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CountryFocus:マレーシアの医療・規制・医療費償還制度の状況

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia

発行 GlobalData 商品コード 299708
出版日 ページ情報 英文 205 Pages
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CountryFocus:マレーシアの医療・規制・医療費償還制度の状況 CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia
出版日: 2014年04月15日 ページ情報: 英文 205 Pages
概要

マレーシアの人口は近年、出生率の高さや死亡率の低下、平均余命の拡大を背景に増加し続けており、2013年には2990万人に達しました。マレーシア政府は幾つもの政策を推進し、医療産業への投資額を持続的に拡大させてきました。マレーシアの医療市場は、2008年は12億米ドルの規模でしたが、2020年には37億米ドルにまで拡大する(その間の年平均成長率(CAGR)は9.5%)と予測されています。同様に、同国の医療機器の市場規模は、2010年には5億8500万米ドルに達し、現在では医療費の25%を占めるまでになっています。

当レポートでは、マレーシアの医療関連市場の動向や、医療費償還制度およびその他の関連規制・制度について分析し、医薬品産業・医療装置産業の全体的構造・動向、医療費償還制度やその周辺の保険市場の動向、医療規制当局の構造や各種規制の概要、ブラジル経済・社会に関するマクロ的指標(医療インフラなど)といった情報を取りまとめて、概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 医薬品・医療機器市場の概要

  • 医薬品市場
    • 市場概況
    • 医薬品の輸出入
    • 供給経路
    • 市場の分類
    • 主な疾患分野
    • 主要企業
  • 医療機器市場
    • 市場概況
  • 市場の促進・阻害要因
    • 促進要因
    • 阻害要因

第4章 市場へのアクセス

  • 医療費償還・保険料支払者の状況
    • 医療制度の概要
    • 医療費償還の過程
    • 保険業者の概要
    • 医療費支出に対する患者負担の比率
    • 医療サービスの価格動向
    • 薬価政策
  • 規制環境
    • 規制機関の概要
    • 医薬品の認証過程
    • 医療機器製品の認証過程
    • 医薬品・医療機器の製造認可過程
    • 医薬品の輸出・輸入の認可
    • 知的所有権
    • 治験関連の規制
    • 医薬品の広告に関する規制
    • 薬局関連の規制
    • ラベリング・包装に関する規制

第5章 国の分析

  • 政治環境
  • 経済環境
  • 経済指標
  • 人口統計
  • 医療インフラ
    • 医療施設
    • 医療関連パラメーター
    • 環境問題
    • 医療従事者
  • 医療費支出
    • 概要
    • 医療費支出の主な要素
    • 公共/民間部門のシェア
    • 医薬品の研究開発(R&D)活動への支出額
  • 業界団体
  • 展示会

第6章 市場機会と課題

  • 市場機会
  • 課題

第7章 付録

図表一覧

目次
Product Code: GDHC0059CHR

GlobalData, the industry analysis specialist, has released its latest report, "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Malaysia". The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Malaysia. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData's team of industry experts.

In 2013, Malaysia's population stood at 29.9 million. The past five years have seen steady population growth, which is expected to continue in the future due to a high birth rate, low mortality rate and increased life expectancy. Government initiatives such as Entry Point Projects (EPPs), specifically EPP3, and National Key Economic Areas (NKEAs) to increase investment in the pharmaceutical industry have so far have been successful. The country's pharmaceutical market was estimated at $1.2 billion in 2008 and is projected to reach approximately $3.7 billion by 2020 at a CAGR of 9.5%. The medical device market was worth approximately $585m in 2010, but is growing and currently constitutes approximately 25% of the healthcare expenditure.

These positive trends can primarily be attributed to -

  • An increasing elderly population
  • Government initiatives to improve healthcare facilities
  • An increase in medical tourism

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Malaysia, 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: Chemical Company of Malaysia Berhad, Pharmaniaga Berhad, Hovid Berhad, Apex Healthcare Berhad and Y.S.P. Southeast Asia Holding Berhad
  • Insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs and medical devices
  • Detailed analysis of the 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 Malaysian 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 Malaysia's healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize on the opportunities and challenges in Malaysia's healthcare market

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. GlobalData Report Guidance

3. Overview of Pharmaceutical and Medical Device Markets

  • 3.1. Pharmaceutical Market
    • 3.1.1. Market Overview
    • 3.1.2. Pharmaceutical Exports and Imports
    • 3.1.3. Supply Channels
    • 3.1.4. Market Segments
    • 3.1.5. Overview of Top Five Disease Areas
    • 3.1.6. Major Players
  • 3.2. Medical Device Market
    • 3.2.1. Market Overview
  • 3.3. Market Drivers and Barriers
    • 3.3.1. Drivers
    • 3.3.2. Barriers

