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市場調査レポート
商品コード
1309724
T細胞療法の世界市場規模、シェア、産業動向分析レポート:エンドユーザー別、適応症別、治療タイプ別、地域別展望と予測、2023年~2030年Global T-Cell therapy Market Size, Share & Industry Trends Analysis Report By End User, By Indication, By Therapy Type, By Regional Outlook and Forecast, 2023 - 2030 |
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T細胞療法の世界市場規模、シェア、産業動向分析レポート:エンドユーザー別、適応症別、治療タイプ別、地域別展望と予測、2023年~2030年 |
出版日: 2023年06月30日
発行: KBV Research
ページ情報: 英文 263 Pages
納期: 即納可能
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T細胞療法市場規模は2030年までに92億米ドルに達すると予測され、予測期間中のCAGRは17.5%で上昇する見込みです。
KBVカーディナルマトリックスに掲載された分析によると、ファイザー社が同市場におけるトップランナーです。2022年1月、ファイザーはドレン・バイオと研究提携およびライセンス契約を締結し、ドレン・バイオ独自の標的化骨髄エンゲイジャーと貪食プラットフォームを活用し、特定の腫瘍標的に対する治療用二重特異性抗体の探索および開発に集中します。Johnson & Johnson、AbbVie, Inc.、Novartis AGなどは、この市場における主要なイノベーターです。
市場成長要因
国際的な政府支援を得るイニシアチブの増加
血液悪性腫瘍の治療に対する政府および非営利団体の取り組みの増加は、市場機会を拡大すると予測されます。例えば、多発性骨髄腫研究財団(MMRF)とラザレックスがん財団(Lazarex Cancer Foundation)の2つの非営利団体は、2023年2月にがん臨床試験を患者にとってより利用しやすいものにするために資源を提供することを約束しました。同様に、リンパ腫研究財団(LRF)は、最先端の研究と、この病気を終わらせるための新規で効果的なリンパ腫治療法の創出を支援しています。その結果、政府支援の高まりがT細胞療法の需要を押し上げ、市場の成長を促進すると予想されます。
T細胞療法の研究開発の増加
現在も数多くの臨床試験が実施されており、CAR T細胞研究は急速に進展しています。研究者らがCAR T細胞の標的になりうる新規腫瘍細胞抗原を発見したことが、この増加の一因となっています。FDAがCAR T細胞療法として承認している抗原はCD19とBCMAの2つだけであるが、複数の抗原を同時に標的とする治療法を含め、血液悪性腫瘍で頻繁に見られるその他の抗原を標的とする新たなCAR T細胞治療法が生み出されています。ほとんどのがん患者に存在する固形がんへのCAR-Tの適用は、この分野の転換点となると思われます。したがって、ほとんどのがん症例に有効なT細胞療法を開発するための研究開発の活発化が、市場の拡大に寄与しています。
市場抑制要因
高コストと厳しい規制に関する問題
特にT細胞療法にかかるコストの高さが、この治療法の市場拡大を妨げています。他の血液がんと同様に多発性骨髄腫もあらゆる場所で増加傾向にあり、特にアジアのような発展途上国で流行しているにもかかわらず、これらの革新的な治療法の一般的な使用を妨げている障壁がいくつかあります。そのひとつが、一部の医薬品が高価なため、貧しい国々での治療率が低いことです。これらの治療法が注目されているにもかかわらず、治療を受けた人の半数以下しか長期生存していないです。これらの要素は、広く普及するための課題となっており、患者のアクセスを制限しています。
治療タイプの展望
治療法の種類によって、市場はCAR T細胞療法とT細胞受容体(TCR)ベースに分類されます。CAR T細胞療法セグメントは、2022年の市場で最も高い売上シェアを獲得しました。CAR-T療法を用いた臨床研究の増加と市場トップ企業の関与の増加が、このセグメントの上昇の原因となっています。多くの新規企業や学術機関が、さまざまな適応症に対するCAR-T療法ソリューションの臨床試験を実施しています。CAR-T療法の製造方法の改善により、さまざまな悪性腫瘍の治療におけるCAR-T療法の利用が増加しています。
CAR-T細胞療法の展望
CAR T細胞療法セグメントはさらに、アキシカブタジーンシロロイセル、チサゲンレクロロイセル、ブレクスカブタジーンオートロイセル、その他に分類されます。アキシカブタジェン・シロロイセルセグメントは、2022年のT細胞療法市場で最大の収益シェアを獲得しました。この薬剤は、少なくとも2種類の全身療法を受けても再発または改善しなかった濾胞性リンパ腫または特定のタイプの大細胞型B細胞リンパ腫の成人患者を治療することを目的としています。さらに、リンパ腫のようないくつかのがんの治療薬としても研究されています。非ホジキンリンパ腫(NHL)の中で2番目に多い濾胞性リンパ腫(FL)は、全リンパ腫の約30%を占める。そのため、これらの薬剤に対する需要は増加しています。
適応症の展望
適応症別に見ると、市場はリンパ腫、急性リンパ性白血病、その他に分けられます。急性リンパ性白血病分野は、2022年の市場成長率が顕著でした。従来の薬では治療が困難なことが多い疾患を治療するための養子細胞移植療法の開発が、関心を集めると予想されます。さらに、TCRをベースとしたものを含むT細胞療法技術の最近の開発により、多発性骨髄腫やメラノーマの治療において有望な結果が示されています。
