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市場調查報告書
商品編碼
1308715
2030 年酵素替代療法 (ERT) 市場預測 - 按產品、疾病、給藥途徑、最終用戶和地區進行的全球分析Enzyme Replacement Therapy Market Forecasts to 2030 - Global Analysis By Product, Disease, Route of Administration, End User and By Geography |
根據Stratistics MRC 的數據,2023 年全球酵素替代療法(ERT) 市場規模將達到101 億美元,預測期內復合年增長率為8.6%,到□□2030 年將達到181億美元預計達到
酵素替代療法(ERT)用於替代遺傳性酵素缺乏綜合徵患者缺失或缺乏的酵素。 酵素替代療法(ERT)是向患者施用不同類型的酵素以克服酵素缺乏和相關功能障礙的過程。 罕見和慢性遺傳病(例如各種類型的溶酵素體貯積病和遺傳性疾病)的患病率不斷增加,增加了對有效治療方案的需求。
根據遺傳和罕見疾病信息中心 (GARD) 的數據,目前美國大約有 25 至 3500 萬人患有罕見疾病。
各國政府正致力於擴大醫療保健領域,以解決人們的治療和健康問題。 隨著世界各國政府和非營利組織加大力度提高公眾意識,罕見病診斷率正在緩慢上升。 由於醫療保健基礎設施投資增加,酵素替代療法(ERT)市場規模預計在評估期間將會增長。
發展中國家對酵素替代療法 (ERT) 缺乏認識,導致其採用速度緩慢。 缺乏技術和適當的基礎設施預計也會阻礙市場增長。 然而,新興國家缺乏熟練掌握這種療法的醫療技術人員和報銷政策不足是限制市場增長的一些因素。
生物技術的重大發展催生了日益複雜的專門酵素替代療法 (ERT)。 重組 DNA 技術的進步導致了高質量重組酵素的生產,包括更高的穩定性、特異性和半衰期。 對基因療法和其他尖端治療方法的進一步研究有可能提高未來 ERT 的療效。
由於復雜的製造程序、專門的基礎設施以及相對有限的患有罕見遺傳性疾病的患者群體,藥品價格昂貴。確實如此。 這種高昂的成本可能會給個人、醫療保健系統和保險公司帶來困難。 高昂的藥品成本可能導致支付或報銷變得困難。 根據持續時間的不同,治療費用也更加昂貴。
COVID-19 大流行是前所未有的全球公共衛生挑戰,預計將對酵素替代療法 (ERT) 市場產生負面影響。 疫情的持續蔓延以及世界各國政府採取的措施對我們的業務產生了影響,包括未來供應鏈以及活性藥物成分和成品的製造和運輸的中斷,並可能繼續對我們的業務產生影響。未來,有。 再加上公共交通的中斷以及對診斷行業的影響。 為了防止 COVID-19 的傳播,一些非緊急的診斷程序和治療已被暫停。
口服細分市場有望實現利潤豐厚的增長,因為越來越多的患者更喜歡口服給藥,因為它是一種方便且非侵入性的給藥方法。 自我給藥方便,患者可以在家服藥,無需醫療專業人員的幫助,因此加大了研發力度,開發酵素替代療法 (ERT) 的口服製劑以及口服特定酵素的潛力提高生物利用度和痰穩定性等優點進一步提高了全球市場中口腔細分市場的增長率。
由於擁有先進的醫療基礎設施、專業醫務人員以及進行酵素替代療法 (ERT) 的支持設施,醫院部門預計在預測期內將以最快的複合年增長率增長。Masu。 醫院和製藥公司之間加強合作,以確保酵素替代療法 (ERT) 的可用性和正確劑量,以及以醫院為基礎的臨床研究和開發活動,正在推動 ERT 市場中醫院細分市場的增長率進一步上升。
由於支持性監管框架、對遺傳疾病的認識和診斷的提高以及有利的報銷政策,預計歐洲在預測期內將呈現最高的複合年增長率。 完善的醫療保健系統和強大的基礎設施能夠對需要酵素替代療法(ERT)的罕見疾病進行有效的診斷、治療和管理,正在推動市場的增長。
2023 年6 月,BioMarin Pharmaceutical Inc. 宣布美國食品和藥物管理局(FDA) 已批准對嚴重A 型血友病的診斷,其中在FDA 批准的藥物中檢測不到腺相關病毒血清型5 (AAV5) 抗體宣布批准 ROCTAVIAN□ (valoctocogene roxaparvovec-rvox) 基因療法用於治療成人。
2023 年 2 月,雀巢健康科學和 Codexis 宣布了 CDX-7108 治療外分泌胰腺功能不全的 1 期臨床試驗的中期結果。 CDX-7108是一種脂肪酵素變體,專門設計用於克服現有胰酵素替代療法(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.