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Trends Shaping U.S. Pharmaceutical Industry Strategies, 13th Edition

MMC International, July 2012, Pages: 240

Innovate and prosper, stagnate and perish. The 13th Edition of the ""Trends Shaping U.S. Pharmaceutical Industry Strategies"" report is designed to challenge senior management thinking and strategic assumptions - to force the hard questions that make the difference between status quo strategies that doom companies and proactive strategies that leverage resources to create increasing shareholder returns. The “Trends” report is designed to challenge conventional thinking, fight “Group Think”, inject fresh/different ways of looking at pharmaceuticals…and to question product development, marketing, business development, and company strategies. It is an effective tool for the orientation of senior management employees new to the pharmaceuticals industry and serves as an excellent reference source for the preparation of the annual strategic plan, marketing plans, presentations and issues discussions.

The 13th Edition of the ""Trends Shaping U.S. Pharmaceuticals Industry Strategies"" report provides insights into how the transformation of the respective United States healthcare industry market segments/stakeholders will redefine how drugs are identified, developed, reimbursed, launched, marketed, prescribed, dispensed, and taken by patients. The period to 2020 presents opportunities for companies to redefine industry norms in select therapeutic and/or product categories to create a competitive advantage.

U.S. Pharmaceuticals represents an industry undergoing redefinition and revitalization. The 2012 to 2020 period will be typified by industry discontinuities, innovation and change. What worked in the past will not work in the future. Pharmaceutical industry norms in 2020 will be radically different than they were at the end of 2011.

Objective, fact-based strategic planning will be the difference between success and failure for most pharmaceutical, biotechnology and generics drug companies. Strategically managed companies anticipate and capitalize on industry change, innovate and prosper; the remainder will be broken up, acquired, merged or driven out of business. The 13th Edition of the ""Trends Shaping U.S. Pharmaceuticals Industry Strategies"" report is designed to challenge internal assumptions and corporate strategies to assist management in refining strategies to better position the company to capitalize on industry change.

Executive Summary

Introduction
- Industry Redefinition and Revitalization
- U.S. Healthcare Cost Containment Is A Huge Opportunity
- How To Read The Book
- Transformational Themes
- U.S. Healthcare Expenditures and Employment
- Interrelated U.S. Healthcare System
- Disruptive Innovation
- Unintended Consequences
- PPACA Transformational Impact
- Requirement For Rx Industry Environmental Audit
- Pharmaceuticals Industry Life Cycle
- Legislators View Of Healthcare
- Industry Change Predates Legislation
- Importance Of Understanding Healthcare Stakeholders' Trends/Evolution
- Introduction – Rx Industry Implications

The U.S. Has To Contain Healthcare Costs
- Growth Of U.S. Healthcare Expenditures
- U.S. Healthcare Inefficiencies and Inappropriate Care
- Forecasted U.S. Per Capita Health Expenditures
- Decreasing American Disposable Income
- OECD Healthcare Expenditures As A Percentage Of GDP
- Forecasted 2020 U.S. Healthcare Expenditures
- The U.S. Has To Contain Healthcare Costs – Rx Industry Implications

Legislative Drivers
- Life Expectancy At Birth and Infant Mortality
- Unhealthy Lifestyles
- Government Lifestyle Programs Have Worked
- Preventative Health Care Services
- U.S. Lags In Preventive Care
- Adoption and Utilization Of Costly Technologies
- Health Technology Assessments (HTAs)
- Out-Of-Pocket Healthcare Expenditures
- Uninsured Population
- Rising U.S. Healthcare Insurance Premiums
- Forecasted Increases In U.S. Healthcare Expenditures
- Logical U.S. Healthcare Cost Containment Priorities
- Aging U.S. Population
- Focus On The Population With Chronic Conditions
- Legislation Has Fragmented Healthcare
- U.S. Is Not A Single Healthcare Market
- U.S. Healthcare Is Inefficient
- International Healthcare Regulatory Agencies Information Exchange
- Market Transformation Requirements
- Regulatory Barriers Have To Be Removed
- PPACA Legislation, Regulation, Implementation, and Execution Timeline
- Ninety Two (92) PPACA Implementation Steps
- Legislative Drivers - Rx Industry Implications

