Presentation on theme: "AFFORDABLE EFFICACIOUS MEDICINES ALL ROADS LEAD TO INDIA"— Presentation transcript:
1 AFFORDABLE EFFICACIOUS MEDICINES ALL ROADS LEAD TO INDIA DAARA B PATELSECRETARY - GENERALINDIAN DRUG MANUFACTURERS’ ASSOCIATION (IDMA)4TH SINO-INDIA FORUM: FINISHED DRUGS EXPORTChina, 14th November 2013
2 80 % Pharma Corporate Office are located MUMBAIIDMA’s HQ80 % Pharma Corporate Office are located
3 INDIAN DRUG MANUFACTURERS’ ASSOCIATION Founded in 1961 – now in 52nd year of service as premier Association of the Indian Pharma IndustryRegarded in Government, Media & Industry Circles as the ‘Voice of the National Sector’6 Region-wise State Boards19 Sub-Committees, headed by ExpertsMembership Strength – over 700 MembersPublications: IDMA Bulletin (Weekly), Indian Drugs (Monthly) & Annual PublicationAwards presented on Annual Day for Quality Excellence, Best Patents, Quality Research,At IDMA- PAC Awards for Eminent Analyst, Outstanding Analyst,Young AnalystSeminars/ Workshops on Regulatory, Technical, Medical affairs, Harmonization projects with US FDA, IP, USP, EDQM, ANVISA
4 IDMA GOING GLOBALIDMA is in talks with leading Associations and Organisations globally for closer Co-operation and Networking on International issues concerning the Pharmaceutical Industry and has signed MOUs with :IDMA-CPIA (China Pharmaceutical Industry Association)IDMA-KPMA (Korean Pharmaceutical Manufacturers Assn)IDMA-Dubiotech (Dubai Biotechnology Park)IDMA-ABLE (Assn. of Biotechnology Led Enterprises)IDMA- Pro Genericos - Brazil (in discussion)4
5 IDMA GOING GLOBAL (contd…) Active participation in International Fora:IGPA Conference, CanadaUSP Convention, WashingtonAPI China Spring, HarbinPropak Asia, Bangkok2nd Annual Pharma Manufacturing China Summit, ShanghaiGenerics R&D & Partnering Asia, ShanghaiIndia-Japan Pharma Industry Seminar, OsakaInternational Pharmaceutical IngredientsExpo & Conference, JapanSino-India Forums5
6 Epidemiological Factors DEMAND DRIVERSAccessibilityOver USD 200 Billion to be spent onmedical infrastructure in the nextdecadeNew business models expectedto penetrate tier-2 and tier-3 citiesOver 160,000 hospital beds expectedto be added each year in the nextIncreasing access to lower-incomesegments due to Governmentinitiatives that increase access andaffordability (e.g. RSBY)AcceptabilityRising levels of education to increase theacceptability of pharmaceuticalsPatients to show greater propensity to self-medicate, boosting the OTC marketAcceptable of biologics and preventivemedicines to riseVaccine market could grow 20 per cent per yearin the next decadeSurge in medical tourism due to increasedpatient inflow from other countriesAffordabilityRising income could drive 73 millions householdsto the middle class over the next 10 yearsOver 650 million people expected to be coveredby Health Insurance by 2020Government-sponsored programmes set toprovide health benefits to over 380 million BPLpeople by 2017By 2017, the Government plans to provide freegeneric medicines to half the population at anestimated cost of USD 5.4 billionEpidemiological FactorsPatient pool expected to increase over 20% in thenext 10 years, mainly due to rise in populationNew diseases and lifestyle changes to boostdemandIncreasing prevalence of lifestyle diseases
9 INDIAN PHARMA INCKnowledge based Industry and one of the world's largest and most developed.Current turnover estimated at US$ 25 bln. growing @ 12%About 300 Large & over 10,000 SMEsAbout 77% units make Formulations and about 23% units make APIsOver 64,000 formulations in market covering almost every therapeutic segment with about 10 to 200 brands per moleculeFor example, Ciprofloxacin has over 180 brands and Atorvastatin has about 96 brands competing in the market.
