By Melanie Streich
Chronic diseases are more widespread than ever before. In industrial nations and, increasingly, in developing countries as well, they are among the most common and economically relevant health problems.
The health sector’s global economic factor is accordingly high and simultaneously acts as leverage for the pharmaceutical industry, which invests a comparably high share of its revenue in research and development (R&D).
In light of global demographic changes, the industry’s development opportunities are excellent. People are living longer and more health-conscious lives – which further increases the high-tech sector’s growth outlook. Growing drug development requirements result in a parallel increase in systems and machine technology demands in the field of packaging and bottling medicines.
“Today, pharmaceutical companies need integrated solutions. Machines provide the foundation for these. An extensive service offer and digital solutions, in particular, are gaining in importance,” explains Norbert Gruber, chairman – Executive Board at Uhlmann, which provides systems for packaging pharmaceuticals in blister packs, bottles, and boxes. The German family business, which has more than 2,300 employees around the world, has accordingly positioned itself as an innovative and digitalized company at interpack 2020, the world’s leading trade fair for the packaging and associated process industries.
From 7 to 13 May 2020, interpack 2020 trade fair will present many cutting-edge solutions that the industry has to offer. As a focal point for pharmaceutical packaging, Halls 15 to 17 offer visitors the opportunity to find out more about innovative packaging and process developments for this specific industry. The other halls also showcase corresponding solutions: The approximately 1,000 companies with exhibits on Industry 4.0, digitalization, automation, personalization, track and trace, and many other interesting topics from the field of pharmaceuticals represent a significant share of the around 3,000 exhibitors at interpack.
Pharmaceutical market forecast
According to figures released by market research company IQVIA, global expenditures for pharmaceuticals are expected to increase to US$ 1.43 trillion (approximately Rs 100 lakh crore) by 2022. In comparison, in 2006, this expenditure amounted to US$ 658 billion (about Rs 46 lakh crore). Of this, the highest spend is on cancer medication and biopharmaceuticals.
The reasons for the increase in market growth are quite apparent. Demographic change with a rise in the number of older patients and increasing urbanization with a growing middle class are the determining market factors for the pharmaceutical sector and the associated process and packaging industries.
The future of biopharmaceuticals
While in pharmerging countries, more and more people are gaining access to traditional medicines such as painkillers and antibiotics, industrial nations are increasingly employing new, complex active ingredients and innovative treatments.
In the pharmaceutical sector, biotechnology is considered a key technology in the global fight against severe diseases such as cancer and autoimmune diseases. Biotech’s share in the medical market has almost doubled in the past ten years and has thus become a decisive factor for the process and packaging industry.
Considerable demands accompany highly effective medicine on packaging and processing technologies, particularly bottling and packaging solutions. When manufacturing biotech medicines, avoiding contamination is essential. Specialized containment solutions aim to prevent contamination.
Isolators are one such example. Liquid medicines can be processed under sterile conditions in vials. Pre-filled syringes also contribute to an increase in safety. They help prevent dosage errors and also eliminate contamination when changing needles. In the hectic daily life of practices and clinics, pre-filled syringes and pens also save precious time. Authenticity checks performed on complex purification processes using combined sensor technology and mathematical models ensure that quality controls can be performed much more quickly with increased process accuracy.
Pharmaceuticals and packaging – real team play
When manufacturers launch new medicines, they depend on the market and technology competence of machines, systems, and packaging manufacturers and processors. Time limits on patent protection require fast and flexible solutions that have to guarantee scale-ups from small laboratory amounts to high volumes in larger plants.
Optima is a single-source provider of packaging machines and bottling and production systems. To ensure that newly developed products are launched as quickly as possible, Optima uses the CSPE method, which will be one of the company’s central topics at interpack 2020. This method reduces delivery times and significantly accelerates the commissioning of pharmaceutical systems. “In light of increased development periods and costs on the one hand and increasingly tough international competition on the other, the time between concluding the approval phase and launching the product has to be as short as possible,” explains Gerhard Breu, chairman – Pharma division of Optima.
At the same time, companies require reliable packaging machines and bottling systems that are easy to use and clean, and that can be retrofit without great effort. Pharmaceutical service provider Harro Höflinger provides support in the early stages. His clean rooms and laboratories can depict extensive processes in a controlled environment, while test setups allow clients to check critical steps in advance. “Our clients increasingly ask to test their own substances and critical conditioning products on machines designed by Harro Höflinger. Our clean rooms and laboratories are the perfect place to implement these tests. They allow us to recognize and minimize risks at an early stage – the basis for quick and safe scale-ups to commercial manufacture,” explains Stefan Mayer, senior director – Process Services.
