Target Audience
- Researchers and healthcare professionals interested in biobanking, large-scale cohort studies, genomic medicine, and the secondary use of health data.
- Policymakers and business development professionals involved in designing, funding, operating, or governing national research infrastructures.
- Readers interested in understanding how the Danish National Biobank differs from UK Biobank and what lessons its experience may offer for Japan and other countries.
Executive Summary
- The Danish National Biobank (DNB) is a national biobanking research infrastructure in Denmark, officially inaugurated in 2012.
- Unlike UK Biobank, DNB primarily leverages existing clinical and research samples and connects them with nationwide health and administrative registries.
- Established through collaboration between public institutions and private foundations, DNB integrates a central storage facility, a nationwide sample registry, and a research coordination center.
- As of July 2025, its nationwide registry contained approximately 27.4 million samples from 5.9 million individuals. By 2026, the central facility stored more than 12 million samples.
- Today, its major challenges include sustainable long-term funding, research access procedures, coordination among distributed sample custodians, privacy protection, and governance.
1. What Is the Danish National Biobank?
The Danish National Biobank (DNB) is one of the world's major national biobanking research infrastructures. It was officially inaugurated on March 21, 2012.
Its most distinctive characteristic is its approach to collecting and using biological samples.
Rather than primarily recruiting a large group of new research participants, as UK Biobank did, DNB was designed to make use of biological samples that had already been accumulated through routine healthcare activities and research programs.
It also enables researchers to connect information about these samples with nationwide health and population registries.[1][2][3]
The underlying idea is straightforward: to preserve biological samples collected from the population as a national scientific resource and make them available for future research.
DNB was conceived as an infrastructure that could prevent valuable clinical and research samples from being lost or dispersed and enable their use in disease research, prevention, and infectious disease studies.
The Scale of DNB
As of July 2025, the nationwide Danish Biobank Register had reached the following scale.[4]
| Indicator | Scale |
|---|---|
| Official inauguration | March 21, 2012 |
| Samples registered nationwide | Approximately 27.4 million |
| Individuals represented in the registry | Approximately 5.9 million |
An important distinction is that the number of samples registered nationwide is not the same as the number physically stored at DNB's central facility.
DNB is both a large centralized storage facility and a research infrastructure that enables researchers to search for and access samples held by multiple institutions across Denmark.
Five Defining Characteristics
DNB can be understood through five major characteristics.
-
Making existing biological samples available for research
DNB facilitates research using biological samples collected during routine healthcare and preserved over many years. -
Joint development by public institutions and private foundations
The infrastructure was developed around Statens Serum Institut (SSI), with financial support from organizations including the Novo Nordisk Foundation. -
Integration of samples, information, and research support
DNB combines centralized sample storage, a nationwide searchable sample registry, and a coordination center supporting research access. -
Nationwide health data linkage
Denmark's population and health registries make it possible to link samples with individual-level information about hospital care, diagnoses, pathology, and other health outcomes. -
Governance designed for long-term operation
DNB operates within a framework addressing research review, sample custodianship, privacy protection, and the allocation of operating costs.
A particularly noteworthy development occurred on July 1, 2026, when DNB introduced user charges for sample retrieval, intake, and storage.[5]
This change is important when considering how large-scale biobanking infrastructures can distribute the financial burden of maintaining their operations over the long term.
2. Why Was the Danish National Biobank Established?
2.1 Two National Assets That Already Existed
The development of DNB was made possible by two assets that Denmark's healthcare and administrative systems had accumulated over many decades.
The First Asset: Nationwide Health and Administrative Registries
Denmark has a long-established system of national population and health registries.
Through the Danish personal identification number, known as the CPR number, researchers can link information about individuals across multiple registries.
These include information about:
- Population registration
- Hospital visits
- Medical diagnoses
- Treatments
- Pathology examinations
- Long-term health outcomes
For medical researchers, this capability is extremely valuable.
