Life Sciences Business
Evolution Series
How Digital Transformation
and Data Are Shaping
Business Models
Foreword
Traditionally, the life sciences industry has grown through innovation, acquisition and geographical expansion.
Now, life sciences companies must evolve their business models to address market saturation, more complex global
regulatory regimes in terms of compliance, law lag due to new innovative and digital products entering the market,
R&D cost inflation and pressure on healthcare expenditures. A survey conducted by Baker McKenzie in collaboration
with Informa Pharma Intelligence looked at how pharmaceutical, biotech, medical devices and medtech companies
plan to leverage new and existing sources of growth over the next 10 years.
This first report of a three-part Life Sciences Business Evolution Series explores how important digitally-enabled
strategies are in addressing changing patterns of demand and streamlining go-to-market approaches. For
example, digital tools and platforms are helping companies transition from product-only offerings to product-
service hybrids, oriented to patient mapping, pre-diagnostics solutions and enhanced treatment administration.
These intertwined value chains will increasingly shape the life sciences industry of the future. The area of digital
therapeutics also shows incredible promise for better patient care and outcomes through the enhanced use of real
world evidence and advanced analytics.
Digital transformation continues to propel the reshaping of business models, with different emphases for
the Americas, Europe and Asia Pacific, depending on the maturity of the market and interplay of life sciences
companies and other healthcare organizations in the broader ecosystem. Globally, respondents noted that
accelerated digitalization (31%), changing demand patterns (38%) and the need for rapid product/service
development (34%) have shaped their businesses the most. These changes signal the evolution of interlinked value
chains driven by digitalization efforts which, according to over 250 global respondents, are most evident in clinical
(73%) and support (69%) functions.
Intertwined Value Chains Are Reshaping Life Sciences Business Models
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How Digital Transformation and Data Are Shaping Business Models
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Foreword (continued)
Vanina Caniza
Global Head of Healthcare and
Life Sciences
Buenos Aires
Henrique Frizzo
Partner at Trench Rossi Watanabe*, Sao Paulo
and Head of Healthcare and Life Sciences
Latin America
Managing Data Volume
Is Key
Digital monitoring has implications ranging
from supply chain management to the transfer
and monetization of data as well as symptom
tracking, among others.
• Data analytics (56%), cloud technology (55%)
and monitoring (55%) are the top three focus
areas, currently.
Data Privacy & Compliance
Could Curtail Data Monetization
The deluge of sensitive data is putting a focus on
reducing risk in the storage, transfer and sharing of
data, vis-à-vis global regimes.
• Respondents are focused on data management
(53%) and data analytics/solutions (44%), with 57%
of life sciences businesses considering the latter as
a new revenue source.
Appetites Are Ripe for All
Things Digital
Digitalization will accelerate the ability to provide
better and more acute diagnoses, treatment and
monitoring, as well as patient self-management.
• In two to five years, up to 70% of respondents
will be pursuing digital therapeutics and AI as
part of their digital transformation efforts.
* Trench Rossi Watanabe and Baker McKenzie have executed a
strategic cooperation agreement for consulting on foreign law
Explore how digitalization is shaping life sciences business models, including current actions, risks and pertinent legal areas for businesses to
navigate. Later installments of the series will explore other key facets related to corporate growth and the trajectory of therapeutic growth
areas for life sciences businesses.
Data management and analytics are top of mind as life sciences businesses look to safely collect, use, store and monetize vast amounts of
data — advanced analytics are critical to targeting and optimizing R&D and product/service launches. Our survey identified three key areas
of focus:
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How Digital Transformation and Data Are Shaping Business Models
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Contents
1.1 Current Areas of Focus on Digitalization and Data 05
1.2 Impact of Digital Transformation 07
1.3 Navigating Risk 09
1.4 Strong Legal Support Needed to Chart Change 11
2 Sub-sector Trajectories 13
• 2.1 Pharma and Biotech
• 2.2 Medical Devices and Medtech
3 Conclusion — Growth at a Glance 17
4 Key Contacts 19
Methodology
All findings across three flagship reports in the Life Sciences Business
Evolution Series are gleaned from a custom survey conducted by
Baker McKenzie in collaboration with Pharma Intelligence in late 2021.
