Generic drugs the global market focus on europe

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  • 1. Generic Drugs: The Global Market--Focus on EuropePublished:September 2011No.Of pages:179Price:US $ 3900Report Summary* An examination of the strategies employed by companies specializing in generics to meet thechallenges of this highly competitive market as well as those utilized by “originator” companiesto forestall generic competition; this report will focus on the markets in Europe* Analyses of market trends, with data from 2010, estimates for 2011, and projections ofcompound annual growth rates (CAGRs) through 2016* Discussion of how fierce price competition has put some companies in difficulties because ofslashed profit margins, and of the resulting wave of merger-and-acquisition activity, and the riseof “supergenerics” that offer added value as well as low prices* A breakdown of the nature and structure of the generics industry, with profiles of severalleading generics companies, and an update of M&A activity* Patent analyses.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. Atthe same time, fierce price competition in this area has created difficulties for some companiesbecause of slashed profit margins. The main result has been a wave of merger and acquisition
  • 2. (M&A) activity, and the rise of “supergenerics,” offering added value as well as low prices. Notall traditional companies are positioned to exploit this trend. A major growth driver for thegenerics sector is the fact that several blockbuster pharmaceutical brands are coming off-patentand are therefore open to generic competition—the phenomenon widely known as the “patentcliff.” But the originator companies are deploying formidable strategies to protect theirfranchises, including marketing their own branded generics. With first-generationbiopharmaceutical products reaching the end of their patent lives, a whole new market field—biogenerics or biosimilars—is opening up for those generics companies capable of (or preparedto buy-into) the technological expertise required. The international landscape is changing forgenerics as for all pharmaceuticals. China, India, Russia, Mexico, and Brazil are among therising markets for generic activity.SCOPE 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 Generic Drugs Market, and the Asian Generic Drugs Market.The American market coverage focuses on the largest markets of North and Latin America (theU.S., Canada, Brazil, and Mexico); 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 coverage focuses on the three major markets of Japan, China, and India.MARKET ANALYSES AND FORCASTSMarket 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
  • 3. other commercial publications. Data for market estimates and forecasts are pooled from a rangeof sources, and are critically assessed by BCC Research.INTENDED AUDIENCEThis report is designed to satisfy the information needs of a wide variety of individuals involvedin the generics marketplace, including company senior management executives seeking to basetheir strategic decisions on the best available information on market forces and trends. However,it is also aimed at managers and executives in marketing, research, planning, and salesdepartments who need readable, comprehensive, and up-to-date background on the marketplacein which they are operating.INFORMATION SOURCESSources of information included marketing strategists, industry executives, government agenciesand regulatory bodies, and surveys of physicians and pharmacists. Company annual reports andSEC filings, journal articles, and data from healthcare institutions were also mined, as well aspublications of relevant trade associations such as the Generic Pharmaceutical Association(GPhA) and the European Generic Medicines Association (EGA).ANALYST CREDENTIALSPaul Evers has been involved in analyzing pharmaceutical market and medical markets for 20years. He is the author of two previous reports on the generics marketplace as well as analyses ofmajor therapeutic categories and the pharmaceutical regulatory environment.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)
