Generic drugs the global marketDocument Transcript
Generic Drugs: The Global MarketPublished:September 2011No.Of Pages:231Price:US $ 4850Report Summary* The global generics market is estimated at about $225 billion in 2011. By 2016, it is expectedthat the value of the total global generics sector will have risen to $358 billion, representing morethan 18% of all pharmaceuticals, a projected compound annual growth rate (CAGR) of 9.7%between 2011 and 2016.* The North American market is estimated to reach nearly $73 billion in 2011 and is expected toincrease at a 7.9% compound annual growth rate to reach nearly $107 billion in 2016.* Emerging market represents the second largest market category for generic drugs with theexpected sale of $57 billion in 2011. This should reach nearly $115 billion in 2016, for a CAGRof 15.1%.INTRODUCTIONSTUDY GOALS AND OBJECTIVESThe aim of this report is to provide detailed market, technology, and industry analyses to helpreaders quantify and qualify the market for prescription generic drugs. Important trends areidentified and sales forecasts by product categories and major country markets are providedthrough 2016; these are based on industry sources and considered assessment of the regulatoryenvironment, healthcare policies, demographics, and other factors that directly affect the genericdrug market. The wider economic environment is also taken into account.The report examines strategies employed by companies specializing in generics to meet thechallenges of this highly competitive market, while also summarizing strategies employed by“originator” companies to forestall generic competition.REASONS FOR DOING THE STUDYThis is a time of growth and change for the generic pharmaceuticals sector. Major aspects thatcombine to create an opportunity for an up-to-date market analysis include the following:* The demand for generics is increasing steadily because of pressure to control healthcare costs.At the same time, fierce price competition in this area has created difficulties for somecompanies because of slashed profit margins. The main result has been a wave of merger andacquisition (M&A) activity, and the rise of “supergenerics,” offering added value as well as lowprices. Not all traditional companies are positioned to exploit this trend.
* A major growth driver for the generics sector is the fact that several blockbusterpharmaceutical brands are coming off-patent and are therefore open to generic competition—thephenomenon widely known as the “patent cliff.” But the originator companies are deployingformidable strategies to protect their franchises, including marketing their own branded generics.* With first-generation biopharmaceutical products reaching the end of their patent lives, a wholenew market field—biogenerics or biosimilars—is opening up for those generics companiescapable of (or prepared to buy-into) the technological expertise required.* The international landscape is changing for generics as for all pharmaceuticals. China, India,Russia, Mexico, and Brazil are among the rising markets for generic activity.Browse All Pharmaceuticals Market Research ReportsSCOPE OF REPORTThis report discusses the implications of all the above-mentioned trends, in the context of thecurrent size and growth of the generics market, both in global terms and analyzed by the mostimportant national markets. The nature and structure of the generics industry is discussed, withprofiles of the leading 20+ generics companies, and an update on M&A activity. Five-year salesforecasts are provided for the national markets and the major