Healthcare, Regulatory and Reimbursement Landscape Israel SAMPLE

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1 Healthcare, Regulatory and Reimbursement Landscape Israel Reference Code: GDHC0032CHR Publication Date: December 2012

2 The Highest Proportion of the Population is in the Economically Productive Working age Group and Government Initiatives have Contributed Significantly to Israel s Economic Development Pharmaceutical Market, Israel, Revenue ($bn), Age Groups, Israel, Population Distribution (%), Source: GlobalData; CBS, 2012e *Estimated figures Factors Such as Technological Advances in the Field of Medicine, High R&D Expenditure and a Robust Economy will Boost the Growth of the Israeli Pharmaceutical Market Source: GlobalData; Sax, 2005; Pharma Israel, 2011 *Estimated figures Medical Device Market, Israel, Revenue ($bn), Source: GlobalData, Medical etrack [accessed November 19, 2012] *Estimated figures Pharmaceutical Players Benefit from Detailed and Well- Defined Regulatory Filing Procedures, Separate Departments for the Assessment of Quality and Safety of Pharmaceutical Products and Ease of Access Page 2

3 The National Health Insurance Law, Prescription Drug Price Regulations and Affordable Pharmaceuticals are the Distinguishing Features of the Israeli Reimbursement System Strong Financial Regulations and an Export-Driven Open- Market Economy has Put Israel on the Path of Economic Growth, but Strained Political Relationships with Neighboring Arab Countries and Terrorism Remain Threats to the Economy Country Profile, Israel, 2012 Source: GlobalData Page 3

4 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Report Guidance Overview of Pharmaceutical and Medical Device Markets Pharmaceutical Market Overview of Pharmaceutical Market Market Segment Major Disease Areas Major Players Medical Device Market Market Overview Overview of the Top Five Segments Major Players Market Drivers and Barriers Drivers Barriers Market Access Reimbursement and Payer Landscape Reimbursement Process Overview of Insurance Providers Drug Price Trend Pricing Policies Regulatory Landscape Overview of Regulatory Agencies New Drug Approval Process Licensing Process for Pharmaceutical and Medical Device Manufacturing Licensing Process for Pharmaceutical Exports and Imports Intellectual Property Rights Clinical Trial Regulations Pharmaceutical and Medical Devices Advertising Regulations Labeling and Packaging Regulations Country Analysis Political Environment Political Structure Analysis of Current Political Environment Healthcare Policy Initiatives Economic Landscape Economic Indicators Gross Domestic Product Gross National Income Inflation Currency Exchange Rate Foreign Direct Investment Foreign Exchange Reserves Trade Balance Government Structural Balance Government Net Debt Major Industries Demography Population Education and Literacy Employment Disease Burden Healthcare Facilities Healthcare Parameters Healthcare Personnel Environmental Health Page 4

