Implantable Medical Devices

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INDUSTRY MARKET RESEARCH FOR BUSINESS LEADERS, STRATEGISTS, DECISION MAKERS NEW industry forecasts for 2011 & 2016 Implantable Medical Devices Study # 2255 October 2007 $4500 US Implantable Medical Device Demand, 2006 US demand to grow 7.7% annually through 2011 The Freedonia Group projects demand for implantable medical devices increas- ing 7.7 percent annually to $40.2 billion in 2011. An expanding prevalence of heart, orthopedic, neurological, visual and urinary disorders, coupled with ongoing improvements in the safety and effectiveness of products, will promote gains. Additionally, the rising popularity of cosmetic surgery will boost growth opportunities for breast, dermal and tissue implants. Less favorably, linkage to potentially fatal complications, along with advances in alternative drug therapies, will weaken the market for a number of implantable medical devices, especially drug-eluting coronary stents. CRT devices to propel slowing cardiac segment Eroding sales of drug-eluting coronary stents will moderate overall growth opportunities for cardiac implants. Total demand posted by this product group is projected to increase 5.2 percent annually to $16.2 billion in 2011. Discontinued usage among high risk cardiac patients will cause the market for coronary drug- eluting stents to decline by $750 million in the 2006-2011 period. However, in spite of this decrease, total demand for cardiac implants will continue to rise due largely to the widening use of cardiac resynchronization therapy (CRT) devices in the treatment of congestive heart failure (CHF). CRT devices are more effective than alternative drug therapies in restoring the blood pumping capabili- ties of CHF patients along with reducing their risk of disease complications, such as atrial fibrillation. Orthopedic implants offer best growth opportunities Demand for orthopedic implants will reach $19.1 billion in 2011, up 8.8 percent annually from 2006. Tissue and spinal implants, along with hip and shoul- der replacement products, will see the fastest sales gains as advances in fusion, fixation and neurological stimulating technologies improve the success rate and cost-effectiveness of related surgical procedures. Demand for knee reconstruc- tive implants and trauma fixation products will expand at a more moderate pace, benefitting from an increasing prevalence of deteriorated joint condi- tions and fracture injuries, but adversely affected by improvements in alternative drug therapies and external fixation devices. Neurological stimulators, eye implants among other leading prospects Other implantable medical devices will post demand of $4.9 billion in 2011, up over 13 percent annually from 2006. Products leading growth will consist of neurological stimulators for treating epilepsy, Parkinson’s disease and other central nervous system disorders; phakic intraocular lenses for correcting near- sightedness; retinal implants for treating macular degeneration; brachytherapy for cancer indications; and cochlear devices for restoring hearing loss. These products offer significant performance and outcome advantages over alternative treatments. Among other implantable medical devices, dermal and tissue implants and silicone breast implants will fare the best in the marketplace reflecting an increasingly appearance-conscious population. Study coverage This new Freedonia industry study, Implantable Medical Devices, is priced at $4500. It presents historical demand data for the years 1996, 2001 and 2006 and forecasts for 2011 and 2016 by implant material (e.g., microelectronics, specialty metals, polymers, elastomers, ceramics) and type (e.g., cardiac, orthopedic). The study also considers market environment factors, details industry structure, evaluates company market share and profiles leading industry competitors. Cardiac Implants 45% Other Implants 10% Orthopedic Implants 45% ($27.8 billion) Distributor of this Report:

Transcript of Implantable Medical Devices

Page 1: Implantable Medical Devices

INDUSTRY MARKET RESEARCH FOR BUSINESS LEADERS, STRATEGISTS, DECISION MAKERS

NEW industry forecasts for 2011 & 2016

Implantable Medical DevicesStudy # 2255 October 2007 $4500

US Implantable Medical Device Demand,2006

US demand to grow 7.7% annually through 2011The Freedonia Group projects demand for implantable medical devices increas-ing 7.7 percent annually to $40.2 billion in 2011. An expanding prevalence of heart, orthopedic, neurological, visual and urinary disorders, coupled with ongoing improvements in the safety and effectiveness of products, will promote gains. Additionally, the rising popularity of cosmetic surgery will boost growth opportunities for breast, dermal and tissue implants. Less favorably, linkage to potentially fatal complications, along with advances in alternative drug therapies, will weaken the market for a number of implantable medical devices, especially drug-eluting coronary stents.