For example, a biomarker measured in a blood sample collected at one point in time can potentially be associated with a disease diagnosed several years later.[4]
If blood collected ten years before the onset of a disease has been preserved, researchers may be able to analyze it to investigate biological changes that occurred before the disease became clinically apparent.
Such studies require more than biological sample storage.
They also depend on a system capable of following individuals and linking their health information over extended periods.
The Second Asset: Biological Samples Already Accumulated Through Healthcare
Even before DNB was established, Denmark had numerous collections of biological samples.
Major examples included:
- Dried blood spot samples collected through newborn screening since 1982
- Residual samples from routine clinical and infectious disease testing conducted by hospitals and SSI
- Maternal blood, umbilical cord blood, and other samples collected through the Danish National Birth Cohort (DNBC), which began sample collection in 1996
- Samples collected for cancer research and other epidemiological studies
These samples had originally been collected for different purposes and were stored at multiple institutions.
The vision behind DNB was to organize these existing samples, both physically and informationally, and transform them into a national research resource accessible to researchers.[1][3]
2.2 The Concept of a "National Biological Archive"
In its official explanation, SSI describes the original vision for DNB using the Danish expression "biologisk rigsarkiv."
This can be translated as a "national biological archive."[1]
The concept incorporated three principal objectives:
- To preserve biological samples for future medical research
- To contribute to disease prevention, understanding disease causes, and developing treatments, including research on infectious diseases
- To transform samples already held within the healthcare system into a research infrastructure accessible to Danish and international researchers
This concept differs from establishing a new cohort for a specific research question.
Instead, it treats biological samples and information accumulated through healthcare and research as public resources that can support many different kinds of future studies.
Understanding this original vision is essential to understanding the distinctive nature of DNB.
3. From the Initial Concept to the Present Day
The development of DNB can be divided into six major periods.
3.1 Before 2008: Accumulation of Samples and Administrative Data
Denmark had already developed important biological and informational resources before DNB was formally established.
These included dried blood spot samples collected through newborn screening since 1982 and samples from the Danish National Birth Cohort, which began collection in 1996.
At the same time, nationwide population and health registries were becoming increasingly well established.
During this period, different healthcare systems and research projects accumulated samples and information independently for their respective purposes.
These resources later became an important foundation for DNB.
3.2 2009–2010: Formalizing the Concept and Securing Initial Funding
Around 2009–2010, the proposal to establish DNB began to take concrete form.
The Novo Nordisk Foundation, which became a major financial supporter, provided a grant of DKK 118 million over ten years.
The Danish ministry responsible for science and research and the Lundbeck Foundation also supported the project.
These contributions enabled the development of a national research infrastructure centered on SSI.[2]
An important feature of this process is that DNB was not created solely through a government-funded construction project.
Instead, public research institutions and private foundations shared responsibilities for building the infrastructure.
3.3 2011–2012: Facility Construction and Official Inauguration
A dedicated facility equipped with advanced automated storage and sample-processing systems was developed at SSI's premises in Copenhagen.
DNB was officially inaugurated on March 21, 2012.[1][2]
This marked the establishment of a national infrastructure capable of preserving large numbers of biological samples over long periods while supporting researchers in locating and accessing them.
3.4 2016: Growth into a Nationwide Sample Discovery Infrastructure
By 2016, the nationwide registry enabled researchers to search approximately 22 million registered samples.
Reports from the same period indicated that the central facility stored approximately 8 million samples and received around 1 million new samples annually.[3]
DNB had therefore evolved beyond a large storage facility.
It was becoming a national platform for discovering and using biological resources distributed across Denmark.
3.5 2024–2025: Continued Operation as a Large-Scale Research Infrastructure
By July 2025, the nationwide registry had expanded to approximately 27.4 million samples from 5.9 million individuals.[4]
The governance framework related to sample access was also updated in 2025.
These developments reflected DNB's continued evolution as an infrastructure that must not only expand its collections but also clarify management responsibilities and procedures for research use.
