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市場調查報告書
商品編碼
1625167
到 2030 年乾癬生物相似藥市場預測:按產品類型、治療類型、應用、最終用戶和地區進行的全球分析Psoriasis Biosimilars Market Forecasts to 2030 - Global Analysis By Product, Therapy Type, Application, End User and By Geography |
根據 Stratistics MRC 的數據,2024 年全球乾癬生物相似藥市場規模為 102.7 億美元,預計到 2030 年將達到 253.1 億美元,預測期內複合年成長率為 12.2%。
乾癬生物相似藥是一種旨在治療乾癬(一種慢性自體免疫皮膚病)的生物製藥,它模仿參考生物製藥(我是創新生物製藥)的效果。這些生物相似藥的開發目的是在安全性、功效和品質方面與參考製劑相當,但價格通常較低。它用於減少發炎、控制皮膚細胞更新並控制中度至斑塊型乾癬患者的症狀。乾癬生物相似藥製劑經過嚴格的臨床測試,以確保它們與參考製劑的治療效果相當。
據國家乾癬基金會稱,超過 800 萬美國患有乾癬。
乾癬盛行率增加
隨著全球被診斷患有乾癬的人數不斷增加,對有效且負擔得起的治療方法的需求不斷成長。生物相似藥是昂貴的參考生物製藥的一種經濟有效的替代品,使其成為面臨治療成本不斷增加的醫療保健系統的有吸引力的選擇。中度至重度乾癬的盛行率正在增加,特別是在人口稠密地區,這為生物相似藥創造了巨大的市場機會。此外,對該疾病認知的提高和早期診斷進一步增加了對乾癬生物相似藥的需求並支持市場擴張。
醫生和病人的抵抗
醫生和患者對乾癬生物相似藥的抵制主要源於對其功效、安全性以及與參考生技藥品的潛在差異的擔憂。由於長期臨床資料有限以及與原廠生技藥品的兼容性不確定性,醫生可能會猶豫是否開立生物相似藥。患者常常擔心生物相似藥可能無法提供相同程度的療效或可能引起副作用。儘管生物相似藥具有成本優勢,但這種懷疑減緩了生物相似藥的採用並抑制了市場成長。
擴大新興市場醫療保健服務的覆蓋範圍
新興地區正在改善其醫療基礎設施,並增加接受乾癬等慢性疾病先進治療的患者數量。生物相似藥是昂貴的參考生技藥品的經濟有效的替代品,並提供負擔得起的治療選擇,特別是在價格敏感的市場。醫療保健專業人員和患者意識的提高以及核准部門對生物學名藥的批准推動推動了生物相似藥的日益普及。這種廣泛的准入滿足了對乾癬治療日益成長的需求,並有助於新興國家的市場擴張。
開發和製造成本高
開發和製造乾癬生物相似藥的成本高昂,是由於生物製藥的製造過程複雜,包括細胞株開發、蛋白質生產以及為確保安全性和有效性而進行的廣泛臨床試驗。此外,嚴格的監管要求進一步增加了成本。這些高成本限制了生物相似藥的承受能力並阻礙了其採用,特別是在價格敏感的市場。
COVID-19 的影響
COVID-19 大流行擾亂了供應鏈、推遲了臨床試驗,並因關閉而限制了醫療服務,從而影響了乾癬生物學名藥市場。因此,生物相似藥的採用暫時放緩。然而,對廉價治療的需求不斷成長,以及對具有成本效益的醫療保健解決方案的日益關注,加速了疫情後的市場發展。此外,遠端醫療的興起有助於維持護理的連續性,並增加了人們對生物學名藥的興趣,將其作為治療乾癬的原研生物製藥的一種易於使用且成本低廉的替代品。
生物製藥產業預計將在預測期內成為最大的產業。
預計生物製藥將在整個預測期內獲得最大的市場佔有率。生物相似藥旨在以較低的成本複製參考生物製藥的有效性、安全性和品質。這些治療可以幫助減輕發炎、減少皮膚細胞更新並緩解中度至重度乾癬患者的症狀。在生物製藥治療中使用生物相似藥為患者提供了更便宜、更容易獲得的選擇,並擴大了治療機會。
斑塊乾癬領域預計在預測期內複合年成長率最高
預計斑塊乾癬部分在預測期內複合年成長率最高。斑塊型乾癬生物相似藥旨在為治療中度至重度斑塊型乾癬的參考生物製藥提供一種有效且具成本效益的替代方案。生物相似藥的使用提供了一種更實惠的治療選擇,同時保持與原始生物製藥相似的安全性和有效性。由於斑塊型乾癬是最常見的疾病之一,對治療該疾病的生物相似藥的需求只會不斷增加,使患者更容易獲得有效的治療方法。
由於乾癬患病率不斷上升、醫療保健成本不斷上升、先進治療方法的普及等,預計亞太地區將在預測期內佔據最大的市場佔有率。市場主要企業包括 Dr. Reddy's Laboratories、Samsung Bioepis、Biocon、Mylan 等。生物相似藥的日益普及,加上法律規範和醫療基礎設施的改進,正在推動市場成長。隨著人們對醫療保健的認知和獲取情況的改善,亞太地區的乾癬生物相似藥市場預計將繼續強勁成長。
由於對負擔得起的生物製藥治療的需求不斷成長,預計北美在預測期內的複合年成長率最高。該地區的主要企業包括安進 (Amgen)、山德士 (Sandoz)、輝瑞 (Pfizer) 和 Celltrion Healthcare。該地區也享有 FDA 的強而有力的監管支持。隨著生物相似藥獲得醫療保健專業人員和患者的認可,北美乾癬生物相似藥市場預計將繼續擴大。
