Romania Medical Devices Report

Published 09 February 2015

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Romania Medical Devices Report

BMI Industry View: We project t he Romanian medical device market to grow by a CAGR of 2.9 % over the 2013-2018 period, in line with economic growth and rising health expenditure. The scarcity of high-tech equipment and the acute need for renovation within hospitals keeps the demand for medical devices high. The market is expected to remain heavily reliant on im ports as the domestic industry mainly produces outdated equipment that can only compete with foreign products in terms of price .

Headline Industry Forecasts

  • In 2013, the Romanian medical device market was estimated at USD436.6mn, or USD20 per capita. This market size is comparable to Belarus; in per capita terms, the market is similar to Ukraine. The market contracted by a CAGR of 4.2% over the 2008-2013 period, but it is expected to expand at a 2013-2018 CAGR of 2.9%, reaching USD503.5mn, or USD24 per capita by 2018.

  • Around 90% of the medical device market is supplied by imports. Romania imported medical devices valued at USD387.2mn in 2013; this represented a decrease of 0.4% compared with 2012, in US dollar terms, and a 2008-2013 CAGR of -4.0%. Imports have increased every year since 2005 with the exception of 2009, 2012 and 2013.

  • Romanian medical device exports have grown strongly in recent years, albeit from a very low base. Exports rose increased by 32.0% in 2013, reaching USD102.1mn. The 2008-2013 CAGR was 10.8%. The trade deficit shrunk from USD311.4mn in 2012 to USD285.1mn in 2013, due to strong export growth and falling imports.

  • Romania produces very little in the way of medical equipment. Items manufactured locally, principally comprise basic consumables. Domestic medical device production is estimated to be around USD150mn.

Headline Industry Risk/Reward Index

  • Romania is the fifth least attractive market in Central & Eastern Europe (CEE) in which to commercialise a medical device, according to BMI's Medical Device Risk/Reward Index (RRI). The country's overall score for...

Table of Contents

Espicom Industry View
7
SWOT
9
Medical Device Market
9
Political
10
Economic
11
Business Environment
12
Industry Forecast
13
Medical Device Market Forecast
13
Past Performance 2008-2013
13
Future Performance 2013-2018
15
Table: Projected Medical Device Market, 2013-2018
16
Table: Detailed Medical Device Market By Product Area, 2008-2018 (US$mn)
17
Consumables Market Forecast
20
Bandages & Dressings
20
Suturing Materials
20
Syringes, Needles & Catheters
21
Other Consumables
21
Table: Consumables Market, 2008-2018 (US$mn)
21
Table: Consumables Market, 2009-2018 (US$mn % Change)
22
Diagnostic Imaging Market Forecast
23
Electrodiagnostic Apparatus
24
Radiation Apparatus
24
Imaging Parts & Accessories
24
Table: Diagnostic Imaging Market, 2008-2018 (US$mn)
25
Table: Diagnostic Imaging Market, 2009-2018 (US$mn % Change)
26
Dental Products Market Forecast
28
Capital Equipment
28
Instruments & Supplies
28
Table: Dental Products Market, 2008-2018 (US$mn)
28
Table: Dental Products Market, 2009-2018 (US$mn % Change)
29
Orthopaedics & Prosthetics Market Forecast
30
Fixation Devices
30
Artificial Joints
31
Other Artificial Body Parts
31
Table: Orthopaedics & Prosthetics Market, 2008-2018 (US$mn)
31
Table: Orthopaedics & Prosthetics Market, 2009-2018 (US$mn % Change)
32
Patient Aids Market Forecast
33
Portable Aids
33
Therapeutic Appliances
33
Table: Patient Aids Market, 2008-2018 (US$mn)
34
Table: Patient Aids Market, 2009-2018 (US$mn % Change)
34
Other Medical Devices Market Forecast
36
Table: Other Medical Devices Market, 2008-2018 (US$mn)
36
Table: Other Medical Devices Market, 2009-2018 (US$mn % Change)
38
Annual Medical Device Imports
40
Table: Medical Device Imports By Product Area, 2009-2013 (US$000s)
43
Table: Medical Device Imports By Product Area, 2009-2013 (US$000s % Change)
44
Table: Medical Device Imports By Product Area, 2009-2013 (Local Currency 000s)
45
Table: Medical Device Imports By Product Area, 2009-2013 (Local Currency 000s % Change)
46
Table: Top 20 Medical Device Suppliers, 2013 (US$000s)
48
Table: Detailed Medical Device Imports By Product Area, 2009-2013 (US$000s)
49
Table: Detailed Medical Device Import Trends by Product Area, 2013
52
Table: Detailed Leading Medical Device Suppliers by Product Area, 2013 (US$000s)
55
Monthly Medical Device Imports
58
Table: Monthly Medical Device Imports By Product Area, May 2011-May 2014 (US$mn)
59
Annual Medical Device Exports
61
Table: Medical Device Exports By Product Area, 2009-2013 (US$000s)
64
Table: Medical Device Exports By Product Area, 2009-2013 (US$000s % Change)
65
Table: Medical Device Exports By Product Area, 2009-2013 (Local Currency 000s)
66
Table: Medical Device Exports By Product Area, 2009-2013 (Local Currency 000s % Change)
67
Table: Top 20 Medical Device Destinations (US$000s), 2013
69
Table: Detailed Medical Device Exports By Product Area, 2009-2013 (US$000s)
70
Table: Detailed Medical Device Export Trends By Product Area, 2013
73
Table: Detailed Leading Medical Device Destinations By Product Area, 2013 (US$000s)
76
Table: Detailed Medical Device Trade Balance, 2009-2013 (US$000s)
79
Monthly Medical Device Exports
82
Table: Monthly Medical Device Exports By Product Area, May 2011-May 2014 (US$mn)
83
Macroeconomic Forecasts
85
Table: Economic Activity (Romania 2009-2018)
90
Industry Risk Reward Ratings
91
Table: CEE Medical Device Risk/Reward Ratings, Q414
92
Market Overview
93
Medical Device Market Overview
93
Table: Medical Device Market, Key Ratios, 2013
94
Table: Medical Device Market By Product Area, 2013
94
Healthcare Overview
95
Health Status
95
Healthcare System
96
Healthcare Funding
98
Healthcare Resources
100
Table: Medical Device Technology By Type And Sector, 2010 (Units)
101
Healthcare Activity
101
Healthcare Personnel
101
Key Healthcare Data
102
Table: Key Healthcare Data, 2008-2013
102
Industry Trends And Developments
105
Regulatory Development
109
Medical Device Regulations
109
EU Medical Device Regulations
109
Designated Authorities
109
Existing Regulations
110
Proposed Regulatory Changes
110
Implications For The Industry
113
Medical Device Pricing & Reimbursement
115
Competitive Landscape
116
Domestic Medical Device Production
116
Table: Medical Device Production By Detailed Product Area, 2009-2013 (EURmn)
116
Table: Medical Device Production By Detailed Product Area, 2009-2013 (US$mn)
119
Table: Medical Device Production By Detailed Product Area, 2009-2013 (% Distribution)
122
Domestic Medical Device Manufacturing
125
National Medical Device Manufacturers
126
Multinational Medical Device Manufacturers
126
Multinational Market Activity
127
Table: Multinational Market Activity, 2014
127
Medical Device Market Access
128
Market Environment
128
Distribution
128
Trade Fair
129
Methodology
130
Medical Device Market Methodology
130
Trade Code Classifications
131
Table: Used HS Trade Codes, 2014
131
Table: Rearranged HS Trade Codes, 2014
133
Risk/Reward Ratings Methodology
136
Table: Medical Devices Risk/Reward Ratings Indicators, 2014
137
Sources
138
Contact
139

