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市場調査レポート
商品コード
1722450
リキッドバイオプシー市場レポート:製品・サービス、循環バイオマーカー、がんタイプ、エンドユーザー、地域別(2025年~2033年)Liquid Biopsy Market Report by Product And Service, Circulating Biomarker, Cancer Type, End User, and Region 2025-2033 |
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リキッドバイオプシー市場レポート:製品・サービス、循環バイオマーカー、がんタイプ、エンドユーザー、地域別(2025年~2033年) |
出版日: 2025年05月01日
発行: IMARC
ページ情報: 英文 146 Pages
納期: 2~3営業日
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世界のリキッドバイオプシーの市場規模は2024年に23億米ドルに達しました。今後、IMARC Groupは、市場は2033年までに72億米ドルに達し、2025年から2033年にかけて12.82%の成長率(CAGR)を示すと予測しています。がん罹患率の増加、個別化医療や治療に対する需要の高まり、リキッドバイオプシー自動化プラットフォームの市場開拓などが、市場成長を促進する主な要因となっています。
主な市場促進要因:次世代シーケンシングの導入に伴うライフスタイルの変化、特に社会人におけるがん罹患率の上昇が市場成長を促進しています。リキッドバイオプシーは、血液や尿などの体液中の循環腫瘍細胞(CTC)、無細胞DNA(cfDNA)、エクソソームなどの癌関連バイオマーカーの検出を可能にします。早期発見は、効果的な治療と患者の転帰の改善に不可欠であり、市場成長の原動力となっています。
主な市場動向:技術の進歩、臨床応用の拡大、多分析アプローチへのシフト、早期発見とスクリーニングへの注目の高まり、臨床試験におけるリキッドバイオプシーの採用の高まりなどは、今後数年間の市場成長を刺激すると予想される主要因の一部です。さらに、シーケンス技術、マイクロ流体工学、バイオインフォマティクスにおける継続的な技術革新は、リキッドバイオプシーアッセイの感度、特異性、拡張性を高め、リキッドバイオプシー市場の収益をさらに強化しています。
地域情勢別:報告書によると、北米が最大の市場シェアを占めています。北米では、がんは依然として健康上の大きな問題であり、人口のかなりの部分が毎年さまざまな種類のがんと診断されています。罹患率の高さが、がんの検出とモニタリングに非侵襲的で正確な方法を提供するリキッドバイオプシーのような革新的な診断ツールに対する需要を促進しています。これは、リキッドバイオプシー市場の需要にさらにプラスの影響を与えています。
競合情勢:リキッドバイオプシー市場の主要企業としては、ANGLE plc、Biocept Inc.、Bio-Rad Laboratories Inc.、Epigenomics AG、Exact Sciences Corporation、F. Hoffmann-La Roche AG、Guardant Health Inc.、Illumina Inc.、MDxHealth SA、Menarini Silicon Biosystems、QIAGEN N.V.、Thermo Fisher Scientific Inc.などが挙げられます。
課題と機会:アッセイの標準化とバリデーション、臨床的バリデーションとエビデンスの作成、コストの検討と償還は、現在市場が直面している主要課題の一部です。しかし、リキッドバイオプシーは、人工知能(AI)や機械学習などのデジタルヘルス技術と統合することで、データ分析、解釈、臨床的意思決定を強化することができます。これはメーカーにとって重要な機会です。
がんの有病率の上昇
がんの罹患率は世界的に上昇傾向にあり、早期発見とモニタリングが重視されるようになっています。例えば、WHOによると、2022年には新たに2,000万人ががんと診断され、970万人が死亡すると予想されています。また、がんと診断されてから5年後に生存している人の数は5,350万人と予想されています。がんは生涯で約5人に1人が罹患します。2050年には3,500万人以上のがん患者が増えると予想され、2022年の推定2,000万人よりも77%増加します。リキッドバイオプシーは、血液や尿などの体液中の循環腫瘍細胞(CTC)や無細胞DNA(cfDNA)などの循環腫瘍バイオマーカーを検出する非侵襲的な方法です。これらのバイオマーカーは、がんの存在、進行、遺伝的プロファイルに関する貴重な洞察を提供し、臨床医がより早い段階でがんを診断し、より効果的に病気の進行を監視することを可能にします。例えば、2023年米国がん学会年次総会において、研究者らは革新的なプラットフォームを用いてDNAメチル化を分析する多がん早期発見検査に関する調査報告を行いました。従来の検査では塩基配列を決定する前にDNAの化学的治療が必要であったが、この新規のアプローチでは化学的・酵素的治療を行うことなくメチル化されたcfDNA分子を捕らえることができます。治療歴のない最近診断されたがん患者と、年齢と性別をマッチさせた対照者を含む約4,000人のサンプルにおいて、このプラットフォームが12種類のがんを検出する能力を検証するためにレトロスペクティブ分析が行われました。がん症例の約半数は初期段階でした。さらに2020年には、ペンシルバニア大学の研究チームが、自分たちのリキッドバイオプシーが早期膵臓がんの診断において92%の精度を示したことを示す論文をClinical Cancer Research誌に発表しました。これらの要因は、リキッドバイオプシー市場予測にさらにプラスの影響を与えています。