According to Stratistics MRC, the Global Psoriasis Biosimilars Market is accounted for $10.27 billion in 2024 and is expected to reach $25.31 billion by 2030 growing at a CAGR of 12.2% during the forecast period. Psoriasis biosimilars are biologic drugs designed to treat psoriasis, a chronic autoimmune skin condition, by mimicking the action of reference biologics (original biologic drugs). These biosimilars are developed to have similar safety, efficacy, and quality to the reference product but are typically offered at a lower cost. They are used to reduce inflammation, control skin cell turnover, and manage symptoms in patients with moderate to severe plaque psoriasis. Psoriasis biosimilars undergo rigorous clinical testing to ensure they match the reference product's therapeutic effects.
According to the National Psoriasis Foundation, more than 8 million Americans have psoriasis.
Increasing prevalence of psoriasis
As the number of individuals diagnosed with psoriasis rises globally, there is a growing demand for effective, affordable treatments. Biosimilars offer a cost-efficient alternative to expensive reference biologics, making them an attractive option for healthcare systems facing rising treatment costs. The increasing incidence of moderate to severe psoriasis, particularly in regions with large populations, creates a substantial market opportunity for biosimilars. Additionally, greater awareness and earlier diagnosis of the condition further contribute to the demand for psoriasis biosimilars, boosting market expansion.
Physician and patient resistance
Physician and patient resistance to psoriasis biosimilars primarily stems from concerns about their efficacy, safety, and potential differences from reference biologics. Physicians may hesitate to prescribe biosimilars due to limited long-term clinical data or uncertainty regarding their interchangeability with original biologics. Patients often fear that biosimilars may not offer the same level of effectiveness or might cause adverse effects. This skepticism hampers market growth by slowing the adoption of biosimilars, despite their cost advantages.
Expanded access to healthcare services in emerging markets
Since healthcare infrastructure improves in emerging regions, more patients gain access to advanced treatments for chronic conditions like psoriasis. Biosimilars, being cost-effective alternatives to expensive reference biologics, offer an affordable treatment option, particularly in price-sensitive markets. The increasing adoption of biosimilars is further supported by growing awareness among healthcare professionals and patients, as well as the regulatory push for biosimilar approvals. This broader access helps meet the rising demand for psoriasis treatments, contributing to market expansion in emerging economies.
