The global sale of psoriasis biosimilars market is estimated to be worth USD 9,228.6 million in 2024 and anticipated to reach a value of USD 26,679.9 million by 2034. Sales are projected to rise at a CAGR of 11.2% over the forecast period between 2024 and 2034. The revenue generated by psoriasis biosimilars market in 2023 was USD 8,412.60 million.
The main factor driving the growth of the psoriasis biosimilars market is increasing prevalence of psoriasis. Increasingly large numbers of people suffering from this chronic inflammatory skin condition around the world spur the demand for effective treatments at low costs, which, in turn, can be effectively attained by biosimilars.
In America, this condition has great economic problems. Due to the increasing prevalence of psoriasis there is a need for effective medications. Whereas biosimilars are nearly identical products to original biologicals but cost less without affecting their efficacy or safety standards. By introducing biosimilars it will enhance patient accessibility to biotherapy in a situation where high costs have made it underutilized.
Global Psoriasis Biosimilars Market Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2023 | USD 8,412.6 million |
| Estimated Size, 2024 | USD 9,228.6 million |
| Projected Size, 2034 | USD 26,679.9 million |
| Value-based CAGR (2024 to 2034) | 11.2% |
According to the National Psoriasis Foundation, more than 8 million Americans have psoriasis. Worldwide, 2 to 3 per cent of the total population, or 125 million people, have psoriasis, according to the consortium World Psoriasis Day. An estimated 30 per cent of people with psoriasis also develop psoriatic arthritis. Almost 40% with psoriatic arthritis reported their disease to be a large problem in everyday life.
An increased prevalence of the psoriasis has also increased research and development in the field of biosimilars. Several pathways involved in the pathogenesis of psoriasis, among which are TNF-alpha and interleukins, have been under study by pharmaceutical firms for developing biosimilars that target those pathways. Competition should then go a notch higher, which will mean a lower price with an increased access.
In conclusion, the rising prevalence of psoriasis is a major driver for the growth of the psoriasis biosimilars market. Since there is a sharp increase in the number of individuals suffering from the disease globally, affordable as well as effective treatment alternatives are growingly wanted.
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The Rapid Growth of the Autoimmune Biosimilars Sector Represents a Transformative Opportunity
The rapidly developing market of autoimmune biosimilars presents a transforming opportunity within the pharmaceutical field for the treatment of diseases like psoriasis. Being among the autoimmune diseases, psoriasis is a result of the overly active response of the immune system against healthy skin cells and presents itself in the chronic inflammatory condition of the skin.
The prevalence of autoimmune diseases, of which psoriasis is a part, consequently fuels great demand for efficient and accessible treatments, making biosimilars an extremely important answer in this respect.
One of the driving factors for the market in psoriasis biosimilars today is the increase in autoimmune diseases all over the world. Usually, autoimmune diseases will continue to increase in prevalence across populations of different backgrounds and age groups, including rheumatoid arthritis, lupus, and even psoriasis. These are induced due to a deranged immune response against their own tissue antigen, causing symptoms that are usually chronic and debilitating with inflammation.
The study published by NCBI estimated that 10% of the world's population is affected by autoimmune diseases, with 4-5% prevalence rates in developed countries. The prevalence of autoimmune diseases has continued to rise over the last few decades, with 12.5% annually in prevalence and 19.1% in incidence in the world.
Exposure to environmental pollutants and chemicals, factors that have been associated with dysregulation in the immune function, may act as triggers to the autoimmune response. Furthermore, the up surging number of autoimmune diseases, incited by environmental and lifestyle factors, is creating a growing need for cost-effective and successful treatment alternatives.
The Need for Long-Term Treatment Options is a Significant Driver of the Psoriasis Biosimilars Market
Psoriasis patients’ skin is represented by thick layers on its surface as they suffer from rapid skin cell production (hyper proliferation). The seriousness of this condition differs from one person to another: some only have mild symptoms which topical creams can relieve whereas others have moderate to severe forms which interfere with the daily lives of their carriers thus needing systemic therapy.
