액체생검 시장의 2024년 시장 규모는 67억 2,000만 달러로 평가되었습니다. 2025년에는 75억 2,000만 달러에 이르고, CAGR 12.24%로 성장하여 2030년에는 134억 4,000만 달러에 달할 전망입니다.
| 주요 시장 통계 | |
|---|---|
| 기준 연도 : 2024년 | 67억 2,000만 달러 |
| 추정 연도 : 2025년 | 75억 2,000만 달러 |
| 예측 연도 : 2030년 | 134억 4,000만 달러 |
| CAGR(%) | 12.24% |
액체생검은 체액 내 순환 바이오마커를 분석함으로써 최소침습적으로 종양 생물학에 접근할 수 있는 창구를 제공함으로써 진단 의학의 패러다임 전환을 상징합니다. 외과적 절제가 필요하고 수술적 위험이 수반되는 기존 조직 생검과 달리, 액체생검은 순환하는 종양 DNA, 세포, 소포를 이용하여 동적 분자 정보를 실시간으로 포착합니다. 이러한 접근법은 개별 분자 프로파일에 맞게 치료 요법을 조정함으로써 환자의 예후를 획기적으로 개선할 수 있는 정밀 종양학에 대한 관심이 높아지고 있는 추세에 부합하는 것입니다.
액체생검을 둘러싼 환경은 차세대 시퀀서, 디지털 PCR, 새로운 바이오인포매틱스 파이프라인의 혁신에 힘입어 전례 없는 속도로 진화하고 있습니다. 이러한 기술적 진보는 분석물의 검출 감도와 특이성을 크게 향상시켜 암의 초기 단계에서 희귀한 순환 종양 DNA 단편을 식별할 수 있게 해줍니다. 동시에, 동반진단약의 임상적 유용성과 재현성에 대한 신뢰를 반영하여 주요 시장 규제 당국은 동반진단약에 대한 보다 합리적인 승인 경로를 발표하기 시작했습니다.
2025년1월1 일, 수입 진단 시약 및 기기에 대한 미국의 새로운 관세가 발효되어 국경 간 공급망에 복잡한 계층을 도입했습니다. 관세가 추가됨에 따라 주요 소모품의 상륙 비용이 상승하여 제조업체와 실험실 파트너는 조달 전략과 재고 모델을 재검토해야 하는 상황에 처해 있습니다. 특수 시약에 의존하는 기업들은 마진을 줄이고 서비스 중단을 피하기 위해 국내 대체 공급업체를 확보하거나 장기 계약을 협상하는 것이 중요한 목표가 되고 있습니다.
바이오마커 클래스에 따른 세분화는 성숙한 분석물과 신흥 분석물의 상호 작용을 밝혀냅니다. 무세포 DNA는 종양 부하 및 돌연변이 프로파일링과의 상관관계가 확립되어 있기 때문에 임상 분석의 중심적인 역할을 계속하고 있으며, 순환 종양 세포는 표현형 분석의 기회를 열어줍니다. 순환 종양 DNA 기술의 출현으로 내성 돌연변이의 실시간 모니터링이 가능해졌고, 세포외 소포의 탐색은 RNA 화물과 단백질체 시그니처에 대한 새로운 연구 분야를 개척하고 있습니다.
북미와 남미는 선진적인 규제 프레임워크와 대량 임상 도입에서 계속 선두를 달리고 있습니다. 암 검진 및 가치 기반 진료에 중점을 둔 정부의 이니셔티브으로 인해 상환에 대한 논의가 가속화되고 있으며, 학술 의료 센터와 지역 병원 모두에서 폭넓게 도입되고 있습니다. 또한, 현지 진단 제약회사와 국제적인 기술 제공업체와의 전략적 제휴를 통해 공급망을 강화하고 최고급 분석에 대한 지역적 접근성을 확대했습니다.
주요 진단 및 생명공학 기업들은 차별화된 플랫폼, 전략적 인수, 광범위한 지적재산권 포트폴리오를 통해 입지를 다지고 있습니다. 기존 실험실 네트워크를 갖춘 레거시 기업들은 심층적인 임상 검증 데이터를 활용하여 분석 메뉴를 확장하고 있으며, 순수 혁신 기업들은 독자적인 화학 물질과 첨단 바이오인포매틱스에 집중하여 초기 시장 진입에 성공하고 있습니다.
