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Medical Diagnostics – India 
Medical Diagnostics India
April 2009
Executive Summary

               Medical Diagnostic  accounts for 10% of the healthcare industry in India
               Diagnostics market comprises of 
  Market         – Diagnostic Services Market : Estimated at INR 37.9 bn in 2008
                 – Diagnostic Products Market: Estimated at INR 15.8 bn 2008
               India has more than 40,000 laboratories
               Drivers: Increase in lifestyle‐related diseases, changing demographics, growth in medical 
 Drivers &      outsourcing, medical tourism, nascent but growing medical insurance, rising PE/VC investments
Challenges
        g      Challenges: Difference in import duty on diagnostic kits for public and private sector and Lack of 
                accreditation/certification of diagnostic centers
               Diagnostic equipments market is regulated by both central and state government
               Major governing  authorities include Directorate General of Health Services, Indian Food and Drug 
 Rules and 
 Rules and                                 g                      g              g
                Administration, Central Drugs Standard Control Organization, Drug Controller General of India
               Regulatory process for diagnostics equipment is segmented into 
Regulations
                 – Critical  ‐ Products used for the diagnosis of HIV, HBsAg, HCV,  Blood grouping reagents, malaria tests
                 – Non critical ‐ Other diagnostics products
               Manufacturers need an import licence and product registration certificate to import diagnostic 
                equipments
               Diagnostic test services market is highly fragmented with many unorganized players 
                 – Some of the major players are Metropolis Health Services, SRL Ranbaxy, Piramal Diagnostics, Dr Lal PathLabs, 
Competition       Thyrocare, Apollo Hospitals 
               Foreign players (like Roche Abbott J&J ) account for 64% share in diagnostic equipment market
                Foreign players (like Roche, Abbott, J&J ) account for 64% share in diagnostic equipment market 
                 – Some of the major domestic manufacturers are Transasia, Tulip Group and Agappe Diagnostics


                                             MEDICAL DIAGNOSTICS – INDIA.PPT                                                       2
• Market Overview
• Drivers & Challenges
  Drivers & Challenges
• Rules & Regulations for              
  Manufacturers/Suppliers
• Competition
•K D l
  Key Developments t



         MEDICAL DIAGNOSTICS – INDIA.PPT   3
Indian diagnostics market is witnessing significant growth with 
major contribution from the In‐Vitro Diagnostic (IVD) segment
Market Overview                                                        Diagnostic Test Services Market
• Indian diagnostic market comprises of                                INR bn                  +20%
    Diagnostic test services market                                  40                                        37.9
    Diagnostic products/instruments market                                                     31.6
                                                                                                31 6
                                                                      30        26.3
• Diagnostic market accounts for 10% of healthcare 
                                                                      20                                                          In 2008, IVD 
  sector
                                                                      10                                                        services market 
• India currently has over 11,500 hospitals and 40,000 
                                                                                                                                 was INR 36 bn
  diagnostic laboratories
  diagnostic laboratories                                              0
• About 70% of the treatments in India are based on lab                         2006           2007            2008
  diagnostic tests                                                     Market size estimation is difficult as diagnostic market is highly unorganized


IVD Test Segments (2008)                                               IVD Instruments & Reagent Market

                                              BioChemistry             INR bn
                      4%                      Immunology              20                                  +18%
                 5%
                        3%                                                                                                        15.8
            6%                                Haematology             15
                               37%                                                                         12.8
                                              Critical care                         11.4
                                                                                    11 4
         7%
                                              Urine Routine           10

          14%                                 Others                   5
                                              Microbiology
                                                                       0
                        24%                   Coagulation                           2006                  2007                    2008



                                                  MEDICAL DIAGNOSTICS – INDIA.PPT                                                                       4
Technological developments has led to the diagnosis of a wide 
spectrum of infectious diseases
    Diagnostics             Consumption & trends                                Type of testing                   CAGR % (2004‐08)
                                                          Infectious Disease
      Tuberculosis                   Increasing                                 ELISA‐90%; Rapid‐10%                    11.0
          HIV                        Increasing                                 ELISA‐65%; Rapid‐35%
                                                                                               d                        10.6
        Malaria                      Increasing                                 Immunodiagnostic‐m                       9.4
      Hepatitis B                     Steady                      ELISA‐65%; Rapid‐34% Agglutination methods‐1%          7.7
      Hepatitis C                     Steady                                    ELISA‐80%; Rapid‐20%                     7.7
        Dengue
        D                             Steady
                                      S d                                       ELISA‐65%; Rapid‐35%
                                                                                ELISA 65% R id 35%                       7.6
                                                                                                                         76
        Syphilis                      Steady                                    ELISA‐65%; Rapid‐35%                     5.7
        Typhoid                       Steady                                    ELISA‐65%; Rapid‐35%                     5.6

                                                              Hormones
 Reproductive hormones               Increasing                          ofLH‐35%, FSH and prolactin kits‐65%            8.6
        Thyroid                      Increasing                     ELISA‐90%, RIA and Chemiluminescence‐10%             7.7

                                                                Others
Blood Grouping reagents               Steady                                     Haemagglutination                       5.7
  Pregnancy diagnosis                 Steady                               Immunochromatography/ Latex                   5.7
    Cancer Markers                    Steady                         Fluorescence, ELISA, Chemiluminescence              5.7

                          Nascent market. Maximum penetration observed only in Polymerase Chain Reaction (PCR) based technologies. 
Molecular Diagnostics
                          Companies offering immunodiagnostics have been largely importing equipments

                               This shows that the market for diagnostic tests has been rising


                                                    MEDICAL DIAGNOSTICS – INDIA.PPT                                                   5
• Market Overview
• Drivers & Challenges
  Drivers & Challenges
• Rules & Regulations for              
  Manufacturers/Suppliers
• Competition
•K D l
  Key Developmentst



         MEDICAL DIAGNOSTICS – INDIA.PPT   6
Drivers & Challenges




  Drivers

  Increase in lifestyle‐related diseases
                                                                      Challenges
  Changing demographics 
                                                                      Difference in import duty on 
  Growth in medical outsourcing                                       diagnostic kits for public and private 
                                                                      sector
  Rapid growth of India as a destination 
  Rapid growth of India as a destination                              Lack of accreditation/certification of 
                                                                                           /
  for medical tourism                                                 diagnostic centers
  Increasing penetration of medical 
  insurance

  Rising PE/VC investments 




                                            MEDICAL DIAGNOSTICS – INDIA.PPT                                     7
Mounting instances of lifestyle diseases in urban areas and the 
 demand for quality diagnosis
 Growth in lifestyle related diseases                                                                             Impact
 • Increasing instances of lifestyle diseases is an urban phenomenon, especially among the young 
   and working class in metropolitan areas
 • Lifestyle diseases such as cardiac ailments, diabetes etc. require expensive diagnostic tests 
   making this segment increasingly lucrative for players



 Prevalence of chronic lifestyle diseases in India
 P    l      f h i lif t l di             i I di                     Diagnostic Tests Cost Comparison
                                                                     Di     ti T t C t C         i


% of Population                           2005             USD/Treatment
               4.91%
    5                                     2015                500
                                                                                                  418
    4                       3.70%                             400
        3.31%
    3                  2.80%                                  300                                         280

    2                                                         200                          150
    1                                                         100
                                      0.18% 0.20%
                                      0 18% 0 20%                        12            5
    0                                                            0
           Cardiac       Diabetes        Cancer                       Hepatitis Thyroid Cardiac Diabetes Cancer
                                                                         A




                                                     MEDICAL DIAGNOSTICS – INDIA.PPT                                       8
Changing demographic scenario in India is expected to drive 
demand 
Changing demographics                                                                               Impact
• Increase in average life expectancy and growth in elderly population is expected to boost 
  demand
• Large scale movement of rural population to urban centers will also opt for these services