CRT devices to propel slowing cardiac segmentEroding sales of drug-eluting coronary stents will moderate overall growth opportunities for cardiac implants. Total demand posted by this product group is projected to increase 5.2 percent annually to $16.2 billion in 2011. Discontinued usage among high risk cardiac patients will cause the market for coronary drug- eluting stents to decline by $750 million in the 2006-2011 period. However, in spite of this decrease, total demand for cardiac implants will continue to rise due largely to the widening use of cardiac resynchronization therapy (CRT) devices in the treatment of congestive heart failure (CHF). CRT devices are more effective than alternative drug therapies in restoring the blood pumping capabili-ties of CHF patients along with reducing

their risk of disease complications, such as atrial fibrillation.

Orthopedic implants offer best growth opportunitiesDemand for orthopedic implants will reach $19.1 billion in 2011, up 8.8 percent annually from 2006. Tissue and spinal implants, along with hip and shoul-der replacement products, will see the fastest sales gains as advances in fusion, fixation and neurological stimulating technologies improve the success rate and cost-effectiveness of related surgical procedures. Demand for knee reconstruc-tive implants and trauma fixation products will expand at a more moderate pace, benefitting from an increasing prevalence of deteriorated joint condi-tions and fracture injuries, but adversely affected by improvements in alternative

drug therapies and external fixation devices.

Neurological stimulators, eye implants among other leading prospectsOther implantable medical devices will post demand of $4.9 billion in 2011, up over 13 percent annually from 2006. Products leading growth will consist of neurological stimulators for treating epilepsy, Parkinson’s disease and other central nervous system disorders; phakic intraocular lenses for correcting near-sightedness; retinal implants for treating macular degeneration; brachytherapy for cancer indications; and cochlear devices for restoring hearing loss. These products offer significant performance and outcome advantages over alternative treatments. Among other implantable medical devices, dermal and tissue implants and silicone breast implants will fare the best in the marketplace reflecting an increasingly appearance-conscious population.

Study coverageThis new Freedonia industry study, Implantable Medical Devices, is priced at $4500. It presents historical demand data for the years 1996, 2001 and 2006 and forecasts for 2011 and 2016 by implant material (e.g., microelectronics, specialty metals, polymers, elastomers, ceramics) and type (e.g., cardiac, orthopedic). The study also considers market environment factors, details industry structure, evaluates company market share and profiles leading industry competitors.

Cardiac Implants45%

Other Implants10%

Orthopedic Implants45%

($27.8 billion)

Distributor of this Report:

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Introduction

ExECUTIvE SUMMaRy MaRkET ENvIRONMENT EconomicFactorsDemographicPatternsHealthCareTrends HealthInsurance AcuteConditions ChronicConditions CardiovascularConditions OrthopedicConditions NeurologicalConditions OtherSelectedChronicConditions NationalHealthExpenditures MedicalProviders Hospitals OutpatientFacilities SkilledNursingHomes Physicians PatientActivity HospitalActivity OutpatientEpisodes SurgicalProcedures TotalProcedures ImplantProcedures Heart-RelatedImplantProcedures OrthopedicImplantProcedures OtherImplantProcedures MedicalProductMarkets Pharmaceuticals&Biologicals SurgicalAppliances&Supplies Surgical&MedicalInstruments ElectromedicalEquipment OtherMedicalProducts

IMPLaNT MaTERIaLS & COMPONENTSMicroelectronicComponentsSpecialtyMetalsPolymersElastomersCeramicsOtherMaterials&Components

PRODUCT OvERvIEWMarketOutlookHistoricalDemandPatternsRegulatoryConsiderationsPricingTrendsUSTradeInternationalMarkets

CaRDIaC IMPLaNTSProductOverviewImplantable Cardioverter Defibrillators (ICDs) ICDTechnology CardiacResynchronizationTherapyDevices ConventionalICDDevices ICDLeads ICDBatteries

CardiacStents Drug-ElutingCoronaryStents PeripheralStents CarotidStents BareMetalCoronaryStents OtherCardiacStentsPacemakers&Accessories DualChamberPacemakers SingleChamberPacemakers PacemakerLeads PacemakerBatteriesHeart-RelatedGrafts Vascular&EndovascularGrafts VascularGrafts EndovascularGrafts PeripheralGrafts Arterial-to-Venous (AV) GraftsHeartValves TissueValves MechanicalValves ValveRepairProducts&AccessoriesVenaCavaFiltersVentricular-AssistDevicesImplantableHeartMonitors

ORTHOPEDIC IMPLaNTSProductOverviewReconstructiveImplants KneeImplants DemandPatterns Products&Producers HipImplants DemandPatterns Products&Producers ShoulderImplants DemandPatterns Products&Producers OtherReconstructiveImplants ElbowImplants AnkleImplants AllOtherReconstructiveImplantsSpinalImplants InternalSpinalFixationDevices BoneGrafts&Substitutes NaturalBone IntravertebralSpacers BoneSubstitutes FusionCages ImplantableSpinalCordStimulatorsTraumaFixationImplants InternalFixationDevices BoneGrafts&Substitutes CraniomaxillofacialImplantsBoneCement AcrylateFormulations OtherFormulationsTissueImplants CulturedCells Allografts&OtherTissueImplants

