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2 TABLE OF CONTENTS 1. India In-Vitro Diagnostics Market Introduction Market Overview Growth Drivers Constraints Regulatory Framework and Accreditation 2. India In-Vitro Diagnostics Market Size by Revenues, FY India In-Vitro Diagnostics Market Segmentation 3.1. By Reagents and Instruments, FY By Urban and Rural Areas, 3.3. By Type of Tests, FY India Immunochemistry Market 4.1. Market Scenario Market Overview Drivers Constraints Emerging Technology Trends 4.2. India Immunochemistry Market Size, FY India Immunochemistry Market Segmentation Reagents and Instruments, ELISA Kits and Rapid Tests, FY India Immunochemistry Instruments and Reagents Market Size, FY India Immunochemistry Instruments and Reagents Market Segmentation By Type of Tests, FY India Immunochemistry Reagents Market Segmentation by End Use, FY Market Share of Major Players in India Immunochemistry Market, 5. India Biochemistry Market 2

3 5.1. Market Scenario Market Overview Growth Drivers Constraints Trends 5.2. India Biochemistry Market Size, FY India Biochemistry Market Segmentation by Reagents and Instruments, FY Market Share of Major Players in India Biochemistry Market, 6. India Hematology Market 6.1. Market Scenario Market Overview Growth Drivers Constraints Trends 6.2. India Hematology Market Size, FY India Hematology Market Segmentation By Reagents and Instruments, FY India Hematology Market Competitive Landscape 7. India Microbiology Market 7.1. Market Scenario Market Overview Growth Drivers Constraints Trends 7.2. India Microbiology Market Size, FY

4 7.3. India Microbiology Market Segmentation by Reagents and Instruments, FY Market Share of Major Players in India Microbiology Market, 8. India Blood Gas and Electrolyte Market 8.1. Market Scenario Market Overview Growth Drivers Constraints Trends 8.2. India Blood Gas and Electrolyte Market Size, FY India Blood Gas and Electrolyte Market Segmentation by Reagents and Instruments, FY Market Share of Major Players in India Blood Gas and Electrolyte Market, 9. India Molecular Diagnostics Market 9.1. Market Scenario Market Overview Growth Drivers Constraints Trends 9.2. India Molecular Diagnostics Market Size, FY India Molecular Diagnostics Market Segmentation by Reagents and Instruments, FY India Urinalysis Market Market Scenario Market Overview Growth Drivers Constraints 4

5 Trends India Urinalysis Market Size, FY India Urinalysis Market Segmentation by Reagents and Instruments, FY India Coagulation Diagnostics Market Market Scenario Market Overview Growth Drivers Constraints Trends India Coagulation Diagnostics Market Size, FY India Coagulation Diagnostics Market Segmentation by Reagents and Instruments, FY India In-Vitro Diagnostics Market Trends and Developments Mounting Demand for Decentralized Laboratory Tests Increasing Penetration in Rural Areas Early Detection as an Emerging Trend Inclining Automation of Labs Increasing Consolidation Increasing Overseas Expansion Inclining Prevalence of Hospital Laboratory Management (HLM) 13. Market Share of Major Players in India In-Vitro Diagnostics Market, 14. Company Profiles of Major Players in India In-Vitro Diagnostics Market 15. India In-Vitro Diagnostics Market Future Outlook and Projections, FY 2014-FY Cause and Effect Relationship Analysis of the In-vitro Diagnostics Market in India 16. Macroeconomic and Industry Factors: Historical and Projections Population in India, FY 2007-FY

6 16.2. Personal Disposable Income in India, FY 2007-FY Consumer Expenditure on Healthcare in India, FY 2007-FY Government Expenditure on Healthcare in India, FY 2007-FY Foreign Direct Investments in Healthcare, FY Private Equity Investments in Healthcare, Appendix Market Definitions Abbreviations Research Methodology Data Collection Methods Approach Variables (Dependent and Independent) Final Conclusion Disclaimer 6