           Average Life Expectancy                            Population (Age 65 years and above)

   years                                                         %
                                                                                  5.3      5.8
100                                                          6         4.7
           63.3      65.1       66.0
                                                             4
 50
                                                             2
  0                                                          0
       2000-04     2005-09    2006-10                                2000         2005    2010




                                                MEDICAL DIAGNOSTICS – INDIA.PPT                              9
Strong outsourcing opportunities due to technological 
enhancements and cost benefits
Growth in outsourcing                                                                                           Impact
• Diagnostics outsourcing has been growing due to technological upgradation of equipment in  
  Indian laboratories meeting international standards
• Cost benefits have also played a major role 
• Specialized tests like molecular diagnostics or hormone related tests cost 70‐80% less in India 
  than in US
• Medical institutions from US and UK have been outsourcing a bulk of tests 
    Outsourcing opportunity specifically from the UK, in healthcare sector, is pegged at around USD 800 mn
• India provides cost arbitrage :

                       Tests                     Cost in US/UK (USD)       Cost in India (USD)   % Difference
   Blood tests, X rays and ultrasounds
   Blood tests, X‐rays and ultrasounds                   574                       84                 583
   Magnetic resonance imaging (MRI) scan                 700                       60                1067
   Thyroid profile blood test                           30‐50                       5              500‐900
 Note: The rates are indicative




                                                      MEDICAL DIAGNOSTICS – INDIA.PPT                                    10
Medical tourism is providing supplemental revenues for the 
diagnostic market
Medical tourism in India                                                                                 Impact
• In addition to growing domestic demand,  medical tourism is generating additional revenue for 
  diagnostics services 
• Medical tourism has been growing at 30% and is expected to become at USD 2 bn industry by 
  2010
• Some part of medical tourism market is expected to accrue to the diagnostics market, primarily 
  benefiting  the hospitals with diagnostic centers 
•M i d i
  Main drivers and challenges for medical tourism are ‐
                   d h ll       f     di l t i

                          Drivers                                                  Challenges
  •   Significant savings                                    •   Inadequate air connectivity
  •   World‐class facilities                                 •   Visa requirements from most countries
                                                                        q
  •   Quality and experience of medical professionals        •   Medico legal jurisdictions
  •   Minimal waiting time                                   •   Country specific restrictions
  •   Large market of uninsured in developed countries




                                                         MEDICAL DIAGNOSTICS – INDIA.PPT                          11
Growing penetration rates of health insurance has made quality 
diagnostic services more affordable
Rising health insurance levels                                                                                         Impact
•In India, penetration of health insurance is very low but growing:
   More families from middle class are now purchasing health insurance
   20% of population is likely to have medical insurance by 2015 compared to current 2%
   Additionally, many companies are providing health insurance coverage to employees 
    thereby driving penetration
•Increasing insurance coverage provide additional revenue to the diagnostics centres
          g                 g p                                     g
   Insurance companies tie up with diagnostic centres to provide better health assessment 
    services (medical screening, diagnostic testing) to life insurance candidates
        – Birla Sun Life Insurance Company Ltd entered into a partnership with Quest Diagnostics India Private Ltd. 
        – ICICI Lombard entered into an insurance partnership with Manipal, Fortis and Apollo Group


                                Health Insurance Premium

    INR bn
1,000                                                                               950
                                                    +35%

  500
                                                     212
                       47
    0
                      2008                          2013                           2018


                                                        MEDICAL DIAGNOSTICS – INDIA.PPT                                         12
Large scale investments from PE/VC firms towards capitalizing 
on the growth prospects in the market 
Increased focus of PE/VC firms                                                                       Impact
• Private equity players are bullish on the healthcare industry in India
• In 2008, the healthcare sector accounted for 13% of total investments amounting to USD 
  5570.48 mn
• Apart from hospitals and pharma, private equity players are also showing interest in diagnostic 
  centers in India

                                                                                   %      Amount 
  Date
  D t                  Investor
                       I    t                             Target  
                                                          T    t
                                                                                  Stake    USD mn 
             ePlanet Ventures and HSBC 
Nov 2007                                    Trivitron                             n.a.      11
             Private Equity (Asia) Ltd
  2007       Sequoia Capital India 
             Sequoia Capital India          Dr Lal PathLabs
                                            Dr Lal PathLabs                       n.a.
                                                                                  na         4
Jun 2006     Bennett, Coleman and Co.       Thyrocare                             n.a.     n.a.
May 2006     ICICI Ventures                 Metropolis Health Services Ltd        n.a.       8
  2005       Sequoia Capital India 
               q       p                    Dr Lal PathLabs                       26         6




                                                MEDICAL DIAGNOSTICS – INDIA.PPT                               13
Biased government regulation and the lack of accreditation 
affecting the of quality services are the major barriers
Difference in import duty on diagnostic kits for public and private sector                                           Impact
• The import structure has been so formulated that it favors the public sector
• Private sector is faced with the issue of providing services at competitive prices across income 
  groups and are often reduced to providing services only to a niche market

                        Public                                                       Private
• In order to import equipments and reagents                • For importing diagnostic equipments a duty of 19.8 ‐
     Government hospitals do not require a an import
      Government hospitals do not require a an import         21.7% is levied
      license; a duty of 5% is levied                       • Equipments and supplies are procured based on  
• Equipment and supplies are procured through                 quality and price, leading  to cost escalations
  tenders with price being the foremost basis of 
  decision making




Lack of accreditation/certification of diagnostic centers                                                            Impact
• Lack of accreditation or certification has led to a large pool of medical centers with minimal 
                                                         g p
  focus on the quality, which is in contrast to mandatory requirements for other aspects of 
 healthcare such as hospitals, doctors, nurses and even pharmacies 
• Less than 1% of the total laboratories are accredited
    14 have College of American Pathologists (CAP) accreditation
    45 have National Accreditation Board of Laboratories (NABL) accreditation



                                                         MEDICAL DIAGNOSTICS – INDIA.PPT                                      14
• Market Overview
• Drivers & Challenges
  Drivers & Challenges
• Rules & Regulations for              
  Manufacturers/Suppliers
• Competition
•K D l
  Key Developments t



         MEDICAL DIAGNOSTICS – INDIA.PPT   15
Diagnostic equipment manufacturers are highly regulated by the 
central and state government bodies
Major governing bodies
       Government Authorities                                                       Operation
                                             Oversees activities of the Indian Food and Drug Administration (FDA) and  Central Drugs 
                                             Oversees activities of the Indian Food and Drug Administration (FDA) and Central Drugs
The Directorate General of Health Services
                                             Standard Control Organization (CDSCO) 
                                             Regulates the manufacture of all diagnostic kits and reagents as it belongs to the 
FDA and CDSCO
                                             category of drugs 
                                             Responsible for approval of licenses of specified categories of drugs and diagnostics 
Drug Controller General of India
Drug Controller General of India
                                             products
                                             They monitor the quality of drugs and diagnostics products that are manufactured by 
State drug offices / State FDA’s 
                                             respective State units and those marketed in the State
Segmentation of products
                                                                                                      Products used for the 
                                                                                                    diagnosis of HIV, HBsAg, 
                                                    Critical Devices
                                                                                                      HCV,  Blood grouping 
                                                                                                     reagents, malaria tests
      Diagnostic Products
      Diagnostic Products


