PRECISION MEDICINE The Swedish Industry Guide 2018 - SwedenBIO
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PRECISION
MEDICINE
The Swedish Industry Guide 2018
Mapping
the Swedish
Precision
Medicine
Industry
Landscape
COLLABORATION MIKAEL DAMBERG, 5 HOT SPOT
FOR SUCCESS MINISTER FOR ENTER REGIONS This report is published by
SwedenBIO with financial support from
PRISE AND INNOVATION IN SWEDEN Business Sweden and Vinnova and
How AstraZeneca, in collaboration with Arthur D. Little.
Pfizer and Thermo “Contemporary life science A vibrant start-up
Fisher Scientific are is data and technolgy- scene across Sweden
collaborating with driven. Therefore, with R&D driven small
Swedish companies infrastructure and sized companies in
and universities to enabling technologies close connection
advance precision are national priorities for to Sweden’s major
medicine. resource allocation”. universities.
“Swedish precision medicine
is a real area of growth and home
to a vibrant start-up scene.”
Thank you!
We would like to express our special thanks to Special thanks go to the following people SwedenBIO project team
everyone who helped and contributed to making this Carina Schmidt, CEO at Athera Biotechnologies, Nicole Hanzon, MSc, Project Leader
report a reality, without whose contribution it would Elisabeth Nielsen, Programme Manager, International Susanne Baltzer, PhD, Senior Advisor
not have been possible to assemble the companies Division at Vinnova, Karin von Wachenfeldt, CEO at Sara Gunnerås, PhD, Editor,
and content presented in the report. Thanks are due Truly Translational, Karl Bergman, CEO at Elypta, sara.gunneras@swedenbio.se
to, by no means exclusively, to all the science parks, Markus Thor, Investment Advisor at Business Sweden,
incubators, regions, other supporting organizations Patrik Hidefjäll, Senior Researcher at the Bioentre- SwedenBIO – The Swedish
and individuals who shared their valuable knowledge preneurship Unit at the Karolinska Institutet, Per Life Science Industry Organization
and insights. Rydberg, CEO at Adduct Analys, Sara Malcus, CEO at Wallingatan 24, 111 24 Stockholm, Sweden
Metabogen, Sirisha Adimatyam, CEO at Innovosens Tel: +46 8 21 66 20, info@swedenbio.se
Special thanks go to the following organisations and Ulrica Sehlstedt, Partner at Arthur D. Little. www.swedenbio.se
Business Region Göteborg, Invest in Skåne, Medicon
Village, Sahlgrenska Science Park, Stockholm Science Special thanks to our students from the Master’s Graphic design: Andreas Hallbert, Greatland
City, Swelife, Umeå Biotech Incubator and Biotech Programme in Bioentrepreneurship at Karolinska Editorial support, proofing and copy:
Umeå, UppsalaBIO, Uppsala Innovation Centre. Institutet: Mengjing Ke, Bing Vu and Rosa Willock Angela Scott, COHELIX Ltd
Share the knowledge. Please cite as Precision Medicine – The Swedish Industry Guide 2018 (SwedenBIO). Download the report at www.swedenbio.se/reports
The content of this report is based on information gathered in good faith and is believed to be correct at the time of publication.
SwedenBIO can however provide no guarantee regarding the accuracy of this content or any misprints that may occur.
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Precision Medicine – The Swedish Industry Guide 2018 SwedenBIO
The Swedish precision medicine
industry landscape at first glance
This report, published by SwedenBIO – the Swedish Life Science Industry Organization,
presents the results of the first mapping of the Swedish precision medicine industry
landscape. It is a guide to 76 companies, all of which are developing innovative products
and services with the potential of advancing the field. At the end of the report, there is
a listing of their relevant R&D projects as well as launched products.
T
he precision medicine landscape is complex and integrating multidisciplinary research areas will have the
consists of overlapping and intersecting elements, potential to really transform precision medicine in the future.
including biomedical research, clinical informa- Many global enterprises have a significant presence in
tion, and lifestyle parameters, plus the enabling Sweden with both R&D and manufacturing sites, as well
tools of digital health, “-omics” technologies, and as through their many collaborations with academia and
computational health sciences. How are Swedish companies innovative Swedish companies. For this report, we asked
active in this field and contributing to realizing the promise AstraZeneca, Pfizer and Thermo Fisher Scientific about their
of precision medicine? To gain more knowledge about this perspective on precision medicine and how they take an active
SwedenBIO initiated a project mapping the Swedish industry part in advancing the field through Swedish collaborations.
and the result is presented in this report. Finally, we have included a description of selected research in-
Using our considerable network of organisations and indi- frastructures, such as Science for Life Laboratory – a national
viduals around Sweden, we invited a wide selection of com- resource for “-omics”-based research and development – to
panies to participate in a survey by describing their business complete the picture by including a view of public sector effort
and research programmes. In parallel, we identified a range in this field.
of additional companies through database searches and these Our conclusion is that Swedish precision medicine is an
were also invited to participate. Details of this process can be area of substantial growth and home to a vibrant start-up scene.
found in the methods section on the last page. In the last four years, 26 companies were established within
In this first edition, we focused on Swedish companies this area. The vast majority (97%) of companies are small
with a business-to-business model. Therapeutic projects were with 50 employees or less. These companies are strongly
excluded as these are regularly presented in “The Swedish connected to academia, with 72% having been spun out from
Drug Discovery and Development Pipeline” report1. Sweden the academic sector. The spin-off clusters are located around
is also home to many high quality service providers and Sweden’s larger cities with the majority originating from
business-to-consumer companies, also part of the precision Karolinska Institutet in Stockholm, Lund University and
medicine landscape. In the future, we intend to revisit and Uppsala University. Linköping, in the heart of southern
report on these latter groups of companies to complement the Sweden, has developed into a national arena for analysis of
present picture. medical imaging using for example, artificial intelligence.
