|
Forecast
Period
|
2024-2028
|
|
Market
Size (2022)
|
USD
1838.98 Million
|
|
CAGR
(2023-2028)
|
4.36%
|
|
Fastest
Growing Segment
|
Type
1 Diabetes
|
|
Largest
Market
|
Germany
|
Market Overview
Europe Biosimilar Insulin
Glargine & Lispro Market has valued at USD 1838.98 Million in 2022 and is
anticipated to project impressive growth in the forecast period with a CAGR of 4.36%
through 2028. Biosimilar Insulin Glargine and Lispro are essential forms of
insulin utilized in the management of high blood sugar levels among individuals
with diabetes. Insulin Glargine, a long-acting insulin, effectively replaces
the naturally produced insulin in the body, facilitating the transportation of
sugar from the bloodstream to various tissues for energy utilization.
Conversely, Insulin Lispro, a fast-acting insulin, exhibits prompt action after
injection and maintains its effectiveness for a duration of two to four hours. As biosimilars, these versions of insulin
closely resemble an already approved insulin product and have been extensively
studied to demonstrate their lack of any clinically meaningful differences from
the reference product. This level of similarity ensures the safety and efficacy
of these biosimilar insulin options for individuals managing diabetes,
providing them with reliable and effective treatment options.
Key Market Drivers
Rising
Levels of Obesity
The rising levels of
obesity in Europe are significantly increasing the demand for biosimilar insulin
glargine and lispro, representing a crucial response to the growing public
health challenge of diabetes management. Obesity is a well-established risk
factor for the development of type 2 diabetes, and its prevalence in Europe has
been steadily increasing. As a result, there is a substantial and growing
population of individuals with diabetes who require insulin therapy for
glycemic control. Biosimilar insulin glargine and lispro offer an attractive
solution to address this rising demand. These biosimilars are highly similar to
their reference products but are often more cost-effective, making them
accessible to a broader segment of the population. As obesity-related diabetes
becomes more prevalent, the affordability and availability of effective insulin
treatments are paramount to ensuring optimal diabetes management.
Moreover, the chronic
nature of diabetes management in the context of obesity necessitates a reliable
and sustainable supply of insulin products. Biosimilars, by offering
alternative sources of insulin, help mitigate the risk of insulin shortages or
supply disruptions that can adversely affect patients' health. Furthermore, the
cost savings associated with biosimilar insulin glargine and lispro can ease
the financial burden on both patients and healthcare systems, allowing
resources to be allocated more efficiently for diabetes care and prevention
efforts. This is especially important in the context of rising healthcare costs
associated with obesity-related comorbidities. The escalating levels of obesity
in Europe are undeniably increasing the demand for biosimilar insulin glargine
and lispro, as they provide a cost-effective and sustainable solution for
diabetes management. As the burden of obesity-related diabetes continues to
rise, ensuring access to affordable and reliable insulin therapies is paramount
to effectively addressing this public health challenge across the continent.
Growing
Expenditure on Healthcare
The growing expenditure on
healthcare in Europe is playing a significant role in increasing the demand for
biosimilar insulin glargine and lispro. Healthcare costs have been on the rise
across the continent, driven by factors such as an aging population, increased
prevalence of chronic diseases like diabetes, and the introduction of
innovative but expensive medical treatments. In this context, biosimilar
insulin glargine and lispro have emerged as cost-effective alternatives to
their reference products, making them an attractive option for healthcare
systems striving to manage healthcare expenditure while maintaining the quality
of care. Furthermore, the adoption of biosimilars aligns with the broader trend
of value-based healthcare, where the focus is on achieving better patient
outcomes at a lower cost. These cost-effective insulin options enable
healthcare providers to deliver high-quality diabetes care while managing
costs, ultimately benefiting both patients and the healthcare system as a
whole.
