Pharma: If it only lasts until the next audit
"As companies work from audit to audit, looking at competitiveness may increasingly take a back seat," says Tore Bergsteiner, Managing Director of MAIN5. The industry experts advise pharmaceutical companies on the path to digitalization of regulated processes.
Hardly any other industry is "slowed down" as much by regulation and audits as the pharmaceutical industry. This is the result of the study "Pharma Insights 2019", published by the consulting firm MAIN5. 65 percent of processes in pharmaceutical companies are audit-focused, and the majority (70 percent) have grown historically.
Only eight percent of the processes are future-oriented, the survey of 94 specialists and managers from the pharmaceutical industry revealed. "The pharmaceutical industry could tap into much more potential, which often lies fallow out of necessity. However, so far only a part of the accruing data from the different business areas is analyzed and used for innovations as well as future optimization.
Big Data: Maximum with half power
64 percent of the respondents assume that a maximum of half of the accumulating data will be analyzed and optimize the processes of the future. 26 percent of the professionals surveyed did not want to answer the Big Data question: "There is a lot of uncertainty about Big Data. However, high-quality inventory data is the most valuable source today when it comes to new innovations and process optimizations," says Tore Bergsteiner from MAIN5.
However, the pharmaceutical industry is also feeling the pressure, which is confirmed by falling sales of blockbuster drugs: 47 percent of the study respondents state that opening up new growth markets and product diversification are equally important challenges. In second place is still the protection of sensitive patient data with compliance with the DSGVO (45 percent), and in third place the business risks due to expiring patent protection and thus generics in the market (44 percent - multiple answers were possible). Falling blockbuster sales are also among the challenges in 2019, with 41 percent.
Digitization: Hardly a risk
The respondents are unanimous in their risk assessment of growing digitalization in the patent- and knowledge-driven pharmaceutical industry: Only 21 percent see a risk, but 70 percent agree less or not at all. "The depth of digitalization determines the distribution of market shares in international competition and also which active ingredients and combinations of active ingredients can be used to launch new products on the market," explains the MAIN5 managing director.
With numerous mandates from the world's largest pharmaceutical companies, the MAIN5 team regularly rebuilds complete processes, structures and systems. The goal is the development of robust, efficiency-based process relationships and the sustainable, competitive positioning of a manufacturer or distributor in the global market of pharmaceutical companies.
Via Main5 (www.main5.de)
was founded in 2013 as a management consulting company and focuses on strategy, process and solution consulting for international life science companies in the regulatory areas of R&D, regulatory affairs and quality management. Main5's consultants combine their methodical and systemic approaches with many years of industry experience. Even complex projects of leading industrial clients are implemented through the holistic approach, with the focus on people on the way to the digital future.