3.6 2026: User Charges and More Explicit Access Procedures
Information published in 2026 indicates that more than 12 million samples were stored at DNB's central facility.[6]
On July 1, 2026, DNB introduced user charges for sample retrieval, intake, and storage.[5]
In August of the same year, its website described a six-step process for accessing research samples.[7]
Approximately fourteen years after its inauguration, DNB had thus entered a stage characterized by both continued infrastructure development and institutional arrangements intended to support long-term operation.
3.7 Initial Funding and Major Participating Organizations
The establishment and operation of DNB involved several organizations.
| Organization | Main Role |
|---|---|
| Statens Serum Institut (SSI) | Establishment and operation of the infrastructure, sample management |
| Novo Nordisk Foundation | Major provider of initial funding |
| Danish ministry responsible for science and research | Public funding and policy support |
| Lundbeck Foundation | Financial support from a private foundation |
| Universities, hospitals, and research institutions | Sample ownership and custody, institutional collaboration, and research use |
The funding provided by the Novo Nordisk Foundation around 2009–2010 supported the establishment and operation of DNB over a ten-year period.
However, this did not mean that the same funding arrangement guaranteed permanent financing beyond that period.
This distinction is important when considering the long-term financial challenges faced by large-scale biobanks.
4. Organizational Structure and Key Features of DNB
DNB is much more than a large freezer facility.
Its research infrastructure is organized around three principal functions.[1][4]
- A nationwide biobank registry
- A central sample storage facility
- A coordination center
Together with Denmark's nationwide health and administrative registries, these functions enable research in fields such as epidemiology, biomarkers, genetics, infectious diseases, and disease prevention.
4.1 Central Storage Facility: A Highly Automated Biobank
The dedicated facility at SSI is equipped with systems for automated sample storage, retrieval, processing, and analysis.
Its major features, as described in official information, include the following.[1][8]
- A building area of 3,225 square meters
- A 19-meter-high low-temperature storage system operating at −20°C
- Robotic systems for storing and retrieving large quantities of samples
- Capabilities for sample processing, DNA extraction, and biomarker analysis
The facility is designed not only to preserve large numbers of samples but also to maintain quality control and traceability throughout their handling and retrieval.
For researchers working with samples preserved for many years, information about when samples were collected, how they were processed, and under what conditions they were stored is essential.
Automated storage and processing systems play an important role in maintaining such information and managing samples at scale.
4.2 Nationwide Biobank Registry: Searching Across Denmark Without Centralizing Every Sample
One of DNB's most important design principles is that not every biological sample in Denmark needs to be physically transferred to SSI.
Samples can remain at universities, hospitals, and research institutions while information about them is registered in a nationwide system.
Researchers can then search across collections held by different organizations.[4]
For example, researchers may search for:
- Blood samples collected before a cancer diagnosis
- DNA samples from individuals with particular diseases
- Blood samples collected during pregnancy in a maternal and child cohort
- Preserved samples from individuals with long-term follow-up information
Once potentially relevant samples have been identified, researchers can proceed with the necessary applications and approvals for access.
DNB therefore focuses not only on bringing physical samples together but also on making distributed biological resources discoverable and potentially accessible for research.
4.3 Coordination Center: Integrating Sample Access and Research Support
DNB's Coordinating Centre assists researchers seeking access to biological samples.
Its main functions include:
- Identifying samples suitable for a research project
- Reviewing sample types, quantities, and required volumes
- Supporting research access applications
- Coordinating with relevant institutions
- Assisting with sample retrieval and provision
DNB can also draw on expertise from epidemiologists and statisticians at SSI, including knowledge relevant to research design and data analysis.[6][7]
In this sense, DNB integrates three complementary capabilities:
- Finding biological samples
- Retrieving and providing biological samples
- Supporting researchers in their use of those samples
4.4 Linkage with Nationwide Health and Administrative Registries
The research value of DNB's biological samples increases substantially when they can be linked with Denmark's nationwide health and administrative registries.