Over 250 life sciences respondents from North America, Latin America,
Europe and Asia Pacific were consulted on their thoughts relating
to the changing market conditions, challenges and opportunities
affecting life sciences business models, growth patterns, funding and
shifting operational dynamics.
Respondents include executives C-suite, EVP/SVP, Head of, Director,
Manager, General Counsel, Assistant General Counsel in various
business functions including clinical operations, business development,
IT, clinical research, strategic operations, quality, R&D, regulatory,
commercialization, digital transformation, market access, medical
affairs, operations, sustainability and legal.
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How Digital Transformation and Data Are Shaping Business Models
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Overall Top Three Areas (Data)
% respondents intending to pursue
Data management
Reflected as top for all regions
Data analytics and solutions
Reflected as top three for the all regions
Data sharing
Reflected as top three for Asia Pacific
Current Areas of Focus on Digitalization and Data 1.1
Overall Top Three Areas (Digital)
% respondents intending to pursue
Data analytics
Reflected as top three for Asia Pacific and Europe
Cloud technology
Reflected as top for Europe
Monitoring
Reflected as top three for the Americas and Europe
56% 53%
55% 44%
55% 32%
Data, cloud technology and monitoring dominate the current digital landscape, while issues of data management, data
analytics and data sharing are top of mind globally, across all regions. However, digital growth strategies are set to shift
in the next five to ten years.
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How Digital Transformation and Data Are Shaping Business Models
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1.1
Americas
The leading three areas of digital focus are
monitoring (61%), apps (61%) and business
support platforms (59%), illustrating the growing
importance of virtual patient management to
hard-pressed health systems.
Digital therapeutics and AI/automation were
more significant over the five-to-ten year term.
A strong focus on data management (53%) and
analytics (48%) indicates that shifting data
regulation and laws could be drawing businesses’
attention to these areas.
Asia Pacific
Respondents are currently the most focused on
data analytics (44%) and telehealth (43%), and
current areas of data interest center mostly on
data management (49%).
However, in five to ten years, more advanced
modalities such as AI/automation (25%), apps
(24%) and digital therapeutics (23%) were cited as
areas of interest.
Europe
Respondents cite cloud technology (67%) and
data analytics (66%) as key current digital
growth strategies. Over the next five to ten
years, preferences shift to telehealth/remote
monitoring (16%), apps (15%) and AI/automation
(14%). This suggests a long-term commitment
to digital as a core component of more holistic
product offerings.
Notably, data is already a key driver of current
strategies in Europe, with 55% of respondents
active in data management, 43% in analytics and
solutions and one-third in data sharing.
“It is often said that data is the new currency.
Like currency, it is critically important that organizations
use both appropriate and practical security measures for
the use, storage and transfer of data. One thing
organizations can do is to make sure they have an
incident response plan in the event of data loss and
actually test this plan to see if it meets the
organization’s needs.”
Stephen Reynolds
Data & Technology Partner, Chicago
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How Digital Transformation and Data Are Shaping Business Models
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Impact of Digital Transformation1.2
While respondents in the Americas and Europe are mostly aligned in their digital priorities, responses from Asia Pacific
reveal the complexity of the life sciences landscape in terms of varied business priorities and the unique challenges in
each region.
Overall Top Three Areas of Digital
Transformation Impact
% respondents
Clinical
Reflected as top three for all regions
Support functions
Reflected as top three for the Americas and Europe
Regulatory
Reflected as top three for the Americas and Europe
73%
69%
66%
Asia Pacific Spotlight
Respondents cited that manufacturing (70%) was most impacted by digital
transformation. This could be due to the fact that this region is home
to large-scale producers of Active Pharmaceutical Ingredients (API) in
addition to business delays and recovery and resilience efforts arising from
the pandemic.
More than two-thirds of respondents in this region also say digital
transformation efforts have affected commercialization, indicating the
influence on go-to-market strategies, likely due to a higher concentration
of sellers of finished products. Asia Pacific businesses may be slightly
behind the curve in applying digitalization to core functions such as
manufacturing and marketing, but nonetheless are determined to reap the
benefits of new technologies.