We have primarily focused on companies developing
research tools suitable for stratification of patient subpopu- Our report encompasses the following topics:
lations, diagnosis and/or prognostication of disease progress. • A map of technologies used by the companies
Examples of such tools are: new validated biomarkers, • Description of areas of rapid technology advancement
companion diagnostics, diagnostic assays based on “-omics” • Presentation of Swedish research infrastructures including
technologies, sequencing technologies or software programs Science for Life Laboratory
for analysis of complex and large datasets. • AstraZeneca, Pfizer and Thermo Fisher Scientific views on
Secondly, we decided to highlight the outstanding Swedish precision medicine and their presence in Sweden
research and development happening in complex data-com- • The list of companies and their projects
puting, bio-imaging, bioinformatics, and large databases.
It is becoming increasingly apparent how these technologies This report has been published with support from Business
are being transformed into companies developing new methods Sweden, the Swedish Trade and Investment Council, and
based on machine learning and artificial intelligence. These Vinnova, the Governmental Agency for Innovation, and in col-
IT-intensive companies are developing advanced imaging laboration with management consulting firm, Arthur D. Little.
techniques using CT, MRI, PET or microscopy, or developing
advanced bioinformatic programming and decision support 1. L
earn more about Swedish Drug Discovery and Development at
www.swedenbio.se/reports
software programmes. We envisage that these efforts of
3
CONTENT
FOREWORDS BY
6
5 SwedenBIO, the life science
industry organization
6 Mikael Damberg,
Minister for Enterprise and Innovation
7 Business Sweden, the Swedish Trade
and Investment Council
Foreword by Mikael Damberg 7 Vinnova, the Governmental Agency
Minister for Enterprise and Innovation for Innovation
“Contemporary life science is data and technology-driven.
Therefore, infrastructure and enabling technologies are WHAT IS PRECISION MEDICINE?
national priorities for resource allocation” 8 Introduction by Arthur D. Little
16 Stratification of patients and
development of new technologies
Learn more about the first PRECISION MEDICINE IN
mapping initiative of the SWEDEN AT A GLANCE
Swedish precision medicine 12 Strong academic connections
12 industry landscape! 13 Five Swedish hot spots
14 Small companies driving innovation
THERAPEUTIC AND
Highlight: Biomedical imaging TECHNOLOGY HIGHLIGHTS
Linking basic molecular 20 Oncology
studies with phenotypic clinical 24 The fight against infectious diseases
manifestations of disease to
26
26 Imaging in the era of precision medicine
promote an accurate diagnosis. 32 Cutting-edge technologies in biopsy
NATIONAL RESOURCES
An exclusive list of 76 companies AND PLATFORMS
developing innovative products 40 Science for Life Laboratory
and services that have 40 Human Protein Atlas
the potential of advancing the 42 National biobanks and quality registers
18 precision medicine sector.
GLOBAL COLLABORATIONS
30 Pfizer
Highlight: Oncology 34 Thermo Fisher Scientific
The increased understanding of 43 AstraZeneca
the biology of different cancers
is now leading to the development COMPANIES AND PROJECTS/PRODUCTS
of new diagnostic methods. 20 18 Companies A-Z
44 List of more than 200 projects
4
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Precision Medicine – The Swedish Industry Guide 2018 SwedenBIO
SwedenBIO –
the life science
industry
organization
We are always open to collaboration and we hope this report
will serve as an invaluable source of information for companies,
investors and other parties seeking collaboration and business
opportunities in Sweden in this exciting area.
S
weden is ranked as one of the and growth to our life science industry.
most innovative countries in the To accomplish this, SwedenBIO is active in
world. Our strong academic base the public debate and represents the industry
and world-leading infrastructure in a continuous dialogue with authorities
for research form the basis for a and politicians. We facilitate the building of
successful and innovative life science industry professional networks and hold several inspi-
accounting for nearly ten percent of our rational and educational meetings, round table
net export. The sector is highly prioritized, discussions, workshops and informal get-to-
and the government recently established a gethers throughout the year. SwedenBIO’s
permanent office for life sciences within the investor-only meeting – vc2vc – encourages
Government Offices in order to generate a investors in life sciences to co-invest in each
coordinated policy, clearer priorities and a other’s portfolio companies. Nordic Life
higher pace in working towards a competitive Science Days, SwedenBIO’s international in-
life science sector in Sweden. vestor and partnering meeting, held annually
As outlined in this report, the tradition of in September, has rapidly grown to become Jonas Ekstand, PhD
innovation development continues to thrive the largest business meeting in the Nordic Director General SwedenBIO
in precision medicine, an area where Swedish region. This event will next take place on
companies are developing novel products and September 10-12, 2018 in Stockholm
technologies for a global market. Accessible (www.nlsdays.com) and is by far the most
biobanks, quality registers and well-developed efficient way to meet the Swedish life science
platforms for interaction between academic community and its many innovative companies.
scientists, clinicians and companies together We are grateful to our partners for making
with our early-adopter mindset, all contribute the production of this report possible and wish
to making Sweden an ideal location for R&D you, as a reader, an informative and enjoyable
in precision medicine. insight into how Swedish companies contrib-
SwedenBIO is the national association for ute to advancements in precision medicine.
the life science industry in Sweden with close
to 250 member companies. Our mission is to Visit us at www.swedenbio.se and www.nlsdays.com
promote an environment which brings success
5
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SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
“The Swedish government
is strongly committed
to supporting continued
rapid development in the
life science sector”
S
Photo: Kristian Pohl
weden is a major player Contemporary life science is data- and
on the life science arena, “In February 2018, an technology-driven. Therefore, infra-
offering a thriving life structure and enabling technologies are
science environment which Office of Life Science national priorities for resource alloca-
is technology-driven and was established in the tion. A state-of-the art e-infrastructure
characterised by close collaboration Government Offices” is being created to facilitate coordinated
between academia, health care, in- and efficient use of the unique biobanks
Mikael Damberg
dustry and patient organisations. As a Minister for Enterprise and Innovation
and national registers. The Science for
logical consequence of this, life science Life Laboratory is a leading national
is a dominating line of business and a and international infrastructure and
cornerstone of the Swedish economy. a national strategy for life science. research environment for molecular
Supporting research, innovation and The digitalisation revolution has biosciences and drug development that
co-creation in the life science sector has been a prerequisite for efficient handling receives long-term government support.
been a long-standing strategic priority of ‘big data’ arising from the new MAX IV and the European Spallation
of the Swedish government. technologies and will continue to speed Source (ESS), two major investments in
The threats to human health are up progress in life science and clinical high-resolution imaging, support a wide
escalating rapidly across the globe, medicine. Here, Sweden has compet- range of scientific areas and have been
rendering human health a major global itive advantages. Our public health set up as core national and European
challenge. Accordingly, in 2015, our care system, along with the personal infrastructures.