非侵襲的出生前検査(NIPT)の需要の高まり
羊水穿刺や絨毛膜絨毛採取(CVS)といった従来の出生前検査法には、流産を含む合併症のリスクが少なからずあります。NIPTは、母親の血液中を循環する無細胞胎児DNA(cffDNA)を分析するもので、出生前スクリーニングに非侵襲的な代替手段を提供します。例えば、国立医学図書館によれば、羊水穿刺は妊娠15週から出産までどこでも実施可能であり、専門家の手による一胎子での損失確率は0.13%です。これに伴い、妊娠15週以降に羊水穿刺を受けるリスクは100人に1人と推定されています。この非侵襲的なアプローチは、その安全性と処置に関連した合併症のリスクの低減により、多くの妊婦の親に好まれています。さらに、NIPTは、21トリソミー(ダウン症候群)、18トリソミー(エドワーズ症候群)、13トリソミー(パタウ症候群)などの一般的な胎児の染色体異常を高い精度で検出できることが実証されています。また、リキッドバイオプシーに基づくNIPTアッセイは、胎児の遺伝子異常を高い感度と特異度で検出することができ、妊婦の両親に赤ちゃんの健康状態に関する信頼できる情報を提供することができます。例えば、2023年11月、Novacyt社の子会社であるYourgene Health社はLaboriad社と協力し、モロッコ初の非侵襲的出生前検査(NIPT)プラットフォームを導入しました。このほか、NIPTは妊娠9~10週という早い時期に実施できるため、胎児の遺伝的健康について早期に知ることができます。染色体異常の早期発見により、妊婦の両親は妊娠について十分な情報を得た上で決断を下し、追加の診断検査や特別なニーズを持つ子供の出産準備を検討することができます。さらに、NIPTは妊娠9~10週という早い時期に実施することができ、胎児の遺伝的健康について早期に洞察することができます。染色体異常を早期に発見することで、妊婦の両親は妊娠について十分な情報を得た上で決断を下し、追加の診断検査や特別な支援を必要とする子供の出産準備を検討することができます。例えば、クリーブランドクリニックが発表した記事によると、NIPT検査は早ければ妊娠10週目から出産まで実施できます。これらの要因は、リキッドバイオプシー市場の最近の価格にさらにプラスの影響を与えています。
研究開発活動と臨床試験の増加
リキッドバイオプシーの技術的進歩の高まりは、がんスクリーニング、治験の最適化、治療法の選択の頻度を高めています。さまざまな政府機関や企業が、リキッドバイオプシーに関する臨床研究を実施するための研究開発投資に注力しています。例えば、2023年6月、Anzu PartnersはCodetta Biosciencesに対して1,500万米ドルのシリーズA投資ラウンドを主導しました。ジェノヴァベンチャーズとVC23 LLCもこの資金調達に貢献しました。この資金調達により、コデッタ社は研究開発、エンジニアリング、マーケティング、経営管理などのチームを急速に拡大し、リキッドバイオプシー用のマルチオミクスdsPCRプラットフォームの開発を加速させる計画です。さらに、臨床試験は、新規のリキッドバイオプシー技術とプラットフォームの性能を評価するためのプラットフォームとして機能します。研究開発への投資により、次世代シーケンス(NGS)プラットフォーム、デジタルPCRシステム、その他リキッドバイオプシーアッセイの感度、特異性、拡張性を高める革新的な技術の開発が可能になります。臨床試験は、これらの進歩を実際の臨床現場で検証する機会を提供し、商業化と普及への道を開きます。例えば、2024年4月、遺伝子治療製造のギャップに対処することに焦点を当てた技術革新企業であるNewBiologix SAは、バイオ医薬品業界に包括的なゲノム解析サービスを提供する新規技術群である次世代シーケンシング(NGS)および光マッピングプラットフォームを発表しました。このような要因が、リキッドバイオプシー市場のシェアをさらに押し上げています。
The global liquid biopsy market size reached USD 2.3 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 7.2 Billion by 2033, exhibiting a growth rate (CAGR) of 12.82% during 2025-2033. The increasing prevalence of cancer, the rising demand for personalized medicine and treatments, and the development of automated liquid biopsy platforms, represent some of the key factors driving the market growth.