7 LIST OF FIGURES Figure 1: India In-Vitro Diagnostics Market Size on the Basis of Revenues in USD Million, FY Figure 2: India In-Vitro Diagnostics Market Segmentation on the Basis of Revenues from Instruments and Reagents in Percentage, FY Figure 3: India In-Vitro Diagnostics Market Segmentation on the Basis of Revenues from Urban and Rural Areas in Percentage, Figure 4: India In-Vitro Diagnostics Market Segmentation on the Basis of Revenues from Different Tests in Percentage, FY Figure 5: India Immunochemistry Market Size on the Basis of Revenues in USD Million, FY Figure 6: India Immunochemistry Market Segmentation on the Basis of Revenues from Reagents and Instruments, ELISA Kits and Rapid Tests in Percentage, FY Figure 7: India Immunochemistry Instruments and Reagents Market Size on the Basis of Revenues in USD Million, FY Figure 8: India Immunochemistry Instruments and Reagents Market Segmentation on the Basis of Revenues from Instruments and Reagents in Percentage, FY Figure 9: India Immunochemistry Instruments and Reagents Market Segmentation on the Basis of Revenues from Different Types of Instruments and Reagents in Percentage, FY Figure 10: India Immunochemistry Reagents Market Segmentation on the Basis of Revenues from End Use in Different Types of Diagnostic Tests in Percentage, FY Figure 11: India Biochemistry Market Size on the Basis of Revenues in USD Million, FY Figure 12: India Biochemistry Market Segmentation on the Basis of Revenues from Reagents and Instruments in Percentage, FY Figure 13: India Biochemistry Instruments Market Segmentation on the Basis of Revenues from Different Types of Analyzers in Percentage, FY Figure 14: Market Share of Major Players on the Basis of Revenues in the Biochemistry Market in India in Percentage, 7

8 Figure 15: India Hematology Market Size on the Basis of Revenues in USD Million, FY Figure 16: India Hematology Market Segmentation on the Basis of Revenues from Reagents and Instruments in Percentage, FY Figure 17: India Hematology Instruments Market Segmentation on the Basis of Revenues from Different Type of Instruments in Percentage, FY 2009-FY 2012 Figure 18: India Microbiology Market Size on the Basis of Revenues in USD Million, FY Figure 19: India Microbiology Market Segmentation on the Basis of Revenues from Reagents and Instruments in Percentage, FY Figure 20: India Blood Gas and Electrolyte Market Size on the Basis of Revenues in USD Million, FY Figure 21: India Blood Gas and Electrolyte Market Segmentation on the Basis of Revenues from Reagents and Analyzers in Percentage, FY Figure 22: India Blood Gas and Electrolyte Analyzers Market Segmentation on the Basis of Revenues from Different Types of Analyzers in Percentage, FY Figure 23: Market Share of Major Players on the Basis of Revenues in the Blood Gas and Electrolyte Market in Percentage, Figure 24: India Molecular Diagnostics Market Size on the Basis of Revenues in USD Million, FY 2007-FY2013 Figure 25: India Molecular Diagnostics Market Segmentation on the Basis of Revenues from Reagents and Instruments in Percentage, FY Figure 26: India Urinalysis Market Size on the Basis of Revenues in USD Million, FY Figure 27: India Urinalysis Market Segmentation on the Basis of Revenues from Reagents and Instruments in Percentage, FY Figure 28: India Coagulation Diagnostics Market Size on the Basis of Revenues in USD Million, FY Figure 29: India Coagulation Diagnostics Market Segmentation on the Basis of Revenues from Reagents and Instruments in Percentage, FY Figure 30: Market Share of Major Players on the Basis of Revenues in the India In-Vitro Diagnostics Market in Percentage, 8