therapeutic categories of productsinvolved.The report presents overall market size estimates and analysis for the overall global market, aswell as more detailed market coverage of the three major segments of the global market: theAmerican market, the European market, and the Asian market. The American market coveragefocuses on the largest markets of North and Latin America (the U.S., Canada, Brazil, andMexico); European market coverage focuses on the markets in France, Germany, Italy, Spain,and the United Kingdom, as well as an analysis of the Russian market; and Asia market coveragefocuses on the three major markets of Japan, China, and India.MARKET ANALYSES AND FORECASTSMarket figures are based on revenues at the manufacturer level and are projected based on 2011dollar value without attempting to predict the effect of inflation/deflation.Therapeutic categories quantified and forecast include antibacterials, antidepressants, anticanceragents, anti-arthritics, cardiovascular drugs (e.g., hypolipidaemics and antihypertensives), anddrugs for respiratory conditions, including asthma and COPD.METHODOLOGYBoth primary and secondary research methodologies were used in preparing this study. Primaryresearch includes interviews with leading individuals in generics companies, industryassociations, and regulatory bodies. Sources of published data include company annual reports,SEC filings, government and industry publications, literature searches, industry journals, and
other commercial publications. Data for market estimates and forecasts are pooled from a rangeof sources, and are critically assessed by BCC Research.Table Of ContentsCHAPTER ONE: INTRODUCTIONSTUDY GOALS AND OBJECTIVESREASONS FOR DOING THE STUDYSCOPE OF REPORTMARKET ANALYSES AND FORECASTSMETHODOLOGYINTENDED AUDIENCEINFORMATION SOURCESANALYST CREDENTIALSRELATED REPORTSBCC ONLINE SERVICESDISCLAIMERCHAPTER TWO: SUMMARYSUMMARYMARKET SIZE AND EVOLUTIONSUMMARY TABLE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)SUMMARY FIGURE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)CHAPTER THREE: OVERVIEWOVERVIEWTABLE 1 GLOBAL PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016($ BILLIONS)RECENT HISTORY OF THE GENERICS SECTORROCHE-BOLARGENERICS LOBBYICHCHAPTER FOUR: THE NEW GENERICS ERATHE PATENT CLIFFTABLE 2 FIRST PATENT EXPIRIES, 2012-2023TYPES OF GENERICS“SIMPLE” GENERICSFactors Influencing the Success or Failure of GenericsAdequate Market SizePatent-Expired TherapiesOlder Products Still UsedLong-Term UseStraightforward Production TechnologyDrugs Used in Primary CareSUPERGENERICS
BIOSIMILARSTABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001-2006Special ChallengesThe Biosimilar MarketSome Biosimilar Developments and IntroductionsEPOG-CSFInterferonsHGHMonoclonal AntibodiesMonoclonal … (Continued)MAJOR GENERIC ISSUESREGULATORY ENVIRONMENTU.S.TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONSEuropean UnionEU Marketing Authorization SystemsThe Centralized ProcedureDecentralized and Mutual RecognitionProceduresMutual-Recognition ProcedureTypes of ApplicationsApplications Under Article 10 (Generic Products)JapanApproval (Shonin) of PharmaceuticalsREGULATION OF BIOSIMILARSEU ProvisionsEvolving Situation in the U.S.Hatch-Waxman and BolarDefensive Strategies by “Big Pharma”“AUTHORIZED GENERICS”User FeesA “Mood Swing” Toward GenericsThe Situation in EuropePATENTS AND IPSUPPLEMENTARY PROTECTION CERTIFICATESCHAPTER FIVE: THE GLOBAL PHARMACEUTICAL AND GENERICS MARKETGLOBAL GENERICS MARKETMAIN NATIONAL GENERICS MARKETSTABLE 5 WORLD PHARMA AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)TABLE 6 CURRENT AND FORECAST NATIONAL GENERICS MARKETS, THROUGH2016 ($ BILLIONS)MARKET OPPORTUNITIES BY PRODUCT CLASS