Major Market Drivers: The rising prevalence of cancer owing to changing lifestyle patterns, especially among working professionals, along with the introduction of next-generation sequencing is propelling the market growth. Liquid biopsies enable the detection of cancer-related biomarkers, such as circulating tumor cells (CTCs), cell-free DNA (cfDNA), and exosomes, in bodily fluids like blood or urine. Early detection is crucial for effective treatment and improved patient outcomes, thereby driving the market growth.
Key Market Trends: Technological advancements, expanding clinical applications, a shift towards multi-analyte approaches, rising focus on early detection and screening, and elevating adoption of liquid biopsies in clinical trials are some of the key factors that are expected to stimulate the market growth in the coming years. Moreover, continuous innovation in sequencing technologies, microfluidics, and bioinformatics is enhancing the sensitivity, specificity, and scalability of liquid biopsy assays, thereby further bolstering the liquid biopsy market revenue.
Geographical Landscape: According to the report, North America accounted for the largest market share. Cancer remains a major health concern in North America, with a significant portion of the population being diagnosed with various types of cancer each year. The high incidence rates drive the demand for innovative diagnostic tools like liquid biopsies that offer non-invasive and accurate methods for cancer detection and monitoring. This is further positively impacting the liquid biopsy market demand.
Competitive Landscape: Some of the leading liquid biopsy market companies are ANGLE plc, Biocept Inc., Bio-Rad Laboratories Inc, Epigenomics AG, Exact Sciences Corporation, F. Hoffmann-La Roche AG, Guardant Health Inc., Illumina Inc., MDxHealth SA, Menarini Silicon Biosystems, QIAGEN N.V., and Thermo Fisher Scientific Inc., among many others.
Challenges and Opportunities: Standardization and validation of assays, clinical validation and evidence generation, and cost consideration and reimbursement are some of the key challenges that the market is currently facing. However, liquid biopsies can be integrated with digital health technologies, such as artificial intelligence (AI) and machine learning, to enhance data analysis, interpretation, and clinical decision-making. This represents key opportunities for the manufacturers.
Rising Prevalence of Cancer
With cancer rates on the rise globally, there's a growing emphasis on early detection and monitoring of the disease. For instance, according to WHO, in 2022, there were expected to be 20 million new cancer diagnoses and 9.7 million fatalities. The expected number of people who survived five years after a cancer diagnosis was 53.5 million. Cancer affects around one in every five persons in their lifetime. Over 35 million more cancer cases are expected in 2050, up 77% over the estimated 20 million in 2022. Liquid biopsies offer a non-invasive method to detect circulating tumor biomarkers, such as circulating tumor cells (CTCs) and cell-free DNA (cfDNA), in bodily fluids like blood or urine. These biomarkers can provide valuable insights into the presence, progression, and genetic profile of cancer, enabling clinicians to diagnose cancer at earlier stages and monitor disease progression more effectively. For instance, at the 2023 American Association of Cancer Research Annual Meeting, researchers presented a report on a liquid biopsy multicancer early detection test that analyzes DNA methylation using an innovative platform. While conventional tests need chemical treatment of DNA before sequencing, the novel approach captures methylated cfDNA molecules without any chemical or enzymatic treatment. The scientists conducted a retrospective analysis to examine the ability of the platform to detect 12 cancer types in a sample of around 4,000 people, including recently diagnosed, treatment-naive cancer patients, and age- and gender-matched controls. Approximately half of the cancer cases were in the early stages. In addition, in 2020, a team of researchers from the University of Pennsylvania released a paper in Clinical Cancer Research demonstrating that their liquid biopsy was 92% accurate in diagnosing early pancreatic cancer. These factors are further positively impacting the liquid biopsy market forecast.
