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V7 CMS23 - 037 2024 Pharma Trend Report

The pharmaceutical industry is increasingly adopting digital technologies like generative AI and big data analytics to digitize supply chain management in 2024. These technologies help optimize production processes, inventory management, and quality control. They also improve transparency across the supply chain. At the same time, cybersecurity is a growing concern as more sensitive data is collected and shared digitally. Regulatory bodies recognize data-driven manufacturing can boost efficiency while ensuring quality and compliance.

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100% found this document useful (1 vote)
233 views60 pages

V7 CMS23 - 037 2024 Pharma Trend Report

The pharmaceutical industry is increasingly adopting digital technologies like generative AI and big data analytics to digitize supply chain management in 2024. These technologies help optimize production processes, inventory management, and quality control. They also improve transparency across the supply chain. At the same time, cybersecurity is a growing concern as more sensitive data is collected and shared digitally. Regulatory bodies recognize data-driven manufacturing can boost efficiency while ensuring quality and compliance.

Uploaded by

thanhloyal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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In Partnership

with

2024 Pharma Trends Outlook:

Collaboration,
Market Maturity,
and Digital Futures
In Partnership
with
Contents

2024 Pharma Trends in Focus


1. Generative AI and supply 7. Pricing, cost, and patients -
chain digitisation balancing the pharma trinity Contributors
2. Consumer driven 8. Evidence-based
packaging innovations herbal medicines
3. Mature quality 9. The future of B2B
management and control pharma marketing
4. Biotech and R&D 10. Accelerating References
outsourcing practices: Alzheimer’s research
investing and acquiring 11. What 2023 drug approvals
5. Collaborative sustainability mean for 2024
by all, for all 12. Middle East rising:
6. Making excipients great again an emerging market in focus

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 2
In Partnership
with
Key Findings

Introduction
The 2023 CPHI Online Pharma Trends Report priority for the industry. Cross-industry enhance efficiency in delivering medicines
delved into critical issues, from reshoring collaboration for sustainability initiatives, to patients securely and on time.
drug production to manufacturing the US FDA’s Quality Management Maturity
The CPHI Online 2024 Pharma Trends
reimagined through Pharma 4.0, program, and patient-centric packaging
Report, sponsored by Arvato Systems,
exploring how the industry grappled designs are leading the pharmaceutical
dissects emerging trends. From the impact
with challenges like supply chain industry into the future. Underpinning these
disruption, security, and escalating strategies is the increased digitisation of of generative AI on the supply chain to
drug manufacturing costs. Amidst the supply chain with generative AI and mature quality management plans for
these hurdles, 2023 provided a chance machine-learning technologies. biomanufacturers, excipient market
for the pharmaceutical supply chain growth, biologics outsourcing, and more,
Arvato CSDB is a leading example of the these expert insights provide a valuable
to proactively address issues, marking
digitisation of the industry – a software outlook for those navigating the global
a shift towards resilience and quality
providing proven serialisation solutions
management. supply chain in 2024.
to over 80 pharmaceutical companies,
Learning from the past, the industry ensuring seamless implementation of Klaus Fetzer
is embracing a proactive mindset, legal requirements against counterfeit Managing Director Health & Public,
propelling it into a new era of supply medicines. This positive shift is anticipated Arvato Systems
chain robustness. Protecting consumers to extend into 2024, with initiatives and
from supply shortages, adulteration, guidance fostering industry investment
and counterfeit products remains a top and collaboration. The goal is clear:

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 3
ADVERTISEMENT
1

Generative AI
and supply chain
digitisation
In Partnership
with
Generative AI and supply chain digitisation

Generative AI enabling better inventory management and minimising


risks of shortages or excess inventory.”

and supply chain Big Data Analytics was one of our 2023 Pharma Trends
Report predictions. Many expect it to continue pushing the

digitisation
industry towards digitalisation in efforts to reduce product
lead times and manufacturing costs [1].

2024 will see the evolution of digital technologies for supply


chain management, according to Stefan Moch, VP Health
of Arvato Systems, who sees this manifesting in two major
ways. “One of the two topics is Big Data Analytics in the
pharmaceutical industry,” he states. “Big Data Analytics
is revolutionising pharmaceutical manufacturing, with
a significant impact on quality control and regulatory
compliance. Manufacturers employ data analytics to
monitor and control product quality by analysing data from
various sensors and equipment. Additionally, production
processes are optimised through the identification of
bottlenecks, waste reduction, and efficiency improvements.
Data analysis is integral to supply chain management,

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 6
In Partnership
with
Generative AI and supply chain digitisation

Data-oriented manufacturing for pharmaceuticals has the supply chain – transparency is a critical element for
been acknowledged by regulatory bodies as a means sustainability and resiliency, and frankly, we are not moving
of not only reducing costs and time-to-market, but also fast enough or with sufficient purpose. Too much data with
ensuring quality and efficiency of processes. With many no data architecture will impede the industry’s progress.”
steps in the pharmaceutical manufacturing process Moch also cites cybersecurity as a leading trend for the
generating large amounts of data from numerous digitalisation of the pharmaceutical supply chain. “A
sensors and equipment, the ability to gather, sort, store, ‘taboo subject’, it is one that should be the focus of every
and analyse all this information will differentiate leading company, especially in an industry with such sensitive
manufacturers from the rest. data,” he states. “In a time where not only criminals but
“In biopharma specifically, it has been challenging to also governments use cyber-crime for their purposes,
balance demand and supply post-COVID,” comments cybersecurity plays a critical role in the pharmaceutical
Nicola Coles, Phorum Director at BioPhorum. “During sector, ensuring the protection of sensitive data such as
the pandemic, healthcare purchasers and governments patient records, research findings, and valuable intellectual
stocked up on medicine and licence holders stocked property.”
up on manufacturing technology and ingredients. Then, Bikash Chatterjee, President and Chief Scientific Officer
demand fell off a cliff. This has had a huge impact on the at Pharmatech Associates, agrees: “Applying machine
pharmaceutical supply chain.” Though Coles acknowledges learning and artificial intelligence can optimise and
these difficulties in supply, AI technologies will be the way accelerate all aspects of bioprocessing, from cell culture
forward for a resilient supply chain: “I would like to see AI and upstream processing to downstream processing with
harnessed to accelerate the flow of information across chromatography and filtration. PAT sensor technology

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 7
In Partnership
with
Generative AI and supply chain digitisation

and sophisticated chemometric modelling all continue to


improve in terms of accuracy, thanks to the maturation of
support vector machine quantum computing software and
analytical tools.”
Digitalisation is not restricted to the manufacturing of
the drug product itself – pharmaceutical packaging is
seeing an uptick in active and intelligent design, with the
market expected to grow at a compound annual growth
rate (CAGR) of 9% by 2025 [2]. Active pharmaceutical
packaging refers to packaging design engineered to
respond to changes in atmospheric conditions inside
and outside the package itself [2]. This is in contrast to
the standard inert packaging solutions well-known to the
industry. With more complex therapeutics entering the
market, pharmaceutical packaging must keep pace with
changing industry demands. “The use of smart packaging,
such as intelligent labels and RFID tags, enables real-time
monitoring of medication usage, temperature control,
and expiration dates,” Peter Schmitt, Co-Founder and
Managing Director at Montesino, states. “This technology