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“Industry, regulatory authorities and stakeholders have embraced
digitalization at warp speed, partially in response to COVID-19. Particularly
in the R&D space, clinical trial design, recruitment and retention are
undergoing a digital transformation that is braced by the understanding
that when pharma leverages digitalization, we can realize an increase in
participant access, enable robust collection of data and generally create
greater efficiencies to lower costs and decrease healthcare disparities.
The FDA is championing the advancement of healthcare through digital
health innovation across products and the product lifecycle, from increasing
its talent with digital health expertise to releasing industry guidance
focusing on digital health content.”
Khelin Aiken
FDA Regulatory & Compliance Partner, Washington DC
1.2
Americas and Europe
Respondents from the Americas and Europe had similar experiences in terms of where
digital transformation had the most impact. In Europe, respondents saw the most
significant positive impact of digital transformation in clinical development (71%),
where data generation, collection and analysis are crucial to pipeline yields. This was
followed closely by support functions (70%) and regulatory/R&D (both 60%). In the latter,
digitalization benefits extend from drug target identification to interactive devices and
streamlined interfaces with regulatory agencies.
Respondents in the Americas placed more emphasis on regulatory (73%) than support
functions (71%), implying that agencies such as the US Food and Drug Administration
(FDA) are ahead of the curve on digital interaction.
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“For life sciences companies, supply chain disruption places products and businesses at
risk. Moreover, such disruption can also have severe consequences for the delivery of
healthcare. For example, products might have a limited shelf life and therefore cannot
be delayed by a shipping bottle-neck, or hospitals, having placed orders for medical
devices, rely on them being delivered on time. This makes supply chain continuity a
must have. Increasingly, life sciences companies are looking to new data driven tools
capable of assisting with identifying supply chain disruption risk factors that companies
then use to develop viable contingency plans such as replanning a supply route if
indicators for supply disruption are present.”
Anne Petterd
Head of International Commercial & Trade
Asia Pacific, Sydney
Navigating Risk1.3
Overall, respondents cited compliance as the largest risk area. Data-related risks such as IP protection, data storage and data
management also featured strongly. Regional outlooks show some variance, particularly for Asia Pacific, where almost one
in three respondents cited supply chain continuity and cross-border data governance issues as key areas of risk.
Overall Top Three Risk Areas
% respondents
Compliance
Reflected as top for the Americas and Europe
Data storage and management
Reflected as top for the Americas and Europe
IP protection for data
Reflected as top three for all regions
34%
32%
32%
As supply chain and trade complexities continue to impact many businesses in the region, these areas of risk
not only relate to digitalization and data but the core of business strategies from an operational perspective.
Specifically, in Asia Pacific, 34% of respondents cited supply chain matters as their top priority. This may
reflect a focus on localization, which has spurred smart manufacturing, such as the use of data analytics
to manage inventories and drug distribution or the use of AI for quality control during production. Shifting
regulation and trade challenges also feature as concerns, as respondents named government actions and
antitrust issues (both 31%) as focus areas for legal advice.
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How Digital Transformation and Data Are Shaping Business Models
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Life sciences respondents from the Americas cited compliance (36%), data storage/
management (36%) and IP protection for data (33%) as key risk areas, broadly mirroring
survey responses in Europe, where digital again figured strongly among perceived areas
of risk.
Legal frameworks have struggled to keep pace with technology and emerging
products driven by digitalization efforts. With companies taking a “data as an asset”
approach, 32% of all responses saw risks in IP protection for data and storage/
management. All of these were outweighed, however, by compliance (34%), as
companies test the stringent regulatory boundaries for life sciences with their new
digital capabilities.
1.3
“In our Connected Compliance research findings,
compliance leaders report that not only are their
organizations implementing technology with little
consideration for risk, but also that compliance is
shut out of conversations relating to critical
technology decision making. It is especially
important for life sciences companies handling
sensitive patient data to consider the intertwining
myriad of issues related to data privacy, technology
and regulatory compliance. Creating a shared
responsibility for compliance across the organization
and breaking down internal silos is key.”
Joanna Ludlam
Global Co-Chair, Compliance & Investigations,
London
Visit Our Connected Compliance Site
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How Digital Transformation and Data Are Shaping Business Models
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Strong Legal Support Needed to Chart Change1.4
Over the next one to two years, one-third of all respondents cite data issues and the impact of government actions as
key areas where they expect to seek legal advice, related to the overall impact of digital transformation on their business
models. Labor and employment, life sciences collaborations and tax were other priority areas for legal advice.
