市場調査レポート
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白斑治療の世界市場-2023年~2030年Global Vitiligo Treatment Market - 2023-2030 |
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白斑治療の世界市場-2023年~2030年 |
出版日: 2023年08月22日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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世界の白斑治療市場は、2022年に14億米ドルに達し、2023-2030年の予測期間中にCAGR 5.2%で成長し、2030年には21億米ドルに達すると予測されています。
世界の白斑治療市場は、有病率の増加、臨床試験の増加など、そのダイナミクスに影響を与える様々な要因によって、長年にわたって大きな成長と変貌を遂げてきました。より良い治療に対する政府の投資は、世界の白斑治療市場を引き続き牽引し、押し上げるでしょう。世界の白斑治療産業は、その影響を軽減するために持続可能な実践をますます重視しています。
治療タイプ別では副腎皮質ステロイド薬が予測期間中最大の市場シェアを占めると予想され、状況によっては副腎皮質ステロイド薬が第一選択薬とされることもあります。同様に、北米は白斑治療市場を独占しており、同地域の有利な償還政策、先進医療インフラ、大手企業の存在によって最大の市場シェアを獲得しています。
米国国立衛生研究所(NIH)によると、白斑は一般的な疾患であり、世界人口の0.5%から1%が罹患しています。しかし、多くの症例は報告されておらず、人口の1.5パーセントが罹患していると指摘する研究者もいます。この症状は、肌の黒い人ほど目立つかもしれないが、すべての民族で同様の頻度で発生します。
尋常性白斑の有病率の増加、認知度の向上、臨床試験の増加、新規治療薬に対する需要の増加、個別化医薬品の採用増加、治療選択肢の進歩が、予測期間中に世界の尋常性白斑治療市場を牽引すると予想される主な要因です。
ダイナミクス
新規治療薬に対する需要の増加が白斑治療市場の成長を牽引
新規治療薬に対する需要の高まりが、予測期間にわたって世界市場を牽引すると期待されています。現在利用可能な白斑治療薬や治療法は、すべての患者に有効とは言えず、より優れた治療効果を達成できる新規治療薬や治療法も必要とされています。新規治療薬は、代替または補完的な治療選択肢を提供することで、白斑治療に関連するアンメットニーズに対処することが目的です。
例えば、2023年6月16日、皮膚修復のためのファーストインクラスの機器と自己細胞療法の開発と商業化をリードする再生医療企業であるAVITA Medical, Inc.は、米国食品医薬品局(FDA)が白斑治療のためのRECELLシステムの市販前承認申請を承認したと発表しました。
さらに、白斑に関する継続的な研究活動により、患者の転帰を改善する治療の機会が拡大し、革新的な治療アプローチの開発により、治療を強化するための局所剤、経口剤、より優れた医療機器などの潜在的な新規治療オプションが発見されています。このような進歩により、異なる作用機序を持つ新薬や新装置のイントロダクションへの道が開かれつつあります。
規制当局の承認と臨床試験の増加も白斑治療市場の成長を促す
継続的に実施されている臨床試験と規制当局の承認は、治療薬の安全性と有効性に関する患者の信頼を構築することで、予測期間中の市場シェアを押し上げると期待されています。臨床試験の良好な結果は、白斑治療薬の使用に対する投資家の信頼と患者の信用を高めることができます。このような信頼性の向上は、さらなる研究開発や臨床試験実施のための資金を呼び込み、企業がより革新的な治療薬に投資することを可能にし、市場を牽引することができます。
例えば、2023年1月2日、プネに拠点を置く新興企業Ahamune Biosciences社は、白斑の局所療法として開発中の治験薬AB1001の第1相臨床試験を完了しました。この新薬の第1相臨床試験が完了したことで、患者にとって待望の治療法がより身近なものとなっています。
医薬品、医療機器、手技などの新しい白斑治療に対する規制当局の承認が増えることで、患者やヘルスケアプロバイダーが利用できる治療選択肢の幅が広がります。このような治療法の選択肢の拡大は、既存の治療法では十分な効果が得られなかった患者のニーズを満たすものであり、市場の成長を高める可能性があります。FDA承認などの規制上の承認も、治療薬の使用に対する患者の信頼を高めます。
例えば、2022年7月18日、米国食品医薬品局(FDA)は、最も一般的な白斑の治療薬としてルキソリチニブ(オプセルラ)クリーム1.5%を承認しました。オプセルラはヤヌスキナーゼ(JAK)阻害剤の外用薬で、現在、12歳以上の免疫不全でない患者において、外用処方療法で病状が十分にコントロールできない場合、またはそれらの治療が望ましくない場合に、軽度から中等度のアトピー性皮膚炎の局所的な短期および非連続的な慢性治療薬として承認されています。
白斑および関連治療に対する認識の高まりが白斑治療市場の成長を牽引
白斑とそれに関連する治療法に関する認知度の向上が、予測期間中の市場の成長を促進すると予想されます。白斑などの皮膚疾患やその他の皮膚関連疾患に対する一般市民の意識は、いくつかの環境要因によって継続的に高まっています。尋常性白斑は、世界中の人口の1%またはそれ以上に発症する可能性のある稀な疾患です。性別や民族を問わず発症する可能性があり、一般的に20~30歳代に発症します。
例えば、毎年6月25日の「世界白斑デー」は、白斑のヘルスケアと教育への取り組みを強化し、白斑に罹患した人々が直面する社会的スティグマと精神的課題に対する認識を高めることを目的としています。
副腎皮質ステロイドの使用に伴うリスクが市場の成長を妨げる
副腎皮質ステロイドの長期使用に伴う大きなリスクがあり、予測期間中の市場成長の妨げになると予想されます。副腎皮質ステロイドの長期使用、特に高用量での使用や皮膚の薄い部位への局所的な使用は、萎縮としても知られる皮膚の菲薄化や他の皮膚疾患のリスク上昇につながる可能性があります。これは、特に顔などの敏感な皮膚部位を治療する場合、患者にとって懸念となり得ます。
