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동반진단 시장 분석 및 예측(-2034년) : 유형, 제품, 서비스, 기술, 구성 요소, 용도, 디바이스, 최종 사용자, 기능
Companion Diagnostics Market Analysis and Forecast to 2034: Type, Product, Services, Technology, Component, Application, Device, End User, Functionality
상품코드 : 1762100
리서치사 : Global Insight Services LLC
발행일 : 2025년 07월
페이지 정보 : 영문 368 Pages
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한글목차

동반진단 시장은 2024년 81억 달러에서 2034년까지는 154억 달러로 확대되며 CAGR은 약 6.6%를 나타낼 것으로 예측됩니다. 분자진단학, 유전체학, 생명공학를 통합한 것으로, 정밀의료의 진보에 뒷받침되고 있습니다.

산업 개요 :

세계의 관세와 지정학적 리스크가 동반진단 시장 특히 일본, 한국, 중국, 대만에 큰 영향을 주고 있습니다. 투자와 전략적 제휴가 증가하고 있습니다. 중국은 자립을 중시하고 있으며, 국산 진단 기술의 급속한 진보를 촉진하고 있습니다. 중동 분쟁은 공급망의 혼란을 악화시키고, 에너지 비용을 상승시키고, 생산과 물류에 영향을 미칠 수 있습니다.

시장 세분화
유형 체외 진단, 생체 내 진단
제품 분석 키트, 시약, 기기, 소프트웨어
서비스 상담, 검증, 교육, 유지보수
기술 중합효소 연쇄반응(PCR), 차세대 시퀀싱(NGS), 면역조직화학(IHC), 현장 혼성화(ISH), 유세포 분석, 질량 분광법
구성 요소 바이오마커, 생물정보학
용도 종양학, 신경학, 심장학, 감염병, 자가 면역 질환
장치 휴대용, 벤치탑, 핸드헬드
최종 사용자 병원, 임상 실험실, 제약회사, 연구기관
기능 검사, 모니터링, 예후 진단

시장 개요 :

동반진단 시장은 기술, 적응증, 최종 사용자 부문으로 구분되며, 암 분야가 시장을 선도하고 있습니다. 암 영역은 유전체학와 분자진단학의 기술적 진보의 혜택을 받고 있으며, 환자의 예후를 개선하는 표적 치료의 개발을 촉진하고 있습니다. 바이오마커 식별 및 신경 퇴행성 질환 및 바이러스성 질환의 동반자 진단의 개발이 진행되고 있습니다. 차세대 시퀀싱(NGS) 기술의 상승과 진단에서 인공지능의 통합은 동반진단의 정확성과 효율성을 높여 시장의 성장과 다양화를 더욱 촉진할 것으로 보입니다.

경쟁 개요 :

동반진단 시장은 다양한 세분화에 의해 특징지어져 암의 유병률 증가와 맞춤형 의료 수요에 견인되어 암 용도가 시장의 대부분을 차지하고 있습니다. 지역적으로는 북미는 견고한 헬스케어 인프라와 고급 진단 기술의 높은 도입으로 주도적인 지위를 유지하고 있으며, 아시아태평양은 헬스케어 투자 증가와 환자수의 확대로 급성장을 이루고 있습니다. Diagnostics, Abbott Laboratories, Thermo Fisher Scientific과 같은 주요 기업에 의해 형성되며, 이들 기업은 제품 포트폴리오를 강화하고 시장 우위를 유지하기 위해 지속적으로 기술 혁신을 수행하고 있습니다. 차세대 시퀀싱과 바이오마커 탐색의 기술 진보에 힘입어 시장은 강력한 성장을 이룰 것으로 예상되고 있습니다.

주요 동향 및 촉진요인 :

동반진단 시장은 맞춤형 의료와 표적 요법의 진보에 힘입어 강력한 성장을 이루고 있습니다. 그리고 안전성을 높이고 시장 확대를 촉진하고 있습니다. 또한, 암과 만성 질환 증가로 인해 환자의 예후를 개선하기 위한 고급 진단 솔루션이 필요합니다. 신흥 시장은 의료 투자 증가와 맞춤형 의료 솔루션에 대한 주목 증가로 유리한 기회를 가져오고 있습니다.

