CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - The Netherlands

  • ID: 4453221
  • Report
  • Region: Netherlands, Holland
  • 175 pages
  • GlobalData
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - The Netherlands

Summary

Pharmaceutical market in the Netherlands was valued at $7.1 Billion in 2009. It declined to $5.8 Billion in 2014 and is expected to further decline to $5.1 Billion in 2017. The decline in value terms has primarily been driven by the increasing use of generic medicines. Between 2013 and 2016, the share of generics in the market reached 70% in terms of volume. Generic medicines are cheap and the lower costs of generics are the primary reason for declining valuation of the pharmaceutical market of Netherlands.

Specific therapeutic segments, such as cardiovascular, gastrointestinal and central nervous system drugs, dominate the market. In order to reduce the healthcare deficit, the government has focused on the use of generics as a cost-containment tool, and between 2013 and 2016, 70% of pharmacy-dispensed medicines were generics. Generic drugs account 72-74% of all prescription drugs sold in 2016, which is high compared with other EU countries and an increase from 56.2% in 2008 and 63.3% 2012 (63.3%).

Whereas, Medical device market was worth $2.7 Billion in 2009 and reached $3.5 Billion in 2016. It is forecast to grow at a CAGR of 4% from $3.6 Billion in 2017 to $4.3 Billion in 2021. The main segments are cardiovascular devices, ophthalmic devices, in vitro diagnostics, and orthopedic devices and wound care management.

Healthcare system in the Netherlands is well developed and efficient. Everyone contributes to the public health insurance scheme in accordance with their income, and all receive care according to their needs. Public health insurance is provided by private health insurers, which manages competition and makes it essential for providers to offer high-quality and efficient healthcare services to subscribers. All subscribers have the right to switch health insurance providers at the time of annual open enrollment, and insurers are obliged to accept all applications. Roughly 60% of the total healthcare budget is allocated to services provided under the Health Insurance Act.

The report "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - The Netherlands", provides information on the healthcare, regulatory, and reimbursement landscape in the Netherlands, 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: Teva, Pfizer, Merck, Roche, and AbbVie; and of major players in the medical device market: Medtronic, Essilor, Roche, Zimmer Biomet, and Ethicon.
  • 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 healthcare environment, demographics, healthcare infrastructure and healthcare expenditure.
  • An overview of the opportunities for and challenges to growth in the Netherlands’ healthcare market.
Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the Netherlands, 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: Teva, Pfizer, Merck, Roche, and AbbVie; and of major players in the medical device market: Medtronic, Essilor, Roche, Zimmer Biomet, and Ethicon
  • 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 healthcare environment, demographics, healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the Netherlands’ 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 Netherlands’ healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the Netherlands’ 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
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1 Table of Contents

2 Executive Summary

3 Introduction
3.1 Report Guidance

4 Overview of 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 of Major Therapeutic 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
5.2 Reimbursement and Payer Landscape
5.3 Reimbursement Process
5.3.1 Overview of Insurance Providers
5.3.2 Patient Share in Healthcare Expenditure
5.3.3 Price Trends in the Healthcare Sector
5.3.4 Pricing Policies
5.4 Regulatory Landscape
5.4.1 Overview of Regulatory Agencies
5.4.2 Market Authorization Procedure for Pharmaceutical Products
5.4.3 Market Authorization Procedure for Medical Devices
5.4.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
5.4.5 Licensing Process for Pharmaceutical Exports and Imports
5.4.6 Intellectual Property Rights
5.4.7 Clinical Trial Regulations
5.4.8 Pharmaceutical Advertising Regulations
5.4.9 Pharmacy Regulations
5.4.10 Labeling and Packaging Regulations

