CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Indonesia

  • ID: 2787904
  • Report
  • Region: Indonesia
  • 150 pages
  • GlobalData
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Indonesia

Summary

Indonesian pharmaceutical market increased from US$3.13 Billion in 2009 to US$6.20 Billion in 2016, at a Compound Annual Growth Rate (CAGR) of 10.3%. The market value is expected to reach US$10.11 Billion in 2021. The growth of the Indonesian pharmaceutical sector is largely driven by the Universal Health Coverage scheme (Jaminan Kesehatan Nasional, JKN), which prioritizes the use of generics. Despite increasing sales of unbranded generics, the sector is witnessing a growing number of new players, which drive price competition and reduce margins. In 2015, the unbranded generic market represented a 10.8% of the pharmaceutical market.

In 2015, the pharmaceutical-sales-to-GDP ratio shrank to 0.57%, despite pharmaceutical sales increasing from US$6.18 Billion in the previous year to US$6.89 Billion. Pharmaceutical sales per capita increased from US$24.5 Billion in 2014 to US$26.9 Billion in 2015. The pharmaceutical-sales-to-health-spending ratio dropped from US$21.4 Billion in 2014 to US$20.5 Billion in 2015. Non-communicable diseases cost the economy US$7 Billion between 2011 and 2015 in treatment and loss of productivity.

Medical device market of Indonesia was worth US$2.28 Billion in 2016, and is expected to reach US$2.83 Billion in 2017 and US$3.54 Billion in 2018. Indonesia manufactures hospital beds, disposable supplies and wheelchairs, but imports more than 90% of its medical devices, as the domestic industry is under-developed.

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

In particular, this report provides the following:
  • Provides an overview of the Indonesian pharmaceutical and medical device markets, covering market size; the market shares of generic, Over-the-Counter (OTC) and biologic/biosimilar products; and the key drivers and barriers for the overall market. It also includes profiles of the major players, as well as SWOT assessments.
  • Covers the reimbursement and payer landscape, and includes details of the reimbursement process, insurance providers, pricing policies and drug price trends in Indonesia. It also looks at the regulatory landscape, and gives an overview of the regulatory agencies and approval processes for new drugs and medical devices.
  • Detailed analysis of the political and economic environment in Indonesia, and analyzes economic indicators, demographics, and healthcare infrastructure and expenditure.
  • Provides an overview of the opportunities for and challenges to growth in the Indonesian healthcare market.
Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Indonesia, 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 (Kalbe Farma, Tempo Scan, Kimia Farma, DaryaVaria and IndoFarma)
  • An 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 Indonesian 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 the Indonesian 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 the Indoensian healthcare market.
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1 Table of Contents

2 Executive Summary

3 Introduction
3.1 Report Guidance

4 Overview of the Pharmaceutical and Medical Device Markets
4.1 Pharmaceutical Market
4.1.1 Market Overview
4.1.2 Pharmaceutical Imports and Exports
4.1.3 Supply Channels
4.1.4 Market Segments
4.1.5 Overview Drug Classes
4.1.6 Major Players
4.2 Medical Device Market
4.2.1 Market Overview
4.3 Market Drivers and Barriers
4.3.1 Drivers
4.3.2 Barriers

5 Market Access
5.1 Reimbursement and Payer Landscape
5.1.1 Overview of Healthcare System
5.1.2 Drug Classifications
5.1.3 Drug Reimbursement Process
5.1.4 Overview of Insurance Providers
5.1.5 Patient Share in Healthcare Spending
5.1.6 Price Trend in Healthcare Services
5.1.7 Pricing Policies
5.2 Regulatory Landscape
5.2.1 Overview of Regulatory Agencies
5.2.2 Market Authorization Procedure for New Drugs
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 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 Analysis of the 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 General Government Structural Balance
6.3.9 General Government Gross Debt
6.3.10 Major Industries
6.4 Demographics
6.4.1 Population
6.4.2 Urban-Rural Share
6.4.3 Distribution by Age Group
6.4.4 Birth Rate
6.4.5 Mortality
6.4.6 Causes of Mortality
6.4.7 Health Status by Gender and Age
6.4.8 Education and Literacy
6.4.9 Employment
6.4.10 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 Public-Private Sector Share
6.6.3 Major Components of Healthcare Spending
6.7 Trade Associations
6.7.1 International Pharmaceutical Manufacturers Group
6.7.2 Indonesia Pharmaceutical Association
6.7.3 Indonesian Medical 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
8.5 Disclaimer

