|
Forecast Period
|
2026-2030
|
|
Market Size (2024)
|
USD 1.89 Billion
|
|
Market Size (2030)
|
USD 2.61 Billion
|
|
CAGR (2025-2030)
|
5.51%
|
|
Fastest Growing Segment
|
Soft Capsule
|
|
Largest Market
|
North America
|
Market Overview
The Global Pharmaceutical Gelatin Market
was valued at USD 1.89 Billion in 2024 and is expected to reach USD 2.61
Billion by 2030 with a CAGR of 5.51%. Pharmaceutical gelatin is a specialized type
of gelatin that is produced and processed to meet strict quality and safety
standards for use in the pharmaceutical industry. It is a critical excipient
(inactive ingredient) in various pharmaceutical and medical applications. Pharmaceutical
gelatin is typically derived from the collagen found in the connective tissues,
skin, and bones of animals, such as cattle (bovine) or pigs (porcine). The choice
of source may depend on factors like regional preferences and regulatory
requirements. The production of pharmaceutical gelatin involves a series of
controlled processes, including extraction, purification, and sterilization, to
ensure the highest quality and safety standards are met. These processes
eliminate impurities and potential contaminants. Pharmaceutical-grade gelatin
is manufactured to be free from harmful substances, including pathogens, heavy
metals, and allergens. It undergoes rigorous testing to ensure it meets
pharmacopoeial standards for safety and purity. Pharmaceutical gelatin is
biocompatible, meaning it is well-tolerated by the human body and does not
elicit adverse reactions when used in pharmaceutical formulations.
The pharmaceutical industry is continuously
expanding due to increasing healthcare needs and advancements in drug
development. This growth drives the demand for pharmaceutical-grade gelatin
used in various drug formulations. An aging global population is associated
with a higher incidence of chronic diseases and the need for pharmaceutical
treatments. Gelatin-based capsules and drug delivery systems are commonly used
for geriatric patients, boosting the demand for pharmaceutical gelatin. Gelatin
capsules are often preferred by consumers due to their ease of swallowing,
digestibility, and versatility. This consumer preference drives the use of
gelatin in various pharmaceutical products. Advances in biopharmaceuticals and
biotechnology lead to new drug formulations that often rely on gelatin for drug
delivery, stabilization, and encapsulation. Gelatin is highly customizable in
terms of size, shape, and color, allowing pharmaceutical companies to
differentiate their products and meet specific patient preferences and therapeutic
requirements.
Key Market Drivers
Growing Pharmaceutical Industry
Gelatin continues to be a pivotal excipient in the pharmaceutical industry, particularly in the formulation of oral dosage forms such as hard and soft capsules. Its versatility extends beyond simple encapsulation, playing a critical role in controlled-release systems, enhancing the stability of active pharmaceutical ingredients (APIs), and improving patient compliance due to its ease of ingestion.
According to the U.S. Food and Drug Administration (FDA), gelatin is recognized as a safe and effective excipient in pharmaceutical formulations. The FDA's Center for Drug Evaluation and Research (CDER) provides guidelines on the use of excipients, including gelatin, emphasizing the importance of quality control and compliance with Good Manufacturing Practices (GMP) to ensure the safety and efficacy of drug products.
Similarly, the European Medicines Agency (EMA) acknowledges gelatin's role in drug delivery systems, particularly in the development of extended-release formulations, and stresses the need for rigorous testing to meet pharmacopoeial standards.
Gelatin is crucial in drug delivery systems, particularly in controlled-release formulations that ensure precise dosing of APIs. This is important for maintaining therapeutic efficacy over extended periods, which is vital for conditions requiring long-term medication adherence. Gelatin also provides a protective barrier against environmental factors such as moisture, oxygen, and light, which can degrade sensitive drugs. As the pharmaceutical industry continues to develop more biologic drugs and complex formulations, the demand for gelatin-based encapsulation and stabilization systems is increasing.
In emerging economies, where healthcare access and pharmaceutical manufacturing capabilities are expanding, gelatin plays an essential role in the growth of the pharmaceutical sector. Regulatory agencies around the world continue to support its use, ensuring that gelatin-based formulations adhere to the highest standards of safety, efficacy, and quality.