10 INDIAN PHARMA INC (contd…) Medicines constitute only about 15% of total healthcare spend in IndiaAbout 90% of India’s pharmaceutical market is made up of branded generics and has the potential to grow at an accelerated 15 to 20% CAGR in the next five years.Patented drugs account for 1% of $12 bln. market, set to grow to 5% of est. $ bln. market by 2020Globally ranks 4th largest in volume and 12th in value10% of World’s Production but 1.5% of Value (Extremely Competitive Prices)
11 SHARE OF GENERIC AND PATENTED DRUGS IN INDIAN MARKET By 2016, share of generics may be about 90% of Indian pharma market, as patented drugs increase to about 10%
13 INDIAN PHARMA INC (contd…) Exports at $12 bln. with formulations at $ 7.5 bln. and APIs at $ 4.5 bln.Exports estimated to cross $16 bln. byExports to almost all countries, with major share in regulated marketsRated world’s single largest producer and top exporter of generic drugsEvery Third Tablet consumed in the World is ‘Made in India’
14 INDIAN PHARMA INC (contd…) India’s five of the largest export markets are USA, UK, Germany, Russia and South AfricaThree out of Global Top 10 fastest growing generic companies are Indian - Glenmark, Dr Reddy’s and Sun PharmaThe Indian pharma market is expected to grow at 12–15 % over next two yearsThe Indian drugs and pharma sector attracted FDI worth US$ 9.6 bln. between April 2000 to May 2012
15 INDIAN PHARMA INC (contd…) India is now among the top five pharma emerging markets globallyFront runner in a wide range of specialties involving complex drugs' manufacture, development and technologyExpected to touch $36 bln. by 2016India has about 40% of all ANDA approvals from US FDA during January-July 2013.USFDA approvals speak about the stringent norms followed by the Indian companies
16 INDIA’S API INDUSTRYThe Indian API Industry services the Domestic and International MarketThe Indian API manufacturing industry is the third largest in the world, to grow at CAGR 17% overProducing over 400 APIsGrowth in Generic Industry spurred API demand worldwideIncreased emphasis of contract manufacturing increases scope of captive API demandHigh percentage of API exports are high value, servicing Highly regulated markets with complex APIsGlobally Indian companies hold more than 90% of APIs approvals for ARVs, Anti-TBs and Anti-malarials
17 RECENT COLLABORATIONS WITH INDIAN COs MNCINDIANTHE DEALFROMRATIONALEMylan Labs, USAMatrix labs71.5%August 2006Expand mfgr platform, Access to key marketsDaiichi Sankyo, JapanRanbaxyAcquiredJune 2008Access to low cost manufacturingPfizer, USAAurobindoContract ManufacturingMarch 200960 products for regulated marketsFresenius Kabi, GermanyDaburApril 2009Access to oncology manufacturingClaris LifesciencesMay 2009Access to sterile injectable drugsGSK, UKDr Reddy’sPartnershipJune 2009Develop & market select products for emerging markets
18 RECENT COLLABORATIONS WITH INDIAN COs MNCINDIANTHE DEALFROMRATIONALEMylan Labs, USBioconContract mfgr & dev.June 2009Develop monoclonal antibodyMylan Labs,USAFamy Care15% stakeAugust 2009Access to oral contraceptive mfg.Sanofi Pasteur, FranceShantha Biotech.Controlling stakeAccess to vaccine manufacturingHospiraOrchid Chem.Buyout of injectable antibioticsDec 2009Access to low cost manufacturingPfizer, USAStridesCollaborationJan 2010 & May 2010Access to 78 oncology products & sterile injectablesReckitt Benckister, UKParas PharmaTakeoverMarch 2010Access to OTC marketAbbott Labs, USANicholas PiramalTakeover of healthcare businessMay 2010Access to generic products
