This 200+ page report is designed to act as a “guide” to the U.S. specialty pharmaceutical market, providing pertinent market data and detailed profiles of companies actively participating in this segment. The report also provides updated information on newly approved and soon-to-be launched specialty pharma products as well as partnerships and acquisitions. The bulk of the report is in table format for ease of use.
Specialty pharmaceuticals are mainly prescribed by clinical specialists and aimed at well-defined patient groups. In many cases, “specialty” products address large unmet needs that in many cases are inadequately being treated. Examples of specialty indications include but are not limited to infertility, gout, cystic fibrosis, pancreatic insufficiency, vitamin deficiencies, bipolar disorder, multiple sclerosis, and fibromyalgia.
Specialty pharmaceutical companies are generally focused on only a few therapeutic categories, and sometimes have a very narrow focus on one or two “specialty” indications. These companies usually have well trained sales representatives that call on specialty physicians, such as allergists, psychiatrists, endocrinologists, or pain management physicians.
Companies active in the specialty pharma sector typically have small to medium-sized sales forces that promote products with annual sales of less than $200 million, although there are exceptions. Purdue Pharma for example, is a fully integrated specialty pharmaceutical company focusing on pain management, but its most successful product (OxyContin®) currently has annual sales of over $3.0 billion. But Purdue still fits into the “specialty” category as it limits its focus to pain and CNS therapeutics.
Specialty pharmaceutical companies may or may not have R&D capabilities; the larger companies like Cephalon, Galderma, and Purdue have extensive in-house capabilities, while other companies such as NextWave Pharmaceuticals and Centrix Pharmaceuticals rely on out-sourcing and partnerships in order to build their product portfolio. Small to medium-sized specialty companies tend to in-license late-stage or under-promoted products in therapeutic categories where they see an opportunity for revenue growth. Increasingly, specialty companies are also pursuing new indications or novel drug delivery formulations of existing pharmaceuticals.
Drug delivery companies are a key provider of specialty pharmaceutical products, and in fact, several of these companies are transitioning into specialty pharmaceutical companies themselves. As a result, the drug delivery company does not have to rely on partners for marketing of their novel drug delivery product. Examples of drug delivery companies that have changed their corporate strategy to become specialty pharma companies include Depomed and Eurand.
MCD Group has identified more than 80 companies actively participating in the specialty pharma space. These companies range in size, from very small (5 employees) to very large (1,000+ employees), but all are actively developing or marketing specialty pharmaceutical products. The leading specialty pharma companies, based on revenues and company size, are Purdue Pharma, Cephalon, Shire, Allergan and King Pharmaceuticals. These companies are all fully integrated with wide product offerings, but they still remain focused on select therapeutic areas.
Specialty pharmaceutical companies are focusing on a number of different therapeutic areas, ranging from pain management and CNS disorders to women's and men's health. Some companies focus on only one area such as dermatology, while others have expanded to focus on three or four therapeutic areas. MCD Group has identified specialty pharma companies focused on the following key therapeutic segments:
- Central Nervous System
- Pain Management
- Respiratory / Allergy
- Women's Health
- Men's Health
- Hospital & Acute Care
- Rare Diseases
The therapeutic areas targeted most frequently by specialty pharmaceutical companies are CNS (neurology), dermatology, respiratory/allergy, and women's health. Ophthalmics, pain management and gastrointestinal illnesses are also growing categories, with an increasing number of participant companies.
The US specialty pharmaceuticals market had an approximate value of $21 billion in 2009. This market value was determined by the US sales of specialty pharmaceutical products, as reported by each pharmaceutical company (ex-manufacturer level). In some cases product sales are not available or reported, therefore MCD Group made estimates based on historical sales data, analyst forecasts, or other industry sources.
Drug delivery specialty pharmaceutical products are key contributors to the US specialty pharma market, generating revenues of $10.6 billion in 2009. Oral modified release specialty products generated revenues of approximately $7.0 billion, accounting for one third of the total specialty pharma market. Examples of the most successful marketed oral drug delivery specialty products currently include OxyContin® (controlled release oxycodone), Adderall XR® (extended release mixed amphetamines), and Asacol® (delayed release mesalamine). Transdermal and pulmonary drug delivery products are also key revenue producers in this market segment.
Currently, there are more than 550 specialty pharmaceutical products marketed in the US. The categories with the largest number of marketed products are women's health (approximately 90 products), and dermatology (approximately 130 products). Overall, the top-selling specialty pharmaceutical products in 2009 were products for pain, sleep disorders, opioid dependence, and ADHD. With respect to total product revenues, four therapeutic categories generated the highest sales: pain management, CNS, ophthalmics, and dermatology.