Biopharmaceutical Advancements
Biopharmaceutical advancements have significantly influenced the utilization of pharmaceutical gelatin, a protein-based excipient integral to the development and delivery of biologics. Gelatin serves multifaceted roles in the formulation of biopharmaceuticals, including monoclonal antibodies, vaccines, and other biologics. It acts as a stabilizing agent, preserving the stability and solubility of these complex molecules during storage and administration. Given that biopharmaceuticals are often large, complex proteins requiring specialized drug delivery systems, gelatin is employed in the production of microspheres, nanoparticles, or drug-loaded gels to encapsulate and deliver protein-based drugs. This ensures controlled release and enhanced bioavailability of therapeutic molecules.
Gelatin has been utilized in the encapsulation of vaccines, including certain viral vaccines and protein subunit vaccines. It aids in protecting vaccine antigens from degradation, enhancing their stability, and facilitating controlled release during vaccination. In the realm of regenerative medicine and tissue engineering, gelatin-based hydrogels serve as scaffolds for cell and tissue growth. These hydrogels provide a biocompatible environment for cell culture, making them valuable tools in biopharmaceutical research and tissue engineering applications.
Gelatin nanoparticles can be functionalized to carry specific ligands or antibodies targeting particular cells or tissues. This targeted drug delivery approach is especially pertinent in biopharmaceuticals, where precision in drug delivery can improve therapeutic outcomes and reduce side effects. One challenge with biopharmaceuticals is their susceptibility to degradation in the digestive tract when taken orally. Gelatin capsules, including enteric-coated gelatin capsules, can protect biopharmaceuticals from gastric degradation, allowing for oral delivery of certain biologics.
Gelatin-based dressings and scaffolds are also employed in wound healing and tissue repair applications, closely related to biopharmaceutical research in regenerative medicine. Additionally, gelatin nanoparticles can serve as carriers for diagnostic agents, such as contrast agents for medical imaging or markers for in vitro diagnostics. These applications are relevant in biopharmaceutical research and diagnostics. The increasing demand for these applications is expected to drive the growth of the global pharmaceutical gelatin market.
While specific recent statistics from government sources are not available, the expanding use of gelatin in these diverse biopharmaceutical applications underscores its critical role in advancing medical treatments and therapies.
Rising Geriatric Population
The elderly often have more complex healthcare
needs due to age-related chronic conditions, such as cardiovascular diseases,
arthritis, and diabetes. This necessitates a greater use of pharmaceuticals and
dietary supplements, many of which utilize gelatin capsules or other
gelatin-based formulations.
As of 2023, the elderly population continues to face complex healthcare needs due to age-related chronic conditions such as cardiovascular diseases, arthritis, and diabetes. According to the Centers for Disease Control and Prevention (CDC), approximately 80% of older adults aged 65 and above have at least one chronic condition, and 68% have two or more. These conditions necessitate a greater reliance on pharmaceuticals and dietary supplements, many of which utilize gelatin capsules or other gelatin-based formulations. Gelatin capsules are preferred by many elderly individuals because they are generally smaller and easier to swallow, making medication adherence more manageable. This is particularly important as studies have shown that nearly 40% of older adults experience difficulty swallowing pills, a condition known as dysphagia. Gelatin capsules, being soft and flexible, are often easier to ingest compared to traditional tablets.
The elderly population also frequently takes nutritional supplements, vitamins, and dietary products, many of which are encapsulated in gelatin. These products address specific health concerns commonly associated with aging, such as bone density loss, cognitive decline, and joint health. For instance, supplements containing calcium, vitamin D, and omega-3 fatty acids are commonly used to support bone and heart health in older adults.
Some medications are tailored to the elderly population, addressing age-related conditions like osteoporosis or cognitive decline. Gelatin capsules are often used for the formulation of these medications. For elderly patients who may need controlled drug release or precise dosing, gelatin capsules can be customized to meet these requirements. Controlled-release formulations are essential for managing chronic conditions effectively.