                                                  Non‐Critical Devices                            Other diagnostics products


                              All diagnostics products manufactured or sold in India requires a license


                                                      MEDICAL DIAGNOSTICS – INDIA.PPT                                                   16
The difference in regulations for critical and non‐critical 
diagnostics devices has led to lack of quality control
Regulatory process for diagnostics equipments                           Quality 
                                                                      checks are 
                                                                                                     Manufact
                                                                      conducted 
                                                                                                        uring 
                                                                         by 
                                                                           y
                                Application is       
                                A li ti i                                                             license 
                                                                                                      li
                              submitted to the                                                       granted 
   Critical Devices                                                   National 
                              Drugs Controller                                                         after an 
                                                                      Institute             
                              General of India                                                       audit of 
                                                                          of 
                                                                     Communica
                                                                                                     manufact
                                                                         ble
                                                                      3‐6 months                     uring unit
                                                                      disease




                             • Test manufacturing license or test batch evaluation is not required
 Non Critical Devices        • No inspections needs to be carried out by the central authorities
                             • The application is to be filed only with the State drug offices
                               The application is to be filed only with the State drug offices




   Lack of sufficient quality control measures has led to substantial number of questionable products in the market


                                                MEDICAL DIAGNOSTICS – INDIA.PPT                                       17
Manufacturers need an import license and product registration 
certificate from the  Central Drugs Standard Control 
                                                       Regulations Related to Imports

                     CDSCO is responsible for quality control of imported products as well as the licensing of new products


               Registration Certificate                                                                   Import License

• Registration Certificate: Application in respect of the                • Documentation
  premises and the devices to be imported                                    Form‐9 is to be forwarded by the manufacturer and should be 
• Submission: The application is reviewed by the Drugs                        attested by the Indian Embassy in the manufacturers country
  Controller General                                                         GMP (Good Manufacturing Practices) certificate
• Registration fee: USD 1000 per product to be registered                    Company Registration certificate
• Other Documents: Bank slips showing requisite fee paid, Form               Free Sales Certificate in the country of manufacture
  40 Power of Attorney to the Indian Agent/Office and dossiers               Manufacturing License
                                                                              Manufacturing License
• Duration: The registration process takes 9 months                          Country of Origin Certificate
• Forwarded by the manufacturer, importer or the agent in                    List of countries where the product is already being exported
  India
                                                                             ISO / TUV / CE certificate
                                                                             Batch Release Certificate (for any one batch)
                                                                             QC certificates (for any one batch)

Other requirements for imported medical diagnostic equipments are ‐
• A batch release certificate for the specific goods that have been imported
• Shelf‐life certificate which must state that the goods have a shelf‐life of more than 60% at the time of landing 
                                                   g                                                             g
• Certificate of Analysis for the products supplied



                                                         MEDICAL DIAGNOSTICS – INDIA.PPT                                                      18
Custom duty is levied on the diagnostic equipments imported 

Import duty structure 
• The Government has been focusing on enhancing private sector participation by reducing the 
  customs duty levied on imports of diagnostic kit and reagents imported by the private players 


     %
40       34.4   34.5
                                                   Pregnancy confirmation reagents/Reagents for diagnosing
30                                                 AIDS/Others
                             21.7    19.8
20                                                 Diagnostic reagents designed to be administered to the
                                                   patient/Blood grouping reagents
10

 0
          Jan 2008             Feb 2009




                                                MEDICAL DIAGNOSTICS – INDIA.PPT                              19
• Market Overview
• Drivers & Challenges
  Drivers & Challenges
• Rules & Regulations for              
  Manufacturers/Suppliers
• Competition
•K D l
  Key Developments t



         MEDICAL DIAGNOSTICS – INDIA.PPT   20
Organized pathlabs are rapidly expanding using the hub and 
spoke model, including small, independent labs in the network
Diagnostic Testing Market Structure                                         Hub and Spoke Model
• Highly fragmented with ~40,000 laboratories:
                                                                                                     CC                CC
    Hospitals: 43%
    Independent labs: 52%
                                                                                         CC                                       CC
• Among the labs in India
    Automated – 5%                                                                                       Reference 
    Semi ‐ Automated – 38%                                                                                  Lab
    Manual 58%
     Manual – 58%                                                                  Satellite 
                                                                                   Satellite                                      Satellite 
                                                                                                                                  S t llit
                                                                                     Lab                                            Lab
• Organized players account for 10% of market and 
  expanding with ‘hub and spoke’ model:
    Reference labs act as regional hubs and are usually located                  CC            CC                          CC           CC
     in large metros
    Collection centres are located in hospitals, nursing homes, 
     pathology labs, doctor’s clinics etc.
    Satellite labs and collection centres are either owned or              • Reference labs: Hub with comprehensive or specialized testing 
     franchised                                                               capability
• As organized players grows their share small
  As organized players grows their share, small,                            • Satellite labs: Limited testing capability; ‘feed’ reference labs
                                                                              Satellite labs:  Limited testing capability;  feed reference labs
  independent labs are:                                                     • Collection centres (CC): Collect samples for forwarding to 
    Becoming franchisees in the hub and spoke model                          either a satellite lab or reference lab
    Partnering with large chains on referral basis                         • A variation in this model is the absence of satellite labs and 
    Getting acquired by large chains, which lowers the cost of               the existence of only reference labs and collection centres
     expansion and start‐up time for the latter



                                                       MEDICAL DIAGNOSTICS – INDIA.PPT                                                         21
Major Players – Diagnostic Test Services Market (1/2)

         Company                                               Overview                                                 Business Outlook
  Apollo Hospitals                  • Started in 1983                                                      • Entered into a JV with Amcare Labs, an 
                                    • Diagnostic facilities in their subsidiary Apollo Clinics               affiliate of Johns Hopkins International of 
                                    • Facilities allow for investigation in Biochemistry Haematology
                                      Facilities allow for investigation in Biochemistry, Haematology,       the US, to set up a diagnostic laboratory in 
                                      Clinical Pathology, Microbiology, X‐ray, Ultrasound with Color         Hyderabad at an investment of USD 2.2 mn
                                      Doppler, ECG, Echo Cardiography and Treadmill
  Dr Lal PathLabs                   • Started in 1977                                                      • Established an international alliance with 
                                    • 40 labs and 500 sample collection centers                              Quest Diagnostics Nicholas Institute for 
                                    • Accreditation: NABL, CAP                                               testing
                                                                                                           • Planning to set up 50 labs and 1000 
                                                                                                             collection centers by 2012 
                                                                                                           • Expand operations in southern and western 
                                                                                                             regions investing INR 600 mn
                                                                                                           • Planning to invest INR 100 mn in brand 
                                                                                                              l                                b d
                                                                                                             building
  Metropolis Health                 • Started in 1981                                                      • Growing inorganically
  Services                          • 10000 laboratories across 125 cities globally, 13 laboratories in    • It is looking at overseas expansion as well as  
                                      India, 350 collection centers 
                                            ,                                                                outsourcing opportunities
                                                                                                                         g pp
                                    • Capability to carry over 3600 routine investigations with over       • Plans on increasing their portfolio to 9 more 
                                      100 technologies ‐ e.g. biochip, DNA sequencing, pathology,            labs
                                      radiology                                                            • Targeted revenue of INR 5 bn by 2010
                                    • ICICI Ventures owns 18% of the company                               • In 2008, acquired two labs in North India 
                                    • Accreditation: CAP NABL
                                      Accreditation: CAP, NABL                                               and a majority stake in Bangalore based RV 
                                                                                                             and a majority stake in Bangalore based RV
                                                                                                             Diagnostic Laboratory
Note: This list is not exhaustive


                                                                  MEDICAL DIAGNOSTICS – INDIA.PPT                                                        22
Major Players – Diagnostic Test Services Market (2/2)

