Ethocle Reports has published its latest Market Research Report on CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – US. Develop business strategies by understanding the trends shaping and driving the US healthcare market. Browse market data tables and figures.

1. CountryFocus: Healthcare,Regulatory and ReimbursementLandscape – US
Ethocle Reportshaspublished its latest MarketResearch Reporton CountryFocus:Healthcare,
Regulatory and ReimbursementLandscape – US.Develop businessstrategiesby understanding the
trendsshaping and driving theUS healthcaremarket.Browsemarketdata tablesand figures.
PublishedOn:20-Dec-2016 | Pages:267
Summary
GlobalData,the industryanalysisspecialist,hasreleaseditslatestreport,“CountryFocus:Healthcare,
RegulatoryandReimbursementLandscape - US”. The reportis an essential source of informationonand
analysisof the healthcare,regulatoryandreimbursementlandscapeinthe US.It identifiesthe key
trendsinthe country’shealthcare marketandprovidesinsightsintoitsdemographic,regulatory,and
reimbursementlandscapeandhealthcare infrastructure.Mostimportantly,the reportprovidesvaluable
insightsintothe trendsandsegmentationof itspharmaceutical andmedical device markets.Itusesdata
and informationsourcedfromproprietarydatabases,secondaryresearch,andin-houseanalysisby
GlobalData’s teamof industryexperts.
The populationof the US in2015 was326 million,havinggrownata CAGR of 1% from2008. In2015, the
governmentspent17.5%of GDP in2015 on medical andhealthscience andexported$32.8 billionof
pharmaceutical products.The pharmaceutical marketinthe USwas worth$354 billionin2015 and is
projectedtoreach$497 billionby2020, at a CompoundAnnual GrowthRate (CAGR) of 4.4%. The
medical device marketwasvaluedat$161 billionin2015 and isprojectedtogrow at a CAGR of 5.5% to
$209 billionby2020.
These positive growthtrendscanbe primarilyattributedto -
- Availabilityof latestdrugsandtechnologies
- Universal healthcoverage
- Accessto healthcare facilities
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Scope

2. The report providesinformationonthe healthcare,regulatory,andreimbursementlandscape inthe US,
and includes -
- Anoverviewof the pharmaceutical andmedical devicemarkets,comprisingmarketsize,segmentation,
and keydriversandbarriers
- ProfilesandSWOTanalysesof the majorplayersinthe pharmaceutical market:Johnson&Johnson,
Pfizer,Merck& Co.,GileadScience andAmgen;andprofilesandSWOTanalysesof the majorplayersin
the medical device market:JohnsonandJohnson,GEHealthcare,Siemens,Medtronic,andPhilips
Healthcare
- Aninsightful reviewof the reimbursementandregulatorylandscape,withanalysiscoveringdetailsof
the country’shealthcare reimbursementprocess,regulatoryagenciesandthe approval processesfor
newdrugsand medical devices
- Detailedanalysisof the country’spolitical andeconomicenvironment,coveringeconomicindicators,
demographics,healthcare infrastructure andhealthcare expenditure
- Anoverviewof the opportunitiesforandchallengestogrowthinthe US healthcare market
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Reasons to buy
Thisreportwill enhance yourdecision-makingcapabilitybyallowingyouto -
- Developbusinessstrategiesbyunderstandingthe trendsshapinganddrivingthe UShealthcare market
- Drive revenuesbyunderstandingthe keytrends,reimbursementandregulatorypolicies,
pharmaceutical marketsegmentsandcompanieslikelytoimpactthe US healthcare marketinthe future
- Formulate effective salesandmarketingstrategiesbyunderstandingthe competitivelandscapeand
analyzingcompetitors’performance
- Organize yoursalesandmarketingeffortsbyidentifyingthe marketcategoriesandsegmentsthat
presentthe mostopportunitiesforconsolidation,investmentandstrategicpartnership
Table of Contents

