Outsourcing

After a five-year downturn, cautious optimism is taking hold among API manufacturers.

Novartis to Expand Generics Hold

Too many players and threats to the main customer base challenge European dose manufacturers.

From solving complex formulation challenges to delivering full product-development programs, outsourcing services organizations provide valuable expertise, experience, and technical know-how.

Patheon is betting the whole is worth more than the sum of the parts in its acquisition of Puerto Rico contract manufacturer Mova.

The blockage in the new product pipeline may be breaking. CROs report increased demand for late-stage development services in their latest round of earnings reports.

What should pharmaceutical companies make of recent corporate developments at several high-profile service providers?

… the real glue that holds the partnership - and project - together, even more so than a formal contract or quality agreement, is the ability to communicate regularly and honestly with each other.

A big problem for the industry seems to be that Phase II has become something of a 'black hole' for drug development; new drug candidates can't seem to escape once they enter.

Beyond the inevitable debate over profit margins, the increasing range and effectiveness of modern medicine leave us with one core issue: the high price of success.

Big Pharma is ramping up capital spending in parenteral manufacturing at the same time that contract manufacturers are completing their own major investment programs.

Early development services continue to be a sweet spot for contract R&D services. The big question is how soon the impact of early-development candidates will be felt in late development and commercialization.

The contract services industry is fertile ground for the investment banking community this summer.

Data from the 2004 Outsourcing Survey indicate that pharmaceutical companies are spending more on outsourced drug development, but with fewer suppliers.

Corporate profile

Despite investors' strong interest in the chemical industry overall, pharmaceutical chemical businesses have not experienced much attention from investors thus far.

It's not clear whether contract service providers can deliver the performance improvements and costs savings that drug companies expect from large, long-term, semi-exclusive contracts.

Sponsors who have been lax in performing financial due diligence on their contractors have been given a wake-up call by the recent developments at aaiPharma.

Recent events in the pharmaceutical outsourcing industry highlight the importance of ongoing attention to contractors' financial situations and their strategic intent.

As outsourcing services become a more integral part of pharmaceutical processes, drug companies are taking a harder line on consequential.

The changing fundamentals of the industry are causing Big Pharma to focus more on operating efficiency instead of just product performance.

As manufacturers move to manufacture to demand rather than to forecast, the traditional wholesaling business model is being transformed.

Exhibitors at October's AAPS meeting confirmed that the demand for services is robust and believe that the industry's pipeline appears stronger than it has been in the past few years.

As FDA tries to bring pharmaceutical manufacturing into the 21st century, competitive dynamics in contract manufacturing are likely to change in favor of companies that have greater manufacturing expertise and the means to invest in new technologies.