表紙:人工多能性幹細胞(iPSC)の世界市場:市場規模、動向、予測(2023年)
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人工多能性幹細胞(iPSC)の世界市場:市場規模、動向、予測(2023年)

Global Induced Pluripotent Stem Cell (iPSC) Industry Report - Market Size, Trends, and Forecasts, 2023

出版日: | 発行: BioInformant | ページ情報: 英文 329 Pages | 納期: 即納可能 即納可能とは

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人工多能性幹細胞(iPSC)の世界市場:市場規模、動向、予測(2023年)
出版日: 2023年12月31日
発行: BioInformant
ページ情報: 英文 329 Pages
納期: 即納可能 即納可能とは
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  • 概要
  • 目次
概要

15年前に人工多能性幹細胞(iPSC)技術が発見されて以来、幹細胞生物学と再生医療において大きな進展がありました。新たな病態メカニズムが同定され、iPSCスクリーニングによって同定された新薬が開発され、ヒトiPSC由来の細胞を用いた最初の臨床試験が開始されました。

iPSCは、病気の発症や進行の原因を探り、新薬や治療法を開発・試験し、これまで不治の病であった病気を治療できる可能性があります。初期化に使用される体細胞には、皮膚細胞や血液細胞などがあり、毛包、臍帯血、尿など他の細胞種も含まれます。

近年、iPSC由来の細胞は、前臨床試験や初期段階の臨床試験に使用されることが増えています。iPSCを用いた最初の臨床試験は2008年に開始され、現在その数は世界で100件を超えています。現在の臨床試験のほとんどは、iPS細胞をヒトに移植するものではなく、臨床目的のためにiPS細胞株を作製し評価するものです。これらの臨床試験の中で、iPSC株は特定の患者集団から作製され、これらの細胞株が対象疾患の良いモデルになり得るかどうかを判断します。

人工多能性幹細胞(iPSC)の治療への応用も近年急増しています。2006年にiPSCが発見されて以来、2013年に初めてiPSC由来の細胞製品がヒト患者に移植されるまで、わずか7年となっています。2013年から現在に至るまで、ヒトiPSC由来細胞を用いた臨床試験や医師主導の研究がいくつか開始されています。

2013年は、神戸の理化学研究所センターでiPS細胞のヒトへの移植を含む初の細胞治療が開始された画期的な年でした。高橋政代博士が主導し、黄斑変性症患者を対象にiPSC由来の細胞シートの安全性を調査しました。

もう一つの世界初として、シナタ・セラピューティクス社は2016年、GvHD治療のための同種iPSC由来細胞製品(CYP-001)の初の正式な臨床試験を開始する承認を受けました。CYP-001はiPSC由来のMSC製品です。この歴史的な臨床試験において、CYP-001は臨床エンドポイントを達成し、ステロイド抵抗性急性GvHDの治療に対する良好な安全性と有効性のデータを得ました。

この初期の成功を踏まえ、シナタ社はiPSC由来MSCをCOVID-19に伴う重篤な合併症、GvHD、重症虚血肢(CLI)に対する第2相試験に進めています。また、変形性関節症(OA)患者440人を対象に、シナタ社のiPSC由来MSC製品であるCYP-004を使用する素晴らしい第3相試験を実施中です。この臨床試験は、iPS細胞由来の細胞治療製品を含む世界初の第3相臨床試験であり、これまでに完了した臨床試験の中でも最大規模のものです。

当レポートでは、世界の人工多能性幹細胞(iPSC)市場について調査し、市場の概要とともに、企業別、タイプ別、用途別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 レポートの概要

第2章 イントロダクション

第3章 IPSC業界の現状

第4章 人工多能性幹細胞(IPSCS)の歴史

第5章 IPSCSに関する調査出版物

第6章 IPSC:特許情勢の分析

第7章 IPSC:臨床情勢

第8章 iPSCSへの調査資金

第9章 iPSC部門におけるM&A、提携、資金調達活動

  • iPSC分野における合併・買収(M&A)
  • iPSC分野におけるパートナーシップ/コラボレーション/ライセンシング契約
  • ベンチャーキャピタルの資金調達とIPO

第10章 人工多能性幹細胞の生成:概要

  • 再プログラミング要因
  • iPSC配信方法の統合
  • 非統合型配信システム
  • iPSCを生成するための配送方法の比較
  • iPS細胞世代におけるゲノム編集技術

第11章 ヒトIPSCバンキング

第12章 IPSCSの生物医学への応用

  • 基礎研究におけるiPSC
  • 創薬におけるiPSC
  • 毒性学研究におけるiPSC
  • 疾患モデリングにおけるiPSC
  • 細胞ベースの治療におけるiPSC
  • iPSCのその他の新規応用
  • 動物保護におけるiPSC

第13章 市場概要

  • 世界のiPSC市場、地域別
  • 世界のiPSC市場、技術別
  • 世界のiPSC市場、生物医学用途別
  • 世界のiPSC市場、派生細胞タイプ別
  • 市場促進要因
  • 市場抑制要因

第14章 企業プロファイル

  • Accellta
  • AddGene, Inc
  • Allele Biotechnology, Inc
  • ALSTEM, Inc
  • アルトス研究所
  • Altos Labs AMS Biotechnology Ltd. (AMSBIO)
  • Aspen Neuroscience, Inc
  • Astellas Pharma, Inc
  • Avery Therapeutics
  • Axol Bioscience Ltd
  • Bit.bio
  • BlueRock Therapeutics
  • BrainXell
  • Brooklyn Immuno Therapeutics
  • Catalent Biologics
  • Celogics, Inc
  • Cellaria
  • CellGenix, GmbH
  • Cellino Biotech
  • Cellular Engineering Technologies (CET)
  • Censo Biotechnologies, Ltd
  • Century Therapeutics, Inc
  • Citius Pharmaceuticals, Inc
  • Clade Therapeutics Creative Bioarray
  • Curi Bio
  • Cynata Therapeutics Ltd.
  • Cytovia Therapeutics
  • DefiniGEN
  • Editas Medicine
  • ElevateBio
  • Elixirgen Scientific, Inc
  • EviaBio
  • Evotec A.G
  • Exacis Biotherapeutics
  • Eyestem
  • Fate Therapeutics
  • FUJIFILM Cellular Dynamics, Inc
  • Heartseed, Inc
  • HebeCell
  • Helios K.K. Hera BioLabs
  • Hopstem Biotechnology
  • Implant Therapeutics, Inc
  • iPS Portal, Inc
  • I Peace, Inc
  • iXCells Biotechnologies
  • iPSirius SAS
  • Kytopen
  • Lindville Bio Ltd
  • LizarBio Therapeutics
  • Lonza Group, Ltd
  • Matricelf Merck/Sigma Aldrich
  • Megakaryon Corporation
  • Metrion Biosciences, Ltd
  • Mogrify
  • Ncardia
  • Ncardia
  • Neukio Biotherapeutics
  • Newcells Biotech, Ltd
  • NEXEL Co., Ltd
  • Orizuru Therapeutics, Inc
  • Phenocell SAS
  • Platelet BioGenesis
  • Pluristyx
  • ReNeuron
  • REPROCELL USA, Inc
  • RxCell, Inc.
  • SCG Cell Therapy Pte Ltd
  • Shoreline Biosciences
  • Stemson Therapeutics
  • Stemina Biomarker Discovery
  • Synthego Corp
  • Tempo Bioscience
  • Thyas, Co., Ltd
  • Universal Cells
  • ViaCyte, Inc
  • Vita Therapeutics
  • XCell Science, Inc
  • Yashraj Biotechnology, Ltd
  • YiPCELL
目次

Since the discovery of induced pluripotent stem cell (iPSC) technology 15 years ago, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated.

iPSCs can be used to explore the causes of disease onset and progression, create and test new drugs and therapies, and potentially, treat previously incurable diseases. The somatic cells used for reprogramming include skin cells and blood cells, and to a lesser degree, other cell types such hair follicles, cord blood and urine.

iPS Cell Commercialization

Today, methods of commercializing iPSCs include:

  • Cell Therapy: iPSCs are being explored in a diverse range of cell therapy applications for the purpose of reversing injury or disease.
  • Disease Modelling: By generating iPSCs from patients with disorders of interest and differentiating them into disease-specific cells, iPSCs can effectively create disease models "in a dish."
  • Drug Development and Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery.
  • Personalized Medicine: The use of techniques such as CRISPR enable precise, directed creation of knock-outs and knock-ins (including single base changes) in many cell types. Pairing iPSCs with genome editing technologies is adding a new dimension to personalized medicine.
  • Toxicology Testing: iPSCs can be used for toxicology screening, which is the use of stem cells or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells.