19 RECENT COLLABORATIONS WITH INDIAN COs MNCINDIANTHE DEALFROMRATIONALEPfizer , USAVetnex Animal HealthControlling stakeJune 2009Access to animal health businessVetoquinol,FranceWockhardt (vet division)BuyoutAccess to Indian marketAbbott Lab., USAWockhardt (nutrition Div)buyoutJuly 2009Access to Indian nutrition marketReckitt Benckister, UKParas PharmaTakeoverMarch 2010Access to OTC marketLitha ealth-care,South AfricaNatco PharmaMarketing of productsSept 2011Access to multitude of dossiersB. Braun SingaporeAhlcon Parenterals(I)March 2012Iv Fluid and medical disposalsMylan Inc, USAStrides Arcolab (Agila Specilaities)Sept 2013Injectables catering to oncology
21 INTERNATIONAL REGULATORY APPROVALS No. of manufacturing sites (APIs + formulations) registered / approved by US FDA (as on )550 / 323Total no. of DMFs filed from India as on> 3000No. of ANDAs final / tentative approvals received from USFDA in Year 2012178 / 42No. of ANDAs final / tentative approved by US FDA between Jan-June 201387 / 25No. of CEPs (certificates of suitability) from EDQM received by 130 companies902No. of sites approved by PDMA (Japan) – 20% of all PDMA aprrovals>190WHO GMP certified plants> 800Australian TGA approvals845
22 R&D Investment in India R&D investments overall is approx 18% of revenueSpending on R&D by 30 leading Indian pharma companies up significantly by 19.7% during the year ended March 2013 over the previous year.Focus of R&D by these companies is on new cost effective generic products in key therapeutic areasWith higher spending on R&D, Indian Pharma Inc. is set to tap upcoming opportunities from loss of patent exclusivity in the coming years.(Improve / Add Value to generics / patented products)
23 R&D Investment in India Net outcome of this trend is higher approvals for ANDAs and DMFs from highly regulated authorities like US, Europe and Japan.Major companies like Shasun Pharma, Unichem Lab., Biocon, Natco Pharma etc have pushed their R&D expenses over 50% duringFor example, R&D expenditure of Shasun Pharma went up by 179%
24 FOCUSSED APPROACH Designing products specifically for low income group Identifying and servicing completely new needsFocusing on New Drug Delivery SystemsGreater focus on prevention rather than treatment, including increasing use of information and communication technologies
25 INDIAN BIOTECHNOLOGY MARKET Global Biotech Revenue$262 billionIndian Biotech Market at $ 4.3 bln. expected to touch $ 11.6 bln. by 2017
26 INDIAN BIOTECH SET-UPWorld's largest producer of vaccines: 60% of the world’s vaccines are manufactured in India – exported to over 150 countries - accounts for 60–80% of annual UN vaccine purchasesOver 300 companies in operationAmong the five rising biotech industries in Asia-PacificAnnual revenue generated is over $4 bln at a growth rate of 21.5%Revenue from biotech exports at $ 2.2 bln in 2013 accounting for 51% of total industry revenuesGenome Valley project at Hyderabad is the largest single cluster for biotech research, training and manufacturing, earns foreign exchange of over $ 1 bln per year
27 THE INDIAN SCENARIOIndia's growing respect and legal / regulatory framework for IPR, favourable economic policies and availability of huge talent pool for sustaining and growing operations is making India an attractive choice for global pharma companies for investment, tie-ups, mergers, acquisitions.
28 THE INDIAN SCENARIOBecause of patent expirations of blockbuster drugs, Indian firms are expected to actively participate in the production of generic version of these products. Indian companies are also ready with generic version of biotech drugs. Therefore, India will be able to maintain a large basket of qualitty affordable generics with assured safety and efficacy.
