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Guide to U.S. Specialty Pharmaceutical Market: Companies, Products and Market Data
MCD Group LLC, Jan 2011, Pages: 203
The growing U.S. specialty pharmaceuticals market is comprised of more than 90 companies marketing more than 550 prescription pharmaceutical products. Our report covers more than 10 therapeutic categories targeted by specialty pharmaceutical companies, such as CNS disorders, pain management, men and women's health, rare diseases, and urology.
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.
Key Players
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.
Therapeutic Categories
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
- Dermatology
- Ophthalmics
- Gastrointestinal
- Respiratory / Allergy
- Women's Health
- Men's Health
- Cardiovascular
- Urology
- Diabetes
- 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.
Market Size
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.
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