Relevant information may include:
- Population data
- Hospital visits
- Diagnoses
- Pathology information
- Disease records
- Long-term health outcomes
Such linkage makes it possible to investigate relationships between biological characteristics at the time of sample collection and diseases or other health outcomes observed later.
However, this does not mean researchers can freely obtain biological samples or personally identifiable information.
Access requires appropriate approvals according to research purposes, legal requirements, and data management responsibilities.
5. Current Scale and Research Resources
5.1 Central Storage and Nationwide Registry
Based on information published in 2026, DNB's scale can be summarized as follows.[4][6]
| Indicator | Scale | Scope |
|---|---|---|
| Samples stored at the central facility | More than 12 million | Physically stored at DNB |
| Samples in the nationwide registry | Approximately 27.4 million | DNB and participating biobanks across Denmark |
| Individuals represented in the nationwide registry | Approximately 5.9 million | Individuals associated with registered samples |
| Annual intake of new samples | More than 1 million | Scale described in DNB's official information |
It is important to distinguish the nationwide registry from the central storage facility.
The number of samples also differs from the number of individuals, since multiple samples may be associated with a single person.
5.2 Major Types of Samples Stored at DNB
According to DNB's official sample information updated on August 4, 2026, the central facility holds several major categories of biological samples.[8]
| Sample Type | Approximate Number |
|---|---|
| Serum | 3.30 million |
| Dried blood spots | 2.50 million |
| Plasma | 1.40 million |
| Whole blood | 830,000 |
| DNA | 700,000 |
| Buffy coat | 350,000 |
| Urine | 320,000 |
| Saliva | 90,000 |
These figures refer to sample categories reported for the central facility, not to all samples registered nationwide.
5.3 Research Value of Newborn Screening Samples
One particularly valuable resource associated with DNB is its collection of newborn screening samples.
Denmark has preserved dried blood spot samples from newborn screening since 1982.
This makes it possible to investigate relationships between biological information obtained at birth and diseases that may develop decades later.
Such samples cannot simply be recreated by collecting blood from adults.
The preservation of biological material reflecting an individual's condition at birth therefore has considerable scientific value.
5.4 Connection with the Danish National Birth Cohort
Another important research resource associated with DNB is the Danish National Birth Cohort (DNBC).
Between 1996 and 2002, DNBC collected biological samples including maternal blood during pregnancy and umbilical cord blood at birth.
Combining these samples with long-term follow-up information enables studies such as:
- Relationships between environmental exposures during pregnancy and children's health
- Associations between genetic factors and diseases developing after birth
- Relationships between biological indicators during pregnancy and long-term health outcomes
The newborn screening collections and maternal-child cohort samples illustrate the distinctive value of DNB's long-term biological resources.
6. Research Access and Governance
To understand how DNB operates, it is essential to examine who controls biological samples and under what conditions researchers may access them.
6.1 Research Access Generally Requires Project-Specific Review
DNB's official procedures, updated in August 2026, describe a six-step process for accessing research samples.[7]
Step 1: Research Planning and Preliminary Consultation
Researchers contact the DNB Coordinating Centre to discuss sample availability and the feasibility of their proposed research.
Step 2: Research Ethics Approval
Researchers obtain approval from the relevant Danish Research Ethics Committee.
Step 3: Institutional Authorization for Personal Data Processing
The research institution confirms the necessary records and authorizations relating to personal data processing activities.
Step 4: Application to DNB
Researchers submit their research protocol and supporting documents, including information about sample types, quantities, volumes, and relevant approvals.
Step 5: Review by the DNB Scientific Committee
The DNB Scientific Committee reviews the application.
The stated objective is generally to provide a response within approximately one month after all required documentation has been completed.
Necessary procedures relating to personal data protection are also addressed.
Step 6: Sample Retrieval and Provision
Once the relevant requirements have been satisfied, arrangements are made concerning sample processing, retrieval, costs, and transportation.
The samples can then be provided under the approved conditions.
6.2 Access for International Researchers and Companies
DNB provides a pathway for international researchers and companies to access biological samples.
