작성일자: 2013.11.1

작성자: 뉴델리 무역관 Ms. Nishi Piplani (nishi@ktcdelhi.net)

 

 

1. 산업동향

 

□ Indian Healthcare Industry & Diagnostic Services Landscape

 

 ○ Transforming Indian Healthcare

  - In India, the average expenditure on healthcare by state governments is INR 1500 per person, which is only about 1.2% of GDP. The 12th Five Year Plan outlay for Ministry of Health & Family Welfare has increased to INR 300,018 crore. The total budgetary allocation for 2013~2014 is INR 32,745 crore under the plan category, while INR 4,585 crore has been allocated under the non-plan category. (Source: Medical Buyer)

 

 ○ Market Trend

  - Indian healthcare sector, one of the fastest growing industry, is expected to advance at a CAGR of 15% during 2011~2017 to reach US$ 158 billion. There is immense scope for enhancing healthcare services penetration in India, this presents ample opportunity for development of the healthcare industry.

 

 ○ Industry Drivers: Rising income levels, ageing population, growing health awareness and changing attitude towards preventive healthcare is expected to boost healthcare services demand in future.

 

Source: IBEF

 

 ○ Of total healthcare revenues in the country

  - Hospitals account for 71%

  - Pharmaceuticals for 13%

  - Medical equipment and supplies for 9%

 

 

  - The increase in the number of hospitals and healthcare facilities, development of healthcare infrastructure and the advancement of medical equipment propelled the growth of diagnostic industry. Further, the increase in the complexity of diseases has prompted the industry to provide better facilities for diagnosis and sample collection.

  - Healthcare spending in India across different sectors:

 

 

   · Bio-Pharma and pharmaceuticals have emerged as strong areas for R &D within the healthcare sector.

   · Main segments within Bio-Pharma are: Vaccines – DPT with Hepatitis B, Hepatitis A, Polio etc.; Therapeutics – TB, HIV, Cholera, Dengue, Typhoid and Cancer.

   · Within Pharmaceuticals, main segments by manufacturing: API’s – 25% of market and Formulations – 75% market; by therapeutic areas: Chronic(28% market): Cardiovascular, CNS, Oncology, Diabetes, Obesity; Acute: Anti-infectives, Gastro, Respiratory, Analgesic, Vitamins. In recent years, the focus of Indian Pharma Industry has shifted from generics to new drug delivery systems and new molecules/ drugs with increased international collaboration.

  - Regulatory Scenario: Foreign Direct Investment Regulations

  - According to existing foreign direct investment regulations, investment in pharmaceutical company is categorized as under:

   · Greenfield investments in the pharmaceuticals sector: 100% FDI permitted under automatic route.

   · Brownfield investments (that is, investments in existing companies), in the pharmaceuticals sector:  100% FDI permitted under the Govt. route, i.e., with the prior approval of FIPB.

 

 

  - The diagnostics market in India is witnessing a 20% growth which is faster than any country in the world (the growth in the US is 1~2%).

  - The diagnostics market revenue in 2012~2013 touched $1.8 billion as against $510 million in 2010~2011. It has been growing for quite some time now, although Chinese and Korean products have created a stiff competition in terms of prices. The key growth products include hematology, reagents, molecular diagnostics, and specialty diagnostics.

  - Diagnostics market in India is dominated by multinationals. Top players in this sector include Roche Diagnostics, Abbott, Tulip Group, Transasia Biomedical and Span Diagnostics.

  - Multinationals have a larger share because they have products which cut across all segments whereas local companies choose to focus only on one segment.

  - Most of the local companies' business is tender-driven. However, this trend is changing now. Several local manufacturers are now adding new capabilities and technologies to match global standards. This sector has over 20 local manufacturers and is seeing new entrants such as Achira Labs and Bigtec Labs working on innovative products. Looking at the scope and need, the government has been taking a gradual interest in investing in this sector and providing incentives to manufacturers.

  - There are about 100,000 diagnostic laboratories in India conducting nearly 2,000 to 3,000 tests per day for larger laboratories.

  - Brar tells DTTR that the Indian diagnostic and pathology labs test services market in India was valued at approximately $2.2 billion and is expected to more than double to $5.5 billion by 2020. The diagnostics market in India is described as having two informal segments—the organized market and the unorganized market.

  - The unorganized market includes a staggering 30,000 to 40,000 laboratories, which are not necessarily owned by a pathologist or doctoral laboratory scientist. By contrast, the organized segment has much better oversight, but not necessarily by a government or regulatory agency. The organized segment is significantly smaller with centers numbered in the hundreds. Only a few of the laboratories in this sector are performing complex molecular diagnostics, including sequencing.

 

 ○ Major Investments

  - In July 08, Mauritius based private equity fund, New York Life Investment Management and Jacob Ballas India Fund invested $22 million in Mumbai based Themis Labs.

  - In Feb’ 2009, India venture invested $18 million in Tamil Nadu based Kaveri Medical while IFC invested $30 million in Max India.

  - Sabre Capital has a $100 million fund focused on investing in mid-size existing hospitals or in start-ups.

  - Chrys Capital, which focuses on the pharmaceutical sector, is looking at opportunities in the healthcare space especially in hospitals, medical diagnostics and devices.

