China Diagnostic Reagent Industry Report, 2011-2012
  • Oct.2011
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Diagnostic reagent can be divided into in vitro diagnostic (IVD) reagent and in vivo diagnostic reagent, wherein the former always holds a larger market share in China, accounting for 92.6% in the overall market for diagnostic reagents in 2010. Despite a late start, China’s IVD reagent industry has achieved fast development, benefiting from the improved medical care spending, support of national policies, etc.
The market size of China’s IVD industry reached RMB12.1 billion in 2010, with the compound annual growth rate of up to 13.8% from 2007 to 2010, higher than the global growth of 12.6% over the corresponding period. Moreover, considering the large population base, improved economy, etc., China’s IVD reagent industry possesses huge potential for future growth, which is expected to hit RMB23.2 billion in 2014.

Market Size and Growth Rate of In Vitro Diagnostic Industry in China, 2007-2014E
Source: ResearchInChina

IVD products mainly consist of diagnostic reagents and instruments. In 2010, the market size of IVD reagents climbed 13.3% YoY to RMB9.7 billion in China, occupying 80.2% of the IVD industry. Large-scale diagnostic reagent manufacturers are often good-sized medical test equipment producers as well, but many Chinese enterprises only deal with diagnostic reagents. In China, the high-end diagnostic instrument market is taken over by foreign brands, such as Hitachi, Toshiba, Olympus, Sysmex, etc. However, after years of rapid improvement in the field of diagnostic instrument, Kehua Bio-engineering (KHB) has become a leading domestic enterprise of diagnostic reagent and instrument.

As far as market segment is concerned, China’s IVD reagents are still focused on lower-end clinical immunology and clinical chemistry diagnostic reagents for now, with separate market sizes up to RMB3.4 billion and RMB3.1 billion in 2010, taking 35% and 32% of China’s IVD reagent market respectively. In recent years, along with the launch of nucleic acid blood screening pilot, nucleic acid diagnostics market has been further expanded, as of the end of 2010, there had already been six pharmaceutical factories to declare nucleic acid blood screening reagents to the State Food and Drug Administration (SFDA), namely, KHB, Da An Gene, Haoyuan Biotech, PG Biotech (later acquired by QIAGEN), Roche and Novartis Diagnostics, which will benefit from the nucleic acid blood screening pilot and subsequent marketing.
1. Industry Profile
1.1 Definition and Classification
1.2 Industrial Chain
1.2.1 Upstream Market
1.2.2 Downstream Market

2. Operating Environment in China
2.1 Global Market
2.1.1 Development of Biopharmaceutical Industry Worldwide
2.1.2 Development of Diagnostic Reagent Industry Worldwide
2.2 Chinese Market
2.2.1 Development of Biopharmaceutical Industry in China
2.2.2 Relevant Policies of China

3. Development in China
3.1 Status Quo
3.2 Market Size
3.3 Competition Pattern
3.4 Import & Export
3.4.1 Import
3.4.2 Export
3.5 Market Segments
3.5.1 Biochemistry Diagnostic Reagent
3.5.2 Immune Diagnostic Reagent
3.5.3 Nucleic Acid Diagnostic Reagent
3.6 Development Tendency of Diagnostic Reagent Sector in China

