‘Turkish Pharmaceutical Market 2015’ - İEİS · TURKISH PHARMACEUTICAL MARKET . TUR KISH PHARM...
Transcript of ‘Turkish Pharmaceutical Market 2015’ - İEİS · TURKISH PHARMACEUTICAL MARKET . TUR KISH PHARM...
2015
TURKISHPHARMACEUTICAL
MARKET
TUR
RKISSH PHHARM
MAC
201
May, 20
www.ieis.o
EUTI
5
016
org.tr
ICAL
L MARRKETT
Copyright 2016 © Pharmaceutical Manufacturers Association of Turkey
This report is the property of Pharmaceutical Manufacturers Association of Turkey and all rights regarding this report is reserved and protected within the scope of the provisions of
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1
Table of Contents
INTRODUCTION
1. Turkish Medicinal Products Market .................................................................... 4
a. New Product Entries on the Market .............................................................. 5 b. Average Prices ............................................................................................. 5
1.1. Turkish Drugs Market ............................................................................. 6
1.1.1. Market Distribution ............................................................................. 7
a. Originator-Generic Drugs ................................................................... 7 b. Import-Local Drugs ............................................................................ 9 c. Biotechnological Drugs ....................................................................... 10 d. New Drug Entries on the Market ...................................................... 12 e. Treatment Groups .............................................................................. 13
1.1.2. Drug Prices ...................................................................................... 14 a. Pharmaceutical Price Legislation ..................................................... 14 b. Average Prices ................................................................................ 15 c. Retail Price Ranges ......................................................................... 16
1.2. Non-Pharmaceutical Products ............................................................ 18
2. Production ........................................................................................................... 19
3. Research & Development .................................................................................. 20
4. Foreign Trade ...................................................................................................... 20
5. Financial Results ................................................................................................ 23
6. Conclusion and Assessment ............................................................................. 25
2
List of Charts Chart 1- Turkish Medicinal Products Market ....................................................................... 4 Chart 2- Turkish Drugs Market ............................................................................................. 6 Chart 3- Sources Of Growth ................................................................................................. 7 Chart 4- Originator-Generic Drugs (Value) .......................................................................... 8 Chart 5- Originator-Generic Drugs (Volume) ....................................................................... 8 Chart 6- Market Share Of Originator-Generic Drugs (Value) .............................................. 8 Chart 7- Market Share Of Originator-Generic Drugs (Volume) .......................................... 8 Chart 8- Import-Local Drugs (Value) ..................................................................................... 9 Chart 9- Import-Local Drugs (Volume) ................................................................................. 9 Chart 10- Market Share Of Import-Local Drugs (Value) .................................................... 10 Chart 11- Market Share Of Import-Local Drugs (Volume) ................................................. 10 Chart 12- Biotechnological Drugs (Value) ......................................................................... 11 Chart 13- Biotechnological Drugs (Volume) ...................................................................... 11 Chart 14- Market Share Of Reference-Biosimilar Drugs (Value) ...................................... 11 Chart 15- Market Share Of Reference-Biosimilar Drugs (Volume) .................................. 11 Chart 16- Therapeutic Groups (Value) ................................................................................ 13 Chart 17- Therapeutic Groups (Volume) ............................................................................ 13 Chart 18- Retail Price Distribution ..................................................................................... 16 Chart 19- Price Distribution Of Originator Products ......................................................... 17 Chart 20- Price Distribution Of Generic Products ............................................................ 17 Chart 21- Price Distribution Of Import Products .............................................................. 18 Chart 22- Price Distribution Of Local Products ................................................................ 18 Chart 23- Non-Pharmaceutical Products .......................................................................... 19 Chart 24- Industrial Production Index Change (2009-2015) ............................................ 19 Chart 25- Pharmaceutical R&D Spending ......................................................................... 20 Chart 26- Pharmaceutical Industry Within Turkish Foreign Trade ................................. 21 Chart 27- Reel Change In Net Sales (2009-2014) .............................................................. 23 Chart 28- Operating Profitability/Net Sales ....................................................................... 23 Chart 29- Net Profitability/ Equity ...................................................................................... 24 Chart 30- Reel Change In Equity (2009-2014) ................................................................... 24 Chart 31- Property Plant And Equipment (2009-2014) ...................................................... 25 Chart 32- Exchange Rates .................................................................................................. 26
