Biohit is working on a new market launch and FDA approval

Translation: Original published in Finnish on 10/10/2024 at 7:07 am EEST.

Biohit that reports semi-annually does not publish business reviews for Q1 and Q3, but the company reports on its progress on the IR blog. The Q3 blog did not comment on progress against financial targets this time, so we expect the business to have continued to operate within the guidance range of 15-20% growth. The company said it is working on a major market launch that, if successful, could bring sales from mid-2025. The FDA approval project is also proceeding according to plan and the company is seeking a marketing authorization in the United States in 2026. 

Growth paved by FDA marketing authorization project and potential new market launch next year

Biohit said the FDA project is progressing according to plan, with the aim of obtaining marketing authorization in 2026. We understand that the project is an application for marketing authorization of Gastropanel® and that obtaining it would provide Biohit with access to a significant US market. What makes the market attractive is its large size, uniform regulation and high achievable prices. Towards the end of Biohit's 2024-2028 strategy period, we expect the US to play a moderately large role in achieving its goals. The company also announced a major market launch that, if successful, would bring sales from the middle of next year. No further details are available at this time, but the company has previously mentioned South America as a potential region. According to the company, positive signals are also coming from South Korea, where the long-term work is beginning to show in sales.

Tough regulatory environment for the entire industry in Europe

Biohit also reported that it continued its efforts to expand its product portfolio. In addition to product development, this requires regulatory approval of products in different market areas. In Europe, in vitro diagnostic products must comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). Compliance applies to both new and old products. This is a major challenge for the whole industry and, we believe, also for Biohit. The company says it has responded to this regulatory challenge with new R&D investments, an extensive network of collaborations and prioritization. We estimate that the slow regulatory environment has already delayed the launch of Biohit's new products and added costs. However, we do not expect regulatory challenges to be a significant headwind for Biohit. The regulatory challenges are also the same for all operators in Europe, so the friction is affecting the market as a whole.