さらに、副腎皮質ステロイドは、副腎皮質ステロイドクリームやその他の外用剤を継続的に使用している一部の患者の目に見える皮膚に妊娠線を発生させることもあります。このことは、特に体の目に見える部分に副腎皮質ステロイドを使用する場合、患者にとって懸念となる可能性があります。
厳しい治療費設定も市場成長の妨げに
厳しい治療費が、予測期間中の市場シェアの妨げになると予想されます。高額な価格設定は、より良い治癒可能な治療を求める多くの白斑患者、特に保険適用が限られている人々のアクセスを制限する可能性があります。高額な治療費は、患者にとって適切な治癒可能な治療を受けるための金銭的な余裕を失わせます。その結果、予測期間中の市場成長が阻害される可能性があります。
高い治療費は、新規治療薬の研究活動や臨床試験の妨げにもなります。最初に治療を開始した患者であっても、高額な費用が治療アドヒアランスの低下につながる可能性があります。白斑の管理において最良の結果を得るためには、一貫した継続的な治療が必要となることが多いため、これは最適な治療結果をもたらさない可能性があります。
Global Vitiligo Treatment Market reached US$ 1.4 billion in 2022 and is expected to reach US$ 2.1 billion by 2030, growing with a CAGR of 5.2% during the forecast period 2023-2030.
The global vitiligo treatment market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics such as increasing prevalence, rising clinical trials, and others. Government investments in better treatment will continue to drive and boost the global vitiligo treatment market. The global vitiligo treatment industry is placing increasing emphasis on sustainable practices to reduce its impact.
The corticosteroids from the treatment type segment are expected to hold the largest market share over the forecast period and in some situations, corticosteroids are considered as first-line treatment. Similarly, North America dominates the vitiligo treatment market, capturing the largest market share owing to the region's favorable reimbursement policies, advanced healthcare infrastructure, and presence of major players.
According to the National Institute of Health (NIH), Vitiligo is a common disorder, affecting between 0.5 percent and 1 percent of the population worldwide. However, many cases may not be reported, and some researchers suggest the condition may affect up to 1.5 percent of the population. While the condition may be more noticeable in dark-skinned people, it occurs with similar frequency in all ethnic groups.
Owing to the increasing prevalence of vitiligo, growing awareness, rising clinical trials, increasing demand for novel therapeutics, increasing adoption of personalized medicines, and advancements in treatment options are the major factors expected to drive the global vitiligo treatment market over the forecast period.
Dynamics
Increasing Demand for Novel Therapeutics Drives the Growth of the Vitiligo Treatment Market
There is an increasing demand for novel therapeutics, which is expected to drive the global market over the forecast period. The currently available vitiligo treatments and therapeutics are not effective for all patients, and there is also a need for new therapies and therapeutics that can achieve better and enhanced treatment results. Novel therapeutics aim to address the unmet needs associated with vitiligo treatment by providing alternative or complementary treatment options.