LEADING GENERIC MOLECULESTABLE 7 WIDELY PRESCRIBED GENERIC MOLECULES IN THE U.S. AND EUROPEAnti-infectivesTABLE 8 LEADING ANTI-INFECTIVE PRODUCTS SALES ESTIMATES WITH YEAR OFPATENT EXPIRY, 2010 ($ BILLIONS)CNS TherapiesTABLE 9 CNS MARKET BY MAJOR INDICATIONS, 2010 ($ BILLIONS)FIGURE 1 CNS MARKET SHARES BY MAJOR INDICATIONS, 2010 (%)AntidepressantsAntipsychoticsTABLE 10 LEADING CNS PRODUCT SALES ESTIMATES, 2010 ($ BILLIONS)AnxiolyticsSleep DisordersEpilepsyParkinson’s DiseaseMigraineCardiovascular ProductsTABLE 11 LEADING CARDIOVASCULAR PRODUCT SALES, 2009 ($ BILLIONS)Anti-arthritis ProductsSteroidsNSAIDsCOX- II InhibitorsDMARDsTABLE 12 LEADING ANTI-ARTHRITIS PRODUCT SALES ESTIMATES, 2009 ($BILLIONS)Respiratory ProductsAsthmaCOPDAllergic RhinitisTABLE 13 LEADING RESPIRATORY PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS)Drugs Used to Treat Asthma and COPDBronchodilatorsInhaled BronchodilatorsAnticholinergicsOral BronchodilatorsLeukotriene AntagonistsSteroidsFIGURE 2 USAGE OF MAIN PRODUCT CATEGORIES BASED REVENUES (%)Anticancer ProductsCytotoxic DrugsHormonal TherapyBiologic Response ModifiersAntiangiogenesis DrugsMonoclonal AntibodiesTABLE 14 LEADING ANTICANCER PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS)
CHAPTER SIX: THE AMERICAN MARKETTHE U.S. MARKETVITAL STATISTICSHEALTH AND HEALTHCARETHE U.S. PHARMACEUTICAL MARKETTHE GENERICS MARKET: SIZE AND GROWTHBiosimilarsGeneric Prices“Carve-Outs”Generics IndustryFIGURE 3 U.S. PHARMACEUTICAL MARKET SHARES BASED ON DOLLAR SALESAND PERCENTAGE SHARE OF PRESCRIPTIONS BY TYPE, 2010 (%)The FutureTABLE 15 U.S. PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($BILLIONS)CANADAVITAL STATISTICSHEALTH AND HEALTHCARETHE PHARMACEUTICAL MARKETGENERICSGeneric PricesFuture Market GrowthHow Generics are SuppliedTABLE 16 GENERICS MARKET IN CANADA, THROUGH 2016 ($ BILLIONS)LATIN AMERICABRAZILVital StatisticsHealth and HealthcarePharmaceutical MarketGenerics MarketM&A ActivityBackgroundPróGenéricosTABLE 17 PHARMACEUTICAL AND GENERICS MARKET IN BRAZIL, THROUGH 2016($ BILLIONS)MEXICOVital StatisticsHealth and HealthcarePharmaceutical MarketMarket ResistorsGeneric SectorGeneric IndustryRegulatory IssuesAMEGI
ForecastsTABLE 18 PHARMACEUTICAL AND GENERICS MARKET IN MEXICO, THROUGH2016 ($ BILLIONS)CHAPTER SEVEN: THE EUROPEAN MARKETTABLE 19 PHARMACEUTICAL PRICES IN EUROPE AND U.S., 2000-2008 ($)FRANCEVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare ProvisionFIGURE 4 TOTAL EXPENDITURES ON HEALTH IN MAJOR EUROPEAN MARKETSAND THE U.S. AS A PERCENTAGE OF GDP, 2007 (%)PHARMACEUTICAL MARKETGENERIC SECTORTABLE 20 PHARMACEUTICAL AND GENERICS MARKET IN FRANCE, THROUGH2016 ($ BILLIONS)GERMANYVITAL STATISTICSHEALTH AND HEALTHCAREProvision of HealthcarePHARMACEUTICAL MARKETPrice ControlsGENERICS SECTORTABLE 21 PHARMACEUTICAL AND GENERICS MARKET IN GERMANY, THROUGH2016 ($ BILLIONS)ITALYVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare SystemPHARMACEUTICAL MARKETImplications for ResearchTABLE 22 SELECTED PRIORITY AREAS IN ITALY’S NATIONAL HEALTH PLANGENERICS SECTORTABLE 23 PHARMACEUTICAL AND GENERICS MARKET IN ITALY, THROUGH 2016($ BILLIONS)SPAINVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare ProvisionPharmaceutical ServicesPHARMACEUTICAL MARKETGENERICS SECTORGenerics IndustryTABLE 24 LEADING GENERICS COMPANIES IN SPAIN, 2010 ($ MILLIONS)TABLE 25 PHARMACEUTICAL AND GENERICS MARKET IN SPAIN, THROUGH 2016