List Of Tables Table 1- Overall Market Sub Distributions .......................................................................... 5 Table 2- Quantitative Distribution Of The Products In The Market ................................... 5 Table 3- Average Price Distribution ..................................................................................... 5 Table 4- Average Price Change ............................................................................................ 6 Table 5- Sub Distributions Of Originator-Generic Drugs .................................................. 9 Table 6- Sub Distributions Of Import-Local Drugs ........................................................... 10 Table 7- Biotechnological Drugs ....................................................................................... 12 Table 8- Quantitative Distribution Of The Drugs In The Market ...................................... 12 Table 9- Reference Price Ratios ......................................................................................... 14 Table 10- Discount Rates .................................................................................................... 15 Table 11- Drug Average Price Distribution (TL) ................................................................ 16 Table 12- Drug Average Price Change .............................................................................. 16 Table 13- Import And Export Of Pharmaceutical Products (Million USD) ....................... 21 Table 14- Export Value Per Kg (USD) ................................................................................. 22 Table 15- Export On Basis Of Countries (Million USD) ..................................................... 22 Table 16- Import On Basis Of Countries (Million USD) ..................................................... 22
3
INTRODUCTION Pharmaceutical manufacturing, with its direct implications in the quality of human life, its high added value and cutting-edge technology, its experienced workforce and export potential, has been named a strategically important industry for its social and economic impacts. Growing in tandem with the expansion of the country’s medical needs, the landscape of the Turkish pharmaceutical industry has changed quickly following the reform of the country’s healthcare sector under the Turkish Ministry of Health’s Health Transformation Program. The Turkish pharmaceutical industry provides more than 11 thousand products to the service of our people produced at 67 facilities at international standards by approximately 300 companies and 31 thousand employees. The operational capabilities of the Turkish pharmaceutical manufacturer are based on decades of production experience which have engendered an industry strongly committed to upholding international quality standards. On par with products manufactured in developed markets and owing to the quality of Turkey’s human capital as well as state-of-the-art technology, the industry’s footprint now extends to 160 countries, including European Union (EU) members, the Commonwealth of Independent States (CIS), North Africa and the Middle East. Established in 1964, the Pharmaceutical Manufacturers Association of Turkey (IEIS) is committed to improving business conditions of its members and contributing to the development of healthcare policies within Turkey. The core of the 52 IEIS members consists of pharmaceutical producers including local and multinational companies. IEIS provides services to the pharmaceutical firms that are active in widespread and different working areas, ranging from production and imports of originator products to branded generics, active ingredients as well as contract manufacturing. It closely follows the interests of all segments of the pharmaceutical industry in seeking to realize the organization’s larger goal of furthering the global presence of an industry strongly focused on both export-led growth and the production of higher value-added products especially biotechnologicals through extensive R&D activities. Turkey’s medicinal products market consists of pharmaceuticals and non-pharmaceuticals. Non-pharmaceutical products include biocidal products; some medical devices in pharmaceutical form; foods for special medicinal purposes; cosmetic and dermocosmetic products licensed by the Ministry of Health; and the vitamins, food supplements, and baby formulas approved by the Ministry of Food, Agriculture, and Livestock. This report prepared by IEIS scrutinizes the prescription and non-prescription drugs market and non-pharmaceutical products over the course of the past six years, which was the execution of the global budget period. Turkish pharmaceutical has been evaluated in the categories of prescription, originator-generic, import-local, and biotechnological drugs. The analyses of production, R&D, and foreign trade of pharmaceutical sector are other significant sections of the report.
