The US Specialty Pharmaceutical Market Report: 2013 Edition
Specialty pharmaceuticals are defined as a new, rapidly growing drugs and biologics that are manufactured as a result of continued advancements in drug technology and design. These pharmaceuticals are specialized, high cost products which can be difficult to administer and may require patient monitoring. Specialty pharmaceuticals are utilized as complex therapies for complex chronic diseases such as cancer, hemophilia, multiple sclerosis, HIV, hepatitis C, apart from others. Some of the specialized drugs that are used for treating such conditions meet all the three H’s: High Cost, High Complexity and High Touch and they require extensive education for safe and cost-effective use. The specialty pharmaceuticals are mostly injectable or infused medicines but may also encompass oral medications.
Specialty pharmacy is a special class of provider that are primarily responsible for distributing and dispensing the pharmaceutical as specialty pharmaceutical require specialized shipping and temperature-controlled storing and handling. Specialty pharmacy can be owned by stand-alone companies or large pharmacy chains. However, some drug wholesalers are also capable of shipping the specialty pharmaceuticals. There exists a substantial incentive for companies to research and develop products that address the unmet need of the patients as the specialty pharmaceutical market has the ability to sustain the high cost of these products thereby additionally offering a business perspective for the biopharmaceutical companies.
The key factors driving growth of the US specialty pharmaceutical industry include accelerating US aging population, ameliorating economic condition, increased life expectancy, and increasing healthcare expenditure. Some of the noteworthy trends and developments of this industry include rising Medicare enrollment, novel specialty products in pipeline, conversion of patents to generic drugs, increased spending on specialty drugs and ongoing merger & acquisition activities. However, the growth of the industry is being hindered by lack of rigorous clinical trials, sluggish pace of innovation and inappropriate use of therapeutic drugs.
The specialty pharmaceutical market witnesses fierce competition with numerous top notch players; such as such as Amgen, Pfizer, Eli Lilly, Roche, Johnson & Johnson and Novo Nordisk; operating in the market place along with small budding players. The fierce competition prevailing in the US specialty pharmaceutical industry has been studied on a number of parameters such as competing drugs, mail pharmacies and distributors. The company profiles of leading aforementioned players in the market are also presented in the report.
By combining SPSS Inc.’s data integration and analysis capabilities with our relevant findings, we have predicted the future growth of the industry. We employed various significant variables that have an impact on this industry and created regression models with SPSS Base to determine the future direction of the industry. Before deploying the regression model, the relationship between several independent or predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables and tests.
Specialty pharmacy is a special class of provider that are primarily responsible for distributing and dispensing the pharmaceutical as specialty pharmaceutical require specialized shipping and temperature-controlled storing and handling. Specialty pharmacy can be owned by stand-alone companies or large pharmacy chains. However, some drug wholesalers are also capable of shipping the specialty pharmaceuticals. There exists a substantial incentive for companies to research and develop products that address the unmet need of the patients as the specialty pharmaceutical market has the ability to sustain the high cost of these products thereby additionally offering a business perspective for the biopharmaceutical companies.
The key factors driving growth of the US specialty pharmaceutical industry include accelerating US aging population, ameliorating economic condition, increased life expectancy, and increasing healthcare expenditure. Some of the noteworthy trends and developments of this industry include rising Medicare enrollment, novel specialty products in pipeline, conversion of patents to generic drugs, increased spending on specialty drugs and ongoing merger & acquisition activities. However, the growth of the industry is being hindered by lack of rigorous clinical trials, sluggish pace of innovation and inappropriate use of therapeutic drugs.
The specialty pharmaceutical market witnesses fierce competition with numerous top notch players; such as such as Amgen, Pfizer, Eli Lilly, Roche, Johnson & Johnson and Novo Nordisk; operating in the market place along with small budding players. The fierce competition prevailing in the US specialty pharmaceutical industry has been studied on a number of parameters such as competing drugs, mail pharmacies and distributors. The company profiles of leading aforementioned players in the market are also presented in the report.
By combining SPSS Inc.’s data integration and analysis capabilities with our relevant findings, we have predicted the future growth of the industry. We employed various significant variables that have an impact on this industry and created regression models with SPSS Base to determine the future direction of the industry. Before deploying the regression model, the relationship between several independent or predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables and tests.
