The US Specialty Pharmaceutical Market -----------------------------------------------------

2013

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Executive Summary

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.

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Special pharmaceutical category can be classified into one of the following types: Orphan Drugs, Biotechnology Products, Blood Products and products defined by complex medical condition.

• The global pharmaceutical market has been consistently growing since almost a decade. Over the past couple of years, a huge success is being noted in the phase III trials of therapeutic drugs. Marking an incline of ….%, the global pharmaceutical market reached US$.… billion at the end of 2012, compared to US$.... billion during the prior year.

• North America held a healthy share of ….% of the global pharmaceutical market at the end of 2012. Europe was the second largest market with ….% share, followed by combined share of ….% of Asia, Africa, India and Australia.

• The pharmaceutical market in the US inclined by ….%, reaching US$.... billion in 2012, compared to US$.... billion during the previous year. Furthermore, the growth of the pharmaceutical industry in the US was noted at a CAGR of …..% during the period spanning 2008 to 2012.

The US Pharmaceutical Market (2008-2012)Regional Percentage Share in Global Pharmaceutical Market (2012)

Global Pharmaceutical Market (2003-2013E)

NA Europe As, Af, In, Aus

Japan Latin America Others

20

03

20

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20

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20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

E

US

$ B

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2008 2009 2010 2011 2012

US

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Specialty pharmaceuticals are specialized, high cost products which can be difficult to administer and may require patient monitoring and are used for treating complex chronic conditions.

• The traditional pharmaceutical sales in the US consistently increased till 2011. However, the overall sales of the traditional pharmaceutical were noted at US$..... billion in 2012, down by ….%, compared to US$..... billion in 2011.

• The sales of the specialty pharmaceuticals increased to US$..... billion in 2012. This represented a remarkable incline of ….%, compared to US$.... billion during the prior year. Further, the growth of the aforementioned segment was recorded at an impressive CAGR of …..%, during the period spanning 2008 to 2012.

• Growth of specialty drug is viewed as one of the major trend of the industry. In the category of specialty drugs, mail delivery and retail dispensing channels held an equal share of ….% each during 2012 immediately followed by physician office with ….% share. The other dispensing channels include outpatients, home health and inpatient with shares of ….%, …% and ….%, respectively.

Specialty Market Share by Dispensing Channels (2012)The US Specialty Pharmaceutical Market (2008-2012)

The US Traditional Pharmaceutical Market (2008-2012)

2008 2009 2010 2011 2012

US

$ B

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Mail Delivery Retail Physician Office Outpatient Home Health

Inpatient2008 2009 2010 2011 2012

US

$ B

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The key factors driving growth of the US specialty pharmaceutical industry include accelerating US aging population, increased life expectancy, and increasing healthcare expenditure.

• In 2012, oncology represented highest sales of US$.... billion immediately followed by rheumatoid arthritis with sales equivalent to US$.... billion. In terms of percentage share, oncology accounted for a healthy ….% of the total sales in 2012. Rheumatoid arthritis was the second largest contributor with moderate ….% share followed by …% share of HIV/AIDS therapeutic area.

• During 2012, AmerisourceBergen commanded a staggering share of ….% while McKesson accounted for ….% of the same. Metro Medical and CuraScript held respective shares of ….% and ….%.

• The leading two companies; Express Script and CVS Caremark; accounting for combined share of …..% of the total market in terms of specialty mail pharmacy market during 2012. Furthermore, Express Script, CVS Caremark and Walgreen represented shares of …..%, …..% and ….%, respectively.

Specialty Mail Pharmacy Market Share (2012)Specialty Distributors Market Share (2012)

Share of Constituents of Specialty Pharmaceutical Market (2012)

ABC McKesson Metro Medical

CuraScript Others

Oncology (incl. oral solids) Rheumatoid arthritis/Crohn's

HIV/AIDS (including oral solids) Multiple sclerosis

Renal IVIG/ Hemophilia

Express Script CVS Caremark

Walgreens Diplomat Specialty Pharmacy

Omnicare Retail and Other Specialty Pharmacies

Specialty pharmacy services are divided sub divided into four types namely; Packaging and Delivery, Reimbursement, Inbound and Outbound Clinical Support and Compliance and Persistence Program.