Collaboration and partnerships with other life
sciences companies*
Reflected as top five for all regions
Tax
Reflected as top five for the Americas and Europe
Overall Top Five Areas for Legal Advice
% respondents
Data issues
Reflected as top five for the Americas and Europe
Impact of government actions
Reflected as top five for all regions
Employment and labor issues
Reflected as top in Europe
33% 30%
33% 28%
32%
* To be covered in more detail in the next
installment of this series
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“Automation of work and the introduction of new technologies have prompted
life sciences organizations to re-skill, restructure and redefine their workforce.
The pandemic has accelerated a trend of hybrid working, including across borders,
and companies now have greater access to a global talent pool. However, change
does not come easy, particularly when workforces are demanding ultimate
flexibility on scope, hours and location. That brings with it a bundle of
employment, immigration, social security, tax, IP and data protection law issues
that companies will need to unpick as they work out what their workforce
policies of the future should look like and how flexible they are willing to be.”
Julia Wilson
Employment & Compensation Partner, London
Regional outlooks show a slight variation in focus beyond data and digitalization or the impact
of government regulations, due to different market-specific influences.
Around one-third of respondents from the Americas are keen to get support on collaboration
and partnership with other life sciences companies, and 32% plan to seek tax-related advice.
Respondents from Europe cite more traditional areas of concern, including employment and labor
issues (36%), just 2% higher than respondents from the Americas.
In Asia Pacific, supply chain matters including supply chain diversification and managing
downstream supply risks remain the top area in which respondents seek legal support (34%).
1.4
“Life sciences businesses continue to recognize
the opportunities presented by more powerful
uses of data while seeking to manage the
related risks. For example, in our 2021 Digital
Transformation and Cloud Survey, 98% of
Healthcare and Life Sciences respondents
indicated they are currently investing in
cybersecurity, and data privacy and
cybersecurity ranked as top concerns for cloud
adoption. Careful legal planning and
involvement in relation to managing digital
assets and data throughout the life cycle of a
product or service, can help businesses grow
with confidence.”
Adam Aft
Global Co-Lead Technology Transactions, Chicago
Empowering Life Sciences Companies, Globally
Baker McKenzie's top 50 Healthcare & Life Sciences clients comprise of:
• 9 of the 10 pharmaceutical companies listed in the 2021 Global Fortune 500
• 7 of the 10 largest medical devices companies ranked in the 2021 Global Fortune 500
• 13 of the top 20 biopharma revenue generators globally
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How Digital Transformation and Data Are Shaping Business Models
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Subsector Trajectories2
While pharma and biotech companies’ digital priorities are based around operational efficiency, medical device and
medtech respondents see digital efforts as a key part of their offering. Both subsectors are concerned about potential
data issues, as well as partnerships with other life sciences companies, with medical device and medtech respondents
additionally concerned about how government actions might impact their operations.
Companies in this sector are storing, managing and analyzing
vast quantities of data in secure, accessible locations such
as the cloud. Pressures to deploy technology at the services
of increasing patient outcomes and speed to market have
also put digital transformation efforts at the center of
activities, from discovery and clinical trials to supply chain
management and customer profiling.
Overall Top Three Digital Focus Areas
Current
(% respondents)
Cloud technology
Data analytics
Apps
59%
57%
56%
In Two to Five Years
(% respondents)
Apps
Digital therapeutics
Telehealth/AI
44%
35%
33%
2.1 Pharma and Biotech
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Enhancing Value
These findings highlight the role of digital
support tools in enhancing value.
are already monetizing
partnerships by integrating
patient-centric treatment with
technology/data
plan to do so in the next two to
five years
36%
39%
Risk Barometer
Legal, regulatory and compliance dominate the
digital engagement risk landscape.
consider IP protection for data as
a risk area
cite compliance as a risk area
see cross-border data governance
as a risk area
40%
40%
36%
New Revenue Streams
Companies are motivated by data and value-
based healthcare.
consider data analytics and
solutions as a new revenue stream
cited value-based healthcare
initiatives as a new revenue stream
identified personalized care for
patients as a new revenue stream
66%
31%
27%
Within the next five years, upwards of 70% of respondents intend to focus on cloud technology, upwards of 80% on data analytics and upwards of 90% on apps. Cloud
technology integration is a way to store large volumes of data, while managing cost pressures. The rising interest in apps can be tied to an accelerated focus on the demand for
virtual solutions, catalyzed by the pandemic. These apps will unlock the potential to better educate, monitor and manage patients, ensure treatment adherence and encourage
the shift toward decentralized clinical trial models.
