Not only can Denmark lay claim to some major life science inventions – from the design of the world’s first ever insulin pen and disposable ostomy pouch to breakthroughs in fundamental discovery such as the development of the Gram Stain as an essential methodology for classifying bacteria – but it also ranks as one of the most R&D-intensive countries on the planet courtesy of its more than a century and a half year old agricultural heritage.
Indeed, last year, locally operative pharma and medtech firms expended over DKK 16 billion on research and development, equating to approximately one third of the Danish business community’s entire R&D investments. Meanwhile, the country placed number two within Europe, second only to Switzerland, for the volume of scientific publications registered per 1000 inhabitants of the population.
It should therefore come as little surprise that Denmark has long been regarded as a hospitable home for drug development and medical device companies’ scientific operations. Reproductive medicine and women’s health speciality firm, Ferring serves as a case in point. “We selected Denmark as the most appropriate site for our International PharmaScience Centre, our largest global R&D hub, covering the entire value chain: from early discovery and pre-clinical development to late-stage clinical trials, regulatory lifecycle management, and post-patent follow-up,” recounts the Swiss company’s General Manager for the Nordic, Maja Lassenius Kramp. “This is because we felt that the Demark offers a uniquely fertile ecosystem for innovation, supported by world-class academic institutions, strong public-private partnerships, and a deeply collaborative mindset that drives progress.”
“When paired with the country’s strong academic institutions, thriving biotech community, and advanced digital infrastructure, it allows us to conduct research that is both scientifically rigorous and socially relevant,” she elaborates.
Meanwhile, much the same calculus has been made by homegrown innovators as well. “From our origins as the inventor of the world’s first self-inflating resuscitator bag in 1956 to becoming a global leader in single-use endoscopy, we have always anchored the majority of our R&D activity within our home market of Denmark, where we interact closely with academic partners and hospitals to advance our pipeline,” confides Britt Meelby Jensen, CEO of the iconic Danish medical device developer, Ambu. “We find the country’s highly educated workforce, leading universities, and close-knit collaboration between public and private institutions to be vitally important to the performance of our business,” she adds.
Clinical Trials Powerhouse
One area where the country has undoubtedly managed to cultivate something of a competitive advantage is as a preferred clinical trials destination with Denmark more often than not boasting the highest volume of trials per million residents in the entirety of the European Union.
“Thanks to long-standing efforts on the part of the government to enhance the regulatory framework and a rather unique healthcare infrastructure and contextual setting Denmark’s clinical research capabilities prove highly appealing to foreign investors, and the majority of growth in this area is indeed driven by foreign firms,” observes Vanessa Vega Saenz, Director of Invest in Denmark.
“For instance, the fact that elevated levels of public trust result in a strong willingness among Danish citizens to participate in trials serves as an important differentiating factor that is highly appreciated abroad where it can often prove challenging to recruit the desired number of patients,” she continues
Certainly, international interest in locally hosted studies shows little sign of abating even in an era of next generation biologics and advanced therapeutic products (ATPs) that are less well suited to traditional clinical trial sequences. “With around 80 trials currently active or launching in Denmark, we are the presently ranked the most engaged sponsor in the country and, while trial activity across the continent has undergone something of a decline, this is one of the countries where we are actually looking to buck the trend and further expand our study presence,” concedes Christof Bischoff, Country Director at AstraZeneca.
Boehringer Ingelheim too has been ramping up its in-country clinical trial footprint. “Our activity has intensified from 19 studies back in 2021 to over 33 active trials today. These span all our core therapeutic areas of cardio-renal-metabolic (CRM) diseases and interstitial lung disease (ILD), cancer, and ophthalmology and we expect to initiate more than 10 new Phase II and III studies in the next 12 to 18 months demonstrating the sheer depth of our engagement and the scale of our ambition,” confides Steve Wright, the company’s General Manager and Head of Human Pharma for Denmark and Norway.
Sustaining Competitiveness
In its bid to preserve Denmark’s allure as a top clinical trials destination, the Danish government has been constantly on the lookout for ways to further fine tune the country’s offering. “There is a strong political consensus in Denmark around the value of locally conducted clinical research, and this has resulted in important initiatives like the formation of Trial Nation, a public-private partnership which acts as a streamlined, single point of entry for clinical trials nationwide,” observes Bischoff.
“Our mission is essentially to increase in-country investments into the clinical trials space by acting as a one-stop shop for companies and researchers looking to identify suitable sites and patients. Acting as a neutral facilitator and representing the full spectrum of stakeholders — from hospital owners, government ministries, and patient organisations, to clinicians and industry — we facilitate access to a nationally coordinated clinical trial infrastructure. Moreover, we proactively try to enhance operational framework conditions and remove any bumps on the road that might hinder trial execution,” explains Marianne Pilgaard, Trial Nation’s CEO.