National Innovation Council, which is identification numbers introduced in Precision medicine targets diagnosis
chaired by the Prime Minister, launched 1947, has made generation of unique, and treatment tailored to the individual.
an innovation partnership programme comprehensive patient registers and Joint efforts in this area will result
in life science to further accelerate functional biobanks possible. Sweden in improved health, strengthened
progress in research and innovation, is also internationally lauded for international competitiveness for all
and promote co-creation involving all its performance in information and stakeholders, increased export and new
major stakeholders. And, in February communication technology, including investments in Sweden. The Swedish
2018, an Office of Life Science was technologies for managing big data and government is strongly committed to
established in the Government Offices, mobile technologies that hugely benefit supporting continued rapid develop-
a first assignment of which is to develop the Swedish life science sector. ment in the life science sector.
6
Business Sweden
The gateway
to business
in Sweden
Expect great things of Sweden!
In Sweden you will find a proven, business friendly envi-
ronment that is characterized by forward thinking, sharp
brains and open minds. Sweden is considered to be one of
the world’s most prominent research nations and provides
full access to Europe. It is a place where not only will you Elisabet Nielsen, Programme Manager, International Division.
Laurent Saunier, Head of Department, Health Division.
get quality and efficiency beyond your expectations, but also
stability and sustainability by default.
Life sciences is a sector of high strategic importance to Vinnova
Sweden –
Sweden. The foundation that underpins innovation in the
Swedish life sciences sector is the fruitful collaboration
an innovation
between academia, industry and healthcare, where all stake-
holders demonstrate an open-minded and boundary-span-
ning approach. Our long track record of investing heavily in
leader
research and development has borne fruit and is yet another
reason to choose Sweden for life science business develop-
ment, licensing, partnerships or direct investments.
About Business Sweden
Business Sweden’s purpose is to help Swedish companies to
According to the Global Innovation Index1, Sweden is rated
grow their international revenues and international compa-
as the second most innovative country in the world. It offers
nies to invest and expand in Sweden. For Swedish companies,
an environment where you can find entrepreneurship, strong
we provide strategic advice, sales execution and operational
R&D clusters, and a thriving start-up scene.
support. For international companies we ensure that they can
rely on our knowledge, experience and extensive network
Supporting innovation
to identify new business opportunities and achieve an accel-
Vinnova, the governmental agency for innovation, funds
erated return on investment. Business Sweden is present in
innovation and research projects. Every year, the agency
50 of the world’s most promising markets and owned by the
invests around SEK 3 billion (> USD 371 million) in pro-
Swedish Government and commercial sector, a partnership
moting innovation. Funds are generally allocated using a
that provides access to contacts and networks at all levels.
“calls for proposals” system.
Visit us at www.business-sweden.com
Precision medicine is an interdisciplinary field that is
expected to drive the health research and innovation agenda
for years to come. To continue enabling advances in this
sector to be made, Vinnova stimulates collaboration be-
tween companies, universities, higher education institutions,
public services and civil society, as well as working to
strengthen international cooperation.
Vinnova is a member of the EC-funded network
“The International Consortium for Personalised Medicine”
(ICPerMed)2. In addition, we fund projects in this field via
our national programmes such as the Strategic Innovation
Programmes (SWELife and Medtech4Health) and Chal-
lenge Driven Innovation. We are also engaged in promoting
international calls for propsosals under the Horizon 2020
framework, as well setting up a Nordic call for proposals
within Personalised Medicine.
Visit us at www.vinnova.se
Photo: Patrick Trägårdh
Ulrika Cederskog Sundling 1. Global Innovation Index 2017 Report, www.globalinnovationindex.org
Executive Vice President Invest & Region Sweden 2. ICPerMed www.icpermed.eu
7
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SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
PRECISION
MEDICINE
Providing the right treatment to the right patient
at the right dose and the right time.
T
he advent of “precision medi- announced the Precision Medicine Initiative,
cine” has long been predicted launched with a $215 million governmental
– essentially ever since, when in backing in the presidential 2016 Budget to
1990, scientists began decoding advance precision medicine in the USA. In the
the human genome. There is no EU, the European Commission has invested
‘single’ definition of the concept of precision heavily into precision medicine within the FP7
medicine, but one that has gained strong and Horizon 2020 frameworks, alongside
support is that precision medicine is defined as other several major national initiatives such
the stratification of patients into groups based as Genomics England, France Medécine
on biological information and biomarkers at Genomique and the Danish National Strategy
the molecular level as a result of our increased for Personalized Medicine. And in Asia,
understanding of disease pathways and within countries like South Korea have declared that
the fields of genomics, proteomics, metabo- the government will establish obligatory data
lomics, epigenomics and pharmacogenomics, platforms and ease regulations to encourage
thus allowing doctors and drug makers to Ulrica Sehlstedt, PhD
innovation in precision medicine. In Sweden,
match a patient to a drug that is likely to Partner, Arthur D. Little initiatives such as Genomic Medicine Sweden
work. That is, precision medicine aims at are in progress, aimed at building a new type
improving the targeting of drug treatment to of infrastructure in the Swedish healthcare
boost the efficacy of drugs and to reduce their system by the introduction of new genetic
adverse reactions. It is not just about devel- screening technologies to enable implemen-
oping new drugs but also about identifying tation of precision medicine throughout the
those patients who are most likely to respond country. A further example is the recent
to existing products, and therefore aimed at significant investment in precision medicine
reducing the number of ineffective therapies in oncology by the Sjöberg Foundation in
clinicians may need to test on a patient before “The opportunities collaboration with the Swedish Regional
finding the right one. Although the term within precision Cancer Centers.
