Global Injectable Generic Drug Market

Ritupon Gogoi, B.Pharm, MBA

Global Injectable Generic Drug Market

This market analysis focuses on the market potential for sterile drugs delivered by injection or infusion. These drugs are used to treat major illnesses, such as Cancer, Central Nervous System disorders, Acute Cardiovascular conditions and Severe infections.

More than one third of injectable generics approved in the US during the last five years are used in Cancer therapy. 23% are anti-infectives, 16% are used in CNS setting and 9% are used for Cardiovascular therapy.

Opportunities continue to exist in these areas, with the patents for a number of high value injectables due expire over the next few years.

Leading generic markets

The leading generic market is the US, estimated at US$29 billion

Germany and UK are leading European markets, estimated at US$14.9 billion and US$6.6 billion respectively.

Major therapeutic areas

Between January 2003 and June 2008 the FDA approved 391 ANDAs for generic injectable drugs. Among these 136 (34.8%) were for drugs used in the treatment of Cancer, 90 (23.0%) were for Anti-infective and 63 (16.1%)were for drugs used in CNS conditions

0 50 100 150

Cancer

Anti-infectives

CNS

Cardiovascular

Anti-infammatory

Genito-urinary

Gastroenterology

Other

Number of approved ANDAs

Leading companies and competition

The companies that gained the most ANDA approvals for injectables between 2003 and the end of June 2008 are Bedford laboratories, APP Pharmaceuticals, Teva, Hospira and Sandoz.

Together, these five companies gained 49.1% of the total.

Teva Pharmaceutical is the world’s largest generic producer. Teva subsidiaries active in the generic injectable market include Pharmachemie in the Netherlands and Teva Parenteral Medicines (formerly Sicor) in the US. In 2007, Teva reported net sales of US$9,408 million, of which US$5,428 million was generated in North America.

Leading companies and competition

Hospira completed its acquisition of Mayne Pharma to become world leader in specialty generic injectables. In 2007, Hospira reported net sales from its US specialty injectable pharmaceuticals business at US$876 million. Mayne Pharma’s sales amounted to US$638 million of which US$101 million were in the US.

Sandoz is the generic business of Novartis. In 2007, Novartis reported revenue for Sandoz at US$7,169 million, of which US$1.959 million was generated in the US market.

FDA ANDA Approvals by Company 2003-2008

0 10 20 30 40 50 60 70

Bedford lab

APP

Teva

Hospira

Sandoz

Apotex

Pharmaforce

Hikma Farmaceutica

Baxter

Wockhardt

Akorn Strides

Orchid

Sun Pharma

GeneralMedix

Watson

Ebewe

Dabur oncology

Pliva

Claris

Others

Number of approved ANDAs