Despite its diminutive size, Denmark boasts a world-renowned healthcare and life science industry containing both household pharma giants as well as a robust network of academia, a host of niche service providers, and a growing throng of biotech start-ups. And with life science exports surpassing EUR 23 billion last year and surging at a rate of 8% per annum, the tiny Nordic nation continues to consolidate its position a popular destination for foreign direct investment.
“Life sciences represents by far and away one of Denmark’s most dynamic and productive sectors. From a macroeconomic standpoint, it generates more turnover annually than any other sector in the country, outpacing other industries not just in growth but also value-add and productivity per employee, and enticing in FDI of over 17.8 billion DKK each year,” observes Vanessa Vega Saenz, Director of Invest in Denmark.
And, with the domestic pharma market is currently valued at around USD 4 billion and registering a solidly reliable, albeit unspectacular CAGR of 3.3% driven by an increase in chronic illness and corresponding rise in prescription drug sales, Denmark offers not insignificant opportunities in the retail space as well.
What originator drug developers especially appreciate, meanwhile, is the country’s longstanding receptiveness to innovative medicine and willingness on the part of the authorities to often go the extra mile in facilitating patient access to next generation, breakthrough therapies.
“In general, Denmark offers a remarkably well-structured environment for life science innovation, where access to novel therapies is not only prioritised by government but supported by a national agenda that is at once both strategic and inclusive,” opines Steve Wright, General Manager and Head of Human Pharma for Denmark & Norway at Boehringer Ingelheim. “Among the more recent developments, has been the introduction of chronic care packages: a highly promising initiative that looks set to do much to strengthen long-term patient access,” he adds.
Ida Sofie Jensen, CEO of Lif, the national association for R&D-driven drug developers acknowledges that Denmark’s policy makers properly understand the value of promoting innovation in medical science and tend to be highly receptive to schemes and proposals that might further support the industry. “The incumbent administration has even committed to establishing a Healthcare Innovation Index that should provide an overview of which new treatment types and technologies are actually being accessed in the system. The goal being to precisely track invention, access, and the speed at which new medicines are adopted, with a view to ensuring continual progress,” she reveals.
Value-Based Access
That’s not to imply, however, that there isn’t still ample scope for further improvements. “Although the policy environment signals a very strong positive intent, sometimes the execution falls short and the political goodwill is not always reflected in the actual speedy uptake of new medicines,” notes Christof Bischoff, Country Director at AstraZeneca Denmark who points out that, on certain counts, the country’s performance according to EFPIA’s Waiting to Access Innovative Therapies (W.A.I.T.) indicator even registers a slight decline in recent years. “This is certainly no time for complacency because, when a market leads in clinical research but starts to lag in access, it can quickly find itself in a spiral of losing momentum,” he warns.
The main bone of contention appears to relate to the conditional nature of access for some of the most advanced and cutting-edge therapies whereby reimbursement is currently limited to specific schemes or patient cohorts rather than being universal and unconditional.
“Although we are often held up as poster child for being a country with strong, well-financed, and effective public health infrastructure, our resources, like those of any system, are of course finite,” reminds Birgitte Klindt Poulsen, Chairman of the Danish Medicines Council. “We must therefore take seriously our responsibility to guide resource allocation in a way that delivers the greatest value across disease areas and care levels.”
“As a Council, we consider ourselves not merely as assessors of medicines, but as contributors to a more equitable and sustainable model of healthcare delivery, one that serves patients both efficiently and fairly. And while speed is important, decisions must always remain firmly grounded in a thorough assessment of efficacy, safety, and cost-effectiveness,” she affirms.
For this reason, an intricate and finely balanced apparatus has been established to ensure value-based access to innovation. “Collaboration plays a critical role in determining how new products should be integrated into treatment guidelines. Unlike in many other markets, over here we possess a structured, national process whereby a centralized Hospital Purchasing Agency, Amgros, handles the price negotiations for new products, while the Danish Medicines Council assesses their clinical value and decides on their place in treatment paradigms. The Council additionally develops national treatment guidelines, drawing heavily upon the expertise and recommendations of the top physicians in the country,” explains Flemming Sonne, CEO of Amgros.
Moreover, this approach covers the full lifecycle of a product, from innovation and new market entries to mature brands and generic medicines. “What makes the Danish model so very unique is the national alignment. We have a single, streamlined framework where clinical, economic, and procurement perspectives blend together seamlessly,” he elaborates.