1. OVERVIEW
1.1 Specialty Pharmaceuticals Vs Traditional Drugs
1.2 Applications of Specialty Pharmaceuticals
1.3 Specialty Pharmacy Services
1.3.1 Packaging and Delivery Services
1.3.2 Reimbursement Services
1.3.3 Inbound and Outbound Clinical Support
1.3.4 Compliance and Persistence Program
1.4 Specialty Product Distribution
1.4.1 Distribution Services
1.5 Specialty Pharma Manufacturer Services
1.6 Value Proposition of Specialty Pharmacy
2. MARKET SIZE
2.1 Pharmaceutical Market
2.1.1 Global Analysis
2.1.2 Regional Analysis
2.2 The US Specialty Pharmaceutical Market
Market Value
Traditional Vs Specialty
Sales by Customers
Sales by Dispensing Channels
2.2.1 The US Specialty Pharmaceutical Market by Therapeutic Area
2.2.2 Specialty Pharmacy in the US
3. MARKET DYNAMICS
3.1 Growth Drivers
3.1.1 Accelerating US Aging Population
3.1.2 Increasing Life Expectancy Rate in the US
3.1.3 Rising Incidences of Complex Chronic Diseases
3.1.4 Rising Pharmaceutical Sales
3.1.5 Healthcare Reforms
3.1.6 Escalating Healthcare Expenditure in the US
3.1.7 Ameliorating Economic Conditions
3.1.8 Patents Expiry of Bio Drugs
3.2 Trends and Developments
3.2.1 Increased Acceptance of Specialty Therapy
3.2.2 Mergers and Acquisitions
3.2.3 Rising Medicare Enrollments
3.2.4 Rising Number of New Molecular Entities
3.2.5 Increased Spending on Specialty Drugs
3.2.6 Shift from Specialty Drug Patents to Generic Conversion
3.2.7 Novel Specialty Product in Pipeline
3.3 Challenges
3.3.1 Lack of Rigorous Clinical Trials
3.3.2 Rising Price Pressure
3.3.3 Inadequate Innovations
3.3.4 Inappropriate Use of Therapeutic Drugs
4. COMPETITIVE LANDSCAPE
4.1 Competition by Drugs
4.2 Competition by Mail Pharmacy
4.3 Competition by Specialty Distributor
5. COMPANY PROFILES
5.1 Novo Nordisk
5.1.1 Business Overview
5.1.2 Financial Overview
5.1.3 Business Strategies
Focus on Product Innovation
Establishing Presence in Obesity & Inflammation Treatments
5.2 Amgen Inc.
5.2.1 Business Overview
5.2.2 Financial Overview
5.2.3 Business Strategies
Business Expansion through Acquisitions
Advancements in Product Pipeline
5.3 Pfizer Inc.
5.3.1 Business Overview
5.3.2 Financial Overview
5.3.3 Business Strategies
Focus on Novel Product Development
Growth through Strategic Acquisitions
5.4 Roche Holdings AG
5.4.1 Business Overview
5.4.2 Financial Overview
5.4.3 Business Strategies
Ceaseless Focus on R&D
Expansion through Strategic Collaboration
5.5 Johnson & Johnson
5.5.1 Business Overview
5.5.2 Financial Overview
5.5.3 Business Strategies
Novel Product Launch
Growth through Acquisitions
5.6 Eli Lilly and Company
5.6.1 Business Overview
5.6.2 Financial Overview
5.6.3 Business Strategies
Focus on Novel Molecule Development
Expansion through Strategic Acquisitions
6. MARKET OUTLOOK
6.1 Market Forecast
6.2 Forecast Methodology
6.2.1 Dependent and Independent Variables
6.2.2 Correlation Analysis
6.2.3 Regression Analysis
1.1 Specialty Pharmaceuticals Vs Traditional Drugs
1.2 Applications of Specialty Pharmaceuticals
1.3 Specialty Pharmacy Services
1.3.1 Packaging and Delivery Services
1.3.2 Reimbursement Services
1.3.3 Inbound and Outbound Clinical Support
1.3.4 Compliance and Persistence Program
1.4 Specialty Product Distribution
1.4.1 Distribution Services
1.5 Specialty Pharma Manufacturer Services
1.6 Value Proposition of Specialty Pharmacy
2. MARKET SIZE
2.1 Pharmaceutical Market
2.1.1 Global Analysis
2.1.2 Regional Analysis
2.2 The US Specialty Pharmaceutical Market
Market Value
Traditional Vs Specialty
Sales by Customers
Sales by Dispensing Channels
2.2.1 The US Specialty Pharmaceutical Market by Therapeutic Area
2.2.2 Specialty Pharmacy in the US
3. MARKET DYNAMICS
3.1 Growth Drivers
3.1.1 Accelerating US Aging Population