Other applications of iPSCs include their use as research products, as well as their integration into 3D bioprinting, tissue engineering, and clean meat production. Technology allowing for the mass-production and differentiation of iPSCs in industrial-scale bioreactors is also advancing at breakneck speed.

The Era of iPSCs

In recent years, iPSC-derived cells have increasingly been used to within preclinical testing and early stage-stage clinical trials. The first clinical trial using iPSCs started in 2008, and today, that number has surpassed 100 worldwide. Most of the current clinical trials do not involve the transplant of iPSCs into humans, but rather, the creation and evaluation of iPSC lines for clinical purposes. Within these trials, iPSC lines are created from specific patient populations to determine if these cell lines could be a good model for a disease of interest.

The therapeutic applications of induced pluripotent stem cells (iPSCs) have also surged in recent years. Since the discovery of iPSCs in 2006, it took only seven years for the first iPSC-derived cell product to be transplanted into a human patient in 2013. From 2013 to present, several clinical trials and physician-led studies employing human iPSC-derived cell types have been initiated.

2013 was a landmark year because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Dr. Masayo Takahashi, it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration.

In another world first, Cynata Therapeutics received approval in 2016 to launch the first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. CYP-001 is a iPSC-derived MSC product. In this historic trial, CYP-001 met its clinical endpoints and produced positive safety and efficacy data for the treatment of steroid-resistant acute GvHD.

Given this early success, Cynata is advancing its iPSC-derived MSCs into Phase 2 trials for the severe complications associated with COVID-19, as well as GvHD and critical limb ischemia (CLI). It is also undertaking an impressive Phase 3 trial that will utilize Cynata's iPSC-derived MSC product, CYP-004, in 440 patients with osteoarthritis (OA). This trial represents the world's first Phase 3 clinical trial involving an iPSC-derived cell therapeutic product and the largest one ever completed.

Not surprisingly, the Japanese behemoth FUJIFILM has been involved with the co-development and commercialization of Cynata's iPSC-derived MSCs through its 9% ownership stake in the company. Headquartered in Tokyo, Fujifilm is one of the largest players in regenerative medicine field. It has pursued a broad base in regenerative medicine across multiple therapeutic areas through its acquisition of Cellular Dynamics International (CDI) and Japan Tissue Engineering Co. Ltd. (J-Tec). The Japanese company Healios K.K. is also preparing, in collaboration with Sumitomo Dainippon Pharma, for a clinical trial using allogeneic iPSC-derived retinal cells to treat age-related macular degeneration (AMD).

Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. FT819 is the world's first CAR T therapy derived from a clonal master iPSC line and is engineered with several novel features designed to improve the safety and efficacy of CAR T-cell therapy. Notably, the use of a clonal master iPSC line as the starting cell source could enable CAR-T cells to be mass produced and delivered off-the-shelf at an industrial scale.

Other companies and organizations with iPSC-derived cell therapeutics under development worldwide include:

  • Allele Biotechnology and Pharmaceuticals is developing a diabetes drug created from iPSC-derived pancreatic beta cells.
  • Aspen Neuroscience is combining stem cell biology and genomics to provide the world's first autologous induced pluripotent stem cell (iPSC)-derived neuron replacement therapy for Parkinson disease.
  • Avery Therapeutics and I Peace, Inc., are collaborating to advance an iPSC-derived cell therapeutic for heart failure. I Peace is generating and supplying GMP-grade iPSCs, while Avery Therapeutics is using them to manufacture its MyCardia™ product.
  • Bayer acquired iPSC cell therapy company BlueRock Therapeutics in August 2019. Since May 2021, BlueRock Therapeutics, Fujifilm Cellular Dynamics, and Opsis Therapeutics have had an R&D alliance to develop allogeneic iPSC-derived cell therapies for ocular diseases.
  • BlueRock Therapeutics, a subsidiary of Bayer since August 2019, develops iPSC-derived cell therapies to target Parkinson's disease, heart failure, and ocular diseases.
  • Bone Therapeutics has partnered with the U.S. company Implant Therapeutics to develop allogeneic, iPSC-derived MSCs.
  • Brooklyn Immuno Therapeutics is developing a set of mesenchymal stem cell (MSC) products, derived from iPSCs, to which it also intends to apply its gene editing technology.
  • Century Therapeutics was created in July 2019 by Versant Ventures and Fujifilm to develop iPSC-derived adaptive and innate immune effector cell therapies.
  • Citius Pharmaceuticals uses iPSCs from a single-donor dermal fibroblast to create iPSC-derived MSCs (i-MSCs). It has completed the development of an i-MSC Accession Cell Bank (ACB) and is testing and expanding these cells to create an allogeneic cGMP i-MSC Master Cell Bank.
  • Cynata Therapeutics manufacturers iPSC-derived MSCs using its proprietary Cymerus™ technology. In partnership with FUJIFILM Corporation, it is clinically testing these cells for the treatment of graft-versus-host disease (GvHD). It is also conducting trials for the treatment of critical limb ischemia (CLI), osteoarthritis (OA), and respiratory failure/distress, including ARDS.
  • Cytovia Therapeutics is developing allogeneic "off-the-shelf" gene-edited iNK and CAR (Chimeric Antigen Receptor)-iNK cells derived from iPSCs.
  • Edigene, Inc. - Edigene and Neukio Biotherapeutics are developing allogenic iPSC-derived NK cell therapies through an R&D collaboration.
  • Editas Medicine (Nasdaq: EDIT), a genome editing company, is developing engineered iPSC-derived natural killer cells (iNKs) for the treatment of cancer.
  • Exacis Biotherapeutics is a development-stage immuno-oncology company that is developing NK cells from iPSCs (ExaNK™ cells) engineered using mRNA gene-editing technology to resist rejection by the patient's immune system.
  • Fate Therapeutics is developing iPSC-derived NK and CAR-T cells for the treatment of cancer and immune disorders.
  • FUJIFILM Cellular Dynamics, Inc. (FCDI) is investing in a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products.
  • Heartseed Inc. is a Japanese biotech company that is developing iPSC-derived cardiomyocytes (HS-001) for the treatment of heart failure. The company is positioned to initiate a phase 1/2 study of this investigational cell therapy in Japan in the second half of 2021.
  • Healios K.K. , in collaboration with Sumitomo Dainippon Pharma, is undertaking a clinical trial using allogeneic iPSC-derived retinal cells to treat age-related macular degeneration.
  • Hopstem Biotechnology is one of the first iPSC cell therapy companies in China and a market leader in iPSC-derived clinical-grade cell products. In June 2021, it partnered with Neurophth Biotechnology to co-develop an iPSC-derived cell therapy for the treatment of ocular diseases. Hopstem has a proprietary neural differentiation platform, as well as a patented iPSC reprogramming method and GMP manufactory and quality systems.
  • Implant Therapeutics is engineering iPSC-MSC cells containing FailSafe™ and induced Allogeneic Cell Tolerance (iACT Stealth Cell™) technologies. These iPSC MSC cells are hypo-immunogenic and can be used as ex-vivo gene therapy vehicles.
  • I Peace Inc. and Avery Therapeutics are collaborating to advance an iPSC-derived cell therapeutic for heart failure. I Peace is generating GMP-grade iPSCs, while Avery Therapeutics is using them to manufacture its MyCardia™ product. I Peace is able to mass production clinical-grade iPSC lines simultaneously in a single room using a miniaturized plate and robotic technology, and its facility is equipped with a fully-closed automated iPSC manufacturing system that meets the safety standards of the U.S. FDA and Japanese PMDA.
  • Keio University won approval from the the Japanese government in February 2018 for an iPSC trial that involves the treatment of patients with spinal cord injuries (led by Professor Hideyuki Okano).
  • Kyoto University Hospital, in partnership with the Center for iPS Cell Research and Application (CiRA), is performing a physician-led study of iPSC-derived dopaminergic progenitors in patients with Parkinson's disease.
  • Neurophth Biotechnology Ltd. is a gene therapy company specializing in AAV-mediated gene therapies for the treatment of ocular diseases. In June 2021, it partnered with Hopstem Biotechnology to develop an iPSC-derived candidate cell product for an agreed upon retinal degenerative disorder.
  • Novo Nordisk signed a co-development agreement with Heartseed in mid-2021 that grants it exclusive rights to develop, manufacture, and commercialize HS-001 globally, excluding Japan where Heartseed retained exclusive rights to develop HS-001. HS-001 is an investigational therapy comprised of purified iPSC-derived ventricular cardiomyocytes for the treatment of heart failure.
  • Osaka University grafted a sheet of iPS-derived corneal cells into the cornea of a patient with limbal stem cell deficiency, a condition in which corneal stem cells are lost.
  • REPROCELL recently launched a "Personal iPS service" in Japan to prepare and store an individual's iPSCs for the treatment of future illness or injury. Individual's iPSCs are created from mature cells in their urine or dental pulp, using RNA reprogramming technology. The iPSCs are then stored at two locations in Japan and the U.S.
  • RIKEN administered the world's first iPSC-derived cell therapeutic into a human patient in 2014 when it transplanted an autologous iPSC-RPE cell sheet into a patient with AMD.
  • RheinCell Therapeutics GmbH is a developer and manufacturer of GMP-compliant human iPSCs derived from HLA-homozygous, allogeneic umbilical cord blood. In January 2021, the company received GMP certification and Manufacturing Authorization within the EU.
  • SCG Cell Therapy Pte Ltd ("SCG") has acquired the rights to human iPSC technology, from the Agency for Science, Technology and Research ("A*STAR")'s Accelerate Technologies Pte Ltd ("A*ccelerate"). SCG is using this iPSC technology to to expand its cell therapy product portfolio and develop off-the-shelf NK cell therapies.
  • SCM Lifescience, a South Korean stem cell therapy developer, licensed exclusive rights within Korea for the development, approval, production, and sale of a diabetic cell therapy being developed by Allele Biotechnology and Pharmaceuticals. The $750K deal was signed in July 2021.
  • Semma Therapeutics, which was acquired by Vertex Pharmaceuticals for $950 million in late 2019, is developing a treatment for Type 1 diabetes. This treatment consists of cells derived from iPSCs that behave like pancreatic cells.
  • Shoreline Biosciences is a biotech company that is developing allogeneic "off-the-shelf" natural killer (NK) and macrophage cellular immunotherapies derived from iPSCs for cancer and other serious diseases.
  • Stemson Therapeutics has been developing a therapy for hair loss involving generation of de novo hair follicles.
  • TreeFrog Therapeutics has a 13,000 sq ft facility in France for the development and scale-up of its cell therapy manufacturing process that leverages human iPSCs. It plans to develop its own iPSC-derived therapies and support co-development programs.
  • The U.S. NIH is undertaking the first U.S. clinical trial of an iPSC-derived therapeutic. Its Phase I/IIa clinical trial will involve 12 patients with advanced-stage geographic atrophy of the eye.
  • Vita Therapeutics, a Cambrian Biopharma affiliate, is developing iPSC-derived therapeutics, including an autologous, genetically engineered iPSC-derived therapeutic (VTA-100) for limb-girdle muscular dystrophy and a genetically engineered iPSC-derived hypoimmunogenic treatment for muscular dystrophy (VTA-200).

