Weekly Pharma Manufacturing News Roundup — October 31, 2014

What’s Next For The Pharma Cold Chain Industry?

Sonoco ThermoSafe recently released the results of its “Assessing the future of the cold chain industry” survey, which highlighted some of the upcoming trends set to affect the cold chain industry. The survey found customers are more regularly reusing passive temperature assured packaging. Similarly, pharma companies’ reliance on outsourcing for non-core activities, along with the increasing weight of global regulations will have a large impact on the cold chain over the course of the next five years. The survey also highlighted the top 5 improvement needs in packaging, key markets, and the reasons 3PL usage is on the rise. An infographic of the results can be viewed here.

The CMO Industry: Shrinking In Size But Poised For Growth

A recent PharmExec blog addresses the top reasons there has been a rise in player exits from the industry.  According to PharmSource Information Services’ Jim Miller, the reason for this includes a rise in demand for captive manufacturing capacity and regulatory compliance difficulties. As more companies expand their pipelines and injectable drugs draw companies that were once primarily contract manufacturers away from the contract business, the industry is becoming less populated.  

However, a recent survey from HighTech Business Decisions says that the biopharmaceutical contract manufacturing sector is set to bring in $2.8 billion in sales this year and grow at a 10 percent clip through the next 5 years. In response to this expectation for growth, biopharm CMOs have been increasing production capacity. The report also reveals that mammalian cell culture technology is predicted to grow faster than the biopharm CMO sector as a whole, in turn becoming a more valuable production service.

Potential FDA Rule For Generics Labeling: Beneficial Or Problematic?

The Wall Street Journal features a Q&A with Jay Lefkowitz, an attorney who previously represented generic drug makers in the 2011 Supreme Court case which ruled generic drug makers cannot initiate changes to a safety label. In this recent Q&A, Lefkowitz discusses why the FDA’s newest proposal that generic makers be allowed to update drug safety warnings independently is problematic. The Q&A addresses the Supreme Court ruling in 2011; why the proposed FDA rule is “a bad idea”; and what would happen to the drug costs should the proposal be passed.  

Thailand Eyes Future In Vaccine Development

In an exclusive interview with The Nation, the director of the National Vaccine Institute, Charung Muangchana, said that Thailand could become the leader of Asean vaccine production.  This possibility is supported by Thailand’s large number of researchers, vaccine developers, and the fact that the country boasts 50 agencies that are currently committed to vaccine R&D. The country has gotten off to a slow start because of officials’ lack of action in moving towards putting a vaccine manufacturing policy into action, as well as concerns over the small profit there was to be made from vaccines. In order to boost productivity in the vaccine field, the NVI and partners in and outside Thailand have established a “Vaccine Agenda” spanning the next decade. Indications of interest in this agenda include rotavirus-triggered diarrhea, hepatitis A, dengue fever, and human papillomavirus (HPV)

India, China Face Prominent Future In Biosimilars Market

Because of the low cost of manufacturing and R&D and an increasing number of drug applications/approvals, Omics Group predicts that India and China together will dominate roughly 70 percent of the global biosimilars market. The countries are expected to grow 30 percent annually over the next four years until 2018 as a result of rising demand for low-cost products and because of the shorter time needed to market biosimilars.

India Bans Plastic Packaging For Liquid Formulations

Indian drug manufacturers are no longer allowed to package liquid pharmaceutical formulations in plastic, the India Ministry of Health recently announced. India’s Ministry of Health says, “No pharmaceutical manufacturer shall use PET or plastic containers for packing liquid oral formulations for primary packaging of drug formulations for use by pediatric, geriatric, and women of reproductive age.” The ban followed a recommendation from the Drug Technical Advisory Board (DTAB), and now domestic manufacturers have 6 months to switch to glass packaging.  Prior to this ruling, the polyethelene terephthalate (PET) bottle industry, currently valued at $1.6 billion, was expected to hit $2.2 billion by 2016.

India Increasingly Turning To China For Raw Materials Supply

An article in The Economic Times reports that, according to a recent Boston Consulting Group (BCG) and Confederation of Indian Industry (CII) report, India relies on China for 90 percent of its raw materials—intermediates and APIs, including semi-synthetic penicillin and semi-synthetic cephalosporins. The report highlights some of the issues that could come from India’s reliance on China for such a large amount of its pharmaceutical raw materials. According to the article, 70 percent of total raw materials –primarily intermediates — are imported from abroad by leading drug makers in India.