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 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

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

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

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 1050 660* 720* 950* 1550* 4060 4625 (Million USD) 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 30 16.5 13.6 15.3 22.5 52.7 56.4 expenditure (USD) Per capita pharmaceutical 194 148 213 266 384 444 520 consumption (volume) * Excluding 300-800 million USD

Phar armaceutic ical c l consumptio ion in Iran an c compared w with other c countrie ies ( (2014 2014) Antidepressants DDDs/1000 inhibitant/day Antibiotics DDDs/1000 inhibitant/day 45 120 40 100 35 80 30 25 60 20 40 15 10 20 5 0 0 Iran Iceland Croatia Norway Greece Cyprus Italy France Belgium Luxembourg Slovak Republic Poland Portugal Malta Ireland EU-23 Spain Lithuania Czech Republic Denmark Bulgaria Finland United Kingdom Austria Sweden Hungary Germany Slovenia Estonia Latvia Netherlands Romania 70 4.5 Antidiabetic DDDs/1000 inhibitant/day 90 4 60 3.5 80 50 3 70 Proportion Average 40 2.5 60 2 50 30 1.5 40 20 1 30 10 0.5 20 0 0 10 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 0 Year Injection Antibiotic Corticosteroid Mean Items

IRAN Pharmaceutical market: number of items (inn) Domestic Drugs Competitive Drugs Imported Drugs Total Drugs 2,500 2,255 2,217 2,190 2,189 2,179 1,911 1,901 2,000 COUNT OF GENRIC DOSE 1,500 1,179 1,164 1,100 1,022 990 981 958 1,000 733 692 682 697 600 583 556 500 516 467 428 458 361 353 323 0 2010 2011 2012 2013 2014 2015 2016

IRAN pharmaceutical market: Number of suppliers & distributors companies suppliers distributors 400 334 330 330 350 330 290 suppliers 300 253 250 52 204 187 distributors 200 11,000 Retail 150 centers 100 53 52 37 35 35 33 32 50 0 2010 2011 2012 2013 2014 2015 2016

IRAN PHARMA MARKET (VALUE, MILLION USD ) Domestic Drugs Competitive Drugs Imported Drugs Total Drugs 6,000 4,784 5,000 4,582 4,265 4,225 4,023 4,035 MILLION DOLLARS 4,000 3,347 3,170 3,022 2,986 2,910 3,000 2,567 2,549 1,920 2,000 998 928 826 1,000 673 668 515 473 807 769 764 735 730 540 358 0 2010 2011 2012 2013 2014 2015 2016

2016 IMPORTED PHARMACEUTICALS ( COUNTRY OF ORIGIN ) NETHERLAND NORWAY 4% KOREA ITALY 3% SPAIN UK 5% 2% 4% INDIA 6% 2% SWEDEN AUSTRIA 1% 2% SLOVENIA USA DENMARK 1% 1% 11% FINLAND HUNGARY GREECE 0% 0% CANADA 0% 1% ARGENTINE ICELAND BELGIUM 0% 0% 1% IRELAND FRANCE PORTUGAL 0% 13% 0% Other CYPRUS 1% AUSTRALIA 0% URUGUAY 0% 0% SWITZERLAND GERMANY 13% 29%

NCD medicines in Iran at a glance (2016) Lipid Anti- Systemic Diabetes CVD COPD CNS CKD Cancer Total modifying coagulants hormones People at risk (1000) 15600 7800 10,400 9360 6,240 4640 15,600 61 416 Available medicines 19 26 94 25 65 17 117 24 111 (items) Total doses distributed 1197 2913 6012 1403 440 651 2353 153 63 (Million) Patients receiving 2187 3193 6588 3846 1206 1758 2150 60 173 medicines (1000) Percentage Covered 14% 41% 63% 41% 19% 37% 13% 98% 41% Market value (Million 61 118 152 385 177 52 173 154 422 1724 USD) 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 305 201 168 657 652 98 931 110 720 3842 patients

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

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

Many thanks for your attention

Examples of licensing out to local manufacturers Cellcept Xeloda Insulin Pegasys +10 Products Mabthera Novo- Nurdisk Roche Sanofi Cipla Krka Taxotere Imatinib Plavix Inhalers Telfast

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

Health Transformation Plan Health Transformation Plan underway since 2014, focused on OOP reduction 2013 (before HTP) 2017 (after HTP)  Population covered by health 85% 97% insurance policy  Out of packet health 58% 36% expenditure  Availabilty of medicine and 62% 97% medical devices at hospitals