Pharma industry overview

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An overview of Pharma market Especially Indian pharma market and healthcare sector.

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Pharma industry overview

  1. 1. Indian Pharmaceutical Evolution Phase V Phase IV Innovation and Growth Phase Research Phase III Development •Rapid expansion •New IP law Phase of domestic •Discovery Research Phase II market •Process •Convergence Phase I Government development •International Control market Early Years •Production •Indian Patent Act development •Market share infrastructure –1970 domination by creation •Research foreign •Drug prices capped orientation •Export companies •Local companies initiatives •Relative begin to make an absence of impact organized Indian companies 1980 1990 2000 2010 1970
  2. 2. Indian Pharmaceutical Evolution:Contd…
  3. 3. HEALTH INFRASTRUCTUREINDIA – 2010- 11Population 1.2 Bn.Doctors 8,48,000 (0.68)*Nurses 9,36,000 (0.8) *Hospitals 17,300Hospital Beds 9,14,543 (0.9)*Primary Health Centres/ 1,64,000Community Health CentresMedical Colleges 180 +Chemists (Pharmacies) 5,50,000Medical Reps 100,000Total Healthcare Market U.S.$ 35 Bn.Government Healthcare Budget ~ 6 Bn US$ ~ 1% of GDP* Per 1000 Population
  4. 4. Key Challenge – Access to Medicines China - 75 % Europe - 86% USA - 79% India - 35 %Over 600 Mn. Indians have NO Access toEssential Medicines 5
  5. 5. GLOBAL PHARMACEUTICAL SCENARIO 2010-11• Global Sales - U.S.$ 837 Bn. (46,03,500 Cr) Growth 5%• U.S.A., Europe and Japan contribute 87% sales• USA – US $244.6 Bn , 3% growth• No.1 company - Pfizer , Sales U.S.$ 50 Bn.• `Pharmerging Market - ( Brazil , Russia, India, China, Korea, Mexico , Turkey ) – 110 Bn$ , 14-15 % Growth• No.1 Drug - LIPITOR - Pfizer - U.S.$ 12.4 Bn ( 67000 Cr)**• No. of Blockbusters - 106 ( U.S.$ 1 Bn. + sales)• Total R&D Spend of Top 100 Cos. – U.S.$107.12 Bn ** Lipitor Patent expired on 30th Nov.11. Ranbaxy`s ANDA approved by US FDA( FTF ) . R`baxy launched generic version Atorvastatin in USA . Earned over 600 Mn $ so far
  6. 6. IPI in Global Scenario India has 17% of global population India has just 1% in global pharma market Current Indian Pharma market is US$ 12 billion (65000 cr) 3rd largest in terms of volume (10% of global share) Its rank is 14th in terms of value (1.5%of Global) Domestic pharma market US$ 20bn by 2015 India health care market: US$ 31.59bn by 2020Global CRAMS Market in 2010 – 67 Bn US$, India`s– 3.8 Bn US$
  7. 7. A snap shot of IPI Highly fragmented pharmaceutical market More than 23000 registered units Leading 250 companies controls 70% market share 250 large units & 8000 SMEs 350 bulk drugs Total IPM : Formulations (79%) & Bulk drugs (21%) 8