2.1
“Protecting IP is crucial as the protection afforded to data requires a different approach that can drive a company’s ability to leverage the value of data
alongside or instead of products under new and emerging business models. Life sciences companies should have a clear understanding of the IP rights
available and the process for protecting innovations across the business, from creation through to development, manufacturing and marketing, as well as in
dealing with third parties such as investors, developers and manufacturers.”
Hiroshi J. Sheraton
Intellectual Property Partner, London
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2.2
Future-proofing With Legal Advice
Commercial implications of business model shifts are prompting medical devices and medtech
respondents to seek legal advice in areas such as government actions (39%), partnerships with other
life sciences companies and other industry sectors including technology and PE/VC funds (35% and
31%, respectively) and data issues (31%) within the next one to two years. As such, regulations and laws
around collaboration and data, as well as funding considerations, will shape the landscape to come.*
* To be covered in more detail in the next installment of this series
In Two to Five Years
(% respondents)
Apps
Cloud technology
Monitoring
Overall Top 3 Digital Focus Areas
Current
(% respondents)
Apps
Telehealth
Monitoring
52% 38%
51%
32%
50%
29%
2.2 Medical Devices and Medtech
Medical devices and medtech respondents are looking to evolve their businesses by adopting product-
service hybrid models. As such, legal and regulatory implications are front and center of the change
journey. Within the subsector, traditional medical device companies, in particular, are set to continue
adapting to a world where data and digital tools have become intrinsic to business renewal.
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How Digital Transformation and Data Are Shaping Business Models
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Digital Shift
of respondents already
consider themselves digital
service providers
see digital as intrinsically linked to
their business model
24%
33%
New Revenue Sources
are already integrating
technology/data to offer
product/service hybrids as a new
revenue source
intend to do so within the next
two to five years
41%
39%
Risk Barometer
see supply chain continuity as the
top risk area
cite cross-border data governance
as a key risk area
identified price pressure and
market access strategies as a
major risk area
35%
33%
33%
2.2
“Government action can greatly facilitate the evolution of life sciences business models. In particular, pharma and biotech companies can benefit
from grants, incubators and incentives, boosting the adoption of digital and data tools through clinical trials. In turn, digitalization can also
facilitate speed to market, development of drugs and drug approval. As medtech companies evolve and take on hybrid product-service models, it
will be essential to continue adopting and integrating digital and data tools.
In general, the future of life sciences collaboration is also contingent on potential regulatory shifts, should new devices and products cross and
require new approvals. Companies will need to have strong IP protection for data and manage cross-border data governance as well.”
Henrique Frizzo
Partner at Trench Rossi Watanabe*, Sao Paulo and Head of Healthcare and Life Sciences Latin America
*Trench Rossi Watanabe and Baker McKenzie have executed a strategic
cooperation agreement for consulting on foreign law.
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How Digital Transformation and Data Are Shaping Business Models
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Conclusion — Growth at a Glance3
Change has been in motion, in many ways accelerated by the pandemic. For many companies, the ability to adapt to new
business conditions has generated a need to assess, transform and safeguard their renewed business models.
At the crux of rapid and prolonged change is the crucial dive into specific areas of digital transformation
and the increasing importance of life sciences data. Life sciences businesses are now, more than ever,
integrating digitalization into the core of their business models. Over half (57%) of respondents are
considering data analytics and solutions as a potential revenue source. Within this set, almost one-third
say personalized care for patients is a key motivation, and 29% are motivated by value-based healthcare
initiatives. Additionally, one in four respondents say they are interested in differentiating their product
and/or service offering.
In order to shape and implement new business models, companies must be both bold and strategic. This
involves identifying key areas of business and legal support. Respondents in this research resoundingly
emphasize two key issues: data-related issues and the impact of government action(s). Again, such
concerns translate into identified risks which center very much around digital and data issues such as
compliance, data storage and management and IP protection for data.