 

 ○ MDI Labs plans 2,000 diagnostic Centers in India

  - Medizinisch Diagnostiche Institute(MDI), one of the world's largest diagnostic testing services, has proposed to invest Rs 150 crores in its Indian subsidiary MDI Laboratories with plans to set up over 2,000 collection centres as part of expanding its network in Karnataka, Maharashtra and Gujarat.

 

 ○ India’s Medical Device Regulatory Structure

  - The import, manufacturing, distribution and sale of medical devices in India are overseen by the Drugs and Cosmetics Act(1940) and Rules(1945).

  - 22 medical devices are currently ‘notified’ under the Drugs & Cosmetics Act.

  - Controls and inspections are carried out by the CDSCO, state drug controllers and central/ state laboratories.

 

 ○ Government Incentives on Diagnostics:

  - The Government of India has decided to increase health expenditure to 2.5% of gross domestic product(GDP) by the end of the Twelfth Five Year Plan (2012~2017), from the existing 1.4%. FDI inflows into hospitals and diagnostic centres, and medical appliances stood at US$ 1.44 billion and US$ 0.6 billion respectively, during April 2000~September 2012 .

   · 100% foreign direct investment(FDI) is permitted for all health related services under the automatic route.

   · Custom duty on life-saving equipment has been reduced to 5% from 25% and exempted from countervailing duty.

   · Import duty on medical equipment has been reduced to 7.5%.

   · Hospitals with at least 100 beds are eligible for 150% deduction for capital expenditure; other measures include exemption of service tax.

 

 ○ Indian Healthcare IT- In the Pink of Health

 

 

 

  - According to Ernst & Young report’ 2012, Indian Medical Devices Industry is growing significantly every year and it ranks amongst the top-20 in the world. It is the fourth-largest medical device industry in Asia after Japan, China and South Korea. The industry is forecasted to reach US$4.8 b by 2015, growing at a CAGR of 15.6% (2009~2015).

  - With its growing popularity and success rate, IVD has created a significant place in the worldwide medical diagnostics market.

  - Focusing on the emerging economies of the world, especially Asian countries, like India, it has been noticed that areas like IVD are recording unabashed adoption in the medical fraternity, which is evident by its increasing market size.

  - In-vitro segment of the industry accrued revenues of US$ 463.50 million in 2012, which is estimated to touch US$ 1,254 million by 2018.

  - Currently the Indian IVD market is valued at US$ 677 Million, and is expected to grow at 19% per annum till 2020.

  - With a compound annual growth rate(CAGR) of 18.1% from 2009 to 2016, IVD has emerged as one of the most profitable markets in the Indian healthcare industry.

  - The improving corporate hospital infrastructure and installation of automated and semi-automated biochemistry, immunology, and hematology equipment have enabled the market to achieve this healthy double-digit growth rate.

  - Growth Triggers: Lifestyle and communicable diseases are no longer restricted to urban centres, but are spreading to rural areas as well. As a large portion of rural areas do not have even the basic healthcare facilities, several cases remain undiagnosed. Certain statistics state that only one-third of the rural population has access to diagnostic centers. Most patients visit health centres outside the village for diagnosis and treatment. Nearly half of these public sector units don’t have treatment facilities for major chronic ailments. These changing disease patterns, rising incidence of diseases, higher healthcare spending, and untapped markets create abundant opportunities for IVD manufacturers. Even hospitals are looking to reach out to patients in tier III cities and rural areas.

  - IVD Market is divided in Public & Private Customers.

  - Industry is made of:

   · MNC’s

   · Indian Corporates

   · Unorganized Players

  - The Indian IVD Market is led majorly by global players in the absence of necessary skills, technical know-how and the infrastructure to bear the high-end costs for carrying out research and development of own products possessed by local players.

  - There is massive prevalence of products imported either in finished form or as OEM & lesser focus on indigenous research.

  - Market leaders offer competitive prices & innovative technologies, which have been in use in developed countries and have been absorbed on a gross scale.

  - Although the prospects are bright for companies, they will not find it easy going in fragmented IVD industry. The major reasons for the market fragmentation are the low entry barriers (leading to the mushrooming of laboratories) and the complete lack of standardization. Only 150~200 laboratories in India have accreditation, and due to the absence of legislation, standardized procedures and equipment are unavailable.

  - Another significant concern for market participants is the inadequate insurance coverage. Responding to the demand for quality healthcare, most corporate laboratories have introduced cost effective and convenient patient care packages.

  - IVD revenues in India are preliminary driven by labs contributing 65% whereas hospitals contribute 35%.

 

 

  - In India, the imaging-diagnosis segment generated revenues of US$ 645.10 million in 2012, projected to reach US$ 1,000 million by 2018. With increased awareness and investments in advanced technology pouring into the segment, the sector has developed considerably over the past five years. One of the prime needs of the imaging diagnosis industry is skilled labor.

  - Drivers: This remarkable growth can be attributed to increased healthcare awareness, desire to undergo preventive health checkups, availability of disease specific tests, corporate setups promoting health focus of employees, and drift from manual to semi-automated and automated equipment. Emergence of new concepts like point of care testing, near patient testing, increased automation; hospital laboratory management and customer relationship management have revolutionized this segment and contributed towards providing accurate and precise diagnosis at much faster rates.