6 Country Healthcare Landscape
6.1 Healthcare Policy Initiatives
6.2 Healthcare Infrastructure
6.2.1 Healthcare Facilities
6.2.2 Healthcare Parameters
6.2.3 Healthcare Personnel
6.2.4 Environmental Health
6.3 Healthcare Expenditure
6.3.1 Overview
6.3.2 Share of Public and Private Sectors
6.3.3 Major Components of Healthcare Expenditure
6.4 Trade Associations
6.4.1 Nefemed
6.4.2 Nefarma
6.4.3 Neprofarm
6.4.4 Diagned
6.5 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, Netherlands, Revenue ($bn), 2009-2016
Table 2: Pharmaceutical Market, Netherlands, Revenue ($bn), 2017-2021
Table 3: Pharmaceutical Market, Netherlands, Imports and Exports ($bn), 2009-2016
Table 4: Pharmaceutical Market, Netherlands, EU Countries, Generic Drugs Market Share (Volume %), 2016
Table 5: Pharmaceutical Market, Netherlands, Biosimilars Approved and Marketed, 2012
Table 6: Pharmaceutical Market, Netherlands, OTC Drugs Market Sales ($m), 2011-2016
Table 7: Pharmaceutical Market, Netherlands, Major OTC Drug Class Market Share (%) and Revenue ($m), 2016
Table 8: Pharmaceutical Market, Netherlands, Expenditure on Major Medicine Groups ($m) and Share (%), 2013
Table 9: Pharmaceutical Market, Teva, Late-Stage Pipeline, 2017
Table 10: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2017
Table 11: Pharmaceutical Market, Merck, Global, Major Products, 2017
Table 12: Pharmaceutical Market, Merck, Global, Late-Stage Pipeline, 2017
Table 13: Pharmaceutical Market, Roche, Global, Revenue ($m) and Annual Growth (%) of Major Products, 2016
Table 14: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2017
Table 15: Pharmaceutical Market, AbbVie, Europe, Late-Stage Pipeline, 2017
Table 16: Medical Device Market, Netherlands, Revenue ($bn), 2009-2016
Table 17: Medical Device Market, Netherlands, Revenue ($bn), 2017-2021
Table 18: Medical Device Market, Netherlands, Revenue ($m) and Market Share (%) by Segment, 2016
Table 19: Cardiovascular Device Market, Netherlands, Revenue ($m), 2009-2016
Table 20: Cardiovascular Device Market, Netherlands, Revenue ($m) and Market Share (%) of Major Players, 2016
Table 21: Ophthalmic Device Market, Netherlands, Revenue ($m), 2009-2016
Table 22: Ophthalmic Devices Market, Netherlands, Revenue ($m) and Market Share (%) of Major Players, 2015
Table 23: In Vitro Diagnostic Market, Netherlands, Revenue ($m), 2009-2017
Table 24: In Vitro Diagnostic Market, Netherlands, Revenue ($m) and Market Share (%) of Major Players, 2017
Table 25: Orthopedic Device Market, Netherlands, Revenue ($m), 2009-2016
Table 26: Orthopedic Device Market, Netherlands, Revenue ($m) and Market Share (%) of Major Players, 2016
Table 27: Wound Care Management Market, Netherlands, Revenue ($m), 2009-2017
Table 28: Wound Care Management Market, Netherlands, Revenue ($m) and Market Share (%) of Major Players, 2017
Table 29: Major Players, Netherlands, Revenue ($m), 2016
Table 30: Medical Device Market, Medtronic, Global, Major Products, 2017
Table 31: Medical Device Market, Essilor, Netherlands, Major Products, 2017
Table 32: Medical Device Market, Roche, Netherlands, Major Products, 2017
Table 33: Medical Device Market, Zimmer Biomet, Global, Major Products, 2017
Table 34: Medical Device Market, Ethicon, Major Products, 2017
Table 35: Healthcare Expenditure, Netherlands, Out-of-Pocket Expenditure (%), 2009-2016
Table 36: Market Access, Netherlands, Consumer Price Index Annual Change (%), 2009-2015
Table 37: Healthcare Infrastructure, Netherlands, Hospitals, 2009-2016
Table 38: Healthcare Infrastructure, Netherlands, Diagnostic Units, 2009-2016
Table 39: Healthcare Infrastructure, Netherlands, Hospitals Beds (per 1,000 population), 2009-2016
Table 40: Demographics, Netherlands, Life Expectancy at Birth (years), 2009-2016
Table 41: Demographics, Netherlands, Life Expectancy at Birth (years), 2017-2021
Table 42: Demographics, Netherlands, Immunization Rate (%), 2009-2016
Table 43: Demographics, Netherlands, Major Causes of Mortality (number of deaths), 2015
Table 44: Demographics, Netherlands, Major Causes of Male Mortality (number of deaths), 2015
Table 45: Demographics, Netherlands, Major Causes of Female Mortality (number of deaths), 2015
Table 46: Demographics, Netherlands, Disability-Adjusted Life Years by Major Disease (‘000), 2015
Table 47: Healthcare Infrastructure, Netherlands, Doctors (per 1,000 population), 2009-2016
Table 48: Healthcare Infrastructure, Netherlands, Nurses (per 1,000 population), 2009-2016
Table 49: Healthcare Infrastructure, Netherlands, Dentists (per 1,000 population), 2009-2016
Table 50: Healthcare Infrastructure, Netherlands, Pharmacists (per 1,000 population), 2009-2016
Table 51: Healthcare Infrastructure, Netherlands, PM2.5 (µg per m³), 2009-2016
Table 52: Healthcare Infrastructure, Netherlands, CO2 Emissions (kilotons), 2009-2016
Table 53: Healthcare Expenditure, Netherlands, Healthcare Expenditure (% of GDP), 2009-2016
Table 54: Healthcare Expenditure, Netherlands, Public-Private Share of Expenditure (%), 2009-2016
Table 55: Healthcare Expenditure, Netherlands, Major Components of Healthcare Expenditure (%), 2016
Table 56: Healthcare Expenditure, Netherlands, Major Healthcare Trade Fairs, 2017