9 Figure 31: India In-Vitro Diagnostics Market Future Projections on the Basis of Revenues in USD Million, FY 2014-FY 2018 Figure 32: Population in India in Million, FY 2007-FY 2018 Figure 33: Personal Disposable Incomes in India in USD Million, FY 2007-FY 2018 Figure 34: Consumer Expenditure on Healthcare and Medical Services in India in USD Million, FY 2007-FY 2018 Figure 35: Government Expenditure on Health Care in India in USD Million, FY 2007-FY 2018 Figure 36: Foreign Direct Investment in Healthcare Sector in India in USD Million, FY Figure 37: Private Equity Investments in Healthcare Sector in India in USD Million,

10 LIST OF TABLES Table 1: India In-Vitro Diagnostics Market Segmentation on the Basis of Revenues from Instruments and Reagents in USD Million, FY Table 2: India In-Vitro Diagnostics Market Segmentation on the Basis of Revenues from Different Tests in USD Million, FY Table 3: India Immunochemistry Market Segmentation on the Basis of Revenues from Reagents and Instruments, ELISA Kits and Rapid Tests in USD Million, FY Table 4: India Immunochemistry Instruments and Reagents Market Segmentation on the Basis of Revenues from Instruments and Reagents in USD Million, FY Table 5: Market Share of Major Players on the Basis of Revenues in the Immunochemistry Market in India in Percentage, Table 6: India Biochemistry Market Segmentation on the Basis of Revenues from Reagents and Instruments in USD Million, FY Table 7: India Hematology Market Segmentation on the Basis of Revenues from Reagents and Instruments in USD Million, FY Table 8: Major Players in Hematology Instruments and Reagents Market in India Table 9: India Microbiology Market Segmentation on the Basis of Revenues from Reagents and Instruments in USD Million, FY Table 10: Market Share of Major Players on the Basis of Revenues in the Hematology Reagents Market in Percentage, Table 11: India Blood Gas and Electrolyte Market Segmentation on the Basis of Revenues from Reagents and Analyzers in USD Million, FY Table 12: Major Players in the India Blood Gas and Electrolyte Market Table 13: India Molecular Diagnostics Market Segmentation on the Basis of Revenues from Reagents and Instruments in USD Million, FY Table 14: India Urinalysis Market Segmentation on the Basis of Revenues from Reagents and Instruments in USD Million, FY Table 15: India Urinalysis Analyzers Market Segmentation on the Basis of Sales Quantity of Different Analyzers in Units and Percentage USD Million, FY 2012 Table 16: India Coagulation Diagnostics Market Segmentation on the Basis of Revenues from Reagents and Instruments in USD Million, FY

11 Table 17: Company Profile of Major Players (Roche Diagnostic, Abbott Laboratories, Transasia Biomedicals, Siemens Healthcare, Beckman Coulter, Becton and Dickinson and Sysmex) in India In-Vitro Diagnostic Market Table 18: Cause and Effect Relationship Analysis between Industry Factors and Expected In- Vitro Diagnostics Market Prospects in India Table 19: India Population Segmentation on the Basis of People Residing in Urban and Rural Areas in Million, FY Table 20: Correlation Matrix of the India In-Vitro Diagnostics Market Table 21: Regression Coefficients Output 11

12 INDIA IN-VITRO DIAGNOSTICS MARKET SIZE BY REVENUES, FY Revenues of India In-Vitro Diagnostics market have grown at a CAGR of 19.4% The in-vitro diagnostics market in India accounts for a small portion of the total revenues from the global IVD market, contributing roughly 1% of the total sales. However, the market has registered a prolific growth over the span of the last six years. The revenues of India In-Vitro Diagnostics market have grown at a CAGR of 19.4%, having increased from USD million in FY 2007 to USD ~ million in. Increasing automation, mounting health awareness, growing consolidations, higher penetration of insurance cover, rapid urbanization, increasing number of laboratories and the overall improvement in the medical infrastructure are some of the major factors responsible for the growth showcased over the last six fiscal years. The market for in-vitro diagnostics recorded revenues of USD million in, growing by ~% from USD ~ million in fiscal year Market growth was primarily led by the immunochemistry and hematology segments, with both the categories showcasing a revenue growth of ~% and 20.5% respectively in fiscal year 2013 Figure: India In-Vitro Diagnostics Market Size on the Basis of Revenues in USD Million, FY , USD Million FY'2007 FY'2008 FY'2009 FY'2010 FY'2011 FY'2012 FY'