Demographics
- More Ethnically Diverse Population
Obesity Epidemic
- Longer Lifespans And Increasing Number Of Chronic Conditions
- High Utilization Of Healthcare Resources By The ?65 Population
- Aging Population Will Drive Care and Research Changes
- Demographics – Rx Industry Implications

Technology
- Five Technologies
- Interoperable Electronic Health Records (EHRs)
- National Health Information Network (NHIN)
- Personal Genome
- Genomics
- Pharmacogenomics
- Biomarkers
- Cybernetics
- Medical Apps
- Cybernetics, provider, patients, medical information and devices connectivity and medical “APPs” –
- Rx Industry Implications

Innovations
- International Classification of Diseases and Related Health Problems No. 10 (ICD-10)
- Accountable Care Organizations (ACO)
- Patient-Centered Medical Home (PCMH)
- Retail Clinics
- Social Networking
- Cloud Computing
- Telemedicine
- Connected Home
- Biophotonics/Smart Apps
- Surgical and Mechanical Interventions
- Stem Cells
- Regenerative Medicine
- Computer/Wi-Fi/Internet enabled and scientific/device/process advancements innovations –
- Rx Industry Implications

Consumers
- Rising Healthcare Premiums
- Insurance and Pharmaceutical Industries Are Seen As The Causes For Healthcare System Problems
- One-Quarter of 19-64 Year Old Adults Had A Gap In Coverage In 2011
- Price Sensitivity of Population Is Increasing
- Acceptance of Generics Is Increasing
- Consumers Are Increasing Their Use of Retail Clinics
- Consumers Are Now Well Connected Through The Internet
- Cyberchondriacs Are On The Rise
- Medical Tourism Expected To Increase
- PPACA's Major Provisions Are Popular
- Consumers – Rx Industry Implications

Payers
- What Medicare Does The Rest Of The Industry Will Follow

Cost Extractions
- The Focus Of Cost Extractions

Strategic Concepts
- Industry Lifecycle
- Rule Of Three And Four
- Competition Follows The Money
- Power Shifts
- Self-Obsolescence
- Shifting Demand For Intermediaries

Prevention, Intervention And Treatment
- The Interconnected U.S. Healthcare Enterprise

Health Insurance
- U.S. Health Insurance Industry Is 32% Of The Way To Becoming Mature
- Health Insurers Best Positioned To Drive And Profit From Healthcare Cost Extractions
- Insurer Strategies Will In Part Be Dictated By PPACA Implementing Regulations
- Health Insurers Will Consolidate, Vertically Integrate, and Diversify
- HMO And PPO Enrollment
- Health Insurance – Rx Industry Implications

Providers
- Introduction
- Reimbursement, Organizational Structures, and Care Delivery Will Significantly Change By 2020
- CONs In Effect Grant Monopolies
- Changing Reimbursement Will By the Key Driver In The Restructuring Of Providers
- Consumer Healthcare Shopping Will Drive Provider Quality Improvements
- Various Care Management Models And Organizational Structures Will Materialize
Physicians
- Physicians Are Moving To Group And Hospital Practices
- Physician Compensation Moving Toward Wellness And Away From Procedures
- Home Healthcare Is Least Expensive, Hospital Care Is The Most Expensive
Hospitals
- The Average American Hospital Barely Breaks Even
- Some Hospitals, Which Include Not-For-Profit Hospitals, Are Very Profitable
Integrated Healthcare Systems
- The Trend Is Toward Highly Integrated Healthcare Systems
- Highly Integrated Healthcare Systems Are Getting Bigger And Integrating Care
Alternate Care Facilities
- A Number Of Alternatives Exist For Non-Hospital Patient Care
- There were 20,858 Senior Living Providers And Nursing Homes Providing Nursing Care in 2011
- Senior Living Providers Are In The Growth Phase Of Their Industry Lifecycle
Nursing Homes
- Nursing Homes Are A Mature Industry
Home Healthcare
- Home Healthcare Is Being Redefined Into A Growth Industry
- Federal And State Governments Pay For 80% Of Home Healthcare Expenditures
Providers – Rx Industry Implications
Intermediaries
- Intermediaries Will Be Under Increasing Pressure To Decrease Costs
PBMs
- Over 96 Percent of Managed Care Plans Use PBM Services
GPOs
- GPO Offerings And Business Practices Are Evolving With The Market
Wholesalers
- U.S. Healthcare Products Wholesaling Is A Consolidated Market
- Drug Wholesaling Is A Mature Industry
Retail Pharmacies
- Retail Pharmacies Is A Maturing Industry Segment That Will Be Redefined Between 2012 and 2020
- The Consolidated Chain Drug Retailer Segment Is Best Positioned To Increase Its Prescriptions Share
Intermediaries – Rx Industry Implications