List of Figures
Figure 1: Pharmaceutical Market, Netherlands, Revenue ($bn), 2009-2021
Figure 2: Medical Device Market, Netherlands, Revenue ($bn), 2009-2021
Figure 3: Country Profile, Netherlands, 2017
Figure 4: Pharmaceutical Market, Netherlands, Revenue ($bn), 2009-2016
Figure 5: Pharmaceutical Market, Netherlands, Revenue ($bn), 2017-2021
Figure 6: Pharmaceutical Market, Netherlands, Imports and Exports ($bn), 2009-2016
Figure 7: Pharmaceutical Market, Netherlands, Distribution Channels, 2016
Figure 8: Pharmaceutical Market, Netherlands, EU Countries, Generic Drugs Market Share (%), 2016
Figure 9: Pharmaceutical Market, Netherlands, OTC Drugs Market Sales ($m), 2011-2016
Figure 10: Pharmaceutical Market, Netherlands, Major OTC Drug Class Market Share (%), 2016
Figure 11: Pharmaceutical Market, Netherlands, Expenditure on Major Medicine Groups ($m), 2013
Figure 12: Medical Device Market, Netherlands, Revenue ($bn), 2009-2016
Figure 13: Medical Device Market, Netherlands, Revenue ($bn), 2017-2021
Figure 14: Medical Device Market, Netherlands, Revenue by Segment ($m), 2016
Figure 15: Cardiovascular Device Market, Netherlands, Revenue ($m), 2009-2016
Figure 16: Cardiovascular Device Market, Netherlands, Market Share of Major Players (%), 2016
Figure 17: Ophthalmic Device Market, Netherlands, Revenue ($m), 2009-2016
Figure 18: Ophthalmic Device Market, Netherlands, Market Share of Major Players (%), 2015
Figure 19: In Vitro Diagnostic Market, Netherlands, Revenue ($m), 2009-2017
Figure 20: In Vitro Diagnostic Market, Netherlands, Market Share of Major Players (%), 2017
Figure 21: Orthopedic Device Market, Netherlands, Revenue ($m), 2009-2016
Figure 22: Orthopedic Device Market, Netherlands, Market Share of Major Players (%), 2016
Figure 23: Wound Care Management Market, Netherlands, Revenue ($m), 2009-2017
Figure 24: Wound Care Management Market, Netherlands, Market Share of Major Players (%), 2017
Figure 25: Major Players, Netherlands, Revenue ($m), 2016
Figure 26: Healthcare Market, Netherlands, Drivers and Barriers, 2017
Figure 27: Market Access, Netherlands, Organizational Structure of Healthcare System, 2016
Figure 28: Market Access, Netherlands, Drug Reimbursement Process, 2014
Figure 29: Market Access, Netherlands, Structure of Health Insurance, 2016
Figure 30: Healthcare Expenditure, Netherlands, Out-of-Pocket Expenditure (%), 2009-2016
Figure 31: Market Access, Netherlands, Consumer Price Index Annual Change (%), 2009-2015
Figure 32: Market Access, EU, Centralized Procedure, Market Authorization, Pre-submission Phase, 2017
Figure 33: Market Access, EU, Centralized Procedure, Market Authorization, Pre-opinion Phase, 2017
Figure 34: Market Access, EU, Centralized Procedure, Market Authorization, Post-opinion Phase, 2017
Figure 35: Market Access, EU, Decentralized Procedure, Market Authorization, 2017
Figure 36: Market Access, EU, Conformity Assessment of Class I Medical Devices, 2017
Figure 37: Market Access, EU, Conformity Assessment of Class IIa Medical Devices, 2017
Figure 38: Market Access, EU, Conformity Assessment of Class IIb Medical Devices, 2017
Figure 39: Market Access, EU, Conformity Assessment of Class III Medical Devices, 2017
Figure 40: Market Access, Netherlands, Patent Approval Process, 2016
Figure 41: Healthcare Infrastructure, Netherlands, Hospitals, 2009-2016
Figure 42: Healthcare Infrastructure, Netherlands, Diagnostic Units, 2009-2016
Figure 43: Healthcare Infrastructure, Netherlands, Hospitals Beds (per 1,000 population), 2009-2016
Figure 44: Demographics, Netherlands, Life Expectancy at Birth (years), 2009-2016
Figure 45: Demographics, Netherlands, Life Expectancy at Birth (years), 2017-2021
Figure 46: Demographics, Netherlands, Immunization Rate (%), 2009-2016
Figure 47: Demographics, Netherlands, Major Causes of Mortality (number of deaths), 2015
Figure 48: Demographics, Netherlands, Major Causes of Male Mortality (number of deaths), 2015
Figure 49: Demographics, Netherlands, Major Causes of Female Mortality (number of deaths), 2015
Figure 50: Demographics, Netherlands, Major Diseases, Disability-Adjusted Life Years by Major Disease (‘000s), 2015
Figure 51: Healthcare Infrastructure, Netherlands, Doctors (per 1,000 population), 2009-2016
Figure 52: Healthcare Infrastructure, Netherlands, Nurses (per 1,000 population), 2009-2016
Figure 53: Healthcare Infrastructure, Netherlands, Dentists (per 1,000 population), 2009-2016
Figure 54: Healthcare Infrastructure, Netherlands, Pharmacists (per 1,000 population), 2009-2016
Figure 55: Healthcare Infrastructure, Netherlands, PM2.5 (µg per m³), 2009-2016
Figure 56: Healthcare Infrastructure, Netherlands, CO2 Emissions (kilotons), 2009-2016
Figure 57: Healthcare Expenditure, Netherlands, Healthcare Expenditure (% of GDP), 2009-2016
Figure 58: Healthcare Expenditure, Netherlands, Public-Private Share of Expenditure (%), 2009-2016
Figure 59: Healthcare Expenditure, Netherlands, Major Components of Healthcare Expenditure (%), 2016
Figure 60: Healthcare Market, Netherlands, Opportunities and Challenges, 2017
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Although the Netherlands’ increasing elderly population and its associated disease burden will continue to drive its pharmaceutical market in the future, price cuts, a reimbursement policy aimed at reducing healthcare expenditure, and the increased prescription of generics will restrict the growth of the market.