 

IVD Market

By Application	By Types	By End-Users
Molecular Diagnostics Immunoassays  Clinical Chemistry Microbiology Haematology Others (Flow cytometry, coagulation, etc.)	Analyzers Reagents Services	Patient Self Testing Laboratories Hospitals Universities Ambulatory Care

 

  - Major companies are entering IVD Businesses with emerging opportunities with CRO’s, Outsourced Clinical Trials.

  - Reagent rental trend has started 4 years back & is receiving fast acceptance.

  - Product registration has started becoming difficult.

  - The molecular diagnostics market has emerged as one of the fastest growing segments of the global IVD industry. It contributed 30~40% of the total market.

  - According to Frost and Sullivan, Asia-Pacific molecular diagnostics market earned total revenue of over $846.50 million in 2012, and is estimated to reach $2,528.10 million in 2019. The market will grow rapidly owing to rising need for better healthcare services.

  - China, Japan, India and Singapore are leveraging on genetic technologies to develop molecular diagnostic platform which is much more efficient and effective in tracking diseases.

 

 

  - The two most common applications for molecular diagnostics are for identification and profiling of cause of infection and to quantify pathogens to monitor therapy. Molecular Diagnostics is quickly expanding for genetic testing, prenatal diagnostics, cancer diagnostics and near patient applications.

  - Nine major companies address 75% of the market. Infectious diseases generate app. 60% of the overall molecular diagnostics market revenues.

  - The primary tests include HIV, HPV, HBV/HCV, and CT/NG with a mature growth rate of around 5% leaving HPV.

  - Molecular diagnosis is working towards making personalized healthcare for detecting diseases with no current symptoms but with chances of any trigger in future, more accessible. India-based Jai Health has developed JaiHeart, a genetic-based test for total heart disease risk developed specifically for Indian, other Asian, Middle Eastern and African populations.

 

 ○ Advancement in Molecular Diagnostics

  - Super-specialty eye hospital Narayana Nethralaya has opened an advanced diagnostic facility in Health City on the outskirts of Bangalore for genetic testing of diseases at molecular level.

  - Set up at a cost of $5 million (Rs.30 crore) as a joint venture(JV) with the US-based genomics and diagnostics firm MedGenome, the hitech lab will be a one-stop solution to test any aspect of disease from molecular DNA to RNA to protein markers.

  - According to Med Genome chairman Sam Santhosh, the market for similar tests in India is still nascent, while it is a $5 billion market segment in the US already.

 

 

  - High expectation of the customer for accurate and precise diagnosis in no time has made companies to constantly think of providing smart solutions.

  - The key market challenges recognized by the analysts include factors like less regulatory norms, no reimbursement of diagnostics tests, no specified quality of the reagents which are used etc. Some of the key trends of the Indian in vitro diagnostics market(IVD) are technological innovations, market consolidation-opening new avenues and cut down turnaround time and ensuring quality results.

 

 

  - The leading player in IVD segment is Transasia Bio-medicals which is ISO 9001:2000 and ISO 13485:2003 certified, has also been rated as India's largest in vitro diagnostics company(2006) by McEvoy & Farmer, USA (International experts on IVD markets). The other major players in this group are Roche Diagnostics, J Mitra, Johnson & Johnson, Beckman Coulter, Trivitron, Accurex, Tulip/Crest, Bayer-Siemens, Agappe, Randox, Span, Wipro Biomed, Merck, Ranbaxy, NPIL-DiaSyS. Apart from these, there are 30 other smaller players operating in this market segment.

 

 

 ○ IVD Regulatory Structure

  - Central Drug Standard Control Organization(CDSCO) (http://cdsco.nic.in), Directorate General of Health Services is the authority responsible for laying down rules, standards and for approving import and manufacture of drugs, diagnostics, devices, and cosmetics.

  - Under the Drug and Cosmetics Act (http://cdsco.nic.in/Drugs&CosmeticAct.pdf), the regulation of

manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

  - Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

  - Vitro Diagnostic kits/reagents are regulated in India under the Provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.

  - The diagnostic kits and reagents have been classified as ‘Notified’ and ‘Non-Notified’.

  - Following IVD kits/reagents are Notified as ‘Drugs’ under Drugs and Cosmetic Act 1940.

   · In-Vitro Diagnostic Devices for HIV

   · In-Vitro Diagnostic Devices for HBV

   · In-Vitro Diagnostic Devices for HCV

   · In-Vitro Blood Grouping Sera

  - All In-Vitro Diagnostic kits and Reagents excluding those listed under Notified category would be covered under the category of Non-Notified IVD products.

  - For the import of Notified IVD kits/ reagents in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules. For import of Notified IVD kits/ reagents, the manufacturing site and products (IVD kits/ reagents) are required to be registered with Indian Drug Regulatory Authority (i.e. Central Drugs Standards Control Organization).

  - For the import of Non- Notified IVD kits/ reagents in India, only Import License in Form 10 is required as per provisions of the Drugs & Cosmetic Act & Rules.

 

□ Laboratory Reagents & Allergy Screening Systems

 

 ○ Creation of corporatized healthcare facilities in the private sector and the advent of health insurance have opened up demand in many areas of healthcare in India. In this scenario, medical laboratories are mushrooming everywhere to support healthcare needs. These laboratories are an integral part of disease diagnosis, treatment, monitoring response to treatment, disease surveillance programs and clinical research. The test results, therefore, should be reliable, accurate and reproducible.

