Innovation is the watchword in the pharmaceutical industry. It is present in almost all strategic plans, and it can be technological, disruptive or incremental. It differs in relation to the risks involved, investment values, and of course: financial return.
Our theme is Incremental Innovation, also known as marginal innovation or sustaining innovation, which consists of adding increments to a given product or process, bringing improvements.
For the pharmaceutical industry, it is a way of innovating, increasing its financial return, with investments and risks lower than radical or disruptive innovation.
New associations, differentiated forms of release, and new pharmaceutical forms are good examples of incremental innovation here in Brazil.
Incremental innovations, where do they begin?
The sources are many, but regardless of their origin and their initial genius, it must be analyzed and validated by a trained multi-professional team, which is usually allocated to new business teams.
Will incremental innovations always be a success?
Unfortunately, we have some very successful ones in the market, and others that have brought only disappointment and financial losses.
Therefore, based on our experience, we will share here some suggestions that can increase the chances of success in choosing incremental Innovation projects:
1 - Validate all innovative ideas, even those of the company president. Many presidents, vice presidents and directors are visionaries and have excellent ideas, but the new business team must do their job to analyze and validate the project with neutrality by issuing technical, marketing and financial recommendations.
2 - Look inside before looking outside. When the company chooses the path of incremental innovation it is suggested to first look at its current portfolio. Successful products can be a good start for new associations, new forms of release and new pharmaceutical forms and, thus, reinvigorate the already existing success. Products of excellent efficacy and safety, but which do not take off due to dosage limitations or inappropriate pharmaceutical form can also be candidates; in this case pharmacotechnical developments can revive products that are dormant.
3 - Look outside, find opportunities. Perhaps, all internal possibilities have already been exhausted, and new opportunities are outside the company. This is the time to seek possibilities for improvement in the products on the market. But which products? It is expected that the company will continue in a market aligned with its vocations; a preliminary analysis of the market figures helps a lot in the beginning of the process, but it is extremely important to involve the medical field to understand the actual current unmet medical needs. Interviews with experts and advisory boards are very welcome at this stage, because in order to move forward it is necessary to make sure that the market really needs this innovation and that it will have a good acceptance.
4 - Outline your competitor. By definition, competitors are those who operate in the market where the incremental innovation will be launched. There are many marketing techniques to define and differentiate yourself from the competition, but another very important aspect must be considered. To register the new product, a clinical study that justifies incremental innovation is likely to be required, and this study will be done on a therapeutic indication versus a comparator. The wrong choice of this comparator and/or indication may compromise the price that will be approved for the new product, as well as make it difficult to use the clinical study in promotional materials. This brings us to the last suggestion.
5 - Maximize the clinical study carried out for approval. Before leaving to carry out the study it is important for the company to be sure of the real need, as it is sometimes possible to justify innovation with data from the literature or by carrying out a study of relative bioavailability. Going along the path of the clinical study, the team of new products and the medical field should seek to carry out the study in the best indication of the product (defined as the best market) and with comparators that have an attractive price, remember that under the current rules it can be the final price of the product approved by CMED. Whenever possible, involve key opinion leaders and renowned institutions in the clinical study, because that way you already start to work on the image and create future lawyers for your new product.
We must also consider that Brazilian legislation has room to modernize and favor incremental innovation programs in the pharmaceutical industry. An intellectual property protection system focused on this segment and a more modern drug pricing policy will certainly encourage these projects even more.