市場調査レポート
商品コード
1129277
ヒト肝臓モデルの世界市場-2022-2029Global Human Liver Models Market - 2022-2029 |
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ヒト肝臓モデルの世界市場-2022-2029 |
出版日: 2022年09月29日
発行: DataM Intelligence
ページ情報: 英文 180 Pages
納期: 約2営業日
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医薬品開発のためのヒト肝臓モデルの革新が、市場成長の原動力になると予想されます。
薬剤減少の顕著な要因である薬剤性肝障害(DILI)は、前臨床動物とヒトとの代謝経路の違いによって部分的に説明されます。バイオ医薬品分野では、関連する薬物輸送や代謝システムの研究、DILIのリスク低減、これらのメカニズムの研究のために、in vitroでヒト肝モデルが使用されています。しかし、肝細胞はコラーゲンでコーティングされたポリスチレン/ガラス上の二次元単培養では1~3日で表現型が失われるため、薬剤や疾患刺激の長期的な影響をシミュレーションするためには使用できないです。バイオエンジニアは、この制約を克服するために、半導体産業やアディティブ・マニュファクチャリングの装置を改良して、肝細胞の微小環境を精密に操作することに成功しました。これらのツールにより、様々なスループット要件やアッセイエンドポイントに対応した最先端の二次元および三次元のヒト肝臓プラットフォーム(マイクロパターン化した共培養、スフェロイド、オルガノイド、バイオプリント組織、マイクロ流体デバイスなど)の構築が可能になりました。これらのプラットフォームは、肝機能を生理的レベルに著しく近づけ、機能寿命を4週間以上に改善し、薬の効果を予測する感度も高くしています。例えば、マイクロ流体デバイスは、微細加工法(ソフトリソグラフィーや3Dバイオプリンティングなど)を用いて構築することができ、細胞を生体内と同様に流体せん断圧や可溶性物質の勾配にさらしながら、栄養分の供給や老廃物の除去を自動的に行うことができます。PDMSは、生体適合性、光学的透明性、手頃な価格、迅速な試作に適していることから、マイクロ流体デバイスの製造に頻繁に使用されています。しかし、PDMSの疎水性と多孔性の特性は、薬物スクリーニング用途では、一部の親油性薬物や媒体添加物の吸収につながる可能性があります。そのため、医薬品開発パイプラインにおける細胞培養用の次世代マイクロ流体デバイスのために、PDMSのコーティング変更または熱可塑性代替品が検討されています。したがって、上記の記述から、予測期間において市場はドライブすると予想されます。
抑制要因
肝臓モデルを現在のワークフローに組み込む際の問題や、ヒト肝臓モデルの高コスト、熟練した専門家の不足、細胞培養ベースの研究のための3Dインフラは、予測期間中に市場が阻害される要因になると予想されます。
産業分析
ヒト肝臓モデル市場は、ポーターファイブフォース、サプライチェーン分析、価格分析などの様々な産業要因に基づいた市場の詳細な分析を提供します。
COVID-19の影響分析
COVID-19のパンデミックは、市場に中程度の影響を及ぼしています。コロナウイルスは呼吸器感染症として注目されていますが、肝胆膵系にどのような影響を与えるかはほとんど分かっていません。全体として、アルブミンの減少、アミノトランスフェラーゼとビリルビンの増加は、コロナウイルスによってもたらされる肝障害の一般的な徴候です。直接傷害、免疫介在性傷害、虚血と低酸素、血栓症、薬剤性肝毒性は、これまで提唱された病態生理学的概念のほんの一部に過ぎません。COVID-19の治療とSARS-COV-2ウイルスに対する防御が急務であるため、新しい抗ウイルス物質とワクチンが、市場投入までの時間を短縮するために、かつてないほど大量に生産されています。現在、当社の医薬品試験設備はフル稼働しています。
また、新薬やワクチンの製剤を開発する機関からは、前臨床肝モデルを用いた安全性評価を無償で依頼され、ヒトでの危険有害性を発見しています。例えば、2020年3月24日、InSphero AGは、コロナウイルス(SARS-COV-2)ワクチンおよびCOVID-19実験薬の製剤の安全性試験を無料で提供すると発表しました。開発中の医薬品のリスク評価を希望する機関(学術、政府、産業)は、InSphero社の3D InSight Human Liverモデルに基づくCOVID-19試験を利用することができます。一方、パンデミックでは、サプライチェーンが中断されます。そのため、上記の通り、市場は影響を受けた。しかし、予測期間では、状況は徐々に改善されると予想されます。
この調査レポートは、世界のヒト肝臓モデル市場の約45+市場データ表、40+図、180ページの構成で提供しています。
Human Liver Models Market size was valued US$ XX million in 2021 and is estimated to reach US$ XX million by 2029, growing at a CAGR of XX % during the forecast period (2022-2029).
The human liver model is a structure used to research the drug's potential for liver failure and other liver diseases. It allows for the improvement of knowledge regarding liver disease and complex spatial relations of the internal anatomy of the liver. Modern liver models consist of tiny organoids or mini-organs designed to mimic the physiology, anatomy, and activities of the human liver from the molecular level onward. These living models are a recent development in science that might displace animal models, and new medications are tested for liver damage using the human liver model.
Innovations in the human liver models for drug development are expected to drive market growth.