’personalized medicine’ is also sometimes used medicine have Delivering on promises with precision
to describe this process, it actually denotes a medicine is inextricably linked to technolog-
unique treatment designed and manufactured attracted much ical advancement of biomarker technologies,
for an individual patient, as for example, the interest, not only digitalization and big data management.
Novartis chimeric antigen receptor therapy The steep decrease in the cost of sequencing
(Car-T).
from scientists, a genome has played, and still does play an
The opportunities within precision med- drug makers and important part in advancing the field, as do
icine have attracted much interest, not only patients but also the high speed development and application
from scientists, drug makers and patients but of data mining, artificial intelligence (AI) and
also from funders and decision makers. In
from funders and machine-learning to predict which patients
2015, former US President Barack Obama decision makers” will respond to specific therapies. The in-
8
New paradigm shift in treatment
Transitioning from the ”One-size-fits-all” to ”Precision Medicine” model
with multi-level patients stratification.
One-size-fit-all Precision
medicine medicine
Patients are grouped by: Individual patient level:
• Disease Subtypes • Genomics and Omics
• Risk Profiles • Lifestyle preferences
• Demographics • Health History
• Socio-economic • Medical Records
• Clinical Features • Compliance
Precision medicine is about the stratification
• Biomarker • Exogenous Factors
• Molecular
of patients into groups, based on biological
sub-populations information and biomarkers at the molecular level –
to match a patient to a drug that is likely to work.
creasing availability and selection of devices drugs and associated diagnostic tools. Being “Sweden, with its
and wearables for collecting “real-world” able to prove the value of the associated
data from patients means that biomarker improvement in care quality or health out- long tradition in bio-
information can be combined with data about comes will become increasingly important for molecular research
individual differences in lifestyle and environ- drug and diagnostic suppliers if they are to and its comprehen-
ment to provide researchers with further tools obtain approval for their precision medicine
to discover paths towards delivering precision solutions, and also have them reimbursed and sive biobanks and
medicine. implemented in the market. quality registers, is
Precision medicine has the potential to Sweden, with its long tradition in bio-
fundamentally alter the existing business molecular research and its comprehensive
very well positioned
logic in the healthcare landscape in several biobanks and quality registers, is very well as a front runner in
ways – by creating a more segmented market positioned as a front runner in the field of pre- the field of precision
through increased interdependency between cision medicine. In this report, we highlight
industrial partners and by the expected tran- Swedish companies that currently innovate,
medicine.”
sition from volume-based payment towards develop and supply researchers and drug mak-
outcome-based payment. One of the major ers with all the important tools and technol-
determining factors which will either drive or ogies that are a prerequisite for the discovery,
hinder the broader uptake of precision med- development and implementation of precision
icine is whether or not healthcare providers medicine for the benefit of patients in Sweden
will be adequately reimbursed for using the and elsewhere.
9
The future of tailored treatment is about HAVING A BETTER UNDERSTANDING OF BIOLOGICAL MECHANISMS AND ENVIRONMENTAL INTERACTIONS 10
11
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SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
An initial map of
the Swedish precision
medicine industry
In this report, we have prepared a guide to 76 companies developing
innovative products and services that have the potential of advancing the
precision medicine sector. The companies are clustered in five major regions,
where the capital region Stockholm-Uppsala is home to almost 50%.
The vast majority has been spun out of academic institutions.
Commercialisation of academic Karolinska Institutet Strong association to incubators
research – 72% of companies are Adduct Analys, Affibody, Athera and science parks
university spin-offs Biotechnologies, AroCell, Chundsell In close connection to the universities,
Nearly three out of four companies in Medicals, Clinical Gene Networks, the incubators and science parks provide
this report have been founded based on CyberGene, DoubleStrand start-ups with relevant business tools
research and innovative technologies Bioinformatics, iCellate Medical, in the commercialisation process. It is
developed at academic institutions. InDex Pharmaceuticals Holding, therefore no surprise that about 50% of
Sweden has the second highest R&D Pelago Bioscience and VLVbio. the companies are associated with an
expenditure in Europe as a percentage incubator or science park. The densest
of GDP1 and a well-established academ- Lund University innovation hubs are naturally collocated
ic and corporate research culture. The Akuru Pharma, Diaprost, Immunovia, with Sweden’s most populated regions
proximity between the universities and Medviso, Qlucore, Reccan Diagnostics, and largest universities, with the princi-
the healthcare sector, as well as the pub- Respiratorius, SAGA Diagnostics, pal ones being the SMILE incubator and
lic research infrastructures, are plausible SensoDetect, SenzaGen, Spectronic Medicon Village Science Park in Lund,
reasons why so many academic inno- Medical. and the Karolinska Institutet Incubator
vations are now being commercialised. and Science Park in Stockholm.
Below is a list of companies spun out of Uppsala University
the major universities. Astrego Diagnostics, BioArctic, Biovica,
CADESS Medical, CRAY Innovation,
Gradientech, Olink Bioscience, Olink
Proteomics, Q-linea.
Chalmers Technical University and
Gothenburg University
How did 1928 Diagnostics, Alzinova, Eigenvision,
the company Elypta, Medfield Diagnostics,
start? Metabogen, Multid Analyses, PExA
and TATAA Biocenter.
Linköping University
AMRA Medical, BioReperia,
ContextVision, Glycobond and Sectra.