4. Market Access

  • 4.1. Reimbursement and Payer Landscape
    • 4.1.1. Overview of Healthcare System
    • 4.1.2. Reimbursement Process
    • 4.1.3. Overview of Insurance Providers
    • 4.1.4. Patient Share in Healthcare Spending
    • 4.1.5. Price Trend in Healthcare Services
    • 4.1.6. Pricing Policies
  • 4.2. Regulatory Landscape
    • 4.2.1. Overview of Regulatory Agencies
    • 4.2.2. Market Authorization Procedure for Pharmaceutical Products
    • 4.2.3. Market Authorization Procedure for Medical Devices
    • 4.2.4. Licensing Process for Pharmaceutical and Medical Device Manufacturing
    • 4.2.5. Licensing Process for Pharmaceutical Exports and Imports
    • 4.2.6. Intellectual Property Rights
    • 4.2.7. Clinical Trial Regulations
    • 4.2.8. Pharmaceutical Advertising Regulations
    • 4.2.9. Pharmacy Regulations
    • 4.2.10. Labeling and Packaging Regulations

5. Country Analysis

  • 5.1. Political Environment
    • 5.1.1. Political Structure
    • 5.1.2. Analysis of Current Political Environment
    • 5.1.3. Healthcare Policy Initiatives
  • 5.2. Economic Landscape
  • 5.3. Economic Indicators
    • 5.3.1. Gross Domestic Product
    • 5.3.2. Gross National Income
    • 5.3.3. Inflation
    • 5.3.4. Currency Exchange Rate
    • 5.3.5. Foreign Direct Investment
    • 5.3.6. Foreign Exchange Reserves
    • 5.3.7. Trade Balance
    • 5.3.8. General Government Structural Balance
    • 5.3.9. General Government Gross Debt
    • 5.3.10. Major Industries
  • 5.4. Demographics
    • 5.4.1. Population
    • 5.4.2. Education and Literacy
    • 5.4.3. Employment
    • 5.4.4. Disease Burden
  • 5.5. Healthcare Infrastructure
    • 5.5.1. Healthcare Facilities
    • 5.5.2. Healthcare Parameters
    • 5.5.3. Environmental Health
    • 5.5.4. Healthcare Personnel
  • 5.6. Healthcare Expenditure
    • 5.6.1. Overview
    • 5.6.2. Major Components of Healthcare Spending
    • 5.6.3. Public and Private Sector Share
    • 5.6.4. Spending in Pharmaceutical Research and Development
  • 5.7. Trade Associations
    • 5.7.1. Pharmaceutical Association of Malaysia
    • 5.7.2. Malaysian Organization of Pharmaceutical Industries
    • 5.7.3. Association of Private Hospital Malaysia
    • 5.7.4. Association of Malaysian Medical Industries
  • 5.8. Trade Fairs

6. Opportunities and Challenges

  • 6.1. Opportunities
  • 6.2. Challenges

7. Appendix

  • 7.1. Abbreviations
  • 7.2. Bibliography
  • 7.3. Research Methodology
    • 7.3.1. Secondary Research
    • 7.3.2. Primary Research
    • 7.3.3. Models
    • 7.3.4. Forecasts
    • 7.3.5. Expert Panel
  • 7.4. Disclaimer