List of Tables
Table 1: Pharmaceutical Market, Indonesia, Revenue ($bn), 2009-2016
Table 2: Pharmaceutical Market, Indonesia, Revenue Forecast ($bn), 2017-2021
Table 3: Pharmaceutical Market, Indonesia, Pharmaceutical Exports and Imports ($bn), 2009-2016
Table 4: Pharmaceutical Market, Indonesia, Pharmaceutical Distribution (%), 2014
Table 5: Pharmaceutical Market, Indonesia, Unbranded Generics, Revenue ($m), 2009-2015
Table 6: Pharmaceutical Market, Indonesia, Unbranded Generics as Percentage of Total Pharmaceutical Market (%), 2009-2015
Table 7: Pharmaceutical Market, Indonesia, Over-the-Counter Drug Market Revenue ($bn), 2009-2015
Table 8: Pharmaceutical Market, Indonesia, Pharmaceutical Market Share (%), 2009-2015
Table 9: Pharmaceutical Market, Kalbe Farma, Indonesia, Major Products, 2016
Table 10: Pharmaceutical Market, Tempo Scan, Major Products, 2017
Table 11: Pharmaceutical Market, Darya Varia, Major Products, 2017
Table 12: Pharmaceutical Market, Indofarma, Major Products, 2017
Table 13: Market Access, Indonesia, JKN Coverage Population (million), 2017
Table 14: Market Access, Indonesia, Out-of-Pocket Expenditure as Percentage of Total Health Expenditure (%), 2009-2015
Table 15: Market Access, Indonesia, Healthcare Inflation (%), 2009-2016
Table 16: Economic Indicators, Indonesia, Gross Domestic Product per Capita ($), 2009-2016
Table 17: Economic Indicators, Indonesia, Gross Domestic Product per Capita Forecast ($), 2017-2021
Table 18: Economic Indicators, Indonesia, Gross Domestic Product Annual Growth (%), 2009-2016
Table 19: Economic Indicators, Indonesia, Gross Domestic Product Annual Growth Forecast (%), 2017-2021
Table 20: Economic Indicators, Indonesia, Gross National Income per Capita ($), 2009-2016
Table 21: Economic Indicators, Indonesia, Average Consumer Price Index, 2009-2016
Table 22: Economic Indicators, Indonesia, Average Consumer Price Annual Change (%), 2009-2016
Table 23: Economic Indicators, Indonesia, Currency Exchange Rate (IDR per $), 2009-2016
Table 24: Economic Indicators, Indonesia, Foreign Direct Investment ($bn), 2009-2016
Table 25: Economic Indicators, Indonesia, Foreign Exchange Reserves ($bn), 2009-2016
Table 26: Economic Indicators, Indonesia, Imports of Goods and Services ($bn), 2009-2016
Table 27: Economic Indicators, Indonesia, Exports of Goods and Services ($bn), 2009-2016
Table 28: Economic Indicators, Indonesia, Government Structural Balance ($bn), 2009-2016
Table 29: Economic Indicators, Indonesia, General Government Gross Debt ($bn), 2009-2016
Table 30: Economic Indicators, Indonesia, Major Industries by Gross Value Added (percentage of GDP), 2016
Table 31: Demographics, Indonesia, Population (million), 2009-2016
Table 32: Demographics, Indonesia, Population (million), 2017-2021
Table 33: Demographics, Indonesia, Urban-Rural Population Share (%), 2009-2016
Table 34: Demographics, Indonesia, Population Distribution by Age Group (%), 2009-2016
Table 35: Demographics, Indonesia, Population Distribution by Age Group Forecast (%), 2017-2021
Table 36: Demographics, Indonesia, Births (per 1,000 population), 2009-2016
Table 37: Demographics, Indonesia, Mortality (per 1,000 population), 2009-2015
Table 38: Demographics, Indonesia, Major Causes of Mortality (‘000), 2015
Table 39: Demographics, Indonesia, Infant Mortality (per 1,000 live births), 2009-2016
Table 40: Demographics, Indonesia, Immunization Rate (%), 2009-2016
Table 41: Demographics, Indonesia, Major Causes of Male Mortality (‘000), 2015
Table 42: Demographics, Indonesia, Major Causes of Female Mortality (‘000), 2015
Table 43: Demographics, Indonesia, Gender Ratio (M/F), 2009-2015
Table 44: Demographics, Indonesia, Life Expectancy at Birth (years), 2009-2016
Table 45: Demographics, Indonesia, Illiteracy by Age Group (%), 2009-2016
Table 46: Demographics, Indonesia, School Enrollment by Age Group (%), 2015
Table 47: Demographics, Indonesia, Unemployment Rate (%), 2009-2016
Table 48: Demographics, Indonesia, Disability-Adjusted Life Years by Major Disease (‘000), 2015
Table 49: Healthcare Infrastructure, Indonesia, Public and Private Hospitals, 2009-2016
Table 50: Healthcare Infrastructure, Indonesia, Health Centers (per 30,000 population), 2009-2016
Table 51: Healthcare Infrastructure, Indonesia, Share of Hospitals by Type of Care, 2015
Table 52: Healthcare Infrastructure, Indonesia, General Hospital Beds (per 1,000 population), 2009-2016
Table 53: Healthcare Infrastructure, Indonesia, PM2.5 (µg per m3), 2009-2015
Table 54: Healthcare Infrastructure, Indonesia, CO2 Emissions (million metric tons), 2009-2015
Table 55: Healthcare Infrastructure, Indonesia, Physicians (per 100,000 population), 2009-2015
Table 56: Healthcare Infrastructure, Indonesia, Dentists (per 100,000 population), 2009-2015
Table 57: Healthcare Infrastructure, Indonesia, Nurses (per 100,000 population), 2009-2015
Table 58: Healthcare Expenditure, Indonesia, Healthcare Expenditure as Percentage of GDP (%), 2009-2015
Table 59: Healthcare Expenditure, Indonesia, Public-Private Share (%), 2009-2015
Table 60: Healthcare Expenditure, Indonesia, Major Components of Healthcare Spending (%), 2015
Table 61: Healthcare Expenditure, Indonesia, Major Healthcare Trade Fairs, 2017

