7.4.1. Measuring ROI

In the questionnaire for the direct mailing survey those questions are asked more straight forward, as “Yes, the gains are substantially exceeding investments! We can already measure the return on the investments quantitatively and they provide a competitive advantage for the company” and “Yes, we expect the gains to be substantial within the next couple of years! Therefore, we are measuring the returns on the investments on a regular basis, even though they have not been positive so far”. However, out of the 11 companies (as each of the 16 companies was addressed only once, the 16 responses represent 16 different companies – out of which 11 have adopted QbD) that had rolled out QbD, none stated to see a positive ROI or to measure ROI at all so far. This seems to be quite difficult to do and so far has not been applied by the pharmaceutical industry to measure the benefits or costs of QbD.

In the version of the questionnaire for the survey initiated via LinkedIn, these two options for question 12 are combined to “Yes, the savings are substantial and exceed initial costs providing a measurable return on the investments and an overall advantage for the company”. Out of the 20 adopters of QbD in this part of the survey only 2 stated that the benefits exceed the initial costs providing a measurable return. Not surprisingly those were also those two responses stating to be fully satisfied and seeing their expectations fulfilled - benefitting from improved quality and capable processes in one case and regulatory flexibility in their QbD applications and reduced costs in the other case. The former response, however, simultaneously also admitted that QbD appears to be increasing overall development costs.

The other options provided for question 12 were consistent for both versions of the questionnaire and thus the responses of both are again combined in Table 12 below focusing on perceived but not measured returns. Once more some of the responses did not select only 1 option as requested, but gave 2 instead of using the second option to explain what in their opinion is still missing to achieve a positive return on investments and a widespread adoption of QbD throughout the pharmaceutical industry.

Table 12: Responses to question 12 of questionnaire: “Can you measure the actual returns on the investments (in % or $ per year) you had to make (e.g. time & costs for experimental designs, investments in manufacturing technologies, analytical methods & software, or additional efforts to implement QRM and PQS) when having to justify these investments in front of your senior management?”

About half of the adopters of QbD see the benefits and returns already exceeding the costs for implementation though they are either not measuring it or feel they can not measure it effectively.

The other half of responses sees the costs for QbD still exceeding the savings, also in the long run. About one third of these also appreciate at the same time that the financial investments are still worth it, as they benefit from an improved quality perception at the side of their customers.

Out of all responses only one opinion stated that the costs are by far exceeding the benefits and that QbD will not provide a competitive advantage at all. This is surprising as this company has started to roll out QbD before 2008 and established it as an integrated approach, though it has been driven solely by the technical development functions. Despite having submitted QbD applications, the lack of harmonisation at the side of the authorities to grant regulatory flexibility within the Design Space is blamed for not seeing their expectations fulfilled at all.