市場調査レポート
商品コード
1355048
T細胞療法の世界市場の評価:モダリティ別、治療タイプ別、適応症別、エンドユーザー別、地域別、機会、予測(2016年~2030年)T-Cells therapy Market Assessment, By Modality, By Therapy Type, By Indication, By End-user, By Region, Opportunities and Forecast, 2016-2030F |
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T細胞療法の世界市場の評価:モダリティ別、治療タイプ別、適応症別、エンドユーザー別、地域別、機会、予測(2016年~2030年) |
出版日: 2023年10月03日
発行: Market Xcel - Markets and Data
ページ情報: 英文 157 Pages
納期: 3~5営業日
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世界のT細胞療法の市場規模は、2022年の33億3,000万米ドルから2030年に129億8,000万米ドルに達し、2023年~2030年の予測期間にCAGRで18.54%の成長が予測されています。
Tecartus、Yescarta、Kymriahが承認された後、いくつかの組織が小規模な化学療法やタンパク質ベースの治療法の開発から改変療法へとビジネスモデルを変更しました。この要素は、民間と公的機関による戦略的投資を促し、市場成長を後押ししています。T細胞療法事業体の市場競合は、製品承認の増加と生産能力の向上により、今後数年間で拡大すると予想されます。
例えば、米国FDAは2022年2月、再発または難治性の大細胞型B細胞リンパ腫(LBCL)を管理するための初のキメラ抗原受容体(CAR)T細胞治療薬であるYescartaを承認しました。NCCN治療ガイドラインのカテゴリ1推奨により、YescartaはCAR-T細胞治療薬として初めてこの栄誉に輝きました。FDAは同様に2022年2月に、治療効果が得られなかった難治性多発性骨髄腫患者、または治療後に再発した多発性骨髄腫患者(再発)を対象に、シルタカブタゲンオートロイセル(Carvykti)を承認しています。
California Institute for Regenerative Medicine(CIRM)は2023年1月、リンパ腫や白血病を含む多様なB細胞悪性腫瘍を治療するCAR-T細胞療法の開発および試験に400万米ドルを拠出しました。
CAR-T細胞療法では、患者から採取したT細胞を人工的に生物工学的な操作を加え、CARを発現させます。CAR-T細胞部門の企業は、提携、事業拡大、合意、共同研究、新製品の導入など、他社との戦略的提携を進めており、これがT細胞療法市場の成長を促進しています。
例えば、Janssen Biotech, Inc. が製造するCARVYKTIは2022年にFDAに認可されました。キメラ抗原受容体T細胞(CAR-T)は、CARVYKTIとして知られる治療法の略称です。骨髄悪性腫瘍である多発性骨髄腫の成人患者は、CARVYKTI(シルタカブタゲンオートロイセル)による治療を受けることができます。CARVYKTIは、4種類以上の前治療の後、再発または治療抵抗性を示した多発性骨髄腫の成人患者を治療します。本薬は、プロテアソーム阻害薬、免疫調節薬、抗CD38モノクローナル抗体から構成されます。
世界のT細胞療法市場は近年大きな進歩を示しています。CAR-T療法のような革新的技術はがん治療に革命をもたらし、研究者たちはTCR療法のような次世代のT細胞療法を探求しており、治療可能な疾患の範囲を広げています。さらに、健康なドナーに由来する同種T細胞療法の開発は、治療をより身近なものにしています。これらのブレークスルーは、個別化されたT細胞療法と既製のT細胞療法の有望な未来を意味し、世界市場における治療オプションの地平を広げています。
COVID-19の発生は、世界の医療産業、特にT細胞療法市場の活動を妨げました。パンデミックは、ほとんどの国がロックダウン政策を実施したため、世界のT細胞療法市場に打撃を与えました。サプライチェーンの中断により、一部の企業ではT細胞治療薬の生産と供給に遅れが生じました。パンデミックは、いくつかのT細胞療法の臨床試験に大きな混乱をもたらし、一部の臨床試験は延期されたり、完全に中止されたりしました。
しかし、パンデミック後、がん患者の増加により医療産業におけるイノベーションの必要性が注目され、多くの企業が研究開発への取り組みを強化していることが指摘されました。そのため、T細胞療法をウイルス感染症の治療に応用する方法を解明することを目的とした研究への資金援助が奨励されています。例えば、Tevogen Bioは2022年11月、研究中のCOVID-19のT細胞療法であるTVGN-489の治療利用の可能性を検討する意向を発表しました。
当レポートでは、世界のT細胞療法市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。
Global T-Cells therapy market size was valued at USD 3.33 billion in 2022, and is expected to reach USD 12.98 billion in 2030, with a CAGR of 18.54% for the forecast period between 2023 and 2030F. The market for T-cell treatment is constantly evolving and expanding, largely due to ongoing research and development initiatives. To improve efficacy and widen the applications of T-cell therapies, scientists and researchers are constantly investigating new methods, tools, and therapeutic targets. The key factors driving the expansion of the T-cell therapy market size are the rise in cancer prevalence, elderly population, and the usage of various cell therapy