Generic drugs the global market focus on the americasDocument Transcript
Generic Drugs: The Global Market-Focus on the AmericasPublished:September 2011No.Of pages:175Price:US $ 3900Report Summary* An examination of the strategies employed by companies specializing in genericsto meet the challenges of this highly competitive market as well as those utilized by“originator” companies to forestall generic competition; this report will focus on themarkets in the Americas* Analyses of market trends, with data from 2010, estimates for 2011, andprojections of compound annual growth rates (CAGRs) through 2016* Discussion of how fierce price competition has put some companies in difficultiesbecause of slashed profit margins, and of the resulting wave of merger-and-acquisition activity, and the rise of “supergenerics” that offer added value as well aslow prices* A breakdown of the nature and structure of the generics industry, with profiles ofthe leading 10 to 20 generics companies in the region, and an update of M&Aactivity* Patent analyses.INTRODUCTIONSTUDY GOALS AND OBJECTIVESThe aim of this report is to provide detailed market, technology, and industryanalyses to help readers quantify and qualify the market for prescription genericdrugs. Important trends are identified and sales forecasts by product categoriesand major country markets are provided through 2016; these are based on industrysources and considered assessment of the regulatory environment, healthcarepolicies, demographics, and other factors that directly affect the generic drugmarket. The wider economic environment is also taken into account.The report examines strategies employed by companies specializing in generics tomeet the challenges of this highly competitive market, while also summarizingstrategies employed by “originator” companies to forestall generic competition.REASONS FOR DOING THE STUDY
This is a time of growth and change for the generic pharmaceuticals sector. Majoraspects that combine to create an opportunity for an up-to-date market analysisinclude the following:The demand for generics is increasing steadily because of pressure to controlhealthcare costs. At the same time, fierce price competition in this area has createddifficulties for some companies because of slashed profit margins. The main resulthas been a wave of merger and acquisition (M&A) activity, and the rise of“supergenerics,” offering added value as well as low prices. Not all traditionalcompanies are positioned to exploit this trend. A major growth driver for thegenerics sector is the fact that several blockbuster pharmaceutical brands arecoming off-patent and are therefore open to generic competition—the phenomenonwidely known as the “patent cliff.” But the originator companies are deployingformidable strategies to protect their franchises, including marketing their ownbranded generics. With first-generation biopharmaceutical products reaching theend of their patent lives, a whole new market field—biogenerics or biosimilars—isopening up for those generics companies capable of (or prepared to buy-into) thetechnological expertise required. The international landscape is changing forgenerics as for all pharmaceuticals. China, India, Russia, Mexico, and Brazil areamong the rising markets for generic activity.Browse All Biotechnology Market Research ReportsSCOPE OF REPORTThis report discusses the implications of all the above-mentioned trends, in thecontext of the current size and growth of the generics market, both in global termsand analyzed by the most important national markets. The nature and structure ofthe generics industry is discussed, with profiles of the leading 20+ genericscompanies, and an update on M&A activity. Five-year sales forecasts are providedfor the national markets and the major therapeutic categories of products involved.The report Generic Drugs: The Global Market-Focus on the Americas presentsoverall market size estimates and analysis for the overall global market, as well asmore detailed market coverage of the three major segments of the global market:the American market, the European market, and the Asian market. The Americanmarket coverage focuses on the largest markets of North and Latin America (theU.S., Canada, Brazil, and Mexico); European market coverage focuses on themarkets in France, Germany, Italy, Spain, and the United Kingdom, as well as ananalysis of the Russian market; and Asia market coverage focuses on the threemajor markets of Japan, China, and India.
