2019 – The Top 5 Trending Topics
In 2019, PharmaLex reviewed and wrote an abundance of contemporary articles on diverse compliance topics in the Pharma/Biopharma sector. As we approach the end of the year, we thought it would be a good idea to summarise what we think are the top five trending general topics in Pharma of 2019.
- The Digital explosion in Pharma
The interface of the electronics industry and the world of Health Product manufacture continues to grow with the increased investment in cloud technology, digital healthcare solutions and Pharma 4.0.
- After holding out for some time, with some legitimate concerns over data security and compliance, resource-saving external computer servers and data management are now the norm in the Pharma sector. Cloud technology’s capacity to decrease overhead costs and provide robust business processes is proving to be essential for smaller research (CRO) and development (CDMO) organizations to thrive.
- The challenge in communicating ‘product value’ to stakeholders, particularly patients and health departments who control the purse strings, is being addressed where consumer electronics such as smartphones and wearables are being used to gather (and potentially dictate) real patient usage and outcome metrics. It is reported that real data from these sources will guide development of new products and devices to meet patient needs.
- Pharma 4.0, or the use of so-called disruptive technologies, in the Pharma industry has been one of the most published areas of interest in 2019. The increasing use of robotics instead of human interfaces in sterile manufacturing, the application of 3-D printing and virtual reality technology on training the factory floor and the use of data analytics and AI in searching for patterns in large drug discovery data sets, are some examples of Pharmaceutical 4.0 in action. The use of disruptive technologies is expected to expand rapidly and the connectivity of these technologies is being augmented using the Industrial Internet of Things (IIoT) where instantaneous integration and analysis of multiple vast data sources and detections will soon be optimised.
- Mergers and Acquisitions (M&A) in Pharma
2019 continued a trend for corporations growing and consolidating through M&A activity in the ‘twenty tens’. Whether it is BMS’s acquisition of Celgene, AbbVie’s purchase of Allergan, Mylan’s merger with Pfizer Upjohn or the multiple M&As in smaller CDMO and CMOs, this activity is driven by one significant factor: a demand for cheaper and innovative pharmaceuticals by a growing and ageing wealthier population. More and more drugs coming off patent are increasing the demand for new generic drugs while simultaneously scientific advances in Biotechnology and Cell and Gene Therapies have increased the potential to meet previously unmet patient need. Emerging biotech development companies with bespoke products or processes are seen as attractive targets for the larger pharma companies. M&A activity continues to create challenges for Pharma in restructuring which can lead to process disruption, staff distraction and loss in growth momentum. However, opportunity knocks for service suppliers where facilities and manufacturing are being divested to CMOs and more services (testing, packaging, etc.) are being outsourced to gain efficiencies.
- Biosimilars and China
66 proprietary biologics are due to come off-patent in the US between 2020 and 2025 and it is expected that an increasing number of biosimilar applications are expected across the established markets in the US and EU. Unsurprisingly some of the largest selling biopharma products such as Adalimumab (Humira®) and bevacizumab (Avastin®) are currently the most popular biosimilars across all stages of clinical development. A significant number of future biosimilar approvals are expected from companies based in Europe and Asia, especially China. China have made substantial investments in bio-processing and bio-production capabilities and capacities have grown substantially in the past number of years. It is expected that China will play a substantial role in the production and worldwide supply of biopharmaceuticals in the next decade.
- Patient Focus
Essentially every major Pharma organisation has ‘Patient Focus’ or ‘Patient Centricity’ as part of its core value, mission or vision. Pharma organisations have connected with patient support groups in their areas of therapeutic interest and have health and patient senior advocacy roles within their organisations in order to better support the patient-centric approach to healthcare. The Patient Focus initiatives seek to align clinical and commercial effort in organisations to drive innovation toward real-world patient results. The design of drug products (formulation, dose form, device, packaging etc.) for optimal patient usability and care is becoming critical to compete and maximise product profitability. More than ever before, new drug development programs focus on the design of new drug products which deliver the most effective, safe and convenient treatment to patients.
In the EU, 2019 has been dominated by the Brexit rollercoaster and the uncertainty caused by the political wrangling in the UK. Following the election result in the UK, it now looks a certainty that Brexit will proceed with a deal and a planned withdrawal of the UK from the EU. The effect on the Pharma industry in the UK remains to be seen and we await with interest on the specifics of the future regulatory alignment between the two jurisdictions during the transitional period and beyond.
At PharmaLex, we provide consultancy advice on all aspects of Quality Management and Compliance in the Pharma/Biopharma sector. If you would like further information or wish to discuss how PharmaLex can support you on any of the topics above, please connect with us at +353 1 8466 4742 or firstname.lastname@example.org.