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Research Report of Chinese Diagnostic Reagent Industry, 2009

The development of Chinese laboratory medicine fell far behind the world’s advanced level for a long time. In the 1970s, China still continued to use the methods in the 1950s, namely, the various necessary diagnostics reagents were self-prepared by the technicians. In the 1970s, China began to introduce some foreign advanced equipments and technologies. Since the 1980s, Chinese clinical diagnostic reagent industry had quickly step into the industrialization process with the introduction of the foreign capitals.

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In 2008, the scale of Chinese diagnostic reagent market was about 600 million USD with the growth speed of 15 to 20 percent in recent years.

Generally speaking, the widely clinically applied and vast market technologies of Chinese major enterprises have achieved the international level of the same period, including the immunodiagnostics of hepatitis, sexually transmitted diseases and fertility test and the enzymes, Lipids, liver function, blood sugar and urinalysis series in the clinical biochemical. The PCR technology for the genetic test had reached to the international advanced level; the technologies of DNA Chips and tumor series are running to catch up the international level.

Due to the market and policy factors and the backward application technologies of domestic electromechanical integration, some projects in the microbiology are developed slowly in low technologies.

The biggest perplex of Chinese diagnostic reagent industry is the repeated appearance of the same kind products in inferior quality, affecting the healthy development of the whole industry. These projects are derived from the domestic researches or imported abroad by various channels but without real creativity.

At present, there are hundreds of diagnostic technology enterprises in various sizes, but the scale is limited and some are even in the laboratory phase. The diagnostic enterprises, as a new biological hi-tech enterprises, start late in China. Compared with the multinational enterprises, the domestic enterprises are in small scales, few varieties and in disparate development. Many enterprises invest huge research capitals in the former period, leading to the meaning losses because of the long exploitation period and fast market changes.

The mergers in Chinese diagnostic reagent industry have been on, in which the small enterprises will be replaced and the large enterprises will be grown in strength.

From the present situation, the diagnostic reagent industry and the equipment industry are under developed in local Chinese enterprises, forming the patterns that the equipments can’t match with the reagents. Compared with foreign companies, the biggest disadvantage of the local enterprises is the brand, because the foreign funded enterprises have long histories, the consumers prefer to choose the foreign brands. The advantages of the local enterprises lie in the familiarity with the local market demands and price competitiveness. At present, these enterprises enable to cover or solve the problems in the second class hospitals. Although there is no problem in covering the third class hospitals, the make-up in the automation systems, data processing and the general industrialization level are behind the foreign technologies.

Although in its beginning phase, the high profit return attracts many investors to enter Chinese diagnostic reagent industry. On 5th June, 2007, the first multinational capital import was succeeded in the field of Chinese diagnostic reagents. Beijing Chemclin Biotech Co., Ltd, provider of the diagnostic reagents and equipments, announced the first round obtainment of 5-million-USD venture investments, dominated by WI Harper Group and Siemens Venture Capital and participated by SB China Venture Capital.

The profit return of the diagnostic reagents is very high. The overall investments in a new diagnostic reagent can be recovered after the public in 2 to 3 years, especially the enterprises with new products or patented products. Once the products exploitation is successful, the technologies will be monopolized with the profit return exceeding 10 folds or more.

Chinese medical reforms had been started since the latter half of 2008. The key point of the medical reforms was to develop towards the medium and low market, request the diagnostics and prevention to be more accurate so as to cut down the costs and improve the medical treatment efficiency. This was a big market and only the products with low costs could meet the demands. In the Major Recent Implementation Plans of Chinese Pharmaceuticals and Hygienic System Reform (2009 to 2010), the intensification in the basic public hygiene services will drive the sharp sales growth of the diagnostic reagent products, pointing out the control and prevention and national immunity plans against the big epidemics, such as T.B. and AIDS. It is predicted that the basic public hygiene services will propel the sales growth of Chinese common diagnostic preparation.   