The psoriasis biosimilars market is largely driven by managing symptoms and treating emergency conditions because psoriasis is a chronic disease that requires long-term biologic treatment. Using biosimilars instead of brand-name biologics is a cheaper and more accessible way to manage the disease over time with more patients turning to it. This emphasis on long-term treatment falls in line with rising global incidence rates for psoriasis and equally high costs associated with biological therapy.
Biosimilars are biologics that are highly similar to an already approved biologic medication (known as reference drug), regarding safety, efficacy, and quality. They provide similar benefits as the original but are exchanged cheaply; hence suitable for long-term management options over time. The introduction of biosimilars in the movement by some patients whose previous access and affordability were very low has resulted in an improvement in their lifestyle.
In conclusion, the chronic nature of psoriasis necessitates ongoing management and consistent adherence to treatment, which are critical for maintaining disease control and improving patient outcomes.
The Opportunity Lies Within the High Commercial Potential of Manufacturers of Biosimilars
Biosimilars hold very high commercial potential, especially for mAbs in various therapeutic areas of the global pharmaceutical industry. In fact, the pharmaceutical players are highly investing in the growth and development of biosimilars toward the improvement of various critical healthcare needs and cost-related issues across South Asia. Most notably, the interest in biosimilars, particularly those targeting chronic conditions such as psoriasis, provides a great opportunity for market expansion and greater access to treatments at lower cost.
Countries like India have made South Asia a major stakeholder in the global biosimilars market. Consequently, pharmaceutical firms across the region have begun to invest more and more in the development and production of biosimilars with expressed intent to capture both local and global markets. With each passing day, these entrants remain a shaping factor in the dynamics of the treatment landscape and, as such, biosimilars are an integral part of meeting the needs of patients and healthcare systems alike.
The psoriasis market has a demand for long-term, usually life-long, therapy, and companies realize that the market demand is stable and sustainable for effective therapies. Manufacturers also believe that, by developing biosimilars to match therapeutic benefits from original biologics, they will ensure access to a wide patient population, thereby fulfilling the growing need of cost-effective treatment.
Regulatory Uncertainty is emerging as the Prominent Challenge for Product Approvals
Regulatory uncertainty is one of the most considerable psoriasis biosimilars market challenges, as it will make impacts on the development, approval, and commercialization of these lifesaving therapies.
Guidelines inconsistencies, evolving regulatory frameworks, and complicated features of demonstrating bio similarity and interchangeability are different dimensions of uncertainty observed in the regulatory environment. All of these combine together to provide a multifaceted environment that makes it difficult for the market to achieve its full potential and impacts access to affordable treatment options for patients suffering from psoriasis.
The EMA has a very clear path in the EU for the approval of biosimilars, including requirements for substantial clinical data to be provided to demonstrate bio similarity with the reference product. However, this may be different from standards and expectations compared with those of the FDA and would therefore have variants of stringency and interpretation.
For instance, whereas the FDA might focus its efforts on being able to demonstrate that a biosimilar will be expected to produce the same clinical result as the reference product, including when switching between products, guidelines from the EMA may not fit perfectly with this approach, thereby creating confusion and possibly delaying market entry for those attempting to work within multiple regulatory contexts.
The entry and marketing of several adalimumab biosimilars, such as Amjevita and Cyltezo, into the market were further complicated by patent litigations during approval, where brand name holder AbbVie warded off patent rights from the regulators. This led to a delay in the USA market even after the FDA had approved these biosimilars.
This uncertainty has been driven by diverse guidelines among regions, evolving regulatory frameworks, and scientific complexity with respect to the demonstration of biosimilarity and interchangeability.
