Global Biosimilar Interleukins Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Type;
IL-17, IL-23, IL-1, IL-5, IL-6 and Others.By Drug Class (Insulin, Recombinant Human Growth Hormone (RHGH), Granulocyte Colony-Stimulating Factor, Interferon, Erythropoietin, Etanercept, Monoclonal Antibodies, Follitropin, Glucagon, Calcitonin, Teriparatide, and Enoxaparin Sodium.By Type of Manufacturing;
In-House Manufacturing and Contract Manufacturing.By Procedure;
Invasive, and Non-Invasive.By Application;
Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Asthma, Inflammatory Bowel Disease (IBD) and Others.By Distribution Channel;
Hospital Pharmacies, Online Pharmacies, Retail Pharmacies, Clinics and Research Institutes.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Biosimilar Interleukins Market (USD Million), 2021 - 2031
In the year 2024, the Global Biosimilar Interleukins Market was valued at USD 4,164.71 million. The size of this market is expected to increase to USD 59,744.08 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 46.3%.
The global biosimilar interleukins market is at the forefront of transformative advancements in biopharmaceuticals, promising innovative solutions in healthcare. Interleukins, vital signaling proteins within the immune system, play pivotal roles in regulating immune responses and inflammation. Biosimilars, bioequivalent alternatives to existing interleukin-based therapies, are poised to revolutionize treatment accessibility and affordability worldwide.
This burgeoning market segment not only addresses the critical need for cost-effective therapeutic options but also fosters competition, driving innovation and enhancing patient care outcomes. As pharmaceutical companies continue to invest in research and development, the landscape of biosimilar interleukins evolves, offering healthcare providers and patients alike a broader spectrum of treatment choices.
This introduction sets the stage for exploring the dynamics, challenges, and opportunities within the global biosimilar interleukins market, underscoring its profound impact on modern healthcare delivery and patient welfare.
Global Biosimilar Interleukins Market Recent Developments
- In September 2023, Biogen, a US-based biotechnology company, received FDA approval for Tofidence (tocilizumab-bavi), the first biosimilar to Genentech's Actemra (tocilizumab). The medication is administered through intravenous infusion
- In February 2022, US-based Equillium acquired Bioniz Therapeutics for $329 million. This acquisition enhances Equillium's portfolio, adding three immunomodulatory drug candidates and further assets in the discovery phase, expanding its innovative therapeutics pipeline
Segment Analysis
The global biosimilar interleukins market is segmented by type, with key categories including IL-17, IL-23, IL-1, IL-5, IL-6, and others. IL-17 and IL-6-based biosimilars are among the most prominent due to their relevance in treating autoimmune diseases like rheumatoid arthritis and psoriasis. The increasing prevalence of these conditions, along with the rising acceptance of biosimilars as cost-effective alternatives to branded biologics, contributes to the strong demand for these products. Other interleukins, such as IL-1 and IL-5, also have growing therapeutic potential, particularly in the treatment of asthma and inflammatory bowel disease, further expanding the market.
The market is also segmented by drug class, with several types of biosimilars being used for different therapeutic purposes. Biosimilars of insulin, recombinant human growth hormone (RHGH), granulocyte colony-stimulating factors, and monoclonal antibodies are expected to experience significant growth. Insulin biosimilars, in particular, are in high demand due to the increasing global prevalence of diabetes. Monoclonal antibodies, which are commonly used to treat conditions like rheumatoid arthritis, are also seeing an uptick in biosimilar options. The growing affordability and accessibility of these biosimilars are important drivers for their uptake in various healthcare settings.
Manufacturing is another key segment in the biosimilar interleukins market, with in-house manufacturing and contract manufacturing playing crucial roles. In-house manufacturing allows companies greater control over quality and production timelines, which is vital for maintaining the efficacy and safety of these complex biologic drugs. However, contract manufacturing is a growing trend as it provides companies with cost-effective solutions and access to specialized expertise in biologic production. As the demand for biosimilars continues to rise, more companies are opting for contract manufacturing partnerships to scale up production and reach global markets.
Geographically, the biosimilar interleukins market is well-distributed, with North America and Europe leading in terms of market share. The high cost of biologic treatments in these regions, coupled with the increasing healthcare burden, drives the demand for biosimilars. In the Asia Pacific region, growing healthcare access and awareness are contributing to market expansion, particularly in countries like India and China, where large patient populations exist. Latin America, the Middle East, and Africa are also emerging markets, where regulatory frameworks are evolving to accommodate the approval and adoption of biosimilars, presenting opportunities for growth in these regions.