Rising Demand for Non-Invasive Pre-Natal Tests (NIPT)
Traditional prenatal testing methods, such as amniocentesis and chorionic villus sampling (CVS), carry a small risk of complications, including miscarriage. NIPT, which involves analyzing cell-free fetal DNA (cffDNA) circulating in the mother's blood, offers a non-invasive alternative for prenatal screening. For instance, according to the National Library of Medicine, amniocentesis can be performed anywhere from 15 weeks of gestation to birth, with a 0.13% chance of loss in singletons in expert hands. In line with this, the risk of getting amniocentesis after 15 weeks of pregnancy is estimated to be 1 in 100. This non-invasive approach is preferred by many expectant parents due to its safety and reduced risk of procedure-related complications. Moreover, NIPT has demonstrated high accuracy in detecting common fetal chromosomal abnormalities, such as trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome). Also, liquid biopsy based NIPT assays can detect fetal genetic abnormalities with high sensitivity and specificity, providing expectant parents with reliable information about their baby's health status. For instance, in November 2023, Yourgene Health, a subsidiary of Novacyt collaborated with Laboriad to introduce the first non-invasive prenatal testing (NIPT) platform in Morocco. Besides this, NIPT can be performed as early as 9-10 weeks into pregnancy, providing early insights into fetal genetic health. Early detection of chromosomal abnormalities allows expectant parents to make informed decisions about their pregnancy and consider additional diagnostic testing or preparation for the birth of a child with special needs. Furthermore, NIPT can be performed as early as 9-10 weeks into pregnancy, providing early insights into fetal genetic health. Early detection of chromosomal abnormalities allows expectant parents to make informed decisions about their pregnancy and consider additional diagnostic testing or preparation for the birth of a child with special needs. For instance, according to an article published by Cleveland Clinic, NIPT testing can be performed from as early as ten weeks of pregnancy until delivery. These factors are further positively influencing the liquid biopsy market's recent prices.
Rising R&D Activities and Clinical Trials
The rising technological advancements in liquid biopsies are escalating the frequency of cancer screening, drug trial optimization, and therapeutic selection. Various government agencies and companies are focusing on investment in research and development to conduct clinical studies on liquid biopsy. For instance, in June 2023, Anzu Partners led a US$15 Million Series A investment round for Codetta Biosciences. Genoa Ventures and VC23 LLC also contributed to the funding. With the funding, Codetta plans to rapidly expand its team in R&D, engineering, marketing, and business administration as well as quicken the development of its multi-omic dsPCR platform for liquid biopsy. Moreover, clinical trials serve as platforms for evaluating the performance of novel liquid biopsy technologies and platforms. Investment in research and development enables the development of next-generation sequencing (NGS) platforms, digital PCR systems, and other innovative technologies that enhance the sensitivity, specificity, and scalability of liquid biopsy assays. Clinical trials provide opportunities to validate these advancements in real-world clinical settings, paving the way for their commercialization and widespread adoption. For instance, in April 2024, NewBiologix SA, a technology innovation company focused on addressing gene therapy manufacturing gaps, launched its next-generation sequencing (NGS) and optical mapping platform, a novel suite of technologies that will provide comprehensive genomic analysis services to the biopharmaceutical industry. These factors are further contributing to the liquid biopsy market share.