3. 1.1 Listof Tables9
1.2 Listof Figures13
2 Introduction17
2.1 GlobalDataReportGuidance 17
3 Overview of the Pharmaceutical andMedical Device Markets18
3.1 Pharmaceutical Market18
3.1.1 Market Overview 18
3.1.2 Pharmaceutical ExportsandImports22
3.1.3 SupplyChannels23
3.1.4 Market Segments24
3.1.5 Major Disease Areas31
3.1.6 Major Companies33
3.2 Medical Device Market78
3.2.1 Overviewof the TopFive Segments80
3.2.2 DiagnosticMarket90
3.2.3 Major Players93
3.3 Market DriversandBarriers133
3.3.1 Drivers133
3.3.2 Barriers134
4 Market Access136
4.1 ReimbursementandPayerLandscape 136
4.1.1 Overviewof Healthcare System136
4.1.2 ReimbursementProcess138
4.1.3 Overviewof Insurance Providers140
4.1.4 PatientShare inHealthcare Spending151

4. 4.1.5 Price Trendsinthe Healthcare Sector 152
4.1.6 PricingPolicies153
4.2 RegulatoryLandscape 155
4.2.1 Overviewof RegulatoryAgencies155
4.2.2 NewDrug Approval Process156
4.2.3 Approval Processof Biological ProductsasBiosimilarorInterchangeable 163
4.2.4 NewMedical Device Approval Process165
4.2.5 IntellectualPropertyRights166
4.2.6 Clinical Trial Regulations171
4.2.7 Pharmaceutical AdvertisingRegulations172
4.2.8 PharmacyRegulations173
4.2.9 LabelingandPackagingRegulations176
5 CountryAnalysis179
5.1 Political Environment179
5.1.1 Political Structure 179
5.1.2 Analysisof the CurrentPoliticalEnvironment180
5.1.3 Healthcare PolicyInitiatives183
5.2 EconomicLandscape 186
5.3 EconomicIndicators188
5.3.1 Gross DomesticProduct188
5.3.2 Gross National Income 192
5.3.3 Inflation194
5.3.4 CurrencyExchange Rate 196
5.3.5 ForeignDirectInvestment199
5.3.6 ForeignExchange Reserves200

5. 5.3.7 Trade Balance 202
5.3.8 General GovernmentStructural Balance 204
5.3.9 General GovernmentNetDebt205
5.3.10 Major Industries206
5.4 Demographics208
5.4.1 Population208
5.4.2 Educationand Literacy224
5.4.3 Employment226
5.4.4 Disease Burden227
5.5 Healthcare Infrastructure 228
5.5.1 Healthcare Facilities228
5.5.2 Healthcare Parameters232
5.5.3 Environmental Health234
5.5.4 Healthcare Personnel236
5.6 Healthcare Expenditure 239
5.6.1 Overview239
5.6.2 Major Componentsof Healthcare Spending240
5.6.3 PublicandPrivate SectorShare 241
5.6.4 SpendinginHealthcare R&D242
5.7 Trade Associations243
5.7.1 Pharmaceutical ResearchandManufacturersof America243
5.7.2 ConsumerHealthcare ProductsAssociation243
5.7.3 International Pharmaceutical ExcipientsCouncil 243
5.7.4 AdvancedMedical TechnologyAssociation244
5.7.5 National AssociationforHome Care & Hospices244

6. 5.7.6 BiotechInnovationOrganization244
5.7.7 The Societyof Chemical ManufacturersandAffiliates245
5.8 Trade Fairs246
6 OpportunitiesandChallenges247
6.1 Opportunities247
6.2 Challenges248
7 Appendix250
7.1 Abbreviations250
7.2 Bibliography253
7.3 ResearchMethodology264
7.3.1 Coverage 264
7.3.2 SecondaryResearch265
7.3.3 Forecasts265
7.3.4 ExpertPanel 266
7.4 Disclaimer266 1.1 Listof Tables
Table 1: Pharmaceutical Market,US,Revenue ($bn),2008-2015 19
Table 2: Pharmaceutical Market,US,Revenue ($bn),2016-2020 20
Table 3: Pharmaceutical Market,US,Exportsand Imports($bn),2008-2015 22
Table 4: Pharmaceutical Market,BiologicsApprovals,US,2014-2016 27
Table 5: Pharmaceutical market,Approvedbiosimilars,US,2016 29
Table 6: Pharmaceutical Market,US,Top Five TherapeuticAreas,2014 32
Table 7: Pharmaceutical Market,Johnson&Johnson,MajorProducts,2016 35
Table 8: Pharmaceutical Market,Johnson&Johnson,Global,Late-Stage Pipeline,2016 36
Table 9: Pharmaceutical Market,Pfizer,Late-StagePipeline,2016 46
Table 10: Pharmaceutical Market,Merck& Co.,Global,Major Products,2015 54