List of Tables

  • Table 1: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008-2013
  • Table 2: Pharmaceutical Market, Malaysia, Revenue Forecast ($bn), 2014-2020
  • Table 3: Pharmaceutical Market, Malaysia, Population, Exports and Imports ($m), 2008-2013
  • Table 4: Pharmaceutical Market, Malaysia, Pharmaceutical Mark-up (%), 2011
  • Table 5: Pharmaceutical Market, Malaysia, Top Five Therapeutic Areas, Pharmaceutical Expenditure, 2008
  • Table 6: Pharmaceutical Market, Major Products, Chemical Company of Malaysia, 2014
  • Table 7: Pharmaceutical Market, Major Products, Pharmaniaga, 2014
  • Table 8: Pharmaceutical Market, Major Products, Hovid, 2014
  • Table 9: Pharmaceutical Market, Major Products, Apex, 2014
  • Table 10: Pharmaceutical Market, Major Products, YSP Southeast Asia Holding, 2014
  • Table 11: Healthcare System, Malaysia, Physician Categories, 2012
  • Table 12: Healthcare System, Malaysia, Contribution to Insurance Fund (%), 2013
  • Table 13: Healthcare Spending, Malaysia, Out-of-Pocket Expenditure (%), 2008-2013
  • Table 14: Price of Prescription Drugs, Malaysia, Average Price in Healthcare Sector (%), 2008-2013
  • Table 15: Healthcare System, Malaysia, Regulatory Review Time, Pharmaceutical Products, 2014
  • Table 16: Healthcare System, Malaysia, Regulatory Fee Structure, Pharmaceutical Products, 2014
  • Table 17: Healthcare System, Malaysia, Regulatory Fee Structure, Medical Devices, 2012
  • Table 18: Healthcare System, Malaysia, License Fee Structure, Medical Devices, 2012
  • Table 19: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008-2013
  • Table 20: Economic Indicators, Malaysia, Gross Domestic Product per Capita Forecast ($), 2014-2020
  • Table 21: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008-2013
  • Table 22: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth Forecast (%), 2014-2020
  • Table 23: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008-2013
  • Table 24: Economic Indicators, Malaysia, Average Consumer Price Index, 2008-2013
  • Table 25: Economic Indicators, Malaysia, Average Consumer Price Index Forecast, 2014-2020
  • Table 26: Economic Indicators, Malaysia, Average Consumer Price Annual Change (%), 2008-2013
  • Table 27: Economic Indicators, Malaysia, Currency Exchange Rate (MYR/$), 2008-2013
  • Table 28: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008-2013
  • Table 29: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008-2013
  • Table 30: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008-2013
  • Table 31: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008-2013
  • Table 32: Economic Indicators, Malaysia, Structural Balance of General Government ($bn), 2008-2013
  • Table 33: Economic Indicators, Malaysia, General Government Gross Debt (% of GDP), 2008-2013
  • Table 34: Economic Indicators, Malaysia, General Government Gross Debt (% of GDP), 2014-2020
  • Table 35: Economic Indicators, Malaysia, Major Industries, Gross Value ($bn), 2010
  • Table 36: Demographics, Malaysia, Population (million), 2008-2013
  • Table 37: Demographics, Malaysia, Population (million), 2014-2020
  • Table 38: Demographics, Malaysia, Population, Urban and Rural Population Share (%), 2008-2013
  • Table 39: Demographics, Malaysia, Population, Urban and Rural Population Share Forecast (%), 2014-2020
  • Table 40: Demographics, Malaysia, Population Distribution by Age Group (%), 2008-2013
  • Table 41: Demographics, Malaysia, Population Distribution by Age Group Forecast (%), 2014-2020
  • Table 42: Demographics, Malaysia, Births (per 1,000 Population), 2008-2013
  • Table 43: Demographics, Malaysia, Mortality (per 1,000 Population), 2008-2013
  • Table 44: Demographics, Malaysia, Major Causes of Mortality ('000), 2008
  • Table 45: Demographics, Malaysia, Leading Causes of Mortality (%), 2011
  • Table 46: Demographics, Malaysia, Children ≤5 Years, Mortality Rate (per 1,000 Live Births), 2008-2013
  • Table 47: Demographics, Malaysia, Immunization Rate (%), 2008-2013
  • Table 48: Demographics, Malaysia, Major Causes of Male Mortality ('000), 2008
  • Table 49: Demographics, Malaysia, Major Causes of Female Mortality ('000), 2008
  • Table 50: Demographics, Malaysia, Gender Ratio (M/F), 2008-2013
  • Table 51: Demographics, Malaysia, Life Expectancy at Birth (Years), 2008-2013
  • Table 52: Demographics, Malaysia, Student Enrollment by Level of Education (%), 2010
  • Table 53: Demographics, Malaysia, Unemployment Rate (%), 2008-2013
  • Table 54: Demographics, Malaysia, Employment by Sector, 2012
  • Table 55: Demographics, Malaysia, Major Causes of Hospitalization (%), 2011
  • Table 56: Demographics, Malaysia, Major Diseases, DALYs (per 100,000 Population), 2004
  • Table 57: Healthcare Infrastructure, Malaysia, Hospitals, 2008-2013
  • Table 58: Healthcare Infrastructure, Malaysia, Public and Private Hospitals, 2008-2013
  • Table 59: Healthcare Infrastructure, Malaysia, Hospitals by Services Rendered (%), 2011
  • Table 60: Healthcare Infrastructure, Malaysia, Diagnostic Equipment (per 1,000,000 Population), 2009-2010
  • Table 61: Healthcare Infrastructure, Malaysia, Hospital Beds (per 1,000 Population), 2008-2013
  • Table 62: Healthcare Infrastructure, Malaysia, Doctors (per 1,000 Population), 2008-2013
  • Table 63: Healthcare Infrastructure, Malaysia, PM10 (micrograms per cubic meter), 2008-2013
  • Table 64: Healthcare Infrastructure, Malaysia, CO2 Emissions (Million Tons), 2008-2013
  • Table 65: Healthcare Infrastructure, Malaysia, Nurses (per 1,000 Population), 2008-2013
  • Table 66: Healthcare Infrastructure, Malaysia, Pharmacists (per 100,000 Population), 2008-2013
  • Table 67: Healthcare Infrastructure, Malaysia, Dentists (per 1,000 Population), 2008-2013
  • Table 68: Healthcare Expenditure, Malaysia, Healthcare Expenditure (% of GDP), 2008-2013
  • Table 69: Healthcare Expenditure, Malaysia, Primary Healthcare Expenditure (%), 2006
  • Table 70: Healthcare Expenditure, Malaysia, Healthcare Expenditure, Public-Private Share (%), 2008-2013
  • Table 71: Healthcare Expenditure, Malaysia, Research and Development Expenditure by Field of Research (%), 2011
  • Table 72: Healthcare Expenditure, Malaysia, Major Healthcare Trade Fairs, 2014-2015