In Vitro Diagnostics
- In Vitro Diagnostics Is An Opportunity Rich Industry
- Traditional High-Volume Business Favors Large Competitors
- The IVD Market Is Made Up A Number Of Customer and Testing Segments – Representing
- Opportunities
- The Intellectual Property Landscape Is Changing
- Genomics Is In The Early Stages Of Redefining The In Vitro Diagnostics Industry
- The Value Of Companion Diagnostics Requires Pharmaceutical Companies To Access IVD
- Technologies
- Pharmaceutical And Diagnostics Deal Making Will Increase Between 2012 And 2020
- In Vitro Diagnostics – Rx Industry Implications

Medical Devices
- Medical Devices, An Opportunity-Rich Market, Will Experience Increasing Consolidation Through 2020
- The Medical Devices Sales Equation Will Shift Between 2012 And 2020
- The Migration Away From Physician Specification Favors Broad Product Line Medical Device
- Companies
- Myriad Technologies Will Transform The Medical Device Industry Between 2012 And 2020
- Companies Are Restructuring, Consolidating, And Globalizing
- Medical Devices – Rx Industry Implications

Pharmaceuticals
- Pharmaceuticals Is An Opportunity Rich Industry
- U.S. Pharmaceuticals, A Maturing Industry, Will Be Revitalized Between 2012 and 2020
- Biologics Are Replacing Small Molecule Products
- The Decreasing 1999 To 2010 New Drug Approvals Trend Is Indicative Of A Maturing Industry
- Average First-In-Class Therapeutic Competition Now Materializes Within Two Years After Market
- Entry
- Most Major Drug Classes Will Be Adequately Served By Generics By 2015
- Patent Expirations, Good News For Generics – Not For Brands Or Biologics Companies
- R&D Will Be Transformed 2012 To 2020
- R&D And The Regulatory Approval Process Are Expected To Be Redefined
- Prescription Persistence And Compliance Will Drive Value, Sales and Profitability
- Drug Reimbursement Will Dictate The Speed And Direction Of Industry Change
- Branded Companies Are Moving Into Generics
- U.S. Generics Market Is Only 40% of the Way To Being Mature
- The Largest Companies Are The Best Positioned
- Pharmaceuticals – Rx Industry Implications