         Company                                               Overview                                              Business Outlook
  Piramal Diagnostics  • Started in 1988                                                                 • Planning to invest INR 2.5 bn to expand its 
  / Wellspring         • 104 diagnostic centers in 48 cities, 300 collection centers                       diagnostic chain in 75 urban centers by 2010
                                    • Carries out over 1500 tests
                                      Carries out over 1500 tests                                        • Acquired Minrad International Inc for USD 
                                                                                                              q
                                    • Accreditation: NABL, CAP                                             40 mn

  Super Religare                    • Started in 1996                                                    • Tie‐ups with UK‐based organizations for 
  Laboratories                      • 35 labs, 800 collection centers distributed in 400 towns across      outsourcing
  Limited/SRL 
         /                            the country and 7 franchisee lab                                   • Plans on developing 2‐3 reference 
                                    • Caters to 25000 doctors, 650 hospitals and ~ 1000 smaller            laboratories in 2009
  Ranbaxy
                                      pathology labs and carries out 34000tests/day based on 95          • Expansion budget is pegged at INR 1.5bn
                                      technologies                                                       • In 2008, acquired Dubai‐based Mena 
                                    • Accreditation: CAP, NABL, CLSI, GCLP                                 Healthcare for USD 20 mn 
                                    • Reported total revenues of INR 804 mn in FY2007
                                         p
  Thyrocare                         • Started in 1995                                                    • Centralized operations through a single 
                                    • Carries out 30000 test/day, over 600 franchised collection           laboratory model, located in Navi Mumabi
                                      centers                                                            • Only player expanding through a 100 % 
                                    • Accreditation: CAP, NABL                                             franchisee model




Note: This list is not exhaustive


                                                                    MEDICAL DIAGNOSTICS – INDIA.PPT                                                   23
Manufacturers – IVD Products/Instruments Market

Players in the market                                          IVD Products Market Share (2008)
•The IVD products market in India is primarily 
             y     g      p
 dominated by foreign companies
•Global IVD companies like Roche Diagnostics, 
 Abbott, J&J, Siemens Healthcare Diagnostics,                               36%
 Beckman Coulter have strong presence in the 
 Indian market
 I di      k t
                                                                                                 64%
•Domestic players have forayed into the market 
 and are establishing themselves by producing 
                    q     yg
 cost effective and quality goods
•60% of diagnostic medical equipment and                                          Foreign Players 
 supplies is imported                                                             Domestic Players
•Low‐cost reagent kits are being imported from 
 China, Taiwan, and Korea 




                                          MEDICAL DIAGNOSTICS – INDIA.PPT                              24
Major Domestic Players – Diagnostic Equipment Manufacturing 
  Market (1/3)
         Company                                               Overview                                               Business Outlook
  Agappe Diagnostics                • Reagents: Clinical chemistry, SyRe Biochemistry), SyRe             • Focusing on the export markets with plans 
                                      (Immunoturbidimetry),  Controls/ Calibrators, serology,              of establishing a subsidiary in Dubai under 
                                      hemoscreen, coagulation, Urinal analyzer, infectious rapid card      Agappe Middle East LLC
                                      test, infectious ELISA, hepatitis markers, torch panel,            • Also plans to expand operations to Africa 
                                      Glucometer                                                           and Europe
                                    • Instruments: Clinical Chemistry Analyzer, Hematology Analyzer,     • Launched Biolis 12i , a fully automatic 
                                      Coagulation Analyzer, Sodium & Potassium Analyzer                    analyser as well as Cystatin C, a more 
                                                                                                           sensitive instrument for the estimation of 
                                                                                                           Glomurular Filtration Rate
  J. Mitra                          • Rapid test kits: HIV range, HCV range, HBV range, Malaria          • Focuses on Point‐of‐Care (POC) for 
                                      range                                                                infectious diseases like HIV and malaria
                                    • ELISA test kits: HIV range, HCV range, HBV range, Dengue           • Mass production at affordable prices
                                      range, LEPTO range, TB range
                                      range LEPTO range TB range                                         • Partnered with WHO for product sales
                                                                                                           Partnered with WHO for product sales
                                    • Confirmatory Tests, Blood Grouping Range                           • Market leader in HIV diagnosis equipment
  Orchid Biomedical                 • Fertility range, Infectious diseases range,  Parasitology range    • Focuses on POCs for infectious diseases 
  Systems (Tulip                                                                                         • Mass production at affordable prices
  Group)                                                                                                 • Partnered with WHO for product sales
                                                                                                           Partnered with WHO for product sales




Note: This list is not exhaustive


                                                                  MEDICAL DIAGNOSTICS – INDIA.PPT                                                     25
Major Domestic Players – Diagnostic Equipment Manufacturing 
  Market (2/3)
         Company                                              Overview                                              Business Outlook
  RFCL                              • IVD, animal healthcare, laboratory solutions and custom         • Adopted an inorganic growth path ‐
                                      synthesis                                                            In April 2008, acquired Bremer Pharma
                                                                                                           In September 2008, acquired US based 
                                                                                                            Mallinckrodt Baker for USD 340 mn
                                                                                                           In January 2008, acquired Godrej Medical 
                                                                                                            Diagnostics and Alved Pharma & Foods
                                                                                                           In July, 2007 acquired Wipro Biomedical
                                                                                                      • Targeted revenue of INR 5 bn by 2010
  Span Diagnostics                  • Diagnostic reagents & kits: Blood banking products, clinical    • It is a leader in Sphilis and thyroid diagnosis 
  Ltd.                                chemical reagents, hematology, infectious diseases serology,      equipment
                                      histopathology, antibiotic discs 
                                    • Instruments: Biochemistry, ELISA, Hematology, 
                                      Chemiluminescence
  Transasia Bio‐                    • Related to bio‐chemistry, hematology, urine analysis,           • Plans to  expand it’s existing product range 
  Medicals                            coagulation, ESR, immunology, liquid handling system              and venture into microbiology and 
                                                                                                        veterinary science
  Tulip Group                       • Immunology Reagents, Cardiac Markers, Cancer Markers,           • It is one of the leader sin syphilis, typhoid, 
                                      Parasitology & Infectious Disease Range
                                      Parasitology & Infectious Disease Range                           malaria, reproductive hormones, blood 
                                                                                                        malaria reproductive hormones blood
                                    • Instruments ‐ Coagulometers, ELISA reader & washer                grouping reagents, cancer markers  and 
                                                                                                        tuberculosis diagnostic equipment




Note: This list is not exhaustive


                                                                MEDICAL DIAGNOSTICS – INDIA.PPT                                                         26
Major Domestic Players – Diagnostic Equipment Manufacturing 
  Market (3/3)
         Company                                             Overview                                           Business Outlook
  Xcyton                            • Immunodiagnostic kits: HIV CheX and HEP CheX C, JEV CheX,    • Strategic partnership with Qualigens fine 
                                      CYSTI‐ CheX, Dengue – CheX                                     chemicals in order to market their HIV
                                    • Molecular diagnostic kits
                                                   g                                                 and hepatitis diagnostic kits 
                                                                                                            p         g




  Yashraj Biotech                   • Antigens: Customized monoclonal and polyclonal antibodies    • Focusing on reducing costs of molecular 
                                                                                                     diagnostics through innovative technology 
                                                                                                     diagnostics through innovative technology
  Other Player : Accurex Biomedical, Bhat Biotech, Medsource Ozone Biomedicals Pvt. Ltd., Trivitron




Note: This list is not exhaustive


                                                               MEDICAL DIAGNOSTICS – INDIA.PPT                                                    27
• Market Overview
• Drivers & Challenges
  Drivers & Challenges
• Rules & Regulations for              
  Manufacturers/Suppliers
• Competition
• Ke De elopments
  Key Developments