However, according to its current guidance, such research requires collaboration with a Danish research institution acting as the data controller.[7]
In addition to ethics approval, applications undergo review by the DNB Scientific Committee.
The committee includes representatives from:
- SSI
- The medical research community
- Danish regional authorities
- Patient organizations
This governance structure incorporates perspectives from researchers, the healthcare system, and patients.
6.3 Not All Samples Are Available Under the Same Conditions
DNB distinguishes between different categories of samples according to their management responsibilities.[8]
| Category | Management Characteristics | Research Access |
|---|---|---|
| Samples for which SSI is the data controller | Includes routine testing, screening, and research samples managed by SSI | SSI and DNB determine access following the necessary approvals |
| Samples stored on behalf of external institutions | SSI provides storage or processing services | Access depends on the original controlling institution and applicable research restrictions |
This distinction is extremely important in practice.
A sample being searchable through the nationwide registry does not mean that it can automatically be obtained through a single application procedure.
DNB functions as a nationwide discovery and coordination infrastructure while maintaining the original purposes and management responsibilities associated with individual sample collections.
6.4 Individual Objections to Research Use and Consent
Denmark has a system known as Vævsanvendelsesregisteret, a registry concerning the use of biological tissue.[9]
Individuals can register their objection to the use of biological samples collected during healthcare for research purposes.
Biobanks are required to check the relevant information.
In addition, research ethics committees determine whether information and consent from participants are required for particular studies.
Consequently, the Danish system does not require fresh individual consent for every secondary use of previously collected samples.
Nor does it permit unrestricted research use without appropriate authorization.
Instead, it provides a framework for balancing research access with individual rights.
7. Current Challenges Facing the Danish National Biobank
When examining DNB's challenges, it is important to distinguish between operational constraints documented in official sources and broader issues that may arise from those constraints.
Publicly available information reviewed for this article does not provide sufficient evidence to quantify DNB's annual financial deficit, application rejection rates, or the extent of storage capacity constraints.
It would therefore be inappropriate to conclude that DNB is experiencing a financial crisis or a decline in research activity.
Nevertheless, several important challenges can be identified.
7.1 Challenge 1: Financial Sustainability of Long-Term Storage
DNB benefited from substantial financial support from private foundations during its initial development.
However, establishing a large biobank is only the beginning.
An infrastructure that continues to receive samples every year must maintain its operations over decades.
Long-term costs include:
- Operating low-temperature storage systems
- Electricity
- Equipment replacement
- Robotic system maintenance
- Quality control
- Information system upgrades
- Retaining specialized personnel
On July 1, 2026, DNB introduced user charges for sample retrieval, intake, and storage.[5][7]
This represents a change toward having users contribute to some of the costs associated with maintaining the infrastructure.
Important questions for the future include:
- How much of the operating costs should be recovered through user fees?
- How can equipment replacement be financed without reducing opportunities for basic research?
- Who should bear the costs of maintaining the infrastructure as a public scientific resource?
However, the available sources do not establish that the introduction of user charges was a direct consequence of financial distress.
7.2 Challenge 2: Multiple Approval Procedures for Accessing Samples and Data
DNB itself acknowledges on its website that the application process may feel lengthy.[7]
Researchers may need to complete several procedures, including:
- Research ethics review
- Institutional authorization for personal data processing
- Review by DNB
- Final coordination for sample provision
Although the Scientific Committee aims to respond within approximately one month after receiving complete documentation, this does not mean the entire process from ethics review to sample receipt can be completed within one month.
DNB also notes that processing requests involving newborn screening samples may take considerable time.
Important issues for future improvement include:
- Reducing administrative burdens on researchers
- Standardizing application documents
- Facilitating international collaborative research
- Balancing timely review with privacy protection
For a large research infrastructure, the time required for researchers to obtain access can be just as important as the capacity to preserve samples.
7.3 Challenge 3: Distributed Ownership and Management of Samples
Although DNB's nationwide registry is extensive, DNB does not directly manage every registered sample.
