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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Taiwan

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Taiwan

Summary

In 2016, the pharmaceutical market of Taiwan was valued at an estimated US$2.42 Billion, and is projected to reach US$2.44 Billion in 2021. The pharmaceutical market grew at a Compound Annual Growth Rate (CAGR) of 0.12% from 2009 to 2016. The government is taking various steps to ensure the growth of the pharmaceutical industry, and has proposed a budget of US$340m for turning Taiwan into an Asian Research and Development (R&D) center. According to the Act for the Development of Biotech and New Pharmaceuticals Industry, the government is providing incentives for new pharmaceutical companies, such as reductions in income tax.

Taiwanese market for medical devices is one of the largest in Asia due to the growing elderly population and consequent increase in demand for healthcare products and services. It was valued at US$1.66 Billion in 2009 and grew at a CAGR of 5% to US$2.27 Billion in 2016. By 2021, it is expected to reach US$2.95 Billion.

Taiwan has a compulsory NHI system that covers about 99% of the population (NHI, 2016). The second-generation NHI system was implemented in January 2013, and in July 2013 the name Bureau of NHI was changed to National Health Insurance Administration (NHIA). Owing to the reforms in the NHIA system, the NHIA no longer has a deficit in funding. The government is planning to initiate a third-generation NHI, which may take six to eight years to complete.

Taiwan plays a leading role as global trade and investment hub primarily due to its strategic location within the Asia-Pacific. With international shipping lanes, five free-trade zones, a modern financial sector and expertise in high-technology production, Taiwan is one of the world’s top destinations for investment in terms of ease of doing business, economic freedom, and competitiveness (US DoS, 2015).

The report CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Taiwan is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Taiwan. It identifies the key trends in the country’s healthcare market and provides insights into its demographic, regulatory, and reimbursement landscape and healthcare infrastructure.

In particular, this report provides the following -

  • Provides an overview of the pharmaceutical and medical device market of Taiwan, including the market size; market segmentation.
  • Covers the country’s reimbursement and payer landscape, as well as the regulatory landscape. The reimbursement and payer landscape section elaborates on the features of the healthcare reimbursement process for Taiwan.
  • Provides a detailed analysis of the political and economic environment of Taiwan. It analyzes its economic indicators, demographics, healthcare infrastructure and healthcare expenditure.
  • Provides an overview of the opportunities and challenges for growth that exist in the healthcare market of Taiwan.
Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Taiwan, and includes -
  • An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
  • Profiles and SWOT analyses of the major players in the pharmaceutical market: China Chemical & Pharmaceutical Co., Yung Shin Pharma, TTY Biopharm, Standard Chem & Pharm Co., and Taiwan Biotech; and of major players in the medical device market: Baxter International, Fresenius, Osstem Implant, Nobel Biocare, and Ivoclar Vivadent
  • An insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices
  • Detailed analysis of the country’s political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the Taiwanese healthcare market
Reasons to buy

