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.
The evolving complex regulatory environment in regulated and pharmerging markets is fuelling the demand of high barrier pharma packaging for protecting molecule sensitivity of various drugs to achieve quality, according to experts.
High barrier pharma packaging 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.
Speaking on the trends in pharma packaging, Johannes Giessler, director, Sales & Marketing, Perlen Packaging recently 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.
According to 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”.
The global pharmaceutical industry has evolved over the last decade and is now increasingly focused on efficacy of the medicine and patient safety. Pharmaceutical packaging too has come of age and is now beginning to get its due importance. Formulation development teams and regulators are both keeping a keen eye on product packaging and its impact on formulation integrity through its shelf life. One of the main reason for this is that new age APIs in addition to being highly potent are also very sensitive to moisture, oxygen and light, says Giessler.
The exposure of solid dosage products like tablets or capsules to hostile conditions can result in physical damage, chemical interaction or oxidative degeneration. In an extreme case, there can be fatality due to absence of the medicament as it has degenerated into something ineffective or harmful. To avoid such a situation, the medicament has to be packed in a suitable protected blister that protects the formulation from moisture, oxygen and light. Barrier protection to the product can be provided by using different material such as metals, silicates or polymers.
Packaging in case of pharma is always demanding and diverse, there is an always continual change and re-alignment happens due to change in the policies by the government, end-users and consumers. These conditions has made transit in the packaging’s role to expand which also include branding, communication, distribution control, anti-counterfeiting, poison protection, and much more.
Packaging is involved in and required to provide guidance and recommendations to researchers and in some cases marketing at the earliest stages of product development regarding materials, packaging options, and sizes of packages. Packaging is also dynamic i.e. its role continues to expand and play a more important part in the delivery of products.
This role is being shaped by a number of key trends that affect the way packaging is developed. These existing and emerging trends will significantly change many of the more common functions of packaging. We have also see day by day health care becomes more expensive and possibly harder to access because of cost, these packaging trends and others that reduce cost will be implemented for cost containment.
Packaging begins with the selection of right materials, and material selection drives the choice and type of packaging equipment and, most importantly, the final package performance. Every time there is invention of new drug, a new packaging is designed to bring this new product through regulatory approval and ultimately to market. Material is choose which will fulfil multiple requirements of the value chain to produce a package that meets all company and regulatory requirements along with the expectations of the final end user in the health care system.
Traditionally, primary packaging materials like glass, metal, plastic and composites, including the composite structures found in flexible films is a starting point. Change, even in plastic materials, comes slowly and requires extensive development and testing. Pharmaceutical companies for the most part choose to use existing materials for similar pharmaceutical products and have not searched for alternatives unless a new need required a change. This is now changing as new drug products and new biologic products demand higher-performance packaging materials.
Slowly, manufacturers are introducing newer plastics that provide improved performance properties, and materials such as polyethylene terephthalate (PET) or polypropylene (PP) are slowly replacing HDPE and PVC. Polyvinylidene Chloride (PVDC)-coated Polyvinyl Chloride (PVC) films are designed to protect products at low costs.
But with advanced coating technology, it is possible to produce a two-layer PVC/ PVDC specification exhibiting identical moisture and gas barrier properties as compared to the existing three-layer constructions. These would inculcate better dimensional stability, UV resistance, and cost-effective high-barrier for the product.
There is also a rise in the use of thin aluminium foil based package, which is costlier but provide better protection compare to plastics. Also there is research going on to use for the biologically derived polylactic acid (PLA).
Today, sustainable packaging is gaining ground and sustainable packaging for OTC products will be one of the principal drivers of change. Environmental awareness and the need for companies to be good corporate citizens will also be factors in the evaluation, qualification, and use of environmentally derived polymer materials and their use in pharmaceutical packaging.
As the pharmaceutical products are becoming complex, so is the technology use too. Depending on the product, the variety of equipment capabilities needed can be wide-ranging. Innovative packaging designs and new materials, serialization requirements, sensitive products, large and small scale projects, are impacting equipment designs and the packaging process. Current trend in this space are dominated by increased automation, serialization needs, and the flexibility to accommodate the variety of the robust present.
Product manufacturers are looking for robust and flexible machinery with high outputs, while complex medicine for targeted treatment demand for flexible platforms and smaller batch sizes. Additionally, more equipment is likely to be equipped with advanced programmes to enable communication with other equipment on the packaging line. The integration of robotics is changing the industry, allowing flexibilities, as well as feeding and connecting speeds that were not previously possible.
Apart from this, strict safety regulations and guidelines are aim at optimizing and monitoring pharma production processes in order to reduce the risk of product recalls and protect consumers from contaminated medicine. Hi-tech inspection systems are among the most important quality safeguards for pharmaceuticals. The ability to evaluate processes in real time, to detect and quantify process or component-related defects, and to take corrective actions is essential for process optimization and ultimately product quality and patient safety.
The global packaging equipment market for pharmaceutical is highly fragmented and commoditized to an extent. In 2012, the top five players in the market accounted for 44.2 per cent of the market share. With intense market competition, a majority of the top players struggle to maintain their leadership positions. To maintain their market shares, several players in this market aim to either diversify their product portfolios or expand their geographic presence.
Currently, the global market is in a transition phase, wherein blister packets and aseptic pharmaceutical products like prefilled syringes are increasing in demand among pharmaceutical end users. The shift in demand is seen in all product segments from bottle filling and sealing equipment for solid dosages to blister packaging equipment. This is due to the increase in demand for individual doses.
During 2010 to 2013, the growing need for novel drug delivery techniques formed the basis of innovations in the market, when a majority of the leading players launched various automatic and integrated packaging lines, such as blister packaging lines and cartoners, among others. The key players involved in these strategies were Robert Bosch GmbH (Germany), Marchesini Group S.p.A. (Italy), and Uhlmann Group (Germany).