List of Figures
Figure 1: Pharmaceutical Market, Indonesia, Revenue ($bn), 2009-2021
Figure 2: Country Profile, Indonesia, 2017
Figure 3: Pharmaceutical Market, Indonesia, Revenue ($bn), 2009-2016
Figure 4: Pharmaceutical Market, Indonesia, Revenue Forecast ($bn), 2017-2021
Figure 5: Pharmaceutical Market, Indonesia, Pharmaceutical Exports and Imports ($bn), 2009-2016
Figure 6: Pharmaceutical Market, Indonesia, Distribution Chain, 2014
Figure 7: Pharmaceutical Market, Indonesia, Pharmaceutical Distribution (%), 2014
Figure 8: Pharmaceutical Market, Indonesia, Unbranded Generics, Revenue ($m), 2009-2015
Figure 9: Pharmaceutical Market, Indonesia, Unbranded Generics as Percentage of Total Pharmaceutical Market (%), 2009-2015
Figure 10: Pharmaceutical Market, Indonesia, Over-the-Counter Drug Market Revenue ($bn), 2009-2015
Figure 11: Pharmaceutical Market, Indonesia, Pharmaceutical Market Share (%), 2009-2015
Figure 12: Pharmaceutical Market, Indonesia, Drivers and Barriers, 2017
Figure 13: Market Access, Indonesia, Healthcare System, 2017
Figure 14: Market Access, Indonesia, History of Health Insurance System, 2017
Figure 15: Market Access, Indonesia, Process for Addition to Hospital Drug Formulary, 2015
Figure 16: Market Access, Indonesia, Registration Procedure for JKN, 2017
Figure 17: Market Access, Indonesia, Members of the JKN, 2017
Figure 18: Market Access, Indonesia, Contributions to BPJS, 2017
Figure 19: Market Access, Indonesia, Out-of-Pocket Expenditure as Percentage of Total Health Expenditure (%), 2009-2015
Figure 20: Market Access, Indonesia, Healthcare Inflation (%), 2009-2016
Figure 21: Market Access, Indonesia, Structure of the National Agency of Drug and Food Control, 2017
Figure 22: Market Access, Indonesia, New Drug Application Procedure, 2017
Figure 23: Market Access, Indonesia, Drug Registration Procedure, 2017
Figure 24: Market Access, Indonesia, Drug Evaluation and Decision Making Pathway, 2017
Figure 25: Market Access, Indonesia, Regulatory Framework on Ensuring Quality, Safety and Efficacy of Medicine, 2017
Figure 26: Market Access, Indonesia, Policy for Biosimilar Product Evaluation, 2017
Figure 27: Market Access, Indonesia, General Guidelines on Evaluation of Biosimilar Products, 2017
Figure 28: Market Access, Indonesia, Registration of Biosimilar Products, 2017
Figure 29: Market Access, Indonesia, Medical Device Approval Process, 2017
Figure 30: Market Access, Indonesia, Licensing Process for Manufacturing, 2017
Figure 31: Market Access, Indonesia, Structure of the Directorate General of Intellectual Property Office, 2017
Figure 32: Market Access, Indonesia, Patent Approval Process, 2017
Figure 33: Market Access, Indonesia, Clinical Trial Regulation Process, 2017
Figure 34: Economic Indicators, Indonesia, Gross Domestic Product per Capita ($), 2009-2016
Figure 35: Economic Indicators, Indonesia, Gross Domestic Product per Capita Forecast ($), 2017-2021
Figure 36: Economic Indicators, Indonesia, Gross Domestic Product Annual Growth (%), 2009-2016
Figure 37: Economic Indicators, Indonesia, Gross Domestic Product Annual Growth Forecast (%), 2017-2021
Figure 38: Economic Indicators, Indonesia, Gross National Income per Capita ($), 2009-2016
Figure 39: Economic Indicators, Indonesia, Average Consumer Price Index, 2009-2016
Figure 40: Economic Indicators, Indonesia, Average Consumer Price Annual Change (%), 2009-2016
Figure 41: Economic Indicators, Indonesia, Currency Exchange Rate (IDR per $), 2009-2016
Figure 42: Economic Indicators, Indonesia, Foreign Direct Investment ($bn), 2009-2016