This report will enhance your decision-making capability by allowing you to -
  • Develop business strategies by understanding the trends shaping and driving Taiwan’s healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact Taiwan’s healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
3 Introduction
3.1 GlobalData Report Guidance
4 Overview of Pharmaceutical and Medical Device Markets
4.1 Pharmaceutical Market
4.1.1 Market Overview
4.1.2 Pharmaceutical Exports and Imports
4.1.3 Supply Channels
4.1.4 Market Segments
4.1.5 Overview of Top Five Disease Areas
4.1.6 Major Players
4.2 Medical Device Market
4.2.1 Market Overview
4.2.2 Overview of Top Five Segments
4.2.3 Major Players
4.3 Market Drivers and Barriers
4.3.1 Drivers
4.3.2 Barriers
5 Market Access
5.1 Overview of Healthcare system
5.1.1 Reimbursement Process
5.1.2 Overview of Insurance Providers
5.1.3 Patient Share in Healthcare Expenditure
5.1.4 Price Trends in the Healthcare Sector
5.1.5 Pricing Policies
5.2 Regulatory Landscape
5.2.1 Overview of Regulatory Agencies
5.2.2 Market Authorization Procedure for Pharmaceutical Products
5.2.3 Market Authorization Procedure for Medical Devices
5.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
5.2.5 Licensing Process for Pharmaceutical Exports and Imports
5.2.6 Intellectual Property Rights
5.2.7 Clinical Trial Regulations
5.2.8 Pharmaceutical Advertising Regulations
5.2.9 Pharmacy Regulations
5.2.10 Labeling and Packaging Regulations
6 Country Analysis
6.1 Political Environment
6.1.1 Political Structure
6.1.2 Current Political Environment
6.1.3 Healthcare Policy Initiatives
6.2 Economic Landscape
6.3 Economic Indicators
6.3.1 Gross Domestic Product
6.3.2 Gross National Income
6.3.3 Inflation
6.3.4 Currency Exchange Rate
6.3.5 Foreign Direct Investment
6.3.6 Foreign Exchange Reserves
6.3.7 Trade Balance
6.3.8 Government Structural Balance
6.3.9 Government Net Debt
6.3.10 Major Industries
6.4 Demographics
6.4.1 Population
6.4.2 Education and Literacy
6.4.3 Employment
6.4.4 Disease Burden
6.5 Healthcare Infrastructure
6.5.1 Healthcare Facilities
6.5.2 Healthcare Parameters
6.5.3 Environmental Health
6.5.4 Healthcare Personnel
6.6 Healthcare Expenditure
6.6.1 Overview
6.6.2 Share of Public and Private Sectors
6.7 Trade Associations
6.7.1 Taiwan Medical and Biotech Industry Association
6.7.2 Taiwan Public Health Association
6.7.3 Taiwan Medical Association
6.7.4 Taiwan Generic Pharmaceutical Association
6.8 Trade Fairs
7 Opportunities and Challenges
7.1 Opportunities
7.2 Challenges
8 Appendix
8.1 Abbreviations
8.2 Bibliography
8.3 Research Methodology
8.3.1 Coverage
8.3.2 Secondary Research
8.3.3 Forecasts
8.3.4 Expert Panel
8.4 Contact Us
8.5 Disclaimer
1.1 List of Tables
Table 1: Pharmaceutical Market, Taiwan, Revenue ($bn), 2009-2016
Table 2: Pharmaceutical Market, Taiwan, Revenue ($bn), 2017-2021
Table 3: Pharmaceutical Market, Taiwan, Exports and Imports ($bn), 2009-2016
Table 4: Pharmaceutical Market, Taiwan, Revenue by Major Therapeutic Areas ($bn), 2014
Table 5: Major Products, CCPC, Taiwan, 2016
Table 6: Pharmaceutical Market, Standard, Taiwan, Major Products, 2016
Table 7: Pharmaceutical Market, Taiwan Biotech, Taiwan, Major Products, 2016
Table 8: Medical Device Market, Taiwan, Revenue ($bn), 2009-2016
Table 9: Medical Device Market, Taiwan, Revenue ($bn), 2017-2021
Table 10: Medical Device Market, Taiwan, Revenue ($m) and Market Share (%) by Segment, 2016
Table 11: Orthopedic Devices Market, Taiwan, Revenue ($m), 2009-2016
Table 12: Orthopedic Devices Market, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2016
Table 13: Healthcare IT Device Market, Taiwan, Revenue ($m), 2009-2016
Table 14: Healthcare IT Devices, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015
Table 15: Ophthalmic Device Market, Taiwan, Revenue ($m), 2009-2016
Table 16: Ophthalmic Devices, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015
Table 17: Diagnostic Imaging Devices, Taiwan, Revenue ($m), 2009-2016
Table 18: Diagnostic Imaging Devices, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015
Table 19: Cardiovascular Device Market, Taiwan, Revenue ($m), 2009-2016
Table 20: Cardiovascular Device Market, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2015