iPS Cell Market Competitors

In addition to the iPSC cell therapy developers, there are an ever-growing number of competitors who are commercializing iPSC-derived products for use across a diverse range of applications. These applications include drug development and discovery, disease modeling, toxicology testing, and personalized medicine, as well as tissue engineering, 3D bioprinting, and clean meat production.

Across the broader iPSC sector, FUJIFILM CDI is one of the largest and most dominant players. Cellular Dynamics International (CDI) was founded in 2004 by Dr. James Thomson at the University of Wisconsin-Madison, who in 2007 derived iPSC lines from human somatic cells for the first time. The feat was accomplished simultaneously by Dr. Shinya Yamanaka's lab in Japan. FUJIFILM acquired CDI in April 2015 for $307 million. Today, the combined company is the world's largest manufacturer of human cells created from iPSCs for use in research, drug discovery and regenerative medicine applications.

Another iPSC specialist is ReproCELL, a company that was established as a venture company originating from the University of Tokyo and Kyoto University in 2009. It became the first company worldwide to make iPSC products commercially available when it launched its ReproCardio product, which are human iPSC-derived cardiomyocytes.

Within the European market, the dominant competitors are Evotec, Ncardia, and Axol Bioscience. Headquartered in Hamburg, Germany, Evotec is a drug discovery alliance and development partnership company. It is developing an iPSC platform with the goal to industrialize iPSC-based drug screening as it relates to throughput, reproducibility, and robustness. Today, Evotec's infrastructure represents one of the largest and most advanced iPSC platforms globally.

Ncardia was formed through the merger of Axiogenesis and Pluriomics in 2017. Its predecessor, Axiogenesis, was founded in 2011 with an initial focus on mouse embryonic stem cell-derived cells and assays. When Yamanaka's iPSC technology became available, Axiogenesis became the first European company to license it in 2010. Today, the combined company (Ncardia) is a global authority in cardiac and neural applications of human iPSCs.

Founded in 2012, Axol Bioscience is a smaller but noteworthy competitor that specializes in iPSC-derived products. Headquartered in Cambridge, UK, it specializes in human cell culture, providing iPSC-derived cells and iPSC-specific cell culture products.

Of course, the world's largest research supply companies are also commercializing a plethora of iPSC-related products. Examples of these market leaders include Lonza, BD Biosciences, Thermo Fisher Scientific, Merck, Takara Bio, STEMCELL Technologies, and others.

iPSC Report Features

This report reveals all major market competitors worldwide, including their strategic advantages, novel technologies, and products under development. Its main objective is to describe the current status of iPSC research, biomedical applications, manufacturing technologies, patents, funding events, strategic partnerships, and clinical trials for the development of iPSC-based cellular therapeutics.

Importantly, the report presents a comprehensive market size breakdown for iPSCs by Application, Technology, Cell Type and Geography (North America, Europe, Asia/Pacific, and RoW). It also presents total market size figures and growth rates through 2030.

This global strategic report reveals:

  • Market size determinations with segmentation and five-year forecasts
  • Clinical trial activity by type, region, phase, and sponsor
  • Patent analysis by applicant, type, date and region
  • iPSC industry partnerships, alliances, and IPOs
  • Emerging trends and future directions
  • Competitors composing the global iPSC marketplace
  • And much more

This 325-page global strategic report will position you to:

  • Capitalize on emerging trends
  • Improve internal decision-making
  • Reduce company risk
  • Approach outside partners and investors
  • Outcompete your competition
  • Implement an informed and advantageous business strategy

Companies and organizations mentioned in the report include:

  • Addgene, Inc.
  • Aleph Farms
  • Allele Biotechnology and Pharmaceuticals, Inc.
  • ALSTEM, INC.
  • American Type Culture Collection (ATCC)
  • AMS Biotechnology Europe, Ltd. (AMSBIO)
  • Applied Biological Materials, Inc. (ABM)
  • Applied StemCell (ASC), Inc.
  • Aruna Bio, Inc.
  • Aspen Neuroscience, Inc.
  • Avery Therapeutics
  • Axol Bioscience, Ltd
  • Bayer
  • BD Biosciences
  • Beckman Coulter Life Sciences
  • BioCat GmbH
  • BlueRock Therapeutics (acquired by Bayer)
  • Bone Therapeutics
  • BrainXell
  • Brooklyn Immuno Therapeutics
  • Cell Biolabs, Inc.
  • Cell Signaling Technology
  • Cellaria
  • CellGenix GmbH
  • Cellular Dynamics International, Inc.
  • Cellular Engineering Technologies (CET)
  • Censo Biotechnologies, Ltd.
  • Century Therapeutics, LLC
  • CiRA
  • Citius Pharmaceuticals
  • Corning, Inc.
  • Creative Bioarray
  • Cynata Therapeutics Ltd.
  • Cytovia Therapeutics
  • DefiniGEN
  • Exacis Biotherapeutics
  • Fate Therapeutics, Inc.
  • FUJIFILM Cellular Dynamics, Inc.
  • GeneCopoeia, Inc.
  • GenTarget, Inc.
  • Heartseed, Inc.
  • Healios K.K.
  • Hopstem Biotechnology
  • InvivoGen
  • I Peace Inc.
  • iPSirius
  • iPS Portal, Inc.
  • iXCells Biotechnologies
  • Keio University
  • Kyoto University Hospital
  • Lindville Bio
  • Lonza Group, Ltd.
  • Megakaryon Corporation
  • Memorial Sloan-Kettering Cancer Center
  • Merck/Sigma Aldrich
  • Metrion Biosciences, Ltd.
  • Miltenyi Biotec B.V. & Co. KG
  • Ncardia
  • NeuCyte
  • Neurophth Biotechnology Ltd.
  • Newcells Biotech
  • Novo Nordisk
  • ONO Pharmaceutical Co., Ltd.
  • ORIG3N
  • Osaka University
  • Oslo University Hospital
  • PeproTech
  • Phenocell SAS
  • Platelet BioGenesis
  • Pluricell Biotech
  • PromoCell GmbH
  • Qiagen
  • R&D Systems, Inc.
  • ReproCELL
  • RheinCell Therapeutics
  • RIKEN
  • SCG Cell Therapy
  • SCM Lifescience
  • Semma Therapeutics
  • Shoreline Biosciences
  • STEMCELL Technologies
  • Stemina Biomarker Discovery
  • Stemson Therapeutics
  • Sumitomo Dainippon Pharma
  • Synthego Corp.
  • System Biosciences (SBI)
  • Takara Bio
  • Takeda Pharmaceutical Co., Ltd.
  • Tempo Bioscience
  • Thermo Fisher Scientific, Inc.
  • TreeFrog Therapeutics
  • University of California
  • U.S. NIH
  • Vertex Pharmaceuticals
  • VistaGen Therapeutics, Inc.
  • Vita Therapeutics
  • Waisman Biomanufacturing
  • xCell Science, Inc.
  • Yashraj Biotechnology, Ltd.