Global Biosimilar Interleukins Segment Analysis
In this report, the Global Biosimilar Interleukins Market has been segmented by Type, Drug Class, Type of Manufacturing, Procedure, Application, Distribution Channel and Geography.
Global Biosimilar Interleukins Market, Segmentation by Type
The Global Biosimilar Interleukins Market has been segmented by Type into IL-17, IL-23, IL-1, IL-5, IL-6 and Others.
The global biosimilar interleukins market is segmented by type into several key categories, each targeting specific aspects of immune system modulation and therapeutic applications. Interleukins, essential signaling proteins in the immune response, are pivotal in regulating inflammation and immune-mediated diseases. IL-17 inhibitors, including biosimilar versions, address conditions such as psoriasis and psoriatic arthritis by targeting IL-17A and IL-17F, key cytokines involved in these inflammatory disorders.
IL-23 inhibitors, another category of biosimilar interleukins, focus on blocking the IL-23 pathway, crucial in autoimmune diseases like psoriasis and inflammatory bowel disease (IBD). Biosimilar IL-1 inhibitors target IL-1, which plays a role in various inflammatory conditions, including rheumatoid arthritis and certain autoimmune disorders. IL-5 inhibitors are used in treating severe eosinophilic asthma, targeting IL-5, a cytokine implicated in eosinophilic inflammation. IL-6 inhibitors, including biosimilars, are utilized in conditions like rheumatoid arthritis and cytokine release syndrome by inhibiting IL-6 signaling pathways. Other categories encompass biosimilar interleukins targeting additional interleukin types, expanding the therapeutic options available for various immune-related disorders.
Global Biosimilar Interleukins Market, Segmentation by Drug Class
The Global Biosimilar Interleukins Market has been segmented by Drug Class into Insulin, Recombinant Human Growth Hormone (RHGH), Granulocyte Colony-Stimulating Factor, Interferon, Erythropoietin, Etanercept, Monoclonal Antibodies, Follitropin, Glucagon, Calcitonin, Teriparatide, and Enoxaparin Sodium.
The global biosimilar interleukins market has been segmented by drug class into several key categories, each serving a unique therapeutic purpose. Insulin and recombinant human growth hormone (RHGH) are commonly used for managing diabetes and growth deficiencies, respectively. These biosimilars are essential in providing cost-effective alternatives to their reference biologics, ensuring broader patient access. Other drug classes in this segment, such as granulocyte colony-stimulating factor and erythropoietin, are used to stimulate blood cell production, often in patients undergoing chemotherapy or suffering from anemia.
Another important category in this market is interferon, which is widely used for treating conditions like multiple sclerosis and chronic hepatitis. Etanercept, a tumor necrosis factor inhibitor, is primarily used for autoimmune diseases like rheumatoid arthritis. Monoclonal antibodies, which are designed to target specific antigens, are an important part of cancer treatment regimens. Follitropin, glucagon, calcitonin, and teriparatide are used for a range of indications, including fertility treatment, diabetes management, and bone disorders, providing biosimilar alternatives to biologics for these conditions.
Enoxaparin sodium, an anticoagulant used to prevent and treat deep vein thrombosis and pulmonary embolism, completes the array of biosimilars in this segment. Each drug class in the biosimilar interleukin market is designed to offer affordable, effective solutions for a wide range of diseases, contributing to the overall growth of the biosimilar market. As healthcare systems worldwide seek cost-effective alternatives to branded biologics, the market for these biosimilars continues to expand, offering enhanced treatment options for patients across various therapeutic areas.
Global Biosimilar Interleukins Market, Segmentation by Type of Manufacturing
The Global Biosimilar Interleukins Market has been segmented by Type of Manufacturing into In-House Manufacturing and Contract Manufacturing.
The Global Biosimilar Interleukins Market is segmented based on the type of manufacturing, which includes in-house manufacturing and contract manufacturing. In-house manufacturing refers to the production of biosimilar interleukins by companies within their own facilities. This approach offers greater control over the production process, quality assurance, and supply chain management. Companies with in-house manufacturing capabilities can ensure compliance with regulatory standards and maintain a competitive edge by optimizing their operations.
