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市场调查报告书
商品编码
1625167
到 2030 年干癣生物相似药市场预测:按产品类型、治疗类型、应用、最终用户和地区进行的全球分析Psoriasis Biosimilars Market Forecasts to 2030 - Global Analysis By Product, Therapy Type, Application, End User and By Geography |
根据 Stratistics MRC 的数据,2024 年全球干癣生物相似药市场规模为 102.7 亿美元,预计到 2030 年将达到 253.1 亿美元,预测期内复合年增长率为 12.2%。
干癣生物相似药是一种旨在治疗干癣(一种慢性自体免疫皮肤病)的生物製药,它模仿参考生物製药(我是创新生物製药)的效果。这些生物相似药的开发目的是在安全性、功效和品质方面与参考製剂相当,但价格通常较低。它用于减少发炎、控制皮肤细胞更新并控制中度至斑块型干癣患者的症状。干癣生物相似药製剂经过严格的临床测试,以确保它们与参考製剂的治疗效果相当。
据国家干癣基金会称,超过 800 万美国患有干癣。
干癣盛行率增加
随着全球被诊断患有干癣的人数不断增加,对有效且负担得起的治疗方法的需求不断增长。生物相似药是昂贵的参考生物製药的一种经济有效的替代品,使其成为面临治疗成本不断增加的医疗保健系统的有吸引力的选择。中度至重度干癣的盛行率正在增加,特别是在人口稠密地区,这为生物相似药创造了巨大的市场机会。此外,对该疾病认识的提高和早期诊断进一步增加了对干癣生物相似药的需求并支持市场扩张。
医生和病人的抵抗
医生和患者对干癣生物相似药的抵制主要源于对其功效、安全性以及与参考生技药品的潜在差异的担忧。由于长期临床资料有限以及与原厂生技药品的兼容性不确定性,医生可能会犹豫是否开立生物相似药。患者常常担心生物相似药可能无法提供相同程度的疗效或可能引起副作用。儘管生物相似药具有成本优势,但这种怀疑减缓了生物相似药的采用并抑制了市场成长。
扩大新兴市场医疗保健服务的覆盖范围
新兴地区正在改善其医疗基础设施,并增加接受干癣等慢性疾病先进治疗的患者数量。生物相似药是昂贵的参考生技药品的经济有效的替代品,并提供负担得起的治疗选择,特别是在价格敏感的市场。医疗保健专业人员和患者意识的提高以及核准部门对生物仿製药的批准推动推动了生物相似药的日益普及。这种广泛的准入满足了对干癣治疗日益增长的需求,并有助于新兴国家的市场扩张。
开发和製造成本高
开发和製造干癣生物相似药的成本高昂,是由于生物製药的製造过程复杂,包括细胞株开发、蛋白质生产以及为确保安全性和有效性而进行的广泛临床试验。此外,严格的监管要求进一步增加了成本。这些高成本限制了生物相似药的承受能力并阻碍了其采用,特别是在价格敏感的市场。
COVID-19 的影响
COVID-19 大流行扰乱了供应链、推迟了临床试验,并因关闭而限制了医疗服务,从而影响了干癣生物仿製药市场。因此,生物相似药的采用暂时放缓。然而,对廉价治疗的需求不断增长,以及对具有成本效益的医疗保健解决方案的日益关注,加速了疫情后的市场发展。此外,远端医疗的兴起有助于维持护理的连续性,并增加了人们对生物仿製药的兴趣,将其作为治疗干癣的原研生物製药的一种易于使用且成本低廉的替代品。
生物製药产业预计将在预测期内成为最大的产业。
预计生物製药将在整个预测期内获得最大的市场占有率。生物相似药旨在以较低的成本复製参考生物製药的有效性、安全性和品质。这些治疗可以帮助减轻发炎、减少皮肤细胞更新并缓解中度至重度干癣患者的症状。在生物製药治疗中使用生物相似药为患者提供了更便宜、更容易获得的选择,并扩大了治疗机会。
斑块干癣领域预计在预测期内复合年增长率最高
预计斑块干癣部分在预测期内复合年增长率最高。斑块型干癣生物相似药旨在为治疗中度至重度斑块型干癣的参考生物製药提供一种有效且具成本效益的替代方案。生物相似药的使用提供了一种更实惠的治疗选择,同时保持与原始生物製药相似的安全性和有效性。由于斑块型干癣是最常见的疾病之一,对治疗该疾病的生物相似药的需求只会不断增加,使患者更容易获得有效的治疗方法。
由于干癣患病率不断上升、医疗保健成本不断上升、先进治疗方法的普及等,预计亚太地区将在预测期内占据最大的市场占有率。市场主要企业包括 Dr. Reddy's Laboratories、Samsung Bioepis、Biocon、Mylan 等。生物相似药的日益普及,加上法律规范和医疗基础设施的改进,正在推动市场成长。随着人们对医疗保健的认识和获取情况的改善,亚太地区的干癣生物相似药市场预计将继续强劲成长。
由于对负担得起的生物製药治疗的需求不断增长,预计北美在预测期内的复合年增长率最高。该地区的主要企业包括安进 (Amgen)、山德士 (Sandoz)、辉瑞 (Pfizer) 和 Celltrion Healthcare。该地区也享有 FDA 的强而有力的监管支持。随着生物相似药获得医疗保健专业人员和患者的认可,北美干癣生物相似药市场预计将继续扩大。
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.