  8. 8. INDIAN PHARMA SCENARIO HIGHLIGHTS 2012• Domestic Sales - 12 Bn US $,Growth 16.2 %• India tops the world in exporting generic medicines worth US$ 11 billion.• Exports – 11 Bn US$ , Growth 20 % +• No. 1 company – Abbott , M.S. 7.0%• No. 1 Drug – corex sales - 250+ cr• Over 75,000 Brands. 60 therapeutic segments• Indian firms manufacture approximately 500 different active pharmaceutical ingredients (APIs)• MNC Market Share – 25.3% likely to reach 35% by 2015
  9. 9. Top 20 Molecules Globally
  10. 10. Top 20 Therapeutic Segments Globally
  11. 11. Market Segments PharmaceuticalsContract research and Active pharmaceuticalmanufacturing services Formulations ingredients (APIs) (CRAMS)India is a fast-growing India’s manufacturing India is the third-largestCMO and custom prowess in formulations player in the world withresearch outsourcing is validated by the fact 500 different APIs(CRO) destination with a that it manufacturesgrowth rate for CMO 60,000 packs across 60thrice the global market therapy areasrate
  12. 12. Strength Weakness SWOT AnalysisCost Effective Less investment in research and development Lack of coordination between industry and academia.Strong Manufacturing Base Negligible expenditure on healthcare in the country.Availability of high quality skilled workforce. Manufacture of fake and low quality medicines bringExcellent marketing and distribution networkDiverse ecosystem SWOT Analysis Opportunities ThreatsIncreased export potential Product patent regime is a major threat to domesticMarketing ties ups with multinational companies to industry unless the industry takes up R&D initiativesell their products in domestic market. aggressively.Immense scope to position India as a centre for Drug Price Control Order puts undue pressure oninternational clinical trials. product prices, affecting the profitability of the pharmaceutical companies.Key player in global pharmaceutical R&D. The new MRP based excise duty regime threatens Export of generic drugs to developed markets the business of smaller pharmaceutical companies
  13. 13. OTC MARKET SCENARIO• Domestic Sales – USD 1.8 Bn ( 2009) Growth 18%• Ranks 11 in global OTC market size.• Main Categories – Vitamins & Minerals, Gastrointestinals, Cough,Cold & Allergy, Analgesics , Dermatologicals• Main Players – J&J , GSK , P&G, Reckitt, Piramal, Pfizer 16
  14. 14. INDIAN BIOPHARMA MARKET• Biotech Market size 4 Bn. U.S.$ - 70% in Biopharma Growth 21%• No.1 Company Biocon – Sales 230 Mn US$• 2 Types of Products - Recombinant Drugs and Monoclonal Antibodies• Products- Erythropoetin, Human Insulin, tPA, Filgrastim, Vaccines, Interferon, Streptokinase, etc.• India emerging as a major global source of Vaccines• Biosimilars – Huge Opportunity, Regulatory Issues a Challenge
  15. 15. First 10 Companies of IPMRank Value Rs.cr Mkt Gr% Share% Indian Pharma Mkt 53094 100 14 1 Abbott 3769 7.1 18 2 Cipla 2695 5.1 11 3 Ranbaxy 2497 4.7 15 4 Glaxo Smith Kline 2137 4.0 8 5 Sun 2066 3.9 21 6 Zydus Cadila 1948 3.7 12 7 Mankind 1789 3.4 22 8 Alkem 1764 3.3 14 9 Pfizer 1681 3.2 14 10 Lupin 1430 2.7 13 41.0 MAT Nov’11 18