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5
Table 1- Overall Market Sub Distributions 2009 2015 Value
(Billion TL) Share Value
(Billion TL) Share Medicinal Products Market 13.20 100% 16.86 100% Drugs 12.71 96.3% 15.87 94.1% Prescription Drugs 12.60 95.5% 15.82 93.8% Reimbursed 12.35 93.6% 14.67 87.0%
Non- reimbursed 0.25 1.9% 1.15 6.8% Non- prescription Drugs 0.10 0.8% 0.04 0.3% Reimbursed 0.10 0.8% 0.02 0.1%
Non- reimbursed 0.00 0.0% 0.03 0.2% Non- pharmaceutical Drugs 0.49 3.7% 0.99 5.9% Reimbursed 0.04 0.3% 0.00 0.0%
Non- reimbursed 0.46 3.5% 0.99 5.9% Source: IMS, IEIS a. New Product Entries on the Market
A total of 552 new products were launched on the medical product market in 2015, of which 358 were licensed drugs and 194 were non-pharmaceutical products such as food supplements. The number of the products reimbursed as of 2015 was 8,104, and 292 of the products added to the market were included on the reimbursement list.
Table 2- Quantitative Distribution of the Products in the Market 2015
Market Total 11,233 Entries 552 Drugs 358 Non- pharmaceutical Drugs 194 Reimbursement List 8,104 Entries 292 Withdrawals 532
Source: IEIS b. Average Prices
While prices of non-pharmaceutical products increased between the years 2009 and 2015, the prices of drugs declined. Average price on the medicinal products market was approximately 9 TL, which was 8.5 TL in drugs and 14 TL in non-pharmaceutical products.
Table 3- Average Price Distribution Years Medicinal Products Drugs Non- pharmaceutical products2009 8.84 8.85 8.53 2010 8.33 8.31 8.63 2011 7.75 7.66 9.51 2012 7.17 7.05 9.71 2013 7.56 7.38 12.18 2014 8.01 7.83 12.78 2015 8.67 8.47 14.03
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0 0.02
0
2009 2010 2
Refere
(million)
Chart 13- B
Source: IM
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%
%
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%
%
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2009rce: IMS, IE
rt 15- MarkBiosimila
6 million TL
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asis of thedrugs hav
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1.99 13.92
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2011 2012 2
nce Bios
Biotechnolo(Volume)
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12
Table 7- Biotechnological Drugs Box Value 2009 2015 2009 2015 Biosimilar 100% 100% 100% 100% Antianemic Preparations 0% 14% 0% 39% Antithrombotic Drugs 0% 75% 0% 27% Immunomodulator Agents 100% 8% 100% 22% Pituitary and Hypothalamus Hormones and Analogues 0% 4% 0% 12% Reference 100% 100% 100% 100% Immunomodulator Agents 8% 7% 34% 32% Insulin and Analogues 62% 61% 25% 26% Antineoplastic Drugs 2% 1% 15% 10% Ophthalmologics 0% 1% 1% 7% Digestive System and Metabolism 0% 0% 2% 5% Vitamine K and other hemostatics 0% 1% 1% 5% Antianemic Preparations 4% 2% 10% 3% Antithrombotic Drugs 17% 20% 3% 3% Sex hormones and Genital System Modulators 2% 2% 4% 3% Pituitary and Hypothalamus Hormones and Analogues 3% 4% 4% 3% Other systemic drugs for obstructive airway diseases 0% 0% 0% 2% Serum Immune Globulins 0% 0% 1% 1% Source: IMS, IEIS d. New Drug Entries on the Market The treatment group that has the highest proportion on quantity basis among the 358 drugs newly launched on the market has been the drugs for nervous system. 47 nervous system drugs, 42 antirheumatic drugs, 39 antibiotic drugs, 34 common cold medications and cough medicines, 27 vitamins and minerals, and 26 oncology drugs have entered the market during the last year. A total of 76 pieces of originator products, 2 of which were biotechnological and 74 chemical, entered the market in 2015. 65 (86%) of the products in question do not have a generic competitor; only 2are produced in Turkey. The average price of the 65 products is 81 TL. 282 generic drugs newly accessed the market, of which only 16 are imported. The average price of these 282 drugs is 8.5 TL.