エンドユーザーの展望
エンドユーザーに基づき、市場は病院とがん治療センターに区分されます。病院セグメントは、2022年の市場で最も高い売上シェアを獲得しました。T細胞治療に必要な確立されたインフラと最先端の医療設備により、病院セグメントは成長しています。さらに、入院患者数の増加、多発性骨髄腫の症例数の増加、より良い患者サービスを可能にする熟練した医療従事者がこれらの施設に存在することなどが、患者の間で病院への選好を高めています。
地域別展望
地域別に見ると、市場は北米、欧州、アジア太平洋、LAMEAで分析されます。北米セグメントは、2022年の市場において最大の収益シェアを記録しました。この地域の市場成長は、がん患者の増加、民間および政府機関の資金提供の増加、研究と商業化のための強固な基盤に関連しています。さらに、北米では高齢者の増加によりがんの有病率が上昇しており、最適な治療法の必要性が高まっています。
List of Figures
The Global T-Cell therapy Market size is expected to reach $9.2 billion by 2030, rising at a market growth of 17.5% CAGR during the forecast period.
Acute Lymphocytic Leukemia is the growing indication type of T-Cell Therapy because of the increasing prevalence of multiple myeloma and the increased research & development. Therefore, acute lymphocytic leukemia is anticipated to generate more than 35% share of the market by 2030. For example, according to the National Center for Biotechnology Information (NCBI), presently, there are 160,000 new cases of MM per year, with 106,000 deaths. 10% of all diagnosed hematological cancers are multiple myeloma, which has gained clinical attention due to major improvements in medical care.
For instance, according to Cancer Australia, there are expected to be 2,625 additional instances of multiple myeloma diagnosed in Australia in 2022. The same source estimates that at 85, a person will have a 1 in 111 chance of receiving a diagnosis with multiple myeloma. The expansion of T-cell therapies is also being aided by the rising number of approvals. For instance, the FDA expedited the approval of teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific BCMA-directed CD3 T-cell engager, in October 2022 for adults with relapsed or refractory (r/r) multiple myeloma.
The major strategies followed by the market participants are Partnerships as the key developmental strategy to keep pace with the changing demands of end users. For instance, In May, 2023, Amgen entered into collaboration with TScan Therapeutics, Inc. to leverage TScan's proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn's disease and enable the company to develop first-in-class therapeutics to address unmet medical needs. Additionally, In May, 2023, Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, teamed up with Cellular Biomedicine Group Inc. to enhance its portfolio in B-cell malignancies and accelerate the development, manufacturing, and commercialization capabilities to deliver best-in-class cell therapies.
