Some hard numbers reveal the paradox: the EU has a highly developed research sector vs. the EU is a region with a challenging commercialization environment compared to other global leaders.

Biotechnology is one of the fastest-growing research and innovation sectors in the world today, and the European Union plays a significant role in this process. Over the past decade, the number of biotechnology researchers in the EU has nearly doubled, from approximately 42,000 in 2012 to over 81,000 in 2021, and the share of employment in this field has reached 17.2% of total R&D employment. These figures confirm that Europe has a strong scientific base and is systematically building capacity in technologies critical to health, industry, and food security.

However, when we look at what happens next – patents, technology scaling, and market penetration – the picture becomes less optimistic. The EU’s share of global biotech patents fell from 22.6% in 2001 to 18.3% in 2020, while the US still accounts for nearly 40% of global patent filings. On a per capita basis, the difference is even more pronounced: in 2020, the US had three times the number of biotech patents per million inhabitants than the EU.

However, it is worth breaking down this general picture into its first factors, because biotechnology is not a single sector, but a collection of very different areas that operate in different market and regulatory conditions.

Red biotechnology:

Red biotechnology, encompassing medical and pharmaceutical applications, is the largest and most capital-intensive segment of the entire sector. It is here that a significant portion of biotechnology patents worldwide are created. Between 2001 and 2020, medical-related technologies, including peptide preparations and antibody-based solutions, accounted for a significant portion of all patent applications in biotechnology.

Europe is scientifically strong in this area. Universities, research institutes, and clinical infrastructure are among the world’s leading. The problem arises at the commercialization stage. Drug development requires enormous financial resources, a long time frame, and a stable, predictable regulatory environment. Meanwhile, in the EU, these processes are often perceived as more complex and dispersed than in the US. As a result, many technologies developed in European laboratories reach the market under the auspices of American companies – through acquisitions, licensing, or transferring further stages of development outside of Europe.

White biotechnology:

White biotechnology, or industrial applications, is the largest category of biotechnology patents worldwide. Technologies such as processes based on microorganisms, enzymes, and biochemical tests collectively account for over one-third of all biotechnology patents filed between 2001 and 2020.

This is an area of particular importance from the perspective of industrial transformation and the green economy. Interestingly, it is in white biotechnology that Europe, alongside Japan and China, demonstrates relatively higher specialization than the United States. Despite this, the EU’s share of the global patent portfolio is not growing. Why? Scaling is again crucial. Industrial technologies require a rapid transition from pilot to large-scale production, which in turn depends on access to capital, infrastructure, and a single market. Regulatory fragmentation and national differences mean that European companies often develop more slowly than their competitors.

Green biotechnology

Green biotechnology, primarily related to agriculture and food security, accounts for the smallest portion of the patent portfolio – the number of applications in this area is relatively low both in the EU and globally. Despite this, the importance of this segment is growing.

Globally, China demonstrates a clear specialization in green biotechnology, while in the EU, only a few countries, such as the Netherlands, have a clear competitive advantage in this area. This demonstrates that the potential exists, but is not being utilized evenly. Mechanisms are lacking to develop these technologies across the EU and make them a real pillar of innovation.

Horizontal biotechnologies

Horizontal biotechnologies, which can be applied across multiple sectors simultaneously, account for a small percentage of patents (around 2%). However, their importance is greater than their scale suggests. These are often technologies that can accelerate innovation in other areas. The example of Great Britain demonstrates that even with a relatively small number of patents, high specialization can be achieved, although in this case we are also talking about a niche, not a mass market.

Analysis of individual areas of biotechnology leads to a common conclusion: regardless of the sector, the European Union is consistently building research and technological potential, but significantly underutilizes it during the growth and commercialization phases. In red biotechnology, barriers include long and costly market development paths; in white biotechnology, barriers include limited ability to rapidly scale industrial processes; in green biotechnology, barriers include low innovation rates and strong differences between Member States; and in horizontal biotechnologies, barriers include small scale despite high technological significance.

As a result, biotechnology in the European Union accounts for a patent portfolio close to the global average, while in other leading regions it accounts for a significantly larger share of total patent activity. At the same time, patent activity in the EU remains highly concentrated geographically in a few Member States, primarily Germany and France. This means that the potential of the single market as a development space is not being fully exploited.

In this context, the Biotech Act addresses the clearly defined gap between potential and utilization. It does this by introducing uniform definitions and procedures, reducing the need to navigate separate national systems. This eliminates the need for projects to undergo separate, uncoordinated administrative processes, and the time required to obtain key approvals is shortened. At the same time, the act facilitates access to financing and regulatory support, especially for SMEs, reducing the risks and costs of market entry. The Biotech Act aims to foster better links between the European research base and the market, strengthen commercialisation capacity and enable companies to develop within the single market rather than seeking more favourable conditions outside Europe.