For instance, on June 16, 2023, AVITA Medical, Inc., a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, announced that the U.S. Food and Drug Administration (FDA) has approved its application for premarket approval of its RECELL System for the treatment of vitiligo.
Moreover, the ongoing research activities on vitiligo enhance the treatment opportunities with better patient outcomes and the development of innovative treatment approaches have led to the discovery of potential novel therapeutic options such as topical agents, oral agents, and better medical devices for enhanced treatment. These advancements increase the way for the introduction of novel drugs and devices with different mechanisms of action.
Rising Regulatory Approvals and Clinical Trials Also Drive the Growth of the Vitiligo Treatment Market
There is a continuous ongoing clinical trials and regulatory approvals, expected to drive the market share over the forecast period, by building trust in patients about the safety and efficacy of the therapeutics. The positive results from clinical trials can boost the investor confidence and patient trust in the usage of medicines for vitiligo treatment. This increased confidence can attract funding for further research and development and conduct more clinical trials, allowing companies to invest in more innovative therapeutics and driving the market.
For instance, on January 02, 2023, Pune-based startup Ahammune Biosciences completed the phase 1 clinical trials of its investigational new drug- AB1001, being developed as a topical therapy for vitiligo. The successful completion of Phase 1 of the molecule brings a much-wanted treatment closer to the patients.
The increasing regulatory approvals for new vitiligo treatments, such as drugs, medical devices, or procedures, improve the range of therapeutic options available to patients and healthcare providers. This treatment expansion choice can increase the market growth as it meets the needs of individuals who not have responded well to existing therapeutics. The regulatory approvals such as FDA approvals also increase the patient's trust in the usage of the therapeutics.
For instance, on July 18, 2022, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Opzelura) cream 1.5 percent as a treatment for the most common form of vitiligo. Opzelura is a topical Janus kinase (JAK) inhibitor currently approved for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Increasing Awareness On Vitiligo and Their Associated Treatments Drive the Growth of the Vitiligo Treatment Market
The increasing awareness about vitiligo and its associated treatment options is expected to drive the growth of the market over the forecast period. Public awareness about skin conditions such as vitiligo and other skin-related diseases is continuously raising due to the several environmental factors. Vitiligo is a rare disease that can occur in about 1% or a little more of the population throughout the world. It can happen to all genders and ethnic groups and generally affects the age group between 20 and 30.
For instance, every year on 25th June, World Vitiligo Day is observed with the aim of increasing the effort for vitiligo healthcare and education and raising awareness of the social stigma and mental challenges faced by those affected by vitiligo.
Risks Associated with the Use of Corticosteroids Will Hamper the Market's Growth
There are major risks associated with the long-term usage of corticosteroids, which are expected to hamper the market growth over the forecast period. This long-term use of corticosteroids, especially at high doses or topical agents on thin skin areas, can lead to skin thinning also known as atrophy, and increased risk of other skin disorders. This can be a concern to the patients, particularly when treating sensitive skin areas such as the face or other parts.
Furthermore, corticosteroids can also cause the occurrence of the stretch marks on the visible skin in some patients who are continuously using the corticosteroid creams and other topical agents. This may results in a concern for patients, particularly when using corticosteroids on visible areas of the body.
Stringent Pricing of the Treatment Will Also Hampers the Market Growth
The stringent treatment costs are expected to hamper the market share over the forecast period. High pricing can limit the access for many vitiligo patients seeking better and curable treatment, especially for people with limited insurance coverage. The high cost makes patients unaffordable for the proper curable treatment. This can results in the hampering the market growth over the forecast period.
The high treatment costs also hamper the research activities and clinical trials for novel therapeutics. Even among patients who initially start treatment, high costs may lead to reduced treatment adherence. This can result in suboptimal outcomes, as consistent and continuous treatment is often necessary for the best results in managing vitiligo.
The global vitiligo treatment market is segmented based on disease type, treatment type, end-user, and region.