5 5.5 Healthcare Expenditure Major Components of Healthcare Spending Share of Public and Private Sector in Healthcare Healthcare Expenditure by Financing Agent Spending in Science and Technology R&D Trade Associations Pharmaceutical Association of Israel Pharma Israel Trade Fairs Opportunities and Challenges Opportunities Challenges Appendix Abbreviations Bibliography Methodology Coverage Secondary Research Forecasting Primary Research Expert Panel Validation Disclaimer List of Tables Table 1: Pharmaceutical Market, Israel, Revenue ($bn), Table 2: Pharmaceutical Market, Israel, Revenue ($bn), Table 3: Major Biotechnology Companies and Products, Table 4: Major Products, Teva, Global, Revenue ($m), Table 5: Late-stage Pipeline, Teva, Table 6: Major Products, Taro, Table 7: Major Products, Dexcel Pharma, Table 8: Major Products, Rekah Pharmaceutical, Table 9: Medical Device Market, Israel, Revenue ($m), Table 10: Medical Device Market, Israel, Revenue Forecast ($m), Table 11: Medical Device Market, Israel, Segments, Revenue ($m), Table 12: Cardiovascular Devices Market, Israel, Revenue ($m), Table 13: Sales Trends for Major Players*, Cardiovascular Devices, Israel, Table 14: Nephrology and Urology Devices, Israel, Revenue ($m), Table 15: Sales Trends for Major Players*, Nephrology and Urology Devices, Israel, Table 16: In Vitro Diagnostics Market, Israel, Revenue ($m), Table 17: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Israel, Table 18: Ophthalmic Devices Market, Israel, Revenue ($m), Table 19: Sales Trends for Major Players*, Ophthalmic Devices, Israel, Table 20: Orthopedic Devices Market, Israel, Revenue ($m), Table 21: Sales Trends for Major Players*, Orthopedic Devices, Israel, Table 22: Major Medical Device Companies, Israel, Revenues ($m), Table 23: Major Products, Medtronic, Global, Revenue ($m), Table 24: Major Products, Boston, Global, Revenue ($m), Table 25: Major Products, Siemens Healthcare, Revenue ($m), Table 26: Late-stage Pipeline, Siemens Healthcare, Table 27: Major Product Division, B. Braun, Global, Revenue ($m), Table 28: Major Products, Roche, Global Revenues ($m), Table 29: Late-stage Pipeline, Roche, Table 30: Healthcare Spending, Israel, Patient Share (%), Table 31: HMOs, Israel, Co-payment Cap for Chronically Ill Patients (NIS), Table 32: Drug Price Trends (%), Israel, Table 33: HMOs, Israel, Co-payments for Chronically Ill Patients (NIS) (%), Table 34: GDP Per Capita ($ 000), Israel, Table 35: GDP Per Capita ($ 000), Israel, Forecast, Table 36: GDP, Annual Growth (%), Israel, Table 37: GDP, Annual Growth (%), Israel, Forecast, Page 5

6 Table 38: GNI Per Capita ($ 000), Israel, Table 39: Average Consumer Price Index, Israel, Table 40: Average Consumer Price Index, Israel, Forecast, Table 41: Average Consumer Price, Israel, Annual Change (%), Table 42: Currency Exchange Rate (NIS/$), Israel, Table 43: Foreign Direct Investment ($bn), Israel, Table 44: Foreign Exchange Reserves ($bn), Israel, Table 45: Imports of Goods and Services ($bn), Israel, Table 46: Exports of Goods and Services ($bn), Israel, Table 47: General Government Structural Balance ($bn), Israel, Table 48: General Government Net Debt ($bn), Israel, Table 49: General Government Net Debt ($bn), Israel, Forecast, Table 50: Major Industry Sectors, Net Domestic Product ($bn), Israel, Table 51: Population ( 000), Israel, Table 52: Population ( 000), Israel, Forecast, Table 53: Urban and Rural Population, Israel, Share (%), Table 54: Age Groups, Israel, Population Distribution (%), Table 55: Births (Per 1,000 Population), Israel, Table 56: Births (Per 1,000 Population), Israel, Forecast, Table 57: Mortality (Per 1,000 Population), Israel, Table 58: Mortality (Per 1,000 Population), Israel, Forecast, Table 59: Major Causes of Mortality (Per 100,000 Population), Israel, Table 60: Infant Mortality (Per 1,000 Live Births), Israel, Table 61: Immunization Rate for MMR, DPT, Hib, HBV (%), Israel, Table 62: Major Causes of Male Mortality (Per 10,0000 Population), Israel, Table 63: Major Causes of Female Mortality (Per 100,000 Population), Israel, Table 64: Gender Ratio (M/F), Israel, Table 65: Life Expectancy at Birth (Years), Israel, Table 66: National Expenditure, Israel, Education and Literacy (% of GDP), Table 67: National Expenditure, Israel, Level of Education (%), Table 68: Unemployment Rate (%), Israel, Table 69: Most Frequently Diagnosed Diseases ( 000), Israel, Table 70: Major Diseases, Israel, DALYs (Per 100,000 Population), Table 71: Total Number of Hospitals, Israel, Table 72: Public and Private Hospitals, Israel, Table 73: Types of Hospital, Israel, Table 74: Long-term Care Hospitals, Israel, Table 75: Hospital Beds (Per 1,000 Population), Israel, Table 76: Doctors (Per 1,000 Population), Israel, Table 77: Dentists (Per 1,000 Population), Israel, Table 78: Nurses (Per 1,000 Population), Israel, Table 79: Pharmacists (Per 1,000 Population), Israel, Table 80: PM10 (µg/m 3 ), Israel, Table 81: CO 2 Emissions ( 000 Tons), Israel, Table 82: NO x, CO, SO 2 Emissions (Tons), Israel, Table 83: Healthcare Expenditure (% of GDP), Israel, Table 84: Healthcare Expenditure, Israel, Types of Services (%), Table 85: Healthcare Expenditure, Israel, Public-Private Share (%), Table 86: Healthcare Expenditure, Israel, Financing Agent (%), Table 87: R&D Expenditure, Israel, Science and Technology ($bn), Table 88: Major Healthcare Trade Fairs, Israel, Page 6