억제요인과 도전 :

동반진단 시장은 몇 가지 큰 시장 성장 억제요인과 문제에 직면하고 있습니다. 첫째, 규제의 복잡성은 엄청난 장벽입니다. 엄격한 승인 프로세스가 타임라인을 연장하고 비용을 팽창시키기 때문입니다. 이 복잡성은 중소기업 시장 진입을 막는 경우가 많습니다. 둘째, 동반진단의 개발과 검증에 드는 비용이 높기 때문에 특히 신흥국 시장에서는 그 이용이 제한됩니다. 이러한 경제적 부담은 혁신을 방해하고 시장 확대를 늦출 수 있습니다. 셋째, 동반진단을 기존 임상 워크플로에 통합하는 것은 번거롭고 의료 종사자의 진료를 크게 변경하거나 추가 교육이 필요합니다. 넷째, 서로 다른 플랫폼 간의 표준화가 불충분하기 때문에 동반진단의 도입이 복잡해지고 상호 운용성 문제가 발생합니다. 마지막으로 기술적 진보의 속도가 빠르기 때문에 지속적인 갱신과 적응이 필요해 진화하는 과학적·임상적 지식에 대응하려고 하는 기업에 있어서는 자원 집약적이 될 수 있습니다. 이러한 과제는 전체적으로 시장의 성장 궤도를 방해합니다.

목차

제1장 동반진단 시장 개요

제2장 주요 요약

제3장 시장에 관한 중요 인사이트

제4장 동반진단 시장 전망

제5장 동반진단 시장 전략

제6장 동반진단 시장 규모

제7장 동반진단 시장 : 유형별

제8장 동반진단 시장 : 제품별

제9장 동반진단 시장 : 서비스별

제10장 동반진단 시장 : 기술별

제11장 동반진단 시장 : 구성 요소별

제12장 동반진단 시장 : 용도별

제13장 동반진단 시장 : 디바이스별

제14장 동반진단 시장 : 최종 사용자별

제15장 동반진단 시장 : 기능별

제16장 동반진단 시장 : 지역별

제17장 경쟁 구도

제18장 기업 프로파일

KTH
영문 목차

영문목차

Companion Diagnostics Market is anticipated to expand from $8.1 billion in 2024 to $15.4 billion by 2034, growing at a CAGR of approximately 6.6%. Companion Diagnostics Market encompasses tests designed to identify patients likely to benefit from specific therapeutics, ensuring personalized treatment efficacy and safety. This market integrates molecular diagnostics, genomics, and biotechnology, driven by advancements in precision medicine. Increasing demand for tailored therapies and regulatory support propels growth, with a focus on oncology, infectious diseases, and genetic disorders. The market emphasizes collaboration between diagnostic firms and pharmaceutical companies to enhance targeted therapy outcomes.

Industry Overview:

Global tariffs and geopolitical risks are significantly impacting the Companion Diagnostics Market, particularly across Japan, South Korea, China, and Taiwan. In Japan and South Korea, trade tensions are prompting increased investment in local R&D and strategic alliances to mitigate dependency on foreign technologies. China's focus on self-reliance is driving rapid advancements in indigenous diagnostic technologies. Taiwan, while a pivotal player in semiconductor supply chains, faces geopolitical vulnerabilities that could disrupt production. The global market for companion diagnostics is witnessing robust growth, driven by advancements in personalized medicine, with projections indicating substantial expansion by 2035. However, Middle East conflicts could exacerbate supply chain disruptions and elevate energy costs, influencing production and distribution logistics. Strategic diversification and regional collaborations will be crucial to navigating these challenges.