With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.

TABLE OF CONTENTS

1. REPORT OVERVIEW

  • 1.1. Statement of the Report
  • 1.2. Executive Summary

2. INTRODUCTION

3. CURRENT STATUS OF IPSC INDUSTRY

  • 3.1. Progress Made in Autologous Cell Therapy using iPSCs
    • 3.1.1. Examples of Autologous iPSC-derived Cell Therapies in Development
  • 3.2. Manufacturing Timeline for Autologous iPSC-Derived Cell Products
  • 3.3. Cost of iPSC Production
  • 3.4. Automation in iPSC Production
  • 3.5. Allogeneic iPSCs Gaining Momentum
    • 3.5.1. Ongoing Clinical Trials involving Allogeneic iPSCs
  • 3.6. Share of iPSC-based Research within the Overall Stem Cell Industry
  • 3.7. Major Focus Areas of iPSC Companies
  • 3.8. Commercially Available iPSC-derived Cell Types
  • 3.9. Relative use of iPSC-derived Cell Types in Toxicology Testing Assays
  • 3.10. Currently Available iPSC Technologies
    • 3.10.1. Brief Descriptions of some recently introduced iPSC-related Technologies
      • 3.10.1.1. Nucleofector Technology
      • 3.10.1.2. opti-ox Technology
      • 3.10.1.3. MOGRIFY Technology
      • 3.10.1.4. Transcription Factor-Based iPSC Differentiation Technology
      • 3.10.1.5. Flowfect Technology
      • 3.10.1.6. Technology for Mass Production of Platelets from Megakaryocytes
      • 3.10.1.7. SynFire Technology

4. HISTORY OF INDUCED PLURIPOTENT STEM CELLS (IPSCS)

  • 4.1. First iPSC Generation from Mouse Fibroblasts, 2006
  • 4.2. First Human iPSC Generation, 2007
  • 4.3. Creation of CiRA, 2010
  • 4.4. First High-Throughput Screening using iPSCs, 2012
  • 4.5. First iPSC Clinical Trial Approved in Japan, 2013
  • 4.6. First iPSC-RPE Cell Sheet Transplantation for AMD, 2014
  • 4.7. EBiSC Founded, 2014
  • 4.8. First Clinical Trial using Allogeneic iPSCs for AMD, 2017
  • 4.9. Clinical Trial for Parkinson's disease using Allogeneic iPSCs, 2018
  • 4.10. Commercial iPSC Plant SMaRT Established, 2018
  • 4.11. First iPSC Therapy Center in Japan, 2019
  • 4.12. First U.S.-based NIH-Sponsored Clinical Trial using iPSCs, 2019
  • 4.13. Cynata Therapeutics' World's Largest Phase III Clinical Trial, 2020
  • 4.14. Tools and Know-how to Manufacture iPSCs in Clinical Trials, 2021
  • 4.15. Production of In-House iPSCs using Peripheral Blood Cells, 2022

5. RESEARCH PUBLICATIONS ON IPSCS

  • 5.1. Rapid Growth in iPSC Publications
    • 5.1.1. PubMed Publications on Pathophysiological Research
    • 5.1.2. PubMed Papers in Reprogramming
    • 5.1.3. PubMed Papers in iPSC Differentiation
    • 5.1.4. PubMed Papers on the use of iPSCs in Drug Discovery
    • 5.1.5. PubMed Papers on iPSC-based Cell Therapy
  • 5.2. Percent Share of Published Articles by Disease Type
  • 5.3. Percent Share of Articles by Country

6. IPSC: PATENT LANDSCAPE ANALYSIS

  • 6.1. Legal Status of iPSC Patents
  • 6.2. Patents by Jurisdiction
  • 6.3. iPSC Patent Applications over Time
  • 6.4. Global iPSC Patent Applicants as of April 19, 2023
  • 6.5. Inventors of iPSC Patents
  • 6.6. iPSC Patent Owners

7. IPSC: CLINICAL TRIAL LANDSCAPE

  • 7.1. Literature and Database Search
  • 7.2. Number of iPSC Clinical Trials by Year
  • 7.3. IPSC Study Designs
    • 7.3.1. Therapeutic and Non-Therapeutic Studies
    • 7.3.2. Non-Therapeutic Clinical Trials by Use
      • 7.3.2.1. Top Ten Countries with the Ongoing Non-Therapeutic Studies
      • 7.3.2.2. Diseases Targeted by Non-Therapeutic Studies
    • 7.3.3. Therapeutic Studies
      • 7.3.3.1. Therapeutic Studies by Phase of Study
      • 7.3.3.2. Therapeutic Studies by Disease Type
      • 7.3.3.3. Examples of Therapeutic Interventional Studies
      • 7.3.3.4. Future Outlook for Therapeutic Clinical Trials using iPSCs
  • 7.4. iPSC-Based Clinical Trials with Commercialization Potential

8. RESEARCH FUNDING FOR iPSCS

  • 8.1. Value of NIH Funding for iPSC Research
  • 8.2. Partial List of NIH Funded iPSC Research Projects

9. M&A, COLLABORATIONS & FUNDING ACTIVITIES IN iPSC SECTOR

  • 9.1. Mergers and Acquisitions (M&A) in iPSC Sector
    • 9.1.1. Evotec & Rigenerand
    • 9.1.2. Catalent & RheinCell Therapeutics
    • 9.1.3. Axol Bioscience & Censo Biotechnologies
    • 9.1.4. Bayer AG & BlueRock
    • 9.1.5. Pluriomics & Axiogenesis
  • 9.2. Partnership/Collaboration/Licensing Deals in iPSC Sector
    • 9.2.1. Evotec & Sernova
    • 9.2.2. Evotec SE & Almirall, SA
    • 9.2.3. Quell Therapeutics & Cellistic
      • 9.2.3.1. Terms of the Collaboration
    • 9.2.4. MDimmune & YiPSCELL
    • 9.2.5. EdiGene & Neukio Biotherapeutics
    • 9.2.6. Matricelf & Ramot
    • 9.2.7. Evotec & Boehringer Ingelheim
    • 9.2.8. Plurityx, Pancella & Implant Therapeutics
    • 9.2.9. Century Therapeutics & Bristol Myers Squibb
    • 9.2.10. Terms of the Collaboration
    • 9.2.11. Fujifilm Cellular Dynamics & Pheno Vista Biosciences
    • 9.2.12. Metrion Biosciences & Bioqube Ventures
    • 9.2.13. Cytovia Therapeutics & Cellectis
    • 9.2.14. Exacis Biotherapeutics & CCRM
    • 9.2.15. Cynata Therapeutics & Fujifilm Corporation
    • 9.2.16. Bone Therapeutics & Implant Therapeutics
    • 9.2.17. REPROCELL & TEXCELL
    • 9.2.18. Jacobio & Herbecell
    • 9.2.19. NeuCyte & KIF1A.ORG
    • 9.2.20. Kite & Shoreline Biosciences
    • 9.2.21. Neurophth Therapeutics & Hopstem Biotechnology
    • 9.2.22. Allele Biotech & Cellatoz
    • 9.2.23. BlueRock Therapeutics, Fujifilm Cellular Dynamics & Opsis Therapeutics
    • 9.2.24. Newcells & Takeda
    • 9.2.25. Biocentriq & Kytopen
    • 9.2.26. Fujifilm Cellular Dynamics & Sana Biotechnology
    • 9.2.27. Evotec & Medical Center Hamburg-Eppendorf (UKE)
    • 9.2.28. NeuCyte & Seaver Autism Center for Research and Treatment
    • 9.2.29. Cytovia Therapeutics & National Cancer Institute
    • 9.2.30. Mogrify & MRC Laboratory of Molecular Biology
  • 9.3. Venture Capital Funding and IPOs
    • 9.3.1. Aspen Neuroscience
    • 9.3.2. Axol Biosciences Ltd.
    • 9.3.3. Thyas Co. Ltd.
    • 9.3.4. Synthego
    • 9.3.5. Cellino Biotech, Inc.
    • 9.3.6. Curi Bio
    • 9.3.7. Ncardia
    • 9.3.8. Evotec SE
    • 9.3.9. bit.bio
    • 9.3.10. Clade Therapeutics
    • 9.3.11. Shoreline Biosciences
    • 9.3.12. Kytopen
    • 9.3.13. Cytovia Therapeutics & CytoLynx
    • 9.3.14. TreeFrog Therapeutics
    • 9.3.15. HebeCell Corporation
    • 9.3.16. Neukio Biotherapeutics
    • 9.3.17. Stemson Therapeutics
    • 9.3.18. Vita Therapeutics
    • 9.3.19. Century Therapeutics
    • 9.3.20. Heartseed
    • 9.3.21. Mogrify
    • 9.3.22. Metrion Biosciences
    • 9.3.23. Axol Biosciences
    • 9.3.24. Axol Bioscience
    • 9.3.25. Elevate Bio
    • 9.3.26. Vita Therapeutics