7 1.2 List of Figures Figure 1: Pharmaceutical Market, Israel, Revenue ($bn), Figure 2: Pharmaceutical Market, Israel, Revenue, Forecast ($bn), Figure 3: Medical Device Market, Israel, Revenue ($m), Figure 4: Medical Device Market, Israel, Revenue Forecast ($m), Figure 5: Medical Device Market, Israel, Segments, Revenue ($m), Figure 6: Cardiovascular Devices Market, Israel, Revenue ($m), Figure 7: Sales Trends for Major Players*, Cardiovascular Devices, Israel, Figure 8: Nephrology and Urology Devices, Israel, Revenue ($m), Figure 9: Sales Trends for Major Players*, Nephrology and Urology Devices, Israel, Figure 10: In Vitro Diagnostics Market, Israel, Revenue ($m), Figure 11: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Israel, Figure 12: Ophthalmic Devices Market, Israel, Revenue ($m), Figure 13: Sales Trends for Major Players*, Ophthalmic Devices, Israel, Figure 14: Orthopedic Devices Market, Israel, Revenue ($m), Figure 15: Sales Trends for Major Players*, Orthopedic Devices, Israel, Figure 16: Major Medical Device Companies, Israel, Revenues ($m), Figure 17: Drivers and Barriers, Healthcare Market, Israel, Figure 18: Overview of Healthcare System, Israel, Figure 19: Healthcare Spending, Israel, Patient Share (%), Figure 20: Drug Price Trends (%), Israel, Figure 21: Overview of Regulatory Bodies, Israel, Figure 22: GDP Per Capita ($ 000), Israel, Figure 23: GDP Per Capita ($ 000), Israel, Forecast, Figure 24: GDP, Annual Growth (%), Israel, Figure 25: GDP, Annual Growth (%), Israel, Forecast, Figure 26: GNI Per Capita ($ 000), Israel, Figure 27: Average Consumer Price Index, Israel, Figure 28: Average Consumer Price Index, Israel, Forecast, Figure 29: Average Consumer Price, Israel, Annual Change (%), Figure 30: Currency Exchange Rate (ILS/$), Israel, Figure 31: Foreign Direct Investment ($bn), Israel, Figure 32: Foreign Exchange Reserves ($bn), Israel, Figure 33: Imports of Goods and Services ($bn), Israel, Figure 34: Exports of Goods and Services ($bn), Israel, Figure 35: General Government Structural Balance ($bn), Israel, Figure 36: General Government Net Debt ($bn), Israel, Figure 37: General Government Net Debt ($bn), Israel, Forecast, Figure 38: Major Industry Sectors, Net Domestic Product ($bn), Israel, Figure 39: Population (000 s), Israel, Figure 40: Population (000 s), Israel, Forecast, Figure 41: Urban and Rural Population, Israel, Share (%), Figure 42: Age Groups, Israel, Population Distribution (%), Figure 43: Births (Per 1,000 Population), Israel, Figure 44: Births (Per 1,000 Population), Israel, Forecast, Figure 45: Mortality (Per 1,000 Population), Israel, Figure 46: Mortality (Per 1,000 Population), Israel, Forecast, Figure 47: Major Causes of Mortality (Per 100,000 Population), Israel, Figure 48: Infant Mortality (Per 1,000 Live Births), Israel, Figure 49: Immunization Rate for MMR, DPT, Hib, HBV (%), Israel, Figure 50: Major Causes of Male Mortality (Per 100,000 Population), Israel, Figure 51: Major Causes of Female Mortality (Per 10,0000 Population), Israel, Figure 52: Gender Ratio (M/F), Israel, Figure 53: Life Expectancy at Birth (Years), Israel, Figure 54: National Expenditure, Israel, Education and Literacy (% of GDP), Figure 55: National Expenditure, Israel, Level of Education (%), Figure 56: Unemployment Rate (%), Israel, Figure 57: Most Frequently Diagnosed Diseases ( 000), Israel, Figure 58: Major Diseases, Israel, DALYs (Per 100,000 Population), Figure 59: Total Number of Hospitals, Israel, Figure 60: Public and Private Hospitals, Israel, Page 7