13 INDIA IN-VITRO DIAGNOSTICS MARKET SEGMENTATION BY TYPE OF TESTS, FY The in-vitro diagnostics market in India is largely The immunochemistry market segmented into immunochemistry, biochemistry, accounted for the largest portion hematology, microbiology, blood gas and electrolyte of IVD revenues in India, analysis, molecular diagnostics, urinalysis and contributing ~% to the total market in coagulation diagnostics. The market has been historically led by revenues from the immunochemistry market, with biochemistry and hematology being the second and the third largest segments respectively. Each of the aforementioned segments is governed by a gamut of different factors, with two of the important factors being the technology used and the nature of diseases. The immunochemistry market has accounted for the largest portion of IVD revenues in India, contributing ~% to the total market in. The market has witnessed a continuous incline since FY 2010 and witnessing a prolific percentage growth. Immunochemistry revenues have grown at a CAGR of ~% since fiscal year A range of factors that have influenced the market growth over the years include the growing general health awareness, launch of new biomarkers by several companies and the growth of smaller laboratories performing routine tests. Extensively used ELISA and semi-quantitative diagnostic methods have contributed to the revenue growth. Additionally, newer technologies such as chemiluminescence immunoassay (CLIA) and immuno-fluorescence immunoassay (IFA) have also been garnering recognition. With a percentage share of ~% in the total IVD revenues, the biochemistry market in India was the second largest segment in. Even though the share of this segment in the overall IVD revenues has declined for the last three fiscal years (FY 2011-), the market has grown at a CAGR of 15.7% over FY The factors that have driven the biochemistry market include opening of a major hospital and laboratory chains in tier-ii and tier-iii cities, the consolidation of diagnostic laboratory chains, inclining government/private sector expenditure on healthcare, affordability of tests and rising healthcare awareness. Also, with the increasing automation in the clinical chemistry labs, the demand for reagents and consumables has grown tremendously for the past few years. 13

14 Figure: India In-Vitro Diagnostics Market Segmentation on the Basis of Revenues from Different Tests in Percentage, FY % 90.0% 80.0% 4.8% 10.7% 70.0% 15.0% Percentage 60.0% 50.0% 40.0% 30.0% 20.0% 35.3% 10.0% 0.0% FY'2007 FY'2008 FY'2009 FY'2010 FY'2011 FY'2012 FY'2013 Immunochemistry Hematology Blood Gas and Elecrolyte Analysis Coagulation Analysis Biochemistry Microbiology Molecular Diagnostics Urinalysis 14

15 Table: India In-Vitro Diagnostics Market Segmentation on the Basis of Revenues from Different Tests in USD Million, FY Category FY'2007 FY'2008 FY'2009 FY'2010 FY'2011 FY'2012 FY'2013 Immunochemistry Biochemistry Hematology 45.4 Microbiology 32.4 Blood Gas and Electrolyte Analysis 14.7 Molecular Diagnostics Coagulation Analysis Urinalysis Total