10. GENERATION OF INDUCED PLURIPOTENT STEM CELLS: AN OVERVIEW

  • 10.1. Reprogramming Factors
    • 10.1.1. Pluripotency-Associated Transcription Factors and their Functions
    • 10.1.2. Different Combinations of Factors for Different Cell Sources
    • 10.1.3. Delivery of Reprogramming Factors
  • 10.2. Integrating iPSC Delivery Methods
    • 10.2.1. Retroviral Vectors
    • 10.2.2. Lentiviral Vectors
    • 10.2.3. piggyBac (PB) Transposon
  • 10.3. Non-Integrative Delivery Systems
    • 10.3.1. Adenoviral Vectors
    • 10.3.2. Sendai Viral Vectors
    • 10.3.3. Plasmid Vectors
    • 10.3.4. Minicircles
    • 10.3.5. oriP/Epstein-Barr Nuclear Antigen-1 (EBNA1) based Episomes
    • 10.3.6. RNA
    • 10.3.7. Proteins
  • 10.4. Comparison of Delivery Methods for generating iPSCs
  • 10.5. Genome Editing Technologies in iPSC Generation
    • 10.5.1. CRISPR/Cas9

11. HUMAN IPSC BANKING

  • 11.1. Cell Sources for iPSC Banking
  • 11.2. Reprogramming Methods used in IPSC Banking
  • 11.3. Factors used in Reprogramming in Different Banks
  • 11.4. Workflow in iPSC Banks
  • 11.5. Existing iPSC Banks
    • 11.5.1. California Institute for Regenerative Medicine (CIRM)
      • 11.5.1.1. CIRM iPSC Repository
      • 11.5.1.2. Key Partnerships Supporting CIRM's iPSC Repository
  • 11.6. Regenerative Medicine Program (RMP)
    • 11.6.1. Research Grade iPSC Lines for Orphan & Rare Diseases with RMP
    • 11.6.2. RMP's Stem Cell Translation Laboratory (SCTL)
  • 11.7. Center for iPS Cell Research and Application (CiRA)
  • 11.8. FiT - Facility for iPS Cell Therapy
  • 11.9. European Bank for Induced Pluripotent Stem Cells (EBiSC)
  • 11.10. Korean Society for Cell Biology (KSCB)
  • 11.11. Human Induced Pluripotent Stem Cell Initiative (HipSci)
  • 11.12. RIKEN - BioResource Research Center (BRC)
  • 11.13. Taiwan Human Disease iPSC Consortium
  • 11.14. WiCell

12. BIOMEDICAL APPLICATIONS OF IPSCS

  • 12.1. iPSCs in Basic Research
    • 12.1.1. To Understand Cell Fate Control
    • 12.1.2. To Understand Cell Rejuvenation
    • 12.1.3. To Understand Pluripotency
    • 12.1.4. To Study Tissue & Organ Development
    • 12.1.5. To Produce Human Gametes from iPSCs
    • 12.1.6. Providers of iPSC-Related Services for Researchers
  • 12.2. iPSCs in Drug Discovery
    • 12.2.1. Advantages
    • 12.2.2. Drug Discovery for Cardiovascular Diseases using iPSCs
    • 12.2.3. Drug Discovery for Neurological Diseases using iPSCs
    • 12.2.4. Drug Discovery for Rare Diseases using iPSCs
  • 12.3. iPSCs in Toxicology Studies
    • 12.3.1. Testing Drugs for DILI
    • 12.3.2. Examples of Drugs Tested in iPSC-derived Cells
    • 12.3.3. Relative use of IPSC-derived Cell Types in Toxicity Testing Studies
  • 12.4. iPSCs in Disease Modeling
    • 12.4.1. Cardiovascular Diseases Modeled with iPSC-derived Cells
      • 12.4.1.1. Percent Share Utilization of iPSCs for Cardiovascular Disease Modeling
    • 12.4.2. Modeling Liver Diseases using iPSC-derived Hepatocytes
    • 12.4.3. iPSCs in Neurodegenerative Disease Modeling
    • 12.4.4. iPSC-derived Organoids for Modeling and Diseases
    • 12.4.5. Cancer-Derived iPSCs
  • 12.5. iPSCs in Cell-Based Therapies
    • 12.5.1. Companies Focusing only on iPSC-based Cell Therapy
  • 12.6. Other Novel Applications of iPSCs
    • 12.6.1. iPSCs in Tissue Engineering
      • 12.6.1.1. 3D Bioprinting Techniques
      • 12.6.1.2. Biomaterials
      • 12.6.1.3. 3D Bioprinting Strategies
      • 2.6.1.4. Bioprinting iPSC-derived Cells
    • 12.6.2. iPSCs from Farm Animals
      • 12.6.2.1. Porcine iPSCs
      • 12.6.2.2. Bovine iPSCs
      • 12.6.2.3. Ovine and Caprine iPSCs
      • 12.6.2.4. Equine iPSCs
      • 12.6.2.5. Avian iPSCs
  • 12.7. iPSCs in Animal Conservation
    • 12.7.1. iPSC Lines for the Preservation of Endangered Species of Animals
    • 12.7.2. iPSCs in Wildlife Conservation
    • 12.7.3. iPSCs in Cultured Meat

13. MARKET OVERVIEW

  • 13.1. Global Market for iPSCs by Geography
  • 13.2. Global Market for iPSCs by Technology
  • 13.3. Global Market for iPSCs by Biomedical Application
  • 13.4. Global Market for iPSCs by Derived Cell Type
  • 13.5. Market Drivers
    • 13.5.1. Current Drivers Impacting the iPSC marketplace
  • 13.6. Market Restraints
    • 13.6.1. Economic Issues
    • 13.6.2. Genomic Instability
    • 13.6.3. Immunogenicity
    • 13.6.4. Biobanking