($ BILLIONS)UNITED KINGDOMVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare ProvisionPrivate Sector InvolvementPharmaceuticalsTHE PHARMACEUTICAL MARKETGENERICS SECTORTABLE 26 PHARMACEUTICAL AND GENERICS MARKET IN THE UNITED KINGDOM,THROUGH 2016 ($ BILLIONS)RUSSIAVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare DeliveryPHARMACEUTICAL MARKET“Pharma 2020”GENERICS SECTORTABLE 27 PHARMACEUTICAL AND GENERICS MARKET IN RUSSIA, THROUGH 2016($ BILLIONS)CHAPTER EIGHT: THE ASIAN REGIONJAPANVITAL STATISTICSHEALTH AND HEALTHCAREPHARMACEUTICAL MARKETTABLE 28 TOP 5 JAPANESE PHARMA COMPANIES, 2008 (%)GENERICS SECTORForeign PresenceMarket ResistanceGenerics IndustryTABLE 29 JAPANESE PHARMACEUTICAL AND GENERICS MARKET, 2011-2016 ($BILLIONS)INDIAVITAL STATISTICSHEALTH AND HEALTHCAREGrowing Affluence—Changing Medical NeedsRegulatory ChangesPHARMACEUTICAL MARKETDemographic FactorsPharma IndustryPatent ReformGENERICS INDUSTRYTABLE 30 LEADING PHARMA COMPANIES IN INDIA, 2010 ($ MILLIONS)TABLE 31 PHARMACEUTICAL AND GENERICS MARKET IN INDIA, THROUGH 2016
($ BILLIONS)CHINAVITAL STATISTICSHEALTH AND HEALTHCAREPHARMACEUTICAL MARKETDomestic IndustryForeign Company InvolvementImportance of R&DChallengesMarket TrendsRegulatory ChangesGeneric ExportsDomestic Generics MarketLocal DominanceFIGURE 5 GENERICS MARKET THERAPEUTIC CATEGORIES 2008 (%)TABLE 32 PHARMACEUTICAL AND GENERICS MARKET, CHINA, THROUGH 2016 ($BILLIONS)CHAPTER NINE: PROFILES OF THE TOP TEN GENERICS COMPANIESTABLE 33 LEADING GENERICS MANUFACTURERS, 2010 ($ BILLIONS/%)TRENDSSTRUCTURE OF THE GENERICS INDUSTRYPROFILES OF TOP 10 GENERICS COMPANIESACTAVISAPOTEX INCDR. REDDY’S LABORATORIES, LTD.AcquisitionsFinancialsHOSPIRA, INC.BiogenericsFinancialsMYLAN INC.FinancialsLooking AheadPAR PHARMACEUTICAL, INC.GenericsFinancialsRANBAXY LABORATORIES, LTD.HistoryAcquisition by Daiichi SankyoFinancialsLooking AheadSANDOZ INTERNATIONAL GMBHProductsTEVA PHARMACEUTICAL INDUSTRIES, LTD.
FinancialsWATSON PHARMACEUTICALS, INC.ProductsFinancialsLooking AheadCHAPTER TEN: PROFILES OF OTHER INTERNATIONAL GENERICS COMPANIESPROFILESALAPIS GROUPAMNEAL PHARMACEUTICALS, LLCAmneal Pharmaceuticals Co. India Pvt., Ltd.ASPEN PHARMACARE HOLDINGS, LTD.Financial ResultsAUROBINDO PHARMA, LTD.ProductsFinancialsLooking AheadBERLIN-CHEMIE AGBIOCONBiocon U.S.BIOGARAN FRANCECIPLA, LTD.COBALTEGIS PHARMACEUTICALS, PLCAPIsPharmaceutical R&DGEDEON RICHTER, PLCGENEPHARM GROUPKRKA, D.D., NOVO MESTOProductsFinancialsLooking AheadKV PHARMACEUTICAL CO.LUPIN, LTD.Lupin, Ltd. (Continued)MITSUBISHI TANABE PHARMA CORP.Tanabe Seiyaku Hanbai Co., Ltd.NICHI-IKO PHARMACEUTICAL CO., LTD.ProductsFinancialsLooking AheadNIPPON CHEMIPHAR CO., LTDFinancialsLooking AheadNOVARTIS INTERNATIONAL AG
Looking AheadORION CORP.ProductsGenericsFinancialsLooking AheadPFIZER INC.U.S. Basic Patent ExpiryTABLE 34 PFIZER’S U.S. PATENT EXPIRIES, THROUGH 2021FinancialsPLIVA D.D.ROXANE LABORATORIES, INC.SANOFI-AVENTISLooking AheadSAWAI PHARMACEUTICALProductsFinancialsLooking AheadSTADA ARZNEIMITTELGenericsBiosimilarsFinancialsLooking AheadSTRIDES ARCOLAB, LTD.Product RangeLooking AheadWOCKHARDT, LTD.FinancialsLooking AheadZYDUS CADILAZydus U.S. Corporate OfficeAbout Us:ReportsnReports is an online library of over 100,000+ market research reports andin-depth market research studies & analysis of over 5000 micro markets. Weprovide 24/7 online and offline support to our customers. Get in touch with us foryour needs of market research reports.Follow us on Twitter: http://twitter.com/marketsreportsOur Facebook Page:http://www.facebook.com/pages/ReportsnReports/191441427571689
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