Chapter Two - Specialty Therapeutic Categories
Top Therapeutic Categories Of Specialty Pharma
Specialty Companies By Therapeutic Focus
Figure 1: Number Of Companies By Therapeutic Focus
Chapter Three - Key Market Facts And Figures
Leading Specialty Pharma Companies By Product Revenue
Us Specialty Market By Therapeutic Category, 2009
Top 25 Products Marketed By Specialty Pharma, 2009
Us Sales of Specialty Pain Products, 2009
Us Sales of Cns Specialty Products, 2009
Us Sales of Specialty Ophthalmic Products, 2009
Us Sales of Specialty Dermatology Products, 2009
Us Sales of Specialty Gastrointestinal Products, 2009
Us Sales of Specialty Respiratory Products, 2009
Us Sales of Women'S Health Specialty Products, 2009
Us Sales of Pediatric Specialty Products, 2009
Us Sales of Specialty Allergy Products, 2009
Us Sales of Specialty Cardiovascular Products, 2009
Us Sales of Specialty Men'S Hrt Products, 2009
Us Sales of Specialty Urology Products, 2009
Us Sales of Specialty Diabetes Products, 2009
Figure 2: Specialty Companies With 600+ Sales Representatives
Figure 3: Specialty Companies With 200-400 Sales Representatives
Chapter Four - Specialty Drug Delivery Products & Market Data
Specialty Drug Delivery Market, 2009
Top 10 Drug Delivery Specialty Products, 2009
Us Sales of Oral Modified Release Specialty Products, 2009
Us Sales of Orally Disintegrating Specialty Products, 2009
Us Sales of Transdermal Specialty Products, 2009
Us Sales of Nasal Specialty Products, 2009
Us Sales of Pulmonary Specialty Products, 2009
Us Sales of Parenteral Dds Specialty Products, 2009
Us Sales of Oral Dds Enhanced Specialty Products, 2009
Us Sales of Mucosal Drug Delivery Specialty Products, 2009
Chapter Five - Marketed Specialty Products By Therapeutic Category
Women'S Health Specialty Products
Pediatric Specialty Products
Cns Specialty Products
Respiratory & Allergy Specialty Products
Dermatological Specialty Products
Ophthalmic Specialty Products
Gastrointestinal Specialty Products
Specialty Cardiovascular Products
Specialty Oncology Products
Urology Specialty Products
Men'S Health Specialty Products
Diabetes Specialty Products
Hospital & Acute Care Specialty Products
Rare Disease & Orphan Specialty Products
Chapter Six - New Specialty Product Approvals & Launches
Specialty Pharma Fda Approvals 2009-2010
Figure 4: Number Of Specialty Pharma Approvals, 2009 Vs. 2010
Figure 5: Specialty Product Approvals By Therapeutic Area, 2009-2010
Anticipated Specialty Product Launches 2011-2012
Chapter Seven - Key Partnerships & Acquisitions
Specialty Pharma Co-Promotion Deals, 2009-2010
Notable Specialty Pharma Acquisitions
Chapter Eight - Specialty Pharma Company Profiles
Actient Pharmaceuticals, Llc
Alaven Pharmaceutical Llc
Alcon Laboratories, Inc.
Arbor Pharmaceuticals, Inc.
Ascend Therapeutics, Inc.
Axcan Pharma, Inc.
Azur Pharma, Inc.
Bausch And Lomb
Braintree Laboratories, Inc.
Cadence Pharmaceuticals, Inc.
Centrix Pharmaceutical, Inc.
Columbia Laboratories, Inc.
Cornerstone Therapeutics, Inc.
Cumberland Pharmaceuticals, Inc.
Dey Pharma, L.P.
Ekr Therapeutics, Inc.
Ferndale Laboratories, Inc.
Ferring Pharmaceuticals, Inc.
Graceway Pharmaceuticals Llc
Hawthorn Pharmaceuticals, Inc
Hill Dermaceuticals, Inc.
Impax Pharmaceuticals, Inc.
Inspire Pharmaceuticals, Inc.
Ista Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc.
King Pharmaceuticals, Inc.
Kowa Pharmaceuticals America, Inc.
Lupin Pharmaceuticals, Inc.
Meda Pharmaceuticals, Inc.
Medicis Pharmaceutical Corporation
Merz Pharmaceuticals, Llc
Mission Pharmacal Company
Nautilus Neurosciences, Inc.
Nextwave Pharmaceuticals, Inc.
