The role logistics plays in pharma’s journey into the future

Niels van Namen - executive vice president, Healthcare at CEVA Logistics and Stephen Barksfield - global BD program director, Healthcare at CEVA Logistics look at how logistics is affecting the future pipeline of pharma. 

The pace of change across the pharmaceutical industry is growing at an ever-increasing rate. Over the last decade, demand from global markets has challenged the industry to act more quickly to produce much needed innovative treatments. With the aid of technology over the past decade, the industry has fundamentally changed the way it operates.

Today, changing molecular and technology shifts are driving new research methods. Small molecule drugs, many of which date back to the 1800s like aspirin that is composed of just 21 atoms, now compare with a growth hormone drug of around 3,000 atoms or a large biologic drug of 25,000 atoms. Accordingly, the complexities of production and distribution have grown in recent years.

Biotech growing significantly in global market

According to industry reports, biotechnology products are estimated to account for 35% of the overall market by 2026 with more diverse product types and therapies—many with shorter life cycles—leading the way. New ways of assessing, approving and monitoring medicines, combined with personalised treatments, have resulted in new modes of delivering healthcare, and this trend will continue to accelerate in the coming years.

In general, these biologics are more susceptible to impurities in the production process and damage during transportation than traditional chemical entities. Gene and tissue-based therapies are especially difficult to manage, because with some treatments, samples must be individually extracted, propagated, prepared and tested before being administered. This requires a unique manufacturing set up and a logistics operation that is fully traceable for the individual patient.

Huge scope of trials delivers extensive, ongoing pipeline

According to the US National Library of Medicine, more than 1,000 clinical trials are underway globally, representing a large pipeline for these products. Almost any gene in the human genome can be targeted, so the potential for new therapies is immense. Gene addition, gene correction, gene silencing, reprogramming and cell elimination are the five main therapeutic strategies in view. Other therapies, such as CART T-cell, have huge market potential with the hematological malignancy market alone expected to reach almost $4 billion by 2027, say industry observers, who also note that nearly 200 clinical trials for chimeric antigen receptor (CAR-T) cell therapies are in progress within just the G7 countries, and up to 100 other companies are working on a CAR-T therapy. This trend means these companies will require logistics support across their activities. In addition, the larger molecules mean greater product sensitivity, and therefore, greater expertise is required in their handling.

These changes will continue, and the future is all about embracing them. Koen Kas is a healthcare futurist, author and guest professor of molecular oncology and health tech at the University of Ghent in Belgium. He highlighted several stark examples during this year’s CEVA Digital Live healthcare event. He pointed out that diabetes patients no longer have to take injections but can receive a small implant that delivers the needed drugs over six months. He also referenced tumor patients that can send their own cells to be modified and made stronger and have them returned to them. His point was that it’s actually part of the patient that is starting to be transported.

Market trends will drive supply chain reinvention toward patient centricity

In general, pharmaceutical production reflects the broader trends in healthcare. Changing demographics, ageing populations, global healthcare budget pressures and the move to home care combine to require an ever-closer relationship between producers, logistics providers and end-user patients. This relationship then merges with the changing nature of therapies and products, triggering more direct-to-patient services and home delivery of medication and diagnostics.

These new, targeted therapies present their own challenges, with affordability and accessibility being at the top of the list. Patients themselves are demanding a premium customer experience with telehealth and eCommerce driving changes in their behaviour. To this end, eCommerce health marketplaces are now creating new buying experiences for lifesaving, life-enabling medicines.

Traditional supply chains must change to meet modern demands

Two decades ago, direct to patient was unheard of as a concept. A traditional pharma supply chain consisted of manufacturing the drug, transporting it to the wholesaler or distributor, delivering it to a hospital or pharmacy and then finally dispensing it to the patient. Patients had direct access to small quantities of over-the-counter drugs, but nothing more. For anything more complex, they went to a hospital, a doctor, or a pharmacy.

Today, that has all changed, with patient-centric fulfilment supply chains delivering strictly controlled, monitored, transparent and regulated interaction between all parties. Biotech and pharma have, like every other industry, been transformed by digital technologies and the use of predictive analytics, Big Data and AI-based tools, all of which give the industry the capacity to redesign its development, manufacturing and overall business processes.

Gene therapy and cell therapy, which are often combined to treat genetic diseases, are good examples of new treatments where expert partners need to work together in close cooperation to achieve the desired, individualised treatments. Oral formulations of large molecule drugs are difficult to produce, and as a result, many of these treatments need novel delivery devices that require dedicated handling and transportation. A large proportion of companies working on these therapies are small or mid-size enterprises requiring support from a logistics provider to create transport solutions for their therapies, especially at the scale-up phase of the development lifecycle in support of operations.

Challenges – drug safety

Looking at the current state of the industry, a number of challenges remain to be addressed. According to various industry associations and institutes, a pharma manufacturer can expect a damage rate of up to 30% attributable to the logistics constraints associated with its product. Some 25% of vaccines reach their destination degraded due to incorrect shipping, while 20% of temperature-sensitive products experience broken cold chains.

The only way to overcome these challenges and improve delivery outcomes—and therefore patient outcomes—is to use expert providers who can seamlessly deliver across the supply chain in all areas of biotechnology, as the culture and demands in the healthcare supply chain can vary significantly when compared with traditional supply chains. 

Logistics: delivering end-to-end across the supply chain

The shipment of pharma products demands a relentless focus on risk mitigation, continuous improvement, quality, service and regulatory expertise—in other words, ethical and operational excellence from one end of the supply chain to the other. The ultimate goal of healthcare logistics is to make healthcare accessible and affordable globally through seamless supply chain solutions.