         MEDICAL DIAGNOSTICS – INDIA.PPT   28
Key Developments

Date        Development
17‐Mar‐09   Roche Diagnostics, a swiss based company, plans on consolidating their  position in the Indian market in 2009. They plan on 
            expanding their reach through innovative diagnostic tests such as the NT‐proBNP and K‐RAS mutation tests related to
            colorectal cancer. 
10‐Feb‐09   Aloka Trivitron Medical Technologies, a medical equipment manufacturing JV of Aloka, Japan and Trivitron healthcare began 
            production of Aloka SSD 500, portable ultrasound scanner from its facility at Poonamallee in Chennai. It plans on developing 
            high quality products on a cost effective basis catering primarily to the developing nations. 
06‐Oct‐08   Wipro an IT giant has entered the medical diagnostics market through its subsidiary Wipro Biomed. They have tied up with 
            GE to develop cutting‐edge technology in order to generate a unique selling price. Wipro is planning to focus on 
            GE to develop cutting‐edge technology in order to generate a unique selling price Wipro is planning to focus on
            telemedicine, especially in the diagnostic radiology.
10‐Mar‐08   Sneha Diagnostics plans on developing 10 state‐of‐the‐art medical diagnostics centres across Andhra Pradesh by 2009. A 
            capital investment of INR 50 mn is expected towards this expansion venture. 
09‐Jan‐08   RFCL Limited, an ICICI venture company acquired Godrej Medical Diagnostics. This led to partnerships with QBC Diagnostics, 
            USA, Asia Gen Corporation, Taiwan and Uritest Medical Electronic Co Ltd, China allowing them to expand their reach. 
            USA Asia Gen Corporation Taiwan and Uritest Medical Electronic Co Ltd China allowing them to expand their reach




                                                   MEDICAL DIAGNOSTICS – INDIA.PPT                                                     29
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                                                         MEDICAL DIAGNOSTICS – INDIA.PPT                                                      30

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Market Research India - Medical Diagnostics Market in India 2009

