Indian Pharmaceutical Industry

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1 Colloquium on India s Growing Dependence on Imports in the area of Bulk Drugs Indian Pharmaceutical Industry Public Health Foundation of India 23 rd December, 2014

2 Pharma Industry and Market in India The country produces medicines worth over Rs. 100,000 crores, 40% of which are supplied to patients outside the country. India boasts of having over 350 drug producing units that are endorsed by EU (European Union) as Good Manufacturing Practices (GMP) compliant and the maximum number of US FDA (United States Food and Drug Authority) approved manufacturing facilities outside the United States The domestic formulations market is worth ~Rs crore (AIOCD-AWACS: based on Jan 2014 MATs)

3 Pharmaceutical Market Structure The pharma market is comprised of a large number of individual submarkets as medicines used in the treatment of different diseases cannot be used interchangeably Pharmaceuticals can be sub-divided into therapeutic segments by referring to the Anatomical Therapeutic Chemical classification (ATC) wherein they are classified according to their site of action/mechanism of action in different organ systems of the human body AIOCD-AWACS market dataset PharmaTrac classifies pharmaceuticals in to Supergroup, Class and Group based on Epharma classification.

4 Therapeutic classification- an example Supergroup/Class/Group Value (Rs.crore) CARDIAC ANTI-HYPERTENSIVES ANTIHYPERTENSIVES (NON-HERBAL) - CENTRALLY ACTING ANTIHYPERTENSIVES (NON-HERBAL) - PERIPHERALLY ACTING RAUWOLFIA ALKALOIDS AND OTHER ANTIHYPERTENSIVES OF HERBAL ORIGIN LIPID-REGULATING / ANTI-ATHEROMA PREPARATIONS ALL OTHER CHOLESTEROL / TRIGLYCERIDE REGULATORS 9.50 ANTI-ATHEROMA PREPARATIONS OF NATURAL ORIGIN FIBRATES FIBRATES, COMBINATION 0.78 ION-EXCHANGE RESIN 1.02 STATINS STATINS COMBINED WITH EZETIMIBE STATINS COMBINED WITH FIBRATES STATINS COMBINED WITH OTHER LIPID REGULATORS STATINS, COMBINATION STATINS, COMBINED WITH ANTI-PLATELET DRUGS Note: values based on January, 2014 MAT Source: AIOCD-AWACS

5 Broad therapeutic segments: Sub-markets Note: values based on January, 2014 MAT Source: AIOCD-AWACS

6 Top 20 Companies (accounting for ~60% of the total market value in 2013) Rank Company name Value (Rs. Crore) 1 SUN PHARMACEUTICAL INDUSTRIES LTD CIPLA LTD ZYDUS CADILA RANBAXY LABORATORIES LTD GLAXOSMITHKLINE PHARMACEUTICALS LTD ABBOTT HEALTHCARE PVT. LTD MANKIND PHARMACEUTICALS LTD LUPIN LTD ALKEM LABORATORIES LTD MACLEODS PHARMACEUTICALS PVT.LTD SANOFI-AVENTIS INTAS PHARMACEUTICALS LTD ARISTO PHARMACEUTICALS PVT.LTD PFIZER LTD DR. REDDYS LABORATORIES LTD GLENMARK PHARMACEUTICALS LTD MICRO LABS LTD ABBOTT INDIA LTD USV LTD TORRENT PHARMACEUTICALS LTD Note: values based on January, 2014 MAT Source: AIOCD-AWACS

7 Most widely used indicators for market concentration Four firm concentration ratio (CR4) CR 4 = S 1 +S 2 +S 3 +S 4 Herfindahl-Hirschman Index (HHI) HHI= S 12 + S S n 2 Where S i = market share of the i th largest firm in the market in terms of market value.

8 Concentration in the overall pharmaceutical market (taken as a single market) Entire pharmaceutical market Herfindahl Hirschman Index (HHI) Number of firms in the market 534 Total number of brands Total market value (Rs. Crore) Note: Market values based on Moving Annual Total (MAT) for the month of January, 2014 Source: Author s computations based on AIOCD-AWACS market dataset PharmaTrac

9 Market concentration at different Market concentration therapeutic levels No. of supergroups SUPERGROUP LEVEL % of supergroups Cumulative market value (Rs. Crore) Market share (%) High Moderate Low Total Market concentration No. of classes CLASS LEVEL % of classes Cumulative market value (Rs. Crore) High Moderate Low Total Market share (%) Note: Market values based on Moving Annual Total (MAT) for the month of January, 2014 Source: Author s computations based on AIOCD-AWACS market dataset PharmaTrac

10 Market concentration at different Market concentration therapeutic levels No. of groups GROUP LEVEL % of groups Cumulative market value (Rs. Crore) High Moderate Low Total Market concentration No. of formulations FORMULATION LEVEL % of formulations Cumulative market value (Rs. Crore) Market share (%) High Moderate Low Total Market share (%) Note: Market values based on Moving Annual Total (MAT) for the month of January, 2014 Source: Author s computations based on AIOCD-AWACS market dataset PharmaTrac

11 CANDESARTAN C9D Note: Market values based on Moving Annual Total (MAT) for the month of January, 2014 Source: Author s computations based on AIOCD-AWACS market dataset PharmaTrac Example Market No. of Therapeutic classification Value (Rs. companie HHI Crore) s Supergroup CARDIAC AGENTS ACTING ON THE RENIN-ANGIOTENSIN Class SYSTEM Group ANGIOTENSIN-II ANTAGONISTS, PLAIN Formulations TELMISARTAN C9D LOSARTAN C9D OLMESARTAN C9D VALSARTAN C9D IRBESARTAN C9D

12 Pharmaceutical Manufacturing Units in India Category API (Bulk drugs, intermediates) Allopathy (formulations) No. of units ISM (Ayurvedic or Unani formulations) 2623 Others (veterinary preparations, etc.) 2109 TOTAL 8590 Source: ASI and NSSO 67 th Round Unit Level Data

13 Percentage of registered and unregistered Indian Pharma Manufacturing Units Indian Pharmaceutical manufacturing industry is dominated by unregistered manufacturing Units which account for 54 % of the total units. 3% 47% 97% 79% 78% 53% 21% 22% API/Bulk Allopathy (Formulation) ISM Others Registered Unregistered Source: ASI and NSSO 67 th Round Unit Level Data

14 Percentage of Registered Pharma Units Engaged in Manufacturing Formulations and APIs Source: ASI and NSSO 67 th Round Unit Level Data

15 GSV (Rs. Crore) Gross Sales Value of Pharmaceuticals in the Registered Sector (in Rs. Crore) API/Bulk Allopathy (Formulation) ISM Others Source: ASI and NSSO 67 th Round Unit Level Data

16 Share of pharmaceuticals in National Trade (In Rs. Crore) Items/Years Total national exports (a) drugs pharmaceuticals and fine chemicals Share in total exports (%) Total national imports (b) medicines and pharmaceutical products Share in total imports (%) Trade balance (a) - (b) Source: Annual Report Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers

17 Import Intensity of Pharmaceuticals Source: ASI and NSSO 67 th Round Unit Level Data

18 Import Intensity in API & Formulations Source: ASI and NSSO 67 th Round Unit Level Data

19 Thank you