MARKET ANALYSES AND FORECASTSMarket figures are based on revenues at the manufacturer level and are projectedbased on 2011 dollar value without attempting to predict the effect ofinflation/deflation.Therapeutic categories quantified and forecast include antibacterials,antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs (e.g.,hypolipidaemics and antihypertensives), and drugs for respiratory conditions,including asthma and COPD.METHODOLOGYBoth primary and secondary research methodologies were used in preparing thisstudy. Primary research includes interviews with leading individuals in genericscompanies, industry associations, and regulatory bodies. Sources of published datainclude company annual reports, SEC filings, government and industry publications,literature searches, industry journals, and other commercial publications. Data formarket estimates and forecasts are pooled from a range of sources, and arecritically assessed by BCC Research.INTENDED AUDIENCEThis report is designed to satisfy the information needs of a wide variety ofindividuals involved in the generics marketplace, including company seniormanagement executives seeking to base their strategic decisions on the bestavailable information on market forces and trends. However, it is also aimed atmanagers and executives in marketing, research, planning, and sales departmentswho 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 agencies and regulatory bodies, and surveys of physicians andpharmacists. Company annual reports and SEC filings, journal articles, and datafrom healthcare institutions were also mined, as well as publications of relevanttrade associations such as the Generic Pharmaceutical Association (GPhA) and theEuropean Generic Medicines Association (EGA).ANALYST CREDENTIALSPaul Evers has been involved in analyzing pharmaceutical and medical markets for20 years. He is the author of two previous reports on the generics marketplace aswell as analyses of major therapeutic categories and the pharmaceutical regulatoryenvironment.
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 ($BILLIONS)RECENT HISTORY OF THE GENERICS SECTORROCHE-BOLARGENERICS LOBBYICHCHAPTER FOUR: THE NEW GENERICS ERATHE PATENT CLIFFTABLE 2 FIRST PATENT EXPIRIES, 2012-2023TYPES OF GENERICS“SIMPLE” GENERICSFactors Influencing the Success or Failure of GenericsAdequate Market SizePatent-Expired TherapiesOlder Products Still UsedLong-Term UseStraightforward Production TechnologyDrugs Used in Primary CareSUPERGENERICSBIOSIMILARSTABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001-2006
Special ChallengesThe Biosimilar MarketSome Biosimilar Developments and IntroductionsEPOG-CSFInterferonsHGHMonoclonal AntibodiesMAJOR GENERIC ISSUESREGULATORY ENVIRONMENTU.S.TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONSEuropean UnionEU Marketing Authorization SystemsThe Centralized ProcedureDecentralized and Mutual Recognition ProceduresMutual-Recognition ProcedureTypes of ApplicationsApplications Under Article 10 (Generic Products)JapanApproval (Shonin) of PharmaceuticalsREGULATION OF BIOSIMILARSEU ProvisionsEvolving Situation in the U.S.Hatch-Waxman and BolarDefensive Strategies by “Big Pharma”“AUTHORIZED GENERICS”User FeesA “Mood Swing” Toward GenericsThe Situation in EuropePATENTS AND IPSUPPLEMENTARY PROTECTION CERTIFICATESCHAPTER FIVE: THE GLOBAL PHARMACEUTICAL AND GENERICS MARKETGLOBAL GENERICS MARKETMAIN NATIONAL GENERICS MARKETSTABLE 5 WORLD PHARMA AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)TABLE 6 CURRENT AND FORECAST NATIONAL GENERICS MARKETS, THROUGH2016 ($ BILLIONS)MARKET OPPORTUNITIES BY PRODUCT CLASSLEADING GENERIC MOLECULESTABLE 7 WIDELY PRESCRIBED GENERIC MOLECULES IN THE U.S. AND EUROPEAnti-infectivesTABLE 8 LEADING ANTI-INFECTIVE PRODUCTS SALESESTIMATES WITH YEAR OF PATENT 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 ProductsTABL 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 GROWTHBiosimilars
Generic Prices“Carve-Outs”Generics IndustryFIGURE 3 U.S. PHARMACEUTICAL MARKET SHARES BASED ON DOLLAR SALES ANDPERCENTAGE 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 IssuesAMEGIForecastsTABLE 18 PHARMACEUTICAL AND GENERICS MARKET IN MEXICO, THROUGH 2016($ BILLIONS)CHAPTER SEVEN: PROFILES OF THE TOP TEN GENERICS COMPANIESTABLE 19 LEADING GENERICS MANUFACTURERS, 2010 ($ BILLIONS/%)TRENDSSTRUCTURE OF THE GENERICS INDUSTRYPROFILES OF TOP 10 GENERICS COMPANIESACTAVIS
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 GENERICSCOMPANIESPROFILESALAPIS 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, PLCAPIs
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