“Research on China IVD Reagent (In Vitro Diagnostic Reagent) Industry, 2013-2017” mainly conducts in-depth analysis on the external environment, market operation, import &export, as well as other aspects of China’s IVD reagent industry, and also summaries the latest development state in 2012 of key domestic enterprises, and finally forecasts the future industrial development. The information can provide investors with decision-making reference.

IVD reagent industry is an emerging industry in China, the start is late and the development is relatively backward compares with occidental countries. According to the data provided by IVD Special Committee, there are 300 to 400 IVD reagent manufacturing enterprises in China, of which, 200 enterprises own above designated scale; however, only about 20 enterprises have the ability to achieve annual sales income of more than CNY 100 million; the enterprises are in small scale in general and the variety is less.

In 2012, the scale of China’s IVD market has reached CNY 19 billion, of which, the scale of IVD reagent market was CNY 13.8 billion.

In recent years, China’s IVD reagent industry has entered the development phase from the introduction stage, and the market demand increased rapidly; domestic enterprises grasped opportunities by virtue of the advantages of high performance cost ratio and closer to the local market, and seized the market share constantly; thus, the market pattern which was dominated by the imported products is breaking down gradually. With the strengthening of R&D investment and the improvement of products quality, a number of local enterprises with relatively strong strength have appeared in China’s IVD reagent industry, which concentrated in biochemical, immune and molecular diagnoses fields, some products have owned the ability to compete with the international giants.

The state policy encourages the competitive enterprises to strengthen their strength. In 2013, a series of policies which target to improve industry standard and threshold will enter the substantive operation stage, which will accelerate the elimination of small enterprises and improve the industry concentration ratio, industrial consolidation is the development trend, and the enterprises with capital, technology and scale advantages will win gradually.

In recent years, due to the continued sluggishness of European and American pharmaceutical market, the international giants target on the market expansion brought by China’s new medical reform, and entered China’s market in succession; after the China-oriented R&D center transfer, these powerful enterprises began to compete with China’s enterprises in the low and medium-end markets through mergers, acquisitions, capital increase and production expansion; therefore, the competitive enterprises in China’s diagnostic reagent subdivided industries will face more sever competitions.

Table Of Contents

1. Overview of Diagnostic Reagent Industry
1.1 Definition and Classification
1.1.1 Definition and Classification of Biological Products
1.1.2 Definition and Classification of IVD Reagents
1.2 Development History
1.3 Industry Chain
1.4 Overview of Main Sub-industries
1.4.1 Biochemical Diagnostic Reagent Industry
1.4.2 Immune Diagnostic Reagent
1.4.3 Molecular Diagnostic Reagent

2. Operating Environment of China’s IVD Reagent Industry
2.1 Development Overview of Global IVD Reagent Industry
2.2 Development Overview of China’s Bio-pharmaceutical Industry
2.3 Related Industry Management and Policy
2.3.1 Industry Competent Departments
2.3.2 Industry Supervision System
2.3.3 Main Laws and Regulations
2.3.4 Main Industry Policies

3. Operation State of China’s IVD Reagent Market
3.1 Development Status
3.2 Demand
3.2.1 Overall Market Demand
3.2.2 Development Trend of Main Varieties
3.3 Competitive Landscape
3.4 Barriers to Entry
3.4.1 Technological Barrier
3.4.2 Quality and Brand Barrier
3.4.3 Marketing Channel Barrier
3.4.4 Market Access Barrier
3.5 Profit Level and Changing Trend
3.6 Adverse Factors for the Industry Development
3.6.1 Low Market Concentration Ratio; Serious Product homogeneity
3.6.2 Relatively Low Overall RandD Investment Level
3.6.3 International Giants Occupy Dominant Positions in China’s High-end Market
3.7 Technological Level and Business Model
3.7.1 Technological Level and Development Trend
3.7.2 Characteristics of Business Model
3.8 Periodicity, Regional Character and Seasonal Character
3.8.1 Periodicity
3.8.2 Regional Character
3.8.3 Seasonal Character
3.9 Relevance and Influence of Upstream Industries and Downstream Industries to the IVD Reagent Industry
3.9.1 Upstream Raw Materials Mainly Depend on Imports
3.9.2 Downstream Demands Present Rigidity
3.9.3 Relevance with the IVD Instrument Industry

4. Import and Export of China’s IVD Reagent Industry
4.1 Import
4.2 Export

5. Key Manufacturers in China’s IVD Reagent Industry
5.1 Shanghai Kehua Bio-engineering Co., Ltd.
5.1.1 Company Profile
5.1.2 Operation
5.1.3 Core Competitiveness
5.1.4 RandD Projects and Business Plan, 2013
5.2 DAAN Gene Co., Ltd.
5.2.1 Company Profile
5.2.2 Business Development, 2012
5.2.3 Main Business Composition, 2012
5.2.4 Core Competitiveness
5.3 Shanghai Fosun Pharmaceutical (Group) CO., Ltd.
5.3.1 Company Profile
5.3.2 Main Business Composition
5.3.3 Development of Medical Diagnosis and Medical Apparatus and Instruments Business
5.4 BioSino Bio-technology and Science Inc.
5.4.1 Company Profile
5.4.2 Operation
5.5 Beijing Leadman Biochemistry Co., Ltd.
5.5.1 Company Profile
5.5.2 Operation
5.5.3 Main Business Composition
5.6 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
5.6.1 Company Profile
5.6.2 Operation
5.6.3 Products Condition

6. Future Development of China’s IVD Reagent Industry
6.1 Development Trend
6.2 Opportunity
6.3 Forecast of Market Scale Growth, 2013-2017




Companies Mentioned

Shanghai Kehua Bio-engineering Co., Ltd.
DAAN Gene Co., Ltd.
Shanghai Fosun Pharmaceutical (Group) CO., Ltd.
BioSino Bio-technology and Science Inc.
Beijing Leadman Biochemistry Co., Ltd.
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

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