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 8
In Partnership
with
Generative AI and supply chain digitisation

ensures medication safety and enhances patient shortage scenarios. Moreover, generative AI expedites drug
adherence.” Moch warns that inadequate digitisation of development, potentially offering alternatives to critical
certain parts of the supply chain may result in internal drugs in short supply. By embracing these digital tools,
disruptions by “hindering the tracking and management pharmaceutical companies can better predict, manage,
of raw materials and finished drugs, contributing to supply and mitigate the impact of drug shortages, ensuring
chain vulnerabilities. This ultimately leads to shortages of reliable access to essential medications for patients.”
medicines around the globe.” He emphasises the value
in stakeholder communication: “Effective communication
among stakeholders is pivotal for managing shortages,
and poor digitisation can impede this exchange, making it “The use of smart packaging, such
difficult to coordinate responses effectively. as intelligent labels and RFID tags,
For example, Generative AI and advanced digital enables real-time monitoring of
technologies are playing increasingly central roles in medication usage, temperature
alleviating drug shortages in the pharmaceutical industry. control, and expiration date. This
These technologies can optimise the pharmaceutical
technology ensures medication safety
supply chain by forecasting demand, identifying potential
bottlenecks, and improving inventory management... these
and enhances patient adherence.”
technologies facilitate seamless communication and Peter Schmitt
Co-Founder and Managing Director, Montesino
collaboration among stakeholders in the pharmaceutical
ecosystem, ensuring efficient coordination during potential

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 9
2

Consumer
driven packaging
innovations
In Partnership
with
Consumer driven packaging innovations

Consumer With such figures, Berta Mota, Circular Economy Director


at Anthesis Group, emphasises that pharmaceutical

driven packaging
packaging must be more than an afterthought.
“Many pharma companies have been working on

innovations
improving their pharmaceutical packaging, and analysing
which part of their operations relates to packaging
better understand the magnitude of these processes,”
Mota states. “Although changes of packaging in pharma
2023 saw the rise of the Contract Packaging Organisation can be more complicated and restricted than in other
(CPO) and an increase of outsourcing activities in the sectors, there is room for improvement – it is a question of
packaging sector; the global pharmaceutical contract identifying where we can create change either in the short
packaging market size is projected to grow 7.43% from 2023 term or long term. This also helps the whole company and
to 2030 [3]. Advancements in technology and changing all departments involved understand which direction to
industry needs are constantly pushing the pharmaceutical follow and set up internal policies to make pharmaceutical
packaging sector to evolve, and 2024 is poised to be a packaging operations be more sustainable and circular.”
transformative year with incoming regulations around
Patient-centric packaging is top of the priority list for
sustainability and safety.
pharmaceutical packaging experts. Schmitt comments
Globally, the pharmaceutical packaging market is that “As personalised medicine becomes more prevalent,
predicted to reach a value of USD $90 billion by 2030 [4], pharmaceutical packaging will also become tailored
with some estimates predicting up to USD $1 trillion [5]. to individual patients. Customised dosing instructions,

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 11
In Partnership
with
Consumer driven packaging innovations

patient information leaflets, and packaging design will the USD $1.75 billion spent on pharmaceutical cold chain
cater to specific patient needs.” User-centric design can logistics was spent on pharmaceutical packaging [6].
range from child-resistant packaging and senior-friendly Continued advancements in pharmaceutical packaging
containers through to intelligent packaging to increase will also be spurred by the development and approval of
patient adherence [2]. Smart packaging can enhance user biologic drugs and complex therapeutics.
experience: increased health literacy with QR-enabled “The rise of biologic drugs, which require specialised
packaging, RFID tags to identify and monitor side effects in storage and transportation conditions, will drive the
real-time, and wearable drug delivery devices exemplify development of new packaging solutions,” Schmitt states.
the potential of smart packaging to improve health Temperature-controlled packaging and advanced cold-
outcomes and trusted interactions between patients and chain logistics will be the frontrunners for such solutions.
the wider pharmaceutical industry [2].
Innovations in pharmaceutical packaging will also force the
By 2025, the market for active and intelligent packaging industry to evolve their operations, with much movement
is expected to grow at a CAGR of 9% [2]. The potential for towards outsourcing partners for packaging. “There are
smart packaging reaches beyond just the patient – supply two separate trends here,” Schmitt explains. “The move to
chain logistics are also reaping the benefits first-hand. outsource pharmaceutical packaging is driven by cost and
Real-time tracking of cold chain transportation provides operational efficiency, lower capital requirements, flexibility
rapid identification of potential risks, proactively responding and scalability. Mature oral solid dosages will continue to
with corrective measures to ensure product safety and lead this trend from in-house to outsourced. The move to
quality [6]. Additionally, such technologies can protect personalised medicine and biologics and corresponding
against costly reactive actions – in 2020, nearly 30% of decrease in Minimum Order Quantity MoQ will drive a trend

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 12
In Partnership
with
Consumer driven packaging innovations

toward in-house packaging. Here, Regulatory and Quality


Control concerns, IP protection, and strategic flexibility “The rise of biologic drugs, which
are key. These trends highlight the ongoing evolution of require specialised storage and
pharmaceutical packaging to meet the needs of patients, transportation conditions, will drive
healthcare providers, and regulators. By embracing
the development of new packaging
innovation and sustainability, the trend continues to
enhance medication safety, improve patient experience,
solutions.”
and reduce environmental impact.” Peter Schmitt
Co-Founder and Managing Director, Montesino
Coles also states the need for standard guidance in areas
of sustainability for packaging. “Shifting to recycled content
for packaging and devices requirements is a classic
example of a change that is encouraged through one set of initiatives, with a particular focus on pharmaceutical
regulations, but this requires alignment of CMC Regulatory packaging. The production and transportation of
to implement at scale. We need to discuss co-validation pharmaceutical products contributes the most significant
wherever possible – a product licenced today could be on impact to the pharmaceutical industry’s carbon footprint
the market unchanged for 30+ years. We need to create [7]. Alternative materials, manufacturing processes,
regulatory environments that encourage flexibility and and transportation methods are all at the frontiers of
rewards innovation rather than stifling it.” sustainable innovation.

In the nearer future, sustainable manufacturing practices However, Mota emphasises the need to go beyond
and a total mindset shift will be at the centre of ESG “replacing materials with alternatives. This can help to

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 13
In Partnership
with
Consumer driven packaging innovations

create more circular and less impactful products but there


is room for improvement on strategies like re-use where
applicable, including take-back systems. The material we
are replacing with an alternative might not be needed,
and we could probably create a packaging that is half
the weight (a monomaterial), one that can even be
included in a take-back system. My colleague Ellen Struther
recently presented at Pharmapack about ‘Designing and
Implementing Successful Take Back Schemes for Used
Devices and Packaging’.”

