The US Specialty Pharmaceutical Market Report: 2015 Edition

The US Specialty Pharmaceutical Market Report: 2015 Edition

Specialty pharmaceuticals are typically high-cost, scientifically engineered drugs used to treat complex, chronic conditions that require special storage, warranting special handling, and temperature-control monitoring. These products are often manufactured for small populations of people suffering from somewhat rare, life-threatening and debilitating diseases. The specialty pharmaceuticals are mostly injectable or infused medicines but may also encompass oral medications.

Currently, specialty drugs are one of the fastest growing segments of the overall pharmaceutical market, as sales growth is being driven by improved efficacy compared with currently marketed therapies, while expanded indications for already marketed drugs and off label prescribing can drive sales of these drugs by increasing potential patient populations. 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. Apart from these growth drivers, many challenges lie ahead for the specialty pharmaceutical market in the US, including the changes in reimbursement process due to healthcare reforms, regulatory pressures, narrowing specialty pharmacy networks and lack of access to specialty pharmacy products.

Some of the noteworthy trends and developments of this industry include novel specialty product launches, growing Hepatitis-C segment, increased spending on specialty drugs and ongoing merger & acquisition activities. The percentage of specialty pharmaceuticals sales of the overall US pharmaceuticals sales continues to rise.

The report, “The US Specialty Pharmaceuticals Market: 2015 Edition” analyzes the growth and development of specialty pharmaceutical in the US. Apart from providing a competitive landscape of the market, the report also profiles the major companies including Amgen, Pfizer, Johnson & Johnson and Merck and Co., along with a discussion of their key financials and business strategies.

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. The US Specialty Pharmaceutical Market
-Market Value
-Traditional Vs Specialty
-Sales by Dispensing Channels

2.1 The US Specialty Market by Therapeutic Area

2.2 Specialty Pharmacy in the US

3. Market Dynamics

3.1 Key Trends and Developments

3.1.1 PBM Mergers and Acquisitions
3.1.2 Increased Specialty Drug Spend
3.1.3 Increasing Number of Specialty Pharmacy Providers
3.1.4 Oncology: No Longer Fastest Growing Specialty Sector
3.1.5 New Product Launches

3.2 Growth Drivers

3.2.1 Accelerating US Aging Population
3.2.2 Increasing Life Expectancy Rate in the US
3.2.3 Rising Incidences of Complex Chronic and Infectious Diseases
3.2.4 Rising Pharmaceutical Sales
3.2.5 Escalating Healthcare Expenditure in the US
3.2.6 Ameliorating Economic Conditions
3.2.7 Rising Medicare Enrollments

3.3 Challenges

3.3.1 Intensifying Pricing Pressure
3.3.2 Narrowing Specialty Pharmacy Networks
3.3.3 Lack of Access to Specialty Pharmacy Products
3.3.4 Regulatory Issues

3.4 Specialty Pharmaceuticals: Pipeline Update

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 Johnson & Johnson

5.1.1 Business Overview
5.1.2 Financial Overview
5.1.3 Business Strategies
-New Product Launch
-Pursue Strategic Acquisitions

5.2 Amgen Inc.

5.2.1 Business Overview
5.2.2 Financial Overview
5.2.3 Business Strategies
-Global Expansion
-Growth through Acquisitions

5.3 Merck & Co.

5.3.1 Business Overview
5.3.2 Financial Overview
5.3.3 Business Strategies
-Augmented Research and Development
-Research Collaborations and License Agreements

5.4 Pfizer Inc.

5.4.1 Business Overview
5.4.2 Financial Overview
5.4.3 Business Strategies
-Focus on Unmet Needs of Patients
-Pioneering New Collaborations

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
The US Pharmaceutical Market (2008-TTM2014)
US Monthly Pharmaceutical Sales Growth (January 2013-September 2014)
The US Traditional Pharmaceutical Market (2008-TTM2014)
The US Specialty Pharmaceutical Market (2008-TTM2014)
Percentage Share of Traditional and Specialty Pharmaceutical in the US (2014)
Distributor Specialty Sales by Customer (2014)
Share of Constituents of Specialty Pharmaceutical Market (2014)
Share of Therapeutics in Specialty Pharmacy Market (TTM through 9/2014)
Specialty Drug Spend (2012-2018)
Specialty Drug Spending Trend (2014 - 2018E)
The US Aging Population (2009-2013)
The US Life Expectancy Rate (2009-2014E)
The US Healthcare Expenditure Per Capita (2006-2013)
GNI of the US (2006-2013)
Medicare Enrollments (2006-2013)
Percentage Share of Specialty Drugs in the US - by Revenue (2014E)
Specialty Pharmacy Market Share (2013)
Specialty Distributors Market Share (2014)
Johnson & Johnson's Revenue Share by Business Segments (2014)
Johnson & Johnson's Revenues and Net Income (2011-2014)
Johnson & Johnson's Pharmaceutical Revenues in the US (2012-2014)
Amgen's Revenue Share by Business segment (2013)
Amgen's Revenues and Net Income (2008-2013)
Breakdown by Business Segments (2014)
Revenues & Net Income of Merck (2011-2014)
Pfizer's Revenue Share by Operating Segments (2014)
Pfizer's Revenues & Net Income (2011-2014)
The US Specialty Pharmaceutical Market (2014-2018E)

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 (TTM through 9/2014)
Specialty Pharmacy Market - by Value (2012-TTM)
Specialty Pharmaceutical Mergers and Acquisitions
Novel Products Launches in Key Specialty Areas
New Specialty/Biotech Product Launch Pipeline (2015-2018)
Leading 20 Specialty Drugs in the US by Company (2014 TTM)
Dependent & Independent Variables (2009-2014)
Correlation Matrix
Model Summary - Coefficient of Determination
Regression Coefficients Output