Creative Market Access Agreements
As with in many equivalent markets, the thorny issue that the Danish regulatory system is grappling with is that the advent of advanced biologics, cell and gene therapies, and increasingly personalized medicine will require wholesale reconfiguration of an infrastructure simply not yet set-up for the easy uptake of novel therapies as treatment guidelines.
“Advanced therapies pose fresh challenges for traditional decision-making structures. The Danish Medicines Council, which is approaching its tenth anniversary, has built a strong and highly respected health technology assessment (HTA) framework grounded in classical clinical research which utilizes randomised, double-blinded studies, and robust data. However, ATMPs often come with single-arm studies and far less documentation so new out-of-the-box solutions will necessarily need to be found,” believes Ida Sofie Jensen.
“What worked well in the past is no longer always fit for purpose in the current and future context. When it comes to integrating the next generation of modern medicines, we are evidently going to need a bit of a rethink. It’s imperative to identify creative ways to deregulate the process intelligently in a manner that continues to protect and safeguard patients, but also facilitates speedy access,” agrees, Jakob Nielsen, CEO of Healthcare Denmark.
“While we strive to evaluate advanced therapy medicinal products (ATMPs) under the same rigorous process as any other medicine approved for the Danish market, their complexity often calls for additional consideration. These therapies are typically introduced with limited clinical data, short follow-up periods, and high price tags, factors that make independent evaluation both more difficult and more important,” maintains Poulsen.
“To navigate these challenges, we are working closely with partners such as Amgros and the drugmakers to develop market entry agreements and explore alternative pricing models, particularly those involving risk sharing. This approach allows us to manage uncertainty, financially and clinically, by ensuring that costs are aligned with actual outcomes and that patients are not exposed to undue risk when evidence is still emerging,” she confirms.
“When it comes to ATMPs, they’re often seen as wonder drugs, and in many ways they actually are, particularly for rare diseases. However, a common challenge we encounter is the lack of sufficient data at the time of market entry. We simply don’t know enough about their real-world effectiveness or long-term outcomes. So, while millions are spent on these new therapies, we have to consider whether we’re doing enough to follow up effectively and verify how patients are actually doing months or years later,” reflects Sonne.
Amgros too has been taking definite steps to explore and encourage alternative access models. “We’ve already established several special agreements with industry actors. Companies can submit applications to propose alternative contract models which might include subscription-based payments, agreements linked to treatment effectiveness, or other arrangements tailored to specific therapeutic areas. One of the most important principles for us is ensuring some level of insurance or protection around the clinical effect of a product. For example, if a gene therapy doesn’t deliver long-term results after several years, someone has to take accountability for bearing that cost when the initial data has been weak, the price tag high, and the long-term efficacy unclear,” he affirms.
“In Denmark, at least, you always get a strong sense that there is a solution to be found,” contemplates Steve Wright. “One of the standout features is the sheer openness of its regulatory institutions to engage in proactive and transparent dialogue, and the readiness to be constructive in identifying win-win solutions that benefit all sides,” he insists.
Generics-Friendly
Denmark’s framework conditions for generics and biosimilars are also exceptionally strong. “We are fortunate to enjoy a system that ensures generics are accessible from day one after patent expiry at both hospitals and community pharmacies. We estimate that approximately 75% of daily doses by volume dispensed through pharmacies are generics, while over half of all daily doses administered within hospitals constitute either generics or biosimilars,” observes Peter Jorgensen, Director of the Danish Generic and Biosimilar Medicines Industry Association (IGL).
“In our opinion, ensuring access to cost-effective generics is just as important as evaluating and negotiating new, innovative treatments: in fact, the success of the former is a prerequisite to freeing up the finances to be able to support the success of the latter,” argues Amgros’ Flemming Sonne. Indeed, annual savings from genericized medicine are estimated at around DKK 10 billion with hospital savings totalling DKK three billion for generics and at least DKK one billion for biosimilars, much of which gets reinvested back into the health system.
Concurrently there tends to be a high trust in generics more widely across Danish society. By law, pharmacists must offer the cheapest available product, which is typically the generic, while patients are motivated by financial logic as well: if they opt for a more expensive brand, they must pay the entire price difference out of their own pocket.
Meanwhile, Denmark remains at the forefront of biosimilar utilization in its hospital segment propelled by a national tender system aimed at cost-effectiveness while sustaining high levels of clinical quality. “Unlike in many other markets, Danish doctors have shown an elevated level of acceptance when switching from originator products to biosimilars, precisely because these transitions are backed by clear clinical guidelines and national coordination,” says Sonne.