 

 ○ The pathology industry in India is around INR 10,000 crore and about INR 1,000 crore is managed by organized sector comprising handful of top laboratories. The industry is highly competitive and price-driven with kickbacks and business referral payments in the absence of a regulatory body.

 

 ○ There are about 100,000 diagnostic laboratories in India conducting nearly 2,000 to 3,000 tests per day for larger laboratories.

 

 ○ India does not have mandatory accreditation for medical laboratories. All laboratories are required to only register themselves with the health departments in the respective states! The only accreditation agency that is authorized by the central government is the National Accreditation Board for Testing and Calibration of Laboratories(NABL).

 

 ○ Enquiries reveal that NABL has accredited around 450 medical laboratories(0.45%), with the rest(99.55%) having only registered themselves with the respective state health departments.

 

 ○ Brar tells DTTR that the Indian diagnostic and pathology labs test services market in India was valued at approximately $2.2 billion and is expected to more than double to $5.5 billion by 2020.

 

 ○ In India, the biochemistry instruments & reagents market is estimated at INR 750 crore, out of which nearly 75% of total market is contributed by reagents, says consultant biochemist, Manipal Hospital, Bangalore.

 

 ○ With a large number of corporate hospitals like Apollo Hospitals, Fortis Healthcare, Manipal Hospitals and Columbia Asia, there has been a trend among users for high-end analyzers under reagent rental schemes.

 

 ○ Integrated systems combining biochemistry and immunochemistry tests are now becoming popular.

 

 ○ On the basis of technology/application, the immunochemistry market accounted for the largest portion of IVD revenues in India, contributing 46.6% to the total market in FY' 2013.

 

 ○ With a percentage share of 20.1% in the total IVD revenues, the biochemistry market in India was the second largest segment in FY' 2013. Even though the share of this segment in the overall IVD revenues has declined for the last three fiscal years (FY' 2011~FY' 2013), the market has grown at a CAGR of 15.7% over FY' 2007~FY' 2013.

 

 ○ The immunochemistry market has registered revenues of US$ 408.8 million in FY' 2013. The revenues increased by 40.2% from US$ 291.6 million in FY' 2012. The highest contribution to these revenues came from the sales of immunochemistry reagents, which along with instruments accounted for 50.5% of the total market in fiscal year 2013.

 

 ○ The biochemistry market in India was dominated by Roche Diagnostics, accounting for a market share of 34.0% in fiscal year 2013.

 

 ○ Leading players in this instrumentation market are Beckman Coulter, Roche Diagnostics, Siemens, Abbott, Mindray, Ortho-Clinical Diagnostics, Randox Laboratories and Alere & Trivitron Diagnostics.

 

 ○ The Indian blood gas and electrolyte analyzers and reagents market in 2012 is estimated at Rs. 165 crore, a 17% increase over 2011.

 

 ○ 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.

 

          

Source: Medical Buyer (May’ 2013)

 

 ○ Consolidation of diagnostic facilities, rising demand for integrated and high-through-put systems, ever-expanding number of diagnostic centers, awareness about accreditation and increasing affordability by patients are some of the prime factors driving the growth of this market.

 

 

 ○ The diagnostics and laboratory service industries are experiencing significant growth in India. With a number of strong drivers in place, this growth is expected to continue, presenting American laboratories and diagnostics manufacturers an opportunity to penetrate this nascent, fragmented market. Ironically regulation, the factor attributed with slowing commercialization efforts in the United States, poses the only threat to growth in India, although in India it is the lack of regulation and the resulting questionable quality of some tests that could derail confidence in the testing market.

 

 

 ○ To succeed in Indian Market, businesses need to have an understanding of the environment, in the country as a whole and the various regions.

 

 ○ Foreign investors into India need to develop an ‘India’ strategy; that is,

  - Look at India as a long term strategic market

  - Choose the right local partner

  - Conceptualize India-specific products (value for money)

  - Establish India-centric culture: consideration for local aspirations & sensitivities

  - Co-ordinate between head office &Indian entity with clear communication channels, cross-cultural competencies, belief in local managerial competencies.

  - Understand the organizational structure and decision making process to avoid delays.

  - Develop India-specific strategy: Finnish business and HR practices may not necessarily work.

  - Optimally blend expatriate management with local talent.

  - Be visible: aggressive marketing and media presence are essential.

  - Closely engage with client/local partner at all times and constantly evolve offering to meet requirements.

  - Complement each other’s strengths; establish R&D linkages with industry·research institutes·academia. Adopt suitable R&D cooperation model – in-house·partly-outsourced·fully outsourced.

  - In short, foreign companies require an India-specific strategy with unique value propositions to address the varied needs of the country. There can be hurdles in the beginning, but these get resolved soon, overcome by opportunities offered by the market. Companies need to overcome their fear of entering India: India is diverse but good local knowledge; team and contacts are useful in making significant inroads into the market.

 

 ○ Surge in allergic diseases in India: WAO

  - Growing industrialization and fast changing biodiversity coupled with sedentary lifestyles are causing a surge in allergic diseases, especially among children in the country, the World Allergy Organization(WAO) has warned.