Table 21: Medical Device Market, Taiwan, Revenue ($m) and Market Share (%) of Major Players, 2012
Table 22: Medical Device Market, Osstem, Major Products, Global, 2016
Table 23: Medical Device Market, Nobel Biocare, Major Products, Global, 2016
Table 24: Medical Device Market, Ivoclar Vivadent, Major Products, Asia, 2017
Table 25: Market Access, Healthcare System, Taiwan, Premium Contribution Ratios under NHI System, 2016
Table 26: Market Access, Healthcare System, Taiwan, Basic Outpatient Care Co-payments ($), 2016
Table 27: Healthcare Expenditure, Taiwan, Out-of-Pocket Expenditure (%), 2009-2016
Table 28: Market Access, Taiwan, Healthcare Consumer Price Index Annual Change (%), 2009-2016
Table 29: Healthcare System, Taiwan, Registration Fee Structure for New Drug Application ($), 2017
Table 30: Healthcare System, Taiwan, Regulatory Requirement for Medical Devices, 2013
Table 31: Healthcare System, Taiwan, Medical Equipment Classification, 2016
Table 32: Healthcare System, Taiwan, Schedule of Patent Fees, 2017
Table 33: Market Access, Taiwan, Schedule of Trademark Fees, 2017
Table 34: Economic Indicators, Taiwan, GDP per Capita ($), 2009-2016
Table 35: Economic Indicators, Taiwan, GDP per Capita ($), 2017-2021
Table 36: Economic Indicators, Taiwan, GDP Annual Growth (%), 2009-2016
Table 37: Economic Indicators, Taiwan, GDP Annual Growth (%), 2017-2021
Table 38: Economic Indicators, Taiwan, GNI per Capita ($), 2009-2016
Table 39: Economic Indicators, Taiwan, Consumer Price Index, 2009-2016
Table 40: Economic Indicators, Taiwan, Average Consumer Price Index, 2017-2021
Table 41: Economic Indicators, Taiwan, Average Consumer Price Index Annual Change (%), 2009-2016
Table 42: Economic Indicators, Taiwan, Average Consumer Price Index, Annual Change (%), 2017-2021
Table 43: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), 2009-2016
Table 44: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), 2009-2016
Table 45: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), 2009-2016
Table 46: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), 2009-2016
Table 47: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), 2009-2016
Table 48: Economic Indicators, Taiwan, General Government Structural Balance ($bn), 2009-2016
Table 49: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2009-2016
Table 50: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2017-2021
Table 51: Economic Indicators, Taiwan, Value Added by Major Industries ($bn), 2015
Table 52: Demographics, Taiwan, Population (million), 2009-2016
Table 53: Demographics, Taiwan, Population (million), 2017-2021
Table 54: Demographics, Taiwan, Urban-Rural Population Share (%), 2009-2016
Table 55: Demographics, Taiwan, Urban-Rural Population Share (%), 2017-2021
Table 56: Demographics, Taiwan, Population Distribution by Age Group (%), 2009-2016
Table 57: Demographics, Taiwan, Population Distribution by Age Group (%), 2017-2021
Table 58: Demographics, Taiwan, Births (per 1,000 Population), 2009-2016
Table 59: Demographics, Taiwan, Mortality (per 1,000 Population), 2009-2016
Table 60: Demographics, Taiwan, Major Causes of Mortality (%), 2015
Table 61: Demographics, Taiwan, Mortality Rate of Children Under One (per 1,000 live births), 2009-2016
Table 62: Demographics, Taiwan, Immunization Coverage (%), 2015
Table 63: Demographics, Taiwan, Gender Ratio (M/F), 2009-2016
Table 64: Demographics, Taiwan, Life Expectancy at Birth (years), 2009-2016
Table 65: Demographics, Taiwan, Life Expectancy at Birth (years), 2017-2021
Table 66: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), 2016
Table 67: Demographics, Taiwan, Unemployment Rate (%), 2009-2016
Table 68: Demographics, Taiwan, Employment by Sector (‘000), 2015
Table 69: Demographics, Taiwan, Personal Health Expenditure by Disease (%), 2014
Table 70: Healthcare Infrastructure, Taiwan, Hospitals, 2009-2016
Table 71: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2009-2016
Table 72: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), 2015
Table 73: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership (%), 2015
Table 74: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, 2009-2016
Table 75: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered, 2015
Table 76: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, 2009-2016
