Belgium's biotech industry is well-established. The country has long supported advancements in life sciences and biotechnology. In the 1970s, Belgian scientists Jozef Schell and Marc Van Montagu developed the world's first genetically modified plant at a university in Ghent.

Fast forward to the present, and biotech in Belgium is a thriving industry at the forefront of innovation in life sciences, pharmaceuticals, medtech, healthcare, and more. According to the federal government, 7% of Europe's biotech companies are based in Belgium. They account for 16% of the continent's entire turnover and almost 10% of its R&D expenditure.

With robust research and development clusters and strong cross-sector collaboration, Belgium's diverse life sciences ecosystem continues to attract foreign investment. Startups, local firms, and multinational enterprises play an integral part in the sector, too.

Underpinned by a supportive government and a finance-friendly landscape, Belgium's biotechnology industry encompasses the entire value chain—from research, discovery, and development to production, commercialization, and global distribution.

The Belgian Federation for Life Sciences and Biotechnology says that sector-specific exports doubled in the last decade alone, reaching more than €83 billion in 2021. During the same period, R&D spending increased by 166%, and the number of workers in the industry rose by 41%.

Despite the unprecedented events of the pandemic, Belgium quickly established itself as a global leader in the development, production, and distribution of coronavirus treatments and vaccines. It's home to some of the biggest pharmaceutical giants, including Pfizer, Janssen Pharmaceutica, GSK, and Plasma Industries.

These factors, together with Belgium's strategic location, above-average patent approval rate, and attractive tax benefits, make the country a biotech hotspot.

But is the market oversaturated?  Are investment opportunities dwindling? Or is Belgium's biotech industry booming amid post-pandemic challenges, ambitious sustainable development goals, and long-winded EU regulations?

Let's find out.

EU Biotech at a Glance

Biotechnology doesn't exist in a vacuum. Rather, it's relied upon across various sectors, including healthcare, pharmaceuticals, chemicals, textiles, and agriculture. It speeds up modernization while supporting public health, sustainable development, and environmental protection—three pillars of modern society.

According to the European Commission (EC), biotechnology contributes to the European Union economy with main applications in:

  • Healthcare, pharmaceuticals, biopharmaceuticals
  • Industrial processes and manufacturing
  • Agriculture, aquaculture, livestock, and veterinary products

The EU has implemented strategies, policies, and regulations to address many of these sector-specific differentiations. Still, the multifaceted nature of the biotech industry presents certain obstacles—particularly for foreign investors and multinational enterprises.

The European market is complex, fragmented, and underscored by an elaborate policy framework, resulting in a challenging environment for biotech and pharma companies.

Europe's biotech market comprises 31 markets (including Switzerland and the UK). Each has its own healthcare system, health tech assessments (HTA), legal framework, and market-specific reimbursement processes.

For instance, the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) are tasked with approving biopharma products. But some countries also require approval at the federal and regional levels.

Meanwhile, the European Food Safety Authority (EFSA) and the European Commission are jointly responsible for approving genetically engineered (GE) products.

Recent updates to EU regulations (such as the new Medical Device/IVD Regulation and the Clinical Trial Regulation) and the potential impact of cross-border collaborations on market access are also contributing factors.

Biotech and Biopharmaceuticals in the EU

Despite these obstacles, Europe's market is too significant to ignore. According to The Economic Intelligence Unit, the continent has a 20% share of the worldwide pharmaceutical market.

As such, Europe is simply the next logical step for non-EU biopharma companies looking to go global. The reasons are many but include the continent's:

  • Overall commercial potential
  • Robust R&D and innovation hotspots
  • Industry expertise
  • Highly-qualified talent pool
  • Strong focus on advanced therapy medicinal products (ATMPs)

In a 2022 Deloitte Insights Report, analysts found that emerging biotechs made up the majority of companies seeking new drug approvals from the European Medicines Agency (EMA) in the past six years. Other findings show that:

  • 55% of all products developed by emerging biotechs are orphan drugs (compared to mature biopharma companies' 29% share).
  • Emerging biotechs gaining EMA approval focussed on oncology, hematology, metabolic, and neurology therapeutic areas, respectively.
  • The majority of emerging biotechs entering Europe's market during the period under review opted for a "go alone" global expansion strategy.
  • A partnership model was the least popular, while "post-EMA approval acquisition" and "pending launch" strategies shared equal popularity among the emerging biotechs analyzed by Deloitte.