“Back in 2016 a critical decision was made that all EMA-approved biosimilars would be used at once in Denmark, even for well-treated patients. This shift saved considerable sums of money and helped hospitals manage their budgets more effectively. In fact, some originator products were completely phased out of hospitals within just three weeks whereas this is a process that ordinarily takes years in other markets,” recounts Jorgensen.
His association applauds both the Council and Amgros for their supportiveness and proactive posture. “They conduct what is called horizon scanning to closely monitor which biologics are nearing patent expiry. This allows Amgros to begin informal discussions with potential biosimilar suppliers up to three years in advance. Then, one year before the biosimilar launch, they initiate formal tender procedures. While the product cannot be sold until the patent expires, tendering and planning can happen beforehand under EU law. As a result, Danish hospitals are always able to be first movers in adopting biosimilars literally from day one,” he explains.
Elite Manufacturing Powerhouse
A final differentiating, if somewhat surprising, feature of the Danish market is its role as a manufacturing powerhouse. Pharma and medical device exports have more than tripled over the past decade with the lion’s share bound for heavyweight consumer nations, notably the United States and China. What immediately stands out is the sheer technical sophistication and niche orientation of many of the locally embedded life science manufacturers. For instance, there is virtually zero domestic production of generics.
“While Denmark may be far from being the most cost-efficient location in Europe, its real value lies in the strength and maturity of its life sciences ecosystem. This is an advantage that, in our experience, far outweighs the comparatively higher operational costs. This is especially important in areas like cell and gene therapies or biosimilars, where success depends less on marginal cost and more on having experienced professionals and purpose-built infrastructure. Once those conditions are in place, cost structures can be optimised over time through scale. But to get there, you need an enabling environment that can support execution from day one, and Denmark delivers exactly that,” expounds Kasper Møller, Chief Technical Officer and Executive Vice President for Europe and Japan Regions at AGC Biologics, a manufacturer of protein-based biologics using both microbial and mammalian systems.
“The name of the game for Danish manufacturers is to compete on quality and expertise, not cost alone. We offset labour intensity with technology by automating processes, embracing digitalisation, and improving operational efficiency. That’s how we continue to grow in a high-cost market. Not by compromising on quality or talent, but by building smarter, faster, and more connected systems on a strong local foundation offering unmatched levels of service and reliability,” agrees Christian Houborg, General Manager and Senior Vice President at FUJIFILM Biotechnologies.
“For example, we’ve incorporated Raman spectroscopy into our bioreactors to continuously monitor critical variables like nutrient levels, cell viability, and product formation without relying on traditional offline sampling. These systems are already improving consistency and our understanding of processes,” he continues.
Indeed, both companies have become pioneers in pushing the boundaries of the possible in life science manufacturing. AGC, which is busy assembling in Denmark one of Europe’s most significant hubs for single-use biologics manufacturing, has been radically adapting their technologies and workflows to meet rising expectations both in the scientific and regulatory domains.
“Many of the antibodies entering clinical development today are bispecific, tri-specific, or fusion proteins, and while this doesn’t fundamentally change our manufacturing layout, it does place far greater demands on our analytical and process development capabilities as we shift towards catering towards escalating demand for complex modalities,” acknowledges Møller who’s company has been investing heavily to stay ahead of the curve. “Incorporating 2,000-litre single-use bioreactors, our latest facility will be capable of delivering up to 200 batches annually, making us one of the world’s leading CDMOs in terms of mammalian single-use capacity,” he reveals.
FUJIFILM’s intention, for its part, is to industrialise biomanufacturing, not just in terms of scale, but also in reliability and speed thus allowing partners, from large innovators to mid-sized biotechs, to remain focused on discovery, knowing that the production segment of the value chain is covered with speed, precision, and global coordination.
“We are confident that our model will increasingly redefine the future of advanced biologics. Our Hillerød giga-facility is currently focused upon large-scale monoclonal antibody (mAb) production and caters to a significant share of global demand. But even within this complex space, things are evolving rapidly, particularly with the advent of formats like antibody-drug conjugates (ADCs) and other novel constructs, and we’re adapting with agility to respond dynamically to those shifting needs,” confirms Houborg.
He recalls that when FUJIFILM first entered the market, the original attraction was in the ability to acquire Biogen’s established infrastructure, affording an immediate foothold in a mature biomanufacturing environment. But what has really sustained and expanded their investment there subsequently has been Denmark’s exceptional concentration of talent and knowledge.
“With over 100,000 professionals working in biotech and pharmaceuticals across the country, the availability of highly skilled people isn’t just a strategic advantage, it’s a strategic imperative for scaling with confidence. You can replicate equipment and buildings, but you can’t develop strong competencies overnight,” he concludes.