Table 8- Quantitative Distribution of Drugs in the Market 2015
Market Total 11,233 Entries 552 Drugs 358 Original 76 With Generics 11
Without Generics 65 Generic 282 Import 16 Local 266
Source: IEIS
13
e. Treatment Groups A scrutiny of the market in terms of treatment groups will demonstrate that oncology and blood products have tended to increase, but antibiotics and antirheumatics have been prone to decrease in the last six years. The group that had the highest share on the market was the oncology products group with 11.1% proportion in 2015. The group that increased most in 2015 was the cardiovascular products group with a 54% increase.
In unit terms, antibiotics continued their tendency to decrease in 2015 as well and became the second most widely consumed treatment group with 10.5% proportion. The antirheumatic product group continued to increase its market share as it maintained its position in the top rank. The product group that exhibited the highest level of increase in 2015 by volume became the cardiovascular drugs.
8.4%
11.11%12.6%
8.0%
13.3%
4.2%
5.0%
8.1%6.2%
3%
5%
7%
9%
11%
13%
15%
2009 2010 2011 2012 2013 2014 2015
Oncology
Antibiotics
Cardiovascular
Blood Products
Antidiabetics
Antirheumatics
Market Share
13.8%12.1%
14.4%
10.5%
8.2%8.7%
9.4%
8.1%
7.5% 7.2%
5.3%5.8%
4%
6%
8%
10%
12%
14%
16%
2009 2010 2011 2012 2013 2014 2015
Antirheumatics
Antibiotics
Cardiovascular
Caugh and ColdMedicines
Anelgesics
Digestive SystemMedicines
Chart 16- Therapeutic Groups (Value)
Source: IMS, IEIS
Chart 17- Therapeutic Groups (Volume)Market Share
Source: IMS, IEIS
14
1.1.2. Drug Prices a. Pharmaceutical Price Legislation Price reference system was first introduced in 2004 in Turkey with the intent of checking governmental healthcare expenditures through associating the price of pharmaceuticals to the lowest price at which a similar pharmaceutical product is produced within a basket of five European nations (France, Greece, Italy, Portugal and Spain). Whichever region produces a specified pharmaceutical at the lowest price, that price is taken to be the reference price for producer prices in Turkey. Once a reference price has been set, official prices of products in different categories are established based on a fraction of the reference price. For example, while an originator product with no generic competitor may have the right to receive 100% of the reference price, an originator and generic product that compete against one another are subject to 60% of the reference price. In effect, the result of this is that as soon as a generic drug that competes against an originator product is introduced on the local market, the price of the originator product falls by 40%. Since the source prices are traced in Euro currency, a fixed foreign currency exchange rate in Euro is determined by the Price Assessment Commission to convert them into TL. This value is determined as 70% of the Euro average of the previous year. For 2016, the conversion Euro value is 2.1166 TL. Table 9- Reference Price Ratios
Producer Price (TL)
2009 2010
-2011
2012-
2014 Producer Price (TL) 2015
Producer Price (TL) 2016
Originator
3.55 and below 100 100 100
3.62 and below 100
3.83 and below 100
3.56- 6.78 100 100 100 3.63- 6.92 100 3.84-7.32 100
6.79 and over 100 100 100
6.93 and over 100
7.33 and over 100
Originator with
Generic and the Generic Product
3.55 and below 100 100 100
3.62 and below 100
3.83 and below 100
3.56- 6.78 80 66 60 3.63- 6.92 60 3.84-7.32 60 6.79 and over 80 66 60
6.93 and over 60
7.33 and over 60
Twenty Years
3.55 and below 100 100 100
3.62 and below 100
3.83 and below 100
3.56- 6.78 100 100 100 3.63- 6.92 100 3.84-7.32 100
6.79 and over 100 100 80
6.93 and over 80
7.33 and over 80
Once a producer price is established by the Ministry of Health, discount rates are applied by the Social Security Institution (SSI) for granting reimbursement status. The following table shows discount rates applied for different product groups.