8 Figure 61: Types of Hospital, Israel, Figure 62: Long-term Care Hospitals, Israel, Figure 63: Hospital Beds (Per 1,000 Population), Israel, Figure 64: Doctors (Per 1,000 Population), Israel, Figure 65: Dentists (Per 1,000 Population), Israel, Figure 66: Nurses (Per 1,000 Population), Israel, Figure 67: Pharmacists (Per 1,000 Population), Israel, Figure 68: PM10 (µg/m 3 ), Israel, Figure 69: CO 2 Emissions ( 000 Tons), Israel, Figure 70: NO x, CO, SO X Emissions (Tons), Israel, Figure 71: Healthcare Expenditure (% of GDP), Israel, Figure 72: Healthcare Expenditure, Israel, Types of Services (%), Figure 73: Healthcare Expenditure, Israel, Public-Private Share (%), Figure 74: Healthcare Expenditure, Israel, Financing Agent (%), Figure 75: R&D Expenditure, Israel, Science and Technology ($bn), Figure 76: Opportunities and Challenges, Healthcare Market, Israel, Page 8

9 2 Introduction 2.1 Report Guidance The report begins with an executive summary which gives an overview of Israel s healthcare market and the key factors driving growth. It also gives a snapshot of the healthcare infrastructure and the demographic, regulatory and reimbursement landscapes. Chapter three gives an overview of Israel s pharmaceutical and medical device markets, covering size; segmentation by product type (generic, Over-The-Counter (OTC) and biologic/biosimilar); and the key drivers and barriers. It also includes profiles and SWOT assessments of each of the major players. Chapter four covers the reimbursement and payer landscape and the regulations governing the Israeli healthcare market. The reimbursement and payer landscape section elaborates on the features of the healthcare reimbursement process, including details of insurance providers, pricing policies and drug pricing trends. The regulatory landscape section gives an overview of the regulatory agencies and approval processes for new drugs and medical devices. The chapter also covers the licensing process for the manufacture, export and import of pharmaceuticals; regulations for pharmaceutical advertising, labeling, packaging and clinical trials; and gives an overview of the intellectual property rights landscape. Chapter five provides detailed analysis of Israel s political and economic environment in terms of economic indicators, demographics, healthcare infrastructure and healthcare expenditure. Chapter six provides an overview of the opportunities for and challenges to growth in Israel s healthcare market. Page 9

10 4 Market Access 4.1 Reimbursement and Payer Landscape Reimbursement Process Ministry of Health Page 63

11 National Insurance Institute Figure 18: Overview of Healthcare System, Israel, 2012 Source: GlobalData, based on information from HiT, Overview of Insurance Providers National Health Insurance Voluntary Health Insurance Page 64

12 Patient Share in Healthcare Spending Figure 19: Healthcare Spending, Israel, Patient Share (%), Source: Globaldata; CBS, 2012b Table 30: Healthcare Spending, Israel, Patient Share (%), Year Source: GlobalData; CBS, 2012b Co-payment - discounts and exemptions for drug purchases Table 31: HMOs, Israel, Co-payment Cap for Chronically Ill Patients (NIS), 2012 Source: GlobalData; MOH, 2012a * Monthly Clalit Maccabi Meuhedet Leumit Page 65

13 4.2 Regulatory Landscape Overview of Regulatory Agencies Pharmaceutical Division Medical Registration Division Institute for Standardization and Control of Pharmaceuticals Figure 21: Overview of Regulatory Bodies, Israel, 2012 Source: GlobalData, based on information from MoH, 2012 Page 68

14 4.2.2 New Drug Approval Process Key Stages Licensing Process for Pharmaceutical and Medical Device Manufacturing Licensing Process for Pharmaceutical Exports and Imports Page 69