Market Segmentation
TypeIn Vitro Diagnostics, In Vivo Diagnostics
ProductAssay Kits, Reagents, Instruments, Software
ServicesConsultation, Validation, Training, Maintenance
TechnologyPolymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Immunohistochemistry (IHC), In Situ Hybridization (ISH), Flow Cytometry, Mass Spectrometry
ComponentBiomarkers, Bioinformatics
ApplicationOncology, Neurology, Cardiology, Infectious Diseases, Autoimmune Diseases
DevicePortable, Benchtop, Handheld
End UserHospitals, Clinical Laboratories, Pharmaceutical Companies, Research Institutes
FunctionalityScreening, Monitoring, Prognosis

Market Overview:

The Companion Diagnostics Market is segmented into technology, indication, and end-user segments, with the oncology segment leading the market. This dominance is attributed to the increasing prevalence of cancer and the growing adoption of personalized medicine, which necessitates precise diagnostics for effective treatment. The oncology segment benefits from technological advancements in genomics and molecular diagnostics, facilitating the development of targeted therapies that improve patient outcomes. Emerging sub-segments include neurology and infectious diseases, driven by advancements in biomarker identification and the development of companion diagnostics for neurodegenerative and viral diseases. These sub-segments hold potential for significant market impact as they address unmet medical needs and enable more tailored therapeutic approaches. Additionally, the rise of next-generation sequencing (NGS) technologies and the integration of artificial intelligence in diagnostics are poised to enhance the accuracy and efficiency of companion diagnostics, further propelling market growth and diversification.

Geographical Overview:

The companion diagnostics market is witnessing diverse growth trends across various regions. North America leads the market, driven by advanced healthcare infrastructure and a strong emphasis on personalized medicine. The region's robust regulatory framework and collaboration between biotech firms and research institutions further bolster its position. Europe follows, characterized by substantial investments in precision medicine and a supportive regulatory environment. The region's focus on innovative healthcare solutions enhances the adoption of companion diagnostics. Additionally, collaborations between pharmaceutical companies and diagnostic firms are prevalent, fostering market growth. In the Asia Pacific, rapid economic growth and increasing healthcare expenditure drive the market. Countries like China and India are investing heavily in healthcare infrastructure, promoting the adoption of companion diagnostics. The region's large patient pool and growing awareness of personalized medicine contribute to its expansion. Latin America and the Middle East & Africa are emerging markets with significant potential. In Latin America, rising investments in healthcare and increasing focus on cancer diagnostics propel market growth. Meanwhile, the Middle East & Africa recognize the importance of personalized medicine, with governments investing in healthcare advancements to support market expansion.

Competition Overview:

The Companion Diagnostics Market is characterized by a diverse segmentation, with oncology applications commanding a significant portion of the market, driven by the increasing prevalence of cancer and the demand for personalized medicine. Infectious diseases and cardiovascular applications also hold substantial shares, owing to advancements in molecular diagnostics and the growing focus on precision healthcare. Geographically, North America maintains a leading position due to robust healthcare infrastructure and high adoption of advanced diagnostic technologies, while the Asia-Pacific region is witnessing rapid growth fueled by rising healthcare investments and expanding patient populations. The competitive landscape of the Companion Diagnostics Market is shaped by key players such as Roche Diagnostics, Abbott Laboratories, and Thermo Fisher Scientific, who are continuously innovating to enhance their product portfolios and maintain market dominance. Regulatory frameworks, particularly in North America and Europe, set stringent standards that drive quality and safety, influencing market dynamics. Looking forward, the market is anticipated to experience robust growth, propelled by technological advancements in next-generation sequencing and biomarker discovery. Challenges such as regulatory complexities and high development costs persist, yet the increasing emphasis on personalized medicine and strategic partnerships between pharmaceutical and diagnostic companies present substantial opportunities for expansion.

Recent Developments:

The Companion Diagnostics Market has witnessed notable developments over the past three months. Roche announced a strategic partnership with Illumina to co-develop and commercialize next-generation sequencing-based companion diagnostics, aiming to enhance precision medicine capabilities. Thermo Fisher Scientific unveiled a new companion diagnostic assay intended to identify patients who could benefit from a novel targeted therapy, thereby broadening their diagnostic portfolio. In a significant merger, Qiagen acquired a smaller biotech firm specializing in companion diagnostics, aiming to strengthen its market position and expand its product offerings. The US FDA granted accelerated approval to a new companion diagnostic test developed by Agilent Technologies, which is designed to identify patients eligible for a specific cancer immunotherapy. Furthermore, a collaborative research initiative between AstraZeneca and a leading academic institution was launched, focusing on the development of innovative companion diagnostics for emerging oncology therapies. These developments underscore the dynamic nature of the Companion Diagnostics Market, emphasizing strategic alliances and regulatory advancements.