7. Table 11: Pharmaceutical Market,Merck& Co.,Global,Late-Stage Pipeline,2016 56
Table 12: Medical Device Market,GileadSciences,MajorProducts,2016 63
Table 13: Pharmaceutical Market,GileadSciences,Global,Late-Stage Pipeline,2016 64
Table 14: Pharmaceutical Market,Amgen,Global,Late-Stage Pipeline,2016 72
Table 15: Medical Device Market,US, Revenue ($bn),2008-2015 79
Table 16: Medical Device Market,US, Revenue ($bn),2016-2020 79
Table 17: Medical Device Market,US, Revenue andMarketShare bySegment,2015 80
Table 18: OrthopedicDevicesMarket,US,Revenue ($bn),2008-2015 82
Table 19: OrthopedicDevicesMarket, US,Revenue andMarketShare byCompany,2015 82
Table 20: IVDMarket, US, Revenue ($bn),2008-2015 83
Table 21: IVDMarket, US, Revenue andMarketShare by Company,2014 84
Table 22: CardiovascularDevice Market,US,Revenue ($bn),2008-2015 85
Table 23: CardiovascularDevice Market,US,Revenue andMarketShare by Segment,2015 86
Table 24: OphthalmicDevice Market,US,Revenue ($bn),2008-2015 87
Table 25: OphthalmicDevice Market,US,Revenue andMarketShare byCompany,2015 88
Table 26: Healthcare IT Market,US, Revenue ($bn),2008-2015 89
Table 27: Healthcare IT Market,US, Revenue andMarketShare by Company,2015 90
Table 28: Medical Device Market,US DiagnosticMarket,Revenue ($bn),2008-2015 91
Table 29: Medical Device Market,US, DiagnosticMarket,Revenue ($bn),2016-2020 92
Table 30: Medical Device Market,GE Healthcare,Global,MajorProducts,2015 100
Table 31: Medical Device Market,Medtronic,Global,MajorProducts,2015 108
Table 32: Medical Device Market,SiemensHealthineers,Global,MajorProducts,2015 119
Table 33: Medical Device Market,PhilipsHealthcare,Global,MajorProducts,2015 126
Table 34: Total Medicare Income,US,Expenditure andTrustFundAssets($bn),2008−2025 144
Table 35: Market Access,US, PovertyGuidelines,2016 149

8. Table 36: Market Access,US, Value of Metal Plans,2016 149
Table 37: Market Access,US, Metal Plans, 2016 150
Table 38: Market Access,US, Coverage byType of HealthInsurance (%),2015 150
Table 39: Market Access,US, Out-of-PocketExpenditure (annual percentage change),2008-2015 152
Table 40: Market Access,Price of Healthcare Products,US,Change inAverage Price of PrescriptionDrugs
(%),2008-2015 153
Table 41: RegulatoryLandscape,US,PatentFees($),2016 168
Table 42: RegulatoryLandscape,US, TrademarkFees($),2016 171
Table 43: EconomicIndicators,US, GrossDomesticProductperCapita ($),2008-2015 189
Table 44: EconomicIndicators,US, GrossDomesticProductperCapita ($),2016-2020 190
Table 45: EconomicIndicators,US, GrossDomestic ProductAnnual Growth(%),2008-2015 191
Table 46: EconomicIndicators,US, GrossDomesticProductAnnual Growth(%),2016-2020 192
Table 47: EconomicIndicators,US, GrossNational Income perCapita($),2008-2015 193
Table 48: EconomicIndicators,US, ConsumerPrice Index,2008-2015 194
Table 49: EconomicIndicators,US, ConsumerPrice Index,2016-2020 195
Table 50: EconomicIndicators,US, ConsumerPrice Annual Change (%),2008-2015 196
Table 51: EconomicIndicators,US CurrencyExchange Rate ($/€),2008-2015 197
Table 52: EconomicIndicators,US CurrencyExchange Rate ($/£),2008-2015 198
Table 53: EconomicIndicators,US CurrencyExchange Rate ($/¥) 2008-2015 199
Table 54: EconomicIndicators,US, ForeignDirectInvestment($bn),2008-2015 200
Table 55: EconomicIndicators,US, ForeignExchange Reserves($bn),2008-2015 201
Table 56: EconomicIndicators,US, Importsof Goodsand Services($bn),2008-2015 202
Table 57: EconomicIndicators,US, Exportsof Goods andServices($bn),2008-2015 203
Table 58: EconomicIndicators,US, GovernmentStructural Balance ($bn),2008-2015 204
Table 59: EconomicIndicators,US, General GovernmentNetDebt($tn),2008-2015 205
Table 60: EconomicIndicators,US, General GovernmentNetDebt($tn),2016-2020 206

