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市场调查报告书
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1308715
2030 年酵素替代疗法 (ERT) 市场预测 - 按产品、疾病、给药途径、最终用户和地区进行的全球分析Enzyme Replacement Therapy Market Forecasts to 2030 - Global Analysis By Product, Disease, Route of Administration, End User and By Geography |
根据Stratistics MRC 的数据,2023 年全球酵素替代疗法(ERT) 市场规模将达到101 亿美元,预测期内復合年增长率为8.6%,到□□2030 年将达到181亿美元预计达到
酵素替代疗法(ERT)用于替代遗传性酵素缺乏综合征患者缺失或缺乏的酵素。 酵素替代疗法(ERT)是向患者施用不同类型的酵素以克服酵素缺乏和相关功能障碍的过程。 罕见和慢性遗传病(例如各种类型的溶酵素体贮积病和遗传性疾病)的患病率不断增加,增加了对有效治疗方案的需求。
根据遗传和罕见疾病信息中心 (GARD) 的数据,目前美国大约有 25 至 3500 万人患有罕见疾病。
各国政府正致力于扩大医疗保健领域,以解决人们的治疗和健康问题。 随着世界各国政府和非营利组织加大力度提高公众意识,罕见病诊断率正在缓慢上升。 由于医疗保健基础设施投资增加,酵素替代疗法(ERT)市场规模预计在评估期间将会增长。
发展中国家对酵素替代疗法 (ERT) 缺乏认识,导致其采用速度缓慢。 缺乏技术和适当的基础设施预计也会阻碍市场增长。 然而,新兴国家缺乏熟练掌握这种疗法的医疗技术人员和报销政策不足是限制市场增长的一些因素。
生物技术的重大发展催生了日益复杂的专门酵素替代疗法 (ERT)。 重组 DNA 技术的进步导致了高质量重组酵素的生产,包括更高的稳定性、特异性和半衰期。 对基因疗法和其他尖端治疗方法的进一步研究有可能提高未来 ERT 的疗效。
由于復杂的製造程序、专门的基础设施以及相对有限的患有罕见遗传性疾病的患者群体,药品价格昂贵。确实如此。 这种高昂的成本可能会给个人、医疗保健系统和保险公司带来困难。 高昂的药品成本可能导致支付或报销变得困难。 根据持续时间的不同,治疗费用也更加昂贵。
COVID-19 大流行是前所未有的全球公共卫生挑战,预计将对酵素替代疗法 (ERT) 市场产生负面影响。 疫情的持续蔓延以及世界各国政府采取的措施对我们的业务产生了影响,包括未来供应链以及活性药物成分和成品的製造和运输的中断,并可能继续对我们的业务产生影响。未来,有。 再加上公共交通的中断以及对诊断行业的影响。 为了防止 COVID-19 的传播,一些非紧急的诊断程序和治疗已被暂停。
口服细分市场有望实现利润丰厚的增长,因为越来越多的患者更喜欢口服给药,因为它是一种方便且非侵入性的给药方法。 自我给药方便,患者可以在家服药,无需医疗专业人员的帮助,因此加大了研发力度,开发酵素替代疗法 (ERT) 的口服製剂以及口服特定酵素的潜力提高生物利用度和痰稳定性等优点进一步提高了全球市场中口腔细分市场的增长率。
由于拥有先进的医疗基础设施、专业医务人员以及进行酵素替代疗法 (ERT) 的支持设施,医院部门预计在预测期内将以最快的复合年增长率增长。Masu。 医院和製药公司之间加强合作,以确保酵素替代疗法 (ERT) 的可用性和正确剂量,以及以医院为基础的临床研究和开发活动,正在推动 ERT 市场中医院细分市场的增长率进一步上升。
由于支持性监管框架、对遗传疾病的认识和诊断的提高以及有利的报销政策,预计欧洲在预测期内将呈现最高的复合年增长率。 完善的医疗保健系统和强大的基础设施能够对需要酵素替代疗法(ERT)的罕见疾病进行有效的诊断、治疗和管理,正在推动市场的增长。
2023 年6 月,BioMarin Pharmaceutical Inc. 宣布美国食品和药物管理局(FDA) 已批准对严重A 型血友病的诊断,其中在FDA 批准的药物中检测不到腺相关病毒血清型5 (AAV5) 抗体宣布批准 ROCTAVIAN□ (valoctocogene roxaparvovec-rvox) 基因疗法用于治疗成人。
2023 年 2 月,雀巢健康科学和 Codexis 宣布了 CDX-7108 治疗外分泌胰腺功能不全的 1 期临床试验的中期结果。 CDX-7108是一种脂肪酵素变体,专门设计用于克服现有胰酵素替代疗法(ERT)(PERT)的局限性。
According to Stratistics MRC, the Global Enzyme Replacement Therapy Market is accounted for $10.1 billion in 2023 and is expected to reach $18.1 billion by 2030 growing at a CAGR of 8.6% during the forecast period. Enzyme replacement therapy (ERT) is carried out to replace a missing or deficient enzyme in a person with an inherited enzyme deficiency syndrome. Enzyme replacement therapy is a process in which different types of enzymes are administered in patients to overcome enzyme deficiencies or related malfunction. The rising prevalence of rare, chronic, and inherited disorders, including various kinds of lysosomal storage diseases and genetic disorders is fostering the demand for effective treatment options.