3.1.2 Increasing Life Expectancy Rate in the US
3.1.3 Rising Incidences of Complex Chronic Diseases
3.1.4 Rising Pharmaceutical Sales
3.1.5 Healthcare Reforms
3.1.6 Escalating Healthcare Expenditure in the US
3.1.7 Ameliorating Economic Conditions
3.1.8 Patents Expiry of Bio Drugs
3.2 Trends and Developments
3.2.1 Increased Acceptance of Specialty Therapy
3.2.2 Mergers and Acquisitions
3.2.3 Rising Medicare Enrollments
3.2.4 Rising Number of New Molecular Entities
3.2.5 Increased Spending on Specialty Drugs
3.2.6 Shift from Specialty Drug Patents to Generic Conversion
3.2.7 Novel Specialty Product in Pipeline
3.3 Challenges
3.3.1 Lack of Rigorous Clinical Trials
3.3.2 Rising Price Pressure
3.3.3 Inadequate Innovations
3.3.4 Inappropriate Use of Therapeutic Drugs
4. COMPETITIVE LANDSCAPE
4.1 Competition by Drugs
4.2 Competition by Mail Pharmacy
4.3 Competition by Specialty Distributor
5. COMPANY PROFILES
5.1 Novo Nordisk
5.1.1 Business Overview
5.1.2 Financial Overview
5.1.3 Business Strategies
Focus on Product Innovation
Establishing Presence in Obesity & Inflammation Treatments
5.2 Amgen Inc.
5.2.1 Business Overview
5.2.2 Financial Overview
5.2.3 Business Strategies
Business Expansion through Acquisitions
Advancements in Product Pipeline
5.3 Pfizer Inc.
5.3.1 Business Overview
5.3.2 Financial Overview
5.3.3 Business Strategies
Focus on Novel Product Development
Growth through Strategic Acquisitions
5.4 Roche Holdings AG
5.4.1 Business Overview
5.4.2 Financial Overview
5.4.3 Business Strategies
Ceaseless Focus on R&D
Expansion through Strategic Collaboration
5.5 Johnson & Johnson
5.5.1 Business Overview
5.5.2 Financial Overview
5.5.3 Business Strategies
Novel Product Launch
Growth through Acquisitions
5.6 Eli Lilly and Company
5.6.1 Business Overview
5.6.2 Financial Overview
5.6.3 Business Strategies
Focus on Novel Molecule Development
Expansion through Strategic Acquisitions
6. MARKET OUTLOOK
6.1 Market Forecast
6.2 Forecast Methodology
6.2.1 Dependent and Independent Variables
6.2.2 Correlation Analysis
6.2.3 Regression Analysis
LIST OF CHARTS
Flow of Products within the Specialty Pharmacy Channel
SP Benefits Model
Global Pharmaceutical Market (2003-2013E)
Global Pharmaceutical Market – by Region (2012)
Regional Percentage Share in Global Pharmaceutical Market (2012)
The US Pharmaceutical Market (2008-2012)
The US Traditional Pharmaceutical Market (2008-2012)
The US Specialty Pharmaceutical Market (2008-2012)
Percentage Share of Traditional and Specialty Pharmaceutical in the US (2012)
Distributor Specialty Sales by Customer (2012)
Specialty Market Share by Dispensing Channels (2012)
Share of Constituents of Specialty Pharmaceutical Market (2012)
Share of Therapeutics in Specialty Pharmacy Market (2012)
The US Aging Population (2008-2012)
The US Life Expectancy Rate (2006-2013E)
The US Healthcare Expenditure per Capita (2006-2012E)
GNI of the US (2006-2012)
Medicare Enrollments (2005-2014E)
FDA Approval of New Molecule Entities (2003-2012)
Growth in Specialty Drug v/s Non-Specialty Drug Spend
Specialty Drug Spending Trend (2012 & 2015E)
Specialty Drug Patent to Generic Conversions (2013E-2020E)
Biotechnology Drugs Currently in Development (2012)
Percentage Share of Leading 10 Specialty Drugs in the US – by Revenue (2012)
Specialty Mail Pharmacy Market Share (2012)
Specialty Distributors Market Share (2012)
Novo Nordisk Revenue Share by Business Segments (2013)
Novo Nordisk Revenue Share by Business Segments (2013)
Novo Nordisk Revenues & Net Income (2009-2013)
Amgen’s Revenue Share by Business segment (2012)
Amgen’s Revenues and Net Income (2008-2012)
Pfizer’s Revenue Share by Business Segments (2013)
Pfizer’s Revenues & Net Income (2009-2013)
Roche’s Revenue by Business Segments (2013)