Deloitte also found that the average-dollar market capitalization for biotechs with go-alone or acquisition models was much higher compared to partnering biotechs ($4.2 billion vs. $1.8 billion).

These numbers suggest that companies in the latter are smaller with fewer finance options. In contrast, the "go-alone" model offers better commercial opportunities, and remains the preferred global expansion option for emerging biotechs.

Deloitte's 2021 R&D ROI Report on its cohort of 15 leading biopharma companies showed:

  • The average internal rate of return (IRR) is at its highest since 2014
  • A large uptick in R&D returns
  • Costs to launch declined in the past three years
  • Peak sales projections increased

While Covid-19 certainly boosted IRR and R&D returns, an uptick was still reflected in 2021, says Deloitte. The pandemic accelerated clinical cycle times but also accentuated the importance of optimizing processes, adopting digital solutions, and practicing collaborative data sharing.

Agricultural Biotech in the EU

The EU's approval process for genetically engineered (GE) products is also lengthy and convoluted, something the US Department of Agriculture USDA) noted in its 2021 Attaché Report. It cites fear-mongering and unfavorable political and regulatory environments as barriers to plant biotech commercialization (at least in the short term).

While Europe contributes significantly to plant biotechnology research, interest in developing cultivation-suitable GE plants has waned. Genetic engineering is an unattractive investment due to the uncertainty of  EU approval processes and continued vandalism by activists.

This, despite the fact that the EU imports the majority of its genetically-engineered feed and produces very few of its own GE crops.

As a result, EU companies in plant biotech are looking elsewhere, focusing on non-EU markets and moving operations outside of Europe. Major European companies like KWS, Bayer, and BASF have already relocated their research sites to the US. The USDA says research and development of innovative biotechnologies is in danger of heading the same way.

The landscape is changing, though, thanks to perceptions around newer techniques like genome editing. In 2018, the European Court of Justice (ECJ) ruled that newer genetic technologies (like genome editing) and the resulting organisms are subject to the same laws, processes, and regulations governing genetically modified organisms (GMOs).

The ECJ ruled further that EU Member States have the authority to regulate organisms that are exempt from the GMO Directive and produced by conventional chemical and radiation mutagenesis. Overarching EU laws still apply, though.

In its April 2021 Study on the Status of New Genomic Techniques Under Union Law and in Light of the Court of Justice Ruling in Case C-528/16, the EC states that these newer techniques can contribute to the EU's Green Deal goals, including its Farm to Fork Biodiversity Strategy. The report also says the EU's current GMO Directive isn't "fit for purpose," and a new draft policy is expected by 2023.

Noteworthy EU regulations, policies, and directives affecting the biotech industry include:

  • EU Biotech Regulations which govern various biotech aspects like the contained use, release, transport, and commercialization of GMOs, medicinal products and health care, and intellectual property.
  • The Bioeconomy Strategy which focuses on shifting the economy towards more sustainable use of renewable resources and the development of competitive bioeconomy sectors like the bio-based products sector and biorefineries.
  • Farm to Fork (F2F) Strategy which aims to enhance sustainable, climate-friendly, profitable, and affordable food production under the EU Green Deal using new innovative techniques, including biotech.

EuropaBio says that biotech-enabled solutions can contribute significantly to sustainable agriculture and biodiversity but that a proportionate and innovation-friendly regulatory framework is needed. The same rings true for biotech in the biopharmaceutical sphere.

Belgium's Biotech Landscape

In its June 2022 Economic Survey of Belgium, the OECD cited labor shortages, rising inflation, and supply bottlenecks due to Russia's invasion of Ukraine as factors hampering Belgium's post-pandemic recovery. The pace of recovery is projected to slow to 2.4% in 2022 and 1% in 2023, with core inflation estimated at 5% through 2023 before easing.

Biotech is Booming...

Against this backdrop, Belgium's biotech industry is doing exceptionally well. The country has garnered international interest since the pandemic, establishing itself as a key player in developing, producing, and distributing coronavirus treatments and vaccines.

According to the USDA, around 80% of Belgium's biotech activity focuses on the health sector ("red biotech"), 15% on industrial purposes ("white biotech"), and 5% is dedicated to agriculture ("green biotech").