Despite the combined efforts of the supply chain, there is


still a long way to go for Mota. “Many countries now have
well-developed recycling systems for standard formats of
packaging materials, but pharma materials can sit outside
the ‘normal’ formats because there are multiple materials,
product residues, non-standard shapes etc. Implementing
take-back schemes can be part of the solution while
ensuring that they are ethically operated and legally
compliant.”

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 14
3

Mature quality
management
and control
In Partnership
with
Mature quality management and control

Mature quality to manufacturing or product quality issues, such as


substandard manufacturing facilities and quality defects in

management
finished products [9].
Up to now, this preparedness has focused on actions to be

and control
taken after such disruptions occur. Many within the industry
are now calling for proactive, front-end quality assurances,
regardless of supply chain continuity (or discontinuity).
Designing quality assurance into operations and processes
Last year saw increasing demands for nearshoring and upfront can help organisations better position themselves
re-shoring efforts to build supply chain resiliency. Ongoing
en-route to market [10].
global instability, including conflicts in Ukraine and Gaza,
continue to disrupt delicate supply chains. The US FDA For Moch, Big Data Analytics will be an integral part of this
reported that while the number of new drug shortages preparedness: “Predictive maintenance is another key
had fallen significantly from a high of 250 in 2011 to just 49 application, allowing for proactive equipment maintenance
in 2022, the US FDA emphasises that continued shortages and reduced downtime. Real-time monitoring, support
pose a real threat to public health [8]. The EMA have for drug development, and maintaining detailed records
also released a guidance on shortage preparedness for for regulatory compliance are all facets of how Big Data
Autumn/Winter 2023–2024, citing shortages in critical Analytics enhances pharmaceutical manufacturing.” He
treatments such as amoxicillin [8]. In 2019, the Federal is also optimistic about the use of generative AI in the
Drug Shortage Task Force reported that 62% of drugs that standardisation of quality control and data extraction for
went into shortage between 2013 and 2017 were linked decision-making: “Generative AI can create regulatory

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 16
In Partnership
with
Mature quality management and control

compliance with regulatory requirements. It can also


produce detailed quality control reports by extracting data
from sensors and manufacturing equipment. This ensures
the consistency and quality of pharmaceutical products
throughout the manufacturing process.”
The continued digitalisation of the pharmaceutical supply
chain may very well extend through to active quality
control for manufacturers and pharmaceutical companies.
Yet, in a highly regulated industry, it is important to place
precision and predictability at the centre of business and
operational decisions. This makes the implementation
of generative AI in the pharma supply chain a challenge
due to the “inherent probabilistic nature of AI outcomes”,
as Moch states. “Sovereign AI, deployed in controlled
environments, offers a promising solution that harmonises
these seemingly opposing requirements. Sovereign
AI refers to the application of large language models
submission documents by extracting and summarising like Chat GPT within secure, managed clouds, private
relevant information from extensive text data sources. cloud environments, or even on-premises by using
This aids in expediting the approval process and ensures quantised models. This deployment flexibility provides

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 17
In Partnership
with
Mature quality management and control

pharmaceutical businesses with a range of options to quality management practices’ [11]. These practices
achieve the level of control and predictability needed to include both tangible solutions and cultural mindset shifts
meet regulatory demands. AI models can be deployed on concerning quality management [11].
high-performance cloud computing infrastructure, private Sireesha Yadlapalli, CEO of Pharmatech Associates,
clouds, and on-premises setups, all fully adhering to data discussed the importance of such programmes in her
regulations and compliance standards. Importantly, these presentation at CPHI Barcelona in October 2023: “Over the
servers and environments can be strategically located last few years, there’s been significant focus on regulatory
in the same jurisdiction as the pharmaceutical business, oversight and regulatory actions. Issues such as product
ensuring alignment with regional legal terms and providing recalls and drug shortages all continue to point to the
regulatory certainty. Within this framework, adhering to importance of focusing on quality...now, we cannot just
the pharmaceutical industry regulations is facilitated. The address quality at the backend by checking whether
sovereign AI model is inherently designed to function within somebody is complying – we need to start at the front end
these frameworks, reducing the friction that often occurs and ask what can be proactively put in place to ensure
when integrating AI into regulated processes.” quality. QMM is a great initiative that looks at culture
Regulatory authorities have also recognised the approaches, fostering a mindset of continual improvement
importance for drug manufacturers and developers to that we hope will result in fewer backend issues that require
implement a quality culture mindset. In August 2023, the correction actions, at a huge cost for all involved.”
FDA’s Center for Drug Evaluation and Research launched Such mindset changes and their evaluation are still being
the Quality Management Maturity Program, aimed at prototyped, but companies are already involved with the US
encouraging drug manufacturers to implement ‘mature FDA’s QMM programme – a positive shift towards mature

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 18
In Partnership
with
Mature quality management and control

quality management throughout the industry. In 2023, the the familiar LMS or training platforms and tools serving the
EMA also updated the ICH Q9 with similar guidance on pre- pharma industry,” she states. “Over the years, these tools
emptively mitigating quality issues in risk management have evolved to support our compliance-based view of
plans [12]. training (e.g. reading procedures and completing training).
What we see emerging during health authority inspections
Additionally, the rise in complex therapeutics, biologics, and
in recent years is stronger interest in a company’s ability
biosimilar manufacturing brings their own set of challenges
to demonstrate that employees are qualified to perform a
[11]. With patents expiring on established drugs, many
function or activity, and the inspectors are astute enough
pharmaceutical companies must contend with the quality
to understand that reading a procedure is not enough.
measures required for commercial production of these
Combine this external pressure with the ever-increasing
products. Designing with quality assurances into each
needs of our industry to respond and deliver at faster
process and aligning these considerations can reduce
speeds, and you end up needing different learning systems
disruptions in the manufacturing and commercialisation
that are at their core adaptive, learner-centric, and support
process, ultimately getting a drug product to market faster
competency-based learning. What’s more, the days of
at less cost [11].
“death by PowerPoint” as a training method are over as
Stephanie Gaulding, CQA, CPGP Managing Director of learners’ demand and expect content in their preferred
Pharmatech Associates also points to a rise in technologies learning style and the ability to learn through collaboration
and digital transformations that empower employees to with others. Our learning experiences going forward will
demonstrate a company’s mature quality management. look more like pathways for employees to navigate and
“There is a trend driving our industry towards competency- consume at their own pace, coupled with collaborative
based learning, so there will be a big change in many of spaces like those that exist in Slack or MS Teams.”

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 19
In Partnership
with
Mature quality management and control

Relegating quality control to an afterthought and not at the the sharing of critical information among stakeholders,
forefront of innovation risks inefficiency and slower time to hampering efforts to predict and address shortages...these
commercial markets. “Regulatory challenges are amplified technologies streamline regulatory compliance through
by inefficient digital systems, resulting in slower regulatory automated data analysis and document management,
processes and inspections, ultimately causing production accelerating approvals and minimising production
disruptions. Real-time monitoring and transparency are
interruptions and drug shortages,” Moch comments.
enhanced through generative AI, allowing for quick issue
“The lack of transparency within the supply chain is a well- identification and response. Data-driven decision-making
documented issue, with modern digital systems capable of supported by AI insights helps allocate resources efficiently
greatly enhancing transparency. Poor digitisation obstructs and adapt to market changes.”