Accounting for ….% share, Humira was the leading drug in the US marketplace in 2012, immediately followed by Abilify with ….% share. Further, Seretide, Lantus and Enbrel accounted for equal share of …..%, each, of the sales of leading 10 drugs. Other drugs which dominated the marketplace during the cited period include Cymbalta, Remicade, Rituxan, Neulasta and Crestor.

The US specialty pharmaceutical market is forecasted to increase by …..% to reach US$.... billion by the end of 2013, compared to US$.... billion in the previous year. Further, the market is forecasted to reach US$..... billion by the end of 2017 thus registering growth at a remarkable CAGR of …..% during the period spanning 2012 to 2017.

The specialty pharmaceutical market witnesses’ fierce competition with numerous top notch players operating in the marketplace along with small budding players steeply inclined towards discovering and devising novel therapeutic molecules which address the unmet needs of the concerned disease area. This represents the evolution of specialty pharmaceutical industry over the past couple of years. Specialty distribution represents lucrative growth opportunity for the distributors as it is one of the largest and rapidly growing segments. Specialty distribution is a densely consolidated industry with handful players dominating the marketplace as compared to the traditional drug distribution channels. Specialty margins tend to be a bit higher as compared to the overall distribution average due to higher margins in the related services.

Note: Market attractiveness is inverse of penetration. Low penetration means high attractiveness and vice-versa

Humira Abilify Seretide/Advair Lantus Enbrel

Cymbalta Remicade Rituxan Neulasta Crestor

Percentage Share of Leading 10 Specialty Drugs in the US

by Revenue (2012)

2008 2009 2010 2011 2012 2013F 2014F 2015F 2016F 2017F

US

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The US Specialty Pharmaceutical Market (2008-2017E)

Table of Contents

1. Overview

1.1 Specialty Pharmaceuticals Vs Traditional Drugs1.2 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 Support1.3.4 Compliance and Persistence Program

1.4 Specialty Product Distribution

1.4.1 Distribution Services

1.5 Specialty Pharma Manufacturer Services1.6 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 Area2.2.2 Specialty Pharmacy in the US

3. Market Dynamics

3.1 Growth Drivers

3.1.1 Accelerating US Aging Population3.1.2 Increasing Life Expectancy Rate in the US

List of Charts & Tables

List of Charts

Flow of Products within the Specialty Pharmacy ChannelSP Benefits ModelGlobal 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 SpendSpecialty 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)

3.1.3 Rising Incidences of Complex Chronic Diseases3.1.4 Rising Pharmaceutical Sales 3.1.5 Healthcare Reforms 3.1.6 Escalating Healthcare Expenditure in the US3.1.7 Ameliorating Economic Conditions 3.1.8 Patents Expiry of Bio Drugs

3.2 Trends and Developments

3.2.1 Increased Acceptance of Specialty Therapy3.2.2 Mergers and Acquisitions 3.2.3 Rising Medicare Enrollments3.2.4 Rising Number of New Molecular Entities3.2.5 Increased Spending on Specialty Drugs 3.2.6 Shift from Specialty Drug Patents to Generic Conversion3.2.7 Novel Specialty Product in Pipeline

3.3 Challenges

3.3.1 Lack of Rigorous Clinical Trials3.3.2 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 Pharmacy4.3 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 Overview5.2.2 Financial Overview

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)  

 

 

5.2.3 Business Strategies-Business Expansion through Acquisitions-Advancements in Product Pipeline

5.3 Pfizer Inc.

5.3.1 Business Overview5.3.2 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 Variables6.2.2 Correlation Analysis 6.2.3 Regression Analysis

  List of Tables Specialty Pharmaceuticals - Key Application AreasSpecialty Pharmacy v/s Specialty DistributorsKey Players Providing Manufacturer ServicesThe 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 TherapySpecialty Pharmaceutical M&A (2007-2013) Larger Specialty Distribution Transactions (2005-2012) Projected Specialty Generic Launches (2013-2015) Specialty Drugs under DevelopmentSelected Product Launches (2012-2016) Leading 10 Specialty Drugs in the US (2012) Dependent & Independent Variables (2008–2012) Correlation MatrixModel Summary – Coefficient of DeterminationRegression Coefficients Outpu

 

 

 

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