Roche Holding’s Revenue and Net Income (2009-2013)
Johnson & Johnson’s Revenue Share by Business Segments (2013)
Johnson & Johnson’s Revenues and Net Income (2009-2013)
Eli Lilly’s Revenue and Net Income (2009-2013)
The US Specialty Pharmaceutical Market (2008-2017E)
Flow of Products within the Specialty Pharmacy Channel
SP Benefits Model
Global Pharmaceutical Market (2003-2013E)
Global Pharmaceutical Market – by Region (2012)
Regional Percentage Share in Global Pharmaceutical Market (2012)
The US Pharmaceutical Market (2008-2012)
The US Traditional Pharmaceutical Market (2008-2012)
The US Specialty Pharmaceutical Market (2008-2012)
Percentage Share of Traditional and Specialty Pharmaceutical in the US (2012)
Distributor Specialty Sales by Customer (2012)
Specialty Market Share by Dispensing Channels (2012)
Share of Constituents of Specialty Pharmaceutical Market (2012)
Share of Therapeutics in Specialty Pharmacy Market (2012)
The US Aging Population (2008-2012)
The US Life Expectancy Rate (2006-2013E)
The US Healthcare Expenditure per Capita (2006-2012E)
GNI of the US (2006-2012)
Medicare Enrollments (2005-2014E)
FDA Approval of New Molecule Entities (2003-2012)
Growth in Specialty Drug v/s Non-Specialty Drug Spend
Specialty Drug Spending Trend (2012 & 2015E)
Specialty Drug Patent to Generic Conversions (2013E-2020E)
Biotechnology Drugs Currently in Development (2012)
Percentage Share of Leading 10 Specialty Drugs in the US – by Revenue (2012)
Specialty Mail Pharmacy Market Share (2012)
Specialty Distributors Market Share (2012)
Novo Nordisk Revenue Share by Business Segments (2013)
Novo Nordisk Revenue Share by Business Segments (2013)
Novo Nordisk Revenues & Net Income (2009-2013)
Amgen’s Revenue Share by Business segment (2012)
Amgen’s Revenues and Net Income (2008-2012)
Pfizer’s Revenue Share by Business Segments (2013)
Pfizer’s Revenues & Net Income (2009-2013)
Roche’s Revenue by Business Segments (2013)
Roche Holding’s Revenue and Net Income (2009-2013)
Johnson & Johnson’s Revenue Share by Business Segments (2013)
Johnson & Johnson’s Revenues and Net Income (2009-2013)
Eli Lilly’s Revenue and Net Income (2009-2013)
The US Specialty Pharmaceutical Market (2008-2017E)
LIST OF TABLES
Specialty Pharmaceuticals - Key Application Areas
Specialty Pharmacy v/s Specialty Distributors
Key Players Providing Manufacturer Services
The US Specialty Pharmaceutical Market Constituents (2012)
Specialty Pharmacy Market – by Value (2011 & 2012)
Expiry of Bio Drugs’ Patents by Company (2013-2019)
Comparison of Traditional Therapy and Specialty Therapy
Specialty Pharmaceutical M&A (2007-2013)
Larger Specialty Distribution Transactions (2005-2012)
Projected Specialty Generic Launches (2013-2015)
Specialty Drugs under Development
Selected Product Launches (2012-2016)
Leading 10 Specialty Drugs in the US (2012)
Dependent & Independent Variables (2008–2012)
Correlation Matrix
Model Summary – Coefficient of Determination
Regression Coefficients Output
Specialty Pharmaceuticals - Key Application Areas
Specialty Pharmacy v/s Specialty Distributors
Key Players Providing Manufacturer Services
The US Specialty Pharmaceutical Market Constituents (2012)
Specialty Pharmacy Market – by Value (2011 & 2012)
Expiry of Bio Drugs’ Patents by Company (2013-2019)
Comparison of Traditional Therapy and Specialty Therapy
Specialty Pharmaceutical M&A (2007-2013)
Larger Specialty Distribution Transactions (2005-2012)
Projected Specialty Generic Launches (2013-2015)
Specialty Drugs under Development
Selected Product Launches (2012-2016)
Leading 10 Specialty Drugs in the US (2012)
Dependent & Independent Variables (2008–2012)
Correlation Matrix
Model Summary – Coefficient of Determination
Regression Coefficients Output