Samples may remain under the control of hospitals, universities, and research institutions.
Consequently, samples relevant to the same research project may differ in terms of:
- Storage location
- Sample quality
- Conditions for provision
- Required approvals
- Available sample volume
Enabling research across these collections requires coordination.
Important considerations include:
- Standardization of sample information
- Common quality indicators
- Frequency of information updates across institutions
- Differences between identifying a sample and actually obtaining access to it
These are structural challenges associated with federated or distributed biobanking models.
They should not be interpreted as evidence of operational failure at DNB.[4][8]
7.4 Challenge 4: Balancing Research Value, Privacy, and Public Trust
The ability to preserve samples collected at birth and link them with diseases diagnosed decades later is one of DNB's greatest scientific strengths.
However, advances in genomic analysis mean that increasingly detailed information can be obtained from biological samples collected many years ago.
Research applications that were not anticipated when samples were originally collected may become technically possible.
This makes transparency about research purposes, individual preferences, and permitted uses particularly important.
In 2015–2016, Danish health authorities established a working group to examine ethical and legal issues associated with the research use of biological samples.
DNB's public information also explains that individuals face limitations in obtaining detailed disclosure about which specific research projects have used their samples.
Important questions include:
- How much information should individuals be able to obtain about research using their samples?
- How should the right to object to research use be communicated?
- How can transparency surrounding genomic research be improved?
For national biobanking infrastructures, maximizing scientific value and maintaining public trust must be pursued together.
7.5 Challenge 5: Depletion of Rare Samples and Long-Term Quality Management
Some biological samples are partially or entirely consumed when used in research.
Historical samples of particular scientific importance may be impossible to collect again.
The Danish Health Data Authority requires additional justification for requests involving rare samples.
Researchers may need to explain:
- Why the specific sample is necessary rather than an alternative
- Whether the analytical technology is sufficiently precise
- Whether the research team has the necessary expertise
This illustrates that a biobank is not merely a service that distributes biological materials.
It is also an institution responsible for allocating finite resources while preserving opportunities for future generations of researchers.
Another important consideration is sample quality.
When comparing samples collected in different periods or under different conditions, researchers must account for variations in collection procedures, processing, storage, and other pre-analytical factors.
7.6 Summary of Current Challenges
| Challenge | Documented Situation | Implications |
|---|---|---|
| Funding | User charges introduced in July 2026 | Sustainable allocation of operating costs |
| Complex approvals | Multiple authorization procedures are required | Administrative burden and access timelines |
| Distributed management | Not all registered samples are directly managed by DNB | Coordination costs across institutions |
| Ethics and privacy | Opt-out mechanisms, ethics review, and disclosure limitations | Balancing scientific value with public trust |
| Finite samples | Additional justification is required for rare samples | Fair allocation and long-term quality management |
These issues are relevant not only to DNB but also to the long-term operation of national-scale biobanking infrastructures more generally.
8. Comparison with UK Biobank
DNB and UK Biobank share an overarching objective: enabling scientific research using large collections of biological samples and health information.
However, their fundamental approaches to acquiring research resources and making them available to researchers differ.[1][4][10]
8.1 Differences in Their Fundamental Designs
| Category | Danish National Biobank | UK Biobank |
|---|---|---|
| Establishment | Inaugurated in 2012 | Established in 2003 |
| Fundamental concept | National research use of existing clinical and research samples | Creation of a large prospective research cohort |
| Population | Individuals represented in nationwide clinical and research sample collections | Approximately 500,000 research participants |
| Sample collection | Primarily routine care, screening, and existing research collections | Primarily standardized blood collection and assessments at research enrollment |
| Data strengths | Linkage with nationwide population and health registries | Detailed baseline measurements, genomics, imaging, and follow-up information |
| Infrastructure model | Central storage, distributed sample registry, and coordination center | Unified cohort and advanced research data environment |
| Funding model | Government and foundation support, with user charges | Government and charitable funding, with research access fees |
| Research access | Emphasis on sample-specific management responsibilities and ethics/scientific review | Designed primarily around research data access for eligible researchers |
8.2 UK Biobank: A Participant-Centered Research Model
UK Biobank created a large population of research participants and collected standardized measurements for research purposes.