29 GLOBAL HEALTHCARE COSTS Rapid hike in pricesOverall economic slowdownRising Govt. deficitReduction in Healthcare budgetsHigh priced prescription drugsAging populationAdministrative costsSpending on chronic diseases etcCompanies forced to reduce prices
30 INDUSTRY’S CHALLENGES Declining ProductivityCompetitive PressureReducing drug approvalsStringent regulationsImplementation of cost control measures by GovernmentsIncreasing development costsIncrease in Clinical trial period due to tightened drug safety regulations- thereby Leading to higher development costs and increased time-to-market
32 GLOBAL PHARMA TRENDSSpending on medicines will reach $1.2 trn. by 2016Rising influence of healthcare access and funding World over is driving demand towards low cost generic options from IndiaAnti-Diabetic Drugs and those for cardiovascular diseases are expected to see the fastest growth.Cardiovascular patients estimated globally at over 250 million, mainly due to changes in demographics and lifestylePharmaceutical industry's R&D programs will need to adjust to broad availability of low-cost generics from IndiaDemand for generics will also increase in oncology, diabetes, multiple sclerosis and HIV therapy areas
33 WHAT IS THE SOLUTION? In-Licencing Arrangements Globally, Governments and pharma companies are looking at opportunities to procure medicines at affordable prices, reduce costs, improve pipeline and reduce the time-to-marketTo reduce healthcare costs, they are adopting strategies like:SOURCING FROM INDIAOutsourcing (manufacturing, research, Clinical Trials etc) to IndiaRestructuring their R&D models to consider genericsAdopting efficient sales & marketing functions to promote ‘value-added’ generics as alternativesIn-Licencing Arrangements
35 ADVANTAGE INDIAWhile clinical trials cost approximately $300 to 350 million in US, they cost only about $25 million in IndiaIndia has the 2nd highest number of qualified doctors in the world. Of every six medical doctors in the US, one is IndianInvestigational New Drug stage costs about $100 to 150 million in US, but costs only around $10 to 15 million in India700,000 science and engineering graduates & 1500 PhDs qualify annually. Over 15,000 scientistsIndia’s huge population and the prevalence of a wide spectrum of disease conditions offer a wide patient-resource for clinical trials
36 ADVANTAGE INDIA On demand India manufactures and exports medicines from all therapeutics groups.Many original innovator companies source their discovered drugs from Indian companies.India is a world leader in anti-AIDS and anti-TB segments and for some of the latest medicines like Glitazones, Celecoxib, Statins, Montelukast and many anti-cancer drugsOn demand
37 US PATENT EXPIRIES Year No. of Patents 2010 70 2020 171 2011 130 2021 13320121652022882013207202395201425320246420152352025452016162202637201720320274220182092028212019202922(Source: USFDA Orange Book, Oct 2011)
38 GLOBAL RECOGNITIONBill Clinton's foundation, Clinton Health Access Initiative (CHAI) got further discounts from Indian generic manufacturers that reduced the cost of combination drug treatments for AIDS, which can reach thousands of dollars per year in the West, to as low as $120 a year per patient.Many Indian companies are part of this agreement where Lamivudine, Stavudine, Zidovudine, Nevirapine will be supplied to a few African countries.India has highest number of approvals from the US President's Emergency Plan for AIDS Relief (PEPFAR).
40 INDIA AS PHARMACY OF DEVELOPING WORLD – Examples Main procurement agencies for developing countries depend overwhelmingly on India70-90% of essential medicines of developing countries comes from India50% of medicines procured by UNICEF for developing countries are from India75-80% of medicines distributed by Dutch-based International Dispensary Association (IDA) Foundation, the chief medical supplier to developing countries is sourced from India
41 INDIA AS PHARMACY OF DEVELOPING WORLD – Examples (contd….) 80% of medicines for AIDS issued by MSF (Doctors Without Borders) come from India and are distributed in treatment projects in over 30 countriesGlobally, 70% of treatment for 87 countries provided by UNICEF, The Global Fund to Fight AIDS, Tuberculosis and Malaria, the Clinton Foundation, etc. come from India91% of the generic ARVs approved by the US FDA for PEPFAR, the US President’s AIDS initiative for distribution in developing countries are from India, resulting in cost-savings up to 90%.