About The Author

Figures

Figure 1 U.S. Pharmaceuticals Industry Lifecycle
Figure 2 U.S. Healthcare Expenditures And Employment
Figure 3 The Interconnected U.S. Pharmaceuticals Industry
Figure 4 Disruptive Innovation
Figure 5 History Of U.S. Healthcare Legislation and Fragmentation Of U.S. Healthcare
Figure 6 The Patient Protection And Affordable Care Act Is Causing And Will Cause Focus Shifts And Power Shifts
Figure 7 Redefining The U.S. Pharmaceutical Industry, 2010 To 2020
Figure 8 Industry Life Cycle
Figure 9 Healthcare Industry Reaction To Proposed And Passed Legislation From Planning To Implementation
Figure 10 U.S. Pharmaceutical Industry Stakeholders
Figure 11 U.S. Health Expenditures and Their Share of GDP 1960–2020 (In Billions of U.S. $)
Fibure 12 U.S. Healthcare Inefficiencies 2010 versus 2020
Figure 13 U.S. Healthcare Inefficiencies By Year, 2012 To 2020, (In $ Billions)
Figure 14 National Health Expenditures Per Capita, 1990-2020
Figure 15 Real Average Family Income Declined $3,540, 4.6 Percent, Between 1999 and If Uncorrected, The Quality Of Life In The United States Will Decline
Figure 16 Healthcare Expenditures as a % of GDP In OECD Countries In 2007
Figure 17 2010 Versus 2020 U.S. Healthcare Expenditures By Major Payer Group (In $ Billions)
Figure 18 Life Expectancy At Birth In OECD Countries In 2007
Figure 19 Infant Mortality, Deaths Per 1,000 Live Births In OECD Countries In 2007
Figure 20 World Obese Population
Figure 21 Map Of Global Obese Population Distribution
Figure 22 Percent 15+ Years Old Daily Smokers
Figure 23 Liters Of Alcohol Per Capita
Figure 24 Diphtheria, Tetanus, Pertussis % of Children Immunized In 2007
Figure 25 United States Vaccination Coverage Among Children 19-35 Months
Figure 26 Influenza Immunizations For =65 Years Population In 2007
Figure 27 United States Women =40 Years Of Age Who Had A Mammogram In The Past 2 Years
Figure 28 CT Scanners Per Million Of Population, 2007
Figure 29 MRI Units Per Million Of Population, 2007
Figure 30 Health Technology Assessments (PCORI)
Figure 31 Out-Of-Pocket Expenses United States Versus OECD Countries
Figure 32 Uninsured U.S. Population (In Millions)
Figure 33 Cumulative Changes in Health Insurance Premiums, Inflation, and Workers' Earnings, 1999-2009
Figure 34 U.S. Health Expenditures and Their Share of GDP 1960–2020 (In Billions of U.S. $)
Figure 35 National Health Expenditures Per Capita, 1990-2020
Figure 36 Logical Top Priorities For Reigning In Healthcare Costs
Figure 37 Aging Population Will Continue To Drive Up Healthcare Costs
Figure 38 U.S. Chronic Disease Population (In Millions)
Figure 39 Concentration of Health Care Spending in the U.S. Population, 2007
Figure 40 Fragmented Care Delivery
Figure 41 Geographic Differences In Healthcare Costs Percentage of National Average
Figure 42 Doctors Use of Electronic Patient Medical Records
Figure 43 Communication Between Country Healthcare Regulatory Agencies
Figure 44 U.S. Healthcare Inefficiencies/Waste
Figure 45 PPACA Regulation and Implementation
Figure 46 Changing U.S. Population Mix
Figure 47 Growth In Percent Of United States Obese Adults By State From 1985 To 2005
Figure 48 Number of Boomers Living with Chronic Conditions, 2000 To 2030
Figure 49 Average U.S. Life Expectancy, 1950 to 2030
Figure 50 Share of Total RXs By Each Payer Type, By Age, 2008–2009
Figure 51 Medicare Payer Share of Hospital Inpatient Cases
Figure 52 Converging Technologies, Characteristics
Figure 53 Connecting Patients, Payers, Providers, Research Centers, Intermediaries, Manufacturers, Etc.
Figure 54 NHIN and HER Industry Lifecycles
Figure 55 The Shrinking Cost of DNA Sequencing, The $1,000 Genome
Figure 56 History of the Human Genome Project
Figure 57 Genomics Applications
Figure 58 Genomics Lifecycle
Figure 59 Pharmacogenomics
Figure 60 Biomarkers
Figure 61 Cybernetics Physician Assistant
Figure 62 Cybernetics, Medical Apps and Connectivity Lifecycle
Figure 63 Connectivity and Medical APPs
Figure 64 Sample Medical APPs
Figure 65 New iPhone Health APP Launch Trends, July 2008 to December 2009
Figure 66 Data Structures Will Change Significantly, As The Number Of NewICD-10 Codes Has Increased Dramatically
Figure 67 Example ACO Structure
Figure 68 Accountable Care Organizations Lifecycle
Figure 69 Patient-centered Medical Home Lifecycle
Figure 70 Retail Health Clinics Lifecycle