Table 77: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, 2015
Table 78: Healthcare Infrastructure, Taiwan, Diagnostic Centers, 2009-2016
Table 79: Healthcare Infrastructure, Taiwan, Hospitals Beds (per 10,000 population), 2009-2016
Table 80: Healthcare Infrastructure, Taiwan, Number of Doctors, 2009-2016
Table 81: Healthcare Infrastructure, Taiwan, CO2 Emissions (kilotons per year), 2009-2016
Table 82: Healthcare Infrastructure Taiwan, Nurses, 2009-2016
Table 83: Healthcare Infrastructure, Taiwan, Pharmacists, 2009-2016
Table 84: Healthcare Infrastructure, Taiwan, Dentists, 2009-2016
Table 85: Healthcare Infrastructure, Taiwan, Healthcare Expenditure as Percentage of GDP (%), 2009-2016
Table 86: Healthcare Infrastructure, Taiwan, Public-Private Share of Expenditure (%), 2009-2016
Table 87: Healthcare Expenditure, Taiwan, Major Healthcare Trade Fairs, 2017
1.2 List of Figures
Figure 1: Pharmaceutical Market, Taiwan, Revenue ($bn), 2009-2021 10
Figure 2: Medical Device Market, Taiwan, Revenue ($bn), 2009-2021 11
Figure 3: Country Profile, Taiwan, 2017 13
Figure 4: Pharmaceutical Market, Taiwan, Revenue ($bn), 2009-2016 16
Figure 5: Pharmaceutical Market, Taiwan, Revenue ($bn), 2017-2021 17
Figure 6: Pharmaceutical Market, Taiwan, Exports and Imports ($bn), 2009-2016 18
Figure 7: Pharmaceutical Market, Taiwan, Revenue by Major Therapeutic Areas ($bn), 2014 22
Figure 8: Medical Device Market, Taiwan, Revenue ($bn), 2009-2016 42
Figure 9: Medical Device Market, Taiwan, Revenue ($bn), 2017-2021 43
Figure 10: Medical Device Market, Taiwan, Revenue by Segment ($m), 2016 44
Figure 11: Orthopedic Devices Market, Taiwan, Revenue ($m), 2009-2016 45
Figure 12: Orthopedic Devices Market, Taiwan, Market Share of Major Players (%), 2016 46
Figure 13: Healthcare IT Device Market, Taiwan, Revenue ($m), 2009-2016 47
Figure 14: Healthcare IT Device Market, Taiwan, Market Share of Major Players (%), 2015 48
Figure 15: Ophthalmic Device Market, Taiwan, Revenue ($m), 2009-2016 49
Figure 16: Ophthalmic Devices, Taiwan, Market Share of Major Players (%), 2015 50
Figure 17: Diagnostic Imaging Devices, Taiwan, Revenue ($m), 2009-2016 51
Figure 18: Diagnostic Imaging Devices, Taiwan, Market Share of Major Players (%), 2015 52
Figure 19: Cardiovascular Device Market, Taiwan, Revenue ($m), 2009-2016 53
Figure 20: Cardiovascular Device Market, Taiwan, Market Share of Major Players (%), 2016 54
Figure 21: Medical Device Market, Taiwan, Revenue of Major Players ($m), 2012 55
Figure 22: Healthcare Market, Taiwan, Drivers and Barriers, 2017 76
Figure 23: Market Access, Healthcare System, Taiwan, Organizational Structure of NHI, 2016 78
Figure 24: Market Access, Healthcare System, Taiwan, Evolution of Healthcare System, 2016 79
Figure 25: Market Access, Healthcare System, Taiwan, HTA Assessment for Application of NHI New Drug Listing, 2016 81
Figure 26: Market Access, Healthcare System, Taiwan, Process for Coverage and Reimbursement of Medical Devices, 2016 82
Figure 27: Market Access, Healthcare System, Taiwan, NHI System, 2016 83
Figure 28: Market Access, Healthcare System, Taiwan, Premium Collection under Second-Generation NHI System, 2016 84
Figure 29: Healthcare Expenditure, Taiwan, Out-of-Pocket Expenditure (%), 2009-2016 87
Figure 30: Market Access, Taiwan, Healthcare Consumer Price Index Annual Change (%), 2009-2016 88
Figure 31: Market Access, Taiwan, Organizational Structure of Center for Drug Evaluation, 2017 91
Figure 32: Market Access, Taiwan, Drug Review Process for NDA, 2017 95
Figure 33: Market Access, Taiwan, Total Product Life Cycle Management Process, 2017 96
Figure 34: Market Access, Taiwan, Marketing Authorization Procedure for Medical Devices, 2013 100
Figure 35: Market Access, Taiwan, IVD Registration Application Process, 2017 101
Figure 36: Market Access, Taiwan, Clinical Trial Regulation Process for an Investigational New Drug, 2014 109
Figure 37: Economic Indicators, Taiwan, GDP Per Capita ($), 2009-2016 118
Figure 38: Economic Indicators, Taiwan, GDP per Capita ($), 2017-2021 119
Figure 39: Economic Indicators, Taiwan, GDP Annual Growth (%), 2009-2016 120
Figure 40: Economic Indicators, Taiwan, GDP Annual Growth (%), 2017-2021 121