  16. 16. Top 10 Pharma Brands in India Rank Brand Company Rs. Cr MS% Gr% 1 Corex Pfizer 226.0 0.4 6 2 Human Abbott 220.0 0.4 23 Mixtard 3 Phensedyl Abbott 202.0 0.4 17 4 Voveran Novartis 197.0 0.4 8 5 Augmentin GSK 191.0 0.4 12 6 Revital Ranbaxy 184.0 0.4 15 7 Monocef Aristo 168.0 0.3 9 8 Dexorange Franco India 161.0 0.3 9 9 Taxim Alkem 150.2 0.3 2 10 Liv 52 Himalaya 148.0 0.3 9 MAT Nov’11 19
  17. 17. Top 10 Therapeutic groupsRank Indian Pharma Mkt 1 Alimentary T Metabolism (GIT) 2 Anti - infective 3 Cardiovascular 4 Respiratory 5 CNS 6 Musculo skeletal 7 Ant diabetic 8 Dermatological 9 Vitamins 10 Genito Urinary System 20 MAT Nov’11
  18. 18. Rank Therapeutic Class Value Rs. Crore MS% Gr% Total IPM Market May’09 36048.38 100 10 1 ALIMENTARY T.& METABOLISM 9012.14 25.0 11 2 SYSTEMIC ANTI-INFECTIVES 7152.06 19.8 7 3 CARDIOVASCULAR SYSTEM 3906.30 10.8 13 4 RESPIRATORY SYSTEM 3287.58 9.1 9 5 NERVOUS SYSTEM 2528.97 7.0 10 6 MUSCULO-SKELETAL SYSTEM 2233.79 6.2 9 7 DERMATOLOGICALS 1791.19 5.0 12 8 VITAMINS 1712.85 4.8 6 9 G.U.SYSTEM & SEX HORMONES 1579.14 4.4 14 10 BLOOD + B.FORMING ORGANS 1534.98 4.3 15 11 SENSORY ORGANS 623.17 1.7 5 12 PARASITOLOGY 616.46 1.7 15 13 SYSTEMIC HORMONES 574.86 1.6 13 14 ANTINEOPLAST+IMMUNOMODUL 263.65 0.7 36 22
  19. 19. Code Therapeutic Class Value Rs. Crore MS% Gr% Total IPM Market may’09 36048.38 100 10 A ALIMENTARY T.& METABOLISM 9012.14 25 11A01 STOMATOLOGICALS 188.33 0.5 10A02 A-ACID A-FLAT A-ULCERANT 1864.23 5.2 9A02A ANTACIDS ANTIFLATULENTS 338.15 0.9 6A02B ANTIULCERANTS 1496.93 4.2 10A02B1 H2 ANTAGONISTS 299.68 0.8 0A02B2 ACID PUMP INHIBITORS 1107.47 3.1 14A03 FUNCTL.GI DISORDER DRUG 508.99 1.4 9A04 ANTIEMETICS-ANTINAUSEANT 157.88 0.4 10A05 CHOLAGOGUES-HEPATIC PROC 361.83 1 20A06 LAXATIVES 233.93 0.6 13A07 A-DIAR ORAL ELEC+A-INFLA 804.40 2.2 7A08 ANTIOBESITY PREPARATIONS 47.08 0.1 8A09 DIGESTIVES INC ENZYMES 233.62 0.6 9A10 DRUGS USED IN DIABETES 1936.12 5.4 23 15
  20. 20. Code Therapeutic Class Value Rs. MS Gr Crore % % Total IPM Market 36048.38 100 10 A ALIMENTARY T.& METABOLISM 9012.14 25 11 A11 VITAMINS 1712.85 4.8 6 A11A MULTIVITAMINS + MINERALS 611.97 1.7 6 A11E VITAMIN B COMPLEX 410.00 1.1 10 A12 MINERAL SUPPLEMENTS 598.87 1.7 15 A12A CALCIUM 578.61 1.6 16 A13 TONICS 155.41 0.4 12 A14 ANABOLICS SYSTEMIC 81.68 0.2 16 A15 APPETITE STIMULANTS 117.74 0.3 157/27/2009
  21. 21. Code Therapeutic Class Value Rs. MS Gr Crore % % Total IPM Market 36048.38 100 10 B BLOOD + B.FORMING ORGANS 1534.98 4.3 15 B01 ANTITHROMBOTIC AGENTS 432.23 1.2 17 B01B HEPARINS 136.50 0.4 11B01B2 FRACTIONATED HEPARINS 127.61 0.4 9 B02 BLOOD COAG SYST OTH PROD 121.18 0.3 1 B03 ANTIANAEMICS 976.69 2.7 16 B03A HAEMATINICS,IRON & COMBS 808.24 2.2 16B03A2 IRON COMBINATION PRODUCT 716.10 2.0 14