From the medically clinical experiences in the developed countries, the diagnostic costs account for 20 to 30 percent of the whole medical costs, but which is less than 10% in China. Therefore, great market space has been not exploited so far.

“Table of Contents
1 Overview on the Development of Chinese Diagnostic Reagent Industry
1.1 Related Concepts of Chinese Diagnostic Reagent
1.1.1 Definition
1.1.2 Categories
1.1.3 Categories of the In Vitro Diagnostic Reagent
1.2 Development Situation of Chinese Biopharmaceuticals Industry
1.2.1 Scales 
1.2.2 Development Trends
1.3 Development of Chinese Diagnostic Reagent Industry
1.3.1Market Scales
1.3.2 Present Technologies
1.3.3 Development Trends

2 Analyses on Chinese Clinical Diagnostic Reagent Industry
2.1 Overview on Chinese Clinical Diagnostic Reagent Industry
2.1.1 Development History 
2.1.2 Analysis on Chinese Clinical Biochemical Diagnostic Reagent
2.1.3 Immunodiagnostics
2.1.4 Molecular Diagnostics
2.2 Present Industrialization Situation of Chinese Clinical Diagnostic Reagent
2.2.1 Overview on Chinese Clinical Diagnostic Reagent Market
2.2.2 Clinical Biochemical Diagnostic Reagent Market
2.2.3 Immunodiagnostics Market
2.2.4 Molecular Diagnostics Market
2.2.5 Other Reagent Market
2.3 Analysis on the Development of Chinese Clinical Diagnostic Reagent Industry
2.3.1 Development Perspectives
2.3.2 Challenges and Opportunities 
2.4 Influences of International Financial Crisis on Chinese Clinical Diagnostic Reagent Industry
2.4.1 Short Term Influences
2.4.3 Medium and Long Term Influences

3 Present Research Situation of Chinese Diagnostic Reagent Industry
3.1 Present Situation and Development Trends of Chinese Laboratory Medicine
3.2 Research Achievements of Chinese Clinical Diagnostic Reagent Industry
3.2.1 Born of the Rapid Self-check Kits for Cervical Cancer
3.2.2 Diagnostic Technologies of Avian Influenza 
3.2.3 Diagnostic Reagent for AIDS Virus 
3.2.4 Rapid Immunodiagnostic Kits for Schistosomiasis
3.2.5 Diagnostic Kits for Dengue
3.2.6 Other Achievements

4 Hot Subdivisions of Chinese Diagnostic Reagent Industry
4.1 Cardiovascular Diagnostic Reagent Market
4.1.1 Analysis on the International Cardiovascular Agent Market
4.1.2 Analysis on the Outbreaks of Chinese Cardiovascular Diseases
4.1.3 Analysis on Chinese Cardiovascular System Agents
4.1.4 Analysis on Chinese Cardiovascular Diagnostic Reagent Market
4.2 Diagnostic Reagent for Sexually Transmitted Diseases 
4.2.1 Analysis on the AIDS Outbreaks in the World
4.2.2 Analysis on the AIDS Outbreaks in China 
4.2.3 Development Situation of Chinese AIDS Diagnostic Reagent Industry
4.3 Diagnostic Reagent for the Hepatitis
4.3.1 Analysis on the Hepatitis Outbreaks in China
4.3.2 Analysis on Chinese Hepatitis Diagnostic Reagent Market
4.4 Diagnostic Reagent for the Tumor Marks 
4.4.1 Analysis on the Tumor Outbreaks in China
4.4.2 Common Tumor Marks and Major Clinical Meanings
4.4.3 Analysis on Chinese Tumor Diagnostic Reagent Market
4.5 Analysis on Chinese HTLV Diagnostic Reagent Industry
4.5.1 Brief Introduction 
4.5.2 Analysis on Chinese HTLV Diagnostic Reagent Industry