진화하는 액체 생검 환경에서 살아남기 위해 업계 이해관계자들은 표적 용도과 광범위한 패널 용도를 모두 지원하는 유연한 분석 아키텍처에 대한 투자를 우선시해야 합니다. 이를 통해 새로운 바이오마커와 규제 변화에 민첩하게 대응할 수 있습니다. 멀티오믹스 기능을 기존 워크플로우에 통합하면 진단 정확도가 향상되고, 종양의 이질성에 대한 풍부한 통찰력을 얻을 수 있습니다.
본 보고서의 조사방법은 2차 조사와 1차 조사를 엄격하게 융합하여 견고성과 신뢰성을 확보하였습니다. 먼저, 기술 및 임상적 이해의 종합적인 토대를 구축하기 위해, 학술지, 임상시험 등록, 특허 출원, 규제 기관 간행물, 백서 등 광범위한 2차 조사를 실시했습니다.
액체생검은 분자 수준의 지식과 개별화된 환자 관리 사이의 간극을 메워주는 현대 진단 진료의 핵심으로 부상하고 있습니다. 비침습적 샘플링을 통해 질병을 감지하고 모니터링할 수 있는 액체생검은 조기 개입, 치료 최적화, 장기적인 감시를 위한 새로운 길을 열어줄 수 있습니다. 기술 플랫폼이 성숙해짐에 따라 액체생검은 틈새 연구용에서 임상 주류로 이동하고 있습니다.
The Liquid Biopsy Market was valued at USD 6.72 billion in 2024 and is projected to grow to USD 7.52 billion in 2025, with a CAGR of 12.24%, reaching USD 13.44 billion by 2030.
| KEY MARKET STATISTICS | |
|---|---|
| Base Year [2024] | USD 6.72 billion |
| Estimated Year [2025] | USD 7.52 billion |
| Forecast Year [2030] | USD 13.44 billion |
| CAGR (%) | 12.24% |
Liquid biopsy represents a paradigm shift in diagnostic medicine by offering a minimally invasive window into tumor biology through the analysis of circulating biomarkers in bodily fluids. Unlike conventional tissue biopsies that necessitate surgical extraction and carry procedural risks, liquid biopsy harnesses circulating tumor DNA, cells, and vesicles to capture dynamic molecular information in real time. This approach aligns with the growing emphasis on precision oncology, where tailoring therapeutic regimens to individual molecular profiles can dramatically improve patient outcomes.
As cancer incidence continues to rise globally, healthcare systems are under pressure to deliver cost-effective, rapid diagnostics that minimize patient discomfort without compromising accuracy. Liquid biopsy addresses these demands by enabling serial monitoring of disease progression, early detection of minimal residual disease, and the identification of actionable mutations that guide targeted therapies. Moreover, its application extends beyond oncology into transplant medicine, prenatal screening, and infectious disease monitoring, positioning liquid biopsy as a versatile tool for modern clinical practice.
Stakeholders across pharmaceutical, diagnostic, and research sectors are now evaluating how to integrate liquid biopsy into existing workflows and regulatory pathways. With technological advances driving down assay time and costs, liquid biopsy is poised to become a standard component of patient management. In the following sections, we explore the transformative forces reshaping this landscape, the implications of recent policy changes, and the strategic insights that will guide industry leaders forward.
The liquid biopsy landscape is evolving at an unprecedented pace, propelled by breakthroughs in next-generation sequencing, digital PCR, and novel bioinformatics pipelines. These technological advancements have significantly increased the sensitivity and specificity of analyte detection, enabling the identification of rare circulating tumor DNA fragments at early stages of cancer. Concurrently, regulatory agencies across key markets have begun to issue more streamlined approval pathways for companion diagnostics, reflecting confidence in the clinical utility and reproducibility of liquid biopsy assays.
At the same time, strategic collaborations between diagnostic manufacturers, academic centers, and pharmaceutical firms are accelerating assay validation and broadening the scope of clinical studies. Such partnerships are fostering the co-development of targeted panels aligned with emerging targeted therapies, thereby integrating diagnostics directly into the drug development lifecycle. Meanwhile, decentralized testing models-ranging from point-of-care platforms to patient-collected sampling kits-are democratizing access and supporting remote monitoring initiatives.