Source: TİTCK (Ministry of Health, Medicines and Medical Devices Agency of Turkey)
15
The discount thresholds have been updated in parallel with the exchange rate increase in order to be valid from February 22, 2016, and the discount ratios in some product groups have been reduced as well. Additionally, price increases between 10% and 20% were applied gradually to the low-price products whose retail sales price was 5.63 TL and below. Likewise, a 3% price increase was applied to the twenty-year-old products whose price range was between 5.64 and 10.77 TL. The recent changes in our sector are promising. Such developments will pave the way for our country to be a more powerful producer and exporter of pharmaceuticals. Table 10- Discount Rates
Producer Price(TL): 2009 2010 2011 2012 2013
-2014
2015
2016
Originator
3.55 and below
4 4 4 4 0
3.62 and below
0 3.83
and below
0
3.56- 6.78
24 23 32,5 41 20 3.63- 6.92 20 3.84-
7.32 10
6.79 and over
24 23 32,5 41 41 6.93 and over
41
7.33-11.02 31
11.03 and over
41
Originator with
Generic and the Generic Product
3.55 and below
4 4 4 4 0
3.62 and below
0 3.83
and below
0
3.56- 6.78
11 11 20,5 28 20 3.63- 6.92 20 3.84-
7.32 10
6.79 and over
11 11 20,5 28 28 6.93 and over
28
7.33-11.02 18
11.03 and over
28
Twenty Years
3.55 and below
4 4 4 4 0
3.62 and below
0
7.32 and below
0 3.56- 6.78
11 11 11 11 7 3.63- 6.92 7
6.79 -10.21
Local - - - 28 20
6.93 -10.42
20
7.33-11.02
10 Reference price available
11 11 20,5 28 20 20
10
No reference price
24 23 32,5 40 20 20
10
10.22 and
over
Local - - - 28 28
10.43 and over
28
11.03 and over
28 Reference price available
11 11 20,5 28 28 28
28
No reference price
24 23 32,5 40 40 40
40
Source: SSI Communique on Healthcare Practices b. Average Prices The highest level of decrease in the average prices between 2009 and 2015 took place in the imported drugs. In 2015, the average price was approximately 8.5 TL on
16
the prescription market, 12 TL on the originator drugs market, 19 TL on the imported drugs market, and approximately 5 TL on the generic drugs market. Table 11- Drug Average Price Distribution (TL)
Av. Price Drug RX Originator Generic Import Local 2009 8.85 9.16 12.71 5.21 23.38 4.94 2010 8.31 8.43 11.96 4.99 17.56 5.08 2011 7.66 7.76 10.77 4.79 15.71 4.82 2012 7.05 7.05 9.85 4.44 16.18 4.29 2013 7.38 7.38 10.48 4.43 16.65 4.36 2014 7.83 7.83 11.19 4.58 17.76 4.52 2015 8.47 8.47 12.24 4.93 19.03 4.89
Source: IMS, IEIS Table 12- Drug Average Price Change
Change Drug RX Originator Generic Import Local 2009-2015 -4.4% -7.6% -3.7% -5.4% -18.6% -1.0% 2014-2015 8.2% 8.2% 9.4% 7.5% 7.1% 8.2%
Source: IMS, IEIS c. Retail Price Ranges As of the end of 2015, the retail price distribution of drugs on the pharmaceutical market is as follows. The products under 5 TL constitute 13% of the total number of drugs on the market and the products above 250 TL constitute 8% of the market. 61% of the entire market consists of products priced below 25 TL.
Drugs above 250 TL and between 0 and 10 TL have increased their shares, whereas there has been a decline in the share of drugs priced in the 25-250 TL range on quantity basis within the originator drugs over the last six years. Drugs priced under 25 TL constitute half of this product group.
0-10 TL33%
10-25 TL28%
25-50 TL13%
50-100 TL10%
100-250 TL8%
>250 TL8%
Source: TİTCK, IEIS
2015
Chart 18- Retail Price Distribution
17
When the price ranges of generic drugs are examined, it is observed that generic drugs within 0-10 TL increased their share by 21 percentage points (pp) compared with 2009 and reached 38% as of 2015. A concentration on the 0-10 TL price range of generic products in the last six years is apparent.
The highest share in 2015 was in the product groups between 10 and 25 TL with 24% and above 250 TL with 20%. In comparison with 2009, the products above 250 TL increased by 11 pp and the products between 0 and 10 TL by 6 pp; the products between 25 and 50 TL declined by 12 pp.
