世界の遺伝子治療市場 – 2031 年までの業界動向と予測

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遺伝子治療市場の分析と規模

遺伝子治療市場では、革新的な治療法が遺伝物質を利用して病気の根本に対処し、症状の管理ではなく潜在的な治癒をもたらします。この変革的なアプローチは、遺伝性疾患から癌までさまざまな病気に有望であり、個人に合わせたターゲットを絞った介入を提供することでヘルスケアに革命をもたらし、最終的には患者の生活の質と予後を改善します。

例えば、2022年12月、日本の厚生労働省は、再発・難治性大細胞型B細胞リンパ腫の治療薬として、カイトファーマ株式会社と第一三共株式会社によるCAR T細胞療法「Yescarta」を承認しました。CD19を標的としたCAR T細胞による前治療歴のない患者のみが対象となります。                 

Data Bridge Market Research の分析によると、世界の遺伝子治療市場規模は 2023 年に 86 億 8,000 万米ドルと評価され、2024 年から 2031 年の予測期間中に 18.3% の CAGR で成長し、2031 年には 333 億 1,000 万米ドルに達すると予測されています。これは、市場価値を示しています。市場価値、成長率、セグメンテーション、地理的範囲、主要プレーヤーなどの市場シナリオに関する洞察に加えて、Data Bridge Market Research がまとめた市場レポートには、詳細な専門家の分析、患者の疫学、パイプライン分析、価格分析、規制の枠組みも含まれています。

遺伝子治療市場の範囲とセグメンテーション

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市場の定義

遺伝子治療は、患者の細胞内の特定の遺伝子を導入、除去、または変更することで遺伝性疾患を治療する医学的アプローチです。この治療法は、遺伝的根本原因を標的にすることで嚢胞性線維症や癌などの遺伝性疾患を治療できる可能性があります。これは個別化医療への期待が持て、臨床試験では有望な結果を示しています。            

世界の遺伝子治療市場の動向

ドライバー

• 遺伝性疾患の罹患率の上昇

嚢胞性線維症、鎌状赤血球貧血、筋ジストロフィーなどの遺伝性疾患の急増により、遺伝子治療の必要性が高まっています。この発症率の上昇は、革新的な治療法の需要を強調しています。遺伝子治療は、これらの疾患の根本原因を標的とすることで潜在的な解決策を提供し、影響を受けた人々の満たされていない医療ニーズに対処する有望な手段となります。

• 遺伝子編集技術の進歩

血友病遺伝子治療や CRISPR-Cas9 などのイノベーションは、遺伝子編集に革命をもたらし、精度、効率、手頃な価格を向上させました。この変革により、疾患治療のための標的遺伝子改変が促進され、遺伝子治療市場の成長が促進されます。これらの進歩により、より効果的な治療法が提供され、投資が促進され、さまざまな病状に対する革新的な遺伝子治療ソリューションの創出が促進されます。

例えば、 2021年3月、米国FDAは、少なくとも4回の治療後に反応がなかった、または再発した多発性骨髄腫の成人患者を対象とした先駆的な細胞ベースの遺伝子治療薬であるAbecma（idecabtagene vicleucel）を承認しました。これは、このタイプのがんに対する細胞ベースの遺伝子治療薬のFDAによる最初の承認であり、新しい治療の道を提供します。

機会

• 拡大する個別化医療アプローチ

Gene therapy facilitates personalized treatment by targeting genetic mutations and offering tailored solutions for individual patients. This approach, honing in on the unique genetic makeup of each person, drives market expansion by providing highly effective and customized therapies, thus revolutionizing the landscape of medical treatment.

• Rise in Strategic Acquisition and Partnership Among Organizations

Organizations are increasingly forming strategic partnerships to develop gene therapy products for detecting genetic disorders. Collaborations facilitate the development of new technologies and platforms for disease detection. Long-term agreements enable companies to offer dynamic pricing of gene therapy products, catering to consumer demand. These partnerships create opportunities for mutual growth and benefit in the market.

For instance, in January 2023, Spark Therapeutics and Neurochase initiated a strategic collaboration to integrate Neurochase's specialized delivery technology with Spark's AAV platform for selected gene therapies targeting rare CNS disorders. Neurochase brings expertise in direct drug delivery, enhancing Spark's capabilities for effective treatment development.