  • 4. 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 CareSUPERGENERICSBIOSIMILARSTABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001-2006Special ChallengesThe Biosimilar MarketSome Biosimilar Developments and IntroductionsEPOG-CSFInterferonsHGHMonoclonal AntibodiesMAJOR GENERIC ISSUESREGULATORY ENVIRONMENTU.S.TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONSEuropean UnionEU Marketing Authorization SystemsDecentralized and Mutual RecognitionProceduresMutual-Recognition ProcedureTypes of ApplicationsApplications Under Article 10 (Generic Products)
  • 5. 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 CLASSLEADING 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 ($
  • 6. 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 EUROPEAN MARKETTABLE 15 PHARMACEUTICAL PRICES IN EUROPE AND U.S., 2000- 2008 ($)FRANCEVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare ProvisionFIGURE 3 TOTAL EXPENDITURES ON HEALTH IN MAJOREUROPEAN MARKETS AND THE U.S. AS A PERCENTAGE OF GDP, 2007 (%)PHARMACEUTICAL MARKETGENERIC SECTORTABLE 16 PHARMACEUTICAL AND GENERICS MARKET IN FRANCE, THROUGH2016 ($ BILLIONS)GERMANYVITAL STATISTICSHEALTH AND HEALTHCAREProvision of HealthcarePHARMACEUTICAL MARKETPrice ControlsGENERICS SECTORTABLE 17 PHARMACEUTICAL AND GENERICS MARKET IN GERMANY, THROUGH2016 ($ BILLIONS)ITALYVITAL STATISTICS
  • 7. HEALTH AND HEALTHCAREHealthcare SystemPHARMACEUTICAL MARKETImplications for ResearchTABLE 18 SELECTED PRIORITY AREAS IN ITALY’S NATIONAL HEALTH PLANGENERICS SECTORTABLE 19 PHARMACEUTICAL AND GENERICS MARKET IN ITALY, THROUGH 2016($ BILLIONS)SPAINVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare ProvisionPharmaceutical ServicesPHARMACEUTICAL MARKETGENERICS SECTORGenerics IndustryTABLE 20 LEADING GENERICS COMPANIES IN SPAIN, 2010 ($ MILLIONS)TABLE 21 PHARMACEUTICAL AND GENERICS MARKET IN SPAIN, THROUGH 2016($ BILLIONS)UNITED KINGDOMVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare ProvisionPrivate Sector InvolvementPharmaceuticalsTHE PHARMACEUTICAL MARKETGENERICS SECTORTABLE 22 PHARMACEUTICAL AND GENERICS MARKET IN THE UNITED KINGDOM,THROUGH 2016 ($ BILLIONS)RUSSIAVITAL STATISTICSHEALTH AND HEALTHCAREHealthcare DeliveryPHARMACEUTICAL MARKET“Pharma 2020”GENERICS SECTORTABLE 23 PHARMACEUTICAL AND GENERICS MARKET IN RUSSIA, THROUGH 2016($ BILLIONS)CHAPTER SEVEN: PROFILES OF THE TOP TEN GENERICS COMPANIESTABLE 24 LEADING GENERICS MANUFACTURERS, 2010 ($ BILLIONS/%)TRENDSSTRUCTURE OF THE GENERICS INDUSTRYPROFILES OF TOP 10 GENERICS COMPANIESACTAVIS
  • 8. APOTEX 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 EIGHT: PROFILES OF OTHER INTERNATIONAL GENERICSCOMPANIES PROFILESALAPIS 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, PLC
  • 9. APIsPharmaceutical R&DGEDEON RICHTER, PLCGENEPHARM GROUPKRKA, D.D., NOVO MESTOProductsFinancialsLooking AheadKV PHARMACEUTICAL CO.LUPIN, LTD.MITSUBISHI TANABE PHARMA CORP.Tanabe Seiyaku Hanbai Co., Ltd.NICHI-IKO PHARMACEUTICAL CO., LTD.ProductsFinancialsLooking AheadNIPPON CHEMIPHAR CO., LTDFinancialsLooking AheadNOVARTIS INTERNATIONAL AGooking AheadORION CORP.ProductsGenericsFinancialsLooking AheadPFIZER INC.U.S. Basic Patent ExpiryTABLE 25 PFIZER’S U.S. PATENT EXPIRIES, THROUGH 2021FinancialsPLIVA D.D.ROXANE LABORATORIES, INC.SANOFI-AVENTISLooking AheadSAWAI PHARMACEUTICALProductsFinancialsLooking AheadSTADA ARZNEIMITTELGenericsBiosimilarsFinancialsLooking AheadSTRIDES ARCOLAB, LTD.Product Range
  • 10. Looking 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/191441427571689Contact:Mr.Priyank7557 Rambler road,Suite727,Dallas,TX75231Tel: + 1 888 391 5441E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comVisit our Market Research Blog