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Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars

Espicom Business Intelligence Ltd, July 2011, Pages: 252


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The generic injectables sector exceeds US$11.2 billion and numerous high-value injectable products will face patent expiry in major markets over the next decade. This critical new report evaluates the markets, players and products in detail.

As companies seek new ways to gain a competitive edge in maturing generics markets, injectables have become increasingly desirable to the major players. Companies like Teva, Sandoz, Mylan, Hospira and Hikma have all increased their presence in the injectables sector through acquisitions in the last couple of years. And interest has not been limited to established generic companies, as pharmaceutical majors like Pfizer have also become attracted to the generic injectables market.

High risks, high reward:

This is hardly surprising with a global injectables market in the region of US$120 billion. While the lion's share remains with the innovative industry for the time being, the generic injectables sector already exceeds US$11.2 billion and numerous high-value injectable products will face patent expiry in major markets over the next decade. But, many of the big sellers are biological products and biosimilar approvals will only be possible for a few companies. Gaining regulatory approval in developed markets is more complex for biosimilars. For companies who are able to navigate the approval process, the sector for biosimilars is inherently different to the traditional generics market. Market acceptance remains a big challenge and the take-up of biosimilars in Europe has been relatively slow. Not only will companies need to convince healthcare providers that biosimilar drugs are as good as the originator products, they will also have to compete with the originator companies who are unlikely to exit the market as they may previously have done when faced with a flood of bioequivalent generics.

Is a biosimilar market inevitable?
The fact remains that the generic drugs sector must either respond vigorously or rely on a diminishing number of non-biological products. Progress to developing a biosimilar market to date has been patchy and slow, and few competitive therapies are beyond early-stage research. But accessing the fast-growing hospital market will be essential. Health payers, the branded industry and investment community will all be watching developments closely.

A complete analysis packed with market facts, product forecasts to 2016 and detailed company evaluations


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