The Corticosteroids from the Treatment Segment Accounted for Approximately 36.7% of the Vitiligo Treatment Market Share
Corticosteroids are considered as first-line treatment for the treatment of vitiligo, expected to hold the largest market share over the forecast period. Corticosteroids are very potent anti-inflammatory agents used in the treatment of the vitiligo. The inflammation that occurs in vitiligo is believed to contribute to the destruction of melanocytes, leading to depigmentation in vitiligo situation. Corticosteroids also helps to reduce this inflammation, potentially slowing the progression of the disease and creating a more favorable environment for repigmentation.
For instance, according to the National Institute of Health (NIH), topical corticosteroids, either potent (betamethasone valerate) or very potent (clobetasol propionate), are considered first-line therapy for vitiligo. The sun-exposed areas have a better response to treatment, while acral regions generally exhibit a poor response.
Moreover, their wide availability, acceptability, and, ease of application helps to hold the largest market share. The corticosteroids can also be used in combination with other treatments, such as phototherapy or calcineurin inhibitors, to enhance their effectiveness. The combination of corticosteroids with the calcineurin inhibitors shows enhanced results. These combining treatments are considered especially in cases where a single treatment modality may not be sufficient.
Geographical Penetration
North America Accounted for Approximately 37.8% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Favourable Reimbursement Policies
North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players, advanced healthcare infrastructure such as dermatology clinics, hospitals, research centers, and others, and favorable reimbursement policies. North America especially the United States and Canada is home to many pharmaceutical and medical device companies, increased clinical trials, research activities, and regulatory approvals such as FDA approvals for vitiligo therapeutics are seen in the region.
For instance, on May 15, 2023, STRATA Skin Sciences, Inc., a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announced that it has entered into an exclusive, three-year agreement with Spectra Medical India Pvt Ltd., a distribution company representing medical laser and aesthetic equipment manufacturers, for the distribution of TheraClearX, VTRAC, and XTRAC. They also announced they are expanding into the acne, psoriasis, and vitiligo market with Spectra Medical.
Furthermore, North America offers favorable reimbursement policies to vitiligo patients for effective treatment. The improved insurance coverage offers the better treatment for many patients at affordable costs, leading to the market dominance in the region.
The major global players in the vitiligo treatment market include Kernel Medical Equipment Co., Ltd, CLINUVEL PHARMACEUTICALS LTD., Incyte Corporation, Clarify Medical, Inc., Dermavant Sciences, Strata Skin Sciences, Ra Medical Systems, Puneet Laboratories Pvt. Ltd, VYNE Therapeutics Inc, and Elixiron Immunotherapeutics Inc, among others.
The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for pharmaceutical industries worldwide, including the global vitiligo treatment market. During the pandemic, many clinical trials, research activities, and regulatory approvals have been temporarily postponed due to the redirected focus on the COVID-19 pandemic and its related restrictions.
The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular skin care check-ups, appointments, and consultations worldwide. Many hospitals are focused on the COVID-19 cases, this reduced the skin care related treatments including the vitiligo treatment.
Moreover, the COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials of vitiligo-related therapeutics and medical devices. Movement restrictions and border closures delayed shipments and caused drug transportation delays. Additionally, some countries faced shortages of drugs for treatment due to disruptions in their supply chain networks.
Russia-Ukraine Conflict Analysis
The Russia-Ukraine conflict is estimated to have a moderate impact on the global vitiligo treatment market. Many clinical trials and research activities are temporarily disrupted. The conflict has less impact mainly due to the low prevalence and absence of key market players in this region.
Moreover, the impact of the import and export of raw materials such as vitiligo therapeutics and medical devices is expected to have little influence over the global vitiligo treatment market growth over the forecast period.
By Disease Type
By Treatment Type
Skin Grafting
Blister Grafting
Cellular Suspension Transplant
By End-User
By Region
U.S.
Canada
Mexico
Germany
U.K.
France
Spain
Italy
Rest of Europe
Brazil
Argentina
Rest of South America
China
India
Japan
Australia
Rest of Asia-Pacific
According to the DataM Intelligence, the vitiligo treatment market experiencing the rapid growth in recent years and is expected to grow rapidly in the coming years due to its increasing prevalence and novel therapeutic innovations for better patient outcomes. Many innovative treatment options are going to develop in the coming years by reducing the adverse effects and for effective treatment. Moreover, many clinical trials and research activities are still going on for novel therapeutics, which is expected to growth of the global vitiligo treatment market in the upcoming years.
The global vitiligo treatment market report would provide approximately 61 tables, 58 figures, and 186 Pages.
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