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 20
4

Biotech and R&D


outsourcing practices:
investing and
acquiring
Biotech and R&D outsourcing practices: In Partnership
with
investing and acquiring

Biotech and R&D


outsourcing
practices:
investing and
acquiring
Our 2023 CPHI Annual Report, which compiles results from
the CPHI Annual Survey of over 250 pharma executives
along with expert analysis of the industry, anticipates a rise
in biotech funding and growth within the pharmaceutical
contract services sector [13]. Additionally, a survey
conducted by Scorpius Biomanufacturing revealed that, out
of 100 respondents, more than half believed their

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 22
Biotech and R&D outsourcing practices: In Partnership
with
investing and acquiring

companies’ outsourcing activities would increase from


2024–2026 [14].
Another 37% expected their outsourcing activity levels
to remain the same [15]. As more and more complex
therapeutics move from R&D to clinical trials and eventually
the commercial market, pharmaceutical companies and
biotechs are rethinking their biomanufacturing studies
for 2024 and beyond. The market for biologics has grown
rapidly, despite the biotech slowdown of recent years [15].
With estimated CAGRs of between 4% and 9.24% by 2030,
the market is estimated to reach USD $500 billion [15].
Biologics are estimated to make up 55% of all innovative
drug product sales by 2027 [14].
With a number of biologics losing exclusivity as patents
expire, the market is primed for biosimilar development and
commercialisation [16]. However, Dan Stanton, Managing
Editor at BioProcess International, states this may be
more difficult to achieve with advanced therapeutics:
“Over the past few years, the contract development and
manufacturing organization (CDMO) sector has seen

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 23
Biotech and R&D outsourcing practices: In Partnership
with
investing and acquiring

dozens of new entrants, driven by the complexities and the biologics R&D boom [15]. So where does that leave the
technological needs of cell and gene therapies, and CDMO space and its players?
intensified through the COVID-19-driven gold rush. But
Stanton explains: “As with all good ‘boom and bust’ cycles,
advanced therapies have somewhat stalled in reaching there are those ready to pick up the pieces, whether they
their commercial potential and the post-pandemic are large players looking to pick up tech and expertise, or
landscape has resulted in overcapacity. Combined with ambitious mid-sized manufacturers hoping to grow by
the difficult investment biotech backdrop, it must be asked acquisition to challenge the likes of Lonza, Fujifilm Diosynth,
whether demand can sustain the current number of start- and Samsung Biologics. We’re already seeing the latter
up CDMOs?” happen through deals such as Ajinomoto’s merger with
The demand for R&D occurring in the biologics arena will Forge Biologics.”
require companies to make critical decisions regarding Additionally, the biotech slowdown of 2019–2022 may be
resource management and outsourcing activities for nearing a shift. Research from the CPHI Annual Report
successful and timely delivery of therapeutics [15]. “We’ve 2023 suggests biotech funding may also be a key driver in
already seen some firms move away from the CDMO space increased contract services trends [13]. Total funding for
– Emergent BioSolutions’ ‘de-emphasis’ on the business, the biotech sector sat at USD $30.2 billion in July 2023, with
Baxter’s exit from the sector, PE-backed AcuraBio shutting the full year trading ahead of 2022 [13]. Though funding for
up shop, for example – and this trend is likely to continue, biotechs is still half the levels of 2020, the tides may change
or even intensify over the coming period,” Stanton states. for R&D pipelines, and consequently CDMO activities, in the
Yet, 71% of the CPHI Annual Survey respondents state that near future [13]. This change might already be in the air –
the drive towards increased outsourcing is being fuelled by Cromatic, a full-stack digital platform for outsourcing

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 24
Biotech and R&D outsourcing practices: In Partnership
with
investing and acquiring

life sciences research, announced in November 2023 their


closure of USD $5.3 million in funding from venture capital
(VC) [17]. With the goal of matching biotechs to relevant
CROs across the industry, investment into platforms such
as Cromatic may be spelling out an increase in outsourcing
activity for the pharmaceutical industry like never before.

“Furthermore, it’s likely new players will see an opportunity


to move into the space and leverage their core life sciences
services to drive synergies in the CDMO space,” Stanton
states. “Bioprocess vendor Danaher, for example, could
make good on rumours it wanted to add a Catalent-
sized CDMO to its offering. Meanwhile, players from India
including Aurobindo and Aragen, perhaps buoyed by the
rapid growth of WuXi Biologics and Korean CDMOs, are
signalling their intentions to become global players in the
space. And with the CDMO environment described above,
acquiring rather than building would make the most sense.”

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 25
5

Collaborative
sustainability
by all, for all
In Partnership
with
Collaborative sustainability by all, for all

Collaborative pharmaceutical industry, at present, are scope 3 emissions


and overall decarbonisation of the supply chain, which

sustainability by
occur throughout the supply chain and are difficult to
quantify from indirect third-party contributors [18].

all, for all


This way, collaboration among industry players is the
best approach to set up and standardise expectations.
“The Pharmaceutical Supply Chain Initiative (PSCI) is the
Pharmaceutical and Healthcare industry group leading this
Environmental, social, and corporate governance collaborative approach,” states Radó.
(ESG) are a continuing point of discussion for the
pharmaceutical industry in 2024. This year we published Yet, such considerations and collaborations across the
our CPHI Sustainability Report 2023, we explored how entire supply chain are exactly what the pharmaceutical
the pharmaceutical industry produces 55% more industry must face together, Mota states: “Strengthening
emissions than the automotive industry. This makes it ties with upstream and downstream players is key. Because
one of the largest global contributors to greenhouse gas scope 3 emissions are not directly controlled by companies
emissions [18]. For Enric Bosch Radó, Global Third-Party despite being responsible for the biggest portion of impact
Chemicals Manager/Human Pharma Supply Chain within companies, it is unreasonable to assume a company
at Boehringer Ingelheim, future sustainability hurdles alone can reach ambitious decarbonisation goals. Not
for the pharmaceutical industry involve “water scarcity only can partnerships help to establish more realistic and
and pharmaceuticals in the environment/antimicrobial transparent objectives, but they also balance efforts. This
resistance.” One of the most problematic issues for the is not a one-year job – it will take time and needs to move