technologies to treat cancer symptoms. The prevalence of certain cancers such as leukemia, myeloma, lymphoma, and cancer relapse increase the need for efficient therapeutic interventions and fuels market growth. Also, multiple medications that are currently in the clinical development stage are fueling the market's expansion. For instance, Caribou Biosciences, Inc.'s CB-010 and CB-011 are undergoing phase I clinical studies. Similarly, Cartesian Therapeutics, Inc.'s DESCARTES-17 and DESCARTES-25 are now undergoing preclinical and Phase I trials, respectively. Thus, it is further projected that key companies' attention to developments may possibly fuel the market for T-cell treatment growth.
After tecartus, Yescarta, and Kymriah were approved, several organizations changed their business models from developing small chemical and protein-based treatments to adoptive therapy. This element has encouraged strategic investments by both private and public organizations, which has helped the market grow. The market rivalry for T-cell therapy entities is anticipated to expand in the coming years due to increasing product approval and rising production capacities.
For instance, the U.S. FDA approved Yescarta, the first chimeric antigen receptor (CAR) T-cell treatment in February 2022 to manage relapsed or refractory large B-cell lymphoma (LBCL). The NCCN Treatment Guideline's Category 1 recommendation for Yescarta makes it the first CAR T-cell treatment to receive this distinction. The FDA similarly approved ciltacabtagene autoleucel (Carvykti) in February 2022 for patients with multiple myeloma that is refractory, which did not respond to treatment, or has reappeared after treatment (relapsed).
The California Institute for Regenerative Medicine (CIRM) committed $4 million in January 2023 to develop and test a CAR T-cell therapy for treating diverse B-cell malignancies, including lymphomas and leukemias.
Following the closure of the transaction in May 2023 , Laurus Labs' share in ImmunoACT will rise to 33.86% on a fully diluted basis. In November 2021, the corporation had already purchased 26.62% of ImmunoACT. The CAR T-cell therapy assets in ImmunoACT's portfolio are in various stages of development and are used to treat various cancers and autoimmune illnesses. With this funding, Laurus Labs is more committed to offering patients revolutionary Cell and Gene Therapy technology at an affordable price. This funding will aid ImmunoACT in preparing to produce more medications.
In CAR T-cell therapy, T-cells taken from patients are artificially bioengineered to express CARS, which can recognize and attach to the cancer cells. Companies in the CAR T-cell segment are engaging in strategic developments with other companies, such as partnerships, expansions, agreements, collaborations, and the introduction of new products, which is promoting the growth of the T-cell treatment market.