List of Figures

  • Figure 1: Pharmaceutical Market, Malaysia, Revenue ($bn), 2008-2013
  • Figure 2: Pharmaceutical Market, Malaysia, Revenue Forecast ($bn), 2014-2020
  • Figure 3: Pharmaceutical Market, Malaysia, Population, Exports and Imports ($m), 2008-2013
  • Figure 4: Pharmaceutical Market, Malaysia, Distribution Channel, 2013
  • Figure 5: Pharmaceutical Market, Malaysia, Top Five Therapeutic Areas, Pharmaceutical Expenditure ($m), 2008
  • Figure 6: Healthcare Market, Malaysia, Drivers and Barriers, 2013
  • Figure 7: Healthcare System, Malaysia, Financial Flow in the Healthcare System, 2008
  • Figure 8: Healthcare System, Malaysia, Addition of Drug in MoH Drug Formulary, 2011
  • Figure 9: Healthcare Spending, Malaysia, Out-of-Pocket Expenditure (%), 2008-2013
  • Figure 10: Price of Prescription Drugs, Malaysia, Average Price in Healthcare Sector (%), 2008-2013
  • Figure 11: Market Access, Malaysia, Generic Drug Marketing Authorization, 2014
  • Figure 12: Market Access, Malaysia, New Drug Marketing Authorization Procedure, 2014
  • Figure 13: Market Access, Malaysia, Medical Device Approval Process, 2014
  • Figure 14: Market Access, Malaysia, Licensing Process for Pharmaceutical Manufacturing, 2014
  • Figure 15: Market Access, Malaysia, Licensing Process for Medical Device Manufacturing, 2012
  • Figure 16: Market Access, Malaysia, Patent Approval Process, 2014
  • Figure 17: Market Access, Malaysia, Trademark Approval Process, 2014
  • Figure 18: Market Access, Malaysia, Clinical Trial Regulation Process, 2011
  • Figure 19: Market Access, Malaysia, Process of Import License for New Drug for Clinical Trial, 2014
  • Figure 20: Market Access, Malaysia, Pharmaceutical Advertisement Approval Process, 2014
  • Figure 21: Economic Indicators, Malaysia, Gross Domestic Product per Capita ($), 2008-2013
  • Figure 22: Economic Indicators, Malaysia, Gross Domestic Product per Capita Forecast ($), 2014-2020
  • Figure 23: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth (%), 2008-2013
  • Figure 24: Economic Indicators, Malaysia, Gross Domestic Product Annual Growth Forecast (%), 2014-2020
  • Figure 25: Economic Indicators, Malaysia, Gross National Income per Capita ($), 2008-2013
  • Figure 26: Economic Indicators, Malaysia, Average Consumer Price Index, 2008-2013
  • Figure 27: Economic Indicators, Malaysia, Average Consumer Price Index Forecast, 2014-2020
  • Figure 28: Economic Indicators, Malaysia, Average Consumer Price Annual Change (%), 2008-2013
  • Figure 29: Economic Indicators, Malaysia, Currency Exchange Rate (MYR/$), 2008-2013
  • Figure 30: Economic Indicators, Malaysia, Foreign Direct Investment ($bn), 2008-2013
  • Figure 31: Economic Indicators, Malaysia, Foreign Exchange Reserves ($bn), 2008-2013
  • Figure 32: Economic Indicators, Malaysia, Imports of Goods and Services ($bn), 2008-2013
  • Figure 33: Economic Indicators, Malaysia, Exports of Goods and Services ($bn), 2008-2013
  • Figure 34: Economic Indicators, Malaysia, Government Structural Balance ($bn), 2008-2013
  • Figure 35: Economic Indicators, Malaysia, General Government Gross Debt (% of GDP), 2008-2013
  • Figure 36: Economic Indicators, Malaysia, General Government Gross Debt (% of GDP), 2014-2020