In 2021, nearly 40,000 people were employed in the biotech and biopharma sectors—1,500 more than in 2020. That's a total of 10,000 employees in ten years. Sector exports increased by 50% while R&D spending more than doubled, amounting to €5.1 billion in 2021. The latest data indicates a positive upward trend for value added, reaching €11.6 billion in 2020.

...But Challenges Persist

According to the Belgian Federation for Life Sciences and Biotechnology (bio.be/essenscia), the life sciences sector can't afford to be stagnant. Many challenges exist, which must be addressed if Belgium wants to remain a biotech leader.

Bio.be/essenscia says that Belgium's industrial production capacity must improve to accommodate the production of biopharma and biotech innovations. By strengthening local capabilities, job creation is imminent.

But to attract foreign investment, the federation says a targeted innovation policy, strategic global positioning, and more STEM talent with digital skills are required. Belgian companies are already turning to digitalization to remain competitive. Machine learning, AI, and digital twins are becoming synonymous with biotech.

And Belgium is Facing Them Head On...

The pandemic exposed numerous weak points in EU and national policy frameworks related to the life sciences sector. It's clear that more resiliency is needed, and the implementation of various regulations to that effect are underway.

The EU introduced the Pharmaceutical Strategy for Europe in 2020, which aims to ensure a robust, competitive, and fair life sciences industry that delivers healthcare products timeously, even during a crisis. Belgian policymakers echo these sentiments, having launched various regulatory initiatives to:

  • Optimize procedures for accelerated access to innovative therapies
  • Accelerate access to Advanced Therapeutic Medicinal Products (ATMPs)
  • Integrate telemedicine into Belgium's healthcare system

In 2021, the EU Regulation 2017/745 on medical devices came into effect. It seeks to reinforce pre-market product control and post-market monitoring, combat counterfeiting, and facilitate the recall of defective devices.

Belgium already participates in the approval processes at the EU level. The country is also preparing the legislative framework for implementation of EU Regulation 2017/746 on in vitro diagnostic medical devices (IVD), effective from May 2022.

The EU's Clinical Trials Regulation (CTR) 536/2014 also came into effect in 2022, aiming to create a transparent and workable regulatory framework. As such, Belgian policymakers introduced a three-year transition period (ending 31 January 2025), where old and new legislation on clinical trials will coexist to facilitate a smooth transition. A national Clinical Trial Information System (CTIS) platform is also in development.

...With Actions and Initiatives

The Belgian government signed a joint charter with various academic and industrial stakeholders to reinforce and strengthen Belgium's position in the biopharmaceutical sector and R&D production. As part of this Health and Biotech Valley of Tomorrow initiative, five key investment areas were identified:

  • Health data sharing
  • Human capital
  • Regional and cross-border collaboration
  • Biopharma value chain
  • Digital therapeutics

A new strategic plan will be implemented on the basis of these factors.

The Belgian Federation for Life Sciences and Biotechnology is also contributing to the creation of the EU Biotech Campus, a world-class training center for local and global talent that should be operational by 2025. The global flagship project has four primary pillars:

  • STEM: Informing students and job seekers about opportunities in the biotech and biopharma sector while educating business leaders on new emerging therapies.
  • Biomanufacturing: Closing the knowledge gap with training on new therapeutic advancements and the digitization and automation of production processes.
  • Digitalization and data management: Providing training to close the skills gap, enhance digital transformation, and optimize innovation processes with efficient data management.
  • Mini MBA and soft skills: Assisting biotech and life sciences startups to acquire sector-specific business management skills.

The campus serves as a business accelerator, complementary to Wallonia's aptaskil Competence Centre and Flanders' life sciences training center, VITalent. Major biopharma company, Janssen Pharmaceutica, is also set to construct its first European cell therapy production center at Tech Lane Ghent Science Park.

Belgium's economic recovery set out in its National Resilience and Recovery Plan provides a unique opportunity for the country to become the European biotech equivalent of Silicon Valley.

With an evidence-based policy (EPB) approach, Belgium has implemented additional initiatives to tackle regulatory issues slowing down the life sciences value chain. For instance, the "#dataforbetterhealth" initiative seeks to address existing barriers to policymaking and establish a central database.

These efforts haven't gone unnoticed. In 2021, the European Investment Bank Group provided a record-breaking €3.42 billion in financing to Belgium. €300 million was also reserved for Europe's life science, biotech, and medtech companies, €100 million (one-hird) of which went to Belgian firms.