14. COMPANY PROFILES

  • 14.1. Accellta
    • 14.1.1. Technology
    • 14.1.2. Maxells
    • 14.1.3. Singles
    • 14.1.4. Differentiation
    • 14.1.5. Services
  • 14.2. AddGene, Inc.
    • 14.2.1. Viral Plasmids
  • 14.3. Allele Biotechnology, Inc.
    • 14.3.1. iPSC Reprogramming and Differentiation
    • 14.3.2. cGMP Facility
  • 14.4. ALSTEM, Inc.
    • 14.4.1. Services
    • 14.4.2. iPSC-related Products
    • 14.4.3. Human iPS Cell Lines
    • 14.4.4. Inducible iPS Cell Lines
    • 14.4.5. Isogenic iPS Cell Lines
    • 14.4.6. Knockout Cell Lines
  • 14.5. Altos Labs
  • 14.6. AMS Biotechnology Ltd. (AMSBIO)
    • 14.6.1. iPSC-derived Cells and Differentiation Kits
    • 14.6.2. iPSC-derived Excitatory Neurons
    • 14.6.3. iPSC-derived Dopaminergic Neurons
    • 14.6.4. iPSC-derived GABAergic Neurons
    • 14.6.5. iPSC-derived Cholinergic Neurons
    • 14.6.6. iPSC-derived Skeletal Muscle
  • 14.7. Aspen Neuroscience, Inc.
    • 14.7.1. Aspen's Clinical Pipeline
  • 14.8. Astellas Pharma, Inc.
    • 14.8.1. Leading Program
  • 14.9. Avery Therapeutics
    • 14.9.1. MyCardia
  • 14.10. Axol Bioscience Ltd.
    • 14.10.1. iPSC-derived Cells
    • 14.10.2. Disease Models
    • 14.10.3. Services
    • 14.10.4. Custom Cell Services
    • 14.10.5. Stem Cell Reprogramming
    • 14.10.6. Genome Editing
    • 14.10.7. Stem Cell Differentiation
  • 14.11. Bit.bio
    • 14.11.1. Opti-OX Reprogramming Technology
    • 14.11.2. ioCells
    • 14.11.3. ioWild Type Cells
    • 14.11.4. ioGlutamatergic Neurons
    • 14.11.5. ioSkeletal Myocytes
    • 14.11.6. ioGABAergic Neurons
    • 14.11.7. ioDisease Models
    • 14.11.8. ioGlutamatergic Neurons HTT50CAGWT
  • 14.12. BlueRock Therapeutics
    • 14.12.1. CELL + GENE Platform
  • 14.13. BrainXell
    • 14.13.1. Products
      • 14.13.1.1. Spinal Motor Neurons
      • 14.13.1.2. Midbrain Dopaminergic Neurons
      • 14.13.1.3. Cortical Glutamatergic Neurons
      • 14.13.1.4. Mixed Cortical Neurons
      • 14.13.1.5. Cortical Astrocytes
      • 14.13.1.6. Layer V Glutamatergic Neurons
      • 14.13.1.7. Cortical GABAergic Neurons
      • 14.13.1.8. Microglia
      • 14.13.1.9. Medium Spiny Neurons
      • 14.13.1.10. Spinal Astrocytes
  • 14.14. Brooklyn Immuno Therapeutics
    • 14.14.1. Synthetic mRNA
    • 14.14.2. Non-Viral Nucleic Acid Delivery
    • 14.14.3. Cellular Reprogramming
    • 14.14.4. Gene Editing
  • 14.15. Catalent Biologics
    • 14.15.1. Human iPSCs
  • 14.16. Celogics, Inc.
    • 14.16.1. Celo.Cardiomyocytes
  • 14.17. Cellaria
    • 14.17.1. Lung Cancer Cell Models
    • 14.17.2. Breast Cancer Cell Models
    • 14.17.3. Colon Cancer Cell Lines
    • 14.17.4. Ovarian Cancer Cell Lines
    • 14.17.5. Pancreatic Cancer Cell Lines
    • 14.17.6. Cancer Research Custom Services
    • 14.17.7. Stem Cell Services
  • 14.18. CellGenix, GmbH
    • 14.18.1. Products
  • 14.19. Cellino Biotech
    • 14.19.1. Cellino's Technology Platform
  • 14.20. Cellular Engineering Technologies (CET)
    • 14.20.1. Products
    • 14.20.2. iPS Cell Lines
    • 14.20.3. Drug Discovery Services
    • 14.20.4. iPSC Reprogramming Services
  • 14.21. Censo Biotechnologies, Ltd.
    • 14.21.1. Neuroinflammation
    • 14.21.2. Inflammation
    • 14.21.3. Neurobiology
  • 14.22. Century Therapeutics, Inc.
    • 14.22.1. Cell Therapy Platform
    • 14.22.2. Century's Pipeline
  • 14.23. Citius Pharmaceuticals, Inc.
    • 14.23.1. Stem Cell Platform of iMSCs
  • 14.24. Clade Therapeutics
  • 14.25. Creative Bioarray
    • 14.25.1. iPSC Reprogramming Kits
    • 14.25.2. QualiStem Episomal iPSC Reprogramming Kit
    • 14.25.3. QualiStem RNA iPSC Reprogramming Kit
    • 14.25.4. QualiStem Retrovirus iPSC Reprogramming Kit
    • 14.25.5. QualiStem Lentivirus iPSC Reprogramming Kit
    • 14.25.6. QualiStem iPSC Protein Reprogramming Kit
    • 14.25.7. iPSC Characterization Kits
    • 14.25.8. Alkaline Phosphatase Staining Assay
    • 14.25.9. Pluripotency Markers (Protein)
    • 14.25.10. Pluripotency Markers (mRNA)
    • 14.25.11. iPSC Differentiation Kits
    • 14.25.12. QualiStem iPS Cell Cardiomyocyte Differentiation Kit
    • 14.25.13. QualiStem Human iPS Cell Dopaminergic Neuron Differentiation Kit
    • 14.25.14. QualiStem iPS Cell Neural Progenitor Differentiation Kit
    • 14.25.15. QualiStem iPS Cell Endoderm Differentiation Kit
    • 14.25.16. QualiStem iPS Cell Ectoderm Differentiation Kit
    • 14.25.17. QualiStem iPS Cell Mesoderm Differentiation Kit
    • 14.25.18. QualiStem iPS Cell Hepatocyte Differentiation Kit
    • 14.25.19. iPSC Myogenic Progenitor Differentiation kit
  • 14.26. Curi Bio
    • 14.26.1. Disease Model Development
    • 14.26.2. Assay Development
    • 14.26.3. Discovery
    • 14.26.4. Cell Repositories
  • 14.27. Cynata Therapeutics Ltd.
    • 14.27.1. Cymerus Platform
    • 14.27.2. Clinical Development
      • 14.27.2.1. Graft vs. Host Disease
      • 14.27.2.2. Critical Limb Ischemia
      • 14.27.2.3. Osteoarthritis
      • 14.27.2.4. Acute Respiratory Syndrome
      • 14.27.2.5. Diabetic Wounds
      • 14.27.2.6. Preclinical Development
      • 14.27.2.7. Idiopathic Pulmonary Fibrosis
      • 14.27.2.8. Renal Transplantation
      • 14.27.2.9. Asthma
      • 14.27.2.10. Heart Attack
      • 14.27.2.11. Coronary Artery Disease
  • 14.28. Cytovia Therapeutics
    • 14.28.1. Technology
    • 14.28.2. iNK & CAR-iNK Cells
    • 14.28.3. Flex-NK Cell Engagers
  • 14.29. DefiniGEN
    • 14.29.1. OptiDIFF iPSC Platform
    • 14.29.2. Services
      • 14.29.2.1. Phenotypic Screening Services
      • 14.29.2.2. iPSC Differentiation Services
      • 14.29.2.3. Disease Modeling Services
    • 14.29.3. Products
      • 14.29.3.1. Hepatocyte WT
      • 14.29.3.2. NAFLD iPSC-Derived Hepatocytes
      • 14.29.3.3. GSD1a Disease Modeled Hepatocytes
      • 14.29.3.4. A1ATD Disease Modeled Hepatocytes
      • 14.29.3.5. Hepatocyte Familial Hypercholesterolemia (FH)
      • 14.29.3.6. Custom Model Development
      • 14.29.3.7. NAFLD PNPLA3
      • 14.29.3.8. NAFLD TM6SF2 Disease Modeled Hepatocytes
      • 14.29.3.9. Intestinal Organoids
      • 14.29.3.10. Intestinal Monolayer
      • 14.29.3.11. Pancreatic Beta Cells (WT)
      • 14.29.3.12. MODY3 Diabetes
      • 14.29.3.13. Neonatal Diabetes Pancreatic Cells
  • 14.30. Editas Medicine
    • 14.30.1. iPSC-Derived NK Cells
  • 14.31. ElevateBio
    • 14.31.1. Technologies
  • 14.32. Elixirgen Scientific, Inc.
    • 14.32.1. Technology
    • 14.32.2. Services
    • 14.32.3. iPSC Products
