In order to meet the evolving complex regulatory environment in regulated and pharma-emerging markets, there is a need to address the demand of high barrier pharma packaging for protecting molecule sensitivity of various drugs to achieve quality, according to experts.
A seminar on this theme was held to address the requirement of high barrier packaging with reference to regulated markets in Mumbai recently.
The seminar holds a lot of relevance as sales of big pharma companies like Sanofi, Novartis, Roche, Astrazeneca and Pfizer are threatened in 2014 through patent cliff. With blockbuster drugs going off patent along with increasing healthcare costs, pharma sector is now waking up to meet the numerous demands for packaging of various generic products in India and globally.
Speaking on the trends in pharma packaging, Johannes Giessler, director, Sales & Marketing, Perlen Packaging, said, "There is a growth in demand of high barrier specifications, standardized specifications for numerous applications, individual patient packages and counterfeit resistant packaging. Besides this, new legislations are being framed which are increasing costs of products i.e. European falsified medicine directive, ePedigree law etc."
Other predominant factors favouring pharma packaging are that world population is growing and is getting older due to improved clinical treatments, improved medical treatments and personalized medications. Ratio of the population over 65 years is increasing by 2 per cent per year and persons over 65 are using 2/3rd of all pharmaceuticals globally.
According to experts, there is a need for innovations adapted to demographic changes and new applications or innovations for personalised medicines. There is a growing trend about pharma companies engaging in more mergers, acquisitions and in-licensing arrangements to replenish its pipeline. Global pharma companies will expand its presence in pharmerging markets.
"We need to intensify our geographical presence accordingly by expansion strategy and strengthening relationship with generic companies in pharmerging countries like India. Barrier films, optimisation for generics and volume can multiply for off-patent drugs in emerging markets, " Giessler explained
Latest trends show how pharma market scenario would be with Asia, Africa and Australia witnessing CAGR of 11.4 to 14.4 per cent, Japan with a CAGR 1.7 to 4.7 per cent, Europe with a CAGR of - 0.4 to 2.6 per cent, US with a CAGR of 0.7 to 3.7 per cent and Latin America with CAGR of 10 to 13 per cent.
Said packaging expert Gautam Buddha, "Protection is required for APIs, formulations, semi finished goods and bulk transfer packs to address molecule sensitivity. Regulatory requirements need to be adhered to in pharma packaging for providing equivalency for thickness and quality of adhesives, coatings, layers and quality. Other requirements which need to be addressed include identification of contact layers, extension of existing shelf life, limited shelf life due to impurity, shelf life of packaging material, extension to other markets, necessary documentation and alternatives to Vinyl based coatings or films etc”.