As of March 2022, Belgian biotechs had a total market value of €42.1 billion—the third highest in Europe.

"Belgium is the gateway to the [biotech] sector in Europe, let's not underestimate that."

—Tineke van Hooland, Deputy Secretary General of bio.be/essenscia.

Biotech in Belgium's Regions

Belgium's biotech ecosystem comprises leading institutions in all domains of biotechnology innovation. With an array of internationally acclaimed universities and research centers, top pharma companies, and a dynamic SME sector, the country remains an incubator for groundbreaking biotech advancements.

Cross-collaboration among federal and regional authorities, public and private institutions, and mega corporations and startups further strengthen the industry. Entrepreneurs have various R&D finance options, and the government approves first-in-human clinical trials in up to 20 days. Numerous federal and regional R&D and innovation tax incentives also exist, attracting foreign investors, startups, and scaleups from across the globe.

Working with government authorities, an increasing number of biotech firms are supporting startups with infrastructure, expertise, and even funding. Innovation clusters exist in each region, comprising universities, companies, and organizations.

Biotech in Flanders

Flanders is home to over 300 life sciences companies—from multinationals and private SMEs to fast-growing startups. It has a sterling reputation for biotech research, discoveries, and innovations, with significant breakthroughs made in botany and genetics.

Boasting eight research centers in five Flemish universities, the Flanders Institute of Biotechnology (VIB) is the main driver of life sciences research, along with the independent cluster, Flanders.bio. Primary research areas include:

  • Immunity and inflammation
  • Medical biotechnology
  • Cancer
  • Microbiology
  • Plant biology
  • Neuroscience
  • Computational biology
  • Structural biology

Biotech in Brussels

Biotech in the Brussels-Capital region is vibrant with a supportive ecosystem of specialist incubators, top-notch research centers, and a favorable government. According to why.brussels, the region has the highest rate of clinical trial authorizations in the EU.

 

Brussels is home to pharma giant Pfizer's global phase I clinical trial unit. Various international CTs and 19% of the world's oncological CTs are also conducted in the region. Brussels' main areas of expertise include:

  • Digital or e-health
  • Medical technologies
  • Clinical trials

Biotech in Wallonia

The Walloon region is known for its prominent export industry. Biotech (chemical and pharmaceuticals) products make up Wallonia's most exports at 35%.

The region is home to numerous multinationals, including Johnson & Johnson, Zoetis, GSK, and Takeda. They act as engines for startups and SMEs while creating sustained relationships with clusters and other global players.

Wallonia's Export and Investment Agency and health cluster, BioWin work together to support biotech companies in everything from scaling up and talent development to collaborative R&I projects. The region's primary life sciences sectors include:

  • Biopharmaceuticals and biomedicines
  • Digital health
  • Biomanufacturing
  • Medical technology

Belgium Means Business

Europe's biotech sector is marred by fragmented markets, an intricate EU policy framework, and drawn-out approval processes. As such, certain biotech investment areas (like genetic engineering) have become unattractive. But despite these issues, the EU biotech market is still a hotspot for global players.

The same can be said for Belgium. Biotech continues to thrive in the face of labor shortages, slowed post-pandemic recovery, the Russia-Ukraine conflict, and rising inflationary pressures.

Public and private stakeholders are making concerted efforts to address these and other issues. With investments, collaborative projects, and new initiatives, they aim to strengthen Belgium's position as the Health and Biotech Valley of Tomorrow.

At the regional level, Belgium's biotech clusters provide a dynamic ecosystem connecting academic research, industry leaders, startups, SMEs, and public authorities. Add to that funding opportunities, innovation grants, and attractive R&D tax incentives, and it seals the deal for biotechs looking to enter the European market.

Biotech startups, companies, and investors must navigate the EU's tricky policy framework, satisfy Belgian law and processes, and enter the market diligently for success. That's why it helps to have a network of professionals on your side. You can learn more here.

Sources: EIU, Deloitte, USDA, European Commission, EuropaBio, OECD, Belgian Federation for Life Sciences and Biotechnology, EUR-LEX, Premier.be, EU Biotech Campus, European Investment Bank Group, Flanders.bio,  Flanders Institute of Biotechnology, Why.brussels, Wallonia's Export and Investment Agency, BioWin

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