Protection against counterfeiting
In the pharmaceutical field, in particular, strict legal provisions and guidelines apply that are of extreme importance for all parties involved in the process and that at the same time mean tremendous investments for the affected companies. Since February 2019, prescription medicine in the EU must have tamper-proof seals that ensure that the packaging has not been opened.
Serialization on the packaging is now also a legal requirement. All affected packaging requires a two-dimensional data matrix code that uniquely identifies the medicine and confirms its authenticity. This code contains information on the batch number, the expiration date, the serial number, and the national reimbursement number.
These new regulations have far-reaching consequences. In individual cases, production facilities have to be expanded, constructed, or modified to accommodate new serialization units. The expansion of the IT infrastructure, in particular, is a real feat of strength for many companies and is associated with high costs.
Körber Medipak Systems offers extensive solutions that protect patients against counterfeit medicine. Pre-serialized folding boxes with tamper-evident seals and targeted system solutions put a stop to counterfeit drugs in the legal value chain, as packages now visibly and unambiguously show whether they have been opened or not.
The silver generation
By 2050, the global population will reach 9.7 billion people; a mere 50 years later, this number is expected to increase to 10.9 billion, according to the most recent UN global population forecasts released in June 2019. In 2050, every sixth person in the world will be over 65, with a total of 426 million people over the age of 80. This forecast means that the number of people over 80 in 2019 which 143 milliion will triple in the next thirty-one years.
These demographic changes also mean a rise in diseases that increasingly occur with age. These include diabetes, rheumatism, multiple sclerosis, as well as dementia and Alzheimer’s disease.
The packaging industry offers smart packaging for patients whose sight and hearing are dwindling or who are losing their finger strength and motor skills. Pharmaceutical technology provider Romaco Siebler created one of these innovations. In cooperation with foil experts Huhtamaki, Romaco Siebler developed Push Packs, which are equipped with unique, accessible features and allow patients to push tablets out of the foil easily. “Push Packs are an affordable alternative to cold-formed aluminum-aluminum blister packs (AI/AI blister packs). As the packaging foils are a lot thinner, they require less material. This reduces packaging costs in direct comparison by up to 60 percent,” calculates Jörg Pieper, chief executive officer at Romaco Holding.
Personalized medicine will change the global health system considerably in the years to come. Studies have shown that more than 70% of all pharmaceuticals currently in development have been customized to meet the needs of specific patient groups. In cancer therapy, individualized medicine is already widespread and will increasingly supplement standard treatments in the future. Scale-out solutions for machines and equipment enable the production of smaller batch sizes. Here, existing equipment is copied exactly for other locations. Personalized medicines require clearly defined processes and machine technology with a high degree of automation.
More and more pharmaceutical manufacturers require flexible bottling and packaging systems that allow them to work on small batches with maximum efficiency. Bausch+Ströbel has a compact solution in its portfolio – the modular VarioSys production system is also suitable for application in laboratories with small batch sizes. “Flexibility is the priority in all our designs. We achieve this by quick and easy module changes on the one hand and short cycle times when sterilizing the isolator on the other,” explains Heiko Schwarz, who is responsible for the development of VarioSys in product management at Bausch+Ströbel.
Print your own tablets
Tablets fresh off the 3D printer are no longer a dream of the future. Spritam, a printed epilepsy treatment, was the first medicine to be approved by the Food and Drug Administration (FDA) in 2015. 3D printing processes allow manufacturers to adapt products precisely to patient needs while reducing time and cost factors in production, as machine components no longer need retrofitting.
Compared to conventional tablet presses, printed pills can also have a more porous surface, which helps them dissolve more quickly and without additional liquid intake. They can also contain more active ingredients. This new way of producing tablets primarily benefits patients who have difficulty swallowing and who depend on various tablets. However, experts say it will be quite sometime before patients can print their own prescription medicine, with a personalized formula put together by their doctor, in the comfort of their own home. The current fields of application are limited exclusively to highly specialized, individual medicines.
Convenience and safety
Personalized medicine is a field that mainly affects the hospital and care sector. Personalized tablets may be blister-packed and ready for use to ensure that patients receive the right drug cocktails relieving carers of the task of putting the necessary medicines together. Blister pack machines in chemists and blister packaging centers pack the patient’s unique tablet mix in an airtight and hygienic strip of sacs and simultaneously ensure that the doses are labeled and delivered in the right order.
Cost pressure and systems efficiency
Despite all the positive market developments in the pharmaceutical sector, we must not forget that even though the industry is growing, the health care systems in several countries are under tremendous cost pressure. Mandatory discounts, price limits, and reimbursement models often force manufacturers to lower their costs for each package. Machine and systems manufacturers have to work on improving overall equipment efficiency. In industry 4.0’s future, this means using integrated systems with reliable availability and continually high product quality to ensure that providers can keep up with a dynamic market in the long run.