The race for COVID-19 vaccines stimulated innovation across the industry, but the sector has been building momentum for years. The clinical trials packaging market had a value of $44.3 billion in 2020 and is expected to reach $47 billion in 2021. In this particular sector, the primary considerations in the design of packaging are functionality and usability.
The clinical trial packaging market is expected to expand at a compound annual growth rate (CAGR) of 7.3% between 2020 and 2027. The market was valued at just under $1,100 million in 2019.
According to the preview report from Transparency Market Research , the primary drivers of growth are:
- Increasing numbers of chronic diseases globally: Chronic diseases and conditions are on the rise worldwide. An ageing population and changes in societal behaviour are contributing to a steady increase in these common and costly long-term health problems. The middle class is growing; and with urbanisation accelerating, people are adopting a more sedentary lifestyle. This is pushing obesity rates and cases of diseases such as diabetes upward.
- The rising number of clinical trials in developing regions
- Increasing investment in to pharmaceutical R&D
Sustainability and restraints
The report also suggested that pressure regarding the sustainability of the industry will shape its growth. With more customers and consumers looking to implement non-plastic alternatives and to minimize waste to lessen the carbon footprint of products, players in the market are having to offer sustainable packaging that can also contain enough space for the ever-evolving regulatory guidelines.
The report also looked at several factors that could restrain the clinical trial packaging market within the forecast period. These include:
- Lack of modern infrastructure in under developed and developing regions
- The scarcity of trained personnel
- Lack of centralized trial registration processes across countries
Clinical trials require detailed instructions and dosage information, as well as a list of all active ingredients and any other regulatory information depending on region.
Requiring the production and distribution of large quantities of drugs, each of these need to be labeled accurately. Regarding blinded studies, the accuracy of the print and color matching is integral to the integrity of the study. Any visual differences could call for the drugs to be recalled.
Options compared to the multi-page leaflet label
On a traditional pressure sensitive label, only so much information can be printed. If that product is to then be distributed to multi-lingual destinations, the product either needs to re-labeled or have additional packaging, such as a folded insert and box, or by increasing packaging size at a significant expense.
As well as the added cost, the logistics and extra processes needed slow down a drug being available to use at trial. The danger of not using a multi-page label direct on to the product is that the information needed can become estranged and dosage and usage instructions are not adhered to.
In some countries the use of a QR code is being used so that the end user can scan the product to receive the information. A QR code (Quick Response Code) is a two-dimensional matrix barcode created for the automotive industry in Japan in 1994 consisting of a pattern of black squares in a vertical and horizontal format able to contain large scale data.
Where these do have the advantages of being able to send the user to large amounts of data, the disadvantages in the pharmaceutical/clinical trials market is that the QR code can become distorted or not read properly. Another disadvantage to the QR code is you must use phone with a camera and the correct reader software that can scan the image of the QR Code.
Only four countries have more than 75% of the population using smartphones, meaning 25% in these countries would not be able to read the QR code. Half of the countries are near 50% usage going right down to 15.9%. Over the world, this equates to nearly 2.7 billion consumers without a smart phone. 971.1 million consumers in India are without a smart phone and even in the highest percentage of smart phone users, being in the United Kingdom, there are still 11.5 million consumers without one.
Global market share
The North American market holds approximately 53% of the global market share in clinical trials packaging and should remain dominant throughout the forecasted period, potentially achieving a CAGR of 7.7% between 2020 and 2027. Europe is also a lucrative market, anticipated to expand at 7.1% CAGR.
The Asia Pacific region is expected to expand at a CAGR of 3.6% with packaging manufacturers likely to take advantage of the low production and packaging costs within the region. The expansion in this region is led by high potential countries such as India and China who are already leading manufacturers and exporters of pharmaceutical drugs whose governments and private sector are investing more in to R&D. This can be capitalized on by the clinical trial packaging manufacturers seeking to profit from the rise of activity within the region.
Accuracy, availability and application
Using a multi-page leaflet label provides the space for communicating enormous documents into a compressed space, which can be applied directly to the product. Leaflet labels also give enough space to cover several languages, regulation compliance of multiple countries and any other relevant information needed. This is particularly useful for countries with lack of modern infrastructure and a lack of centralized trial registration processes as the same end product can be labeled once and sent to countries requiring different legislation, streamlining the packaging and labeling process.
Clinical trials are demanding on quality and accuracy. Label manufacturers have to look for the most accurate way of being able to place the leaflet label to adhere to strict legislations and tight regulations.
Denny Bros assists Fix-a-Form in delivering multi-page labels to the clinical trial business sector.
Ashley Simpson, commercial director at Denny Bros, states “The clinical trial market is very significant to Denny Bros and has been a key market to us for over 30 years. The increased country participation to clinical studies has increased the demand for more pages being required in a Fix-a-Form, normally in a booklet format. These requirements have helped us to continue to innovate our Fix-a-Form products. To be a successful supplier in this market your quality of product must be 100%."
Fix-a-Form International offers a range of multi-page leaflet/booklet placing machinery, offering the precision placement of multi-page leaflets or booklets. Being based at the Denny Bro label manufacturers headquarters in Bury St Edmunds, UK, they have evolved their machinery to what the label manufacturer needs. The leaflets/booklets can be either laminated or unlaminated, offering either single or twin rotafix heads, rotary or flatbed diecutting. The machines really can be tailored to your label manufacturing needs.
All of the Fix-a-Form leaflet label machinery is easy to operate, needing just one operator, with fast setup times and remote diagnostics as standard. Support to the label manufacturer is offered by joining the Fix-a-Form network, and you will benefit from the expertise and years of experience from some of the biggest label manufacturers around the globe. From speaking to our network of leaflet label manufacturers, you can expect to see a ROI within 5 years of purchasing a Fix-a-Form leaflet label machine.