The Romania Medical Devices Report features market forecasts supported by trade, production and healthcare estimates by Espicom, a BMI Research's company. These forecasts and estimates focus on six product areas: Consumables, Diagnostic Imaging, Dental Products, Orthopaedics & Prosthetics, Patient Aids and Other Medical Devices.

Detailed product breakdown for market, trade and production data in Romania provides industry professionals, strategists, company executives and analysts with independent forecasts and competitive intelligence on the Romania Medical Devices industry.

Key Benefits

  • Benchmark BMI's Medical Devices market forecasts, which take into account macroeconomic and industry-specific forecasts for Romania, to test analysis as it is a key input for budgeting and strategic business planning. Use our standardised data to gain a better understanding of market performance in Romania.
  • Target Business Opportunities in the Romania Medical Devices market by using our assessments and projections for demographic trends, regulatory developments, investment dynamics and domestic demand in Romania.
  • Assess the activities and market position of your competitors via our assessments of domestic production, national and multinational manufacturers, along with the trade and distribution outlets of multinationals, key company developments and future growth prospects.

Coverage

BMI Industry View

Provides industry, political and economic views. Briefly analyses the medical devices market, taking into account the latest industry forecasts, healthcare indicators and industry trends & developments.

SWOT

SWOT analyses of the medical devices market, the political environment, the economic landscape and the business environment.

Industry Forecasts

Evaluates and analyses the medical devices market in terms of historical and forecast trends, covering six product areas: Consumables, Diagnostic Imaging, Dental Products, Orthopaedics & Prosthetics, Patient Aids and Other Medical Devices. Additionally, presents annual and monthly import and export trade data.

Macroeconomic Forecasts

Presents macroeconomic forecasts impacting the medical devices market.

Industry Risk Reward Index

Risk Reward Indices tool, which provides a globally comparative and numerically based assessment of the medical devices market’s attractiveness.

Market Overview

Assesses the medical devices market in the current year. Additionally, covers healthcare trends shaping the market, focusing on health status, healthcare system, healthcare funding, healthcare resources, healthcare activity and healthcare personnel. Includes historical healthcare data.

Industry Trends & Developments

Analyses the latest industry trends and developments shaping the market, in terms of monthly trade performance, forecast trends, production changes, regulatory developments, competitive strategies, political events and economic performance.

Regulatory developments

A focus on government healthcare reforms, epidemiological trends, mergers and acquisitions, product launches, market entries, FDI activity, R&D, biotechnology, clinical trials and supply chain issues.

Competitive Landscape

Values historical medical devices production, and analyses the presence of national and multinational manufacturers operating in the market. Also, compares the presence of leading multinational company operations, either via sales & marketing, distribution or manufacture. Finally, takes into account market access drivers, including major distribution channels, trade associations and trade shows.

Methodology

Carefully explains the medical devices market methodology, trade classifications, Risk Reward Index methodology and sources used in the medical devices market Report.

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Testimonials

'An essential, multi-faceted research tool. BMI’s thorough understanding of the major market players enables an informed – and informative – review of the sector’s actual performance, together with useful insights into current industry issues, which are topped-off with detailed and invaluable forecasts of industry and macroeconomic trends.’

Senior Research Analyst, ABC International Bank plc