OTHER IMPLaNTaBLE MEDICaL DEvICESNeurologicalStimulatorsOphthalmicImplants IntraocularLenses Retinal&OtherOphthalmicImplants

BreastImplants SalineImplants SiliconeImplantsDrugImplants DrugInserts BrachytherapyImplants ImplantableDrugPumpsUrologicalImplants PenileImplants BiliaryStents OtherUrologicalImplantsCochlearImplants Technology ProductsDermalImplants Collagen-BasedProducts OtherDermalImplantsAllOtherImplantableMedicalDevices Airway&EsophagealStents GastricBands MiscellaneousImplants

INDUSTRy STRUCTUREMarketShareCompetitiveStrategiesMergers&AcquisitionsLicensing&RelatedAgreementsResearch&DevelopmentMarketing&DistributionManufacturingActivitiesCompany Profiles

ExECUTIvE SUMMaRy 1 SummaryTable

MaRkET ENvIRONMENT 1 MacroeconomicIndicators 2 PopulationbyAgeGroup 3 AcuteConditions 4 SelectedChronicConditions 5 NationalHealthExpenditures 6 SelectedMedicalProvidersbyType 7 SelectedPatientActivitybyType 8 SelectedImplantProceduresbyType 9 MedicalProductDemandbyType

IMPLaNT MaTERIaLS & COMPONENTS 1 ImplantableMedicalDeviceMaterial &ComponentDemandbyTypeCht ImplantableMedicalDeviceMaterial& ComponentDemandbyType,2006

PRODUCT OvERvIEW 1 ImplantableMedicalDeviceDemand byProductGroupCht ImplantableMedicalDeviceDemand byProductGroup,2006 2 ImplantableMedicalDevices-Demand Patterns,1996-2006 3 USTradeinImplantableMedicalDevices 4 WorldImplantableMedicalDevice DemandbyRegion

NEW US IndUStry StUdy with ForecaStS For 2011 & 2016

Implantable Medical Devices

Table of ConTenTs

lisT of Tables & CharTs

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INDUSTRY MARKET RESEARCH: BUSINESS INTELLIGENCE FOR BUSINESS LEADERS, STRATEGISTS, DECISION-MAKERS

indUStry StUdieS ■ cUStom reSearch ■ FocUS reportS

cardiac implants

cardiac resynchronization therapy (crt) devices Continuingshortcomingsinavailablepharmaceuticalsthattreatconges-tiveheartfailurewillunderliearapidlygrowingmarketforcardiacresynchroni-zationtherapy(CRT)devices.Demandfortheseimplantsisprojectedtoreach$4.2billionin2011,upnearly20percentannuallyfrom2006.CongestiveheartfailureisawidelyprevalenthealthproblemintheUS,afflictingoverfivemillionindividualsintotalandstrikingmorethan550,000newvictimseachyear.Thediseaseisresponsibleformorethanonemillionhospitaladmissionsand$45billioninhealthcarecostsannually.Mostcongestiveheartfailurepatientsdiewithineightyearsofinitialonset.

Congestiveheartfailureisadegenerativechronicconditioncharacterizedbyagraduallossintheheart’sbloodpumpingability.Availabledrugtherapiesforthedisease,includingangiotensin-convertingenzyme(ACE)inhibitors,arenoteffectiveinrestoringthisfunction,butonlyslowitsprogression.Amorepromisingtreatmentisofferedbyspeciallydesigned,tri-chamberimplantablecardioverterdefibrillators,knownascardiacresynchronizationtherapy(CRT)devices.Availablesince2001,CRTdevicesserveasbroad-basedpacingsystemsthatterminatefastventriculartachycardiaepisodesaswellasotherheartrhythmdisorderssuchasatrialfibrillation.

TwotypesofCRTdevicesareavailableforthetreatmentofcongestiveheartfailure.Onetypeisaspeciallydesignedpacemakerknownasacardiacre-synchronizationtherapypacemaker(CRT-P).Theother,referredtoasacardiacresynchronizationtherapydefibrillator(CRT-D),isthesamedevicewithaddedanti-tachycardiapacinganddefibrillationfeatures.CRTdevicesresynchronizecontractionsoftheheart’sventriclesbysendingtinyelectricalimpulsestotheheartmuscles.Theseimpulseshelptheheartpumpbloodthroughoutthebodymoreefficiently.CRT-Ddevicesaddthecapabilitytoterminateabnormallyfastheartbeatsquickly.Manypatientswithmoderatetosevereheartfailurecondi-tionsarevulnerabletolife-threateningtachyarrhythmias.