16 INDIA IMMUNOCHEMISTRY REAGENTS MARKET SEGMENTATION BY END USE, FY Immunochemistry reagents are used to diagnose a broad variety of diseases and health conditions and operate on the principle of antigen-antibody reactions. The market for reagents in India has witnessed a high growth. The growth can be majorly attributed to the incline in the number of cases related to hypo and hyperthyroidism, an increase in the number of cardiovascular diseases and the mounting number of oncology cases. Additionally, investments by several laboratories to include a wide assortment of tests in their menus have also propelled application of immunochemistry reagents across a wide variety of diseases. In the immunochemistry reagents category, the market was dominated by reagents consumed for thyroid testing such as T3, T4, TSH, FT3, and FT4, accounting for a ~% share in fiscal year Thyroid tests were followed by reagents utilized for infectious diseases such as HIV, hepatitis B, hepatitis C, TORCH panel and others, having recorded a share of ~% in the immunochemistry reagents market in Figure: India Immunochemistry Reagents Market Segmentation on the Basis of Revenues from End Use in Different Types of Diagnostic Tests in Percentage, FY % 90.0% 10.0% 80.0% 70.0% 10.0% Percentage 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 18.0% FY'2007 FY'2008 FY'2009 FY'2010 FY'2011 FY'2012 FY'2013 Thyroid Infectious Disease Fertility Hormones Tumor Marker Auto-Immune Kits Cardiac Markers Others 16

17 MARKET SHARE OF MAJOR PLAYERS IN INDIA BIOCHEMISTRY MARKET, The biochemistry market in India was dominated by Roche Diagnostics, accounting for a market share of ~% in fiscal year The company has been successful in capturing a major share of the biochemistry market over the years and offers IVD products for laboratories with varying workloads. For instance, Cobas 6000 provides medium workload laboratories with custom-made solutions for clinical chemistry testing, whereas Cobas 4000 is ideal for a complete clinical chemistry solution in laboratories with small workload. Owing to its expertise in manufacturing biochemistry instruments, Siemens registered a healthy market share of ~% in. Beckman Coulter, which has been operating in the Indian market with its DxC systems that provides maximum productivity for laboratories, registered a market share of ~% in the same year. Transasia has been on the forefront in the biochemistry market in India, catering to specific needs with the introduction of products such as fully automated random access EM200 Figure: Market Share of Major Players on the Basis of Revenues in the Biochemistry Market in India in Percentage, Roche Diagnostics Siemens Diagnostics Beckman Coulter Transasia Bio-Medicals Others 17

18 INDIA MOLECULAR DIAGNOSTICS MARKET SIZE, FY The advent of the latest inventions and technologies in accurate detection and quicker screening, and the prolific growth in genetic testing have driven the revenues of the Indian molecular diagnostics market in recent years. The increase in the number of patients stricken with infectious diseases propelled the revenue growth in, where the total turnover was USD ~ million, growing from USD ~ million in FY 2012 by ~%. The market was adversely impacted during the global economic slowdown in FY The revenues in this year plummeted by ~%. The volatility in exchange rates as well as the decline in diagnostic tests for infectious diseases caused the market to decline from USD 15.8 million in FY 2008 to USD ~ million in FY A major factor that contributed to the decline in the number of tests was the price increases by several pathological laboratories in this period. The molecular diagnostics market has augmented from USD ~ million to USD ~ million over the period of FY 2007-, growing at a CAGR of ~%... Figure: India Molecular Diagnostics Market Size on the Basis of Revenues in USD Million, FY 2007-FY USD Million FY'2007 FY'2008 FY'2009 FY'2010 FY'2011 FY'2012 FY'

19 INDIA COAGULATION DIAGNOSTICS MARKET SEGMENTATION BY REAGENTS AND INSTRUMENTS, FY Coagulation reagents are largely classified as Prothrombin Time (PT), Activated Partial Thromboplastin Time (aptt), factor assays, fibrinogen, fibrinolysis, thrombin time (TT), thrombophillic profile, and specialty assays. The advent of a variety of coagulation tests has warranted an increasing use of the aforementioned reagents over the years. The share of coagulation reagents was ~% of the total coagulation market in. Coagulation instruments are categorized as semi automated and fully automated. Semi automated instruments are capable of performing only clotting assays. Several single, double and four channel analyzers are available in the Indian market. These instruments are largely used in the PT/aPTT clotting assay categories. On the other hand, fully automated instruments are segmented according to the types of tests they are capable of performing or by the throughput of PT and aptt. Analyzers contributed ~% to the revenues from the coagulation market in fiscal year 2013 Figure: India Coagulation Diagnostics Market Segmentation on the Basis of Revenues from Reagents and Instruments in Percentage, FY % Percentage 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 30.3% 69.7% FY'2007 FY'2008 FY'2009 FY'2010 FY'2011 FY'2012 FY'2013 Reagents Instruments 19