15 7 Appendix 7.1 Abbreviations API: Active Pharmaceutical Ingredient BOI: Bank of Israel CAGR: Compound Annual Growth Rate cgmp: current Good Manufacturing Practice CO: Carbon Monoxide COPD: Chronic Obstructive Pulmonary Disease CPI: CT: Consumer Price Index Computed Tomography DALY: Disability-Adjusted Life Year DPT: FDA: FDI: GDP: GMP: GNI: HBV: Hib: HMO: ISCP: MMR: MS: NCE: NHI: NII: NO2: NOx: OTC: PET: Diphtheria, Pertussis and Tetanus Food and Drug Administration Foreign Direct Investment Gross Domestic Product Good Manufacturing Practice Gross National Income Hepatitis B Virus Haemophilus influenzae type b Health Maintenance Organization Institute for Standardization and Control of Pharmaceuticals Measles, Mumps, and Rubella Multiple Sclerosis New Chemical Entity National Health Insurance National Insurance Institute Nitrogen Dioxide Nitrogen Oxide Over-The-Counter Positron Emission Tomography RRMS: Relapsing Remitting Multiple Sclerosis SO2: SOx: VHI: WHO: Sulfur Dioxide Sulfur Oxide Voluntary Health Insurance World Health Organization Page 136

16 7.2 Bibliography Aharoni E (2012). Israelis overpay for OTC drugs, Globes, January 19, Available from: [Accessed September 25, 2012]. Amitai Y (2012). The Equivalent Drug and the System Sustainability: The Israeli Experience. The Israeli Ambulatory Pediatric Association, 2 nd International Congress on Primary Care Pediatrics, Prague, May 11, Available from: Central Bureau of Statistics (CBS) (2011a). OECD Health at a Glance 2011: Key findings for Israel. Central Bureau of Statistics. Available from: aspx. [Accessed August 21, 2012]. Central Bureau of Statistics (CBS) (2011b). Women and men in Israel Central Bureau of Statistics. Available from: Central Bureau of Statistics (2012a). Persons Reporting Myocardial Infarction, By Sex and Socio- Demographic Characteristics. Central Bureau of Statistics. Available from: [Accessed August 21, 2012]. Central Bureau of Statistics (2012b). National Expenditure on Health Central Bureau of Statistics. Available from: Central Bureau of Statistics (2012c). National Accounts (Data from 1995) Exports of Goods and Services at Constant and Current Prices. Central Bureau of Statistics. Available from: &level_3=1. [Accessed August 21, 2012]. Central Bureau of Statistics (2012d). Net Domestic Product and National Income, By Industry. Central Bureau of Statistics. Available from: Central Bureau of Statistics (2012e). Israel in Figures. Central Bureau of Statistics. Available from: [Accessed July 21, 2012]. Central Bureau of Statistics (2012f). Deaths and Mortality Rates, By Cause and Population Group. Central Bureau of Statistics. Available from: Central Bureau of Statistics (2012g). Immunization Coverage of Two-Year-Olds. Central Bureau of Statistics. Available from: Central Bureau of Statistics (2012h). Health---Mortality Rates, By Causes of Death---Data by Select Causes. Central Bureau of Statistics. Available from: level_3=1. [Accessed July 21, 2012]. Central Bureau of Statistics (2012i). National Expenditure on Education in Central Bureau of Statistics. Available from: Central Bureau of Statistics (2012j). Chronic Diseases. Central Bureau of Statistics. Available from: [Accessed July 21, 2012]. Central Bureau of Statistics (2012k). Hospitals, By Type and Ownership. Central Bureau of Statistics. Available from: Central Bureau of Statistics (2012m). National Expenditure on Health. Central Bureau of Statistics. Available from: [Accessed July 21, 2012]. Central Bureau of Statistics (2012n). Indices - Percent Change between two selected periods. Central Bureau of Statistics. %2Fprices_db%2FCompare_TwoPeriods_E.html&Radio1=5_3&DataType=Ind&Subjects=38&MyCod e= &separated= &multmin=198301&multmax=201208&datemin=01%2f1983&da temax=08%2f2012. [Accessed September 22, 2012]. Page 137

