The US Specialty Pharmaceutical Market Report
2012 Edition

The US Specialty Pharmaceutical Market Report 2012 Edition

With the advent of novel technologies, companies operating in the healthcare/pharmaceutical/therapeutic industry are now scaling new heights. Also, this industry is boosted by the rising number of incidences of health related issues emanating from the changing lifestyle and continuously evolving surrounding environment. To address the growing demand for better healthcare options and the unmet needs within the chronic disease segment, respective companies are coming up with new and improved therapies some of which fall within the bounds of specialty pharmaceuticals.

There is no particular definition for specialty pharmaceutical but on the basis of some parameters, it takes into account the following:

• Biotech origin of drugs/plasma derivatives
• Orphan drugs
• Skyrocketing cost of treatment
• Treatment for a chronic condition by specialist
• Patient monitoring and education is required
• Distribution calls for special handling

The specialty drugs cater to the disease areas like deep vein thrombosis, cancer, multiple sclerosis, HIV, hepatitis C, cardiovascular and autoimmune diseases among others. These diseases are quite difficult to treat and require special drugs for placating the condition. The respective therapeutic molecules and biologics require special packaging, handling and distribution channel termed as specialty distribution when taken together, and are sold via specialty pharmacies.

This report provides a comprehensive overview of the US specialty pharmaceutical market covering various disease segments and the specialty pharmacy market. The specialty pharma realm is intensely competitive with numerous corporations holding the reins of the same. The leading industry players include Pfizer, Amgen, Roche, Eli Lilly, NovoNordisk and J&J. Also, market dynamics viz., key trends, industry developments, growth drivers and the challenges faced by the industry are discussed in detail.