  - Around 300 million people in the world are suffering from asthma and the figure can rise to 400 million by 2025, says the World Allergy Organization(WAO).

  - India, with a diverse and unique food culture, has acquired its own portfolio of allergens too. Granted, nuts and wheat and dairy and others can be a problem to south Asians, but research led by Professor Mahesh PA, Director at Allergy Asthma Associates in Mysore, India, has uncovered many others – with brinjal(aubergine), cucumber, lady’s finger(okra) and papaya among the most common foods causing clinical symptoms in population samples from Mysore City and from Bangalore.

  - With a population of well over a billion, food allergy could become an enormous problem in India. Some estimates suggest up to 3% of Indians may already have food allergies, the majority under 40 years of age. Food allergies cause roughly 30,000 emergency treatments and 100 to 200 deaths per year in the nation. Up to 3 million Indians may have peanut allergy alone.

  - Currently, about 20 to 30% of people in India are having one or more allergic diseases and their prevalence is raising dramatically, WAO said.

  - The diseases included asthma, rhinitis, anaphylaxis, food and drug allergy, insect allergy, eczema and urticaria(hives) and angioedema, it said.

  - The prevalence of asthma and rhinitis-two major forms of allergies-was one and 10% respectively in 1964 in the country. But, new data shows that about 14% people now have asthma, while over 20% are suffering from allergic rhinitis(AR) which results from an IgE-mediated inflammation of the nasal mucosa.

  - "This increase is especially affecting children, who are bearing the greatest burden of the rising trend which has occurred over the last two decades," said Dr Ruby Pawankar, the President Elect of WAO.

  - "The way these are occurring, we believe by 2050, about 50% of all children will have some sort of allergies," Dr Pawankar, an Indian doctor who is currently associated with Nippon Medical School in Tokyo, told PTI.

  - Effective management of allergic diseases relies on the ability to make an accurate diagnosis. Allergy testing can help confirm or rule out allergies. Correct diagnosis, counseling and avoidance advice based on valid allergy test results will help reduce the incidence of symptoms, medications and improve quality of life. For assessing the presence of allergen-specific IgE antibodies, two different methods can be used:

   · a skin prick test

   · An allergy blood test

  - Both methods are recommended and have similar diagnostic value.

  - In recent times, there have been enormous improvements in the medical practices used to treat allergic conditions. With respect to anaphylaxis and hypersensitivity reactions to foods, drugs, and insects and in allergic skin diseases, advances have included the identification of food proteins to which IgE binding is associated with severe reactions and development of low-allergen foods, improvements in skin prick test predictions; evaluation of the atopy patch test; in wasp sting outcomes predictions and a rapidly disintegrating epinephrine tablet, and anti-IL-5 for eosinophilic diseases.

 

List of some common Allergens in India

 

  - The following laboratories have carved niche in diagnostics and pathological testing.

   · Dr. Lal’s Pathology

   · Religare SRL Diagnostics

   · Metropolis

   · Piramal Diagnostics

   · Thyrocare

   · Anand Labs

 

 ○ Views from Market Players on Allergy Screening Systems & Reagents:

  - As such, no published data on allergy screening kits and systems is available.

  - The global players like USA and Germany have captured Indian market in this field.

  - Imports of these products require licenses and registration certificate. Taxation charges also have to be incurred by the importer.

  - These kits follow a multi-level distribution structure.

  - In some cases, manufacturer directly sells kits to big labs and hospitals via importers whereas some less prominent ones are channeled through dealers and marketing agents.

  - Companies do not normally wish to disclose prices of the reagents.

  - According to Mr. Soji, Group Product Manager Immunology, India, “The market for allergy screening kits is growing. Owing to advancement in technology and price sensitivity in Indian masses, these are highly procured from overseas”.

  - Germany and USA are the main hubs exporting kits and other diagnostic products in India.

  - According to Mr. Banik, there are very few players in allergy screening industry (in India) but mainly nowadays market is with Lilac Medicare for the German system they offer.

  - The Korean companies looking forward to market their products in India would face challenges from already established network of German and USA companies, who offer high quality products at competitive prices.

  - Mr. Chandan from Lab India Instruments mentioned that import of systems do not need licenses but for consumables, companies need to apply in Form-9 after which DCGI issues Form-10, thereafter, reagents for systems can be imported. No clinical trials required.

  - According to Mr. Hussain, General Manager- Star Biomed (employed with Samsung Medison-India previously), Allergy Screening Systems is a niche product. Lack of technology in India has paved way for bulk imports especially from Germany and USA.

  - He mentioned that Korean company should come up with a marketing strategy so that it is easier for Indian distributors·importers to sell their products in the market.

  - Absence of marketing strategy would call for additional expenses (for buyer) thereby decreasing profitability.

  - He stated that top global players in this field like Roche & Abbott have their medical representatives in every state.

  - This increases the awareness of the product in the masses thereby leading to the demand of the product.

  - He further stated that it is easier to sell branded products directly to big labs and hospitals, whereas, less known products have to be supplied through a chain of dealers, distributors and sales channel.

 

 

2. 수입동향

 

□ HS Code 3822

 

 ○ The Indian IVD market is led majorly by global players in absence of necessary skills, technical knowhow and the infrastructure to bear the high end costs for carrying out research and development of own products possessed by local players. There is massive prevalence of product imported either in finished form or as Original Equipment Manufacturer(OEM) and lesser focus on indigenous research. Market leaders usually offer competitive prices and innovative technologies which have been in use in the developed countries and have been absorbed on a gross scale.