Drug-induced liver injury (DILI), a prominent factor in drug attrition, is partially accounted for by differences in the metabolic pathways between preclinical animals and humans. In vitro, human liver models are used in the biopharmaceutical sector to study relevant drug transport and metabolic systems, lower the risk of DILI, and study these mechanisms. However, liver cells can't be used to simulate the long-term effects of medications and disease stimuli since they lose their phenotypic properties in two-dimensional monocultures on collagen-coated polystyrene/glass within 1-3 days. Bioengineers have modified equipment from the semiconductor industry and additive manufacturing to precisely manipulate the microenvironment of liver cells to overcome this constraint. These tools have enabled the creation of cutting-edge two-dimensional and three-dimensional human liver platforms for various throughput requirements and assay endpoints (such as micropatterned cocultures, spheroids, organoids, bioprinted tissues, and microfluidic devices); these platforms have significantly improved liver functions closer to physiologic levels and improved functional lifetime to >4 weeks, which has translated to higher sensitivity for anticipating drug outcomes. For instance, Microfluidic devices can be constructed using microfabrication methods (such as soft lithography and 3D bioprinting), which can provide nutrients and remove waste products automatically while exposing cells to fluid shear pressures and gradients of soluble substances just as they would in vivo. Since it is biocompatible, optically transparent, reasonably priced, and suitable for rapid prototyping, polydimethylsiloxane (PDMS) is frequently used to create microfluidic devices. However, PDMS' hydrophobic and porous characteristics for drug screening applications can lead to the absorption of some lipophilic medications and media additives. Therefore, coating changes for PDMS or thermoplastic substitutes are being investigated for the next generation of microfluidic devices for cell culture in the drug development pipeline. Thus, from the above statements, the market is expected to drive in the forecast period.
Restraint
The issues in incorporating liver models into the current workflow and the high costs of human liver models, lack of skilled professionals and 3D infrastructure for cell culture-based research are factors the market is expected to get hampered in the forecast period.
Industry Analysis
The human liver models market provides in-depth analysis of the market based on various industry factors such as porter five forces, supply chain analysis, pricing analysis etc.
COVID-19 Impact Analysis
The COVID-19 pandemic has moderately impacted the market. Although coronaviruses have received much attention as respiratory tract infections, little is known about how they affect the hepatobiliary system. Overall, decreased albumin and increased aminotransferase and bilirubin levels are common signs of liver damage brought on by coronaviruses. Direct injury, immune-mediated injury, ischemia and hypoxia, thrombosis, and medication hepatotoxicity are just a few of the pathophysiological concepts that have been put forth. Due to the urgent need for COVID-19 treatments and protection against the SARS-COV-2 virus, new antiviral substances and vaccines are being produced in an unprecedented amount of time to shorten the time to market. Our drug testing facilities are currently fully operating.
Moreover, organizations developing novel drug and vaccine formulations request free safety evaluations utilizing preclinical liver models to spot any hazardous effects in humans. For instance, on March 24, 2020, InSphero AG announced that it would provide free safety testing for formulations of the coronavirus (SARS-COV-2) vaccine and experimental COVID-19 drugs. Any institution (academic, governmental, or industrial) that wishes to conduct risk assessments on its medicines under development may use the COVID-19 tests based on InSphero's 3D InSight Human Liver models. In contrast, the pandemic interrupts the supply chain. Thus, from the above statements, the market got affected. However, the situation is expected to improve gradually in the forecast period.
Liver-on-a-chip segment is expected to hold the largest market share in human liver models market
The liver-on-a-chip segment accounted for the largest market share in 2021. The bioengineered systems known as liver-on-a-chip can emulate the essential elements of the liver's basic operation. Compared to other variants, liver-on-a-chip is simpler and less expensive. For instance, CN Bio Innovations, multi-well PhysioMimix Liver-on-a-Chip consumable plates are ideally suited to primary liver cell culture and co-culture assays. They enable researchers to identify liver toxicity markers, model liver disease and study drug metabolism. Moreover, the rising need for low-cost substitutes for animal models used in drug research and development, growing initiatives for liver organoids and technological developments in human organ modeling are the other factors the market segment holds the largest market share in the forecast period.
North America region holds the largest market share in the global human liver models market
In 2021, the North America Human Liver Models accounted for the highest revenue share in the global market. The increasing prevalence of liver disorders and non-alcoholic fatty liver, technological advancements in the human liver models, increasing aid from governments and increasing investments and focus on tissue culture diagnostics are some of the factors the market is expected to boost in the forecast period. For instance, according to the American Liver Foundation, Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common chronic liver condition in the United States. It's estimated that about 25 percent of adults in the U.S. have NAFLD. Consequently, there is a requirement for drug toxicity detection at an earlier stage which helps in minimizing the financial losses in the later stages. Hence, it has increased the demand for human liver models in the region.
Major key players in the human liver models market are Emulate, Inc., InSphero, BioIVT, Organovo Holdings Inc., Kirkstall, Cyprio, CELLINK, MIMETAS BV, CN Bio Innovations, Thermo Fisher Scientific.
Emulate was established in 2014 and headquartered in the United States. It is a privately held company. It is the creator of a platform for automated bio-emulation that may be used to study endothelial and neuronal cells in a living, micro-engineered environment. The company's platform is a novel living system that mimics human biology to understand how various illnesses, medications, chemicals, and foods affect human health by fusing micro-engineering with living human cells, allowing doctors to gain in-depth insights from the human body and its cells.
Liver-Chip: The quad-culture Emulate Liver-Chip combines four human cell types in a dynamic microenvironment to support in vivo like gene expression, functionality, and physiology. Applications include general and mechanistic toxicity evaluation, biomarker identification and mechanism of action determination.
The global human liver models market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.
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