Spin-off from academia, 55
Umeå University 1. B
usiness Sweden, Why Sweden leads the
Independent, 17 AcureOmics, HiloProbe, InfiCure and innovation game (www.business-sweden.se/en/
Other, 4 UmanDiagnostics. Invest/industries/Manufacturing/innovation)
1276
companies within precision medicine
50%
associated with incubators or science parks
72%
spin-offs from academia
7% Umeå
Region
Five Swedish hot spots
for precision medicine
development in Sweden
The capital region of Stockholm together
with its northern neighbour Uppsala, are
home to almost half of the 76 companies
included in this report. More than one
47%
fourth of the companies are located in the
southern Malmö-Lund region, followed
by 14% in the Gothenburg region and Stockholm/
7% in the Umeå region. Linköping region Uppslala
also hosts 5% of the companies, mainly Region
within imaging technologies.
Göteborg
Region 14%
5% Linköping
Region
26%
1% Other
Malmö/Lund
Region
13Small
companies –
driving
innovation
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Precision Medicine – The Swedish Industry Guide 2018 SwedenBIO
A
ll but two of the 76 companies swer to the question as to which competencies As many as 77%
presented in this report, Elekta were being sought, the response was that the
and Sectra, have less than 50 highest demand is for expertise in bioinfor- of the companies
employees (n=74) and most of matics and software skills, and interestingly plan to recruit more
these can be classed as micro- or also, several companies are looking for skills staff, and 47% plan
virtual companies (n=61). These small research in artificial intelligence.
based companies, are part of the vibrant Swedish to increase their
start-up scene, which is further fuelled by a 26 companies founded over number of special-
well-established network of funding organisa- the last four years
tions, support organisations such as incubators The high activity within the area of precision
ised consultants/
and science parks, contract research organiza- medicine is manifested by the significant num- contractors
tions and other expert service providers. This ber of newly founded companies measured
all contributes to Sweden’s well-established over the last four years. On average, more
position as a global innovation leader, which is than 6 new companies were founded each year
due to the country’s attractive research infra- (2014: +7; 2015: +5; 2016: +10; 2017: +4).
structure, high-level of competence and skills,
as well as a flourishing, cross-disciplinary
learning and testing environment.1 2014 2015 2016 2017
Elekta and Sectra are the two largest Swedish 1928 Diagnostics Bionamic Data Consulting Akuru Pharma Astrego Diagnostics
companies active in the field of precision Antaros Medical BioReperia CADESS Medical CartaNA
medicine. These two companies employ about
CRAY Innovation Eigenvision Doctrin DoubleStrand
250 people each in Sweden, and 3581 and
Bioinformatics
616 worldwide, respectively. Together, the 76
Gnosco EMPE Diagnostics HiloProbe Elypta
companies mentioned in this report employ
the equivalent of 1000 FTEs in Sweden. Life Genomics Neodynamics InDex Pharmaceuticals
Holding
We asked the companies how they see their
company developing over the next three years, PExA Liv Diagnostics
and more specifically if they plan to recruit Reccan Diagnostics Medsens
within their R&D departments. As many as Olink Proteomics
77% of the companies plan to recruit more Oncosignature
staff, and 47% plan to increase their number
Saga Diagnostics
of specialised consultants/contractors. In an-
N. B. Companies InDex Pharmaceu-
The majority of the 76 companies have less than 50 employees
ticals Holding and Olink Proteomics
were registered in 2016, but existed
previously in the form of other
company structures.
61
13
0 2 1. B
usiness Sweden, Why Sweden
leads the innovation game
0–10 11–50 51–200 >200
Micro Small Medium Large (www.business-sweden.se/en/
Invest/industries/Manufacturing/
innovation)
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SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
Stratification of patients
and development of new
technologies is on the agenda
for Swedish companies
We are all unique. Our health is determined by our inherent genetic differences
combined with our lifestyles and environment. Precision medicine is about
having a better understanding of biological mechanisms and environmental
interactions that govern health and disease.
V
arious diagnostic meth- Based on the data provided by the com- technologies are also placed in this
ods and instrumentation panies participating in the survey, it can group.
platforms serve to facili- be concluded that Swedish companies The companies were asked if their
tate our ability to identify in the field are numerous and work technological sectors are typical for
changes in the human across a broad spectrum of research and precision medicine. The top five tech-
body. It is the combination of the infor- methods. For purposes of this report, nologies listed were bioinformatics,
mation we observe or diagnose by these they have been divided into groups data management (big data), machine
means, and our increasing knowledge with the focus being on two groups of learning, patient monitoring and predic-
of human biology (through ongoing companies: tive analytics. For more information,
advances in “-omics” technologies) that – Those working with stratification see page 18-19.
enables us to determine our individual of patients based on genetic and pheno- Sweden is home to outstanding
risk of developing disease, detect illness typic patterns. research and development in complex
earlier, and to choose the most effective These include companies developing data computing, bioinformatics and
interventions to help improve our methods and products for: companion large databases, and these technologies
health, be it through medicines, lifestyle diagnostics, biomarker discovery and are now being translated into compa-
choices, or even simple changes in diet. validation, molecular diagnostics, muta- nies developing new methods based
A model for describing the over- tion analysis by sequencing, expression on artificial intelligence or machine
lapping and intersecting elements that profiling, bioinformatics, genomics, learning. These IT-intensive companies
make up the field of Precision Medicine proteomics, pharmacogenomics, are developing advanced imaging
are shown in the diagram in this sec- metabolomics, translational imaging techniques using CT, MRI, PET or
tion. The figure depicts these individual with PET-ligands, or next generation microscopy, or developing advanced bi-
elements, which include biomedical sequencing (NGS) of whole genomes. oinformatics programming and decision
research, clinical information, and life- – Those working on development of support software programmes.