By combining information gathered at enrollment with subsequent follow-up information, it has accumulated extensive multidimensional data for individual participants.[10]
Its principal characteristics include:
- A predefined participant cohort
- Standardized baseline assessments
- Genomic and imaging data
- Continuous follow-up of health outcomes
The strength of this model lies in its ability to accumulate detailed information collected through consistent research procedures across a defined study population.
8.3 Danish National Biobank: A Healthcare-Asset-Centered Model
DNB takes a different approach.
It combines existing samples held by healthcare providers and research institutions with information accumulated over many years in nationwide administrative and health registries.
This reduces reliance on recruiting entirely new research participants.
It also makes it possible to transform biological samples continuously generated through healthcare activities into research resources.
Consequently, DNB can support research using information originally collected during healthcare and public health activities, rather than relying only on measurements obtained specifically for research.
8.4 Complementary Rather Than Competing Models
DNB should not be understood as a smaller version of UK Biobank.
The fundamental distinction can be summarized as follows:
- UK Biobank: A model that creates a standardized population of research participants.
- Danish National Biobank: A model that transforms biological samples accumulated throughout the healthcare system into research infrastructure.
Each has distinct strengths.
UK Biobank's detailed and standardized measurements offer valuable opportunities for research.
DNB's long-term biological resources and nationwide health registry linkage provide different types of research value.
The two approaches can therefore be understood as complementary, depending on the scientific questions being investigated.
9. Lessons for Japan
The experience of DNB offers several lessons for countries considering the development of national biobanks and health data research infrastructures.
Four points are particularly important for Japan.
9.1 Reorganizing Existing Biological and Information Resources as an Alternative to Recruiting New Cohorts
Creating a new large-scale cohort is not the only way to establish a national biobanking infrastructure.
Another approach is to make existing biological samples from hospitals, research institutions, health examinations, and screening programs searchable across organizational boundaries.
DNB demonstrates a model for transforming existing healthcare assets into research infrastructure.
In this approach, the primary challenge is not simply to recruit additional participants.
It is to organize and connect the samples and information that already exist within the healthcare system.
9.2 Integrating Sample Information May Be More Important Than Centralizing All Physical Samples
The number of samples registered nationwide through DNB is substantially larger than the number physically stored at its central facility.
This illustrates the potential value of combining distributed storage with centralized discovery.
Building a national biobank does not necessarily require moving all biological samples into a single physical location.
However, a federated approach requires several components:
- Common sample metadata
- Standardized quality information
- Clearly defined access rights
- Coordination among custodial institutions
- Systems through which researchers can search for samples and submit access applications
Integrating information and governance can therefore be just as important as consolidating physical storage.
9.3 Designing Biobanking and Health Data Linkage Together
The scientific value of DNB cannot be explained simply by the number of biological samples it holds.
The ability to link samples with individual-level medical information over long periods is equally important.
For example, connecting biological samples collected at birth with diseases diagnosed decades later may generate insights that would be difficult to obtain through conventional cross-sectional research.
Developing a similar model in Japan would require careful consideration of:
- Identifiers enabling long-term individual follow-up
- Methods for linking biological samples with healthcare data
- Consent and legal bases for processing
- Collaboration among data controllers
- Balancing privacy protection with research use
Even a well-equipped biobank facility may struggle to realize its full scientific potential without effective linkage to longitudinal health information.
9.4 Planning for Operating Costs 10 or 20 Years After Establishment
DNB was initially established with the support of long-term funding from private foundations.
However, it introduced additional user charges in 2026.
This experience highlights the importance of considering long-term financial sustainability from the earliest stages of biobank planning.
It is useful to distinguish among several cost categories:
- Initial establishment costs
- Recurring sample storage costs
- Equipment replacement costs
- Information system maintenance and upgrades
- Research access and support services
An appropriate funding structure may need to combine government support, research funding, and user fees.