 

 ○ During 2012, the imports of Diagnostic Reagents by India were to the tune of US$ 270,019,851 which has consistently grown.

 

 ○ A further analysis based on the level of technology involved in the manufacture of Diagnostic Reagents indicates that the import of quality products have increased during calendar year 2010~2012. The imports from Jan~Mar’ 2013 stood at 46,783,806. According to the statistics given by the DGCI&S, Ministry of Commerce, there has been a steep increase in imports as shown below.

 

World Imports of Diagnostic Reagents in USD

Source: DGCI&S, Ministry of Commerce

 

 ○ Import Statistics of HS Code 3822 - Composite Diagnostic or Laboratory Reagents

  - India’s country-wise import statistics in terms of value of the items covered under HS Code 3822 during the year 2010, 2011, 2012 and 2013 (Jan~June) is given below.

  - In past 3 years maximum imports of diagnostic reagents have been done from USA, Germany and France. The total imports (in India) increased from US$ 233,122,321 in 2011 to US$ 270,019,851 in 2012.

 

2010~2012 India Import Statistics

Composite Diagnostic Or Laboratory Reagents,

Other than Pharmaceutical Preparations of Heading 3002 or 3006

                             (Unit: US$, %)

Rank	Partner Country	Value				Share
		2010	2011	2012	2013	2010	2011	2012	2013.1~6
-	World	187,910,436	233,122,321	270,019,851	146,783,806	100.00	100.00	100.00	100.00
1	United States	65,422,043	72,433,489	98,114,051	54,471,083	34.82	31.07	36.34	37.11
2	Germany	34,797,084	29,323,508	36,451,776	19,250,183	18.52	12.58	13.50	13.11
3	France	17,195,886	18,621,050	22,446,201	12,653,457	9.15	7.99	8.31	8.62
4	United Kingdom	13,120,220	16,830,848	18,991,190	8,758,083	6.98	7.22	7.03	5.97
5	Switzerland	1,511,877	12,876,002	18,358,823	13,083,253	0.80	5.52	6.80	8.91
6	China	8,464,965	18,628,916	10,388,267	3,400,936	4.50	7.99	3.85	2.32
7	Singapore	4,553,305	7,146,266	9,453,532	6,236,930	2.42	3.07	3.50	4.25
8	Japan	7,064,173	6,779,129	9,281,751	3,932,106	3.76	2.91	3.44	2.68
9	South Korea	8,008,822	9,713,266	6,367,277	4,749,785	4.26	4.17	2.36	3.24
10	Taiwan	4,020,782	2,748,532	4,699,799	2,156,667	2.14	1.18	1.74	1.47

Source: DGCI&S, Ministry of Commerce

 

 ○ Country-wise Import trend in values: 2013.1~6

  - 2013.1~6 in terms of value.

  - The analysis shows that maximum imports are done from USA, Germany and Switzerland.

 

Korea ranks 7th in world imports (2013.1~6)

Source: DGCI&S, Ministry of Commerce

 

Import policy & Tariff trend

HS Code	3822
Item Description	Diagnostic or Laboratory Reagents on a Backing, Prepared Diagnostic or Laboratory Reagents Whether or Not on a Backing, Other Than Those of Heading 3002 (Human Blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms-excluding yeasts and similar products) or 3006 (Pharmaceutical Goods)
Total import Duty (%)	28.851
Duty Structure (%)	Basic Duty(BD): 10 Countervailing Duty(CVD): 12 Special CVD(SCVD): 4 Educational Cess(EC): 3
Import Policy	- In Vitro Diagnostic kits/ reagents are regulated in India under the Provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. - For the import of Notified IVD kits/ reagents in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules. For import of Notified IVD kits/ reagents, the manufacturing site and products (IVD kits/ reagents) are required to be registered with Indian Drug Regulatory Authority (i.e. Central Drugs Standards Control Organization). - http://cdsco.nic.in/Final%20FAQS-IVD.pdf

Source: Custom Tariff 2013~2014

 

 ○ The shipment for diagnostic products arriving on the Indian port should be accompanied with:

  - Batch release certificate for the specific lot sent.

  - Shelf-life certificate stating that the products shipped have more than 60% shelf-life at the time of landing in India.

  - Certificate of Analysis for the lot supplied.

 

 ○ The product carton, in turn, should have following information:

  - Name & address of the manufacturer

  - Name & address of the importer

  - Import license number

  - Date of manufacture

  - Date of expiry

 

 

3. 수출동향

 

□ Export Statistics of 3822 - Composite Diagnostic or Laboratory Reagents

 

 ○ India’s country-wise export statistics in terms of value of the items covered under HS Code 3822 during the year 2010, 2011, 2012 and 2013 (Jan~June) is given below.

 

 ○ In past 3 years maximum exports of diagnostic reagents have been done to Malawi, Germany and Zimbabwe. The total exports (from India) increased from US$ 26,612,345 in 2011 to US$ 30,623,498 in 2012.