Figure 43: Economic Indicators, Indonesia, Foreign Exchange Reserves ($bn), 2009-2016
Figure 44: Economic Indicators, Indonesia, Imports of Goods and Services ($bn), 2009-2016
Figure 45: Economic Indicators, Indonesia, Exports of Goods and Services ($bn), 2009-2016
Figure 46: Economic Indicators, Indonesia, Government Structural Balance ($bn), 2009-2016
Figure 47: Economic Indicators, Indonesia, General Government Gross Debt ($bn), 2009-2016
Figure 48: Economic Indicators, Indonesia, Major Industries by Gross Value Added (percentage of GDP), 2016
Figure 49: Demographics, Indonesia, Population (million), 2009-2016
Figure 50: Demographics, Indonesia, Population (million), 2017-2021
Figure 51: Demographics, Indonesia, Urban-Rural Population Share (%), 2009-2016
Figure 52: Demographics, Indonesia, Population Distribution by Age Group (%), 2009-2016
Figure 53: Demographics, Indonesia, Population Distribution by Age Group Forecast (%), 2017-2021
Figure 54: Demographics, Indonesia, Births (per 1,000 population), 2009-2016
Figure 55: Demographics, Indonesia, Mortality (per 1,000 population), 2009-2015
Figure 56: Demographics, Indonesia, Major Causes of Mortality (‘000), 2015
Figure 57: Demographics, Indonesia, Infant Mortality (per 1,000 live births), 2009-2016
Figure 58: Demographics, Indonesia, Immunization Rate (%), 2009-2016
Figure 59: Demographics, Indonesia, Major Causes of Male Mortality (‘000), 2015
Figure 60: Demographics, Indonesia, Major Causes of Female Mortality (‘000), 2015
Figure 61: Demographics, Indonesia, Gender Ratio (M/F), 2009-2015
Figure 62: Demographics, Indonesia, Life Expectancy at Birth (years), 2009-2016
Figure 63: Demographics, Indonesia, Illiteracy by Age Group (%), 2009-2016
Figure 64: Demographics, Indonesia, School Enrollment by Age Group (%), 2015
Figure 65: Demographics, Indonesia, Unemployment Rate (%), 2009-2016
Figure 66: Demographics, Indonesia, Disability-Adjusted Life Years by Major Disease (‘000), 2015
Figure 67: Healthcare Infrastructure, Indonesia, Public and Private Hospitals, 2009-2016
Figure 68: Healthcare Infrastructure, Indonesia, Health Centers (per 30,000 population), 2009-2016
Figure 69: Healthcare Infrastructure, Indonesia, Health Centers (per 100,000 population), 2009-2016
Figure 70: Healthcare Infrastructure, Indonesia, General Hospital Beds (per 1,000 population), 2009-2016
Figure 71: Healthcare Infrastructure, Indonesia, PM2.5 (µg per m3), 2009-2015
Figure 72: Healthcare Infrastructure, Indonesia, CO2 Emissions (million metric tons), 2009-2015
Figure 73: Healthcare Infrastructure, Indonesia, Physicians (per 100,000 population), 2009-2015
Figure 74: Healthcare Infrastructure, Indonesia, Dentists (per 100,000 population), 2009-2015
Figure 75: Healthcare Infrastructure, Indonesia, Nurses (per 100,000 population), 2009-2015
Figure 76: Healthcare Expenditure, Indonesia, Healthcare Expenditure as Percentage of GDP (%), 2009-2015
Figure 77: Healthcare Expenditure, Indonesia, Public-Private Share (%), 2009-2015
Figure 78: Healthcare Expenditure, Indonesia, Major Components of Healthcare Spending (%), 2015
Figure 79: Healthcare Market, Indonesia, Opportunities and Challenges, 2017
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A Growing Urban Population, Increased Government Healthcare Spending and an Increasing Life Expectancy are The Key Drivers of Growth in the Indonesian Healthcare Market; However Counterfeit Medicines and The Increasing Use of Generics with the Aim of Reducing Healthcare Expenditure, May have a Negative Effect