Increasing
Adoption of Sedentary Lifestyle
The increasing adoption of
sedentary lifestyles in Europe is undeniably contributing to the rising demand
for biosimilar insulin glargine and lispro. Sedentary behavior, characterized
by prolonged sitting and low physical activity levels, is a significant risk
factor for the development of type 2 diabetes, a condition that often
necessitates insulin therapy for effective glycemic control. As sedentary
lifestyles become more prevalent in the region, there is a growing population
at risk of diabetes, subsequently driving up the demand for insulin treatments.
Sedentary lifestyles are associated with obesity, another significant risk
factor for diabetes. As obesity-related diabetes becomes more prevalent, the
demand for insulin treatments, including biosimilars, is expected to surge
further. Biosimilar insulin glargine and lispro's cost-effectiveness can help
alleviate some of the economic pressures associated with managing diabetes and
its complications in sedentary individuals.
The increasing adoption of
sedentary lifestyles in Europe is a compelling factor contributing to the
growing demand for biosimilar insulin glargine and lispro. These cost-effective
alternatives play a crucial role in addressing the healthcare challenges posed
by sedentary behavior, providing affordable and accessible insulin therapies to
individuals at risk of or living with diabetes due to their sedentary
lifestyles.
Increasing
Ageing Population
The increasing aging
population in Europe is a significant driver of the rising demand for
biosimilar insulin glargine and lispro. As the continent witnesses a
demographic shift with a growing proportion of elderly individuals, the
prevalence of diabetes, particularly type 2 diabetes, is on the rise. Diabetes
is more common in older adults due to factors such as reduced physical
activity, changes in metabolism, and genetic predisposition. Consequently,
there is a pressing need for effective insulin therapy to manage the glycemic
control of the elderly population. The complexities of managing diabetes in the
elderly population require insulin options that are not only cost-effective but
also reliable and consistent. Biosimilars offer a well-established track record
of safety and efficacy, providing healthcare providers with confidence in
prescribing these treatments to older patients who may have multiple
comorbidities.
With the aging population
trend expected to persist, the demand for biosimilar insulin glargine and
lispro is likely to continue its upward trajectory. These biosimilars play a
vital role in ensuring that older adults with diabetes receive appropriate and
affordable treatment options, ultimately enhancing their quality of life and
contributing to the sustainability of healthcare systems in Europe.
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Key Market Challenges
Stringent
Regulatory Requirements for The Approval Of Biosimilar Insulins
Stringent regulatory
requirements for the approval of biosimilar insulins have posed challenges that
are impacting the demand for biosimilar insulin glargine and lispro in Europe.
While biosimilars are designed to be highly similar to their reference biologic
counterparts in terms of safety and efficacy, the rigorous regulatory standards
imposed by authorities such as the European Medicines Agency (EMA) have
resulted in protracted approval processes and increased development costs. One
significant hurdle is the need for comprehensive comparative clinical trials to
establish the biosimilarity of these products, requiring time and resources for
data generation and analysis. These trials must demonstrate similar
pharmacokinetics, pharmacodynamics, and clinical outcomes, which can be
logistically complex and costly. Moreover, the stringent regulatory
requirements create barriers for biosimilar manufacturers to enter the market.
Meeting these demands necessitates substantial investments in research,
development, and manufacturing facilities, which can deter potential
competitors from pursuing the biosimilar insulin market.
Additionally, the
perception of biosimilars among healthcare providers and patients can be
influenced by the rigorous regulatory requirements. Some healthcare
professionals may perceive them as less reliable or less safe than the
originator products, impacting their willingness to prescribe or use biosimilar
insulin products. As a result of these challenges, the uptake of biosimilar
insulin glargine and lispro in Europe may be slower than anticipated, limiting
the cost-saving potential and accessibility of these alternatives. However, as
the regulatory pathway for biosimilars continues to evolve and healthcare
stakeholders become more familiar with these products, the demand for
biosimilar insulins may gradually increase, ultimately offering affordable and
effective alternatives to patients with diabetes across the continent.