Contract manufacturing, on the other hand, involves outsourcing the production process to third-party manufacturers. This model is particularly advantageous for smaller companies or those looking to minimize capital expenditure on infrastructure. Contract manufacturing allows companies to leverage the expertise and resources of established manufacturers, benefiting from their specialized knowledge in biosimilar production. This segment is expected to see significant growth as more pharmaceutical companies look to reduce operational costs and focus on core activities such as research and development.
Both in-house and contract manufacturing models have their distinct advantages, and the choice between the two depends largely on the strategic objectives, resources, and regulatory considerations of the companies involved. In-house manufacturing provides more direct control over production, while contract manufacturing offers flexibility and cost efficiency. As the biosimilar interleukins market continues to grow, the segmentation by manufacturing type is expected to play a critical role in shaping the overall market landscape.
Global Biosimilar Interleukins Market, Segmentation by Procedure
The Global Biosimilar Interleukins Market has been segmented by Procedure into Invasive, and Non-Invasive.
The global biosimilar interleukins market has witnessed significant growth in recent years, driven by increasing demand for affordable treatment options for various diseases. The market is segmented by procedure into invasive and non-invasive categories. Invasive procedures generally involve the use of injections or infusions to administer biosimilar interleukins directly into the body. These procedures are often used in hospital or clinical settings and are essential for the management of serious conditions such as rheumatoid arthritis, psoriasis, and certain cancers.
Non-invasive procedures, on the other hand, focus on treatments that do not require penetration into the body. In the context of biosimilar interleukins, non-invasive options may include oral medications, topical treatments, or other delivery methods that avoid the need for injections or surgeries. This segment is increasingly gaining popularity due to its convenience and ease of use, allowing patients to manage their conditions more independently at home.
Both invasive and non-invasive procedures play vital roles in the treatment of diseases linked to interleukin imbalances. However, the choice between invasive and non-invasive methods often depends on the severity of the condition, patient preference, and healthcare provider recommendations. The growing accessibility of non-invasive treatment options is expected to drive demand in the market, while invasive procedures continue to serve critical needs in more severe cases. As the market evolves, both segments are likely to complement each other, offering patients tailored treatment approaches based on their individual needs.
Global Biosimilar Interleukins Market, Segmentation by Application
The Global Biosimilar Interleukins Market has been segmented by Application into Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Asthma, Inflammatory Bowel Disease (IBD) and Others.
The global biosimilar interleukins market is segmented by application, reflecting the diverse therapeutic uses of these biologic therapies across different medical conditions. Psoriasis and psoriatic arthritis represent prominent applications, where biosimilar interleukins targeting IL-17 and IL-23 pathways are utilized to manage chronic inflammatory skin conditions and associated joint inflammation. Rheumatoid arthritis is another significant application area, with biosimilar interleukins targeting IL-1 and IL-6 pathways, offering effective treatment options to manage autoimmune-driven joint inflammation and systemic symptoms.
Asthma, particularly severe eosinophilic asthma, benefits from biosimilar IL-5 inhibitors that mitigate eosinophil-mediated airway inflammation. Inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis utilize biosimilar IL-23 inhibitors to modulate inflammatory responses within the gastrointestinal tract. Other applications encompass a spectrum of autoimmune and inflammatory conditions, where biosimilar interleukins are increasingly adopted to address specific cytokine-driven pathways contributing to disease pathology.
Each application segment underscores the versatility of biosimilar interleukins in targeting precise mechanisms of immune dysregulation, offering patients therapeutic options that can potentially improve disease management and quality of life. As research and development in biopharmaceuticals continue to advance, the application scope of biosimilar interleukins is expected to expand, catering to a broader range of medical conditions and patient populations worldwide.
Global Biosimilar Interleukins Market, Segmentation by Distribution Channel
The Global Biosimilar Interleukins Market has been segmented by Distribution Channel into Hospital Pharmacies, Online Pharmacies, Retail Pharmacies, Clinics and Research Institutes.
The global biosimilar interleukins market is segmented by distribution channel, encompassing various avenues through which these specialized biopharmaceutical products reach healthcare providers and patients. Hospital pharmacies play a pivotal role as key distribution channels, offering direct access to biosimilar interleukins within hospital settings where patients receive specialized medical care. Online pharmacies have emerged as convenient platforms, facilitating the purchase and delivery of biosimilar interleukins directly to patients' homes, thereby enhancing accessibility and convenience.
