■ 英語タイトル：Hemophilia Market - Growth, Trends, Covid-19 Impact, and Forecasts (2023 - 2028)
	■ 発行会社/調査会社：Mordor Intelligence ■ 商品コード：MOR23MAC076 ■ 発行日：2023年1月23日 ■ 調査対象地域：アメリカ、カナダ、メキシコ、ドイツ、イギリス、フランス、イタリア、スペイン、中国、日本、インド、オーストラリア、韓国、中東、南アフリカ、ブラジル、アルゼンチン ■ 産業分野：医療 ■ ページ数：115 ■ レポート言語：英語 ■ レポート形式：PDF ■ 納品方式：Eメール（受注後2-3営業日）

The Hemophilia market is expected to witness a CAGR of 5.7% during the forecast period (2022-2027).

The outbreak of COVID-19 worldwide is expected to impact the market, as individuals with chronic medical conditions, such as hemophilia, should take extra precautions to minimize the risk of contracting COVID-19, as this group of the population is more prone to infectious diseases. In addition, according to the study published in the Journal of Dental and Medical Sciences, titled ‘Impact of Covid-19 pandemic on Hemophilia prophylaxis in children: experience of a hemophilia treatment center in West Bengal, India’ in August 2020, the mean annualized bleed rate before the lockdown was 2.4, whereas it significantly increased to 8.2 during the lockdown in children who were on regular prophylaxis earlier. Among various reasons cited by them for not attending a Hemophilia treatment center, the important reasons were non-availability of transport (97.5%), fear of coronavirus infection (95%), and high cost of alternate transport (90%). This has slowed down the market growth during the pandemic.

Certain factors that are driving the market growth include growing prevalence of hemophilia, favorable government initiatives, and rising research and revelopment for the development of novel therapies,among others.

Furthermore, according to the World World Federation of Hemophilia October 2021 report, owing to the sex-linkage of the disorder, there is a bigger prominence in males than females. Hemophilia occurs worldwide and across all racial groups. According to the World Federation of Hemophilia global report published in October 2021, there were 209,614 people diagnosed with hemophilia including 165,379 Hemophilia A patients, 33,076 Hemophilia B patients, and 11,159 Hemophilia type unknown patients globally. Such a huge prevalence of hemophilia globally will lead to increased adoption of therapies for hemophila, driving the market growth.

In addition, rising grants for the research on hemophilia is further expected to contribute the market studied over the forecast period. For instance, in March 2022, with the support of a USD 12 million funding from the National Heart, Lung, and Blood Institute, an Indiana University School of Medicine researcher will head a multi-institute effort to develop haemophilia medicines. This will lead to development of novel therapies for hemophilia a thereby expected to drive the market growth over the forecast period.

In addition, rising product approvals for the United States Food and Drug Administration is further expected to propel the market growth. For instance, in April 2020, The United States Food and Drug Administration has approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).

However, high cost of treament of hemophilia along with the lack of awareness among people regarding advanced technologies is expected to hinder the market studied.

Hemophilia Market Trends

Hemophilia A is Expected to Hold Significant Market Share in the Disease Type Segment

Hemophilia A is expected to hold a significant market share over the forecast period. Hemophilia A is the most common severe bleeding disorder. Replacement therapy, providing the missing coagulation factor, has been the mainstay of treatment both prophylactically and to treat bleeding.

According to the data published by the World Federation of Hemophilia in 2021, in 2020, hemophilia A is more recorded among males accounting for 146,246 (88%), followed by females with 5,636 (3%) and sex not known 9,917 (6%). The key medication to treat hemophilia A has concentrated FVIII product, also known as clotting factor. The recombinant factor products that are developed in a laboratory using DNA technology impede the use of human-derived pools of donor-sourced plasma due to the advances in recombinant protein engineering and the introduction of gene therapy and novel strategies to target the coagulation cascade. For instance, in December 2021, Pfizer Inc. and Sangamo Therapeutics, Inc., a genomic medicines company, has released updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe hemophilia A. The rise in research on gene therapies for Hemophilia A is therefore expected to drive the growth of this segment.

In addition, in July 2021, BioMarin presented positive one-year results at the International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress regarding its GENEr8-1 Phase III pivotal trial, in which adults with severe hemophilia A are treated with the gene therapy Roctavian (valoctocogene roxaparvovec). Such results will lead to drive the market due to the entry of novel gene therapies for Hemophilia A, driving this segment growth over the forecast period.

Furthermore, according to the National Clinical Registry (NCT), as of August 11, 2020, worldwide, there were about 139 ongoing clinical trials across different phases of development for hemophilia A (HA). Moreover, the increasing demand for advanced products for the diagnosis and treatment of hemophilia is projected to trigger the growth of this segment in the forecast period.

Therefore, owing to the above mentioned factors, this segment growth is expected to drive over the forecast period.

North America Expected to Hold Significant Share in the Market and Expected to do Same Over the Forecast Period

The North America region is expected to hold a significant share in the market and is expected to do the same over the forecast period.

The major factors driving the growth of the hemophilia market in the region include the therapeutic advances in hemophilia, which led to a wave of new Food and Drug Administration-approved agents and increasing awareness about technologically advanced products, increasing prevalence of hemophilia, and the presence of a huge patient pool.

The United States is the largest market in the region. According to the World Federation of Hemophilia 2021 report, there were about 14,816 patiens with hemophilia including (Hemophilia A -11,790 and Hemophilia B-3,026) in the United States in 2020 and people diagnosed with hemophilia in the United States and 3,924 patients with hemophilia in Canada in 2020 including (Hemophilia A -3,223 and Hemophilia B-701) . Such a high number of hemophilia cases in these regions is expected to drive the growth of the market in this region due to higher adoption of therapies for hemophilia.

In addition, according to the news in November 2021 in the United States, researchers of Spark Therapeutics suggest that gene therapy has the ability to reduce, and even stop, potentially life-threatening bleeding episodes in persons with haemophilia. The novel adeno-associated viral (AAV) vector-based gene therapy is intended to help haemophilia A sufferers express FVIII in their livers, and a phase 1/2 clinical study indicated that it did so in the majority of patients. The rise in research on gene therapies and favourable results of the same is thereby expected to drive the growth of this market in the United States over the forecast period.

Furthermore, according to the study published in Frontiers in Immunology, titled ‘T Cell-Mediated Immune Responses to AAV and AAV Vectors’ in April 2021 in the United States, patients with hereditary disorders, such as haemophilia B, have benefited from Adeno-associated virus (AAV)-mediated gene transfer by attaining long-term expression of the therapeutic transgene. Such studies will further bolster the gene therapies in this regions, thereby driving the market growth.

Morever, rising initiatives from key market players is also expected to drive the market growth in this regon. For instance, in December 2020,Takeda Pharmaceutical Company Limited has launched myPKFiT for ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], a web-based software and mobile application that is the first and only pharmacokinetic (PK)-dosing software in the United States.

Thus, the increasing research and development in the development of new effective therapies, along with the rising prevalence of hemophilia in the United States, is expected to drive the market over the forecast period in this region.

Hemophilia Market Competitor Analysis

The Hemophilia market is moderately competitive and consists of a few major players. Additionally, the key players have been involved in various startegic alliances such as acquisitions, collaborations along with the launch of advanced products and research studies to secure the position in the global market. Some of the key market players in this market include Bayer AG, BioMarin Pharmaceutical, Inc., CSL Behring, Kedrion, Novo Nordisk, Pfizer, Inc., Roche (Chugai Pharmaceutical Co.), Sanofi (Genzyme Corporation), Takeda Pharmaceutical (Shire Plc.)., among others.

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