style parameters, plus the enabling tools new technologies and instrumentation. Big data analytics, based on the
of digital health, “-omics” technologies, These companies are primarily devel- wealth of information held in Sweden’s
and computational health sciences. oping new diagnostic methods such as: large and numerous databases, is be-
When integrated, these elements can sampling techniques (biopsies), patient coming an important area of research
inspire the development of new research monitoring, bio-imaging and medical in precision medicine. Handling large
and technologies which eventually can imaging and clinical-decision support amounts of data requires the type
lead to more precise and predictive systems. Companies developing new of new software development that is
healthcare. software and advanced programming needed for artificial intelligence (AI)
16Information Discovery Knowledge
INDIVIDUALS RESEARCH ENABLING TOOLS INTEGRATE,
INTERPRET AND
VISUALIZE
COLLECTED DATA
Basic Clinical Digital Omics
Discovery Discovery Health Technologies
Social/Behavioral Computational
Discovery Health
Genomics
Microbiome
POPULATIONS
Exposures
Behaviors
Clinical Tests
MORE PRECISE Patient Contributed
Data
DIAGNOSTICS, TREATMENTS
AND PREVENTION
Adapted from Precision Medicine at UCSF.
and machine learning programs. AI and
machine learning algorithms are now
also being applied to practices such as
diagnostic processes, treatment protocol
development, patient monitoring and care.
We also asked the companies about
their projects and products. The major-
ity have applications in specific therapy
areas. The strongest area is by far on-
cology followed by infection. New diag-
nostic tools for Alzheimer’s disease and
cardiovascular diseases are also in focus
for several companies. In addition to
disease specific tools, several companies
are developing new instrumentation
for improved bio-imaging techniques
as well as technologies within biopsy
instrumentation. All the projects and
This “wordle” captures and measures
products reported by the companies, the words used by the companies
totalling more than 200, are listed on when describing the applications of
the last pages. their products.
17|
SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
COMPANIES A-Z
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Company 29 28 25 23 23 17 14 13 13 11 11 10 9 9 7 6 6 6 6 5 4 20
1928 Diagnostics
AcureOmics
Adduct Analys
AMRA Medical
Affibody
Akuru Pharma
Alzinova
Antaros Medical
AroCell
Ascelia Pharma
Astrego Diagnostics
Athera Biotechnologies
Atlas Antibodies
Axcentua Pharmaceuticals
BioArctic
Biomotif
Bionamic
BioReperia
Biovica
CADESS Medical
Calmark Sweden
CartaNA
Chundsell Medicals
Clinical Gene Networks
ContextVision
Corpus Data & Image Analysis
CRAY Innovation
CyberGene
DanPET
Diaprost
Doctrin
DoubleStrand Bioinformatics
Eigenvision
Elekta
Elypta
Emotra
EMPE Diagnostics
Glycobond
18We listed a selection of technologies typical for precision medicine and asked the companies to mark relevant
areas for their business. The result is outlined below. The following companies did not participate in the web-
based questionnaire, but do touch upon precision medicine and are therefore also briefly mentioned in the report:
Alpha Biotech, Apodemus, BiBBInstruments, Cavidi, Chromalytica, Hermes Medical Solution, ImaGene-iT,
Molecular Fingerprint Sweden, Phase Holographic Imaging, Sensabues, SyntheticMR.
S)
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Company 29 28 25 23 23 17 14 13 13 11 11 10 9 9 7 6 6 6 6 5 4 20
Gnosco
Gradientech
HiloProbe
iCellate Medical
Immunovia
InDex Pharmaceuticals Holding
InfiCure Bio
Life Genomics
Liv Diagnostics
Lytics Health
Medfield Diagnostics
Medsens
Medviso
MetaboGen
Multid Analyses
Neodynamics
Olink Bioscience
Olink Proteomics
OncoSignature
Pelago Bioscience
PExA
Q-linea
Qlucore
Reccan Diagnostics
Redhot diagnostics
Respiratorius
SAGA Diagnostics
Sectra
SensoDetect
SenzaGen
Single Technologies
Spago Nanomedical
Spectronic Medical
Symcel
TATAA Biocenter
Truly Translational Sweden
UmanDiagnostics
VLVbio
19|
SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
ONCOLOGY
The inceased understanding of the biology of different cancers is
now leading to the development of new diagnostic methods.
A
ccording to the World Health The future is approaching
Organization (WHO) cancer is, The arrival of next-generation sequencing Since no
after ischemic heart disease and (NGS) has accelerated the implementation of
stroke, the second leading cause genomic profiling in the care and management
validated serum
of morbidity and mortality of patients with cancer. Initial efforts have fo- biomarkers for
worldwide. Cancer was responsible for 8.8 cused on target identification in patients with breast cancer
million deaths in 2015. The number of new advanced cancer. Prognostication, resistance have yet been
cases of cancer is expected to rise by about detection, disease monitoring, and early detec-
70% in two decades, from 14 million in 2012 tion efforts are also underway. identified,
to 22 million by 2030. Our increased understanding of the biology there is a great
Lung, prostate, colorectal, stomach and of different cancers is now leading to the clinical need
liver cancer are the most common types of development of new diagnostic methods for
cancer in men, while breast, colorectal, lung, detecting biomarkers specific for certain can-
for a better
cervix and stomach cancer are the most com- cers and different stages of the cancer. non-invasive
mon among women. test that allows
Improved diagnostics in breast cancer correct
Finding and treating cancer at an Breast cancer is one of the most common
early stage can save lives cancers with more than 1,300,000 cases and diagnosis
Cancer mortality can be reduced if cases are 450,000 deaths occurring annually world-
detected and treated early. Screening pro- wide.1 Breast cancer diagnostics today include
grammes and early diagnosis are two major the diagnostic management of the breast as
components of early detection. Figures from well as the axillary lymph nodes. Since no
Cancer Research UK suggest that more than validated serum biomarkers for breast cancer
90% of women diagnosed with breast cancer have yet been identified, there is a great clin-
at the earliest stage survive their disease for ical need for a better non-invasive test that
at least 5 years compared to around 15% for allows correct diagnosis as well as prognosis
women diagnosed with the most advanced and recurrence.