9. Table 61: EconomicIndicators,US, Major Industries,GDP($bn),2015 207
Table 62: Demographics,US,Population(million),2008-2015 208
Table 63: Demographics,US,Population(million),2016-2020 209
Table 64: Demographics,US,Population,Urban-RuralPopulationShare (%),2008-2015 210
Table 65: Demographics,US,Population,Urban-RuralPopulationShare (%),2016-2020 211
Table 66: Demographics,US,PopulationDistributionbyAge Group(%),2008-2015 212
Table 67: Demographics,US,PopulationDistributionbyAge GroupForecast(%),2016-2020 213
Table 68: Demographics,US,Births(per1,000 population),2008-2015 214
Table 69: Demographics,US,Mortality(per1,000 population),2008-2015 215
Table 70: Demographics,US,Numberof Deaths(‘000),2015 217
Table 71: Demographics,US,MortalityRate in ChildrenunderFive (per1,000 live births),2008-2015 218
Table 72: Demographics,US,ImmunizationRate (%),2008-2015 219
Table 73: Demographics,US,Major Causesof MortalityinMales (Deaths‘000), 2015 220
Table 74: Demographics,US,Major Causesof MortalityinFemales(Deaths‘000),2015 222
Table 75: Demographics,US,GenderRatio(M/F),2008-2015 223
Table 76: Demographics,US,Life ExpectancyatBirth (years),2008-2015 224
Table 77: Demographics,US,Gross EnrollmentbyLevel of Education(%),2008-2015 225
Table 78: Demographics,US,UnemploymentRate (%),2008-2015 226
Table 79: Demographics,US,Disability-AdjustedLife YearsbyMajorDisease (millions),2012 228
Table 80: Healthcare Infrastructure,US,Hospitals,2008-2015 229
Table 81: Healthcare Infrastructure,US,PublicandPrivate Hospitals,2008-2015 230
Table 82: Healthcare Infrastructure,US,DiagnosticUnits(permillionpopulation),2008-2015 231
Table 83: Healthcare Infrastructure,US,Hospital Beds(per1,000 population),2008-2015 232
Table 84: Healthcare Infrastructure,US,Doctors(per1,000 population),2008-2015 233
Table 85: Healthcare Infrastructure,US,PM2.5 (µg/m3),2008-2015 234