4. Major Domestic Producers
4.1 Shanghai Kehua Bio-Engineering Co., Ltd. (KHB)
4.1.1 Profile
4.1.2 Operation
4.1.3 Operation of Diagnostic Reagent Business
4.1.4 Prospects and Dynamics
4.2 Da An Gene Co., Ltd. of Sun Yat-Sen University
4.2.1 Profile
4.2.2 Operation
4.2.3 Operation of Diagnostic Reagent Business
4.2.4 Prospects and Dynamics
4.3 Fosun Pharmaceutical (Group)  Co., Ltd.
4.3.1 Profile
4.3.2 Operation
4.3.3 Prospects and Dynamics
4.3.4 Shanghai Fosun Long March Medical Science Co., Ltd.
4.3.5 Shanghai Fosun Med-Tech Development Co., Ltd.
4.4 Biosino Bio-Technology & Science Inc.
4.4.1 Profile
4.4.2 Operation
4.4.3 Prospects and Dynamics
4.5 Beijing Kinghawk Pharmaceutical Co., Ltd.
4.5.1 Profile
4.5.2 Operation
4.5.3 Prospects and Dynamics
4.6 Zhuhai Livzon Diagnostics Inc.
4.6.1 Profile
4.6.2 Operation
4.7 ACON Biotech (Hangzhou) Co., Ltd.
4.7.1 Profile
4.7.2 Operation
4.8 Beijing Leadman Biochemistry Co., Ltd
4.8.1 Profile
4.8.2 Operation
4.8.3 Prospects and Dynamics
4.9 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
4.10 Shanghai Rongsheng Biotech Co., Ltd.
4.11 Shenzhen PG Biotech Co., Ltd.
4.11.1 Profile
4.11.2 Major Products
4.12 Shanghai Upper Bio-Tech Pharma Co., Ltd
4.13 Blue Cross Bio-Medical (Beijing) Co., Ltd.
4.14 Inverness Medical (Shanghai)  Co., Ltd.
4.15 Baso Diagnostics Inc.
4.16 Beijing North Institute of Biological Technology
4.17 Xiamen Boson Biotech Co., Ltd.
Global Biopharmaceutical Market Scale, 2007-2012
Global Biopharmaceutical Revenue by Region, 2009
Market Size of IVD Industry Worldwide, 2008-2012
China’s Biopharmaceutical Sales and YoY Growth, 2005-Jan-May 2011 
Relevant Polices of Diagnostic Reagent Industry in China
Product Structure of Diagnostic Reagent Industry in China, 2010
Structure of In Vitro Diagnostic Reagents in China, 2010
Market Size and Growth Rate of In Vitro Diagnostic Industry in China, 2007-2014 
Market Size and Growth Rate of In Vitro Diagnostic Reagents in China, 2007-2014
Major Manufacturers of IVD Products in China
China’s Import Value, Import Volume and Average Price of Contrast Agent for X-Ray Inspection and Diagnostic Reagent for Patients, 2007-Jan.-Aug. 2011
China’s Accumulated Import Volume & Value and Proportion of Contrast Agent for X-Ray Inspection and Diagnostic Reagent for Patients by Country of Origin, Jan.-Aug. 2011
Distribution of China’s Imported Contrast Agent for X-Ray Inspection and Diagnostic Reagent for Patients by Destination, 2008- Jan- Aug.2011
China’s Export Value, Export Volume and Average Price of Contrast Agent for X-Ray Inspection and Diagnostic Reagent for Patients by Destination, 2007-Jan.-Aug. 2011
China’s Accumulated Export Volume & Value and Proportion of Contrast Agent for X-Ray Inspection and Diagnostic Reagent for Patients by Destination, Jan.-Aug. 2011
Export Origins Distribution of China’s Contrast Agent for X-Ray Inspection and Diagnostic Reagent for Patients, Jan.-Aug. 2011
China’s Biochemical Reagent Market Scale, 2007-2014
China’s Immune Reagent Market Scale, 2007-2014
Operating Revenue and Net Income of KHB, 2006- H1 2011
Operating Revenue of KHB by Product, 2007- H1 2011 
Gross Margin of KHB by Product, 2008-H1 2011
Proportion of Operating Revenue of KHB by Region, 2008-H1 2011
Diagnostic Reagent Products of KHB
Operating Revenue and Gross Margin of KHB, 2011-2013E
Operating Revenue and Net Income of Da An Gene, 2006- H1 2011 
Operating Revenue of Da An Gene by Product, 2007- H1 2011 
Gross Margin of Da An Gene by Product, 2008-H1 2011
Proportion of Operating Revenue of Da An Gene by Region, 2008-H1 2011
R&D Input and Its Ratio to Operating Revenue of  Da An Gene, 2008-2010
Operating Revenue and Gross Margin of Da An Gene, 2011-2013E
Operating Revenue and Net Income of Fosun Pharmaceutical (Group), 2006- H1 2011
Operating Revenue and Gross Margin of Fosun Pharmaceutical (Group), 2011-2013 E
Operation of Shanghai Fosun Long March Medical Science, 2008-2009
Operation of Shanghai Fosun Med-Tech Development, 2008-2009
Operating Revenue and Net Income of Biosino Bio-Technology & Science, 2006- H1 2011 
Operating Revenue of Biosino Bio-Technology & Science by Product, 2008- H1 2011
Licenses and Patents for In-vitro Diagnostic Reagents of Biosino Bio-Technology& Science, 2010
Operating Revenue and Net Income of Beijing Kinghawk Pharmaceutical, 2008- H1 2011
Operating Revenue of Beijing Kinghawk Pharmaceutical (by Product), 2010- H1 2011 
Operating Revenue of Beijing Kinghawk Pharmaceutical (by Region), 2010- H1 2011
Operating Revenue of Zhuhai Livzon Diagnostics, 2007- H1 2011 
Certificate Acquired by Zhuhai Livzon Diagnostics, Jun.2010-Sep.2011
Operation of ACON Biotech, 2008-2009 
Certificate Acquired by ACON Biotech for the Registration of Medical Devices, Mar. 2010 & May 2011
Capacity, Output and Sales Volume of Beijing Leadman’ s IVO Reagent, 2008-2011(Kiloliter )
Output and Sales Volume Breakdonw of Beijing Leadman’s IVO Reagent 2010-2011(Liter)
Sales Revenue and Its Proportion of Beijing Leadman’s IVO Reagent, 2008-2011(RMB mIn)
Sale Model of Beijing Leadman’s IVO Reagent, 2008-2011
New Projects of Beijing Leadman’s IVO Reagent by IPO
Progress of Overseas Product Registration of Beijing Leadman by Jul.2011
Operation of Beijing Wantai Biological Pharmacy, 2008-2009 
Operation of Shanghai Rongsheng Biotech, 2008-2009 
Operation of PG Biotech, 2008
Detection Reagent of PG Biotech
Operation of Shanghai Upper Bio-Tech Pharma, 2008-2009 
Diagnostic Reagents and Diagnostic Instruments of Shanghai Upper Bio-Tech Pharma
Operation of Blue Cross Bio-Medical (Beijing), 2008-2009 
Operation of Inverness Medical (Shanghai), 2008-2009 
Operation of Baso Diagnostics, 2008-2009 
Operation of Beijing North Institute of Biological Technology, 2008-2009 
Operation of Boson Biotech, 2009 

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