The global psoriasis biosimilars market industry recorded a CAGR of 11.2% during the historical period between 2019 and 2023. The growth of psoriasis biosimilars market industry was positive as it reached a value of USD 8,412.60 million in 2023 from USD 5,778.7 million in 2019.
Management of psoriasis has evolved from conventional modes to the latest biologics. Traditionally, treatments for psoriasis have been mainly topical, with corticosteroids, coal tar, and calcipotriene being used to help reduce inflammation and scaling. Phototherapy was used as a key treatment for more severe psoriasis.
Psoriasis treatment changed with the introduction of the biologic therapies. The biologics, directed at selective components of the immune system responsible for psoriasis, grossly outperformed conventional treatments. But it was these extremely expensive drugs that, in turn, gave rise to major access problems.
Many biosimilars for key biologics such as adalimumab, etanercept, and infliximab have been launched in the market and eventually present cheaper alternatives for patients. This has been a function of an increasing emphasis on cost containment and ensuring access to care. Moving forward, advanced technologies are also foreseen for personalized medicine with digital health tools in optimizing treatment strategies.
Principal Consultant
Tier 1 companies comprise market leaders with a market revenue of above USD 1000 million capturing significant market share of 38.7% in global market.
These companies follow strategies like investing heavily in R&D to develop high-quality biosimilars that closely match reference biologics, securing patents and exclusivity periods to protect their products, and forging strategic partnerships with healthcare providers and distributors to enhance market penetration. Prominent companies in tier 1 include Merck KGaA, Pfizer Inc., Novartis International AG, Amgen Inc and Others.
Tier 2 companies include mid-size players with revenue of USD 500 to 1000 million having presence in specific regions and highly influencing the local market and holds around 26.7% market share emphasize cost-efficient manufacturing processes to produce biosimilars at competitive prices, which helps in pricing their products attractively compared to both originator biologics and other biosimilars.
Additionally, forming alliances with contract research organizations (CROs) and contract manufacturing organizations (CMOs) allows Tier 2 companies to access advanced technologies and expertise without substantial capital investment. Prominent companies in tier 2 include Coherus BioSciences, Hoffmann-La Roche Ltd and Samsung Bioepis.
Finally, Tier 3 companies, such as Celltrion, Sandoz, Fresenius Kabi and others. They specialize in specific products and cater to niche markets, adding diversity to the industry. Overall, while Tier 1 companies are the primary drivers of the market, Tier 2 and 3 companies also make significant contributions, ensuring the psoriasis biosimilars market sales remains dynamic and competitive.
The section below covers the industry analysis for the psoriasis biosimilars market for different countries. Market demand analysis on key countries in several regions of the globe, including North America, Asia Pacific, Europe, and others, is provided. The United States is anticipated to remain at the forefront in North America, with higher market share through 2034. In Asia Pacific, India is projected to witness a CAGR of 11.3% by 2034.
| Countries | Value CAGR (2024 to 2034) |
|---|---|
| USA | 7.9% |
| Canada | 10.8% |
| UK | 8.2% |
| Germany | 7.7% |
| France | 9.1% |
| Italy | 9.7% |
| India | 11.3% |
| Spain | 10.4% |
Germany’s psoriasis biosimilars market is poised to exhibit a CAGR of 7.7% between 2024 and 2034. Currently, it holds the prominent market share in the Western Europe market, and the trend is expected to continue during the forecast period.
With its strong pharmaceutical innovation, Germany has a solid infrastructure for performing biotech research and development. This enables German companies to be at the front line in the development of biosimilars, ensuring high-quality products that match most of the stringent standards. The regulatory environment in Germany is set up in collaboration with the European Medicines Agency, and therefore, biosimilars are taken through a thorough assessment before being released to the market.
This makes the knowledge of health care providers the most important factor in driving biosimilars uptake in Germany, for much learning and high expertise among health care professionals took place. Doctors and pharmacists are well-oriented on biosimilars through educational work and continuous professional improvement; this would easily allow them to penetrate the treatment plan for psoriasis.