Collectively, these forces are redefining the competitive dynamics of the liquid biopsy domain. Incumbent laboratory providers are investing in proprietary platforms to maintain differentiation, while nimble start-ups continue to innovate assay chemistries and data analytics. Looking ahead, convergence around multi-omics integration and standardized reporting frameworks will further solidify liquid biopsy's role as a cornerstone of personalized care.
On January 1, 2025, new U.S. tariffs on imported diagnostic reagents and instrumentation took effect, introducing a layer of complexity for cross-border supply chains. The added duties have increased landed costs for core consumables, prompting manufacturers and laboratory partners to reassess sourcing strategies and inventory models. For companies reliant on specialized reagents, securing alternative domestic suppliers or negotiating long-term contracts has become a critical objective to contain margins and avoid service disruptions.
The ripple effects extend into pricing structures, as laboratories pass incremental expenses to payers and patients, potentially impacting adoption rates in price-sensitive segments. To mitigate these pressures, several industry players have begun exploring localized manufacturing solutions, including establishing regional production hubs and partnering with contract development organizations. In parallel, increased collaboration with customs authorities and trade associations has enabled more efficient classification and duty minimization, offering relief to stakeholders navigating the evolving tariff landscape.
Despite these headwinds, many organizations view the 2025 tariffs as a catalyst to strengthen domestic supply resilience and foster innovation in reagent design. By investing in robust regional capabilities and diversifying supplier networks, the industry anticipates a more balanced cost structure over the long term, ultimately supporting sustainable growth and uninterrupted patient access.
Segmentation by biomarker class reveals the interplay between mature and emerging analytes. Cell-free DNA continues to anchor clinical assays due to its well-established correlation with tumor burden and mutational profiling, while circulating tumor cells unlock opportunities for phenotypic analysis. The advent of circulating tumor DNA technologies enables real-time monitoring of resistance mutations, and the exploration of extracellular vesicles is opening new research frontiers around RNA cargo and proteomic signatures.
When considering sample origin, blood-based tests dominate current workflows because of established venipuncture protocols and high analyte yield. However, urine-based assays are gaining traction as a noninvasive alternative for longitudinal screening, particularly in urological and genitourinary indications. Advances in sample stabilization and extraction methods are narrowing performance gaps, setting the stage for wider clinical adoption of diversified fluid matrices.
In terms of product taxonomy, assay kits form the backbone of commercial offerings by delivering standardized workflows that simplify laboratory implementation. Instruments add value through automation and throughput optimization, while services encompass bespoke assay development, data interpretation, and clinical reporting. On the technology front, multi-gene parallel analysis using next-generation sequencing is prized for its multiplexing capacity and depth of coverage, whereas single-gene analysis via PCR microarrays maintains a strong presence in targeted mutation detection due to rapid turnaround.
Indication-driven segmentation underscores the primacy of cancer applications, with breast, colorectal, lung, melanoma, and prostate cancers accounting for the majority of clinical validation studies. Non-cancer indications are expanding into areas such as organ transplant rejection monitoring and prenatal aneuploidy screening. Among end-users, academic and research centers spearhead exploratory studies, while clinical diagnostic laboratories, hospitals, and physician office labs drive routine testing volumes. Finally, application segmentation reveals a balanced portfolio of early cancer screening initiatives, recurrence monitoring protocols, therapy selection assays, and treatment monitoring programs, reflecting the multifaceted utility of liquid biopsy in patient management.
The Americas continue to lead with advanced regulatory frameworks and high-volume clinical adoption. Government initiatives focusing on cancer screening and value-based care have accelerated reimbursement discussions, enabling broader uptake in both academic medical centers and community hospitals. Moreover, strategic partnerships between local diagnostic companies and international technology providers have fortified supply chains and expanded regional access to cutting-edge assays.
Europe, Middle East, and Africa present a heterogeneous landscape marked by diverse regulatory regimes and reimbursement environments. In Western Europe, centralized health technology assessments and national screening programs drive standardization, whereas emerging markets in Eastern Europe, the Middle East, and Africa are gradually integrating liquid biopsy into oncology networks through pilot projects and center-of-excellence collaborations. Cross-border data sharing and harmonized clinical guidelines remain key enablers of sustainable growth across these jurisdictions.
Asia-Pacific is characterized by rapid market expansion underpinned by significant public health investments and rising cancer incidence. Government funding for cancer genomics and domestic manufacturing incentives have catalyzed indigenous assay development. Collaborative research between regional academic institutions and global diagnostic firms is intensifying, while the rollout of digital pathology and telemedicine platforms supports remote sample collection and result dissemination, extending the reach of liquid biopsy solutions.