42 INDIA AS PHARMACY OF DEVELOPING WORLD – Examples (contd….) In Zimbabwe, 75% of all tenders for medical expenditure come from IndiaIn Lesotho, it is 95%90% of the ARVs used in Zimbabwe’s national treatment programme come from IndiaIn addition, raw materials are exported from India to other countries for local production of affordable medicinesThis has been crucial to enable national AIDS programmes, such as those in Brazil or Thailand, to provide universal free access to ARVs.Thailand gets 90% of its raw materials for ARV production from India
43 INDIA’S SUPPORT TO USA Over 40% of generics prescribed are from India To ensure continued supply of the low cost quality generics from India, the US FDA has opened India office1 out of 5 US FDA inspections for approvals are in IndiaIndian firms have over 40% of total ANDA approvals in USA80% of all retail prescriptions filled in USA are for generic drugsBased on their marketing and distribution networks and manufacturing capacities, Indian firms could see as much as % annual growth from the US, predict experts.To overcome the recent shortage of cancer drugs J & J’s Doxil in USA, the US FDA sought Sun Pharma’s help in providing their chemotherapeutic drug Lipodox drugs from India43
44 LARGEST SUPPLIER TO UNICEF India has consistently been the largest supplier to UNICEF since 2007.India was the largest supplier country in 2012, with $558 million worth of supplies such as vaccines, pharmaceuticals, nutrition, medical suppliesOf the 2.14 bln. purchases by UNICEF in 2012, more than 25% were from IndiaSerum Institute of India Ltd., an IDMA Member supplied vaccines / biologicals worth $254 mio dollars, making it the largest supplier in IndiaOther significant suppliers include Hetero Labs, Ranbaxy Labs, Aurobindo Pharma, Haffkine Bio-Pharma Corp., Micro Labs etc, all Members of IDMA.
45 LARGEST SUPPLIER TO UNICEF UNICEF has recognised India's contribution to glocal aid, and international groups have lauded India's role in increasing access to medicines in the developing world.Anti RetroViral (ARV) treatment in Europe was $10,000 per patient a year, until Indian manufactured drugs brought it down to $95 patient a year.India is not only the largest supplier to UN groups, but also to the MSF and International Dispensary Association.
46 Affordable Efficacious Medicines – All Roads Lead India happens to be the largest supplier of generic ARVs to low and middle income countries.Paul Cawthome (MSF Access Campaign Coordinator-Asia) highlighted the worldwide dependency on India as a drug supplier best, when he said : 'It comes as a great relief to millions around the world who depend on a continuous supply of Indian generic medicines that the Indian Supreme Court has ruled against Novartis.‘To meet increasing global requirements, the Government of India has set a target of $25 bln. for pharmaceutical exports by 2016.
47 Affordable Efficacious Medicines – All Roads Lead to India Over 100 countries, mostly in the developing world, depend on India for affordable and quality essential medicines, vaccines and medical suppliesEvery fifth generic drug and every third HIV drug consumed anywhere in the world, mostly in the developing world, home to over 80 % of the world's population, is manufactured in India
48 CHINDIA BILATERAL TRADE China’s Premier Li Keqiang chose India for his first foreign tripPremier Li was confident that “we are not a threat to each other, nor do we seek to contain each other”Prime Minister Manmohan Singh had earlier assured China that “the world is big enough for both countries and each is too big to be contained by the other“China has emerged as India’s largest trading partner as it replaced the US (in March 2008)Premier Li has assured that China’s markets will be opened to Indian products to address the trade imbalance and boost commerce to $100 billion a year
49 CHINDIA BILATERAL TRADE Despite a clear value proposition, Indian companies find it difficult to win government procurement contracts due to regulations that favour Chinese companies.Again, China accounts for nearly 73% of Indian imports of APIs and other organic compounds.
50 CHINDIA - PARTNERSHIP IN GLOBAL TENDERING As a reciprocal measure, China should import drug formulations from India to offset the trade deficit against API imports and set a timeline for review and approval of drug dossiersIndia’s closer engagement with China in the global production network could be a possible way to improve its technology-intensive exports.Our trade must focus on ‘trade creation’ and ‘trade diversion’
51 IN CONCLUSION A Win-Win situation!! IDMA has always promoted access to quality affordable medicines, as our Annual themes confirm:Affordable Medicines for All (2003)Indian Pharmaceutical Industry – Going Global (2004)People First… Patents Next (2005)Global Pharma, India has Arrived (2006)Contract Research and Manufacturing Services -Destination India (2007)Indian Pharmaceutical Industry – Exciting Times Ahead (2008)India’s Quality Affordable Generics: For Global Healthcare (2009)India- The Generics Pharma Capital of the World (2010)Healthcare Of People – Always In All Ways (2011)INDIAN PHARMA INC. CREATING A GLOBAL IMPACT (2012)AFFORDABLE EFFICACIOUS MEDICINES – ALL ROADS LEAD TO INDIA (2013)