Digital transformation and healthcare data are double-edged swords. While they present a realm of
advantages, they also bring new legal challenges and amplify existing ones. The impact of government
actions is a significant concern for respondents across the globe as are legal issues arising out of
collaboration and partnerships with other life sciences companies. Tax and employment and labor
issues are major concerns as well. In addition, the healthcare and life sciences industry has always been
highly regulated, plagued by lack of regulatory harmonization and regulatory voids across the globe.
These problems have increased and taken on greater relevance in light of digital transformation and the
importance of data within the industry.
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Digitalization is no doubt a frame of reference for how life sciences business models have begun to evolve and will
continue to do so over the next five to ten years. However, the far-reaching impact of digital transformation on
businesses and indeed the life sciences ecosystem will affect other key aspects of business renewal such as patterns of
growth, funding, supply and manufacturing, as well as the nature of collaboration and partnerships.
Upcoming reports from Baker McKenzie’s Life Sciences Business Evolution Series will explore these themes and more,
citing key steps businesses can take to capture growth.
Complementary to this series, we invite you to explore our Hyper-Hybridity report, which explores challenges, priorities
and potential collaboration pathways in digital health, as well as our upcoming 2021 Digital Transformation and Cloud
Survey report, which features key trends for digital transformation and cloud strategies for businesses.
Data/tech-savvy actors
are essential for digital
transformation and data
issues, but cannot function
without meaningful
interaction with digital
health professionals.
Regulators around the
world must improve their
knowledge of digital
transformation and data.
Regulators would greatly
benefit from sharing
their thoughts around new
legislation with
other regulators and
industry players.
Digital transformation
represents a drastic cultural
transformation, especially
for patients. Interaction
with patients to lead them
through the transformation
and gain their trust is
essential to success.
3
Digital transformation cannot be treated as an isolated goal. To the contrary, it poses a new and critical need for interaction among multiple
stakeholders, many of whom are vastly different. Businesses should consider these four key areas:
Conclusion (continued)
Life Sciences Business Evolution Series
How Digital Transformation and Data Are Shaping Business Models
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Vanina Caniza
Global Head of Healthcare and
Life Sciences
Buenos Aires
+54 11 4310 2226
vanina.caniza@bakermckenzie.com
Anne Petterd
Head of International Commercial & Trade
Asia Pacific, Sydney
+61 2 8922 5888
anne.petterd@bakermckenzie.com
Randall B. Sunberg
Head of Healthcare and Life Sciences
North America, New York/Princeton
+1 212 626 4525
randall.sunberg@bakermckenzie.com
Khelin N. Aiken
FDA Regulatory & Compliance Partner
Washington DC
+1 202 452 7007
khelin.aiken@bakermckenzie.com
Henrique Kruger Frizzo
Partner at Trench Rossi Watanabe*
and Head of Healthcare and Life
Sciences Latin America, Sao Paulo
+55 11 3048 6905
henrique.frizzo@trenchrossi.com
Hiroshi Sheraton
Intellectual Property Partner
London
+44 20 7919 1889
hiroshi.sheraton@bakermckenzie.com
Roel Meers
Head of Healthcare and Life Sciences
EMEA, Brussels
+32 2 639 36 51
roel.meers@bakermckenzie.com
Stephen E. Reynolds
Data & Technology Partner
Chicago
+1 312 861 2895
stephen.reynolds@bakermckenzie.com
Elisabeth White
Head of Healthcare and Life Sciences
Asia Pacific, Sydney
+61 2 8922 5386
elisabeth.white@bakermckenzie.com
Joanna Ludlam
Global Co-Chair, Compliance &
Investigations, London
+44 20 7919 1822
joanna.ludlam@bakermckenzie.com
Julia M. Wilson
Employment & Compensation Partner
London
+44 20 7919 1357
julia.wilson@bakermckenzie.com
Adam Aft
Global Co-Lead Technology
Transactions, Chicago
+1 312 861 2904
adam.aft@bakermckenzie.com
Key Contacts4
*Trench Rossi Watanabe and Baker McKenzie have executed a strategic
cooperation agreement for consulting on foreign law.
Life Sciences Business Evolution Series
How Digital Transformation and Data Are Shaping Business Models
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