Older adults may be taking multiple medications simultaneously. Gelatin capsules help with medication organization and reduce the risk of dosage errors, improving pharmaceutical compliance. Many elderly individuals are accustomed to gelatin-based medications and prefer them. Familiarity with these dosage forms can lead to continued demand. Gelatin is known for its digestibility, which is important for older adults who may have gastrointestinal issues or compromised digestion. Gelatin-based dosage forms are gentle on the stomach. The development of new medications for geriatric populations often involves clinical trials. Gelatin-based formulations may be chosen for these trials to ensure ease of administration and minimize variables in drug delivery. This factor will accelerate the demand for the Global Pharmaceutical Gelatin Market.
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Key Market Challenges
Raw Material Supply and Price Volatility
Pharmaceutical gelatin is predominantly derived
from animal sources, such as bovine (cattle) and porcine (pig) skins and bones.
The availability and cost of these raw materials are subject to factors such as
disease outbreaks in livestock, fluctuations in animal populations, and changes
in the global supply of animal hides and bones. Climate conditions, such as
droughts and extreme weather events, can affect animal husbandry and the
quality of hides and bones. These environmental factors can disrupt the supply
chain for gelatin production. Disease outbreaks in livestock, such as
foot-and-mouth disease or African swine fever, can lead to significant
disruptions in the availability of raw materials, as affected animals may not
be suitable for gelatin production. The cost of animal feedstock, which
directly impacts the health and growth of animals, can fluctuate due to factors
like feed crop yields, transportation costs, and global demand for animal feed.
The prices of animal-derived raw materials can be volatile, affecting the
overall production costs of gelatin. Price fluctuations can result from market
dynamics, currency exchange rates, and supply-demand imbalances. Concerns about
the environmental impact and ethical considerations related to animal-derived
gelatin have led to increased interest in alternative sources, such as
plant-based gelatin alternatives. This transition can introduce uncertainty in
the raw material supply chain. Gelatin used in pharmaceuticals must meet
stringent regulatory standards for safety and quality. Compliance with these
standards can require additional quality control measures and documentation,
which can impact production costs.
Sustainability and Ethical Concerns
Gelatin production, especially when derived from
animal sources, has environmental implications. The livestock industry, which
provides the raw materials for gelatin, can contribute to deforestation,
greenhouse gas emissions, and water usage. Sustainable sourcing practices and
the reduction of environmental footprints are becoming more critical. The
sourcing of animal-derived gelatin raises ethical questions about animal
welfare. Concerns about the treatment of animals in the meat industry and the
conditions in which they are raised have prompted calls for more humane
practices and alternatives to animal-derived gelatin.
Dependence on animal-derived gelatin creates
concerns about the reliability and sustainability of these sources. Disease
outbreaks, such as foot-and-mouth disease or avian influenza, can disrupt the
supply chain and raise questions about the safety of gelatin derived from
affected animals. Consumer preferences are shifting toward products that align
with ethical and sustainability values. As a result, some consumers may seek
alternatives to traditional gelatin, potentially impacting the market. Compliance
with evolving environmental and ethical regulations can be challenging for
pharmaceutical gelatin manufacturers. Meeting sustainability standards and
ensuring ethical sourcing practices require investment and adherence to new
regulatory requirements. The development and adoption of plant-based
alternatives to gelatin have gained momentum in response to sustainability and
ethical concerns. Plant-based gelatin alternatives are appealing to consumers
looking for cruelty-free and environmentally friendly options. Ensuring
transparency in the gelatin supply chain, from raw material sourcing to
production processes, is essential for addressing sustainability and ethical
concerns. This requires robust tracking and verification systems.