Restraints/Challenges

• Concern About Immune Responses

Immune responses to viral vectors or foreign gene products can impede gene therapy efficacy and cause adverse events. Strategies to address this challenge include immunomodulatory interventions and engineered vectors designed to evade immune detection. Overcoming these responses is crucial for ensuring the safety and effectiveness of gene therapy treatments. 

• High Development Costs

Gene therapy's substantial research and development costs stem from intricate manufacturing, extensive clinical trials, and stringent regulatory demands. These financial hurdles pose challenges for companies, limiting investment capacity and potentially hindering innovation and market accessibility. Overcoming the high costs of gene therapy is essential for progressing the field and ensuring wider accessibility for patients.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• In December 2023, Libmeldy received approval from the Swiss Agency for Therapeutic Products to treat early-onset metachromatic leukodystrophy, marking a significant advancement in addressing this rare disorder's therapeutic needs
• In May 2023, Krystal Biotech's VYJUVEK gene therapy gained approval for treating Dystrophic Epidermolysis Bullosa, offering hope to patients with this debilitating condition
• In January 2023, Voyager Therapeutics and Neurocrine Biosciences initiated a strategic collaboration to commercialize and develop Voyager's GBA1 program and other innovative gene therapies targeting neurological disorders, promising advancements in this critical field of medicine
• In August 2022, the USFDA approved Zynteglo (betibeglogene autotemcel) as the first cell-based gene therapy for treating beta-thalassemia in adults and children. The approval of Zynteglo gene therapy is driving market growth, fueled by heightened research and development in gene therapy. This breakthrough promises innovative treatments for genetic disorders, marking a significant advancement in the field of medical science
• In December 2022, Ferring Pharmaceuticals saw FDA approval for Adstiladrin, a gene therapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer. This novel therapy, based on an adenovirus vector, targets adult patients with carcinoma in situ, with or without papillary tumors, bolstering the company's product range and therapeutic options

Gene Therapy Market Scope

The market is segmented on the basis of vector type, method, gene type, application, and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Vector Type

• Viral Vector
• Non-Viral Vector

 Method

• Ex-Vivo
• In-Vivo

 Gene Type

• Antigen
• Cytokine
• Tumor Suppressor
• Suicide
• Deficiency
• Growth factors
• Receptors
• Others

 Application

• Oncological Disorders
• Cardiovascular Diseases
• Infectious Diseases
• Rare Diseases
• Neurological Disorders
• Other Diseases

 End User

• Cancer Institutes
• Hospitals
• Research institutes
• Others

Global Gene Therapy Market Regional Analysis/Insights

The market is analysed and market size insights and trends are provided by country, vector type, method, gene type, application, and end user as referenced above.

The countries covered in the market report are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa, Brazil, Argentina, and Rest of South America.

North America is expected to dominate the market, propelled by rising R&D investments. The U.S., led by key players such as Novartis AG and Kite Pharma, holds significant regional control, fostering market growth and innovation.

Europe is expected to be fastest growing in the gene therapy market, propelled by Germany's mass production and emerging market demand. Expansion initiatives bolster its dominance, meeting the growing need for innovative treatments and solidifying its position as a global leader in biotechnology.

Asia-Pacific is expected to dominate the gene therapy market, led by China's prominence. Increasingly, customers favor minimally invasive medical procedures, propelling the region's growth. This trend aligns with gene therapy's promise of advanced treatments, fostering a favorable environment for its adoption.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure growth Installed base and New Technology Penetration

The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for global autoimmune disease diagnosis market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.

Competitive Landscape and Global Gene Therapy Market Share Analysis

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Some of the major players operating in the market are:

• Novartis AG (Switzerland)
• Gilead Sciences, Inc. (U.S.)
• uniQure NV (Netherlands)
• Oxford Biomedica PLC (U.K.)
• Spark Therapeutics, Inc. (U.S.)
• SIBONO (China)
• bluebird bio, Inc. (U.S.)
• Shanghai Sunway Biotech Co., Ltd. (China)
• Biogen (U.S.)
• Dendreon Pharmaceuticals LLC (U.S.)
• Amgen Inc. (U.S.)
• AnGes, Inc. (Japan)
• Enzyvant Therapeutics GmbH  (Switzerland)
• エピウス・バイオテクノロジーズ社（米国）
• アステラス製薬株式会社（日本）
• アメリカン・ジーン・テクノロジーズ（米国）
• バイオマリン（米国）

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