The pharmaceutical market in Indonesia was worth approximately $3.1 billion in 2008 and is projected to reach approximately $17.6 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 10.2% (Sudharta et al., 2010). This growth is expected to be due to the introduction of government healthcare reimbursement programs such as Jamkesmas and the Family Hope Program (Program Keluarga Harapan, PKH). Approximately 26.1% of the population was covered by health insurance in 2007, which increased to 65% in 2011. This increase is mainly due to efficient implementation of the government healthcare reimbursement program Jamkesmas and the introduction of an operational assistance health fund in 2010.

Therapeutic segments such as anti-infectives and respiratory are expected to grow in the future due to the rising incidence of communicable diseases such as Tuberculosis (TB), Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS), pneumonia and leprosy (MoHRI, 2011).

Multinational Companies (MNCs) will increase their presence in the pharmaceutical market as they offer largely patented drugs, which are covered by free pricing policies. A lack of R&D activity from domestic manufacturers has limited their ability to offer generic drugs. The generic market itself is undergoing rapid expansion, driven by government incentives and the loss of patent protection for several high-volume products. The government has introduced two laws to promote the use of generics. Physicians in government health facilities should prescribe unbranded generic drugs to all patients wherever possible, and the government has also regulated the price of almost 500 generic drugs (Kalbe Farma, 2011; Kalbe Farma, 2013).

In 2008, OTC drugs accounted for approximately 43% of the pharmaceutical market, which increased to an estimated 48% in 2013 due to an increase in self-medication as a result of increase in cases of minor ailments and limited insurance coverage.

Counterfeit medicines are however expected to restrict growth, and accounted for approximately 25% of the Indonesian pharmaceutical market in 2005 (WHO, 2005). As a result, the National Agency of Drug and Food Control (NA-DFC), or Badan Pengawas Obat dan Makanan, has strengthened its investigations in an attempt to reduce their influence in the pharmaceutical market (WHO, 2005).

In 2010, according to US Commercial Service estimates, Indonesia’s medical device market was worth approximately $573m. Indonesia manufactures a range of medical equipment such as hospital beds, disposable supplies and wheelchairs; however, it imports more than 90% of its medical devices as the domestic industry is poorly developed. In 2010, according to US Commercial Service estimates, total imports in the medical device market were worth $543m, an increase of 7% over 2009. In 2010, the US accounted for the highest proportion of medical device imports in Indonesia, with 20% (ITA, 2014).

In 2012, the Association of Southeast Asian Nations (ASEAN) Medical Device Directive (AMDD) was introduced by the Medical Device Product Working Group (MDPWG) and is to be fully exercised by all member states by 2015. It will bring much-needed uniformity to the medical device registration system and increase foreign investment in the Indonesian market
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