Retail pharmacies serve as local hubs where patients can obtain prescribed biosimilar interleukins, providing personalized consultations and pharmaceutical services. Clinics also serve as distribution channels, particularly in outpatient settings where biosimilar interleukins may be administered or prescribed based on clinical assessments and treatment protocols. Research institutes contribute to the distribution channel by facilitating clinical trials and research collaborations, advancing the development and accessibility of biosimilar interleukins through scientific innovation and regulatory approvals.
Each distribution channel plays a critical role in ensuring widespread availability and accessibility of biosimilar interleukins, thereby supporting healthcare providers in delivering targeted treatments for autoimmune and inflammatory disorders globally. As the market continues to evolve, optimizing distribution strategies and enhancing patient education and engagement are crucial to fostering greater adoption and utilization of biosimilar interleukins across diverse healthcare settings.
Global Biosimilar Interleukins Market, Segmentation by Geography
In this report, the Global Biosimilar Interleukins Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Biosimilar Interleukins Market Share (%), by Geographical Region, 2024
The global biosimilar interleukins market is segmented by geography, reflecting regional variations in market dynamics, regulatory frameworks, and healthcare infrastructure that influence the adoption and distribution of these biopharmaceutical products. North America represents a significant market segment, driven by robust healthcare expenditure, advanced biotechnology sector, and favorable regulatory environment facilitating the approval and commercialization of biosimilar interleukins.
Europe is another prominent market region, characterized by stringent regulatory standards governing biosimilars and a well-established market for biopharmaceuticals. The region's emphasis on cost-effective healthcare solutions and biosimilar adoption policies contributes to market growth. Asia-Pacific emerges as a rapidly expanding market, driven by increasing healthcare investments, growing prevalence of chronic diseases, and rising demand for affordable biologic therapies. Countries like China, India, and South Korea are key contributors to market expansion in this region.
Latin America and the Middle East & Africa regions also present growth opportunities, albeit with unique challenges related to healthcare access, regulatory frameworks, and market penetration. These regions are witnessing increasing investments in healthcare infrastructure and regulatory reforms aimed at enhancing biosimilar adoption and market competitiveness.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Biosimilar Interleukins Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers:
- Cost-effectiveness
- Increasing healthcare expenditure
- Patent expirations
-
Rising prevalence of chronic diseases - The rising prevalence of chronic diseases is a global health challenge that is significantly impacting healthcare systems and driving demand for effective treatments, including biosimilar interleukins. Chronic diseases such as diabetes, cardiovascular diseases, cancer, and autoimmune disorders are increasingly prevalent worldwide, affecting millions of individuals and placing substantial burdens on healthcare resources.
One of the primary drivers of this trend is demographic changes, including aging populations in many countries. As people live longer, they are more likely to develop chronic conditions that require ongoing management and treatment. Lifestyle factors such as sedentary lifestyles, unhealthy diets, and tobacco use also contribute to the increasing incidence of chronic diseases.
Advances in medical diagnostics and screening have improved disease detection and management, leading to earlier diagnoses of chronic conditions. This early detection, while beneficial for timely intervention, also means that more individuals are living with these conditions for extended periods, necessitating long-term therapeutic strategies.
In response to these challenges, biosimilar interleukins offer promising solutions by providing more affordable and accessible alternatives to costly biologic therapies. By targeting specific cytokine pathways involved in chronic inflammation and immune dysregulation, biosimilar interleukins can effectively manage symptoms and improve outcomes for patients with conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
Restraints:
- Regulatory hurdles
- Complex manufacturing processes
-
Market competition - Market competition in the biosimilar interleukins sector is intensifying as more pharmaceutical companies enter this rapidly growing market. The competition is driven by several factors, including the expiration of patents on originator biologics, which opens opportunities for biosimilar developers to introduce more affordable alternatives. This has led to a surge in research and development efforts to produce biosimilars that can offer comparable efficacy, safety, and quality to their reference products.
Pharmaceutical companies are also competing based on their ability to navigate regulatory pathways efficiently and gain approvals for biosimilar interleukins across different geographic regions. Regulatory approvals are crucial as they determine market access and adoption rates among healthcare providers and patients. Companies that can demonstrate robust clinical data and manufacturing capabilities often have a competitive edge in securing approvals and building trust in the market.
Market competition is influenced by pricing strategies, with biosimilar developers aiming to offer cost savings compared to originator biologics. Price competitiveness is a significant factor in driving adoption among healthcare providers, payers, and patients who seek more affordable treatment options without compromising on quality or efficacy.