5 Competition Patterns of Chinese Diagnostic Reagent Market 
5.1 Competition Situation of Chinese Diagnostic Reagent Industry
5.1.1 Major Categories of the Diagnostic Reagents in China
5.1.2 Present Competition Situation of the Major Diagnostic Reagents
5.1.3 Competition Characteristics
5.1.4 Distributions of the Foreign Funded Enterprises in China
5.2 Competition Trends of Chinese Diagnostic Reagent Industry
5.2.1 Merger and Acquisition Trends
5.2.2 Prediction on the Distributions of the Foreign Funded Enterprises in China

6 Major Foreign Funded Enterprises of Chinese Diagnostic Reagent Industry
6.1 Roche Group
6.1.1 Company Profiles
6.1.2 Operations in China
6.1.3 Development Strategies
6.2 Johnson & Johnson Services, Inc
6.2.1 Company Profiles
6.2.2 Operations in China
6.2.3Development Strategies
6.3 GlaxoSmithKline
6.3.1 Company Profiles
6.3.2 Operations in China
6.3.3 Development Strategies
6.4 Pfizer Limited
6.5 Abbott Laboratories

7 Major Local Enterprises of Chinese Diagnostic Reagent Industry
7.1 Shanghai Fosun Pharmaceutical (Group) Co., Ltd
7.1.1 Company Profiles
7.1.2 Major Diagnostic Reagent Products
7.1.3 Development Strategies
7.2 Shanghai Kehua Bio-engineering Co., Ltd
7.2.1 Company Profiles
7.2.2 Major Diagnostic Reagent Products
7.2.3 Development Strategies
7.3 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
7.3.1 Company Profiles
7.3.2 Major Diagnostic Reagent Products
7.3.3 Development Strategies
7.4 Shanghai Rongsheng Biotech Co., Ltd
7.5 Nanjing Jiancheng Bioengineering Institute
7.6 Livzon Pharmaceutical Group Inc.
7.7 Huamei Bioengineering Co., Ltd
7.8 Huasin Science Co., Ltd
7.9 DaAn Gene Co., Ltd

8 Development Strategies to Entry Chinese Diagnostic Reagent Market 
8.1 Investment Problems in Chinese Biopharmaceuticals Industry
8.2 Product Strategies of Chinese Diagnostic Reagent Enterprises
8.3 Competition Strategies of Chinese Diagnostic Reagent Enterprises
8.4 Development Strategies of Chinese Diagnostic Reagent Industry
8.5 Comparisons of the Marketing Strategies between Chinese and Foreign Diagnostic Reagent Enterprises
8.5.1 Strategies of the Product Orientation
8.5.2 Strategies of the Product Price Making
8.5.3 Comparisons of the Distribution Channels

9 Development Trends of Chinese Diagnostic Reagent Industry
9.1 Development Trends of Chinese Pharmaceuticals Industry 
9.1.1 Prediction on the Market Scales
9.1.2 Prediction on the Market Structures
9.1.3 Prediction on the Development of Chinese Biopharmaceuticals Industry
9.2 Development Perspectives of Chinese Diagnostic Reagent Industry
9.2.1 SWOF Analysis on the Development
9.2.2 Prediction on the Scales
9.2.3 Prediction on the Technologies
9.3 Prediction on the Development and Investments of Chinese Diagnostic Reagent Industry

Selected Charts
Chart Analysis on Chinese Diagnostic Reagent Products
Chart Scales of Chinese Diagnostic Reagent Market, 2004-2008
Chart Outbreak and Mortality Rates of Chinese Major Infectious Diseases, 2008
Chart Purchase Amounts of the Anti-tumor Drugs in Chinese Hospitals, 2004-2008
Chart Fierce Competitions among the Anti-tumor Products and Immunomodulator Products in China
Chart Quantity Sheet of Chinese Approved Anti-tumor Drugs and Immunomodulator Products in Class A and B
Chart Categories and Technologies of POCT
Chart Synopsis of the Major Diagnostic Reagent Varieties and the Manufacturers in China  
Chart Operations of Shanghai Kehua Bio-engineering Co., Ltd, 2004-2008



Source by Alice Chen

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