Kits and reagents assist dominates the market
According to the liquid biopsy market outlook, the growth of kits and reagents segment is driven by the surging demand for liquid biopsy tests, especially for cancer diagnostics. These kits are used to isolate cell-free DNA from plasma or serum samples. They often utilize methods like spin column-based purification, magnetic bead-based purification, or precipitation-based methods. Moreover, rising research and development activities by the key players for the development of advanced kits are proliferating the segment's growth. For instance, in September 2023, Pillar Biosciences, Inc., Decision Medicine company, launched oncoReveal Core LBx, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories with a solution for liquid biopsy-based pan-cancer tumor profiling.
Circulating tumor cells hold the largest share in the market
According to the liquid biopsy market overview, the surging demand for Circulating Tumor Cells (CTC) is attributed to its wide range of applications in biomarkers such as gene expressions, protein expressions, and DNA mutations. Moreover, the clinical utility of CTC analysis in cancer diagnosis, prognosis, and treatment monitoring is increasingly recognized. As more clinical studies demonstrate the prognostic value of CTC enumeration, characterization, and genomic profiling in various cancer types, there is a growing demand for CTC-based tests in routine clinical practice. For instance, in September 2023, nRichDX introduced a novel RUO-labeled CTC enrichment kit that isolates Circulating Tumor Cells (CTCs) from up to 40mL of whole blood samples, assisting researchers in liquid biopsy assay research and development.
Lung cancer accounts for the majority of the market share
Liquid biopsy offers a non-invasive method for detecting and monitoring lung cancer compared to traditional tissue biopsies. Sampling blood for circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), or exosomes is less invasive and can be performed more frequently, allowing for real-time monitoring of disease progression and treatment response. Moreover, it enables the detection of lung cancer at early stages when tumors are smaller and more amenable to curative treatments. Additionally, it facilitates longitudinal monitoring of treatment response and disease recurrence, leading to timely adjustments in treatment strategies. For instance, in April 2024, researchers at The Royal Marsden and Guardant Health collaborated to develop a new liquid biopsy test that would assist thousands of lung cancer patients. Marsden360, a cutting-edge circulating tumor DNA (ctDNA) test, is expected to accelerate and personalize treatment for this patient population.
Hospitals and laboratories hold the largest share in the market
The growing demand for liquid biopsies in hospitals is mainly driven by the surging adoption of liquid biopsy tests for cancer diagnosis. Additionally, as the clinical utility of liquid biopsy in cancer management becomes increasingly recognized, there is a growing demand from hospitals and laboratories for tests that utilize liquid biopsy techniques. Liquid biopsy offers non-invasive methods for detecting and monitoring cancer, providing valuable information for diagnosis, prognosis, treatment selection, and monitoring of treatment response. For instance, in May 2024, Syndicate Bio, a Nigeria-based biotechnology lab, collaborated with SophiaGenetics, a cloud-native software corporation specialized in data-driven medicine, to provide extensive genomic profiling and liquid biopsy services.
North America exhibits a clear dominance in the market
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia and others); Latin America (Brazil, Mexico and others) and the Middle East and Africa. According to the report, North America was the largest market for liquid biopsy.
According to the liquid biopsy market statistics, some of the factors driving the North America liquid biopsy market included continual technological advancements, ongoing improvements in the healthcare industry, extensive research and development (R&D) activities conducted by key players, etc. Moreover, cancer remains a major health concern in North America, and the incidence rates continue to rise. Liquid biopsies offer a non-invasive method for detecting and monitoring cancer, which is particularly beneficial for early detection and personalized treatment strategies. Continuous advancements in technologies such as next-generation sequencing (NGS), digital PCR, and microfluidics have enhanced the sensitivity, accuracy, and reliability of liquid biopsy tests. These technological improvements have expanded the applications of liquid biopsies across various cancer types and stages. For instance, in April 2023, Quest Diagnostics, a diagnostic information services provider headquartered in U.S., acquired Haystack Oncology, an early-stage oncology company focused on minimal residual disease (MRD), the fastest-growing category of liquid biopsy testing to aid in the early, accurate detection of residual or recurring cancer and better inform therapy decisions.