The benefits of having such levels of coordination in place have certainly not been lost on some multinational drug developers. “The combination of a collaborative ecosystem and a high degree of centralization and uniformity delivers distinct advantages. “For example, when we launched our most recent innovation, a treatment for metastatic urothelial carcinoma, we were able to involve all the relevant hospitals nationwide in the clinical trial. Achieving this kind of coordinated participation across an entire country is rare and something we very much appreciate,” points out Montse Jansà, Managing Director of Merck’s local affiliate.
Meanwhile Trial Nation’s contribution includes initiatives to ensure that Demark remains ahead of the game when it comes to new trial formats. “Since 2022, we have been at the forefront of a major project focused on decentralised clinical trials. This model brings some or all aspects of a trial closer to the patient. Whether that means data collection, treatment, or communication, the goal is to make the entire process more accessible and patient centred,” mentions Pilgaard.
A raft of fresh tax breaks are also soon to be introduced with the Danish government promising to increase the cap on tax credits for R&D expenditure from DKK 25 million to DKK 35 million, thus allowing life science companies to claim the tax value of losses arising from R&D expenditures of up to DKK 35 million annually.
Some aspects still remain a work in progress however. “There is general recognition that ethics committees have become something of a bottleneck due to capacity constraints and, as they are the entry point for most clinical research in Denmark, can sometimes lead to unnecessary delays,” recounts Ida Sofie Jensen CEO, The Danish Association of the Pharmaceutical Industry (Lif), though she points out that the recently unveiled Life Science Strategy 2030 contains provisions to resolve this.
“By advancing AI integration, risk-based assessments, and cross-border harmonisation, we are working towards redefining ethical oversight. We are well aware that the existing one-size-fits-all methodology represents an inefficient allocation of resources, consuming valuable time on routine compliance reviews rather than focusing on substantive ethical considerations,” admits Helle Harder, Head of the Science & Ethics Division at the Danish National Centre for Ethics.
“Adopting a differentiated, risk-based approach will eliminate the current disconnect where experienced sponsors question extensive reviews for routine applications they have successfully completed multiple times previously. Simple applications following established precedents would receive expedited processing, whilst novel, complex, or controversial protocols would undergo comprehensive review. And for multinational trials, it will enable us to guarantee a maximum fourteen-day processing time,” she anticipates.
Medtech Innovation
One noticeable shortcoming with the Danish framework relates to clinical studies of medical technologies, however. “Clinical trials involving both medicinal products and medical devices often sit at the intersection of different regulations, creating uncertainty and, at times, contradictory guidance for researchers so this aspect still needs to be addressed,” concedes Nils Falk Bjerregaard, Director General of the Danish Medicines Agency (DKMA).
“Moreover, the current version of the Medical Device Regulation presents real challenges particularly for small and mid-size medtech companies because there is a mismatch between their developmental stage and the heavy administrative burden imposed by regulation,” points out Trial Nation’s Marianne Pilgaard.
“The regulatory fees required place a disproportionate burden on smaller players, even though larger pharmaceutical companies may absorb these costs with relative ease,” laments Mads Koch Hansen, Director of Medicoindustrien, the Danish association for med device developers, though he remains optimistic that the issue will be revisited as part of the new life science strategy, which explicitly recognises the medtech and healthtech segments as strategically vital components of the life science value chain.
“Medtech is Denmark is largely built around small and medium-sized enterprises, while pharma, by contrast, tends to be dominated by major multinationals, often through consolidation. And while medtech trials are typically smaller in scale than pharmaceutical ones – owing to the nature of the technologies involved and the size of the companies – this does not diminish their clinical relevance. Devices often require surgical intervention or are implanted directly into the body, making large-scale studies impractical, yet the impact of the results is equally significant,” opines Hansen.
RWE Generation
Denmark’s distinctive appeal, meanwhile, stretches beyond the formal clinical trials process and also encompasses the gathering of real-world evidence, a characteristic that augers well in an age when complex cell and gene therapies are increasingly the next frontier of medical science.
“Denmark enjoys of some of the best health data in the world thanks to the CPR system: a lifelong personal registry that links extensive healthcare records with disease-specific registries and more than 500 biobanks, alongside a tradition of registering the entire population from embryo to grave,” explains Vanessa Saenz.
“The country’s digital infrastructure, national registries, and access to high-quality data are incredibly advanced and go a long way towards facilitating epidemiological and pharmaceutical research which is extremely useful as we view real-world evidence as an increasingly important component of modern healthcare,” agrees Merck’s Montse Jansà.
“While clinical trials might provide rigorously controlled insights, they’re often limited in scope. Real-world data, on the other hand, captures outcomes across large, diverse patient groups, giving us a much clearer picture of how treatments perform in everyday practice. This not only boosts clinical confidence but also informs new indications and supports broader, evidence-based decision-making,” she reasons.
Søren Granhøj Pedersen, Managing Director of MSD for Denmark and Iceland, very much concurs. “The country’s infrastructure for data collection is both sophisticated and reliable. Institutions including comprehensive patient registries and advanced biobanks enable the generation of meaningful real-world evidence at unprecedented scale. All together, these factors make Denmark not only an attractive site for conventional clinical trials, but also a strategic investment location and partner for long-term scientific collaboration,” he concludes.