Figure 41: Economic Indicators, Taiwan, GNI per Capita ($), 2009-2016 122
Figure 42: Economic Indicators, Taiwan, Consumer Price Index, 2009-2016 123
Figure 43: Economic Indicators, Taiwan, Average Consumer Price Index, 2017-2021 124
Figure 44: Economic Indicators, Taiwan, Average Consumer Price Index, Annual Change (%), 2009-2016 125
Figure 45: Economic Indicators, Taiwan, Average Consumer Price Index, Annual Change (%), 2017-2021 126
Figure 46: Economic Indicators, Taiwan, Currency Exchange Rate (TWD/$), 2009-2016 127
Figure 47: Economic Indicators, Taiwan, Foreign Direct Investment ($bn), 2009-2016 128
Figure 48: Economic Indicators, Taiwan, Foreign Exchange Reserves ($bn), 2009-2016 129
Figure 49: Economic Indicators, Taiwan, Imports of Goods and Services ($bn), 2009-2016 130
Figure 50: Economic Indicators, Taiwan, Exports of Goods and Services ($bn), 2009-2016 131
Figure 51: Economic Indicators, Taiwan, Government Structural Balance ($bn), 2009-2016 132
Figure 52: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2009-2016 133
Figure 53: Economic Indicators, Taiwan, Government Net Debt as a Percentage of GDP (%), 2017-2021 134
Figure 54: Economic Indicators, Taiwan, Value Added by Major Industries ($bn), 2015 135
Figure 55: Demographics, Taiwan, Population (million), 2009-2016 136
Figure 56: Demographics, Taiwan, Population (million), 2017-2021 137
Figure 57: Demographics, Taiwan, Urban-Rural Population Share (%), 2009-2016 138
Figure 58: Demographics, Taiwan, Urban-Rural Population Share (%), 2017-2021 139
Figure 59: Demographics, Taiwan, Population Distribution by Age Group (%), 2009-2016 140
Figure 60: Demographics, Taiwan, Population Distribution by Age Group (%), 2017-2021 141
Figure 61: Demographics, Taiwan, Births (per 1,000 Population), 2009-2016 142
Figure 62: Demographics, Taiwan, Mortality (per 1,000 Population), 2009-2016 143
Figure 63: Demographics, Taiwan, Major Causes of Mortality (%), 2015 144
Figure 64: Demographics, Taiwan, Mortality Rate of Children Under One (per 1,000 live births), 2009-2016 145
Figure 65: Demographics, Taiwan, Immunization Coverage (%), 2015 146
Figure 66: Demographics, Taiwan, Gender Ratio (M/F), 2009-2016 147
Figure 67: Demographics, Taiwan, Life Expectancy at Birth (years), 2009-2016 148
Figure 68: Demographics, Taiwan, Life Expectancy at Birth (years), 2017-2021 149
Figure 69: Demographics, Taiwan, Student Net Enrollment by Level of Education (%), 2016 150
Figure 70: Demographics, Taiwan, Unemployment Rate (%), 2009-2016 151
Figure 71: Demographics, Taiwan, Employment by Sector (‘000), 2015 152
Figure 72: Demographics, Taiwan, Personal Health Expenditure by Disease (%), 2014 153
Figure 73: Healthcare Infrastructure, Taiwan, Hospitals, 2009-2016 154
Figure 74: Healthcare Infrastructure, Taiwan, Public and Private Hospitals, 2009-2016 155
Figure 75: Healthcare Infrastructure, Taiwan, Public Hospitals, Share by Ownership (%), 2015 156
Figure 76: Healthcare Infrastructure, Taiwan, Private Hospitals, Share by Ownership (%), 2015 157
Figure 77: Healthcare Infrastructure, Taiwan, Hospitals by Standard of Care, Contracted by NHIA, 2009-2016 158
Figure 78: Healthcare Infrastructure, Taiwan, Hospitals by Services Rendered (%), 2015 159
Figure 79: Healthcare Infrastructure, Taiwan, Beds by Type of Hospital, 2009-2016 160
Figure 80: Healthcare Infrastructure, Taiwan, Beds by Specialty Care, 2015 161
Figure 81: Healthcare Infrastructure, Taiwan, Diagnostic Centers, 2009-2016 162
Figure 82: Healthcare Infrastructure, Taiwan, Hospitals Beds (per 10,000 population), 2009-2016 163
Figure 83: Healthcare Infrastructure, Taiwan, Number of Doctors, 2009-2016 164
Figure 84: Healthcare Infrastructure, Taiwan, CO2 Emissions (kilotons per year), 2009-2016 166
Figure 85: Healthcare Infrastructure, Taiwan, Nurses, 2009-2016 167
Figure 86: Healthcare Infrastructure, Taiwan, Pharmacists, 2009-2016 168
Figure 87: Healthcare Infrastructure, Taiwan, Dentists, 2009-2016 169
Figure 88: Healthcare Infrastructure, Taiwan, Healthcare Expenditure as Percentage of GDP (%), 2009-2016 170
Figure 89: Healthcare Infrastructure, Taiwan, Public-Private Share of Expenditure (%), 2009-2016 171
Figure 90: Healthcare Market, Taiwan, Opportunities and Challenges, 2017 175

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