Figure 71 Retail Clinic Growth By Major Players
Figure 72 Number Of Retail Health Clinics
Figure 73 Medical Center-Based Telemedicine Networks
Figure 74 Computer/Wi-Fi/Internet Enabled Lifecycles
Figure 75 Scientific/Device/Process Advancements Lifecycles
Figure 76 Average Annual Firm and Worker Premium Contributions
Figure 77 Cumulative Change In Familty Premiums and CPI, 1999-2009
Figure 78 Most Important Issues For Government To Address
Figure 79 One-Quarter of Adults Reported a Gap in Coverage in 2011
Figure 80 Average Annual Out-of-Pocket Drug Expenditures
Figure 81 Sample Average 2009 Out-of-Pocket Costs Per Prescription
Figure 82 Use Of Retail Clinics, 2009 and 2010
Figure 83 Percentage of Covered Workers Enrolled in a Plan With a High Deductible
Figure 84 Social Networking Use Continues To Grow Among Older Users
Figure 85 A Typical Day: Where Social Media Use Fits In
Figure 86 Cyberchondriacs: Trends 1998 – 2010
Figure 87 Trusted Third-Party Sources
Figure 88 2010 Comparison of Surgical Procedure In Various Countries
Figure 89 U.S. Healthcare Expenditures By Major Payer, 2010 Versus 2020
Figure 90 U.S. Healthcare Sectors Between The Patient and The Physician
Figure 91 Industry Lifecycle
Figure 92 The Interconnected U.S. Healthcare Enterprise
Figure 93 Enrollment By Type fo Insurance, 2010, 2015, 2020
Figure 94 U.S. Health Insurance Lifecycle
Figure 95 Top Five U.S. Health Insurance Companies 2009 Relative Market Shares
Figure 96 2010 U.S. Healthcare Expenditures In Billions of U.S. Dollars
Figure 97 Historic Health Insurer Business Model
Figure 98 Number of HMO and PPO Operating Plans
Figure 99 HMO Operating Plans Versus Enrollment
Figure 100 Number of Medicare/Medicaid HMO Enrollees
Figure 101 2009 Insured U.S. Population By Payer Type
Figure 102 U.S. Patient Care Continuum
Figure 103 Providers Industry Lifecycle
Figure 104 2010 Level Of ACO Integration
Figure 105 U.S. Physicians By Type Of Practice
Figure 106 Number Of U.S. Hospitals In And Out Of Multihospital Systems (MHS), 2001-2009
Figure 107 Total Costs Per Admission, By MHS Ownership, 1999-2009
Figure 108 Growth Of Hospitals In Highly Integrated Healthcare Systems, 2004 To 2010
Figure 109 Percent Of Nursing Care Facilities By Type
Figure 110 Senior Living Providers Lifecycle
Figure 111 Nursing Homes Lifecycle
Figure 112 Number Of Nursing Homes
Figure 113 Nursing Homes By Ownership Type
Figure 114 Nursing Homes By Bed Size
Figure 115 Home Healthcare Lifecycle
Figure 116 Number Of Medicare-Certified Home Care Agencies, By Auspice, 2000-2009
Figure 117 Home Healthcare Payers
Figure 118 U.S. PBM Industry Lifecycle
Figure 119 U.S. 2010 PBM Covered Lives Relative To Market Share
Figure 120 Top Nine Group Purchasing Organizations Based Upon 2011 Average Purchase Volume
Figure 121 Drug And Medical Products Wholesaler Interfaces
Figure 122 U.S. Drug Wholesalers Lifecycle
Figure 123 U.S. Drug Wholesalers Concentration
Figure 124 Sales And Prescription Brands And Generics Market Shares
Figure 125 In Vitro Diagnostics Industry Lifecycle
Figure 126 Global In Vitro Diagnostics Major Competitors' Relative Market Shares
Figure 127 Sample IVD Commercial Lab And Hospital Systems
Figure 128 Sample Point of Care (PoC) Diagnostic Systems
Figure 129 Demonstrating Clinical Utility And Health Economic Benefit – Increasing Returns
Figure 130 295 Genes Predict Prostate Cancer Clinical Recurrence
Figure 131 Benefits From Personalized Healthcare, Rewards Both Pharmaceutical And Diagnostic Companies
Figure 132 In Vitro Diagnostics Companies Portfolio Breadth By Market Segment
Figure 133 Medical Device Brand Choice, Shifting From Physicians To Institutions And Patients
Figure 134 Medical Device Industry Lifecycle
Figure 135 Moving To A Redefined, Growth Pharmaceutical Care Industry
Figure 136 NME Versus Biologics Approvals, 1999 To 2010
Figure 137 Total NME And BLA Approvals Versus Five Year Peak Sales
Figure 138 Illustrative Pharmaceutical Lifecycle
Figure 139 Drug And 2010 Sales For NME And BLA Protection Expirations, 2010 To 2020
Figure 140 Pharmaceuticals, Private And Public R&D Spending In $ Billions
Figure 141 The United States Drug Approval Process Can Be Compressed
Figure 142 Samples Of Non-Traditional Partners
Figure 143 Branded Market Share Erosion Upon Expiration
Figure 144 Top 10 Generics Companies Relative Market Share By Dispensed Generic Prescriptions