Based on the Analysis presented in the KBV Cardinal matrix; Pfizer, Inc. is the forerunner in the Market. In January, 2022, Pfizer signed a research collaboration and license agreement with Dren Bio to concentrate on the discovery and development of therapeutic bispecific antibodies for select oncology targets utilizing Dren Bio's proprietary Targeted Myeloid Engager and Phagocytosis Platform. Companies such as Johnson & Johnson, AbbVie, Inc., Novartis AG are some of the key innovators in the Market.
Market Growth Factors
Rising number of initiatives gaining more international government support
Increased government as well as nonprofit organization efforts to treat hematological malignancies are predicted to improve the market opportunity. For instance, two nonprofit organizations, the Multiple Myeloma Research Foundation (MMRF) and the Lazarex Cancer Foundation, committed their resources to make cancer clinical trials more accessible to patients in February 2023. Similarly, the Lymphoma Research Foundation (LRF) supports cutting-edge research and the creation of novel, effective lymphoma therapies to end this illness. As a result, rising government support is anticipated to boost demand for T-cell therapies and propel market growth.
Growing number of research and development in T-cell therapies
Numerous clinical trials are still being conducted, and CAR T-cell research is progressing quickly. Researchers' discovery of novel tumor cell antigens that potentially make suitable CAR T- cell targets has contributed to some of this increase. Although the only two antigens that have FDA approval for CAR T-cell therapies are CD19 and BCMA, new CAR T-cell treatments have been created that target additional antigens frequently seen in blood malignancies, including treatments that target multiple antigens simultaneously. The application of CAR T to solid tumors, which are present in most cancer patients, will mark a turning point in the field. Hence, the increasing R&D in developing T-cell therapies effective in most cancer cases is aiding in expanding the market.
Market Restraining Factors
Issues related to high cost and strict regulations
Numerous problems, notably the high cost of T-cell therapy, are impeding the market expansion of this treatment. Even though multiple myelomas, as well as other blood cancers, are on the rise everywhere and are particularly prevalent in developing nations like Asia, there are several barriers hindering the general use of these innovative treatments. One of these is the low treatment rates in poor countries due to the expensive costs of some medicines. Despite all the attention surrounding these treatments, less than half of those who receive them survive for a long time. These elements present a challenge to its wide adoption and restrict patient access.
Therapy Type Outlook
Based on therapy type, the market is characterized into CAR T-cell therapy and T-cell Receptor (TCR)-based. The CAR T-cell therapy segment garnered the highest revenue share in the market in 2022. The increase in clinical studies using CAR-T therapy and the increasing involvement of the market's top companies is responsible for the segment's rise. Many new companies and academic institutions are conducting clinical trials for CAR-T therapy solutions for various indications. Improvements in its manufacture have led to an increase in the utilization of CAR-T procedures in the treatment of various malignancies.
Car T-Cell Therapy Outlook
The CAR T-cell therapy segment is further classified into axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, and others. The axicabtagene ciloleucel segment acquired the largest revenue share in the T-cell therapy market in 2022. This medication is intended to treat adult patients with follicular lymphoma or specific types of large B-cell lymphoma who had either relapsed or failed to improve after receiving at least two different forms of systemic therapy. Additionally, it is being researched for the treatment of several cancers like lymphoma. The second most prevalent form of non-Hodgkin lymphoma (NHL), follicular lymphoma (FL), makes up about 30% of all lymphomas. Therefore, the demand for these medications is increasing.