stage of the disease. Prediction of the risk of the cancer reoc-
The promise of precision medicine is that curring, especially in parts of the body distant
treatments will one day be tailored to the to the breast, is difficult using current clinical
genetic changes in an individual’s cancer. and histopathological parameters. Conse-
Information about genetic changes in a quently, a number of patients are over and/
tumour will help decide which treatment will or non-optimally treated, resulting in largely
work best for that person. However, it is now unnecessary side-effects for patients and
known that cancer is an extremely hetero- increased costs for healthcare providers. Thus,
geneous disease, which explains differences tools for predicting the metastatic migration
not only between cancer cells from different behaviour of cancer cells are needed.
patients, but also between cancer cells within A number of Swedish companies are currently
a single patient. This calls for new and better engaged in this race to fight breast cancer. The
sampling technologies, an increased under- methods they are developing span a variety of
standing of the genetics behind cancer devel- technologies – from improved biopsy methods,
opment and better screening and diagnostic analysis of cancer specific enzymes and bio-
methods. markers to cell migration assays and diagnostic
tools based on machine learning. 1. WHO, GLOBOCAN 2012
20Photo: AcureOmics
Company Technology Application/s A number of Swed-
Affibody HER2 PET imaging agent. Imaging in metastatic breast cancer. ish companies are
In clinical validation.
AroCell TK1 serum biomarker ELISA analysis Monitoring treatment efficiency and survival
currently
of serum. in stage 2 breast cancer. engaged in this
Biovica Analysis of TK enzyme activity in blood. Monitor and predict treatment response in stage 2
breast cancer therapy. In clinical validation.
race to fight
ContextVision Digital diagnostics / machine learning. Analysing tumour proliferation speed as a
breast cancer.
decision support tool/treatment plan.
Immunovia Panel of breast cancer biomarkers on Early detection of breast cancer. Possible prediction
microarray platform /software algorithm. of development of distant metastases.
Liv Diagnostics Lab-on-a-chip, analysis of cells Diagnosis and follow-up of breast cancer.
from biopsy. Measure of tumour invasiveness.
Neodynamics Biopsy system with ultrasound Tissue sampling of small lesions and axillary
guided imaging with end sampling. lymph nodes. Product launched.
21|
SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
The challenges of prostate cancer do not have prostate cancer.3
In the future There is no question that screening can help Once the prostate cancer is diagnosed there
find many prostate cancers early. Until recently, are other challenges in the treatment regime
of precision PSA (prostate specific antigen) tests for pros- that need to be addressed. Androgen depriva-
medicine, tate cancer were considered to be exemplary tion therapy (ADT) is generally the first choice
treatments for successful early cancer detection leading for the management of advanced prostate
will be tailored to improved treatment outcomes. But over the cancer. Unfortunately, after an initial response
last few years, a series of studies has suggested to ADT, prostate cancer eventually loses
to the genetic that the tests are not sensitive enough: frequent responsiveness to the androgen blockade and
changes in an false positives lead to too many unnecessary progresses into castration-resistant prostate
individual’s medical procedures, and false negatives give cancer (CRPC). Again, the way to successfully
men a false sense of security. Even if screening targeting CRPC lies with the advancement of
cancer detects prostate cancer, doctors are often precision medicine i.e. analyse gene mutations
unable to tell if the cancer is truly aggressive. and expressed genes in tumour samples and
Because of an elevated PSA level, some men combine these with patient data.
may be diagnosed with a prostate cancer that A promising on-going research project in
would otherwise have gone unnoticed, not Sweden is the combination of the “Stock-
caused any symptoms nor led to their death. holm3 test” with magnetic resonance imaging
As a result, most healthcare authorities in Eu- scans to further improve the identification of
rope, including Sweden and around the world, aggressive prostate cancer. The “Stockholm3
do not recommend introducing screening for test” is a blood-based prostate cancer test that
prostate cancer with the PSA test.2 predicts the risk for aggressive prostate cancer
Consequently, there is a need for more at biopsy by analyzing five protein markers,
accurate diagnostic tests than are presently more than 100 genetic markers and clinical
available. In the future of precision medicine, data. The hope, now, is that the combinations
treatments will be tailored to the genetic of different biomarkers and imaging tech-
changes in an individual’s cancer, but they niques will lead to better detection and predic-
will also be taking account of the normal tion of prostate cancer.
variations seen in healthy individuals. Indeed, In Sweden, there is a growing number
in a recently published paper, a genome-wide of companies developing new methods and
association study suggested that 40 genetic re- analysis tools for more accurate diagnosis of
gions could together predict nearly 10 percent prostate cancer.
of normal variation in PSA levels in men who
Company Technology Application/s
AroCell TK1 serum biomarker ELISA analysis. Prognostic and monitoring treatment efficiency
in prostate cancer.
CADESS Medical Cloud-based decision support system based Identification of malignant glands in tissue images
on digital imaging analysis of biopsies. and prognosis of the prostate cancer development.
Chundsell Combination of gene expression, of IGFBP3, Decision support
Medicals F3 and VGLL3, with clinical parameters. Prognosis of aggressive prostate cancer and survival
for various treatment options. Product launched.
ContextVision Digital diagnostics / machine learning. Analysing tumour proliferation speed as a decision
support tool/treatment plan.
CRAY Innovation Genetic analysis of loss of chromosome Y Predict risk for all-cause mortality of prostate
(LOY) in blood cells. cancer in men.
Diaprost Mab-PET-ligand (anti-hK2) in combination with In vivo screening for identification and detection
anatomical imaging (CT/MR). of prostate cancer.
Elypta Platform based metabolic profiling analysis Early detection, differential diagnosis, surveillance
(machine learning algorithms) of 20 cancer-type of recurrence and monitoring or prediction of
specific metabolites in blood or urine. treatment response.
iCellate Medical Whole genome sequencing (of CTC and ctDNA) Analysis of aggressive prostate cancer. Risk profiling
and germ-line DNA, from normal blood samples. in hereditary investigation. In clinical validation.
Immunovia Panel of prostate cancer biomarkers on microar- Early detection of prostate cancer.