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 27
In Partnership
with
Collaborative sustainability by all, for all

forward steadily without time for a pause.” requirements are enables suppliers to gear up,” she states.
“Suppliers need strong signals from licence holders so
Mota cites Ferrer Pharma’s presentation at CPHI Barcelona,
focused on their Sustainable Packaging Model, created that they can direct resources to sustainable alternatives.
with the support of Anthesis. It is a part of Ferrer’s objective The more coherent licence holders can be, the faster this
“to lead change towards more sustainable production ship will turn. That coherence is coming from carbon SBTi
by adopting criteria and commitments that minimise the commitments – a strong commitment and signal for the
environmental footprint of its containers and packaging,” need to reduce emissions. But I do not see that clarity for
Mota explains. “Of course, this is not done in a month, but circularity and without it, we cannot hope to achieve our
it is an iterative and long-term process, which involves stated emission targets.”
the collaboration of different departments as well as key
Aurelio Arias, Director, Thought Leadership at IQVIA, also
players such as providers.”
comments on the impact of scope 3 emissions for the
Additionally, initiatives like the PSCI or Together for pharmaceutical industry: “Pharmaceutical companies,
Sustainability are committed to the dissemination realising the urgency of environmental stewardship,
of information amongst its members. Supplier audits are reporting commitments to curtail greenhouse gas
and assessments, once completed, are shared with all emissions in their ESG reports. Aggregating the results
members, saving time and energy in conducting industry- of companies with extensive audits shows that scope 3
wide audits and creates more transparency. (indirect emissions throughout the supply chain makes up
Coles also sees the impact of licence holders as essential. 95% of a company’s average emissions, as shown in Figure
“Programs such as Energize and Activate are essential – 1. The complexities of scope 3 emissions mean that precise
with licence holders, communicating clearly what their reporting is challenging, but we do know that raw material

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 28
In Partnership
with
Collaborative sustainability by all, for all

extraction, manufacturing, and the use of medicines are the Figure 2:


largest components in scope 3 emissions,” Arias explains. Average Pharma emissions reduction (Percent of
“In 2022, there were sharp rises across Scope 3 for major company-reported baseline, CO2e)
companies as shown in Figure 2. This is due to various
factors including COVID-19 vaccine distribution, changes :

Figure 1:
Average Reported Emissions (n = 15, CO2e, 2022)

in transportation modes from sea to air, and increased


business travel as restrictions eased.
For Arias, collaboration will also be a key component of
coordinating ESG efforts in 2024. He states: “Tackling
these indirect emissions requires coordination and buyer

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 29
In Partnership
with
Collaborative sustainability by all, for all

pressure from healthcare systems, and 2024 will be the To be blunt – even as an industry full of scientists we
year when commitments are set. As part of an international have yet to fully experience our Enlightenment period. If
initiative attempting to achieve this stewardship, the WHO we did, we might also consider sustainable pharma in
launched their Operational Framework for Sustainable the context of sustainable society – truly tackling health
Healthcare Systems [19] on the run up to COP28. The key inequalities. We have a key role in shifting the agenda from
objectives of the framework are to guide and support them cure to prevention, which would make us sustainable. We
in strengthening their climate-related initiatives. So far, 74 have a key role in demonstrating how to manufacture
countries (since COP28) have committed to sustainable sustainably – not just in terms of carbon, but land use,
low-carbon healthcare systems [20], with 28 having gone water use, material sourcing. Sadly, I think there is a lifetime
a step further and pledged to achieve net zero. Every year, of work before we can consider sustainability achievable.
more and more countries pledge their commitments and But there are great minds working on this in every corner
with a model to follow, this will give further clarity in 2024 and of the industry – the trick is to connect them through
beyond.” Radó also states that while sustainability may be collaboration such as BioPhorum – to connect, collaborate,
an achievable goal, it will be “beyond 2024, as it will not be and accelerate.”
achieved in the short term but rather as a long-term goal.”
For scope 3 emissions in particular, organisations such as
Coles is less optimistic about the future of sustainability, Energize conduct Scope 3 Peer Groups. These cross-industry
but still emphasises the importance of collaboration. “The groups approach suppliers from the pharmaceutical and
majority of the industry has not yet developed clear plans chemical industries to report on scope 3 emissions. Meeting
to reduce carbon emissions, which I see as base camp on a monthly basis, these groups provide transparency
in terms of the transition to a more sustainable industry. throughout the industry supply chains.

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 30
6

Making excipients
great again
In Partnership
with
Making excipients great again

Making excipients That’s a worrying statement. After all that investment and
time to meet a therapeutic need, and then it fails because

great again
there isn’t an appropriate excipient.”
Market research projects a CAGR of 6.1% from 2022–2027 for
pharmaceutical excipients, while nutraceutical excipients
In last year’s CPHI Online 2023 Pharma Trends Report, are also projected at a growth rate CAGR of 6%. By 2029,
we took a look at how excipients may incentivise it is expected that the global market for pharmaceutical
biotechnological innovation [21]. The COVID-19 pandemic excipients will reach upwards of USD $12 billion [22]. With a
saw the use of two novel lipid excipients in mRNA vaccines. relatively stable market that is expected to only increase in
This bolstered existing interest in excipients – in 2021, the US its rate of growth to 2027, it’s little wonder CPHI Barcelona
FDA launched the Novel Excipients Pilot Program to further saw an explosion of excipient developers and service
incentivise research and manufacturing of novel excipients providers on the show floor this past year. Exhibitors such
[21]. as Roquette, Clariant, and IFF showcased such excipient
innovations as moisture-sensitivity and low nitrite solutions,
In a CPHI Online Feature Article, Iain Moore of IPEC Europe
while the inaugural CPHI start-up market welcomed
discussed the awakening of regulatory authorities to the
excipient manufacturers like Galvita AG [23].
importance of excipient development and manufacturing:
“I think the FDA are very enlightened – they did some This boom in excipient R&D and manufacturing is
surveys and got back some hard messages about being driven by several factors. An increasing demand
drug products failing to make it to market because the for generics, where close to 9 out of 10 prescriptions
excipients weren’t effective enough in delivering the API. administered in the US were for generics in 2023, is

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 32
In Partnership
with
Making excipients great again

leading to an increased need for their excipients [22].


With governments in developing countries boosting local
manufacturing of generics to improve healthcare systems
and cost burdens, the rise of generic drugs is pushing
the global demand for excipients [22]. Advancements in
personalised medicine, multifunctional ingredients, and
nanotechnology are also enhancing drug delivery solutions,
leading to the investigation of other excipient forms and
applications [24].
Excipient markets to watch for growth are led by the Asia
Pacific pharmaceutical excipient region. This market is
expected to grow to nearly USD $2 billion by 2028 [25].
China and India, similar to APIs, are leading the APAC
pharmaceutical hubs in manufacturing excipients for
the region [25]. Existing markets in North America and
Europe have also demonstrated strong growth, with the
US dominating the North American region and Germany
to lead the pharmaceutical excipients market in Europe to
meet the rise in production of novel drug medications and
the development of customised therapies.