Intense
Competition from Branded Products
Intense competition from
branded insulin products has been a significant factor in decreasing the demand
for biosimilar insulin glargine and lispro in Europe. The insulin market in
Europe has long been dominated by well-established and trusted branded insulin
manufacturers, making it challenging for biosimilar counterparts to gain market
share. The familiarity and confidence that healthcare providers and patients
have in these branded products often lead to a reluctance to switch to
biosimilars. Branded insulin
manufacturers have invested heavily in marketing, research, and development,
fostering brand loyalty and a perception of superior quality. As a result,
biosimilar insulin products face substantial resistance in convincing both
healthcare professionals and patients to transition from trusted branded
products to biosimilars, even when they offer similar safety and efficacy
profiles at potentially lower costs. Additionally, the influence of
pharmaceutical companies and the healthcare industry's complex ecosystem can
play a role in sustaining the dominance of branded insulin products. Marketing
tactics, incentives, and longstanding relationships between pharmaceutical
companies and healthcare providers can make it challenging for biosimilar
manufacturers to penetrate the market effectively.
Moreover, concerns about
the interchangeability of biosimilar insulins with their branded counterparts
may lead to hesitancy among healthcare providers. The fear of potential clinical
consequences or adverse outcomes can further discourage the adoption of
biosimilar insulin products. Despite the cost-saving potential of biosimilar
insulins, the intense competition and established presence of branded insulin
products have created a formidable barrier to their widespread acceptance in
Europe. Overcoming these challenges may require continued education and
awareness campaigns, as well as regulatory measures to encourage the adoption
of biosimilars while ensuring patient safety and confidence in these
alternatives.
Key Market Trends
Rising
Number of Diabetes Patients
The diabetes population in
the European region is projected to experience a growth of over 15% during the
forecast period. As per the IDF 2021 report, approximately 1 in 11 adults in
Europe had diabetes, accounting for around 61 million individuals. The total
expenditure on diabetes in Europe amounted to USD 189 billion. These figures
suggest that approximately 19.6% of global healthcare expenses are allocated to
diabetes in Europe.
In recent years, the
European region has witnessed a concerning rise in the prevalence of diabetes.
Patients with diabetes require frequent adjustments throughout the day to
maintain normal blood glucose levels, such as oral anti-diabetic medication or
additional carbohydrate intake, all while monitoring their blood glucose
levels. The incidence and prevalence of newly diagnosed type-1 and type-2
diabetes cases are notably increasing, largely due to factors such as obesity,
an unhealthy diet, and physical inactivity. The rapid growth in the number of
diabetic patients, as well as healthcare expenditure, indicates a rising
utilization of diabetic drugs.
According to the IDF, the
overall diabetes expenditure in Europe for individuals aged 20–79 years was USD
156 billion, and it is projected to reach USD 174 billion by 2040.
Additionally, statistics from the IDF reveal that approximately 21,600 children
are added to the type-1 diabetic population pool each year. These figures
suggest that around 9% of the total healthcare expenditure in Europe is
allocated to diabetes.
Growing
Demand for Affordable and Readily Accessible Insulin Treatments
The growing demand for
affordable and readily accessible insulin treatments is a compelling factor
driving the increasing demand for biosimilar insulin glargine and lispro in
Europe. Diabetes, particularly type 2 diabetes, has become a widespread health
concern in the region, with an aging population and changing lifestyle factors
contributing to its prevalence. As the diabetic population continues to expand,
there is a pressing need for cost-effective and accessible insulin therapies to
ensure that individuals can effectively manage their condition. Biosimilar
insulin glargine and lispro offer a solution that addresses this demand. These
biosimilars are designed to be highly similar to their reference insulin
products, providing comparable efficacy and safety profiles while often being
available at lower prices. The cost-effectiveness of biosimilar insulins makes
them an attractive option for healthcare systems striving to manage the
financial burden of diabetes care and reduce healthcare expenditures.
Moreover, the
accessibility of biosimilar insulins aligns with the goal of ensuring equitable
healthcare access for all individuals with diabetes. These products increase
the availability of insulin treatments, reducing potential barriers to access
and helping to bridge healthcare disparities. The growing demand for affordable
and accessible insulin treatments is not only driven by healthcare providers
but also by advocacy groups and policymakers who recognize the urgency of
addressing the diabetes epidemic. As a result, there is increasing support for
the adoption of biosimilar insulins as part of a comprehensive strategy to
improve diabetes care and reduce the economic burden of the disease on
individuals and healthcare systems.