High development and manufacturing costs
High development and manufacturing costs in psoriasis biosimilars arise from the complex processes involved in creating biologic drugs, such as cell-line development, protein production, and extensive clinical testing to ensure safety and efficacy. Additionally, stringent regulatory requirements further increase costs. These high expenses can limit the affordability of biosimilars, hindering their widespread adoption, especially in price-sensitive markets.
Covid-19 Impact
The covid-19 pandemic impacted the psoriasis biosimilars market by disrupting supply chains, delaying clinical trials, and limiting healthcare access due to lockdowns. This led to a temporary slowdown in biosimilar adoption. However, the growing demand for affordable treatments, along with increased focus on cost-effective healthcare solutions, accelerated the market post-pandemic. Additionally, the rise in telemedicine helped maintain treatment continuity, boosting interest in biosimilars as an accessible, lower-cost alternative to original biologics for psoriasis management.
The biologic therapy segment is expected to be the largest during the forecast period
The biologic therapy segment is predicted to secure the largest market share throughout the forecast period. Biosimilars are designed to replicate the efficacy, safety, and quality of reference biologics at a lower cost. These treatments help control inflammation, reduce skin cell turnover, and alleviate symptoms in patients with moderate to severe psoriasis. The use of biosimilars in biologic therapy provides a more affordable and accessible option for patients, expanding treatment opportunities.
The plaque psoriasis segment is expected to have the highest CAGR during the forecast period
The plaque psoriasis segment is anticipated to witness the highest CAGR during the forecast period. Psoriasis biosimilars in plaque psoriasis applications are designed to provide effective, cost-efficient alternatives to reference biologics for managing moderate to severe plaque psoriasis. The use of biosimilars offers a more affordable treatment option while maintaining similar safety and efficacy profiles as original biologics. As plaque psoriasis is one of the most common forms, the demand for biosimilars in its treatment continues to grow, enhancing patient accessibility to effective therapies.
Asia Pacific is expected to register the largest market share during the forecast period driven by the increasing prevalence of psoriasis, rising healthcare costs, and growing access to advanced treatments. Key players in the market include Dr. Reddy's Laboratories, Samsung Bioepis, Biocon, and Mylan. The growing adoption of biosimilars combined with supportive regulatory frameworks and improving healthcare infrastructure, is propelling market growth. As awareness and healthcare access improve, the Asia-Pacific psoriasis biosimilars market is expected to continue its robust growth trajectory.
North America is expected to witness the highest CAGR over the forecast period fuelled by the growing demand for affordable biologic treatments. The region is home for key players such as Amgen, Sandoz, Pfizer, and Celltrion Healthcare. The region also has strong regulatory support from the FDA. With the increasing acceptance of biosimilars among healthcare providers and patients, the North American psoriasis biosimilars market is poised for continued expansion.
Key players in the market
Some of the key players profiled in the Psoriasis Biosimilars Market include Amgen, Pfizer, Mylan, Eli Lilly, Boehringer Ingelheim, Coherus BioSciences, AbbVie, Novartis, Teva Pharmaceuticals, Glenmark Pharmaceuticals, Zydus Cadila, Lupin, Biocon Biologics, Alvotech, Hetero, Cipla, Hisun Biopharma and BIOCAD.
In December 2024, Biocon Biologics has received the USFDA nod to launch the biosimilar version of Janssen's Stelara (Ustekinumab) used for the treatment of autoimmune disorders such as Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The biosimilar will be marketed under brand name Yesintek.
In April 2024, Alvotech and Teva Pharmaceuticals received Food and Drug Administration (FDA) approval for Selarsdi, a biosimilar of Johnson & Johnson's Stelara, a leading treatment for moderate to severe psoriasis and other autoimmune conditions. This approval marks a significant milestone in the competitive landscape for psoriasis treatment, as Stelara has been a top-selling biologic with billions in annual sales.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.