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 33
7

Pricing, costs, and


patients - balancing
the pharma trinity
In Partnership
with
Pricing, costs, and patients - balancing the pharma trinity

Pricing, costs, putting the resiliency of the pharma supply chain to the
test. Recent GLP-1 supply chain shortages are just one

and patients -
such example – ongoing supply issues with Ozempic
(semaglutide) and Trulicity (dulaglutide) began in
September 2022 [26]. As of July 2023, all GLP-1 analogues

balancing the have been affected by these continuing supply chain


shortages [26]. “The off-label use of GLP-1 for weight loss

pharma trinity
has driven worldwide drug shortages and left patients
scrambling to find alternative supplies,” Chatterjee explains.
“Big Pharma companies are committing funds to build
Patient-centricity is now less of a trend and more capacity for both API and drug products while contract
a necessity for the pharmaceutical industry. Now, manufacturers struggle to keep pace with demand.
pharmaceutical companies and contract services must Realistically, intermittent shortages of GLP-1 receptor
finally contend with the delicate balance to be made agonists will be the norm through 2024, and potentially
between business and patient. Now, pharmaceutical 2025 for some programs, as Big Pharma looks to bring new
companies and service providers alike are contending capacity online.”
with the balance between rising costs and getting the right Despite increased manufacturing for generics, pricing
drugs to the right patients. challenges are putting pressure on drug manufacturers
Supply chain shortages are nothing new for the and their businesses, particularly in North American
pharmaceutical industry. However, new challenges are markets: “The US domestic market is in untested waters

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 35
In Partnership
with
Pricing, costs, and patients - balancing the pharma trinity

inflation in pharmaceutical pricing is expected to soar


Supply chain shortages are nothing into the double digits in 2024 [27]. “New modalities such
new for the pharmaceutical industry. as cell and gene therapy and mRNA vaccine technology
have increased from 11% to 21% of the drug development
However, new challenges are putting the
pipeline,” Moch states. “This change is likely to bring
resiliency of the pharma supply chain to more fragmentation of technology, new supply chains,
the test. and unique product life cycles. For instance, CAR T-cell
therapy is a type of treatment in which a patient’s T cells
are genetically engineered to express a chimeric antigen
regarding generic drug pricing,” Chatterjee states. receptor that targets a specific tumour antigen.” Continuing
“Between 2022 and 2023, more than 46% of drugs on the to invest in innovation and R&D will rely on the willingness
market saw prices increases above the inflation rate. The of drug manufacturers to balance patient access to
passage of the Inflation Reduction Act would penalise drug therapeutics [27].
manufacturers for price increases above the inflation rate
However, there may be some relief on the horizon for both
for any drugs sold to Medicare, and since Medicare makes
manufacturers and patients – the rise of biosimilars thanks
up approximately 18.7% of the US population today, its
to patent expirations can have a substantial effect on
impact on bottom line profitability is tangible. As inflation
managing rising drug costs [27]. “I would look for the larger
cools, so will the ability to raise prices significantly.”
generic drug manufacturers entering the US market to pivot
Inflationary pressures are not limited to generics – with toward biologic drugs and biosimilars that enjoy higher
accelerated approvals for new cell and gene therapies, margins compared to small molecule drug therapies, to

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 36
In Partnership
with
Pricing, costs, and patients - balancing the pharma trinity

better withstand downward pricing pressures,” Chatterjee


advises. Though the maturity of the biosimilar market is still
nascent, 2024 will prove to be a pivotal year for the industry
to test the 2023 launches of biosimilars to therapeutics such
as Humira.

Moch also sees the role of digitalisation throughout the


supply chain as essential but warns of the challenges: “The
pressure to digitise in the pharmaceutical industry is high.
Companies want to be competitive, minimise costs, and
streamline processes – with the help of digital solutions.
Informing, deciding, implementing all of that with the
acceptance of the employees is a big challenge. Effective
change management strategies are critical to successful
implementation,” Moch explains.

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 37
8

Evidence-based
herbal medicines
In Partnership
with
Evidence-based herbal medicines

Evidence-based in part by an interest in customised healthcare and


integrative medicinal practices, is paving the way for

herbal medicines
industry investment in research and manufacturing for
natural ingredients and products [29].

While interest in natural ingredients for therapeutic use is


Interest in nutraceuticals and natural extracts continues nothing new, science-based evidence for their efficacy and
to gather momentum; the nutraceuticals market grew to safety is on the rise, as demonstrated in the CPHI Online
USD $291.33 billion in 2022, with an expected CAGR of 9.4% Trend Report Pharma’s Next Big Opportunity: Exploring the
between 2023 and 2030 [28]. Nigel Pollard, Chair of the Potential of Herbal Medicines in Modern Healthcare.
Board of Directors for Empowered by Evidence, states that Consumers are not only scrutinising established and
“as some consumers become more informed through experimental pharmaceutical treatment options – they are
better access to evidence, there will be more incentives for critically analysing the science in support of nutraceuticals
companies to serve these consumers better with tangible, and natural ingredients. Ingredients that will see a surge
product-specific evidence of safety and efficacy.” in interest from pharmaceutical companies might include
The coming year is set to bring an increase in interest Ashwagandha, CBD, and psychedelics.
of evidence-based traditional remedies and natural
Regulatory incentives will also play a role. “Organic
ingredients for use in modern pharmaceuticals and
certification from the United States Department of
nutraceuticals.
Agriculture’s Strengthening Organic Enforcement rules and
Consumer demand for natural health products, driven Empowered by Evidence independent certification

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 39
In Partnership
with
Evidence-based herbal medicines

of reproducibility and specific clinical evidence are new


initiatives this year,” Pollard explains. “Also, regulators
continue to attempt to address issues of products that
are outside of clear regulatory pathways, such as the
Australian Therapeutic Goods Administration looking at
medicinal mushroom products. The responsible industry,
which is increasingly global in nature, has little guidance on
recognised international standards. This is an impediment
to patient and evidence-based innovation.” Increased
regulatory guidance and incentives in the coming year
will help push the research required for science-based
evidence for natural products.

Trending areas in the natural products market, according


to Pollard, include brain health and e-gaming performance,
with companies across the globe “seeking new innovative
product formulations and building the evidence base for
their products in this area.”

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 40
9

The future of B2B


pharma marketing
In Partnership
with
The future of B2B pharma marketing

The future of B2B company or consumer brand,” Raman Sehgal, Global


President and Founder of ramarketing, states. “We’re on

pharma marketing
that journey but for us it’s about getting visibility about
someone at a certain point of their customer funnel,
handing over some data, and eventually converting them
into a client.”
The power of in-person interactions cannot be understated
– as the events industry recovers from the COVID-19 More than 60% of healthcare providers state they use
pandemic, the appetite for a return to face-to-face digital media for professional purposes, and close to
meeting and events may be even larger than pre- 70% of patients are using digital solutions for healthcare
pandemic. However, the rise of digital B2B marketing for monitoring [31]. The successful pharmaceutical service
the pharmaceutical industry during the pandemic years provider will also make the shift towards digital solutions to
is set to continue in tandem with a return to in-person engage their business and customer base.
connections [30]. B2B pharmaceutical marketing must contend with a
Traditional channels of brand visibility and marketing saw changing customer landscape. Healthcare marketeers are
a leap towards digital and hybrid solutions during the shifting towards a digital mindset to continue delivering
pandemic, but pharma seemed to lag behind. “Part of the to their consumers [32]. The rise of digital therapeutics,
challenge for pharma marketing teams at the minute, precision medicine, and customised clinical trials and
particularly for CDMOs, CROs, or equipment manufacturers, therapeutics are leading to a digital marketing revolution
is that they don’t have sophisticated CRMs and marketing focused on delivering personalised customer experiences
automation systems that would expect from a tech [32].