Segmental Insights
End User Insights
Based on the end user, the market is bifurcated into
Type 1 Diabetes and Type 2 Diabetes, representing two distinct patient
populations with different insulin requirements. Type 1 Diabetes, characterized
by the body's inability to produce insulin, has consistently dominated the
market with the largest market share until 2022. This can be attributed to the
increasing prevalence of this autoimmune disease worldwide, necessitating a
continuous supply of effective and affordable treatment options. The demand for
biosimilar insulin glargine and lispro is expected to continue to be driven by
the growing number of patients diagnosed with Type 1 Diabetes. These patients
rely on insulin therapy to manage their condition and maintain a healthy
quality of life. As a result, Type 1 Diabetes is anticipated to maintain its
dominant position in the market during the forecast period as well, reflecting
the ongoing need for innovative and accessible treatment options for this
patient population.
Country
Insights
Germany dominates the
European market for Biosimilar Insulin Glargine & Lispro. This is primarily
attributed to its robust healthcare infrastructure and the proactive adoption
of biosimilars. The German healthcare system has not only recognized the
potential cost-effectiveness of biosimilars but has also actively supported
their use as an alternative to traditional insulin drugs, thereby facilitating
their faster market penetration. Moreover, the country's stringent regulations
favor high-quality biosimilars, instilling confidence in their safety and
efficacy among healthcare professionals and patients alike.
Furthermore, Germany's
demographic factors contribute to the significant market demand for Biosimilar
Insulin Glargine & Lispro. With an ageing population and a high incidence
of diabetes, there is an increasing need for a steady and reliable supply of
insulin medications. This demand creates a favorable environment for the growth
and sustainability of the Biosimilar Insulin Glargine & Lispro market in
Germany, making it a key player in the European biosimilar landscape.
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Recent Developments
- October 2022: Novo Nordisk has announced the headline
results of the ONWARDS 5 phase 3a trial, evaluating the efficacy and safety of
once-weekly insulin icodec in individuals with type 2 diabetes. This 52-week, treat-to-target
trial compared once-weekly insulin with once-daily basal insulin (insulin
degludec or insulin glargine U100/U300).
- September 2022: The
European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have
issued a joint statement affirming the interchangeability of biosimilar
medicines approved in the European Union (EU) with their reference medicine or
an equivalent biosimilar.
Key Market Players
- Sanofi
S.A.
- Biocon Ltd
- Eli Lilly-Boehringer Ingelheim
- Wockhardt Ltd
- Geropharm LLC
- Novo Nordisk A/S
- Merck & Co.
- Sandoz-Gan Lee
|
By
End User
|
By
Country
|
- Type
1 Diabetes
- Type
2 Diabetes
|
- Germany
- France
- United
Kingdom
- Italy
- Spain
- Russia
- Poland
|
Report
Scope:
In this report, the Europe
Biosimilar Insulin Glargine & Lispro Market has been segmented into the following
categories, in addition to the industry trends which have also been detailed
below:
- Europe Biosimilar Insulin Glargine & Lispro Market, By End User:
o
Type 1 Diabetes
o
Type 2 Diabetes
- Europe Biosimilar Insulin Glargine & Lispro Market,
By Country:
o Germany
o France
o United
Kingdom
o Italy
o Spain
o Russia
o Poland
Competitive
Landscape
Company
Profiles: Detailed analysis of the major companies present in
the Europe Biosimilar Insulin Glargine & Lispro Market.
Available
Customizations:
Europe Biosimilar Insulin
Glargine & Lispro Market report with the given market data, Tech Sci
Research offers customizations according to a company's specific needs. The
following customization options are available for the report:
Company
Information
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analysis and profiling of additional market players (up to five).
Europe Biosimilar Insulin Glargine & Lispro Market
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