Iran Pharmaceutical Sector: opportunities and challenges Rassoul - - PowerPoint PPT Presentation

iran pharmaceutical sector opportunities and challenges
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Iran Pharmaceutical Sector: opportunities and challenges Rassoul - - PowerPoint PPT Presentation

Iran Pharmaceutical Sector: opportunities and challenges Rassoul Dinarvand, PhD Professor of Pharmaceutics, Tehran University of Medical Sciences 7 th World Health Summit Regional Meeting, KISH ISLAND, April 2019 Iran Health Sector: general


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SLIDE 1

Iran Pharmaceutical Sector:

  • pportunities and challenges

Rassoul Dinarvand, PhD

Professor of Pharmaceutics, Tehran University of Medical Sciences 7th World Health Summit Regional Meeting, KISH ISLAND, April 2019

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SLIDE 2

Iran Health Sector: general overview (2017)

  • Total population

81 million

  • Urban population

70%

  • Life expectancy at birth

78 years

  • Population Growth Rate

1.2%

  • Infant Mortality Rate (per 1000)

15

  • Under five mortality rate (per 1000)

19

  • Total expenditure on health as % of GDP

8.9%

  • % of government expenditure on health

19.5%

  • Per capita Gross Domestic Product (PPP USD)

11,500

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SLIDE 3

National Drug Policy & Medicines Regulatory Framework

  • Promotion of Generic Medicines
  • Supporting the Local Pharmaceutical Industry
  • Price control and Market regulation
  • Access to Essential Medicines for all
  • Improved Quality of Medicines
  • PIC/s, QC (IFDA Central Labs, Vigilance)
  • Quality of pharmacists’ Services
  • Supply management control (Integration, Monitoring and Regulation (TTAC))
  • Promotion of Rational use of Medicines
  • Promotion of Herbal and Traditional Medicines
  • Promotion of Pharmaceutical Export
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SLIDE 4

Overview of current Pharmaceutical situation

  • Largely a generic market
  • Domestic industry supplies at low prices
  • Legal frameworks to support knowledge based companies: flourishing local

knowledge based companies (biotechnology and nanotechnology)

  • Recombinant proteins, monoclonal antibodies, ADCs, Nanomedicines, liposomes, …..
  • Trade barriers (both technical and custom tariffs) against imports (Tariffs of up to

32%)

  • Local industry not practically privatized yet: public entities have bigger share of

the local manufacturing market though private sector has been steadily growing

  • Regulatory framework is being improved over time. Iran officially joined PIC/S in
  • Sept. 2017
  • Huge public subsidies (USD 800 million) for more expensive medicines
  • Risk of counterfeit/substandard drugs entering the market (TTAC implemented)
  • Shortages of medicines due to sanctions
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SLIDE 5

40 years of pharmaceutical market in Iran at a glance

Year

1978 1981 1989 1997 2005 2013 2018

Population (million)

35 40 53 62 69 76 82

Pharmaceutical market size (Million USD)

1050 660* 720* 950* 1550* 4060 4625

Local manufacturing share

25% 44% 89% 84% 72% 63% 70%

Market size (billion items)

6.8 5.9 11.3 15.8 26.5 34.2 42.7

Local manufacturing share

31% 48% 95% 96% 96% 95% 96%

Per capita pharmaceutical expenditure (USD)

30 16.5 13.6 15.3 22.5 52.7 56.4

Per capita pharmaceutical consumption (volume)

194 148 213 266 384 444 520

* Excluding 300-800 million USD

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SLIDE 6

Phar armaceutic ical c l consumptio ion in Iran an c compared w with other c countrie ies ( (2014 2014)

20 40 60 80 100 120

Antidepressants DDDs/1000 inhibitant/day

10 20 30 40 50 60 70 80 90

Antidiabetic DDDs/1000 inhibitant/day

5 10 15 20 25 30 35 40 45

Romania Netherlands Latvia Estonia Slovenia Germany Hungary Sweden Austria United Kingdom Finland Bulgaria Denmark Czech Republic Lithuania Spain EU-23 Ireland Malta Portugal Poland Slovak Republic Luxembourg Belgium France Italy Cyprus Greece Norway Croatia Iceland Iran

Antibiotics DDDs/1000 inhibitant/day 0.5 1 1.5 2 2.5 3 3.5 4 4.5 10 20 30 40 50 60 70

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Average Proportion Year

Injection Antibiotic Corticosteroid Mean Items

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SLIDE 7

IRAN Pharmaceutical market: number of items (inn)

1,179 1,164 1,100 981 990 1,022 958 428 361 697 516 467 323 353 583 692 458 682 733 556 600 2,189 2,217 2,255 2,179 2,190 1,901 1,911 500 1,000 1,500 2,000 2,500 2016 2015 2014 2013 2012 2011 2010 COUNT OF GENRIC DOSE Domestic Drugs Competitive Drugs Imported Drugs Total Drugs