According to the Genetic and Rare Diseases Information Center (GARD), at present, there are around 25 to 35 million people in the United States that suffer from rare diseases.
Governments of different nations are focusing on expanding the healthcare sector to treat people and combating health issues. Increasing initiatives by government and non-profit organizations in various countries to promote awareness among the general population lead to a gradual rise in the diagnosis rate of rare diseases. As a result of rising investment in healthcare infrastructure, the market size of enzyme replacement therapy is expected to expand in the assessment period.
Lack of awareness about enzyme replacement therapy among developing nations is slowing down the adoption rate of enzyme replacement therapy. Also, the deficiency of technology and adequate infrastructure is expected to hamper the market growth. However, the lack of skilled healthcare technicians for this therapy and inadequate reimbursement policies in emerging countries are some of the factors limiting the market growth.
Significant developments around biotechnology have produced increasingly sophisticated and specialised enzyme replacement treatments. Recombinant enzymes may now be produced with better qualities such higher stability, specificity, and half-life due to advancements in recombinant DNA technology. Further investigation into gene therapy and other cutting-edge therapeutic approaches has the potential to boost ERT's efficacy in the future.
Due to the intricate manufacturing procedures required, the need for specialised infrastructure, and the relatively limited patient populations affected by uncommon genetic illnesses, medications are sometimes costly. For individuals, healthcare systems, and insurance companies, this high cost may provide access difficulties. The high cost of medications may make them difficult to afford and reimburse. The cost of treatments is also made more expensive by their duration.
The COVID-19 pandemic is an unprecedented global public health challenge and is anticipated to have a negative impact on the enzyme replacement therapy market. The continuous spread of the pandemic and the measures taken by the governments of various countries have affected, and could continue to affect, the businesses, including future disruptions to supply chain and the manufacture or shipment of drug substance and finished drug products. In addition, has resulted in decreased public mobility, as well as impacted the diagnostic industries. Several diagnostic procedures and therapies that are non-emergent were put on hold to prevent the transmission of the novel corona virus.
The oral segment is estimated to have a lucrative growth, due to the increasing patient preference for oral administration as it is convenient and non-invasive method of drug delivery. Ease of self-administration that allow patients to take their medication at home without the need for healthcare professional assistance, growing R&D efforts to develop oral formulations of enzyme replacement therapies and the potential advantages such as improved bioavailability and stability of certain enzymes when administered orally further boost the growth rate of the oral segment in the global market.
The hospital segment is anticipated to witness the fastest CAGR growth during the forecast period, due to the availability of advanced healthcare infrastructure, specialized medical personnel, and supportive facilities for administering enzyme replacement therapy. The growing number of collaborations between hospitals and pharmaceutical companies to ensure the availability and proper administration of enzyme replacement therapies and hospital-based clinical research and development activities further boost the growth rate of the hospital segment in the ERT market.
North America is projected to hold the largest market share during the forecast period owing to the availability of infusion centers, increase in acceptance of newer therapies, and rise in prevalence of enzyme deficiency. The presence of advanced healthcare infrastructure, including well-established hospitals, research centers, and pharmaceutical companies that contribute to the development and adoption of enzyme replacement therapies is one of the major factors propelling the market growth.
Europe is projected to have the highest CAGR over the forecast period, owing to supportive regulatory frameworks, the growing awareness and diagnosis of genetic disorders and favorable reimbursement policies. The presence of well-developed healthcare systems and robust infrastructure in that enable efficient diagnosis, treatment, and management of rare diseases requiring enzyme replacement therapy drive the growth of the market.
Some of the key players profiled in the Enzyme Replacement Therapy Market include Takeda pharmaceutical Company Ltd., Leadiant Biosciences Inc., Biomarin Pharmaceuticals Inc., Genzyme Corporation, Pfizer Inc., Shire plc, Amicus Therapeutics, Sigma-Tau Pharmaceuticals, Inc., Essential Pharmaceuticals Limited, Merck KGa, AbbVie Inc, Sanofi Genzyme, Alexion Pharmaceuticals, Nestle Health Science and Astrazeneca Plc.
In June 2023, BioMarin Pharmaceutical Inc. , announced that the United States Food and Drug Administration (FDA) approved ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.
In February 2023, Nestle Health Science and Codexis Announce Interim Results from Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency. CDX-7108 is a lipase variant specifically engineered to overcome the limitations of existing pancreatic enzyme replacement therapy (PERT).
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.