USA psoriasis biosimilars market is poised to exhibit a CAGR of 7.9% between 2024 and 2034. Currently, it holds the highest share in the North American market, and the trend is expected to continue during the forecast period.
USA dominance in biopharmaceutical industry has provided base for the manufacturing of biosimilars with advanced technologies. Additionally, high prevalence among the population drives huge demand for effective treatment, for which biosimilars are particularly critical in order to manage the chronic condition.
This will equally be advantageous for the USA, since the country has in place a well-grounded regulatory framework under the FDA to allow easy passage of biosimilars to the market, ensuring that they go through necessary hard safety and efficacy standards.
This regulatory environment, apart from vast infrastructure for healthcare and dissemination of education, calls for wide diffusion and use at the clinical point of biosimilars. The USA, therefore, continues to drive growth and innovation in the North American psoriasis biosimilars market.
India’s psoriasis biosimilars market is poised to exhibit a CAGR of 11.3% between 2024 and 2034. Currently, it holds the highest share in the South Asia & Pacific market, and the trend is expected to continue during the forecast period.
One of the other major factors contributing to growth in the psoriasis biosimilars market is the large pharmaceutical manufacturing capacity of India. The Indian government, over recent years, has attained recognition globally for a well-established pharmaceutical industry marked by advanced manufacturing facilities and substantial production capacities.
With such infrastructure, the Indian government can manufacture biosimilars at high standards but at lower costs and hence make such treatments highly affordable and accessible to the masses.
Large-capacity manufacturing not only helps to the local demand but also facilitates export supplies to international markets, hence giving further impetus to growth in the sector. This manufacturing capability in India thus complements and enhances the competency in biotechnology, hence ensuring that advanced and complex biologic drugs, including biosimilars for psoriasis, are efficiently produced.
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The section contains information about the leading segments in the industry. By indication, the plaque psoriasis segment holds the highest market share of 85.0% in 2024.
| By Indication | Plaque Psoriasis |
|---|---|
| Value Share (2024) | 85.0% |
The chronicity of plaque psoriasis and the impairment in quality of life have created a demand for treatments that are efficient and affordable. Biologics have become effective in the management of moderate to serious plaque psoriasis targeted against specific pathways of the inflammation process. However, high-cost treatments derived from originator biologic processes have meant that many patients are unable to access them and hence providing an excellent opportunity for biosimilars.
With similar profiles of efficacy and safety, though at much lower costs, as their reference biologics, biosimilars are quite attractive to healthcare providers and patients alike. Due to this fact, the coming of biosimilars has broadened the therapeutic options available for plaque psoriasis, increasing adoption and use in clinical settings.
Moreover, biosimilars introduced for the indication of plaque psoriasis have been supported by favorable regulatory frameworks and growing physician confidence in these therapies. Thus, it further reinstates plaque psoriasis's dominance in the indication segment of the psoriasis biosimilar market.
| By Sales Channel | Retail Pharmacy Chains |
|---|---|
| Value Share (2024) | 39.8% |
Retail chains of pharmacies are usually very large, with a number of locations throughout many given city or rural area. This allows the psoriasis patient ease of access to their biosimilar medication without having to travel an extensive distance, which for most would be a problem as they require their medications on a regular basis.
Convenience factors include extended hours and accessible locations. This helps patients manage their prescriptions better, benefiting from walk-in services, which have a special significance in the management of a chronic condition like psoriasis, which many times requires consistent treatment.
In conclusion with wide network, which guarantees accessibility and thus convenience to patients with any other chronic condition, retail chains take the lead in the current psoriasis biosimilars market. Their wide presence allows for easy access to medication, something very crucial in the management of a chronic condition such as psoriasis.
The companies are building distribution networks and integrating supply chains to reach more markets. They target the emerging markets that have increasing healthcare needs and a growing population of patients. With a cost-effective manufacturing process.