 

2010~2012 India Export Statistics

Composite Diagnostic Or Laboratory Reagents,

Other than Pharmaceutical Preparations of Heading 3002 or 3006

                             (Unit: US$, %)

Rank	Partner Country	Value				Share
		2010	2011	2012	2013	2010	2011	2012	2013.1~6
-	World	18,952,583	26,612,345	30,623,498	20,361,613	100.00	100.00	100.00	100.00
1	Malawi	19,760	30,707	2,871,718	2,663,329	0.10	0.12	9.38	13.08
2	Germany	1,260,776	2,296,975	1,827,087	1,292,464	6.65	8.63	5.97	6.35
3	Zimbabwe	69,652	557,604	1,806,258	199,233	0.37	2.10	5.90	0.98
4	Nepal	582,136	1,467,459	1,527,408	787,363	3.07	5.51	4.99	3.87
5	Bangladesh	2,046,803	1,594,049	1,385,027	564,839	10.80	5.99	4.52	2.77
6	United States	2,081,650	2,500,749	1,312,792	1,433,259	10.98	9.40	4.29	7.04
7	Kenya	346,479	907,693	1,231,384	686,424	1.83	3.41	4.02	3.37
8	United Kingdom	822,630	833,729	934,626	511,347	4.34	3.13	3.05	2.51
9	Sri Lanka	696,891	920,065	879,472	415,393	3.68	3.46	2.87	2.04
10	Nigeria	1,203,025	1,041,923	871,381	626,002	6.35	3.92	2.85	3.07

Source: DGCI&S, Ministry of Commerce

 

 

4. 경쟁동향

 

□ India’s diagnostic segment is so far dominated by unorganized local players. However, there are no doubts few organized players too like Roche Diagnostics, Abbott, Tulip Group, Transasia Biomedical, Span Diagnostics, etc are making their presence felt in this domain. As per the industry experts, the diagnostics market in India is witnessing a 20% growth which is faster than any country in the world. In the financial year 2011~2012, revenue earned by the diagnostics sector is US$ 600 million as against US$ 510 million in 2010~2011. The growth factors can be attributed to facts such as improved diagnostics tools, treatment monitoring, faster response times, and increased availability of over-the-counter(OTC) tests, which patients can perform in the comfort and convenience of their homes.

 

 

□ Major industry participants with immunoassay analyzers that offer a menu of test products include:

 

 ○ Roche Diagnostics, Switzerland: http://www.roche-diagnostics.co.in/Pages/default.aspx

  - After its foundation 116 years ago, Roche over the years has specialized as a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics.

  - Roche Diagnostics encompasses five segments: Diabetes Care, Molecular Diagnostics, Centralized Diagnostics, Near Patient Testing and Applied Sciences. Both Diabetes Care and Centralized Diagnostics account for 70% of the revenues for the division, with both coming in with 35% each.

 

 

  - Research and development

   · Received approvals for three new cancer medicines

   · Delivered positive results in 11 out of 14 late-stage clinical trials

   · Continued clinical development of 72 promising new molecular entities

   · Launched 55 new diagnostic products in key markets

  - Marketing and distribution

   · Customized innovative market solutions to increase access to our medicines.

   · Launched an educational initiative in nine Asian countries to promote excellence in testing for HER2-positive breast cancer.

   · Started a program with the Peruvian government to provide cancer care access for 12 million of the country’s poorest citizens.

   · 18,000,000 patients received treatment with one of 25 top selling Roche medicines in 2012.

   · 82,089 employees worldwide are working for Roche.

 

 

 

  - Roche Diagnostics India was established in January 2002 in India as an outcome of global acquisition of AVL Biomedical, leaders in blood gas and electrolytes testing market.

 

 

 ○ Abbott India Limited (www.abbott.co.in)

  - Headquartered in Mumbai, Abbott India Limited, a publicly listed company and a subsidiary of Abbott Laboratories, enjoys strong brand equity in multiple therapeutic categories such as Women’s Health, Gastroenterology, Neurology, Thyroid, Diabetes & Urology, Pain Management, Vitamins, Anti-Infectives & other therapy areas.

  - Abbott India is healthcare company that discovers, develops, manufactures and markets innovative products and services. In 1888 a young Chicago physician, Dr Wallace Calvin Abbott founded Abbott Laboratories.

  - In international market it has developed various products in area of Anesthesia, Animal Health, Anti-Infectives, Cardiovascular, Diabetes Care, Hematology, Immunodiagnostics and Clinical Chemistry, Immunology, Metabolics, Molecular, Neuroscience, Nutrition, Oncology, Pain Care, Point of Care, Renal Care, Vascular, Virology.

  - Today Abbott a global diversified company focuses on products and services for treatment, cure, diagnosis and preventions.

  - The company has in-house development and medical teams to undertake product and clinical development tailored to the needs of the Indian market. Abbott provides quality health care worldwide by creating healthcare solutions, which directly affects the life of the common man.

  - It has employee strength of over 65,000 people across the world. It markets its products in 130 countries.

  - It has network of 18 distribution points catering 11,000 stockists and 70,000 retailers.

  - It has successfully developed brands like Digene, Cremaffin, Epilex, Zolfresh and Obimet. It has also brought various global products to Indian consumers such as Brufen, Prothiaden, Ganaton, Sevorane, Thyronorm and Leptos.