10. Table 86: Healthcare Infrastructure,US,CO2 Emissions (metrictonspercapita),2008-2015 236
Table 87: Healthcare Infrastructure,US,Nurses(per1,000 population),2008-2015 237
Table 88: Healthcare Infrastructure,US,Dentists(per1,000 population),2008-2015 237
Table 89: Healthcare Infrastructure,US,Pharmacists(per1,000 population),2008-2015 238
Table 90: Healthcare Expenditure,US,Healthcare Expenditure (% of GDP),2008-2015 239
Table 91: PublicHealthcare Expenditure,US,Share of Major Components(%),2015 240
Table 92: Healthcare Expenditure,US,Healthcare Expenditure,Public-PrivateShare (%),2008-2015 241
Table 93: Healthcare Expenditure,US,R&Dexpenditure ($bn),2008-2015 242
Table 94: Healthcare Expenditure,US,MajorHealthcare Trade Fairs,2017 246 1.2 Listof Figures
Figure 1: Pharmaceutical Market,US,Revenue ($bn),2008-2015 19
Figure 2: Pharmaceutical Market,US,Revenue ($bn),2016-2020 20
Figure 3: Pharmaceutical Market,US,Exportsand Imports($bn),2008-2015 22
Figure 4: Pharmaceutical Market,US,SupplyChannels,2016 24
Figure 5: Pharmaceutical Market,US,Top Five TherapeuticAreas($bn),2014 31
Figure 6: Medical Device Market,US, Revenue ($bn),2008-2015 78
Figure 7: Medical Device Market,US, Revenue ($bn),2016-2020 79
Figure 8: Medical Device Market,US, Revenue bySegment($bn),2015 80
Figure 9: OrthopedicDevicesMarket,US,Revenue ($bn),2008-2015 81
Figure 10: OrthopedicDevicesMarket,US,Market Share by Company(%),2015 82
Figure 11: IVDMarket, US, Revenue ($bn),2008-2015 83
Figure 12: IVDMarket, US, Market Share byCompany(%),2014 84
Figure 13: CardiovascularDevice Market,US,Revenue ($bn),2008-2015 85
Figure 14: CardiovascularDevice Market,US,Revenue andMarketShare bySegment,2015 86
Figure 15: OphthalmicDeviceMarket,US,Revenue ($bn),2008-2015 87
Figure 16: OphthalmicDeviceMarket,US,Market Share by Company(%),2012 88

11. Figure 17: Healthcare ITMarket, US, Revenue ($bn),2008-2015 89
Figure 18: Healthcare ITMarket, US, Market Share by Company(%),2015 90
Figure 19: Medical Device Market,US,DiagnosticMarket,Revenue ($bn),2008-2015 91
Figure 20: Medical Device Market,US,DiagnosticMarket,Revenue ($bn),2016-2020 92
Figure 21: Healthcare Market,US, DriversandBarriers,2016 135
Figure 22: Healthcare System,Flow of Funds,US,2016 136
Figure 23: MarketAccess,US, Out-of-PocketExpenditure (annual percentagechange),2008-2015 151
Figure 24: MarketAccess,Price of Healthcare Products,US,Change inAverage Price of Prescription
Drugs (%),2008-2015 153
Figure 25: MarketAccess,US, Structure of Foodand Drug Administration,2016 156
Figure 26: MarketAccess,US, Outline of the Clinical DevelopmentProcessforaNew Drug,2016 161
Figure 27: MarketAccess,US, Outline of the Clinical DevelopmentProcessforaGenericDrug,2016 162
Figure 28: MarketAccess,US, Medical Device Approval Process,2016 166
Figure 29: MarketAccess,US, PatentApproval Process,2016 169
Figure 30: EconomicIndicators,US,Gross DomesticProductperCapita($), 2008-2015 189
Figure 31: EconomicIndicators, US,Gross DomesticProductperCapita($), 2016-2020 190
Figure 32: EconomicIndicators,US,Gross DomesticProductAnnual Growth(%),2008-2015 191
Figure 33: EconomicIndicators,US,Gross DomesticProductAnnual Growth(%),2016-2020 192
Figure 34: EconomicIndicators,US,Gross National Income perCapita($),2008-2015 193
Figure 35: EconomicIndicators,US,ConsumerPrice Index,2008-2015 194
Figure 36: EconomicIndicators,US,ConsumerPrice Index,2016-2020 195
Figure 37: EconomicIndicators,US,ConsumerPrice Annual Change (%),2008-2015 196
Figure 38: EconomicIndicators,US,CurrencyExchange Rate ($/€), 2008-2015 197
Figure 39: EconomicIndicators,US,CurrencyExchange Rate ($/£), 2008-2015 198
Figure 40: EconomicIndicators,US,CurrencyExchange Rate ($/¥) 2008-2015 199
Figure 41: EconomicIndicators,US,ForeignDirectInvestment($bn),2008-2015 200

