Growth Prospects of the U.S. Specialty Pharmaceuticals Market

Published Date : Jul 17, 2014

Specialty pharmaceuticals are fast becoming an integral part of the pharmacy industry worldwide. This niche of drugs can be defined as a novel segment of rapidly-growing biologics and drugs that are manufactured based on cutting-edge drug technology advancements. Specialty pharmaceuticals, as the name suggests, constitute a specialized product segment, making them costlier than other pharmaceutical products. An important aspect about specialty pharmaceuticals is that they are not as easy to administer as other pharmaceutical products. This calls for patient monitoring.

Specialty pharmaceuticals are increasingly being used to treat chronic diseases that require complex therapies. These diseases include: HIV, multiple sclerosis, cancer, hepatitis C, and cancer. Whether or not a drug is classified as a specialty drug depends on three H’s: High complexity, high cost, and high tolerance. Administering such drugs safely requires extensive education. Propagating awareness about therapies based on specialty pharmaceuticals will improve their safety as well as cost-efficiency in the long run. While most specialty pharmaceuticals are administered via injection – and in some cases infused medicines – administering them orally is not uncommon.

The complexities of specialty pharmaceuticals

Given that specialty pharmaceuticals are a special class of drugs, they are generally distributed and dispensed by a specialty pharmacy. Specialty pharmacies are a special category of drug providers that adheres to highly stringent, temperature-controlled storage, handling and shipping regulations. This is also the reason why specialty pharmacies are a feasible business proposition for large pharmacy chains and financially-secure standalone companies. That having been said, there are several drug wholesalers that possess the capability to ship these specialty medicines.

Analyzing demand-supply dynamics of the specialty pharmaceutical market

If developing, distributing, and dispensing U.S. specialty pharmaceuticals Market [] require such exacting capabilities, it is evident that substantial incentives exist for players in this market. Companies operating in this segment are offered support to encourage them to research and develop pharmaceutical products that address unmet patient needs. The specialty drugs market can sustain the high cost of medicines it develops, and this offers an extended business opportunity to biopharmaceutical companies.

Sizing the U.S. Specialty Pharmaceutical Sector

The specialty pharmaceuticals sector received a major boost in 2012 when the United States Food and Drug Administration (U.S. FDA) approved as many as 39 new agents. This was the highest number of approvals in any single year in the last 15 years. Of these 39 new approvals in 2012, 25 were specialty agents, of which 13 (or 50 percent) were for cancer alone. According to pharmaceutical industry observers, the focus on specialty drug development will likely intensify from here and could potentially drive pharmacy cost in the coming years.

Growth factors in the U.S. Specialty Pharmaceuticals Market

According to market research firm Transparency Market Research, the U.S. specialty pharmaceutical industry will see growth as a result of a rapidly aging population in the country, as well as a resuscitation of the general economy. Other influencers include: a growing life expectancy and increasing spends on healthcare by families. In view of these aspects, certain developments and trends are likely to become more prominent over the next five-six years are: growing enrollment for Medicare, pipeline products that include several novel therapies, patent expiration and their conversion to generic drugs, as well as increased spending on specialty pharmaceuticals and an overall boost in M&A activities. At the same time, factors such as a sub-par pace of innovation, a lack of stringent clinical trials, and the improper prescription of therapeutic drugs could prove to be a hindrance to the specialty medicines market. Fierce competition exists in the specialty medicines market in the United States, and this will – to a great extent – shape the future of the industry. 

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