17 Central Bureau of Statistics (2012o). National Expenditure on Health, By Operating Sector, Type of Expenditure and service. Central Bureau of Statistics. Central Bureau of Statistics (2012p). National Accounts (Data from 1995) ---Imports of Goods and Services---At Constant and Current Prices. Central Bureau of Statistics. Available from: &level_3=1. [Accessed August 21, 2012]. Central Bureau of Statistics (2012q). Environment, Greenhouse Gases, Greenhouse Gas Emissions Precursors by Source. Central Bureau of Statistics. Available from: &level_3=3. [Accessed August 21, 2012]. Central Bureau of Statistics (2012r). Environment, Greenhouse Gases, Direct Greenhouse Gas Emissions by Source, Co2 Equivalent Central Bureau of Statistics. Available from: &level_3=1. [Accessed August 21, 2012]. Health System in Transition (2009). Israel Health system in review. Available from: data/assets/pdf_file/0007/85435/e92608.pdf. International Monetary Fund (IMF) (2012). World Economic Outlook. Available from: &ssd=1&sort=country&ds=.&br=1&pr1.x=53&pr1.y=7&c=436&s=ngdp_r%2cngdp_rpch%2cn GDP%2CNGDPD%2CNGDP_D%2CNGDPRPC%2CNGDPPC%2CNGDPDPC%2CPPPGDP%2CP PPPC%2CPPPSH%2CPPPEX%2CNID_NGDP%2CNGSD_NGDP%2CPCPI%2CPCPIPCH%2CPC PIE%2CPCPIEPCH%2CTM_RPCH%2CTMG_RPCH%2CTX_RPCH%2CTXG_RPCH%2CTXGO%2 CTMGO%2CLUR%2CLE%2CLP%2CGGR%2CGGR_NGDP%2CGGX%2CGGX_NGDP%2CGGXC NL%2CGGXCNL_NGDP%2CGGSB%2CGGSB_NPGDP%2CGGXONLB%2CGGXONLB_NGDP%2 CGGXWDN%2CGGXWDN_NGDP%2CGGXWDG%2CGGXWDG_NGDP%2CNGDP_FY%2CBCA% 2CBCA_NGDPD&grp=0&a=. [Accessed August 29, 2012]. Invest in Israel (2012). Life Science in Israel. Investment Promotion Center; Ministry of Industry, Trade & Labor. Available from: B212-1E582629B0BA/0/LifeSciencesBrochure2012.pdf. Israel Advanced Technology Industries (IATI) (2012). The Israeli Life Science Industry. Israel Advanced Technology Industries. Available from: [Accessed August 20, 2012]. Israeli Patent Office (2012a). How to Apply for the Patent? Israeli Patent Office. Available from: [Accessed July 26, 2012]. Israeli Patent Office (2012b). What is Trademark?. Israeli Patent Office. Available from: [Accessed July 26, 2012]. Ministry of Health (MoH) (1969). Pharmacists Regulations (packaging and marketing of drugs, toxins and harmful chemicals), Law. Available from: Ministry of Health (MoH) (1986). Pharmacists Regulations (Preparations) Ministry of Health. Available from: Ministry of Health (2006). Guidelines for Clinical Trials in Human Subjects. Available from: Ministry of Health (2012a). Copay - Discounts and Exceptions. Ministry of Health. Available from: s/discounts.aspx. [Accessed July 25, 2012]. Page 138