All data used in this document come from: Grassano, N., Napolitano, L., M’barek, R., Rodriguez Cerezo, E., Lasarte Lopez, J., Exploring the global landscape of biotech innovation: preliminary insights from patent analysis, Joint Research Centre, European Commission , Luxembourg , Publications Office of the European Union, 2024.

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The European Union has launched a comprehensive regulatory framework for biotechnology and support for businesses in this field. It is estimated that approximately 80 percent of active pharmaceutical ingredients are imported, particularly from countries such as China and India. The European economy cannot afford this current state of affairs if it is to remain competitive, stable, and attractive to investors. For this reason, the so-called Biotech Act, which is intended to regulate the field and industry of biotechnology, as well as research conducted on it, in such a way as to solve the current problems occurring therein.

First of all, it should be pointed out that the legislative form in which Biotech Act is to be issued is planned as a regulation, which will not need to be adopted by individual member state parliaments, but will apply directly after an appropriate transition period (if one is provided). Currently, the new normative act is scheduled for adoption in the second quarter of 2026, so changes will be implemented quickly, according to these assumptions.

The definition of biotechnology that is to apply within the scope of this regulation is to cover all its zones, i.e. white biotechnology – industrial, green-food (agri-food), red – medical and therapeutic, blue – marine, and therefore it will cover this discipline in its entirety without exceptions.

Although the EU points out that in 2022 alone, as a side effect of the creation of new biotechnology-related jobs, another 650,000 new jobs were created, it recognizes certain current and serious problems with the competitiveness of its economy. The main current challenges that comprehensive regulation aims to address include the inability to utilize a very good and qualified research base for development. Due to the complex procedures for awarding research grants to scientists working on the development of this discipline and for obtaining financial support by micro, small, and medium-sized enterprises, there is a very high tendency to emigrate abroad to countries where these procedures are easier to complete. Regarding the lack of investment support, data has emerged indicating that in the US, 52% of investments go to biotech industry, while in the European Union only 2%. Another problem is the certain state of “regulation dispersion” in this field, meaning the lack of a single normative act that regulates every procedural issue that may arise in the field of biotechnology. Biotech Act aims to address this very obstacle. One of the last problems mentioned by the European Commission is the lack of realization of the potential of artificial intelligence (AI/ML)-based models in the biotechnology industry. Furthermore, Biotech Act is expected to significantly impact the operation of the food industry and the use of biotechnology in food processing and treatment, including the field of novel food. It will simplify the procedure for introducing new food products to the market for the first time, the financing procedure, and access to investment support for startups, as well as introduce new compliance requirements for the creation of food and other products.

The European Union emphasizes that bioproduction and biotechnology are pillars of the competitiveness and strength of its economy, and even a kind of pillar.

The regulation in question will contain general provisions containing definitions for the application of the Act and will also outline a specific objective for implementing the measures provided for therein. The inclusion of such provisions (especially in the recitals) will likely facilitate the interpretation of the regulation’s specific provisions. The draft addresses several key issues: improving the functioning of the internal market by creating a foundation for increasing the competitiveness of the economy in the field of biotechnology, enabling more effective and rapid implementation of research in this field in production and marketing, and tempering this desire and goal with appropriate requirements regarding professional ethics, the protection of human and animal life and health, morality, and high standards of good industrial practice. The general objectives also address the introduction of innovations into the internal market, new biomedical engineering and biotechnology products, the use of new technologies in industry to improve it, and the use of its products in the daily lives of EU citizens.

The organizational plans also include the creation of a special commission composed of members of member state governments. Its task will be to act as an intermediary between EU bodies and biotechnology stakeholders (both scientific and business), ensuring the effective implementation of new ideas and research as quickly and efficiently as possible. This is intended to increase pro-competitive activity and thus lead to faster development of the internal market. A support network for smaller entrepreneurs, start-ups, and researchers, as well as a procedure for obtaining support, are also planned.

According to the project’s assumptions, a special investment program will also be introduced in cooperation with the European Investment Bank Group and other partners. Entities operating in regulated sectors will be able to receive funding for their operations in accordance with the regulations on financial support and assistance.

In addition, an extension of the SPC (Supplementary Protection Certificate) for 12 months covering medical products and those created using biotechnology, as well as Advanced Therapy Medical Products are planned. This is intended to support the continued support for patients provided by these products and the activities of companies involved in their production.

The project includes a strategy for implementing artificial intelligence policy in the biotechnology industry, in line with the recommendations of the European Medicines Agency. Other provisions that contribute to the overall biotechnology regulatory landscape include the implementation of Directive 2001/83/EC on interactions and combinations between medicinal products and medical devices and on regulatory sandboxes, and the creation of an EU regulatory sandbox for early-stage health biotechnology products that fall outside the existing health regulatory framework.

At the very end of the proposed Biotech Act regulation are provisions to prevent the misuse of biotechnology products. They provide mechanisms for monitoring, reporting, and tracking suspicious transactions related to biotechnology products that raise concerns, as well as enforcement mechanisms to ensure legal compliance with EU regulations.

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