Key Market Trends
Shift Towards Plant-Based Alternatives
Plant-based
alternatives are often considered more sustainable than animal-derived gelatin
because they typically have a lower environmental footprint. The production of
plant-based gelatin alternatives may involve fewer greenhouse gas emissions,
less water usage, and reduced land impact compared to livestock farming for
gelatin production. Concerns about animal welfare and the ethical treatment of
animals in the food and pharmaceutical industries have led to a growing
interest in cruelty-free alternatives. Plant-based gelatin alternatives
eliminate the need for animal-derived ingredients, addressing these concerns. There
is a significant and increasing demand for vegan and vegetarian products,
including pharmaceuticals and dietary supplements. Plant-based gelatin
alternatives cater to these dietary preferences and align with vegan and
vegetarian lifestyles. Some religious and cultural dietary restrictions
prohibit the consumption of animal-derived ingredients, making plant-based
gelatin alternatives a suitable choice for individuals following these dietary
guidelines. Plant-based alternatives can be advantageous for individuals with
allergies or sensitivities to animal-derived products. They offer an
allergen-friendly option for pharmaceutical manufacturers and consumers. Advances
in food science and technology have led to the development of innovative
plant-based ingredients that can mimic the properties of traditional gelatin.
This allows for customization and the creation of plant-based alternatives with
specific characteristics, such as gelling properties and texture.
Segmental Insights
Source
Insights
Based
on the Source, Porcine emerged as the dominant segment in the Global Pharmaceutical
Gelatin Market in 2024. This is due to its widespread availability,
cost-effectiveness, and favorable functional properties. Porcine-derived
gelatin is extensively used in pharmaceutical applications such as capsule
manufacturing, wound dressings, and vaccine production, owing to its high gel
strength, clarity, and thermo-reversible properties. Its chemical composition
is well-suited for the development of both hard and soft gelatin capsules,
making it a preferred choice for drug delivery systems. The processing of
porcine gelatin is relatively easier and more scalable compared to other
sources, allowing manufacturers to maintain consistent quality while meeting
large-scale demand. Pharmaceutical companies benefit from the reliable supply
chain and well-established regulatory approvals associated with porcine
gelatin, particularly in markets like North America, Europe, and parts of Asia.
Function
Insights
Based on the Function, Stabilizing emerged as the
dominant segment in the
Global Pharmaceutical Gelatin Market in 2024. This is driven by its crucial
role in maintaining the integrity and effectiveness of various pharmaceutical
formulations. Gelatin is widely used as a stabilizing agent due to its unique
colloidal properties, film-forming ability, and compatibility with a wide range
of active pharmaceutical ingredients (APIs). In vaccines, biologics, and
complex drug formulations, gelatin helps prevent degradation and extends shelf
life, ensuring consistent therapeutic efficacy. The stabilizing function of
gelatin is particularly valuable in the production of vaccines, where it
protects sensitive biological components from heat and mechanical stress during
manufacturing, storage, and transport. It also plays a key role in preventing
crystallization and maintaining the uniform dispersion of ingredients in
suspensions and emulsions. With the rising demand for biopharmaceuticals and
complex therapies, the need for reliable stabilizers has intensified,
reinforcing the demand for pharmaceutical-grade gelatin.
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Regional Insights
North America emerged
as the dominant region in the Global Pharmaceutical Gelatin Market in 2024. This is due to its well-established
pharmaceutical infrastructure, high healthcare expenditure, and strong presence
of key market players. The region benefits from advanced research and
development capabilities, supporting the large-scale production and innovation
of gelatin-based pharmaceutical products. The growing demand for softgel
capsules, particularly in dietary supplements and prescription drugs, has
significantly boosted the market in the United States and Canada. Regulatory
support and streamlined approval processes from agencies such as the U.S. Food
and Drug Administration (FDA) have further facilitated the commercialization of
gelatin-based formulations.
Asia-Pacific emerged as
the fastest growing region in the Global Pharmaceutical Gelatin Market during
the forecast period. This is driven by the expanding pharmaceutical
manufacturing base, rising healthcare investments, and increasing population
with growing healthcare needs. Countries like India, China, South Korea, and
Japan are experiencing rapid advancements in pharmaceutical production,
supported by favorable government policies and foreign direct investments. The
demand for gelatin-based capsules and excipients is escalating in the region
due to a shift toward more efficient drug delivery formats and rising consumer
awareness regarding health supplements. The expansion of contract manufacturing
organizations (CMOs) and growing domestic pharmaceutical companies are further
boosting the demand for high-quality pharmaceutical gelatin. With
cost-effective labor, lower production costs, and evolving regulatory
frameworks, Asia-Pacific has become a hub for large-scale pharmaceutical
manufacturing, driving the consumption of gelatin in formulations.