  • 2. Executive Summary  Medical Diagnostic  accounts for 10% of the healthcare industry in India  Diagnostics market comprises of  Market – Diagnostic Services Market : Estimated at INR 37.9 bn in 2008 – Diagnostic Products Market: Estimated at INR 15.8 bn 2008  India has more than 40,000 laboratories  Drivers: Increase in lifestyle‐related diseases, changing demographics, growth in medical  Drivers &  outsourcing, medical tourism, nascent but growing medical insurance, rising PE/VC investments Challenges g  Challenges: Difference in import duty on diagnostic kits for public and private sector and Lack of  accreditation/certification of diagnostic centers  Diagnostic equipments market is regulated by both central and state government  Major governing  authorities include Directorate General of Health Services, Indian Food and Drug  Rules and  Rules and g g g Administration, Central Drugs Standard Control Organization, Drug Controller General of India  Regulatory process for diagnostics equipment is segmented into  Regulations – Critical  ‐ Products used for the diagnosis of HIV, HBsAg, HCV,  Blood grouping reagents, malaria tests – Non critical ‐ Other diagnostics products  Manufacturers need an import licence and product registration certificate to import diagnostic  equipments  Diagnostic test services market is highly fragmented with many unorganized players  – Some of the major players are Metropolis Health Services, SRL Ranbaxy, Piramal Diagnostics, Dr Lal PathLabs,  Competition Thyrocare, Apollo Hospitals   Foreign players (like Roche Abbott J&J ) account for 64% share in diagnostic equipment market Foreign players (like Roche, Abbott, J&J ) account for 64% share in diagnostic equipment market  – Some of the major domestic manufacturers are Transasia, Tulip Group and Agappe Diagnostics MEDICAL DIAGNOSTICS – INDIA.PPT 2
  • 3. • Market Overview • Drivers & Challenges Drivers & Challenges • Rules & Regulations for               Manufacturers/Suppliers • Competition •K D l Key Developments t MEDICAL DIAGNOSTICS – INDIA.PPT 3
  • 4. Indian diagnostics market is witnessing significant growth with  major contribution from the In‐Vitro Diagnostic (IVD) segment Market Overview Diagnostic Test Services Market • Indian diagnostic market comprises of INR bn +20%  Diagnostic test services market 40 37.9  Diagnostic products/instruments market 31.6 31 6 30 26.3 • Diagnostic market accounts for 10% of healthcare  20 In 2008, IVD  sector 10 services market  • India currently has over 11,500 hospitals and 40,000  was INR 36 bn diagnostic laboratories diagnostic laboratories 0 • About 70% of the treatments in India are based on lab  2006 2007 2008 diagnostic tests Market size estimation is difficult as diagnostic market is highly unorganized IVD Test Segments (2008)  IVD Instruments & Reagent Market BioChemistry INR bn 4% Immunology 20 +18% 5% 3% 15.8 6% Haematology 15 37% 12.8 Critical care 11.4 11 4 7% Urine Routine 10 14% Others 5 Microbiology 0 24% Coagulation 2006 2007 2008 MEDICAL DIAGNOSTICS – INDIA.PPT 4
  • 5. Technological developments has led to the diagnosis of a wide  spectrum of infectious diseases Diagnostics Consumption & trends Type of testing CAGR % (2004‐08) Infectious Disease Tuberculosis Increasing ELISA‐90%; Rapid‐10% 11.0 HIV Increasing ELISA‐65%; Rapid‐35% d 10.6 Malaria Increasing Immunodiagnostic‐m 9.4 Hepatitis B Steady ELISA‐65%; Rapid‐34% Agglutination methods‐1% 7.7 Hepatitis C Steady ELISA‐80%; Rapid‐20% 7.7 Dengue D Steady S d ELISA‐65%; Rapid‐35% ELISA 65% R id 35% 7.6 76 Syphilis Steady ELISA‐65%; Rapid‐35% 5.7 Typhoid Steady ELISA‐65%; Rapid‐35% 5.6 Hormones Reproductive hormones Increasing ofLH‐35%, FSH and prolactin kits‐65% 8.6 Thyroid Increasing ELISA‐90%, RIA and Chemiluminescence‐10% 7.7 Others Blood Grouping reagents Steady Haemagglutination 5.7 Pregnancy diagnosis Steady Immunochromatography/ Latex 5.7 Cancer Markers Steady Fluorescence, ELISA, Chemiluminescence 5.7 Nascent market. Maximum penetration observed only in Polymerase Chain Reaction (PCR) based technologies.  Molecular Diagnostics Companies offering immunodiagnostics have been largely importing equipments This shows that the market for diagnostic tests has been rising MEDICAL DIAGNOSTICS – INDIA.PPT 5
  • 6. • Market Overview • Drivers & Challenges Drivers & Challenges • Rules & Regulations for               Manufacturers/Suppliers • Competition •K D l Key Developmentst MEDICAL DIAGNOSTICS – INDIA.PPT 6
  • 7. Drivers & Challenges Drivers Increase in lifestyle‐related diseases Challenges Changing demographics  Difference in import duty on  Growth in medical outsourcing  diagnostic kits for public and private  sector Rapid growth of India as a destination  Rapid growth of India as a destination Lack of accreditation/certification of  / for medical tourism  diagnostic centers Increasing penetration of medical  insurance Rising PE/VC investments  MEDICAL DIAGNOSTICS – INDIA.PPT 7
  • 8. Mounting instances of lifestyle diseases in urban areas and the  demand for quality diagnosis Growth in lifestyle related diseases Impact • Increasing instances of lifestyle diseases is an urban phenomenon, especially among the young  and working class in metropolitan areas • Lifestyle diseases such as cardiac ailments, diabetes etc. require expensive diagnostic tests  making this segment increasingly lucrative for players Prevalence of chronic lifestyle diseases in India P l f h i lif t l di i I di Diagnostic Tests Cost Comparison Di ti T t C t C i % of Population 2005 USD/Treatment 4.91% 5 2015 500 418 4 3.70% 400 3.31% 3 2.80% 300 280 2 200 150 1 100 0.18% 0.20% 0 18% 0 20% 12 5 0 0 Cardiac Diabetes Cancer Hepatitis Thyroid Cardiac Diabetes Cancer A MEDICAL DIAGNOSTICS – INDIA.PPT 8
  • 9. Changing demographic scenario in India is expected to drive  demand  Changing demographics Impact • Increase in average life expectancy and growth in elderly population is expected to boost  demand • Large scale movement of rural population to urban centers will also opt for these services Average Life Expectancy Population (Age 65 years and above) years % 5.3 5.8 100 6 4.7 63.3 65.1 66.0 4 50 2 0 0 2000-04 2005-09 2006-10 2000 2005 2010 MEDICAL DIAGNOSTICS – INDIA.PPT 9
  • 10. Strong outsourcing opportunities due to technological  enhancements and cost benefits Growth in outsourcing  Impact • Diagnostics outsourcing has been growing due to technological upgradation of equipment in   Indian laboratories meeting international standards • Cost benefits have also played a major role  • Specialized tests like molecular diagnostics or hormone related tests cost 70‐80% less in India  than in US • Medical institutions from US and UK have been outsourcing a bulk of tests   Outsourcing opportunity specifically from the UK, in healthcare sector, is pegged at around USD 800 mn • India provides cost arbitrage : Tests Cost in US/UK (USD) Cost in India (USD) % Difference Blood tests, X rays and ultrasounds Blood tests, X‐rays and ultrasounds 574 84 583 Magnetic resonance imaging (MRI) scan  700 60 1067 Thyroid profile blood test  30‐50 5 500‐900 Note: The rates are indicative MEDICAL DIAGNOSTICS – INDIA.PPT 10
  • 11. Medical tourism is providing supplemental revenues for the  diagnostic market Medical tourism in India Impact • In addition to growing domestic demand,  medical tourism is generating additional revenue for  diagnostics services  • Medical tourism has been growing at 30% and is expected to become at USD 2 bn industry by  2010 • Some part of medical tourism market is expected to accrue to the diagnostics market, primarily  benefiting  the hospitals with diagnostic centers  •M i d i Main drivers and challenges for medical tourism are ‐ d h ll f di l t i Drivers Challenges • Significant savings • Inadequate air connectivity • World‐class facilities • Visa requirements from most countries q • Quality and experience of medical professionals • Medico legal jurisdictions • Minimal waiting time • Country specific restrictions • Large market of uninsured in developed countries MEDICAL DIAGNOSTICS – INDIA.PPT 11
  • 12. Growing penetration rates of health insurance has made quality  diagnostic services more affordable Rising health insurance levels Impact •In India, penetration of health insurance is very low but growing:  More families from middle class are now purchasing health insurance  20% of population is likely to have medical insurance by 2015 compared to current 2%  Additionally, many companies are providing health insurance coverage to employees  thereby driving penetration •Increasing insurance coverage provide additional revenue to the diagnostics centres g g p g  Insurance companies tie up with diagnostic centres to provide better health assessment  services (medical screening, diagnostic testing) to life insurance candidates – Birla Sun Life Insurance Company Ltd entered into a partnership with Quest Diagnostics India Private Ltd.  – ICICI Lombard entered into an insurance partnership with Manipal, Fortis and Apollo Group Health Insurance Premium INR bn 1,000 950 +35% 500 212 47 0 2008 2013 2018 MEDICAL DIAGNOSTICS – INDIA.PPT 12
  • 13. Large scale investments from PE/VC firms towards capitalizing  on the growth prospects in the market  Increased focus of PE/VC firms Impact • Private equity players are bullish on the healthcare industry in India • In 2008, the healthcare sector accounted for 13% of total investments amounting to USD  5570.48 mn • Apart from hospitals and pharma, private equity players are also showing interest in diagnostic  centers in India %  Amount  Date D t Investor I t Target   T t Stake USD mn  ePlanet Ventures and HSBC  Nov 2007 Trivitron n.a. 11 Private Equity (Asia) Ltd 2007 Sequoia Capital India  Sequoia Capital India Dr Lal PathLabs Dr Lal PathLabs n.a. na 4 Jun 2006 Bennett, Coleman and Co.  Thyrocare n.a. n.a. May 2006 ICICI Ventures Metropolis Health Services Ltd n.a. 8 2005 Sequoia Capital India  q p Dr Lal PathLabs 26 6 MEDICAL DIAGNOSTICS – INDIA.PPT 13