12. Figure 42: EconomicIndicators,US,ForeignExchange Reserves($bn),2008-2015 201
Figure 43: EconomicIndicators,US,Importsof Goodsand Services($bn),2008-2015 202
Figure 44: EconomicIndicators,US,Exportsof Goodsand Services($bn),2008-2015 203
Figure 45: EconomicIndicators,US,GovernmentStructural Balance ($bn),2008-2015 204
Figure 46: EconomicIndicators,US,General GovernmentNetDebt($tn),2008-2015 205
Figure 47: EconomicIndicators,US,General GovernmentNetDebt($tn),2016-2020 206
Figure 48: EconomicIndicators,US,Major Industries,GDP($bn),2015 207
Figure 49: Demographics,US,Population(million),2008-2015 208
Figure 50: Demographics,US,Population(million),2016-2020 209
Figure 51: Demographics,US,Population,Urban-Rural PopulationShare (%),2008-2015 210
Figure 52: Demographics,US,Population,Urban-Rural PopulationShare (%),2016-2020 211
Figure 53: Demographics,US,PopulationDistributionbyAge Group(%),2008-2015 212
Figure 54: Demographics,US,PopulationDistributionbyAge Group(%),2016-2020 213
Figure 55: Demographics,US,Births(per1,000 population),2008-2015 214
Figure 56: Demographics, US,Mortality(per1,000 population),2008-2015 215
Figure 57: Demographics,US,Numberof Deaths(‘000),2015 216
Figure 58: Demographics,US,MortalityRate inChildrenunderFive (per1,000 live births),2008-2015
218
Figure 59: Demographics,US,ImmunizationRate (%),2008-2015 219
Figure 60: Demographics,US,Major Causesof MortalityinMales(Deaths‘000), 2015 220
Figure 61: Demographics,US,Major Causesof MortalityinFemales(Deaths‘000),2015 221
Figure 62: Demographics,US,GenderRatio(M/F),2008-2015 223
Figure 63: Demographics,US,Life ExpectancyatBirth(years),2008-2015 224
Figure 64: Demographics,US,GrossEnrollmentbyLevel of Education(%),2008-2015 225
Figure 65: Demographics,US,UnemploymentRate (%),2008-2015 226
Figure 66: Demographics,US,Disability-AdjustedLifeYearsbyMajor Disease (millions),2012 227

13. Figure 67: Healthcare Infrastructure,US,Hospitals,2008-2015 229
Figure 68: Healthcare Infrastructure,US,PublicandPrivate Hospitals,2008-2015 230
Figure 69: Healthcare Infrastructure,US,DiagnosticUnits(permillionpopulation),2008-2015 231
Figure 70: Healthcare Infrastructure,US,Hospital Beds(per1,000 population),2008-2015 232
Figure 71: Healthcare Infrastructure,US,Doctors(per1,000 population), 2008-2015 233
Figure 72: Healthcare Infrastructure,US,PM2.5 (µg/m3),2008-2015 234
Figure 73: Healthcare Infrastructure,US,CO2Emissions(metrictonspercapita),2008-2015 235
Figure 74: Healthcare Infrastructure,US,Nurses(per1,000 population),2008-2015 236
Figure 75: Healthcare Infrastructure,US,Dentists(per1,000 population),2008-2015 237
Figure 76: Healthcare Infrastructure,US,Pharmacists(per1,000 population),2008-2015 238
Figure 77: Healthcare Expenditure,US,Healthcare Expenditure (% of GDP),2008-2015 239
Figure 78: PublicHealthcare Expenditure,US,Share of Major Components(%),2015 240
Figure 79: Healthcare Expenditure,US,Public-PrivateShare of Healthcare Expenditure (%),2008-2015
241
Figure 80: Healthcare Expenditure,US,R&D expenditure ($bn),2008-2015 242
Figure 81: Healthcare Market,US, OpportunitiesandChallenges,2016 249