  22. 22. Code Therapeutic Class Value Rs. Crore MS% Gr % Total IPM Market 36048.38 100 10 C CARDIOVASCULAR SYSTEM 3906.30 10.8 13 C01 CARDIAC THERAPY 370.30 1.0 10 C02 HYPOTENSIVES 83.17 0.2 10 C03 DIURETICS 157.28 0.4 3 C04 CEREB/PERIPH.VASOTHERAPE 141.28 0.4 25 C05 TOPICAL ANTIHAEMORRHOIDA 97.58 0.3 9 C06 OTH CARDIOVASCULAR PRDS 2.15 0.0 74 C07 BETA BLOCKING AGENTS 489.40 1.4 12 C08 CALCIUM ANTAGONISTS 707.73 2.0 12 C09 AGENTS: RENIN-ANGIOTENST 1095.65 3.0 15 C10 LIPID-REG/ANTI-ATHEROMA 693.41 1.9 16 C11 C.V.MULTITHER.COMB.PRODS 68.37 0.2 187/27/2009 26
  23. 23. Code Therapeutic Class Value Rs. Crore MS Gr% % Total IPM Market 36048.38 100 10 D DERMATOLOGICALS 1791.19 5 12D01 ANTIFUNGALS DERMATOLOGIC 165.27 0.5 -2D02 EMOLLIENTS & PROTECTIVES 163.85 0.5 20D03 WOUND-HEALING AGENTS 15.52 0.0 -5D04 TOPICAL ANTIPRURITICS 9.18 0.0 -37D05 NON-STER PRD INFLAM SKIN 38.24 0.1 15D06 TOP A-BACTS & A-VIRALS 184.43 0.5 12D07 TOPICAL CORTICOSTEROIDS 697.23 1.9 15D08 ANTISEPTICS+DISINFECTANT 174.00 0.5 6D10 ANTI-ACNE PREPARATIONS 151.68 0.4 13D11 OTHER DERMATOLOGICAL PRE 191.79 0.5 25
  24. 24. Code Therapeutic Class Value Rs. Crore MS Gr% % Total IPM Market 36048.38 100 10 G G.U.SYSTEM & SEX HORMONES 1579.14 4.4 14G01 GYNAE ANTI-INFECTIVES 56.85 0.2 7G02 OTHER GYNAECOLOGICALS 248.15 0.7 8G03 SEX HORMONES-SYSTEMC ONL 824.67 2.3 14G04 UROLOGICALS 449.46 1.2 17 H SYSTEMIC HORMONES 574.86 1.6 13H01 PITUITARY+HYPOTHAL HORM 7.42 0 -13H02 SYSTEMIC CORTICOSTEROIDS 438.97 1.2 12H03 THYROID THERAPY 110.62 0.3 21H04 OTHER HORMONES 17.84 0 17
  25. 25. Code Therapeutic Class Value Rs. Crore MS Gr% % Total IPM Market 36048.38 100 10 J SYSTEMIC ANTI-INFECTIVES 7152.06 19.8 7 J01 SYSTEMIC ANTIBACTERIALS 6284.28 17 4.8J01A TETRACYCLINES & COMBS 104.26 0.3 0J01B CHLORAMPHENICOLS + COMBS 69.95 0.2 24J01C BROAD SPECTRUM PENICILLI 1256.31 3.5 8J01C1 BROAD SPECT PENICILL ORA 1003.50 2.8 6J01C2 BROAD SPECT PENICILL INJ 252.82 0.7 15J01D CEPHALOSPORINS & COMBS 2780.28 7.7 10J01D1 CEPHALOSPORINS ORAL 1803.56 5.0 11J01D2 CEPHALOSPORINS INJECT 976.73 2.7 8
  26. 26. Code Therapeutic Class Value Rs. Crore MS Gr% % Total IPM Market 36048.38 100 10 J SYSTEMIC ANTI-INFECTIVES 7152.06 19.8 7 J01 SYSTEMIC ANTIBACTERIALS 6284.28 17 4.8 J01E TRIMETHOPRIM COMBS 64.00 0.2 3 J01F MACROLIDES & SIMILAR TYP 570.06 1.6 9 J01G FLUOROQUINOLONES 910.90 2.5 -1J01G1 ORAL FLUOROQUINOLONES 855.38 2.4 -1J01G2 INJ FLUOROQUINOLONES 55.52 0.2 -2 J01H MED+NARROW SPECTRUM PENI 51.00 0.1 -7J01H1 MED/NARROW SPECT PEN PLA 48.90 0.1 -9J01H2 PENICILL/STREPTOM COMBS 2.10 0 93 J01K AMINOGLYCOSIDES 282.31 0.8 167/27/2009
  27. 27. Code Therapeutic Class Value Rs. Crore MS Gr% % Total IPM Market 36048.38 100 10 J SYSTEMIC ANTI-INFECTIVES 7152.06 19.8 7 J01 SYSTEMIC ANTIBACTERIALS 6284.28 17 4.8J01L CARBENICILLINS+SIMILARES 3.37 0 10J01M RIFAMPICIN/RIFAMYCIN 9.30 0 -19J01P OTH B-LACTAM EX PEN,CEPH 107.95 0.3 26J01P1 MONOBACTAMS 7.89 0 -10J01P2 PENEMS AND CARBAPENEMS 100.06 0.3 31J01X OTHER ANTIBACTERIALS 74.59 0.2 27J01X1 GLYCOPEPTIDE ANTIBACT. 23.90 0.1 44J01X2 POLYMYXINS 0.56 0 >999J01X9 ALL OTHER ANTIBACTERIALS 50.14 0.1 19