  • Figure 37: Economic Indicators, Malaysia, Major Industries, Gross Value ($bn), 2010
  • Figure 38: Demographics, Malaysia, Population (million), 2008-2013
  • Figure 39: Demographics, Malaysia, Population Forecast (million), 2014-2020
  • Figure 40: Demographics, Malaysia, Population, Urban and Rural Population Share (%), 2008-2013
  • Figure 41: Demographics, Malaysia, Population, Urban and Rural Population Share Forecast (%), 2014-2020
  • Figure 42: Demographics, Malaysia, Population Distribution by Age Group (%), 2008-2013
  • Figure 43: Demographics, Malaysia, Population Distribution by Age Group Forecast (%), 2014-2020
  • Figure 44: Demographics, Malaysia, Births (per 1,000 Population), 2008-2013
  • Figure 45: Demographics, Malaysia, Mortality (per 1,000 Population), 2008-2013
  • Figure 46: Demographics, Malaysia, Major Causes of Mortality ('000), 2008
  • Figure 47: Demographics, Malaysia, Children ≤5 Years, Mortality Rate (per 1,000 Live Births), 2008-2013
  • Figure 48: Demographics, Malaysia, Immunization Rate (%), 2008-2013
  • Figure 49: Demographics, Malaysia, Major Causes of Male Mortality ('000), 2008
  • Figure 50: Demographics, Malaysia, Major Causes of Female Mortality ('000), 2008
  • Figure 51: Demographics, Malaysia, Gender Ratio (M/F), 2008-2013
  • Figure 52: Demographics, Malaysia, Life Expectancy at Birth (Years), 2008-2013
  • Figure 53: Demographics, Malaysia, Student Enrollment by Level of Education (%), 2010
  • Figure 54: Demographics, Malaysia, Unemployment Rate (%), 2008-2013
  • Figure 55: Demographics, Malaysia, Major Causes of Hospitalization (%), 2011
  • Figure 56: Demographics, Malaysia, Major Diseases, DALYs (per 100,000 Population), 2004
  • Figure 57: Healthcare Infrastructure, Malaysia, Hospitals, 2008-2013
  • Figure 58: Healthcare Infrastructure, Malaysia, Public and Private Hospitals, 2008-2013
  • Figure 59: Healthcare Infrastructure, Malaysia, Hospitals by Services Rendered (%), 2011
  • Figure 60: Healthcare Infrastructure, Malaysia, Diagnostic Equipment (per 1,000,000 Population), 2009-2010
  • Figure 61: Healthcare Infrastructure, Malaysia, Hospital Beds (per 1,000 Population), 2008-2013
  • Figure 62: Healthcare Infrastructure, Malaysia, Doctors (per 1,000 Population), 2008-2013
  • Figure 63: Healthcare Infrastructure, Malaysia, PM10 (micrograms per cubic meter), 2008-2013
  • Figure 64: Healthcare Infrastructure, Malaysia, CO2 Emissions (Million Tons), 2008-2013
  • Figure 65: Healthcare Infrastructure, Malaysia, Nurses (per 1,000 Population), 2008-2013
  • Figure 66: Healthcare Infrastructure, Malaysia, Pharmacists (per 100,000 Population), 2008-2013
  • Figure 67: Healthcare Infrastructure, Malaysia, Dentists (per 1,000 Population), 2008-2013
  • Figure 68: Healthcare Expenditure, Malaysia, Healthcare Expenditure (% of GDP), 2008-2013
  • Figure 69: Healthcare Expenditure, Malaysia, Primary Healthcare Expenditure (%), 2006
  • Figure 70: Healthcare Expenditure, Malaysia, Healthcare Expenditure, Public-Private Share (%), 2008-2013
  • Figure 71: Healthcare Expenditure, Malaysia, Research and Development Expenditure by Field of Research (%), 2011
  • Figure 72: Healthcare Market, Malaysia, Opportunities and Challenges, 2013
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