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The Medical Device Market: Serbia

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No. of Pages : 72
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The Republic of Serbia is located in the south of Central Europe and has two ‘autonomous’ provinces, Vojvodina in the north and Kosovo in the south. Kosovo declared its independence from Serbia in February 2008. Many EU members supported this move, but Serbia refuses to do so.

The Kosovo issue, and co-operation over alleged war criminals, clouds Serbia’s potential membership of the EU, although the country was granted official candidate status in March 2012. The general consensus is that membership is unlikely before 2015.

The health system in Serbia is funded primarily by the Republican Health Insurance Fund (HIF). In theory, the insurance scheme provides universal coverage and reimburses a wide range of services. The generous packages in addition to non-payments by farmers and the self-employed have led to financial difficulties in the fund, however. The government is considering raising out-of-pocket expenditure to reduce the deficit.

In 2012, the Serbian market for medical equipment and supplies is estimated at US$194.6 million, or US$27 per capita. The market shrank in 2009 and 2010, but is expected to return to strong growth of 12.7% CAGR over the 2012-17 period, reaching US$353.5 million, or nearly US$50 per capita by 2017.

Around 92% of the medical device market is supplied by imports, due in part to the implementation of health reforms that increased the demand for new equipment. These are sourced primarily from the USA and western Europe. Imports fell substantially in 1999, as a result of the NATO aerial bombing and wider military operations. They gradually increased in value between 2000 and 2008, but fell again in 2009 and 2010, before returning to growth in 2011.

Medical device legislation based on EU directives was introduced in September 2004. The regulations required manufacturers to update their facilities in accordance with GMP standards within five years, dating from the enforcement of the Law on Medicinal Products and Medical Devices.

Table Of Contents

Executive Summary 1
Key Background Data 4
Geographic 4
Political 4
Economic 4
Healthcare System 5
Healthcare System Reform 5
Improvement of Preventive Health Services in Serbia Project 6
World Bank Health Project 6
Healthcare Expenditure 6
Market Developments 8
Health Sector Continues to Receive Financial Support from Japan 8
Serbia to Strengthen its Health Institutions in Kosovo 8
Poor Import Performance in 2012 8
Amendments to Healthcare Laws 8
Health Insurance Financial Plan for 2013 8
Continued Cooperation with China 9
Cooperation between Serbia and Egypt 9
Medical Market Analysis 10
Overview 10
The Market in 2012 11
Past Performance 2007-11 12
Future Performance 2012-17 13
The Serbian Market for Consumables 19
The Serbian Market for Diagnostic Imaging 21
The Serbian Market for Dental Products 23
The Serbian Market for Orthopaedic & Prosthetic Products 25
The Serbian Market for Patient Aids 27
The Serbian Market for Other Medical Devices 29
Annual Imports 32
Consumables 33
Diagnostic Imaging 33
Dental 33
Orthopaedic & Prosthetic Products 33
Patient Aids 33
Other Medical Products 33
Monthly Imports 45
Annual Exports 46
Consumables 47
Diagnostic Imaging 47
Dental Products 47
Orthopaedic & Prosthetic Products 47
Patient Aids 47
Other Medical Products 47
Monthly Exports 61
Domestic Production 62
Domestic Manufacturing 63
Local Manufacturers 63
Boci Co 63
Prizma d.o.o 63
Proxima 63
Zdravlje 63
Multinational Manufacturers 64
Fresenius Medical Care Srbija (Hemomed) 64
Multinational Activity 65
Accessing the Market 66
Distribution 66
Medical De vice Regulations 67
Competent Authority 68
Medical Device Classification 68
Marketing Authorisation 68
Methodology & Sources 69
Trade Code Classifications 69
Methodology 71
Sources 72