Indication Outlook
By indication, the market is divided into lymphoma, acute lymphocytic leukemia, and others. The acute lymphocytic leukemia segment garnered a remarkable growth rate in the market in 2022. The development of adoptive cell transfer therapy for treating disorders, which are frequently more challenging to treat with conventional medicines, is expected to garner increased interest. Additionally, recent developments in T-cell therapy technology, including TCR-based, have demonstrated encouraging outcomes in managing multiple myeloma and melanoma.
End User Outlook
Based on end user, the market is segmented into hospitals and cancer treatment centers. The hospitals segment procured the highest revenue share in the market in 2022. Due to its established infrastructure and cutting-edge medical facilities, which are required for T-cell treatment, the hospital segment is growing. Additionally, an increase in the number of patients admitted, a rise in the number of cases of multiple myeloma, and the presence of skilled medical personnel in these facilities, which enables better patient services, are increasing the preference for hospitals among patients.
Regional Outlook
Region wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment recorded the largest revenue share in the market in 2022. The market growth in this region is linked to an increase in cancer cases, an increase in private and governmental agency funding, and a solid foundation for research and commercialization. Additionally, the prevalence of cancer has increased in North America due to the rise in the number of elderly people, which has increased the need for optimum therapies.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Merck KGaA, Johnson & Johnson, AbbVie, Inc., Gilead Sciences, Inc., Amgen, Inc., Novartis AG, Sorrento Therapeutics, Inc., Bristol Myers Squibb Company, Immunocore Holdings plc and Pfizer, Inc.
Recent Strategies Deployed in T-Cell Therapy Market
Partnerships, Collaboration and Agreements:
May-2023: Amgen entered into collaboration with TScan Therapeutics, Inc. a clinical-stage biopharmaceutical company. With this collaboration, the company aimed to leverage TScan's proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn's disease and enable the company to develop first-in-class therapeutics to address unmet medical needs.
May-2023: Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, teamed up with Cellular Biomedicine Group Inc., developer of proprietary immune cell therapies for the treatment of various cancers. The collaboration enables the company to enhance its portfolio in B-cell malignancies and accelerate the development, manufacturing, and commercialization capabilities to deliver best-in-class cell therapies.
Apr-2023: Johnson & Johnson and Legend Biotech signed an agreement with Novartis, a Swiss multinational pharmaceutical corporation that engages in the development, manufacture, and marketing of healthcare products. Novartyi would supply Caryvkti from its cell therapy site in Morris Plains, New Jersey which would provide J&J and Legend with the extra clinical capacity for ramping up commercial supply.
Jan-2023: AbbVie teamed up with Immunome, Inc., a clinical-stage biopharmaceutical company, for the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's Discovery Engine. The company looks forward to utilizing its Discovery Engine to enhance the existing oncology pipeline through this collaboration.
Dec-2022: Merck KGaA entered into an agreement with Synplogen, a startup spun out of Kobe University's Graduate School of Science, Technology, and Innovation. With this agreement, both companies aimed to combine capabilities for offering streamlined development, manufacturing, and testing for viral vector gene therapies for Japan.
Dec-2022: Bristol Myers Squibb formed a collaboration with Century Therapeutics, an innovative biotechnology company that builds industry-leading allogeneic iPSC-derived cell therapy platforms. With this collaboration, the company aimed to develop allogeneic cell therapies to help patients with hematologic and solid tumor malignancies.
Dec-2022: Immunocore Holdings plc joined hands with Gadeta B.V., an innovative clinical-stage biopharmaceutical company. Through this collaboration, the company aimed to combine Gadeta's expertise in gamma delta TCRs with their scientific, development, and commercialization capabilities to offer new TCR therapies.
Jan-2022: Pfizer signed a research collaboration and license agreement with Dren Bio, a biopharmaceutical company, a developer of therapeutic antibodies for the treatment of cancer. This agreement aimed to concentrate on the discovery and development of therapeutic bispecific antibodies for select oncology targets utilizing Dren Bio's proprietary Targeted Myeloid Engager and Phagocytosis Platform
Oct-2021: Immunocore entered into an agreement with Medison Pharma Ltd., a global pharma company engaged in providing access to highly innovative therapies. The agreement would enable Immunocore to obtain regulatory approval and market tebentafusp (IMCgp100) in Canada, twenty markets in Central Eastern Europe, and Israel for the treatment of metastatic uveal melanoma.