• 1. Specialty Pharmaceuticals
  • 1.1 Overview
  • 1.1.1 Specialty Pharmaceuticals Vs Traditional Drugs
  • 1.2 Key Application Areas of Specialty Pharmaceuticals
  • 1.3 Specialty Products Distribution
  • 1.4 Specialty Pharmacy
  • 1.4.1 Services Provided by Specialty Pharmacy
  • 1.4.2 Value Proposition of Specialty Pharmacy
  • 1.5 Specialty Distribution
  • 1.5.1 Specialty Distribution Services
• 2. Specialty Pharmaceutical Market Size
  • 2.1 The US Specialty Pharmaceutical Market
  • 2.1.1 The US Specialty Pharmaceutical Market by Therapeutic Area
  • 2.1.2 Specialty Pharmacy in the US
• 3. Market Dynamics
  • 3.1 Key Trends
  • 3.1.1 Increasing M&A activities
  • 3.1.2 Advent of Biosimilars and Biobetters
  • 3.2 Industry Developments
  • 3.2.1 Ongoing Clinical Trials and Novel Product Development
  • 3.2.2 Projected Novel Therapeutic Product Launches
  • 3.2.3 Improved Biological Molecule Formulations
  • 3.3 Growth Drivers
  • 3.3.1 Higher Spending on Medicines
  • 3.3.2 Upcoming Patent Expiries of Original Bio Drugs
  • 3.3.3 Quick Acceptance of Biologics Worldwide
  • 3.3.4 Launch of NMEs (New Molecular Entities)
  • 3.3.5 Growth in Therapeutic Drug Markets and Increasing Patient Population
  • 3.3.6 Rising Demand for Better Healthcare Options
  • 3.3.7 Growing Ageing Population
  • 3.3.8 Rising Healthcare Expenditure
  • 3.4 Challenges
  • 3.4.1 Sluggish Pace of Innovation
  • 3.4.2 Requirement of Extensive Clinical Trials for Obtaining Approval
  • 3.4.3 Abusive Uses of Therapeutic Drugs
  • 3.4.4 Escalating Price Pressure
• 4. Competitive Landscape
  • Competitive Overview
  • Market Share
• 5. Company Profiles
  • 5.1 Amgen Inc.
  • 5.1.1 Business Overview
  • 5.1.2 Financial Overview
  • 5.1.3 Business Strategies
  • Growth through Strategic Alliances
  • Capitalizing on Acquisitions
  • 5.2 Novo Nordisk
  • 5.2.1 Business Overview
  • 5.2.2 Financial Overview
  • 5.2.3 Business Strategies
  • Focus on Obesity Treatment & Hormone Therapy
  • Leadership in Hemophilia Treatment Market
  • 5.3 Pfizer Inc.
  • 5.3.1 Business Overview
  • 5.3.2 Financial Overview
  • 5.3.3 Business Strategies
  • Focus on Growth
  • Strategic Acquisitions
  • 5.4 Roche
  • 5.4.1 Business Overview
  • 5.4.2 Financial Overview
  • 5.4.3 Business Strategies
  • Focus on Innovation
  • Excellence in the Field of Molecular Biology
  • 5.5 Johnson & Johnson
  • 5.5.1 Business Overview
  • 5.5.2 Financial Overview
  • 5.5.3 Business Strategies
  • Focus on Financial Risk Minimization
  • Concentration on Long Term Growth
  • 5.6 Eli Lilly and Company
  • 5.6.1 Business Overview
  • 5.6.2 Financial Overview
  • 5.6.3 Business Strategies
  • Focus on Novel Therapeutic Molecules
  • Capacity Expansion
• 6. Market Outlook
  • List of Charts
  • Oral Specialty Drugs Dispensed by Location
  • Injectable Specialty Drugs Dispensed by Location
  • Flow of Products within the Specialty Pharmacy Channel
  • SP Benefits Model
  • Specialty Distributor sales by Customer
  • Global Pharmaceutical Market (2003-2011)
  • The US Specialty Pharmaceutical Market Size (2011)
  • The US Plasma Derived FVIII Market Share by Companies
  • Biotechnology Drugs Currently in Development (2011)
  • Global Spending on Medicines (2006-2016E)
  • Global Spending on Medicine Share by Region (2006-2016E)
  • The US Spending on Medicine (2007-2016E)
  • Japan's Spending on Medicine (2007-2016E)
  • Global Recombinant FVIII Market Revenues (2005-2011)
  • Global Recombinant FIX Market Size (2006-2011)
  • Causes of ESRD in the US (2011)
  • Worldwide Patients with End Stage Renal Disease (2005-2010)
  • Global Diabetic Population (2006-2011)
  • Number of Cancer Cases Worldwide (2007-2011)
  • Global Ageing Population (+60 years) (2005-2013F)
  • Global Healthcare Spending (2005-2015E)
  • Specialty Mail Pharmacy Market Share (2011)
  • Specialty Distributors Market Share (2011E)
  • Amgen's Revenue Share by Business segment (2011)
  • Amgen's Revenues and Net Income (2011)
  • Novo Nordisk Revenue Share by Business Segments (2011)
  • Novo Nordisk Revenues & Net Income (2008-2011)
  • Pfizer's Revenue Share by Business Segments (2011)
  • Pfizer's Revenues & Net Income (2008-2011)
  • Roche's Revenue Share by Business Segments (2011)
  • Roche's Revenues and Net Income (2007-2011)
  • Johnson & Johnson's Revenue Share by Business Segments (2011)
  • Johnson & Johnson's Revenues and Net Earnings (2008-2011)
  • Eli Lilly's Revenues by Segment (2011)
  • Eli Lilly's Revenue and Net Income (2008-2011)
• List of Tables
  • Specialty Pharmaceuticals' Key Application Areas
  • Novel Product Launches in Key Specialty Areas (2009-2011)
  • Key Players Providing Manufacturer Services
  • The US Specialty and Overall Market Size (2008-2011)
  • The US Specialty Pharmaceutical Market Constituents (2011)
  • Key Oncology Therapy Sales (2011)
  • Key Rheumatoid Arthritis Therapies' Sales (2011)
  • Key HIV/AIDs Therapies' Sales (2011)
  • Key Multiple Sclerosis Therapies' Sales (2011)
  • Key Renal Therapies' Sales (2011)
  • Key DVT Therapies' Sales (2011)
  • Key Growth Hormone Therapies' Sales (2011)
  • Key Hepatitis-C Therapies' Sales (2011)
  • Key PAH Therapies' Sales (2011)
  • Orphan Drug Sales (2011)
  • Specialty Pharmacy market (2010 & 2011)
  • Specialty Pharmacy Transactions (2005-2012)
  • Specialty Distribution Transactions (2007-2011)
  • Biosimilar Adoption Rates by Region and Drug Class
  • Biobetters
  • Specialty Drugs under Development
  • Selected Product Launches (2012-2016)
  • Projected Specialty Generic Launches (2012-2015)
  • Long Acting FIX & FVIII under Late-Stage Development
  • Extended Half Life rFVIII Agents
  • Extended Half Life rFIX Agents
  • Recombinant and Improved Formulations of Erythropoietin
  • Global Spending Outlook for Top 20 Therapy Area (2016E)
  • Expiry of Bio Drugs' patents by company (2012-2019)
  • Major protection expiries by country (2012-2016)
  • Global Biologics Spending (2006-2016E)
  • Global Availability of NMEs (2011)
  • New Patient Registrations in Worldwide Bleeding Disorders Market (2008-2013E)
  • Patients Worldwide Waiting for Better Treatment Options (2011)
  • Leading 20 Specialty Drugs (2011)