0-10 TL15%
10-25 TL
25%
25-50 TL
25%
50-100 TL
17%
100-250 TL
12%
over 250 TL
6%
2009
0-10 TL24%
10-25 TL
26%25-50 TL
13%
50-100 TL
11%
100-250 TL
10%
over 250 TL
16%
2015
0-10 TL17%
10-25 TL
31%25-50
TL25%
50-100 TL
15%
100-250 TL
10%
over 250 TL
2%
2009
Source: TİTCK, IEIS
0-10 TL38%
10-25 TL
29%
25-50 TL
13%
50-100 TL
10%
100-250 TL7%
over 250 TL
3%
2015
Source: TİTCK, IEIS
Chart 19- Price Distribution of Originator Products
Chart 20 – Price Distribution of Generic Products
Source: TİTCK, IEIS Source: TİTCK, IEIS
18
A similar situation manifests within the local products, as most of them are generics. The product group that has the highest proportion is the 0-10 TL product group with a ratio of 42%. This group has increased its shares by 23 pp since 2009. Products under 25 TL constitute 72% of local products.
1.2. Non-pharmaceutical Products
Products available within the portfolios of pharmaceutical companies but which are non-pharmaceuticals include biocidal products licensed from the Ministry of Health, some medical devices in pharmaceutical form, medical formulas, cosmetics and
0-10 TL8%
10-25 TL
23%
25-50 TL
28%
50-100 TL
17%
100-250 TL
15%
over 250 TL
9%
Source: TİTCK, IEIS
2009
0-10 TL14%
10-25 TL
24%
25-50 TL
16%
50-100 TL
14%
100-250 TL
12%
over 250 TL
20%
Source: TİTCK, IEIS
2015
0-10 TL19%
10-25 TL
32%
25-50 TL
24%
50-100 TL
15%
100-250 TL9%
over 250 TL
1%
Source: TİTCK, IEIS
2009
0-10 TL42%
10-25 TL
30%
25-50 TL
12%
50-100 TL8%
100-250 TL6%
over 250 TL
2%
Source: TİTCK, IEIS
2015
Chart 21 - Price Distribution of Import Products
Chart 22 - Price Distribution of Local Products
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art 26- Pha
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he foreign e deficit is from the p2009. In thrts and pu
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15 Import
22
In addition, also for the same reason, export value per kilogram is declining on an annual basis. Our exports grow in terms of quantity, but such increase is not reflected into value. Hence, since 2010 such value has decreased by 16% to 27.2 US dollars from 32.3 US dollars. Table 14- Export Value per Kg (USD)
2001-2005 2006-2010 2011-2014 32.5 32.3 27.2
Source:International Trade Center One of the setbacks to overcome for increasing and facilitating the export of pharmaceuticals is that the GMP certificates granted to our production facilities by Turkey are not recognized by some health authorities in foreign markets. Currently, re-performance of inspection and reissuance of a GMP certificate by the recipient country inflict significant expenses and loss of labor and time. South Korea, the U.S.A., Iraq, Germany, Switzerland, and Azerbaijan were the countries to which the sector exported most in 2015. The most important import markets are Germany, U.S.A., Switzerland, France, and the United Kingdom. Table 15- Export on Basis of Countries (Million USD) Country 2015 2014 2015-2014 (%) South Korea 225 110 104% U.S.A. 53 45 18% Iraq 52 48 8% Germany 50 58 -13% Switzerland 48 60 -20% Azerbaijan 31 29 6% Russian Federation 27 32 -18% TRNC 26 29 -8% Iran 25 44 -43% Slovenia 21 18 18%
Source: TurkStat Table 16- Import on Basis of Countries (Million USD) Country 2015 2014 2015-2014 (%) Germany 817 883 -7% U.S.A. 557 598 -7% Switzerland 421 429 -2% France 389 450 -14% England 306 298 3% Ireland 301 281 7% Italy 298 326 -9% South Korea 225 137 64% Denmark 164 160 2% Spain 164 135 22%
Source: TurkStat
5. Fin The prinegativAccord2015 athe phadeclinebehind These contrasis obvioindustr2009 aand 57
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Chart 27
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hart 29- Ne
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