  - Products

   · In Primary care segment, it markets products in the areas of Pain Management, Gastroenterology, with well-known brands like Brufen, Digene, Cremaffin.

   · Specialty Care segment - It provides Metaboloics Urology, Neurology and Psychiatric solutions in the areas of Thyroid, Obesity, Diabetes and Benign Prostratic Hyperplasia.

   · Hospital Care segment - It offers products in the field of anesthesiology and neonatology namely Forane, Sevorane and Survanta.

 

Date of Establishment	1944
Revenue	304.503 (USD in Millions )
Market Cap	28442.190727 ( Rs. in Millions )
Corporate Address	3-4 Corporate Park,Sion Trombay Road, Mumbai-400071, Maharashtra
Management Details	Chairperson - Munir Shaikh  MD - Rehan Khan Directors - Ashok Dayal, Bhaskar lyer, Kaiyomarz Marfatia, Krupa Anandpara, Laurent Van Lerberghe, Mario Durante, Munir Shaikh, Neil Aylward, R A Shah, Rajendra A Shah, Rajendra Shah, Ramon F Neira Hoyos, Ranjan Kapur, Rehan Khan, Sachin Dharap, Thomas Dee, Vivek Mohan, Zahir Lavji
Business Operation	Pharmaceuticals & Drugs
Background	Abbott India is healthcare company that discovers, develops, manufactures and markets innovative products and services. In 1888 a young Chicago physician, Dr Wallace Calvin Abbott founded Abbott Laboratories.
Financials	Total Income - Rs. 16753.84 Million (year ending Dec 2012)  Net Profit - Rs. 1447.005 Million (year ending Dec 2012)

 

 ○ Abbott India products are among the Top 300 brands in Indian Pharmaceutical Market(IPM)

  - Digene continues to be # 1 prescribed Antacid with over 5.5 million prescriptions annually. Approximately 29,000 doctors prescribe Digene every month.

  - Duphaston maintained its # 1 position in its segment (Progestogen and similar combinations) and is a Top 50 brand in IPM

  - Thyronorm was ranked 8th in IPM in December 2012.

  - Vertin jumped 13 positions from 112 in January’ 2012 to 99 in November 2012 and entered the Top 100 brands in IPM.

  - Zolfresh moved to #2 in the Extended Sleep Market, jumping 234 positions in a span of 2 years

  - Digecaine has become the # 3 brand (Antacid + Local Anaesthetic) in a span of 2 years

 

 

 ○ Siemens Medical Solutions Diagnostics, Deerfield, IL (www.siemens.com)

  - Siemens Healthcare Diagnostics offers a broad portfolio of performance-driven diagnostics solutions that provide more effective ways to assist in the diagnosis, monitoring and management of disease. Its products and services offers the right balance of science, technology and practicality across the healthcare continuum to provide healthcare professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe.

  - The company's broad portfolio of innovative products include a variety of diagnostic systems—integrated chemistry, immunoassay, routine chemistry, automation, hematology, hemostasis, microbiology, diabetes, urinalysis, blood gas monitoring and molecular testing. Its dedicated professionals are committed to meet the needs of their customers by providing high-quality products and highly-responsive service and support.

  - Product range of the company includes:

   · Point of Care: Blood Gas, Diabetes, Urinalysis, Cardiology

   · Molecular Diagnostics: Molecular Diagnostics

   · Disease States: Allergy, Cardiovascular Disease. Liver Disease, Oncology

   · Integrated Diagnostics: Integrated Diagnostics

   · Siemens Healthcare Portfolio: Diagnostic Imaging, Therapy & IT

 

Date of Establishment	1974
Revenue	39.5932 (USD in Millions )
Market Cap	2706.49998 ( Rs. in Millions )
Corporate Address	589, Ajwa Road, Sayajipura Vadodara - 390019, Gujarat www.siemens.com
Management Details	Chairperson - Narendra J Jhaveri  MD - P Siva Kumar Directors - Anil Shankar, D Ragavan, Etienne Szivo, Haresh Khilnani, Narendra J Jhaveri, P Siva Kumar, Pradip V Nayak
Business Operation	Hospital & Healthcare Services
Background	Siemens Healthcare Diagnostics is the largest clinical diagnostics company in the world, serving a critical role in the health care continuum. It offers products and services designed for efficient delivery of patient test results used for diagnosing medical conditions, monitoring patient therapy and providing quality healthcare. Built on a rich history of innovation from Diagnostic Products Corporation.
Financials	Total Income - Rs. 1832.285 Million (year ending Sep 2010)  Net Profit - Rs. 96.802 Million (year ending Sep 2010)

 

 

5. 유통동향

 

 ○ The Indian diagnostics sector is largely unorganized and there is a high presence of players located at the regional or city level. However, the market is effectively establishing a clear and structured format that will seek to have better regulations and proper definition. Currently, the Indian diagnostics sector consists of instruments, reagents, and services.

 

 ○ The market structure of allergy screening kits and systems is multi-level. The first stage involves manufacturing of kits and supply to various entities such as the distributors/ dealers and importers. Companies operate through their appointed distributors who supply to the dealers in the market. Importers also supply the kits to the dealers, who then supply them to hospitals & diagnostic laboratories.

 

 ○ The top manufacturers have well organized distributors and dealers throughout the country. There are very less number of domestic manufacturers in the market.