Norgenix Pharmaceuticals, Llc
Noven Therapeutics, Llc
Onset Therapeutics, Inc.
Pernix Therapeutics, Inc.
Pharmaderm / Nycomed Us
Prism Pharmaceuticals, Inc.
Prometheus Laboratories, Inc.
Purdue Pharma, L.P.
Qol Medical, Llc
Questcor Pharmaceuticals, Inc.
Quinnova Pharmaceuticals, Inc.
Reckitt Benckiser Pharmaceutical, Inc.
Roxro Pharma, Inc.
Shionogi Pharma, Inc.
Shire Pharmaceuticals, Inc.
Sigma-Tau Pharmaceuticals, Inc.
Sunovion Pharmaceuticals, Inc.
Tiber Laboratories, Inc.
Url Pharma, Inc.
Us Pharmaceutical Corporation
Us Worldmeds, Llc
Valeant Pharmaceuticals International
Validus Pharmaceuticals, Llc
Vistakon Pharmaceuticals, Llc
Watson Pharmaceuticals, Inc.
Xanodyne Pharmaceuticals, Inc.
- Adolor Corporation
- Akorn, Inc.
- Alaven Pharmaceutical Llc
- Alcon Laboratories, Inc.
- Arbor Pharmaceuticals, Inc.
- Ascend Therapeutics, Inc.
- Auxilium Pharmaceuticals
- Axcan Pharma, Inc.
- Azur Pharma, Inc.
- Bausch And Lomb
- Biovail Corporation
- Braintree Laboratories, Inc.
- Cadence Pharmaceuticals, Inc.
- Centrix Pharmaceutical, Inc.
- Cephalon, Inc.
- Columbia Laboratories, Inc.
- Cornerstone Therapeutics, Inc.
- Cumberland Pharmaceuticals, Inc.
- Depomed, Inc.
- Dey Pharma, L.P.
- Ekr Therapeutics, Inc.
- Endo Pharmaceuticals
- Ferndale Laboratories, Inc.
- Ferring Pharmaceuticals, Inc.
- Fleming Pharmaceuticals
- Fsc Laboratories
- Graceway Pharmaceuticals Llc
- Hawthorn Pharmaceuticals, Inc
- Hill Dermaceuticals, Inc.
- Impax Pharmaceuticals, Inc.
- Inspire Pharmaceuticals, Inc.
- Ista Pharmaceuticals, Inc.
- Jazz Pharmaceuticals, Inc.
- Jsj Pharma
- King Pharmaceuticals, Inc.
- Kowa Pharmaceuticals America, Inc.
- Lupin Pharmaceuticals, Inc.
- Meda Pharmaceuticals, Inc.
- Medicis Pharmaceutical Corporation
- Merz Pharmaceuticals, Llc
- Mission Pharmacal Company
- Nautilus Neurosciences, Inc.
- Nextwave Pharmaceuticals, Inc.
- Norgenix Pharmaceuticals, Llc
- Noven Therapeutics, Llc
- Onset Therapeutics, Inc.
- Orphan Europe
- Pediapharm, Inc.
- Pedinol Pharmacal
- Pernix Therapeutics, Inc.
- Pharmaderm / Nycomed Us
- Primus Pharmaceuticals
- Prism Pharmaceuticals, Inc.
- Prometheus Laboratories, Inc.
- Promius Pharma
- Purdue Pharma, L.P.
- Qol Medical, Llc
- Questcor Pharmaceuticals, Inc.
- Quinnova Pharmaceuticals, Inc.
- Reckitt Benckiser Pharmaceutical, Inc.
- Roxro Pharma, Inc.
- Salix Pharmaceuticals
- Santarus, Inc.
- Shionogi Pharma, Inc.
- Shire Pharmaceuticals, Inc.
- Sigma-Tau Pharmaceuticals, Inc.
- Sirion Therapeutics
- Somaxon Pharmaceuticals
- Stiefel Laboratories
- Strativa Pharmaceuticals
- Sunovion Pharmaceuticals, Inc.
- Teva Respiratory
- Ther-Rx Corporation
- Tiber Laboratories, Inc.
- Ucb Pharma
- Upsher-Smith Laboratories
- Url Pharma, Inc.
- Us Pharmaceutical Corporation
- Us Worldmeds, Llc
- Valeant Pharmaceuticals International
- Validus Pharmaceuticals, Llc
- Victory Pharma
- Vistakon Pharmaceuticals, Llc
- Warner Chilcott
- Watson Pharmaceuticals, Inc.
- Wraser Pharmaceuticals
- Xanodyne Pharmaceuticals, Inc.
- Zogenix, Inc.