  • 14. Biased government regulation and the lack of accreditation  affecting the of quality services are the major barriers Difference in import duty on diagnostic kits for public and private sector Impact • The import structure has been so formulated that it favors the public sector • Private sector is faced with the issue of providing services at competitive prices across income  groups and are often reduced to providing services only to a niche market Public Private • In order to import equipments and reagents  • For importing diagnostic equipments a duty of 19.8 ‐  Government hospitals do not require a an import Government hospitals do not require a an import  21.7% is levied license; a duty of 5% is levied  • Equipments and supplies are procured based on   • Equipment and supplies are procured through  quality and price, leading  to cost escalations tenders with price being the foremost basis of  decision making Lack of accreditation/certification of diagnostic centers Impact • Lack of accreditation or certification has led to a large pool of medical centers with minimal  g p focus on the quality, which is in contrast to mandatory requirements for other aspects of  healthcare such as hospitals, doctors, nurses and even pharmacies  • Less than 1% of the total laboratories are accredited  14 have College of American Pathologists (CAP) accreditation  45 have National Accreditation Board of Laboratories (NABL) accreditation MEDICAL DIAGNOSTICS – INDIA.PPT 14
  • 15. • Market Overview • Drivers & Challenges Drivers & Challenges • Rules & Regulations for               Manufacturers/Suppliers • Competition •K D l Key Developments t MEDICAL DIAGNOSTICS – INDIA.PPT 15
  • 16. Diagnostic equipment manufacturers are highly regulated by the  central and state government bodies Major governing bodies Government Authorities Operation Oversees activities of the Indian Food and Drug Administration (FDA) and  Central Drugs  Oversees activities of the Indian Food and Drug Administration (FDA) and Central Drugs The Directorate General of Health Services Standard Control Organization (CDSCO)  Regulates the manufacture of all diagnostic kits and reagents as it belongs to the  FDA and CDSCO category of drugs  Responsible for approval of licenses of specified categories of drugs and diagnostics  Drug Controller General of India Drug Controller General of India products They monitor the quality of drugs and diagnostics products that are manufactured by  State drug offices / State FDA’s  respective State units and those marketed in the State Segmentation of products Products used for the  diagnosis of HIV, HBsAg,  Critical Devices HCV,  Blood grouping  reagents, malaria tests Diagnostic Products Diagnostic Products Non‐Critical Devices Other diagnostics products All diagnostics products manufactured or sold in India requires a license MEDICAL DIAGNOSTICS – INDIA.PPT 16
  • 17. The difference in regulations for critical and non‐critical  diagnostics devices has led to lack of quality control Regulatory process for diagnostics equipments Quality  checks are  Manufact conducted  uring  by  y Application is        A li ti i license  li submitted to the  granted  Critical Devices National  Drugs Controller  after an  Institute              General of India audit of  of  Communica manufact ble 3‐6 months uring unit disease • Test manufacturing license or test batch evaluation is not required Non Critical Devices • No inspections needs to be carried out by the central authorities • The application is to be filed only with the State drug offices The application is to be filed only with the State drug offices Lack of sufficient quality control measures has led to substantial number of questionable products in the market MEDICAL DIAGNOSTICS – INDIA.PPT 17
  • 18. Manufacturers need an import license and product registration  certificate from the  Central Drugs Standard Control  Regulations Related to Imports CDSCO is responsible for quality control of imported products as well as the licensing of new products Registration Certificate Import License • Registration Certificate: Application in respect of the  • Documentation premises and the devices to be imported    Form‐9 is to be forwarded by the manufacturer and should be  • Submission: The application is reviewed by the Drugs  attested by the Indian Embassy in the manufacturers country Controller General  GMP (Good Manufacturing Practices) certificate • Registration fee: USD 1000 per product to be registered  Company Registration certificate • Other Documents: Bank slips showing requisite fee paid, Form   Free Sales Certificate in the country of manufacture 40 Power of Attorney to the Indian Agent/Office and dossiers  Manufacturing License Manufacturing License • Duration: The registration process takes 9 months  Country of Origin Certificate • Forwarded by the manufacturer, importer or the agent in   List of countries where the product is already being exported India  ISO / TUV / CE certificate  Batch Release Certificate (for any one batch)  QC certificates (for any one batch) Other requirements for imported medical diagnostic equipments are ‐ • A batch release certificate for the specific goods that have been imported • Shelf‐life certificate which must state that the goods have a shelf‐life of more than 60% at the time of landing  g g • Certificate of Analysis for the products supplied MEDICAL DIAGNOSTICS – INDIA.PPT 18
  • 19. Custom duty is levied on the diagnostic equipments imported  Import duty structure  • The Government has been focusing on enhancing private sector participation by reducing the  customs duty levied on imports of diagnostic kit and reagents imported by the private players  % 40 34.4 34.5 Pregnancy confirmation reagents/Reagents for diagnosing 30 AIDS/Others 21.7 19.8 20 Diagnostic reagents designed to be administered to the patient/Blood grouping reagents 10 0 Jan 2008 Feb 2009 MEDICAL DIAGNOSTICS – INDIA.PPT 19
  • 20. • Market Overview • Drivers & Challenges Drivers & Challenges • Rules & Regulations for               Manufacturers/Suppliers • Competition •K D l Key Developments t MEDICAL DIAGNOSTICS – INDIA.PPT 20
  • 21. Organized pathlabs are rapidly expanding using the hub and  spoke model, including small, independent labs in the network Diagnostic Testing Market Structure Hub and Spoke Model • Highly fragmented with ~40,000 laboratories: CC CC  Hospitals: 43%  Independent labs: 52% CC CC • Among the labs in India  Automated – 5% Reference   Semi ‐ Automated – 38%  Lab  Manual 58% Manual – 58%  Satellite  Satellite Satellite  S t llit Lab Lab • Organized players account for 10% of market and  expanding with ‘hub and spoke’ model:  Reference labs act as regional hubs and are usually located  CC CC CC CC in large metros  Collection centres are located in hospitals, nursing homes,  pathology labs, doctor’s clinics etc.  Satellite labs and collection centres are either owned or  • Reference labs: Hub with comprehensive or specialized testing  franchised capability • As organized players grows their share small As organized players grows their share, small,  • Satellite labs: Limited testing capability; ‘feed’ reference labs Satellite labs:  Limited testing capability;  feed reference labs independent labs are: • Collection centres (CC): Collect samples for forwarding to   Becoming franchisees in the hub and spoke model  either a satellite lab or reference lab  Partnering with large chains on referral basis • A variation in this model is the absence of satellite labs and   Getting acquired by large chains, which lowers the cost of  the existence of only reference labs and collection centres expansion and start‐up time for the latter MEDICAL DIAGNOSTICS – INDIA.PPT 21
  • 22. Major Players – Diagnostic Test Services Market (1/2) Company Overview Business Outlook Apollo Hospitals  • Started in 1983 • Entered into a JV with Amcare Labs, an  • Diagnostic facilities in their subsidiary Apollo Clinics affiliate of Johns Hopkins International of  • Facilities allow for investigation in Biochemistry Haematology Facilities allow for investigation in Biochemistry, Haematology,  the US, to set up a diagnostic laboratory in  Clinical Pathology, Microbiology, X‐ray, Ultrasound with Color  Hyderabad at an investment of USD 2.2 mn Doppler, ECG, Echo Cardiography and Treadmill Dr Lal PathLabs • Started in 1977 • Established an international alliance with  • 40 labs and 500 sample collection centers Quest Diagnostics Nicholas Institute for  • Accreditation: NABL, CAP testing • Planning to set up 50 labs and 1000  collection centers by 2012  • Expand operations in southern and western  regions investing INR 600 mn • Planning to invest INR 100 mn in brand  l b d building Metropolis Health  • Started in 1981 • Growing inorganically Services  • 10000 laboratories across 125 cities globally, 13 laboratories in  • It is looking at overseas expansion as well as   India, 350 collection centers  , outsourcing opportunities g pp • Capability to carry over 3600 routine investigations with over  • Plans on increasing their portfolio to 9 more  100 technologies ‐ e.g. biochip, DNA sequencing, pathology,  labs radiology • Targeted revenue of INR 5 bn by 2010 • ICICI Ventures owns 18% of the company  • In 2008, acquired two labs in North India  • Accreditation: CAP NABL Accreditation: CAP, NABL and a majority stake in Bangalore based RV  and a majority stake in Bangalore based RV Diagnostic Laboratory Note: This list is not exhaustive MEDICAL DIAGNOSTICS – INDIA.PPT 22