For instance, the FDA authorized CARVYKTI produced by Janssen Biotech, Inc. in 2022. Chimeric antigen receptor T-cell, or CAR-T, is the abbreviation for the therapy known as CARVYKTI. Adult patients with multiple myeloma, a bone marrow malignancy, can receive treatment with CARVYKTI (ciltacabtagene autoleucel). After four or more prior lines of therapy, CARVYKTI treats adult patients with multiple myeloma that have relapsed or become resistant to treatment. It comprises a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
Astellas committed USD 50 million to Poseida's CAR T-cell therapy in August 2023. Astellas will have exclusive negotiating rights and first choice for licensing P-MUC1C-ALLO1 in solid tumors as part of the agreement.
The development, testing, and marketing of cell therapies and other biologics used in T-cell therapy treatments, such as adoptive cell transfer (ACT), are governed by the U.S. Food and Drug Administration (FDA).
Cell therapy evaluation standards and guidelines have been published by the European Medicines Agency (EMA) for use in clinical and human trials.
The safety, effectiveness, and quality of biological products used in T-cell therapy treatments are overseen by the FDA's Center for Biologic Evaluation and Research (CBER).
Best practices have been established by the National Institutes of Health (NIH ) for carrying out clinical trials utilizing cell therapies, particularly for T-cell therapy. Guidelines for patient selection criteria, risk assessment techniques, and monitoring procedures are included.
To guarantee that cell therapies are produced safely and ethically, the International Society for Cellular Therapy (ISCT) offers rules and criteria.
The global T-cell therapy market has witnessed significant advancements in recent years. Innovative technologies like CAR-T therapy have revolutionized cancer treatment, researchers are exploring next-generation T-cell therapies, such as TCR (T-cell Receptor) therapies, which broadens the scope of treatable diseases. Furthermore, the development of allogeneic T-cell therapies, derived from healthy donors, is making treatments more accessible. These breakthroughs signify a promising future for personalized and off-the-shelf T-cell therapies, expanding the horizon of therapeutic options in the global market.
The U.S. Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Autolus Therapeutics plc, a clinical-stage biopharmaceutical firm, to its lead gene therapy obecabatagene autoleucel (obe-cel) in April 2022. In the ongoing FELIX Phase 2 study in adult relapsed/refractory B-Acute Lymphocytic Leukemia, a CD19-directed autologous chimeric antigen receptor (CAR) T treatment is being examined.
In 2022, Novartis International AG introduced a novel T-Cell Therapy known as Kymriah, specifically designed for addressing relapsed or refractory follicular lymphoma. This innovative therapy, classified as a CD19-targeted CAR-T-cell therapy, received FDA approval.
The COVID-19 outbreak hampered operations in the global health care industry, especially the T-cell treatment market. The pandemic hurt the global T-cell treatment market since most nations implemented lockdown policies. Due to supply chain interruptions, certain businesses encountered delays in producing and delivering T-cell therapies. The pandemic caused significant disruptions to several clinical trials of T-cell treatments, with some trials being postponed or discontinued entirely.
However, it was noted that post-pandemic, the prevalence of cancer cases has brought attention to the need for innovation in the healthcare industry, and many businesses are boosting their efforts in R&D. It has encouraged funding for research aimed at figuring out how T-cell treatments might be applied to treat viral infections. For instance, Tevogen Bio announced, in November 2022, it intended to examine the potential therapeutic uses of TVGN-489, an investigational COVID-19 T-cell therapy, in Long COVID. The highly purified cytotoxic CD8+ T lymphocytes (CTLs) TVGN-489 are designed to locate and eradicate SARS-CoV-2 infected cells.
The increasing number of businesses engaging in CAR-T therapy development is projected to boost market competition. Novartis AG and Kite Pharma currently dominate the T-cell therapy market through innovative and novel product introductions. In addition, numerous prominent corporations are launching significant initiatives to strengthen their market presence. For instance, in June 2022, Immunocore Ltd., a commercial-stage biotechnology startup, engaged into a clinical trial collaboration and supply deal with Sanofi. Sanofi can use KIMMTRAK to analyze their precisely PEGylated, tailored form of IL-2, SAR444245 in this collaboration. The agreement will help the company's expansion by improving cell therapy manufacturing operations.
All segments will be provided for all regions and countries covered:
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.