Recent Developments
- In January 2025, Lonza Capsules
announced the expansion of its hard gelatin capsule manufacturing capacity in
India and China. The move adds new production lines to support high-quality
capsule output for both pharmaceutical and nutraceutical applications. This
initiative is part of Lonza CHI’s global strategy to enhance competitiveness
and align with top-tier quality and sustainability standards.
- In January 2025, GELITA launched its
Endotoxin Controlled Excipients (ECE) product line—VACCIPRO and MEDELLAPRO designed
for advanced bioscience applications such as vaccine stabilization, medical
devices, and 3D bioprinting. These specialized, medical-grade gelatins and
collagen peptides offer high purity, biocompatibility, and enhanced stability,
addressing the critical need for endotoxin control in pharmaceutical and
healthcare settings.
- In July 2024, Yaral Pharma, the U.S.
generics arm of Swiss-based IBSA, became the exclusive supplier of authorized
generic levothyroxine sodium capsules in the United States. Used to treat
hypothyroidism, the capsules offer an alternative for patients who have
difficulty tolerating traditional tablets. CEO Stephen Beckman emphasized the
product’s improved tolerability, reliable supply, and strong customer support.
- In May 2024, Roquette launched LYCAGEL
Flex, a hydroxypropyl pea starch premix designed for nutraceutical and
pharmaceutical softgel capsules. Based on its LYCAGEL technology, the
plasticizer-free excipient allows manufacturers to choose their preferred plasticizer
combinations, offering greater flexibility in formulation and production.
Key Market Players
- Gelita AG
- Trobas Pharmaceutical
gelatine B.V
- Rousselot SAS
- Gelatines Weishardt SAS
- Sterling Biotec Ltd.
- Catalent, Inc
- Nitta Pharmaceutical Gelatin
India Limited
- Aspire Pharmaceuticals
- Gelco International
- Lapi Gelatine S.p.a
|
By Type
|
By Source
|
By Function
|
By End-User
|
By Region
|
|
|
|
- Porcine
- Bovine Skin
- Bovine Bone
- Fish
- Poultry
|
- Stabilizing
- Thickening
- Gelling
- Others
|
- Hard Capsule
- Soft Capsule
- Tablet
- Absorbable
Hemostat
- Others
|
- North
America
- Asia-Pacific
- Europe
- South
America
- Middle East
& Africa
|
|
Report Scope:
In this report, the Global Pharmaceutical Gelatin
Market has been segmented into the following categories, in addition to the
industry trends which have also been detailed below:
- Pharmaceutical
Gelatin Market, By
Type:
o Type A
o Type B
- Pharmaceutical
Gelatin Market, By
Source:
o Porcine
o Bovine Skin
o Bovine Bone
o Fish
o Poultry
- Pharmaceutical
Gelatin Market, By Function:
o Stabilizing
o Thickening
o Gelling
o Others
- Pharmaceutical Gelatin Market, By End User:
o Hard Capsule
o Soft Capsule
o Tablet
o Absorbable Hemostat
o Others
- Pharmaceutical Gelatin Market, By Region:
o North America
§
United
States
§
Canada
§
Mexico
o
Asia-Pacific
§ China
§ India
§ South Korea
§ Australia
§ Japan
o
Europe
§
Germany
§
France
§
United
Kingdom
§
Spain
§
Italy
o
South
America
§
Brazil
§
Argentina
§
Colombia
o
Middle
East & Africa
§
South
Africa
§
Saudi
Arabia
§
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the Global Pharmaceutical
Gelatin Market.
Available Customizations:
Global Pharmaceutical Gelatin Market report with
the given market data, TechSci Research offers customizations according to a
company's specific needs. The following customization options are available for
the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
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