The value of a large biobank is not fully realized when the facility is inaugurated.
It is realized through maintaining an infrastructure that researchers can continue to use over many years.
10. Overall Assessment: What Can We Learn from DNB's History?
The development of the Danish National Biobank can be understood through four broad stages.
Stage 1: Accumulation of Existing Assets
Important resources were developed through newborn screening beginning in the 1980s, cohort research beginning in the 1990s, and nationwide population and health registries.
These assets existed before the formal establishment of DNB.
Stage 2: Integration into Research Infrastructure
Between approximately 2009 and 2012, joint investment by public institutions and private foundations enabled the establishment of a central storage facility, nationwide sample registry, and coordination center.
This created the foundations for transforming previously distributed clinical and research resources into a national research infrastructure.
Stage 3: Expansion as a Nationwide Research Platform
During the 2010s and 2020s, the number of registered and stored samples increased.
DNB developed into a platform supporting sample discovery and research across multiple institutions.
Long-term sample preservation and individual-level linkage with health data became central sources of its scientific value.
Stage 4: Maturing Governance and Long-Term Operations
DNB now operates within a framework that addresses management responsibilities, ethics, access procedures, and cost allocation associated with the secondary use of existing biological samples.
The introduction of user charges in 2026 is a noteworthy development in considering its long-term operation.
The True Value of a Biobank Is Not Determined by Sample Numbers Alone
Perhaps the most important lesson from DNB's experience is that the competitiveness and scientific value of a national biobank cannot be measured solely by the total number of samples collected.
What matters is the infrastructure that makes it possible to identify, link, preserve, and appropriately use those samples over long periods.
UK Biobank established a major medical research resource by creating a large, standardized population of research participants.
DNB developed a different type of national research infrastructure by connecting existing healthcare samples with nationwide information systems.
This distinction provides an important perspective for future biobanking initiatives.
However, a rigorous evaluation of DNB's financial sustainability and the reasons behind recent policy changes would require additional information beyond the publicly available descriptions reviewed here.
Important areas for further investigation include:
- DNB's operating budget
- Annual sample utilization
- Research application review times
- Effects of the introduction of user charges
- Contributions to scientific publications and research outcomes
Understanding these aspects would make it possible to evaluate DNB not only as a biobanking facility or governance framework but also as a sustainable operational model for national research infrastructure.
References
[1] Statens Serum Institut (SSI), "Om DNB," Danish National Biobank. https://www.nationalbiobank.dk/om-dnb
[2] Science Cluster Denmark, "The Danish National Biobank," Partner Profile. https://sciencecluster.dk/partner/the-danish-national-biobank/
[3] Statens Serum Institut (SSI), "EPI-NEWS, No. 47 — 2016," 2016. https://en.ssi.dk/news/epi-news/2016/no-47---2016
[4] Danish National Biobank, "Danish Biobank Register," information published in July 2025. https://www.danishnationalbiobank.com/danish-biobank-register
[5] Danish National Biobank, "Access to Research Samples," information concerning the introduction of user charges in July 2026. https://www.danishnationalbiobank.com/research-info/access-to-research-samples
[6] Danish National Biobank, "Research Info," information published in 2026. https://www.danishnationalbiobank.com/research-info
[7] Danish National Biobank, "Access to Research Samples," information updated in August 2026. https://www.danishnationalbiobank.com/research-info/access-to-research-samples
[8] Danish National Biobank, "DNB Biological Samples," updated August 4, 2026. https://www.danishnationalbiobank.com/research-info/dnb-biological-samples
[9] Danish Health Data Authority (Sundhedsdatastyrelsen), "Vævsanvendelsesregisteret." https://sundhedsdatastyrelsen.dk/data-og-registre/nationale-sundhedsregistre/vaevsanvendelsesregisteret
[10] UK Biobank, "Our History." https://www.ukbiobank.ac.uk/about-us/our-history/