The value of the pharmaceutical market in the Netherlands was estimated at $6.7 billion in 2013. Specific therapeutic segments, such as cardiovascular, anticancer and gastrointestinal drugs, dominate the market. In order to reduce the healthcare deficit, the government is focusing on the use of generics as a cost-containment tool. The increasingly elderly population and the corresponding increase in the incidence of chronic diseases will help to boost the growth in the pharmaceutical market. It is expected to grow at a steady Compound Annual Growth Rate (CAGR) of 0.9% from $6.7 billion in 2014 to $7.2 billion in 2020.

The 2008–2012 period saw an increase in expenditure on expensive medicines (medicines priced at more than €500 ($670.4)), and in 2011, the revenue generated from their sale increased by €107m ($143.4m) to €1.11 billion ($1.49 billion) (SFK, 2012). However, expenditure on expensive medicines within pharmaceutical care declined in 2012 due to the transfer of the financing of drugs such as Tumor Necrosis Factor (TNF)-alfa inhibitors and associated medicines to the reimbursement list of medicines, as lay out by that year’s hospital budget and based on the cost of the drugs alone. From 2013, other drugs such as oncology drugs and growth hormones may also be transferred to the hospitals’ budget from community pharmacies.

The Ministry of Health, Welfare and Sport (MoHWS) sets the prices for medicines twice a year (in April and October). The Drug Price Act (Wet Geneesmiddelenprijzen, WGP) has played an important role in pricing since its introduction in 1996. Continual price cuts have seen drug prices decline by an average of 3–4% per year, and from 1996 to 2012, prices declined by 50% (SFK, 2012). The price regulations aimed at cost-containment have had a negative impact on the pharmaceutical market.

Since 2003, health insurance providers have adopted an extensive preference policy that restricts the claims of insured patients to one medicine per active ingredient. From June 2008, this policy has resulted in a decline in the prices of generic medicines. The introduction of preference policies by health insurers has played a significant role in the increase in the share of prescriptions dispensed as generic medicines. The share of prescriptions dispensed as generic drugs increased from 56.2% in 2008 to 63.3% in 2012 (SFK, 2010; SFK, 2012). This will mitigate the growth of the pharmaceutical market.

In 2013, the medical device market in the Netherlands was valued at $3.2 billion, having grown at a CAGR of 4.4% from $2.6 billion in 2008. In 2013, the major segments were cardiovascular devices (13.1%), ophthalmic devices (12.1%), In Vitro Diagnostics (IVD) (11.9%), orthopedic devices (11.3%), and hospital supplies (6.0%). The market is driven by factors such as increasing awareness regarding the early detection and diagnosis of disease, advancements in medical technology, and an increase in the elderly population.
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