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 42
In Partnership
with
The future of B2B pharma marketing

“Precision medicine refers to the creation of tailored treatment connections [31]. “The pharma industry now finds themselves
plans for individual patients,” Moch states. “In practice, with little choice than to adopt an omnipresent, integrated,
this is increasingly being done with technology and data. and data-driven approach,” Sehgal states.
Precision medicine takes into account differences between
individual patients and seeks to take advantage
of them with the aim to find the right drug for
the right patient at the right time.” This precision
in treatment plans must be mirrored in the
marketing practices of pharmaceutical vendors
as it will be an expectation by customers in
2024 for such digital solutions, including digital
engagement, telehealth, e-detailing, and direct-
to-consumer approaches [32].
According to IQVIA, evolving digital capabilities
will lead to greater interconnections between
pharmaceutical service providers, healthcare
providers, and the patients themselves
[31]. B2B pharma marketing will have to
adopt an omnichannel approach to digital
communications to nurture these multi-pronged

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 43
10

Accelerating
Alzheimer’s research
In Partnership
with
Accelerating Alzheimer’s research

Accelerating lecanemab – a humanised monoclonal antibody targeting


key abnormal proteins linked to dementia, beta-amyloid.

Alzheimer’s
This significant milestone followed the 2021 approval of
another amyloid antibody aducanumab.

research
Landmark progress has been made in the past year for a
phase III clinical trial that demonstrated that donanemab,
a monoclonal antibody, significantly slowed cognitive and
functional decline in patients [33].
“The impact of neurological diseases (Alzheimer’s disease,
multiple sclerosis, Parkinson’s disease etc.) is two-fold,” It’s important to note that the observed changes were
states Alan Palmer, CEO of Elixa MediScience. “The first is small and the clinical meaningfulness is not yet entirely
morbidity and the second is mortality (death). Neurological clear. Nevertheless, these findings pave the way for further
disorders have such a profound effect that the term exploration and hold great promise in the ongoing quest for
Disability-Adjusted Life Year (DAL) accounts for the number effective treatments.
of years lost because of premature death due to the Successful study results have also probed the
disorder and the number of years lived with a disability. For quantification of Alzheimer’s disease biomarker proteins
neurological disorders, the global number of DAL years is with a whole-blood test, which can be developed into a
270 million.” screening system for the detection of Alzheimer’s disease
before symptom onset [34].
In a ground-breaking year for Alzheimer’s disease
treatments, the FDA granted accelerated approval for For Palmer, 2024 will bring an increased focus to Alzheimer’s

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 45
In Partnership
with
Accelerating Alzheimer’s research

disease research development and therapeutic innovation.


“Some of the biggest steps forward in the last year for the
pharmaceutical industry regarding Alzheimer’s disease
treatments are amyloid-based therapies approved by the
FDA. These approvals have stimulated pharmaceutical
industry interest, and the market for a drug that slows
disease progression or delays disease onset (or preferably
both) onset is huge,” he explains. Plans are in work for
human clinical trials for novel neurodegenerative disease
drugs such as biopharma company CuraSen Therapeutics,
which received USD $5.8 million in funding from the
Alzheimer’s Drug Discovery Foundation to cover trial costs in
2024 [35]. “Some of the biggest steps forward in
“The baby boomer generation is aging and this is going the last year for the pharmaceutical
to have a profound effect on the impact of neurological industry regarding Alzheimer’s disease
disorders in the near future,” Palmer explains. “The global treatments are amyloid-based
incidence of dementia in 2019 was 57 million. By 2050, this
therapies approved by the FDA.”
number is expected to be 153 million. This will place huge
Alan Palmer
pressures on healthcare systems across the globe. So the
CEO of Elixa MediScience
need is big and the need is growing starkly.”

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 46
11

What 2023 drug


approvals mean
for 2024
In Partnership
with
What 2023 drug approvals mean for 2024

What 2023 wealthy nations [37]. Some treatments, such as in the case
of GLP-1s, are repurposed from their original indications, and

drug approvals
have since gained approval for others. Several GLP-1 receptor
agonist treatments gained approval for indications like non-
alcoholic fatty liver disease and diabetes, mainly acting on

mean for 2024 insulin levels within patients [37]. When weight loss effects
were observed in these trials, manufacturers have since
shifted their focus to weight loss-specific drugs [37]. Novo
By June 2023, 26 novel drugs had been approved, a Nordisk’s Ozempic and Wegovy are the most well-known
staggering amount for halfway through a calendar year examples. Wegovy was approved specifically for obesity
[36]. Key trends in drug development and approvals include, treatment in 2021, but Ozempic currently is only approved
according to Radó, will be “the continued dominance of for use as a type 2 diabetes treatment, with off-label use for
small molecule drugs, increasing adoption of biologics, weight loss [37].
and growing demand for personalised medicines.” Major
With these demands for off-label use of existing drugs,
drug approvals in 2023 include full, comprehensive US FDA
there’s been much discussion regarding accelerate
approval of COVID-19 treatment Paxlovid, cell and gene
approval schemes among regulatory bodies. During the
therapies for oncology, and orphan drugs for rare disease
BIO International Convention on June 7, 2023 in Boston,
treatments under FDA fast-tracked programmes [36].
Commissioner of the FDA Dr Robert Califf addressed pressing
Experts believe 2024 will prioritise the approval of drugs for issues concerning drug approvals and shortages. Accelerated
so-called ‘first-world problems’ - diseases affecting mainly approvals and legal challenges for the FDA have highlighted

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 48
In Partnership
with
What 2023 drug approvals mean for 2024

where regulatory authorities can work with others to improve


drug approval procedures: “I’m totally in favour of Accelerated
Approval... There’s the FDA and the Centers for Medicare and
Medicaid Services (CMS),” Califf stated during his panel at BIO.
“The FDA [looks at what is] safe and effective. CMS – [what
is] reasonable and necessary. It’s like a relay race. We run a
lap and then we hand the baton to CMS. CMS doesn’t tell us
what’s safe and effective. We can’t tell them what’s reasonable
and necessary... That baton handoff is very dependent on an
evidence generation system that doesn’t exist in our country
right now... We need to have this data generation system that
works and that should bring us together with CMS to make the
transition smoother and better. [38]”
Cell and gene therapies in particular are expected to make
up the most prominent approvals in 2024, with treatments
for severe haemophilia A and sickle cell disease in the
pipeline [39]. Continuing on from 2023, the approval of
several monoclonal antibody treatments for autoimmune
diseases and orphan drugs for rare diseases are set to make
headlines in 2024 [39].