  28. 28. Code Therapeutic Class Value Rs. Crore MS Gr% % Total IPM Market 36048.38 100 10 J SYSTEMIC ANTI-INFECTIVES 7152.06 19.8 7J01 SYSTEMIC ANTIBACTERIALS 6284.28 17 4.8J02 SYST ANTIFUNGAL AGENTS 133.45 0.4 14J03 SYSTEMIC SULPHONAMIDES 0 0 0J04 ANTIMYCOBACTERIALS 300.87 0.8 -6 J04A ANTITUBERCULAR PRODUCTS 296.17 0.8 -6J04B TREATMENT OF LEPRA 4.71 0 12J05 ANTIVIRALS SYSTEMIC USE 124.61 0.3 6J06 SERA & GAMMAGLOBULIN 42.14 0.1 -9J07 VACCINES 236.46 0.7 5J08 OTHER ANTI-INFECTIVES 30.26 0.1 -2 (ANAEROBICIDES )
  29. 29. Cod Therapeutic Class Value Rs. MS Gr% e Crore % Total IPM Market 36048.38 100 10 L ANTINEOPLAST+IMMUNOMODUL 263.65 0.7 36 L01 ANTINEOPLASTICS 123.92 0.3 47 L02 CYTOSTATIC HORMONE THERA 56.81 0.2 23 L03 IMMUNOSTIMULATING AGENTS 13.27 0 20 L04 IMMUNOSUPPRESIVE AGENTS 69.65 0.2 347/27/2009 33
  30. 30. Code Therapeutic Class Value Rs. Crore MS% Gr% Total IPM Market 36048.38 100 10 M MUSCULO-SKELETAL SYSTEM 2233.79 6.2 9M01 ANTIRHEUMATIC SYSTEM 1570.25 4.4 8M01A ANTIRHEUMATIC NON-STEROI 1514.24 4.2 7M01A1 ANTIRHEUMATICS NON-S PLN 699.79 1.9 10M01A2 ANTIRHEUMATIC NON-S COMB 737.49 2.0 7M01A3 COXIBS PLAIN 76.97 0.2 -5M01C SPEC ANTIRHEUMATIC AGENT 56.01 0.2 32M02 ANTIRHEUMATICS TOPICAL 250.98 0.7 11M03 MUSCLE RELAXANTS 202.30 0.6 17M04 ANTI-GOUT PREPARATIONS 32.03 0.1 34M05 OTHER MUSCULO-SKELETAL 178.24 0.5 3
  31. 31. Code Therapeutic Class Value Rs. Crore MS% Gr % Total IPM Market 36048.38 100 10 N NERVOUS SYSTEM 2528.97 7 10N01 ANAESTHETICS 47.60 0.1 7N02 ANALGESICS 561.26 1.6 7N03 ANTI-EPILEPTICS 755.13 2.1 14N04 ANTI-PARKINSON PREPS 62.22 0.2 7N05 PSYCHOLEPTICS 449.15 1.2 7 HYPNOTICS , SEDATIVES & TRANQUILLIZERSN06 PSYCHOANALEPTICS 465.37 1.3 9 ANTIDEPRESS.& MOOD STAB.N07 OTH CNS DRUGS 188.24 0.5 12 ANTISMOKING, ANTIVERTIGO & ANTI- ALZHEIMER
  32. 32. Code Therapeutic Class Value Rs. Crore MS% Gr % Total IPM Market 36048.38 100 10 P PARASITOLOGY 616.46 1.7 15P01 ANTIPROTOZ.& ANTHELMINT. 554.44 1.5 15P01A AMOEBICIDES 109.25 0.3 2P01B ANTHELMINTICS 159.73 0.4 5P01D ANTI-MALARIALS 284.46 0.8 29P01G OTHER ANTI-PARASITICS 1.01 0 -49P03 ECTOPARASITICIDES 62.02 0.2 18P03A ECTOPARAS.INCL SCABICIDE 62.00 0.2 18
  33. 33. Code Therapeutic Class Value Rs. Crore MS% Gr% Total IPM Market 36048.38 100 10 R RESPIRATORY SYSTEM 3287.58 9.1 9R01 NASAL DECONG/ANTIINFECT. 216.17 0.6 13R02 PHARYNGEAL PREPARATIONS 20.16 0.1 8R03 ANTI-ASTHMA & COPD PROD 942.46 2.6 18R04 CHEST RUBS & INHALANTS 64.54 0.2 23R05 COUGH & COLD PREPARATION 1639.96 4.5 7R05C EXPECTORANTS 533.07 1.5 1R05D ANTITUSSIVES 725.29 2 13R07X ALL OTH RESPIRAT SYSTEM 0.72 0 -34R06 ANTIHISTAMINES SYSTEMIC 402.64 1.1 0R07 OTHER RESPIRATORY PREPS 1.64 0 -73