Leading diagnostic and biotechnology companies are positioning themselves through differentiated platforms, strategic acquisitions, and expansive intellectual property portfolios. Legacy players with established laboratory networks are leveraging deep clinical validation data to extend their assay menus, while pure-play innovators focus on proprietary chemistries and advanced bioinformatics to achieve early market entry.
Collaborative alliances between pharmaceutical companies and diagnostic developers are accelerating the co-development of companion diagnostics tailored to specific targeted therapies. Start-ups are forging partnerships with contract research organizations to streamline multicenter clinical trials, ensuring robust evidence generation and regulatory alignment. At the same time, instrument manufacturers are integrating connectivity features and cloud-based data analytics into their platforms, enhancing operational efficiency and facilitating seamless integration with laboratory information systems.
Beyond technology differentiation, corporate strategies are increasingly oriented toward geographic expansion through regional sales networks and production hubs. By aligning global R&D pipelines with localized commercialization strategies, leading companies are building scalable models that address diverse regulatory requirements and market access challenges.
To navigate the evolving liquid biopsy environment, industry stakeholders should prioritize investment in flexible assay architectures that support both targeted and broad-panel applications. This approach ensures agility in responding to emerging biomarkers and regulatory shifts. Integrating multi-omics capabilities into existing workflows will enhance diagnostic accuracy and provide richer insights into tumor heterogeneity.
Building resilient supply chains through regional manufacturing partnerships and dual-sourcing agreements can mitigate exposure to trade policy fluctuations. Organizations should also establish cross-functional teams that unite regulatory, commercial, and scientific experts to streamline product approvals and reimbursement negotiations. Collaborative initiatives with payers and healthcare providers will strengthen the value proposition by demonstrating real-world clinical utility and cost savings.
Digital transformation should remain a strategic priority, with investments in cloud-native analytics, artificial intelligence-driven variant interpretation, and telehealth-enabled sample collection. These technologies will support decentralized testing models and personalized patient engagement. Finally, fostering open innovation through consortiums and public-private partnerships will accelerate the validation of novel analytes and drive the harmonization of reporting standards, reinforcing liquid biopsy's role in precision medicine.
This report's methodology integrates a rigorous blend of secondary and primary research to ensure robustness and credibility. Initially, extensive secondary research was conducted, encompassing peer-reviewed journals, clinical trial registries, patent filings, regulatory publications, and white papers to establish a comprehensive foundation of technical and clinical understanding.
Primary research was conducted through in-depth interviews with senior executives, laboratory directors, and key opinion leaders across diagnostics, pharmaceutical, and academic sectors. These expert dialogues provided nuanced perspectives on assay development, regulatory strategy, and commercialization challenges. Data triangulation techniques validated qualitative insights against proprietary databases and financial disclosures to reinforce accuracy.
Quantitative analysis involved mapping product pipelines, technology adoption metrics, and regional deployment patterns. Key variables were cross-referenced with public health statistics and reimbursement schedules to contextualize application potential. Validation workshops with external advisors and technical specialists were organized to resolve discrepancies and refine assumptions.
Collectively, this multi-layered approach delivers a holistic view of the liquid biopsy domain, balancing empirical evidence with expert interpretation to guide strategic decision-making.
Liquid biopsy has emerged as a cornerstone of modern diagnostic practice, bridging the gap between molecular insights and personalized patient management. Its capacity to detect and monitor disease through noninvasive sampling unlocks new avenues for early intervention, treatment optimization, and long-term surveillance. As technology platforms mature, liquid biopsy is transitioning from niche research applications to mainstream clinical adoption.
Strategically, stakeholders who align their portfolios with the evolving landscape-incorporating flexible assay designs, resilient supply chains, and digital innovation-will be best positioned to capitalize on market opportunities. Continued collaboration across industry, academia, and regulatory bodies will drive the standardization of workflows and reimbursement frameworks, further reducing barriers to implementation.
Looking ahead, the integration of liquid biopsy with complementary diagnostics and therapeutic modalities promises to accelerate the shift toward truly individualized medicine. By embracing a data-driven, patient-centered approach, industry leaders can unlock significant clinical and commercial value, reinforcing liquid biopsy's role as a transformative force in healthcare.