Aug-2021: Kite, a Gilead Company joined hands with Appia Bio, Inc., an early-stage biotechnology company developing engineered allogeneic cell therapies from hematopoietic stem cells (HSCs) for cancer patients. Through this collaboration, the company aimed to tackle the unique biological properties of invariant natural killer T cells to research and develop allogeneic cell therapies for cancer.
Jun-2021: Kite, a Gilead Company formed a partnership with Shoreline Biosciences, Inc., a biotechnology company developing intelligently designed allogeneic off-the-shelf for cancer and other serious diseases. The partnership is aimed to develop novel cell therapies across a variety of cancer targets. Initially, the collaboration would focus on chimeric antigen receptor (CAR) NK targets with the company having the option to expand the collaboration to include an iPSC CAR Macrophage program.
Mar-2021: Merck KGaA signed an agreement with Gilead Sciences, Inc., an American biopharmaceutical company. The agreement is aimed to co-develop and co-commercialize treatment options for people living with HIV by combining the company's investigational nucleoside reverse transcriptase translocation inhibitor, islatravir with Gilead's investigational capsid inhibitor, lenacapavir.
Mar-2021: Pfizer signed a worldwide license agreement with Pyxis Oncology, a preclinical oncology company. This agreement aimed to develop and commercialize two antibody-drug conjugates (ADC) candidates and a license to Pfizer's ADC technology platform, also allowing expansion of the ADC portfolio and strengthening the developmental capabilities and demonstrating successful implementation of overarching corporate strategy to align in-house organic growth with strategic in-licensing and partnerships to develop the multi-asset multi-platform portfolio.
Feb-2021: AbbVie formed a collaboration with Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome editing biotechnology company. Through this collaboration, the company would be able to advance its efforts to provide new hope for patients.
Product Launch and Product Expansions:
Dec-2021: Novartis unveiled T-Charge, the company's next-generation CAR-T platform that would serve as the foundation for various new investigational CAR-T cell therapies in the Novartis pipeline. With this launch of T-Charge, the company aimed to further reimagine CAR-T cell therapy and offer an ultimate potential for a cure by giving patients a higher likelihood of durable responses.
Acquisitions and Merger:
May-2023: Gilead Sciences completed the acquisition of XinThera, a small molecule drug discovery company. The acquisition enables the company to use XinThera's portfolio of two small molecule inhibitor programmes and improve outcomes for people living with cancer and inflammatory diseases.
Dec-2022: Kite, a Gilead Company took over Tmunity Therapeutics, a clinical-stage, private biotech company focused on next-generation CAR T-therapies and technologies. The acquisition of Tmunity complements in-house cell therapy research capabilities of Kite by adding platform capabilities, pipeline assets, and licensing agreement with the University of Pennsylvania (Penn).
Aug-2022: Bristol Myers Squibb completed the acquisition of Turning Point Therapeutics, a pharmaceutical company engaged in the discovery and development of precision medicine for cancer and other diseases. The acquisition added a product line of investigational medicines designed for targeting the most common mutations related to oncogenesis, to Bristol Myers' portfolio.
Jun-2022: Novartis acquired Kedalion Therapeutics, a clinical-stage, venture-funded ophthalmic drug company based in Menlo Park, California. Through this acquisition, Novartis attained AcuStreaM technology of Kedalion Therapeutics. The acquisition aimed to increase Novartis' ophthalmics portfolio and progressed its efforts to investigate revolutionizing ophthalmic methods that would assist in addressing unmet patient needs in front-of-eye conditions.