List Of Tables

Espicom Analysis of the Serbian Medical Market, 2013 2
SWOT Analysis of the Serbian Medical Device Market, 2013 3
Summary of Key Data Projections, 2013-18 4
Summary of Key Data, 2006-12 7
Projected Health Insurance Revenues for 2013 8
Serbian Medical Device Market, Key Ratios, 2012 10
Serbian Medical Device Market by Category, 2012 11
Projected Medical Device Market, 2012-17 13
The Serbian Medical Device Market, 2007-17 (US$ millions) 14
The Serbian Medical Device Market, 2007-17 (US$ per capita) 16
The Serbian Medical Device Market, 2007-17 (% of Total) 17
The Serbian Medical Device Market, 2007-17 (% Change) 18
The Serbian Consumables Market, 2007-17 (US$ millions) 19
The Serbian Consumables Market, 2007-17 (US$ Per Capita) 19
The Serbian Consumables Market, 2007-17 (% Change) 19
The Serbian Diagnostic Imaging Market, 2007-17 (US$ millions) 21
The Serbian Diagnostic Imaging Market, 2007-17 (US$ Per Capita) 21
The Serbian Diagnostic Imaging Market, 2007-17 (% Change) 22
The Serbian Dental Products Market, 2007-17 (US$ millions) 23
The Serbian Dental Products Market, 2007-17 (US$ Per Capita) 24
The Serbian Dental Products Market, 2007-17 (% Change) 24
The Serbian Orthopaedic & Prosthetic Products Market, 2007-17 (US$ millions) 25
The Serbian Orthopaedic & Prosthetic Products Market, 2007-17 (US$ Per Capita) 25
The Serbian Orthopaedic & Prosthetic Products Market, 2007-17 (% Change) 26
The Serbian Patient Aids Market, 2007-17 (US$ millions) 27
The Serbian Patient Aids Market, 2007-17 (US$ Per Capita) 27
The Serbian Patient Aids Market, 2007-17 (% Change) 27
The Serbian Other Medical Devices Market, 2007-17 (US$ millions) 29
The Serbian Other Medical Devices Market, 2007-17 (US$ Per Capita) 29
The Serbian Other Medical Devices Market, 2007-17 (% Change) 30
Summary Medical Equipment Imports by Product Area, 2008-2011 (US$000s) 33
Summary Medical Equipment Imports by Product Area, 2009-2011 (US$000s % Change) 34
Summary Medical Equipment Imports by Product Area, 2008-2011 (000s Dinars) 34
Summary Medical Equipment Imports by Product Area, 2009-2011 (Dinars % Change) 35
Summary Medical Equipment Imports by Product Area, 2007-2011 (% of Total) 36
Leading Medical Equipment Suppliers by Product Area, 2011 (US$000s) 37
Top 20 Suppliers to the Serbian Market, 2011 (US$000s) 38
Detailed Imports of Medical Equipment, 2008-2011 (US$000s) 39
Detailed Imports of Medical Equipment, 2008-2011 (Growth Trends) 41
Detailed Imports, Leading Suppliers, 2011 (US$000s) 43
Monthly Imports of Medical Equipment, November 2009-December 2012 (US$ Millions) 45
Summary Medical Equipment Exports by Product Area, 2008-2011 (US$000s) 47
Summary Medical Equipment Exports by Product Area, 2008-2011 (US$000s % Change) 48
Summary Medical Equipment Exports by Product Area, 2008-2011 (Dinars 000s) 48
Summary Medical Equipment Exports by Product Area, 2008-2011 (Dinars % Change) 49
Summary Medical Equipment Exports by Product Area, 2008-2011 (% of Total) 50
Leading Medical Equipment Destinations by Product Area, 2011 (US$000s) 51
Top 20 Destinations for Serbian Exports, 2011 (US$000s) 52
Detailed Exports of Medical Equipment, 2008-2011 (US$000s) 52
Detailed Exports of Medical Equipment, 2008-2011 (Growth Trends) 54
Detailed Exports, Leading Destination, 2011 (US$000s) 56
Balance of Medical Trade, 2007-2011 (US$000s) 58
Monthly Exports of Medical Equipment, November 2009-December 2012 (US$ Millions) 61
Serbian Medical Device Regulations, 2010-2012 67
HS Trade Codes Used in This Report 69
HS Trade Codes, Rearranged 70

List Of Charts

Serbian Medical Device Market by Category, 2012 (%) 11
Change in the Serbian Medical Device Market, 2007-17 (%) 12
CAGR of the Serbian Medical Device Market by Product Area, 2007-11 (%) 12
Market Projections, 2012-17 (US$ millions) 13
Projected CAGR of Medical Device Market by Product Area, 2012-17 (%) 14
The Serbian Market for Consumables, 2007-17 (US$ millions) 20
The Serbian Market for Consumables, 2007-17 (CAGR) 20
The Serbian Market for Diagnostic Imaging, 2007-17 (US$ millions) 22
The Serbian Market for Diagnostic Imaging, 2007-17 (CAGR) 23
The Serbian Market for Dental Products, 2007-17 (US$ millions) 24
The Serbian Market for Dental Products, 2007-17 (CAGR) 25
The Serbian Market for Orthopaedic & Prosthetic Products, 2007-17 (US$ millions) 26
The Serbian Market for Orthopaedic & Prosthetic Products, 2007-17 (CAGR) 26
The Serbian Market for Patient Aids, 2007-17 (US$ millions) 28
The Serbian Market for Patient Aids, 2007-17 (CAGR) 28
The Serbian Market for Other Medical Devices, 2007-17 (US$ millions) 30
The Serbian Market for Other Medical Devices, 2007-17 (CAGR) 31
Medical Equipment Imports, 2008-11 (US$ millions) 32
Change in Medical Equipment Imports, 2008-11 (%) 32
CAGR of Medical Imports by Product Area, 2008-11 (%) 35
Medical Equipment Imports by Product Area, 2011 (%) 36
Leading Medical Equipment Suppliers, 2011 (%) 38
Exports of Medical Equipment, 2004-2011 (US$ millions) 46
CAGR of Medical Exports by Product Area, 2009-2011 (%) 49
Medical Equipment Exports by Product Area, 2011 (%) 50
Leading Medical Equipment Destinations, 2011 (%) 51

The Medical Device Market: Serbia

Published By: Espicom Limited
 

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