This is helpful in the penetration of biosimilars and their accessibility to more and more patients. Additionally, companies are treading complex regulatory pathways to secure approval for their biosimilars. They liaise with the regulatory authorities on issues that pertain to the safety, efficacy, and quality of their products, observing strict standards.
Recent Industry Developments in Psoriasis Biosimilars Market
In terms of drug class, the industry is divided into TNF-alpha inhibitors (infliximab, etanercept, adalimumab) and other biosimilars.
In terms of Indication, the industry is segregated into plaque psoriasis, psoriatic arthritis and other types.
In terms of route of administration, the industry is segregated into subcutaneous, intravenous oral and topical.
In the terms of distribution channel, the market is segmented into hospital pharmacies, retail pharmacy chains and online pharmacies.
Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia & Pacific, East Asia and Middle East and Africa (MEA) have been covered in the report.
The global psoriasis biosimilars market is projected to witness CAGR of 11.2% between 2024 and 2034.
The global psoriasis biosimilars market industry stood at USD 8,412.6 million in 2023.
The global psoriasis biosimilars market is anticipated to reach USD 26,679.9 million by 2034 end.
India is set to record the highest CAGR of 11.3% in the assessment period.
The key players operating in the global psoriasis biosimilars market include Merck KGaA, Gyros Protein Technologies AB, Pfizer Inc., Novartis International AG, Amgen Inc, Samsung Bioepis Co., Ltd., Coherus BioSciences, Hoffmann-La Roche Ltd, Celltrion, Samsung Bioepis, Sandoz, Fresenius Kabi, Viatris, Reddy's Laboratories and GenScript.
1. Executive Summary 2. Industry Introduction, including Taxonomy and Market Definition 3. Market Trends and Success Factors, including Macro-Economic Factors, Market Dynamics, and Recent Industry Developments 4. Global Market Demand Analysis 2019 to 2023 and Forecast 2024 to 2034, including Historical Analysis and Future Projections 5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034 5.1. By Drug Class 5.2. By Indication 5.3. By Route of Administration 5.4. By Sales Channel 5.5. By Region 6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Drug Class 6.1. TNF-alpha Inhibitors 6.1.1. Infliximab 6.1.2. Etanercept 6.1.3. Adalimumab 6.2. Other Biosimilars 7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Indication 7.1. Plaque Psoriasis 7.2. Psoriatic Arthritis 7.3. Other Types 8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, Route of Administration 8.1. Subcutaneous 8.2. Intravenous 8.3. Oral 8.4. Topical 9. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Sales Channel 9.1. Hospital Pharmacies 9.2. Retail Pharmacy Chains 9.3. Online Pharmacies 10. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Region 10.1. North America 10.2. Latin America 10.3. Western Europe 10.4. Eastern Europe 10.5. South Asia & Pacific 10.6. East Asia 10.7. Middle East & Africa 11. North America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 12. Latin America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 13. Western Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 14. Eastern Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 15. South Asia & Pacific Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 16. East Asia Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 17. Middle East and Africa Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 18. Sales Forecast 2024 to 2034 by drug class, by indication, by route of administration, and by Sales Channel Form for 30 Countries 19. Competition Outlook, including Market Structure Analysis, Company Share Analysis by Key Players, and Competition Dashboard 20. Company Profile 20.1. Merck KGaA 20.2. Gyros Protein Technologies AB 20.3. Pfizer Inc. 20.4. Novartis International AG 20.5. Amgen Inc 20.6. Samsung Bioepis Co., Ltd. 20.7. Coherus BioSciences 20.8. Hoffmann-La Roche Ltd 20.9. Celltrion 20.10. Samsung Bioepis 20.11. Sandoz 20.12. Fresenius Kabi 20.13. Viatris 20.14. Dr. Reddy's Laboratories 20.15. GenScript
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Psoriasis Biosimilars Market