18 Ministry of Health (2012b). Collection Arrangements in HMOs - Drugs Collection Arrangements in HMOs - Drugs. Ministry of Health. Available from: s/drugs.aspx. [Accessed July 25, 2012]. Ministry of Health (2012c). Israel's Method of Determining Drug Prices - Summary. Available from: Ministry of Health (2012d). New Drug Registration. Ministry of Health. Available from: egistration.aspx. [Accessed July 25, 2012]. Ministry of Health (2012e). Issuing permits to import raw materials for the production of medicines. Ministry of Health. Available from: oimportrawmaterials.aspx. [Accessed July 26, 2012]. Ministry of Health (2012f). Issuing permits to export drugs/substances psychotherapy/precursors. Ministry of Health. Available from: ermitstoexportdrugs.aspx. [Accessed July 26, 2012]. National Cancer Registry (2011). Estimate of the risk of morbidity malignant disease throughout Population living Israel. National Cancer Registry. Available from: OANDA (2012). Historic Currency Exchange Rate. OANDA. Available from: [Accessed August 3, 2012]. Pharma Israel (2011). Economic Report Pharma Israeli Org. Available from: [Accessed September 3, 2012]. Sax P (2005). Spending on medicines in Israel in an international context. Israel Medical Association Journal; 7: The World Bank (2012a). GNI per capita, Atlas method (current US$). Available from: [Accessed August 3, 2012] The World Bank (2012b). Foreign direct investment, net inflows (BoP, current US$). Available from: [Accessed November 19, 2012]. The World Bank (2012c). Total reserves (includes gold, current US$). Available from: [Accessed August 3, 2012]. The World Bank (2012d). Mortality rate, infant (per 1,000 live births). Available from: [Accessed August 3, 2012] The World Bank (2012e). PM10, country level (micrograms per cubic meter). Available from: [Accessed November 19, 2012]. World Health Organization (2009). Global Burden of Disease. World Health Organization. Available from: [Accessed September 16, 2012]. United Nations Conference on Trade and Development (UNCTAD) (2012). World Investment Report United Nations Conference on Trade and Development. Available from: The United State Patents and Trademark Office (USPTO) (2009) via Israel Advanced Technology Industries (IATI) (2012). The Israeli Life Science Industry. Israel Advanced Technology Industries. Available from: [Accessed August 20, 2012]. Economy Watch (2012). Israel Total Government Net Debt (% of GDP) Statistics. Economy Watch. Available from: [Accessed August 20, 2012]. Japan External Trade Organization (JETRO) (2012). Online Trade Fair Database (J-messe). Japan External Trade Organization. Available from: [Accessed August 20, 2012]. Page 139

19 7.3 Methodology GlobalData s dedicated research and analysis teams consist of experienced professionals with advanced statistical expertise and marketing, market research and consulting backgrounds in the pharmaceutical industry. GlobalData adheres to the codes of practice of the Market Research Society ( and the Strategic and Competitive Intelligence Professionals ( All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports Coverage The objective of updating GlobalData s coverage is to ensure that it represents the most up to date vision of the industry possible. Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources. Company coverage is based on three key factors: revenues, products and media attention/innovation/market potential. The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage. Companies which are making the news or which are of particular interest due to their innovative approach are prioritized. GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated on a daily basis. The coverage is further streamlined and strengthened with additional inputs from GlobalData s expert panel (see below) Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to, the following. Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings. Industry trade journals, scientific journals and other technical literature. Internal and external proprietary databases. Relevant patent and regulatory databases. National government documents, statistical databases and market reports. Procedure registries. News articles, press releases and web-casts specific to the companies operating in the market. Country reports are largely based on secondary research and make use of reliable and authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, MHLW, NHS, and BEA, among others Forecasting For country reports, GlobalData uses the data available from reliable and authoritative secondary sources to forecast the future trends for the healthcare market for the country, as well as the parameters related to the economy and healthcare infrastructure and expenditure of the country. The trends are further validated through the secondary sources. Page 140

20 7.3.4 Primary Research GlobalData conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions. It provides first-hand information on the market size, market trends, growth trends, competitive landscape and future outlook of a market. It helps in validating and strengthening secondary research findings. It develops the analysis team s expertise and market understanding. Primary research involves correspondence and telephone interviews as well as face-to-face interviews for each market, category, segment and sub-segment across the geographies covered. The participants who typically take part in such a process include, but are not limited to, the following. Industry participants: Chief Executive Officers (CEOs), Vice Presidents (VPs), marketing/product managers, market intelligence managers and national sales managers. Hospital stores, pharmacies, distributors and paramedics. Outside experts: investment bankers, valuation experts, research analysts specializing in specific pharmaceutical markets. Key Opinion Leaders (KOLs): Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of pharmaceuticals Expert Panel Validation GlobalData uses a panel of experts to cross verify its databases and forecasts. GlobalData s expert panel comprises marketing managers, product specialists, international sales managers from pharmaceutical companies; academics from research universities, KOLs from hospitals, consultants from venture capital funds, and distributors/suppliers of pharmaceuticals and supplies. Historic data and forecasts are relayed to GlobalData s expert panel for feedback and adjusted in accordance with their feedback. 7.4 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. Page 141