  34. 34. Code Therapeutic Class Value Rs. Crore MS% Gr % Total IPM Market 36048.38 100 10 S SENSORY ORGANS 623.17 1.7 5S01 OPHTHALMOLOGICALS 483.00 1.3 8S02 OTOLOGICALS 65.16 0.2 5S03 EYE-EAR PREPARATIONS 75.01 0.2 -12 T DIAGNOSTIC AGENTS 36.03 0.1 11 V VARIOUS 731.43 2 11V06 GENERAL NUTRIENTS 417.99 1.2 11V06B PROTEIN SUPPLEMENTS 132.37 0.4 17V06C INFANT FORMULAS 129.57 0.4 18V06D OTHER GENERAL NUTRIENTS 154.12 0.4 2V07 OTHER NON-THERAPEUTIC 30.45 0.1 -4
  35. 35. MNC’S IN INDIA
  36. 36. Major Policy Changes Central Drug Authority (on the Lines of USFDA)* National Biotechnology Regulatory Authority Bill* Medical Council of India ( Professional Conduct Etiquette & Ethics Regulations ) Dept. Of Pharmaceuticals – Drug Marketing Code FDI Policy : Greenfield -100% , Brownfield – Thru` CCI Fiscal Incentives – R& D expenses, weighted deduction increased to 200 % from 150% for Tax Companies Bill 2012 ( 2 % Mandatory CSR ? )* * Proposed
  37. 37. Major Policy Changes NATIONAL PHARMACEUTICAL PRICING POLICY 2011 (Draft ) - 348 Essential Drugs ( New NLEM ) under Price Control Span of Price Control to increase from 20% to 60% Cost based to Market based – Weighted Average of Top 3 Brands 10 % Cap per year for Price Increase US FDA Generic Drugs User Fee Act - The US Congress approves Generic Drugs User Fee Act . GPhA commits 300Mn$ User Fee per year. Approx. Fees – ANDA 60K $ , DMF 40K$, Facility 85K$ ( Testing Labs / BA ,BE Studies exempted )
  38. 38. Generic Market
  39. 39. Generic Market• Global generic Market - US$123.85bn (2010)• China, the largest generic drug market in the world,• India tops exports of generic drugs worth US $11 billion in 2011• predicted to grow at a CAGR of 17 per cent between 2010-11 and 2012-13. 2 World Teva Novartis Watson Mylan Actavis Hospira
  40. 40. ADVANTAGE TO INDIA
  41. 41. FDI by Country in India The largest source of FDI in Indian pharmaceutical industry is Mauritius. Many global investors in India route their FDI through Mauritius to take advantage of the India- Mauritius bilateral tax treaty.
  42. 42. Conclusion Remarkable growth in the pharmaceutical industry in India India and Japan: only two countries where western MNCs do not dominate India: net exporter and self sufficient in drugs Drug prices among the lowest in the world Source of good quality cheap drugs for the rest of the world India has the largest number of US FDA approved manufacturing facilities outside USA It was not product patent protection but its abolition which operated as a pull mechanism in India by provided the Indian companies the space of operations and the opportunity to develop and innovate Aided by the push programs of public investments in manufacturing and R&D, what Indian companies innovated are processes for manufacturing. And it is this capability which has permitted India to have an international presence and be a global source of drugs

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