2. T
he National Board of Health ray platform /software algorithm.
and Welfare (Socialstyrelsen)
3. W
itte, & Van Den Eeden, 2017. Spectronic Software that provides AI driven technology Treatment planning for MRI only radiotherapy
Nature Communications Medical to enhance radiotherapy by enabling MRI. planning. Ongoing registration of the product.
22Cancer of the pancreas HCC diagnosis is usually achieved using
According to WHO, hepatocellular pancreatic biomarkers and early diagnosis is critical for
cancer is probably the most lethal tumour, successful treatment. Today, only 10% of
forecast to become the second most fatal HCC patients are diagnosed at an early stage
cancer by 2020 in developed countries. Pan- and there is a significant unmet need for diag-
creatic cancer often does not cause any signs nostic markers enabling early detection.
or symptoms in the early stages, making early AroCell is developing a screening test based
diagnosis difficult. Detection at a curable on measuring TK1 levels to monitor cancer
stage demands screening intervention for early therapy with activated T-cells for liver cancer.
detection and differential diagnosis. However, This project is currently in clinical validation.
to date, no successful strategy or image tech- Ascelia Pharma, detection and localization
nology has been found to offer an effective of primary liver cancer. Clinical validation of
approach. Currently, the hope for this cancer this project is on-going.
is to be able characterise relevant non-invasive Glycobond has developed an ELISA-based
biomarkers. assay that detects aberrant and cancer-specific
Axcentua Pharmaceuticals is developing spe- glycosylation on alpha-1 acid glycoprotein.
cific biomarkers for stratification of pancreatic The protein is secreted into the blood stream
cancer patients. This project is currently in where analysis can be performed on a simple
clinical validation. blood sample. This product is launched.
Elypta is developing a blood- and urine-based
liquid biopsy platform for detection and clas- Kidney or renal cancer
sification of multiple cancer indications, one The two most common types of kidney cancer
of which is pancreatic cancer. are renal cell carcinoma and transitional
Immunovia is working on a diagnostic cell carcinoma. The different types of kidney
multiplexing serum test for early detection cancer have different long-term outcomes and
of pancreatic ductal adenocarcinoma. need to be staged and treated in different ways.
Reccan Diagnostics is investigating a serum Akuru Pharma is using a bioinformatics
biomarker panel for pancreatic cancer. platform for identification of novel surface
This project has reached clinical validation. molecules that can serve as biomarkers for
renal cancer. This project has reached clinical
Liver cancer validation.
Hepatocellular carcinoma (HCC) is responsi- Elypta is developing response monitoring and
ble for causing over 700,000 deaths annually. recurrence detection of renal cell carcinoma.
23|
SwedenBIO Precision Medicine – The Swedish Industry Guide 2018
THE FIGHT AGAINST
INFECTIOUS DISEASES
S
weden is deeply committed to the A benefit of adopting precision medicine for
global fight against the development bacterial and viral infection is that improved A number
of multidrug resistant pathogens. diagnostics will help drive new drug develop-
In 2016, the Swedish government ment for novel antimicrobials and antivirals,
of Swedish
presented the Swedish strategy to combat anti- particularly agents to be reserved for resistant companies
biotic resistance. The Public Health Agency of pathogens or agents that are intended for use are developing
Sweden contributes to the Global AMR Sur- only against a limited range of pathogens. New, new tests and
veillance System through both the WHO and rapid diagnostics can support development of
bilateral cooperation with e.g. India, China narrow spectrum agents and targeted therapy platforms to push
and EU. The Unit for Antibiotics and Infec- that will generate new business models for an- diagnostics to
tion Control of the Agency has in fact been tibacterial and antiviral agents, to focus treat- the next level.
designated as a WHO Collaborating Centre ments to the right patients at the right time.
for Antimicrobial Resistance Containment. The development of transformational
Serious bacterial infections need to be diagnostics and biomarkers that can easily
treated rapidly to maximize a patient’s chance be used to diagnose infections directly from
of survival. In some infections, such as venti- clinically relevant specimens should focus on
lator associated pneumonia and sepsis, and in features such as being inexpensive, simple,
certain critical situations, minutes can matter. rapid and having a high degree of accuracy.
Traditional bacterial identification relies Furthermore, being able to distinguish both
primarily on culture-based methodologies bacterial and viral etiologies as well as colo-
requiring 12 to 24 hours for isolation and an nizing organisms from infecting pathogens is
additional 24 to 48 hours for species identi- also crucial to future developments.
fication. In the absence of rapid diagnostics, A number of Swedish companies are
empiric therapy, based on an “educated guess” developing new tests and platforms to push
as to the causative agent of the infection, has diagnostics to the next level. These are shown
become the standard. in the table below:
Company Pathogen Methods Application
1928 Bacteria Software platform for whole Antibiotic resistance detection
Diagnostics genome sequencing data. and surveillance.
Alpha Biotech Bacteria PCR Detection of Rickettsia bacteria
in cerebrospinal, bronchial
lavage, synovial fluid.
Apodemus Virus PCR, NGS, Immunology. Presence of different viruses.
Astrego Bacteria Microfluidics, real time imaging. Antibiotic susceptibility. Testing
Diagnostics in urinary tract infections.
CAVIDI AB Virus Reverse Transcriptase assay. Automated drug resistance test-
ing in near-patient HIV viral load.
EMPE Bacteria Padlock probe-dependent Antibiotic susceptibility testing;
Diagnostics DNA rolling circle amplification Detection of bacteria, virus,
and lateral flow biosensors. fungi, and other microbes.
Gradienttech Bacteria Microfluidics, real-time imaging. Rapid antibiotic susceptibility
testing.
Q-linea Bacteria Padlock probes and circle-to- Fully automated multiple antibiotic
circle isothermal nucleic acid susceptibility testing.
amplification technology (C2CA).
Symcel Bacteria Real-time cell calorimetry. Multiple antibiotic resistance
testing.
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