Tables

Table 1 Transformational Themes
Table 2 Healthcare Messages Being Received By Legislators
Table 3 Market Transformation Requirements
Table 4 PPACA Coordinated Implementation Steps By Year and Area of Impact
Table 5 The United States =65 Population Is Better Educated, Wealthier, More Diverse, More Mobile, More Active, and In Better Shape
Table 6 EMRs, EHRs, PHRs, and HIEs, HIOs, RHIOs Defined
Table 7 Sample Exchange and Patient Record Customers
Table 8 ARRA Meaningful Use Payment Schedule
Table 9 HER/NHIN Industry Revenues
Table 10 Pharmacogenomic Testing Required On Label
Table 11 Label Recommends Pharmacogenomic Testing
Table 12 Potential Accountable Care Organizations (ACO) Models And Their Characteristics
Table 13 PPACA Patient-centered Medical Home Initiatives
Table 14 Summary of Joint Principles of the Patient-Centered Medical Home
Table 15 Medical Home Pilot Program Savings Per Patient
Table 16 September 2009 RAND Study Findings
Table 17 Retail Health Clinics Companies, August 2010
Table 18 2010 Social Network Examples
Table 19 How Much Various Industries Are Blamed For Problems With Current Healthcare
Table 20 Preference For Generic or Brand Name Drugs
Table 21 Where People Buy Prescription Drugs Now
Table 22 21 Most Popular Health Information Sites
Table 23 Popularity of PPACA
Table 24 Insurers Complimentary Revenue and Margin Improvement Opportunities
Table 25 Medical Facilities And Services Regulated By Certificate Of Need In 2010 By State
Table 26 2011 Top Twenty U.S. Medical Groups By Number Of Physicians
Table 27 Comparison Of Hospital, Skilled Nursing Facility, And Home Healthcare Medical Charges2005 To 2009
Table 28 Top 20 Multihospital Systems, Ranked By Number Of Staffed Beds
Table 29 20 Selected Integrated Systems And Their Facilities
Table 30 Growth In Owned And Contracted Provider Units In Highly Integrated HealthcareSystems, 2001 Versus 2010
Table 31 Nursing Facility Ownership
Table 32 Top 20 Largest Senior Living Providers (January 1, 2011)
Table 33 Top 20 Nursing Home Groups By Number of Facilities
Table 34 Top 12 Home Healthcare Groups
Table 35 Top 10 PBM Companies Represented 74.8% of PBM Covered Lives And 75.0% OfPrescriptions As Of The 3rd Quarter 2010
Table 36 U.S. Prescription Market By Channel Of Distribution
Table 37 Estimated Sales By Major Product Groups By Major Retail Channel
Table 38 2009 Top 25 United States Pharmacy Chains Ranked by Number of Pharmacies
Table 39 Top 100 Medical Device Companies Worldwide In 2010
Table 40 Top 20 Medical Device Technologies
Table 41 Top 20 Medical Device Companies, Estimated 2010 United States Device Sales In Billions
Table 42 Major Drugs By Drug Class, Protection Expiration And Prescription Trends
Table 43 Dispensed Generic Prescriptions By Leading Companies
Table 44 Top 50 2010 Companies Ranked By Healthcare Revenue

Edmund L. Valentine is a healthcare industry expert with over 27 years of global healthcare industry experience. He is the author of award winning Multi-Trillion Dollar U.S. Healthcare To 2020 Gold Rush, Industrializing Healthcare, multiple editions of MMC International's Trends Shaping U.S. Pharmaceutical Industry Strategies report, and is the editor of Rx Marketer's Reference Guide, 2nd Edition as well as therapeutic area reviews. Valentine is Chairman and C.E.O. of MMC International, a strategy, general management, business development, marketing, manufacturing, and technology assessment advisory firm primarily focusing on the global healthcare industry. He is a recognized authority on the trends shaping the U.S. healthcare system.

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