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SLIDE 8

204 187 290 253 334 330 330 33 37 35 35 32 53 52 50 100 150 200 250 300 350 400 2010 2011 2012 2013 2014 2015 2016 suppliers distributors

IRAN pharmaceutical market:

Number of suppliers & distributors companies

11,000 Retail centers 52

distributors

330

suppliers

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SLIDE 9

3,347 3,022 2,910 2,567 2,986 2,549 1,920 673 473 998 928 826 668 515 764 730 358 540 769 807 735 4,784 4,225 4,265 4,035 4,582 4,023 3,170 1,000 2,000 3,000 4,000 5,000 6,000

2016 2015 2014 2013 2012 2011 2010

MILLION DOLLARS

Domestic Drugs Competitive Drugs Imported Drugs Total Drugs

IRAN PHARMA MARKET (VALUE, MILLION USD)

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SLIDE 10

2016 IMPORTED PHARMACEUTICALS (COUNTRY OF ORIGIN)

GERMANY 29% SWITZERLAND 13% FRANCE 13% DENMARK 11% UK 6% KOREA 5% SPAIN 4% NETHERLAND 4% NORWAY 3% INDIA 2% ITALY 2% AUSTRIA 2% SWEDEN 1% USA 1% SLOVENIA 1% CANADA 1% BELGIUM 1% PORTUGAL 0% URUGUAY 0% AUSTRALIA 0% ICELAND 0% FINLAND 0% HUNGARY 0% GREECE 0% ARGENTINE 0% IRELAND 0% CYPRUS 0% Other 1%

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SLIDE 11
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SLIDE 12
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SLIDE 13

Lipid modifying Diabetes CVD Anti- coagulants COPD Systemic hormones CNS CKD Cancer Total People at risk (1000)

15600 7800 10,400 9360 6,240 4640 15,600 61 416

Available medicines (items)

19 26 94 25 65 17 117 24 111

Total doses distributed (Million)

1197 2913 6012 1403 440 651 2353 153 63

Patients receiving medicines (1000)

2187 3193 6588 3846 1206 1758 2150 60 173

Percentage Covered

14% 41% 63% 41% 19% 37% 13% 98% 41%

Market value (Million USD)

61 118 152 385 177 52 173 154 422 1724

Locally manufactured (%)

100% 70% 76% 99% 72% 35% 47% 72% 28%

Cost per patient (USD)

27 37 23 100 146 29.5 80 2566 2439

Cost to cover 70% of all patients

305 201 168 657 652 98 931 110 720 3842

NCD medicines in Iran at a glance (2016)

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SLIDE 14

Can ancer s situation ion ( (2014 2014)

  • Tobacco consumption and excessive alcohol consumption cause bout 40% of the total

cancer burden. The precise figures vary from country to country.

  • If the consequences of inappropriate diet, obesity and insufficient physical activity are

added, the percentage of cancers due to an unhealthy lifestyle rises to 60%. Iran USA EU-28 Population (million) 77 320 504 Number new cancer cases 97,000 1,665,000 3,200,000 Cancer incidence per 100,000 126 520 635 Total oncology drug market (M $) 340 37,000 22,000 Per capita oncology drug cost ($) 4.4 115.6 43.6 Per new patient oncology drug cost ($) 3,505 22,222 6,875

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SLIDE 15

To be noted:

  • No Patent protection yet
  • Low cost energy
  • Less regulated marketing environment
  • Sanctions and Years of isolation of financial institutes: difficulties in

money flow (mainly from India, China, Turkey)

  • Government Guarantees and legal infrastructure For Foreign

Investment

  • MOH and IFDA Support (Rules & Regulations) for foreign Investment in

local industry

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SLIDE 16

Many thanks for your attention

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SLIDE 17

Examples of licensing out to local manufacturers

Cellcept Xeloda Pegasys Mabthera Insulin Taxotere Plavix Telfast Imatinib Inhalers +10 Products

Roche Sanofi Novo-Nurdisk Cipla Krka

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SLIDE 18

Other projects

Company Country Field Type of investment Investment 1Novo Nordisk Denmark Injectable Sole investment/ green field Euro 70 M 2IPSEN France Diphereline Joint venture/ green field Euro 12 M 3Chemo Spain Hormons Purchase of established facility Euro 25 M 4Biotest Germany Plasma collection/ Fractionation Joint venture ?

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SLIDE 19

Health Transformation Plan

Health Transformation Plan underway since 2014, focused on OOP reduction

2013 (before HTP) 2017 (after HTP)

 Population covered by health

insurance policy

85% 97%

 Out of packet health

expenditure

58% 36%

 Availabilty of medicine and

medical devices at hospitals

62% 97%