    • 14.32.4. Reagents
  • 14.33. EviaBio
    • 14.33.1. iPSCs Cryopreservation Solutions
  • 14.34. Evotec A.G.
    • 14.34.1. iPSCs Platform
    • 14.34.2. Drug Discoveries
  • 14.35. Exacis Biotherapeutics
    • 14.35.1. ExaCELLs
  • 14.36. Eyestem
    • 14.36.1. Eyecyte-RPE
  • 14.37. Fate Therapeutics
    • 14.37.1. iPSCs Platform
    • 14.37.2. Pipeline
    • 14.37.3. Collaborations
      • 14.37.3.1. Janssen Biotech
      • 14.37.3.2. ONO Pharmaceutical
  • 14.38. FUJIFILM Cellular Dynamics, Inc. (FCDI)
    • 14.38.1. Products
    • 14.38.2. MyCell Custom Services
    • 14.38.3. Disease Modeling Applications
    • 14.38.4. Drug Discovery Applications
    • 14.38.5. Applications in Toxicity Testing
  • 14.39. Heartseed, Inc.
    • 14.39.1. Technology
  • 14.40. HebeCell
    • 14.40.1. Technology
  • 14.41. Helios K.K.
  • 14.42. Hera BioLabs
    • 14.42.1. Services
    • 14.42.2. Products
    • 14.42.3. piggyBac Transposase/Transposon
  • 14.43. Hopstem Biotechnology
    • 14.43.1. Research & Development
    • 14.43.2. Product Pipeline
  • 14.44. Implant Therapeutics, Inc.
    • 14.44.1. Services
  • 14.45. iPS Portal, Inc
    • 14.45.1. Services
      • 14.45.1.1. Research Support and Contract Testing Services
      • 14.45.1.2. Development Support Services
    • 14.45.2. Business Support
  • 14.46. I Peace, Inc.
    • 14.46.1. Mass Production of iPSCs
  • 14.47. iXCells Biotechnologies
    • 14.47.1. Products
    • 14.47.2. Services
    • 14.47.3. iPS Cell Generation
    • 14.47.4. Genome Editing
    • 14.47.5. iPSC Differentiation
  • 14.48. iPSirius SAS
    • 14.48.1. IPVAC 1.0
    • 14.48.2. Key Features & Benefits of IPVAC 1.0
  • 14.49. Kytopen
    • 14.49.1. Flowfect Technology
  • 14.50. Lindville Bio Ltd.
    • 14.50.1. Services
  • 14.51. LizarBio Therapeutics
    • 14.51.1. Pipeline
  • 14.52. Lonza Group, Ltd.
    • 14.52.1. iPSC Manufacturing Expertise
    • 14.52.2. Nucleofector Technology
  • 14.53. Matricelf
  • 14.54. Merck/Sigma Aldrich
    • 14.54.2. Merck's iPSC Products and Services
  • 14.55. Megakaryon Corporation
    • 14.55.1. Technology
    • 14.55.2. Research and Development Pipeline
    • 14.55.3. Cryopreservable Megakaryon Strain
    • 14.55.4. Treatable Diseases by Products from Megakaryon
  • 14.56. Metrion Biosciences, Ltd.
    • 14.56.1. Cardiac Safety Screening Services
    • 14.56.2. Neuroscience Assay Services
    • 14.56.3. Cardiac Assay Services
    • 14.56.4. Neuroscience Translational Assay Services
    • 14.56.5. Integrated Drug Discovery Service
  • 14.57. Mogrify
    • 14.57.1. MOGRIFY Platform
    • 14.57.2. epiMOGRIFY Platform
  • 14.58. Ncardia
    • 14.58.1. iPSC Platform
    • 14.58.2. Human iPSC-derived Cell Models
    • 14.58.3. Drug Discovery Solutions
    • 14.58.4. Developing iPSC-derived Cell Types
    • 14.58.5. Assay Development
    • 14.58.6. High-Throughput Screening
  • 14.59. NeuCyte
    • 14.59.1. SynFire Technology
  • 14.60. Neukio Biotherapeutics
    • 14.60.1. iPSC-CAR-NK
  • 14.61. Newcells Biotech, Ltd
    • 14.61.1. Retinal Platform
    • 14.61.2. Kidney Platform
    • 14.61.3. Lung Model
  • 14.62. NEXEL Co., Ltd.
    • 14.62.1. Cardiosight-S
    • 14.62.2. Hepatocyte-S
    • 14.62.3. Neurosight-S
    • 14.62.4. NeXST Cardiac Safety Service
  • 14.63. Orizuru Therapeutics, Inc.
    • 14.63.1. iCM Project
    • 14.63.2. iPIC Project
  • 14.64. Phenocell SAS
    • 14.64.1. Cells and Kits
    • 14.64.2. R&D Outsourcing Services
  • 14.65. Platelet BioGenesis
    • 14.65.1. Technology
  • 14.66. Pluristyx
    • 14.66.1. RTD and RTU Technologies
    • 14.66.2. Products
    • 14.66.3. Services
  • 14.67. ReNeuron
    • 14.67.1. Technology Platform
  • 14.68. REPROCELL USA, Inc.
    • 14.68.1. RNA Reprogramming Kit
    • 14.68.2. NutriStem Culture Medium for Human iPSCs and ES Cells
    • 14.68.3. Induced Pluripotent Stem Cells
    • 14.68.4. StemRNA Neuro
    • 14.68.5. iPSCs Master Cell Bank
  • 14.69. RxCell, Inc.
    • 14.69.1. Services
  • 14.70. SCG Cell Therapy Pte Ltd.
    • 14.70.1. Acquisition of Technology
  • 14.71. Shoreline Biosciences
    • 14.71.1. iNK Cell Platform
    • 14.71.2. iPSC-Derived iMACs
  • 14.72. Stemson Therapeutics
    • 14.72.1. Hair Follicle Biology
  • 14.73. Stemina Biomarker Discovery
    • 14.73.1. Cardio quickPredict
    • 14.73.2. devTOX quickPredict
  • 14.74. Synthego Corp.
    • 14.74.1. Knockout iPSCs
    • 14.74.2. Knock-in iPSCs
  • 14.75. Tempo Bioscience
    • 14.75.1. Human iPSC-derived Sensory Neurons
    • 14.75.2. Human iPS-derived Schwann Cells
    • 14.75.3. Human iPS-derived Phagocytes
    • 14.75.4. Human iPSC-derived CD14+ Monocytes
    • 14.75.5. Human iPSC-derived Cardiomyocytes
    • 14.75.6. Human iPSC-derived Kidney Proximal Tubules and Podocyte 3D Spheroids
    • 14.75.7. Human iPSC-derived Osteoblasts
    • 14.75.8. Human iPSC-derived MSCs
    • 14.75.9. Human iPSC-derived Retinal Pigment Epithelials
    • 14.75.10. Human iPS-derived Motor Neurons
    • 14.75.11. Human iPSC-derived Microglia
    • 14.75.12. Human iPSC-derived Keratinocytes
    • 14.75.13. Human iPSC-derived Melanocytes
    • 14.75.14. Human iPSC-derived Dopaminergic Neurons
    • 14.75.15. Human iPSC-derived Cortical Neurons
    • 14.75.16. Human iPSC-derived Oligodendrocyte Progenitor Cells (OPCs)
    • 14.75.17. Human iPSC-derived Astrocytes
    • 14.75.18. Human iPSC-derived Neural Progenitor Cells
  • 14.76. Thyas, Co., Ltd.
    • 14.76.1. iTCR-T (iPSC-derived TCR-T)
    • 14.76.2. iCAR-NK/ILC (iPSC-derived CAR-NK/ILC)
    • 14.76.3. Thya's Product Pipeline
  • 14.77. Universal Cells
    • 14.77.1. Technology
    • 14.77.2. Editing the Genome without Breaking It
    • 14.77.3. Cells for Every Organ
  • 14.78. ViaCyte, Inc.
    • 14.78.1. PEC-01 Cells
    • 14.78.2. Device Engineering
  • 14.79. Vita Therapeutics
    • 14.79.1. Technology
    • 14.79.2. VTA-100
  • 14.80. XCell Science, Inc.
    • 14.80.1. Cell Products
    • 14.80.2. Control Lines
    • 14.80.3. Services
  • 14.81. Yashraj Biotechnology, Ltd.
    • 14.81.1. iPSC and Differentiated Derivatives
      • 14.81.1.1. iPSC-derived Human Cardiomyocytes
      • 14.81.1.2. iPSC-derived Hepatocytes
      • 14.81.1.3. iPSC-derived Astrocytes
      • 14.81.1.4. iPSC-derived Forebrain Motor Neurons
      • 14.81.1.5. iPSC-derived Endothelial Cells
      • 14.81.1.6. iPSC-derived Midbrain Dopaminergic Neurons
  • 14.82. YiPCELL
    • 14.82.1. R&D Programs
    • 14.82.2. MIUChon
    • 14.82.3. MIUKin
    • 14.82.4. MIURon