In addition to pricing, companies differentiate themselves through distribution networks and partnerships with healthcare providers and institutions. Establishing strong distribution channels, including hospital pharmacies, retail pharmacies, and online platforms, is crucial for ensuring widespread availability and accessibility of biosimilar interleukins.
Opportunities:
- Expanding biopharmaceutical sector
- Growing demand for affordable therapies
-
Emerging markets - Emerging markets play a crucial role in the global biosimilar interleukins landscape, presenting significant growth opportunities driven by several key factors. These markets, which include regions in Asia-Pacific, Latin America, and parts of Eastern Europe, are characterized by expanding healthcare infrastructures, increasing healthcare expenditures, and growing patient populations with unmet medical needs.
One of the primary drivers of growth in emerging markets is the rising prevalence of chronic diseases. As these regions experience demographic shifts, including aging populations and urbanization, there is a corresponding increase in the incidence of chronic conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. This demographic trend fuels demand for affordable biologic therapies like biosimilar interleukins that offer effective treatment options while addressing cost constraints.
Regulatory reforms and initiatives in many emerging markets are aimed at accelerating the approval and adoption of biosimilars. Governments and regulatory authorities are implementing policies to streamline approval processes, establish clear guidelines for biosimilar development, and encourage competition in the biopharmaceutical sector. These efforts are designed to enhance market access and affordability of biosimilar interleukins, thereby improving healthcare outcomes for patients.
In addition to regulatory advancements, partnerships and collaborations between multinational pharmaceutical companies and local manufacturers in emerging markets are facilitating technology transfer and knowledge exchange. This collaboration enhances local manufacturing capabilities for biosimilar interleukins, ensuring sustainable supply and reducing dependency on imports.
Competitive Landscape Analysis
Key players in Global Biosimilar Interleukins Market include:
- MabPharm
- Gedeon Richter
- Bio-Thera Solutions
- Sorrento Therapeutics/MabTech
- Sunshine Guojian Pharmaceutical
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Type
- Market Snapshot, By Drug Class
- Market Snapshot, By Type of Manufacturing
- Market Snapshot, By Procedure
- Market Snapshot, By Application
- Market Snapshot, By Distribution Channel
- Market Snapshot, By Region
- Global Biosimilar Interleukins Market Trends
- Drivers, Restraints and Opportunities
- Drivers
- Cost-effectiveness
- Increasing healthcare expenditure
- Patent expirations
- Rising prevalence of chronic diseases
- Restraints
- Regulatory hurdles
- Complex manufacturing processes
- Market competition
- Opportunities
- Expanding biopharmaceutical sector
- Growing demand for affordable therapies
- Emerging markets
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
-
Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Biosimilar Interleukins Market, By Type, 2021 - 2031 (USD Million)
- IL-17
- IL-23
- IL-1
- IL-5
- IL-6
- Others
- Global Biosimilar Interleukins Market, By Drug Class, 2021 - 2031 (USD Million)
- Insulin
- Recombinant Human Growth Hormone (RHGH)
- Granulocyte Colony-Stimulating Factor
- Interferon
- Erythropoietin
- Etanercept
- Monoclonal Antibodies
- Follitropin
- Glucagon
- Calcitonin
- Teriparatide
- Enoxaparin Sodium
- Global Biosimilar Interleukins Market, By Type of Manufacturing, 2021 - 2031 (USD Million)
- In-House Manufacturing
- Contract Manufacturing.
- Global Biosimilar Interleukins Market, By Procedure, 2021 - 2031 (USD Million)
- Invasive
- Non-Invasive
- Global Biosimilar Interleukins Market, By Application, 2021 - 2031 (USD Million)
- Psoriasis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Asthma
- Inflammatory Bowel Disease (IBD)
- Others
- Global Biosimilar Interleukins Market, By Distribution Channel, 2021 - 2031 (USD Million)
- Hospital Pharmacies
- Online Pharmacies
- Retail Pharmacies
- Clinics
- Research Institutes
- Global Biosimilar Interleukins Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Biosimilar Interleukins Market, By Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- MabPharm
- Gedeon Richter
- Bio-Thera Solutions
- Sorrento Therapeutics/MabTech
- Sunshine Guojian Pharmaceutical
- Company Profiles
- Analyst Views
- Future Outlook of the Market