© Copyright by The Freedonia Group, Inc.

orthopedic implants

spinal implants Ongoingimprovementsinavailableproduces,advancesinlessinvasivesurgicaltechniquesandrisingnumbersofinjuriesandchronicbackconditionswillcreatestronggrowthopportunitiesforspinalimplants.Themarketforthesedevicesisprojectedtoincreasemorethantenpercentannuallyto$7.2billionin2009.Implantsusedinspinalfusionsurgery,especiallyintherepairofvertebraeandtreatmentofdegenerativediskconditions,willpostthelargestshareofdemandandbestgrowthopportunities.Spinalfusionsurgeryisthepreferredtreatmentformostspinalcordinjuriesandabnormalitiesasitprovidesforafasterandmorecompletepatientrecoverythanalternativedrugandphysi-caltherapyregimens.Inthebasicspinalfusiontechnique,autogenousbonegrafts,boneallograftsorsubstitutebonematerialsareimplantedtoformabridgebetweenadjacentvertebrae.Theseimplantsservetostimulatenewbonegrowth.Inmanyprocedures,additionalvertebraefusionisachievedthroughtheuseoffixationdevices,suchashooks,plates,rods,screwsandwires.Thesedevicesareintendedtoholdjoinedvertebraetogetherandenablenewbonetogrowbetween

taBle Vi-7

spinal implant demand BY tYpe(million dollars)

Item 1996 2001 2006 2011 2016

SpinalFusionProcedures(000) 192 317 465 660 925 000$implants/procedure 6.8 7.7 9.4 10.9 12.6 SpinalImplantDemand 1300 2430 4360 7180 11700 InternalFixationDevices 657 1160 2170 3510 5550 BoneGrafts&Substitutes 508 849 1400 2310 3780 FusionCages -- 238 550 1050 1970 ImplantableStimulators 135 183 240 310 400 %spinalimplants 27.1 30.3 34.8 37.6 40.8OrthopedicImplantDemand 4790 8030 12540 19100 28700

CaRDIaC IMPLaNTS 1 CardiacImplantDemandbyProductGroupCht CardiacImplantDemand byProductGroup,2006 2 Implantable Cardioverter Defibrillator DemandbyType 3 CardiacStentDemandbyType 4 Pacemaker&AccessoryDemandbyType 5 Heart-RelatedGraftDemandbyType 6 HeartValveDemandbyType 7 VenaCavaFilterDemand 8 Ventricular-AssistDeviceDemand 9 ImplantableHeartMonitorDemand

ORTHOPEDIC IMPLaNTS 1 OrthopedicImplantDemand byProductGroupCht OrthopedicImplantDemand byProductGroup,2006 2 ReconstructiveImplantDemand byProductGroup 3 KneeImplantDemandbyType 4 HipImplantDemandbyType 5 ShoulderImplantDemandByType 6 OtherReconstructiveImplant DemandbyType 7 SpinalImplantDemandbyType 8 TraumaFixationImplantDemandbyType 9 BoneCementDemandbyFormulation 10 TissueImplantDemandbyType

OTHER IMPLaNTaBLE MEDICaL DEvICES 1 OtherImplantableMedicalDevice DemandbyProductGroupCht OtherImplantableMedicalDeviceDemand byProductGroup,2006 2 ImplantableNeurologicalStimulatorDemand 3 OphthalmicImplantDemandbyType 4 BreastImplantDemandbyType 5 DrugImplantDemandbyType 6 UrologicalImplantDemandbyType 7 CochlearImplantDemand 8 DermalImplantDemandbyType 8 AllOtherImplantableMedicalDevice DemandbyType

INDUSTRy STRUCTURE 1 ImplantableMedicalDevice SalesbyCompany,2006Cht ImplantableMedicalDevice MarketShare,2006 2 SelectedAcquisitions&Divestitures 3 SelectedCooperativeAgreements

COMPaNy PROFILESProfiles for 26 US competitors in

such as Biomet, Boston Scientific, Johnson & Johnson, Medtronic,

Smith & Nephew, Stryker, St. Jude Medical, WL Gore and Zimmer

SaMPLE TExT Data illustrated with the aid of more than 50

tables and charts

SaMPLE TaBLE Historical data for 1996, 2001 and 2006 as well as

Freedonia forecasts for 2011 and 2016

SaMPLE PaGE Explanations that

support each table’s data and forecasts