20 MARKET SHARE OF MAJOR PLAYERS IN INDIA IN- VITRO DIAGNOSTICS MARKET, The in-vitro diagnostics market in India has been dominated by the local unorganized players for the past many years. However, the industry has witnessed a re-vamp with the arrival of foreign players as well as increasing consolidations amongst the homegrown players. In the organized segment, the Indian IVD market is primarily led by foreign players. Owing to the deficiency of required skills, technical expertise and the infrastructure to support the elevated costs for conducting research and development for products, the share of domestic players has been considerably lowered. There is has been a colossal prevalence of imported products from other countries, both as original equipment manufacturer and in finished form. Emphasis on indigenous research has been notably lacking amongst the local players. Several foreign companies have been offering innovative technologies at competitive prices, which have found an increasing use in India and have been absorbed on a larger scale Figure: Market Share of Major Players on the Basis of Revenues in the India In-Vitro Diagnostics Market in Percentage, Roche Diagnostics Transasia Bio-Medicals Siemens Healthcare Abbott Sysmex Beckman Coulter Becton and Dickinson Alere Medical BioMerieux J&J Others 20

21 INDIA IN-VITRO DIAGNOSTICS MARKET FUTURE OUTLOOK AND PROJECTIONS, FY 2014-FY 2018 Even though the focus of the Indian government on developing healthcare for the increasing population has been sporadic, initiatives taken by the government will facilitate the growth of invitro diagnostics market in India. The National Urban Health Mission (NUHM) and National Rural Health Mission (NHRM) are soundly funded and have been taking several vital steps to cater to the masses, by means of offering the healthcare delivery to patients below the poverty line. This is expected to help the IVD space enhance its presence in the rural areas. Encouraged by several state governments, public private partnership will also boost the dispersion of healthcare delivery into rural markets, further propelling the revenues from the IVD market in India. Furthermore, an increase in the number of pathology laboratories and inclining number of hospitals, both in the public and the private sector will result in the enhancement of the overall healthcare infrastructure, given that there is still a shortage of nearly 400,000 hospital beds in India. Consequently, easier accessibility of healthcare will provide a significant thrust to the sales of diagnostic products in India. Also, critical resources such as doctors and nurses will also drive the demand of diagnostics in India with the inclining focus of the government to build medical/para-medical colleges to produce more talents by providing quality medical education. Figure: India In-Vitro Diagnostics Market Future Projections on the Basis of Revenues in USD Million, FY 2014-FY , , ,000.0 USD Million 1, , FY'2014 FY'2015 FY'2016 FY'2017 FY'

22 CAUSE AND EFFECT RELATIONSHIP ANALYSIS OF THE IN- VITRO DIAGNOSTICS MARKET IN INDIA Table: Cause and Effect Relationship Analysis between Industry Factors and Expected In- Vitro Diagnostics Market Prospects in India Industry Factors Increasing Disposable Incomes Mounting Number of Lifestyle Diseases Increasing Expenditure on Healthcare Consumer Inclining Number of Hospitals and Clinical Laboratories Technological Innovation Inclining Population Market Impact Positive; Comments Cause: Better economic conditions, rising education levels and increasing employment opportunities have resulted in an increase in the disposable income of the population in India. Effect: Inclining disposable incomes are expected to lead to an increased spending on disease diagnostics in India, consequently leading to an increase in the revenues from the IVD market in India. Note: Shaded portion represents the degree of impact 22

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