  • 23. Major Players – Diagnostic Test Services Market (2/2) Company Overview Business Outlook Piramal Diagnostics  • Started in 1988 • Planning to invest INR 2.5 bn to expand its  / Wellspring • 104 diagnostic centers in 48 cities, 300 collection centers diagnostic chain in 75 urban centers by 2010 • Carries out over 1500 tests Carries out over 1500 tests • Acquired Minrad International Inc for USD  q • Accreditation: NABL, CAP 40 mn Super Religare  • Started in 1996 • Tie‐ups with UK‐based organizations for  Laboratories  • 35 labs, 800 collection centers distributed in 400 towns across  outsourcing Limited/SRL  / the country and 7 franchisee lab • Plans on developing 2‐3 reference  • Caters to 25000 doctors, 650 hospitals and ~ 1000 smaller  laboratories in 2009 Ranbaxy pathology labs and carries out 34000tests/day based on 95  • Expansion budget is pegged at INR 1.5bn technologies • In 2008, acquired Dubai‐based Mena  • Accreditation: CAP, NABL, CLSI, GCLP Healthcare for USD 20 mn  • Reported total revenues of INR 804 mn in FY2007 p Thyrocare • Started in 1995 • Centralized operations through a single  • Carries out 30000 test/day, over 600 franchised collection  laboratory model, located in Navi Mumabi centers • Only player expanding through a 100 %  • Accreditation: CAP, NABL franchisee model Note: This list is not exhaustive MEDICAL DIAGNOSTICS – INDIA.PPT 23
  • 24. Manufacturers – IVD Products/Instruments Market Players in the market IVD Products Market Share (2008) •The IVD products market in India is primarily  y g p dominated by foreign companies •Global IVD companies like Roche Diagnostics,  Abbott, J&J, Siemens Healthcare Diagnostics,  36% Beckman Coulter have strong presence in the  Indian market I di k t 64% •Domestic players have forayed into the market  and are establishing themselves by producing  q yg cost effective and quality goods •60% of diagnostic medical equipment and  Foreign Players  supplies is imported Domestic Players •Low‐cost reagent kits are being imported from  China, Taiwan, and Korea  MEDICAL DIAGNOSTICS – INDIA.PPT 24
  • 25. Major Domestic Players – Diagnostic Equipment Manufacturing  Market (1/3) Company Overview Business Outlook Agappe Diagnostics • Reagents: Clinical chemistry, SyRe Biochemistry), SyRe  • Focusing on the export markets with plans  (Immunoturbidimetry),  Controls/ Calibrators, serology,  of establishing a subsidiary in Dubai under  hemoscreen, coagulation, Urinal analyzer, infectious rapid card  Agappe Middle East LLC test, infectious ELISA, hepatitis markers, torch panel,  • Also plans to expand operations to Africa  Glucometer and Europe • Instruments: Clinical Chemistry Analyzer, Hematology Analyzer,  • Launched Biolis 12i , a fully automatic  Coagulation Analyzer, Sodium & Potassium Analyzer analyser as well as Cystatin C, a more  sensitive instrument for the estimation of  Glomurular Filtration Rate J. Mitra • Rapid test kits: HIV range, HCV range, HBV range, Malaria  • Focuses on Point‐of‐Care (POC) for  range  infectious diseases like HIV and malaria • ELISA test kits: HIV range, HCV range, HBV range, Dengue  • Mass production at affordable prices range, LEPTO range, TB range range LEPTO range TB range • Partnered with WHO for product sales Partnered with WHO for product sales • Confirmatory Tests, Blood Grouping Range • Market leader in HIV diagnosis equipment Orchid Biomedical  • Fertility range, Infectious diseases range,  Parasitology range  • Focuses on POCs for infectious diseases  Systems (Tulip  • Mass production at affordable prices Group) • Partnered with WHO for product sales Partnered with WHO for product sales Note: This list is not exhaustive MEDICAL DIAGNOSTICS – INDIA.PPT 25
  • 26. Major Domestic Players – Diagnostic Equipment Manufacturing  Market (2/3) Company Overview Business Outlook RFCL • IVD, animal healthcare, laboratory solutions and custom  • Adopted an inorganic growth path ‐ synthesis  In April 2008, acquired Bremer Pharma  In September 2008, acquired US based  Mallinckrodt Baker for USD 340 mn  In January 2008, acquired Godrej Medical  Diagnostics and Alved Pharma & Foods  In July, 2007 acquired Wipro Biomedical • Targeted revenue of INR 5 bn by 2010 Span Diagnostics  • Diagnostic reagents & kits: Blood banking products, clinical  • It is a leader in Sphilis and thyroid diagnosis  Ltd. chemical reagents, hematology, infectious diseases serology,  equipment histopathology, antibiotic discs  • Instruments: Biochemistry, ELISA, Hematology,  Chemiluminescence Transasia Bio‐ • Related to bio‐chemistry, hematology, urine analysis,  • Plans to  expand it’s existing product range  Medicals coagulation, ESR, immunology, liquid handling system  and venture into microbiology and  veterinary science Tulip Group • Immunology Reagents, Cardiac Markers, Cancer Markers,  • It is one of the leader sin syphilis, typhoid,  Parasitology & Infectious Disease Range Parasitology & Infectious Disease Range malaria, reproductive hormones, blood  malaria reproductive hormones blood • Instruments ‐ Coagulometers, ELISA reader & washer grouping reagents, cancer markers  and  tuberculosis diagnostic equipment Note: This list is not exhaustive MEDICAL DIAGNOSTICS – INDIA.PPT 26
  • 27. Major Domestic Players – Diagnostic Equipment Manufacturing  Market (3/3) Company Overview Business Outlook Xcyton • Immunodiagnostic kits: HIV CheX and HEP CheX C, JEV CheX,  • Strategic partnership with Qualigens fine  CYSTI‐ CheX, Dengue – CheX chemicals in order to market their HIV • Molecular diagnostic kits g and hepatitis diagnostic kits  p g Yashraj Biotech • Antigens: Customized monoclonal and polyclonal antibodies • Focusing on reducing costs of molecular  diagnostics through innovative technology  diagnostics through innovative technology Other Player : Accurex Biomedical, Bhat Biotech, Medsource Ozone Biomedicals Pvt. Ltd., Trivitron Note: This list is not exhaustive MEDICAL DIAGNOSTICS – INDIA.PPT 27
  • 28. • Market Overview • Drivers & Challenges Drivers & Challenges • Rules & Regulations for               Manufacturers/Suppliers • Competition • Ke De elopments Key Developments MEDICAL DIAGNOSTICS – INDIA.PPT 28
  • 29. Key Developments Date Development 17‐Mar‐09 Roche Diagnostics, a swiss based company, plans on consolidating their  position in the Indian market in 2009. They plan on  expanding their reach through innovative diagnostic tests such as the NT‐proBNP and K‐RAS mutation tests related to colorectal cancer.  10‐Feb‐09 Aloka Trivitron Medical Technologies, a medical equipment manufacturing JV of Aloka, Japan and Trivitron healthcare began  production of Aloka SSD 500, portable ultrasound scanner from its facility at Poonamallee in Chennai. It plans on developing  high quality products on a cost effective basis catering primarily to the developing nations.  06‐Oct‐08 Wipro an IT giant has entered the medical diagnostics market through its subsidiary Wipro Biomed. They have tied up with  GE to develop cutting‐edge technology in order to generate a unique selling price. Wipro is planning to focus on  GE to develop cutting‐edge technology in order to generate a unique selling price Wipro is planning to focus on telemedicine, especially in the diagnostic radiology. 10‐Mar‐08 Sneha Diagnostics plans on developing 10 state‐of‐the‐art medical diagnostics centres across Andhra Pradesh by 2009. A  capital investment of INR 50 mn is expected towards this expansion venture.  09‐Jan‐08 RFCL Limited, an ICICI venture company acquired Godrej Medical Diagnostics. This led to partnerships with QBC Diagnostics,  USA, Asia Gen Corporation, Taiwan and Uritest Medical Electronic Co Ltd, China allowing them to expand their reach.  USA Asia Gen Corporation Taiwan and Uritest Medical Electronic Co Ltd China allowing them to expand their reach MEDICAL DIAGNOSTICS – INDIA.PPT 29
  • 30. Thank you for your time For an updated report or any customized research requirements, please contact: Gaurav Kumar E‐Mail: gaurav.kumar@netscribes.com; sales@netscribes.com Phone: +91 33 4064 6214; +91 983 030 9715 Netscribes’ Services: RESEARCH & ANALYTICS RESEARCH & ANALYTICS MARKET INTELLIGENCE MARKET INTELLIGENCE CONTENT SOLUTIONS CONTENT SOLUTIONS Investment Research Market Monitoring & Competitive  Social Media Marketing Enterprise Market Research Intelligence Marcom Support Services Patent Research Sales & Prospect Intelligence Content Management Services Syndicated Market Research S di t d M k t R h Listening & Media Monitoring Li t i & M di M it i Book Packaging Services B kP k i S i Brand Surveillance For further details, visit us at: www.netscribes.com About Netscribes Netscribes supports the organic and inorganic growth objectives of global corporations through a combination of Enterprise Market,  Investment & Patent Research, Market & Sales Intelligence, Social Media Monitoring & Management and Custom Publishing solution. Disclaimer: This report is published for general information only. High standards have been used for preparing this market research report;  Disclaimer: This report is published for general information only High standards have been used for preparing this market research report; however, Netscribes, Inc. or “Netscribes” is not responsible for any loss or damage arising from use of this document. This document is the sole  property of Netscribes and prior permission is required for guidelines on reproduction. MEDICAL DIAGNOSTICS – INDIA.PPT 30