Feb-2022: Merck completed the acquisition of Exelead, a biopharmaceutical contract development, and manufacturing business. Through this acquisition, Exelead's leading abilities, and highly experienced crew, Merck acquires a crucial landmark in evolving one of the supreme CDMO players in mRNA vaccines and therapeutics, delivering a combined CDMO across the mRNA value chain from pre-clinical to retail.
Dec-2021: Merck signed an agreement to acquire Chord Therapeutics, a Swiss-based biotech company. By this acquisition, Merck aimed at leveraging its existing capabilities to further develop an oral cladribine product tailored particularly for MS, oncologic disorders, gMG, and NMOSD.
Dec-2021: Novartis signed an agreement to acquire Gyroscope Therapeutics, a clinical-stage gene therapy company. Through this acquisition, Novartis would achieve access to the prior guide experimental gene treatment, GT005.
Nov-2021: Pfizer acquired Trillium Therapeutics, a clinical-stage immuno-oncology company that develops innovative therapies for cancer treatment. The acquisition added a biologics portfolio that enhanced the patient's innate immune system ability to detect and destroy cancer cells.
Jul-2021: Amgen took over Teneobio, a clinical-stage biotechnology company. With this acquisition, the company aimed to leverage Teneobio's antibody platform in order to complement its prevailing capabilities. Moreover, the company also aimed to gain a diverse range of building blocks that can be created into new multispecific therapeutics.
Jun-2021: Sorrento Therapeutics, Inc. took over ACEA Therapeutics Inc., developer of oncology drugs. The company, through this acquisition, aimed to expand its development and commercialization of innovative medicines that would save and improve lives globally.
Apr-2021: Amgen took over Five Prime Therapeutics, a clinical-stage biotechnology business. Through this acquisition, the company aimed to integrate Five Prime's offerings into its oncology portfolio in order to strengthen its vision for international expansion and further pipeline programs.
Geographical Expansions:
Apr-2023: Bristol Myers Squibb expanded its geographical footprints by opening a U.S.-based manufacturing facility. The new facility would enable the company to increase its capabilities to produce viral vectors for both of Bristol Myers Squibb's CAR T cell therapies.
Trials and Approvals:
Jun-2022: Bristol Myers Squibb got approval from U.S. FDA for CAR T Cell Therapy Breyanzi® for Relapsed or Refractory Large B-cell Lymphoma after a Prior Therapy once. This therapy is indicated for the treatment of follicular lymphoma grade 3B, primary mediastinal large B-cell lymphoma, large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), and high-grade B-cell lymphoma, among adult patients.
May-2022: US Food and Drug Administration (FDA) has approved Kymriah (tisagenlecleucel) by Novartis AG for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. The approval enables the company to help break the unrelenting cycle of treatment for patients with follicular lymphoma.
Jan-2022: Kite, a Gilead Company received approval from U.S. Food and Drug Administration for Yescarta. With this approval, the company would be able to offer treatment for adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Jan-2022: Japan's Ministry of Health, Labour and Welfare has approved Bristol-Myers Squibb's Abecma (idecabtagene violence), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, to treat adult patients with relapsed or refractory (R/R) multiple myeloma, who have received at least three prior therapies. The approval would enable the company to address unmet medical needs for patients in Japan and help them prevail over serious diseases.
Jan-2022: Immunocore Holdings plc received approval from United States Food and Drug Administration (FDA) for KIMMTRAK (tebentafusp-tebn), for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). With this approval, the company would be able to help those with this aggressive form of cancer.
Aug-2021: Sorrento Therapeutics, Inc received approval for Sorrento's IND application from the FDA for the Phase 1 clinical testing of allogeneic anti-CD38 Dimeric Antigen Receptor (DAR) - T Cell therapy for relapsed or refractory multiple myeloma. This approval would open the doors for numerous other DAR-T cell therapies.
Market Segments covered in the Report:
By End User
By Indication
By Therapy Type
By Geography
Companies Profiled
Unique Offerings from KBV Research