Key Companies:

Myriad Genetics, Qiagen, Illumina, Roche Diagnostics, Thermo Fisher Scientific, Agilent Technologies, Biocartis, Guardant Health, Foundation Medicine, Adaptive Biotechnologies, Natera, Exact Sciences, Invitae, Neo Genomics Laboratories, Bio- Rad Laboratories, Luminex Corporation, Perkin Elmer, Fulgent Genetics, Hologic, Dia Sorin

Key Trends and Drivers:

The Companion Diagnostics Market is experiencing robust growth, propelled by advancements in personalized medicine and targeted therapies. A significant trend is the increasing collaboration between pharmaceutical companies and diagnostic manufacturers to co-develop companion diagnostics, ensuring precise treatment regimens. This synergy enhances drug efficacy and safety, fostering market expansion. Regulatory bodies are streamlining approval processes for companion diagnostics, encouraging innovation and accelerating market entry. The demand for precision medicine is driving the adoption of companion diagnostics, as healthcare providers seek to tailor treatments to individual genetic profiles. Moreover, the growing prevalence of cancer and chronic diseases necessitates advanced diagnostic solutions to improve patient outcomes. Technological advancements, such as next-generation sequencing and liquid biopsies, are transforming the landscape, offering non-invasive and highly accurate diagnostic options. Emerging markets present lucrative opportunities, with increasing healthcare investments and a rising focus on personalized healthcare solutions. Companies that leverage these trends and drivers are well-positioned to capture significant market share, capitalizing on the evolving needs of the healthcare industry.

Restraints and Challenges:

The companion diagnostics market is confronted with several significant restraints and challenges. Firstly, regulatory complexities present a formidable barrier, as stringent approval processes extend timelines and inflate costs. This complexity often discourages smaller companies from entering the market. Secondly, the high cost of development and validation of companion diagnostics limits their accessibility, particularly in emerging markets. This financial burden can stifle innovation and slow market expansion. Thirdly, the integration of companion diagnostics into existing clinical workflows can be cumbersome, requiring significant changes in practice and additional training for healthcare professionals. Fourthly, there is a lack of standardization across different platforms, which complicates the deployment of these diagnostics and creates interoperability issues. Lastly, the rapid pace of technological advancements necessitates continuous updates and adaptations, which can be resource-intensive for companies attempting to keep pace with evolving scientific and clinical knowledge. These challenges collectively impede the market's growth trajectory.

Research Scope:

Our research scope provides comprehensive market data, insights, and analysis across a variety of critical areas. We cover Local Market Analysis, assessing consumer demographics, purchasing behaviors, and market size within specific regions to identify growth opportunities. Our Local Competition Review offers a detailed evaluation of competitors, including their strengths, weaknesses, and market positioning. We also conduct Local Regulatory Reviews to ensure businesses comply with relevant laws and regulations. Industry Analysis provides an in-depth look at market dynamics, key players, and trends. Additionally, we offer Cross-Segmental Analysis to identify synergies between different market segments, as well as Production-Consumption and Demand-Supply Analysis to optimize supply chain efficiency. Our Import-Export Analysis helps businesses navigate global trade environments by evaluating trade flows and policies. These insights empower clients to make informed strategic decisions, mitigate risks, and capitalize on market opportunities.

TABLE OF CONTENTS

1: Companion Diagnostics Market Overview

2: Executive Summary

3: Premium Insights on the Market

4: Companion Diagnostics Market Outlook

5: Companion Diagnostics Market Strategy

6: Companion Diagnostics Market Size

7: Companion Diagnostics Market, by Type

8: Companion Diagnostics Market, by Product

9: Companion Diagnostics Market, by Services

10: Companion Diagnostics Market, by Technology

11: Companion Diagnostics Market, by Component

12: Companion Diagnostics Market, by Application

13: Companion Diagnostics Market, by Device

14: Companion Diagnostics Market, by End User

15: Companion Diagnostics Market, by Functionality

16: Companion Diagnostics Market, by Region

17: Competitive Landscape

18: Company Profiles

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