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 49
12

Middle East rising:


an emerging
market in focus
In Partnership
with
Middle East rising: an emerging market in focus

Middle East rising: pharmaceuticals within the Middle East. Saudi Arabia leads
with a pharmaceutical market valued at approximately

an emerging
USD $10.74 billion by the end of 2023 [42]. Multinational
pharmaceutical giants present in the region include Sanofi,
Novartis, and Pfizer, along with a strong global manufacturing

market in focus presence – Saudi Arabia manufactures 22.55% of drug


products in current global markets [43]. This growth in the
region has multiple drivers.
In December 2024, CPHI Middle East will launch in Riyadh, Manel Chikh, CEO of Zaphyr Pharmaceuticals, comments:
Saudi Arabia – a country responsible for 60% of the Gulf’s “The healthcare sector in the Gulf region is experiencing
pharma market [40]. A strategic event for regional drug significant growth, presenting substantial opportunities for
manufacturers and global suppliers to gather in Saudi Arabia, global healthcare companies. This expansion is driven by
the event reflects the exponential increase in interest in the factors like population increase, aging demographics, and
Middle East and Africa (MEA) pharmaceutical market and evolving consumption habits. The Gulf countries, including
supply chain. According to research from IQVIA, in 2019 the Saudi Arabia, UAE, Qatar, Bahrain, Oman, and Kuwait, are
pharmaceutical market in the MEA surpassed UDS $25 billion dedicating around 7% of their GDP to healthcare, with a
in value and demonstrated a CAGR of 8%, outperforming a combined population of 50 million. Significant investments,
global CAGR of 5.27% [41]. such as Saudi Arabia’s $200 billion in its Vision 2030 for
healthcare modernization, are underway.”
The Kingdom of Saudi Arabia and The United Arab
Emirates are currently the largest regional markets for As part of the Saudi government’s Vision 2030 plan,

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 51
In Partnership
with
Middle East rising: an emerging market in focus

dedicated efforts are in place to develop the nation’s foreign investment and promote the growth of the local
healthcare and pharmaceutical infrastructure [44]. These pharmaceutical industry, contributing to a more resilient and
efforts are in response to the nation’s aging population and diversified economy. At the core of CPHI’s beliefs are three
the rise of chronic diseases [44]. Drug accessibility and guiding principles: to inspire innovation, enable collaboration,
affordability are also top concerns for the region, influencing and drive change. These principles align perfectly with the
government investment [41]. With rising incidences of transformative objectives of Vision 2030.”
diabetes and cancer in the Arab population – Saudia Arabia Saudi Arabia is also quickly becoming a critical location
has the second-largest diabetes prevalence rate in the for multinational companies looking to increase their
Middle East, and seventh-largest in the world – the Kingdom global presence and reach. Geographically, the country is
is heavily invested in both establishing a global presence a strategic hub to serve wider regional markets in the MEA
and bolstering domestic manufacturing capacity of both region [44]. As of August 2023, the Kingdom boasts nearly
generics and innovator products [45]. 50 local pharmaceutical manufacturing facilities [46]. The
Muased Alkholief, Professor and Management Consultant Kingdom also saw a tripartite agreement between the
at King Saud University, comments: “The announcement nation’s National Industrial Development Center, Jubail
of the inaugural CPHI event in Saudi Arabia in 2024 not Pharma, and RR Holding Co. to boost local manufacturing
only marks a significant milestone for the country’s of chemical compounds required in the production of
growing pharmaceutical and biotechnology sectors but pharmaceuticals [45].
also aligns seamlessly with the aspirations laid out in Chikh states: “For healthcare companies seeking to enter this
Saudi Vision 2030. Rooted in the Vision’s strategic goals market, strategies must include local production, technology
of economic diversification, the event is poised to attract transfer, and creating job opportunities for nationals. The

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 52
In Partnership
with
Middle East rising: an emerging market in focus

market offers prospects in medical technology, construction


and renovation of hospitals and clinics, knowledge transfer in
MedTech and Biotech, and establishing local pharmaceutical
branches.
Success in this market requires a deep understanding of local
regulations, cultural norms, and standards. Building strong
relationships with local health authorities and hospitals and
adapting to local requirements are key for these companies
to thrive in the Gulf’s burgeoning healthcare sector.”
Such partnerships will consolidate the manufacturing of
APIs, intermediates, and other necessary pharmaceutical
ingredients in the MEA region.
“The emphasis on inspiring innovation resonates with the
Vision’s commitment to fostering a culture of research and
development, pushing the boundaries of scientific discovery
in the pharmaceutical and biotech domains,” Alkholief states.
“CPHI provides a dynamic platform for local stakeholders to
showcase their innovative solutions, learn from international
best practices, and engage in discussions that can shape the
future of the industry.”

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 53
In Partnership
with
Middle East rising: an emerging market in focus

Talent attraction is also driving the rapid growth of the the growth and development of the pharmaceutical and
Saudi Arabian pharmaceutical sector. With largely tax-free biotechnology sectors in Saudi Arabia and the region.”
salaries and a range of benefits seldom found elsewhere,
The 2023–2024 forecast for the Saudi Arabian
2024 may see an influx of top candidates to Saudi Arabia
pharmaceutical market is proving to be pivotal time for its
[42]. While an emphasis will be placed on local talent through
growth, with many experts agreeing that the Kingdom is one
nationalisation programmes within the MEA region, those
to watch for pharmaceutical investors and stakeholders.
who have experience working abroad or expatriates may find
that the booming Saudi Arabian pharmaceutical market is “Hosting CPHI MEA, one of the world’s most prestigious
where their career can grow [42]. pharmaceutical event, in Saudi Arabia underscores the
region’s growing role in the global healthcare market. This
“In the context of Saudi Vision 2030’s focus on healthcare
event will foster international partnerships and will showcases
infrastructure development, CPHI’s significance extends to
the region’s healthcare advancements, aligning with its
the potential enhancement of research and development
investment in healthcare development creating an ideal
capabilities, the establishment of state-of-the-art
platform for foreign healthcare companies to explore local
manufacturing facilities, and the creation of high-skilled
opportunities,” comments Chikh.
jobs,” Alkholief explains. “The platform not only provides
an opportunity for local companies to showcase their
capabilities but also for international player to understand
and contribute to the evolving healthcare ecosystem in Saudi
Arabia. We are excited to host CPHI in Saudi Arabia and I am
certain that the event is going to contribute significantly to

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 54
Contributors
In Partnership
with
Contributors

Thanks to our Contributors


Stefan Moch Aurelio Arias Musaed Alkholief
VP Health, Director, Thought Leadership, Professor and Management
Arvato Systems IQVIA Consultant, King Saud University

Peter Schmitt Nigel Pollard Dan Stanton


Co-Founder and Managing Chair of the Board of Directors, Managing Editor,
Director, Montesino Empowered by Evidence BioProcess International

Bikash Chatterjee Raman Sehgal Nicola Coles


President and Chief Scientific Global President and Founder, Phorum Director,
Officer, Pharmatech Associates ramarketing BioPhorum

Berta Mota Alan Palmer Manel Chikh


Circular Economy Director, CEO, CEO,
Anthesis Group Elixa MediScience Zaphyr Pharmaceuticals

Sireesha Yadlapalli Enric Bosch Radó Klaus Fetzer


CEO, Global Third-Party Chemicals Managing Director
Pharmatech Associates Manager/Human Pharma Health & Public,
Supply Chain, Boehringer Arvato Systems
Stephanie Gaulding Ingelheim
CQA, CPGP Managing Director,
Pharmatech Associates

2024 Pharma Trends Outlook: Collaboration, Market Maturity, and Digital Futures 56
References
In Partnership
with
References

References
[1] Zagar J and Mihelic J. Big data collection in pharmaceutical manufacturing and [8] Strengthening and transforming the pharmaceutical supply chain [Accessed
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