INDEX OF FIGURES

  • FIGURE 3.1: Manufacturing Timeline for Autologous iPSC-derived Cell Products
  • FIGURE 3.2: Manufacturing Cost for Manual and Automated Processes
  • FIGURE 3.3: Technical Set-up of the StemCellFactory (SCF)
  • FIGURE 3.4: Share of iPSC-based Research within the Overall Stem Cell Industry
  • FIGURE 3.5: Major Focuses of iPSC Companies
  • FIGURE 3.6: Commercially Available iPSC-derived Cell Types
  • FIGURE 3.7: Relative use of iPSC-derived Cell Types in Toxicology Testing Assays
  • FIGURE 3.8: Schematic Comparing Nucleofection and Lipofection
  • FIGURE 3.9: Schematic of Steps involved in Platelet Production
  • FIGURE 5.1: Number of Research Publications on iPSCs in PubMed.gov, 2006-2022
  • FIGURE 5.2: Number of Published Papers in Pathophysiological Research, 2006 - 2022
  • FIGURE 5.3: Number of PubMed Papers in Reprogramming, 2008-2022
  • FIGURE 5.4: Number of PubMed papers on iPSC Differentiation, 2006-2022
  • FIGURE 5.5: PubMed Papers on the use of iPSCs in Drug Discovery, 2006-2022
  • FIGURE 5.6: PubMed Papers on the use of iPSCs in Cell Therapy, 2008-2022
  • FIGURE 5.7: Percent Share of Published Articles by Disease Type
  • FIGURE 5.8: Percent Share of Articles by Country
  • FIGURE 6.1: Legal Status of iPSC Patents
  • FIGURE 6.2: iPSC Patent Applications over Time, 2000-2022
  • FIGURE 7.1: Number of iPSC Clinical Trials by Year, 2006-April 2023
  • FIGURE 7.2: Study Designs in iPSC Clinical Trials
  • FIGURE 7.3: Therapeutic and Non-Therapeutic Studies
  • FIGURE 7.4: Non-Therapeutic Clinical Trials by Use
  • FIGURE 7.5: Top Ten Countries with the Ongoing Non-Therapeutic Studies
  • FIGURE 7.6: Diseases Targeted by Non-Therapeutic Studies
  • FIGURE 7.7: Therapeutic Studies by Type of iPSCs Used
  • FIGURE 7.8: Therapeutic Studies by Phase of Study
  • FIGURE 7.9: Therapeutic Studies by Disease Type
  • FIGURE 8.1: Number of NIH Funding for iPSC Projects, 2010 - May 2022
  • FIGURE 8.2: Value of NIH Funding for iPSC Research, 2010-2022
  • FIGURE 10.1: Overview of iPSC Technology
  • FIGURE 10.2: Generation of iPSCs from MEF Cultures using 24 Factors by Yamanaka
  • FIGURE 10.3: The Roles of OSKM Factors in the Induction of iPSCs
  • FIGURE 10.4: Schematic of Delivery Methods for iPSC Induction
  • FIGURE 10.5: Schematic of Retroviral Delivery Method
  • FIGURE 10.6: Schematic of Lentiviral Delivery
  • FIGURE 10.7: piggyBac (PB) Transposon Delivery
  • FIGURE 10.8: Adenoviral Vector Delivery
  • FIGURE 10.9: oriP/Epstein-Barr Nuclear Antigen-1 (EBNA1) based Episomes
  • FIGURE 10.10: RNA Delivery
  • FIGURE 10.11: Protein Delivery
  • FIGURE 11.1: Workflow in iPSC Banks
  • FIGURE 12.1: Biomedical Applications of iPSCs: An Overview
  • FIGURE 12.2: Basic Cell Types Differentiated from iPSCs
  • FIGURE 12.3: Advantages of iPSCs in Drug Discovery
  • FIGURE 12.4: iPSCs and their Potential for Toxicity Testing and Drug Screening
  • FIGURE 12.5: Testing Drugs for Drug Induced Liver Injury using iPSCs
  • FIGURE 12.6: Relative use of IPSC-derived Cell Types in Toxicity Testing Studies
  • FIGURE 12.7: Percent Share Utilization of iPSCs for Cardiovascular Disease Modeling
  • FIGURE 12.8: Schematic of Techniques used for iPSC Bioprinting
  • FIGURE 12.9: Schematic Showing the use of iPSCs in Protecting Endangered Species
  • FIGURE 12.10: General Workflow for Cultured Meat Production
  • FIGURE 13.1: Estimated Global Market for iPSCs by Geography, 2022-2030
  • FIGURE 13.2: Estimated Global Market for iPSCs by Technology, 2022-2030
  • FIGURE 13.3: Estimated Global Market for iPSCs by Biomedical Application, 2022-2030
  • FIGURE 13.4: Estimated Global Market for iPSCs by Derived Cell Type, 2022
  • FIGURE 14.1: Century's Approach in iPSC Therapy
  • FIGURE 14.2: Elixirgen's iPSCs Differentiation
  • FIGURE 14.3: MyCell Custom Services
  • FIGURE 14.4: Hopstem's Research & Development
  • FIGURE 14.5: Kytopen's Push Button System
  • FIGURE 14.6: Manufacturing Flow of Products from Magakaryon
  • FIGURE 14.7: Treatable Diseases by Products from Megakaryon
  • FIGURE 14.8: Schematic of developing iPSC Neurons by SynFire Technology
  • FIGURE 14.9: Cardio quickPredict Process
  • FIGURE 14.10: Schematic of Thya's iTCR-T (iPSC-derived TCR-T)
  • FIGURE 14.11: Thya's iCAR-NK/ILC (iPSC-derived CAR-NK/ILC)

INDEX OF TABLES

  • TABLE 3.1: Progression of Autologous iPS-derived Cell Therapies toward the Clinic
  • TABLE 3.2: Examples of Autologous iPSC-derived Cell Therapies in Development
  • TABLE 3.3: Examples of Clinical Trials involving Allogeneic iPSCs
  • TABLE 3.4: Currently Available iPSC Technologies
  • TABLE 4.1: Timeline of Important Milestones Reached in iPSC Industry, 2006-2022
  • TABLE 5.1: Number of Research Publications on iPSCs in PubMed.gov, 2006-2022
  • TABLE 6.1: Number of iPSC Patents Filed by Jurisdiction, as of April 2023
  • TABLE 6.2: Global iPSC Patent Applicants, as of April 2023
  • TABLE 6.3: Inventors of iPSC Patents as of April 2023
  • TABLE 6.4: Owners of iPSC Patents
  • TABLE 7.1: Recruitment Status of iPSC Clinical Trials
  • TABLE 7.2: Examples of Therapeutic Interventional Studies
  • TABLE 8.1: A Partial List of Research Projects Supported by NIH
  • TABLE 9.1: Mergers and Acquisitions (M&A) in iPSC Sector, 2017-2022
  • TABLE 9.2: Partnership/Collaboration Deals in iPSC Sector, 2021-2022
  • TABLE 9.3: Venture Capital Funding and IPOs, 2021-2022
  • TABLE 10.1: Pluripotency-Associated Transcription Factors and their Functions
  • TABLE 10.2: Different Combinations of Factors for Different Cell Sources
  • TABLE 10.3: Comparison of Delivery Methods for in Producing iPSCs
  • TABLE 10.4: iPSC Disease Models Generated by CRISPR/Cas9
  • TABLE 11.1: Cell Sources and Reprogramming Agents Used in iPSC Banks
  • TABLE 11.2: Diseased iPSC Lines Available in CIRM Repository
  • TABLE 11.3: CIRM's iPSC Initiative Awards
  • TABLE 11.4: Research Grade iPSCs Available with RMP
  • TABLE 11.5: Research Grade iPSC Lines for Orphan & Rare Diseases with RMP
  • TABLE 11.6: SCTL's Collaborations
  • TABLE 11.7: A Partial List of iPSC Lines Available with EBiSC
  • TABLE 11.8: List of Disease-Specific iPSCs Available with RIKEN
  • TABLE 11.9: An Overview of iPSC Banks Worldwide
  • TABLE 12.1: Providers of iPSC Lines & Parts Thereof for Research
  • TABLE 12.2: Drug Discovery for Cardiovascular Diseases using iPSCs
  • TABLE 12.3: Drug Discovery for Neurological and Neuropsychiatic Diseases using iPSCs
  • TABLE 12.4: Drug Discovery for Rare Diseases using iPSCs
  • TABLE 12.5: Examples of Drugs Tested in iPSC-derived Cells
  • TABLE 12.6: Published Human iPSC Models
  • TABLE 12.7: Partial List of Cardiovascular & other Related Diseases Modeled using iPSCs
  • TABLE 12.8: Liver Diseases and Therapeutic Interventions Modeled using iPSCs
  • TABLE 12.9: Examples of iPSC-based Neurodegenerative Disease Modeling
  • TABLE 12.10: Organoid Types and Disease Modeling Applications
  • TABLE 12.11: Examples of Cancer-derived iPSCs
  • TABLE 12.12: Diseases Addressed by iPSC-derived Cells in Studies in Advanced Stages
  • TABLE 12.13: Companies focusing exclusively on developing iPSC-based Therapies
  • TABLE 12.14: Features of Different Bioprinting Techniques
  • TABLE 12.15: Bioprinting of iPSC-derived Tissues
  • TABLE 12.16: Achievements made using iPSCs for the Conservation of Animals
  • TABLE 12.17: Companies using iPSCs for Cultured Meat Production
  • TABLE 13.1: Estimated Global Market for iPSCs by Geography, 2022-2030
  • TABLE 13.2: Estimated Global Market for iPSCs by Technology, 2022-2030
  • TABLE 13.3: Estimated Global Market for iPSCs by Biomedical Application, 2022-2030
  • TABLE 13.4: Global Market for iPSCs by Derived Cell Type, 2022-2030
  • TABLE 14.1: Aspen's Clinical Pipeline
  • TABLE 14.2: iPS Cell Lines from CET
  • TABLE 14.3: Century Therapeutics' Pipeline Products
  • TABLE 14.4: Cytovia's Product Pipeline
  • TABLE 14.5: Fate Therapeutics' Product Pipeline
  • TABLE 14.6: HebeCell's Product Pipeline
  • TABLE 14.7: Healios' Research and Development Status
  • TABLE 14.8: Hopstem's Product Pipeline
  • TABLE 14.9: LizarBio's Pipeline Products
  • TABLE 14.10: Megakaryon's Multiple Pipelines for iPS Platelet Products
  • TABLE 14.11: StemRNA Human iPSCs from ReproCELL
  • TABLE 14.12: Thya's Product Pipeline