore at a disadvantageous status in international competition. Because TCM are agricultural and sideline products, the processing methods are relatively simple, resulting in that many products are of low technological content. Some of the materials are not only impossible to be quantitatively tested, but also difficult to be qualitatively tested, so it is difficult to guarantee the stability of the quality. In addition, many TCM materials do not have relatively stable active ingredients and show inconsistent clinical efficacy, leading to undesirable sales and low profit. Currently, there are no unified standards in TCM planting, manufacturing, active ingredients determination and measurement, toxicological and efficacy testing, quality control, packaging ad storage in China. Another problem is the high content of pesticide residues and heavy metals caused by the abuse of pesticides in the process of the cultivation of medicinal herbs, (usually higher than standards required by FAO / WHO), which seriously affect the safety of TCM drugs. It is required that pharmaceutical production shall meet the international GMP standards, non-clinical safety studies are required to comply with GLP standards, clinical safety studies are required to comply with GAP, GMP, GLP and GCP, and the products can not obtain market access if their productions do not meet the standards. There are no more than 3% TCM enterprises that have obtained GMP certification in China, and many companies have serious problems such as simple workshop with unreasonable layout, outdated equipment, etc.3). 机会分析：中国加入WTO后，中国中药凭借资源优势、劳动力优势和价格优势可平等且具有竞争力地通过竞争走向国际。近年来人们已经将目光投向自然、民族传统医药、草药、植物药等天然药物，天然产物已经成为国际医药产业的热点领域，这为中药产业的发展提供了战略契机。据世界卫生组织统计，当前世界上有80%的人使用过天然药物，在世界药品市场，天然药物已占30%，国际上植物药市场金额已达300多亿美元，且每年以超过20%的速度递增。世界上知名制药企业大多已在中国大陆设厂，中药产业已被国内外厂商一致看好。中医药文化不断地被更多国家政府所接受，越来越多的国家将中药纳入了药品管理体系或已承认了中医的合法地位，如法国目前约有2800个中医诊所，每年消耗草药或植物药约4.3万吨；在英国仅伦敦就有600多家中医诊所；美国制订了植物药研究指南，开始接受传统药物中的天然药物复方混合制剂作为治疗药物，为中药作为治疗药进入美国打开了大门。3). Opportunity: After accession to WTO, TCM walks into international market with resource advantages, labor advantages and price advantages. In recent years, people have started to pay attention to the natural, traditional medicine, herbal medicine, medicinal plants and other natural drugs. Natural products have become a hot area of the international pharmaceutical sector, which provides a strategic opportunity for the development of TCM industry. According to the statistical data of the World Health Organization, today 80% of people in the world have used natural drugs; natural drugs account for 30% shares in the pharmaceutical market, and the sales of medicinal plants has reached more than 30 billion dollars in international market and increased at the rate of more than 20% year by year. Most of the leading pharmaceutical companies in the world have set up factories in Mainland China, and the domestic and foreign manufacturers are unanimously optimistic about the Chinese medicine industry. More and more countries start to accept TCM culture and TCM was included in the pharmaceutical management system or obtained recognition in its legal status in many countries. For example, there are about 2,800 TCM clinics and about 43,000 tons of herbs or medicinal plants consumed every year in France; in the UK, there are more than 600 TCM clinics in London alone; the United States have published Guidance for Industry Botanical Drug Products, and start to accept natural compound medicines of traditional medicine as therapeutic drugs, opening the door for TCM to be marketed in the United States.4). 不利分析：中国中药至今尚未真正进入国际医药主流市场，主要原因是中国中药在药效和安全性的评价、生产工艺、质量标准、制剂技术、临床研究等方面发展滞后；此外，中国中药产业还停留在传统产业阶段，中药企业规模小、产值低、效益差、无竞争实力，所以中药难以冲出国门，致使在国际植物药市场（不包括中国市场）份额中仅占5%，其余被日、韩、印度、泰国“四分天下”。 4).Threat: TCM has not yet truly entered the mainstream of the international pharmaceutical market, mainly due to the slow development in the field of the evaluation of TCM efficacy and safety, production processes, quality standards, preparation techniques and clinical research; in addition, TCM industry is still a traditional industry. Chinese enterprises are relatively small in size with low output value, low efficiency and low competitiveness, making it difficult for TCM to go abroad. TCM exported from China only accounts for 5% share in the international herbal market (excluding the China market), and the remaining is divided to four parts occupied by Japan, South Korea, India and Thailand respectively.3. 中国中药出口情况3. Export of TCM1). 中国中药出口数据。海关数据显示，本世纪以来中国中药出口平均年增长达到了10.2%，2006年中药出口首次突破了 10亿美元大关，达10.9亿美元，同比增长28.45%。2007年出口额为11.8亿美元，其中中药药材和饮片出口4.8亿美元，占中药出口总值的40.7%，同比增长17.1%。1). Export data of TCM for China. China Customs data shows that the average annual growth rate of TCM export value reached 10.2% in 2010s. TCM exports exceeded USD1.0 billion in 2006, reaching USD1.09 billion, increasing by 28.45% year on year. Export value was USD1.18 billion in 2007, of which the export value of raw TCM herbs and prepared TCM herbs was USD480 million in total, accounting for 40.7% of the total value of TCM export, increasing by 17.1% year on year.2004年2007年中药行业年出口金额Annual Export Value of TCM Industry in China (2004 -2007) 年份Year年出口金额（亿美元）Annual Export Value (100 million USD)2004720058.4200610.9200711.8（数据来源：国家海关）(Source: China Customs)2007年中国部分城市中药出口累计金额（单位：万美元）Total Export Value of TCM in Certain Cities in 2007 (unit: ten thousand USD)城市/省City/Province中药材及饮片Raw TCM herbs and Prepared TCM herbs 中药提取物Chinese herb extracts保健品Health-care product中成药Chinese patent drugs合计Total 北京Beijing 2281.672919.23576.292808.588585.77长春Changchun 723.9220.245.6315.09764.88长沙Changsha 3.35691.9021.6099.11815.96成都Chengdu 1273.882734.6941.68253.214303.45广州Guangzhou 540.81342.902.19890.981776.88桂林Guilin 125.46873.7671.361070.58杭州Hangzhou 2045.752482.711097.80103.975703.23上海Shanghai 474.927540.90224.541069.949310.29泰州Taizhou 287.70107.78395.47通化Tonghua 473.6474.3319.83567.80淄博Zibo 2.6044.0616.190.9763.83河北省Hebei Province2020.07769.047.66141.512938.27陕西省Shaanxi Province428.192171.1825.7732.622657.76合计Total10394.2620952.622019.345614.9538981.17（数据来源：中国食品产业网）(Data source: )2008年14月中国医药保健品进出口商品分类统计表 (单位：美元)Imported and Exported Medicines and Health Products of China, January-April, 2008 (Unit: USD)分类Classification进出口Imports and exports进口Imports出口Exports 进出口额Total Import and export value同比增减Y-o-y Growth（%）比重Proportion in Total （%）进口额Importvalue同比增减Y-o-y Growth （%）比重Proportion in Total（%）出口额 Export value