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市場調查報告書
商品編碼
2049474
伴隨診斷市場報告:按產品/服務、技術、適應症、最終用戶和地區分類(2026-2034 年)Companion Diagnostics Market Report by Product & Service, Technology (Immunohistochemistry, Polymerase Chain Reaction, In-situ Hybridization, Real-time PCR, Gene Sequencing, and Others), Indication, End User, and Region 2026-2034 |
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2025年,全球伴隨診斷市場規模達85億美元。展望未來,IMARC Group預測,該市場將在2026年至2034年間以11.86%的複合年成長率成長,到2034年達到240億美元。北美地區憑藉其先進的醫療基礎設施、個人化醫療的高滲透率以及強力的監管支持,正引領市場成長。該地區還受益於研發方面的巨額投資以及生物技術和製藥公司數量的不斷成長。癌症發生率的上升、對個人化醫療日益成長的需求以及包括次世代定序(NGS)在內的持續技術進步,是推動市場成長的關鍵因素。
根據個人基因譜客製化治療方法的個人化醫療是伴隨診斷市場的主要驅動力。針對患者獨特的基因譜調整特定治療方法需要精準的診斷工具,因此,對伴隨診斷的需求日益成長,以支持旨在改善療效和減少副作用的治療方法選擇。此外,診斷技術的進步,特別是分子診斷和次世代定序(NGS)技術的進步,顯著提高了伴隨診斷的準確性和可靠性。這些進步使得基因突變和生物標記的檢測更加精確,從而提高了治療效果,並推動了醫療機構對伴隨診斷的需求。此外,醫療保健領域的投資也越來越集中於“精準醫療”,即利用診斷測試實現個人化治療。隨著越來越多的醫療系統採用標靶治療和個人化治療方法,對伴隨診斷的需求也不斷成長,尤其是在腫瘤領域,個人化治療至關重要。
基因治療和罕見疾病診斷的進展
隨著基因療法在遺傳疾病治療中的應用日益廣泛,對能夠確保安全有效實施這些療法的診斷工具的需求也日益成長。伴隨診斷在確定哪些患者適合接受基因治療方面發揮著至關重要的作用,對於治療效果高度依賴特定生物標記的罕見遺傳疾病而言,伴隨診斷的重要性尤為突出。這些診斷方法有助於識別可能影響治療效果的現有抗體和遺傳因素,從而確保患者獲得最合適的治療。診斷和製藥行業的領導者正積極應對這一關鍵挑戰,開發並獲得監管部門核准的先進伴隨診斷檢測方法,以促進基因療法的安全有效實施。 2024年,LabCorp的nAbCyte™抗AAVRh74var HB-FE檢測獲得FDA核准,該檢測是輝瑞公司用於治療B型血友病的基因療法BEQVEZ™(fidanacogen elaparvovek-dzkt)的伴隨診斷試劑。此檢測可辨識患者體內是否存在預先存在的抗AAVRh74var抗體,確保基因療法的安全性和有效性。此次核准標誌著罕見遺傳疾病基因療法診斷領域的突破性進展。
將人工智慧應用於診斷
人工智慧工具透過分析包括基因和臨床數據在內的龐巨量資料集,並以前所未有的精準度識別生物標記物,從而提高診斷測試的速度、準確性和效率。人工智慧演算法有助於預測患者對特定治療方法的反應,從而實現更個人化的治療策略。在腫瘤學和各種複雜疾病領域,人工智慧最佳化了臨床試驗的患者篩選流程,確保只有最有可能從治療中受益的患者才能入組。企業間的策略合作進一步強化了這項技術進步,整合人工智慧解決方案以最佳化診斷流程並加速臨床試驗進程。 2024年,ABION與Deep Bio在韓國首爾簽署了一份合作備忘錄,旨在就人工智慧驅動的伴隨診斷和癌症臨床試驗展開合作。此次合作將Deep Bio的人工智慧病理診斷工具整合到ABION的藥物研發管線中,提高了病患篩選的準確性並簡化了臨床試驗流程。這為ABION正在進行的肺癌聯合治療試驗提供了支持。
擴大對醫療保健領域的投資
隨著全球醫療體系致力於改善治療效果並降低成本,醫療保健領域的投資已成為推動市場發展的關鍵因素。各國政府、私人投資者和醫療機構正著力發展個人化和精準醫療,而伴隨診斷的應用正是其中的關鍵。伴隨診斷能夠識別最有效的治療方法,從而最大限度地減少傳統治療中常見的試驗誤法,實現醫療資源的更有效率配置。此外,人們越來越關注“價值醫療”,即根據患者的治療效果而非醫療服務量來確定報銷金額,這與伴隨診斷在提高治療精準度方面的作用不謀而合。伴隨診斷帶來的標靶治療的成本效益進一步推動了其在全球醫療體系中的應用。在醫療體系面臨日益成長的經濟壓力之際,對伴隨診斷等能夠促進高效醫療的工具的投資,正在推動市場成長。
人口老化的過程
隨著老年人口的成長,慢性病和與老齡化相關的疾病(例如癌症、心臟病和神經系統疾病)的盛行率也在上升。老年人通常需要更個人化的治療,而根據其基因譜量身定做的治療方案能夠達到最佳療效。世界衛生組織(WHO)預測,到2030年,全球六分之一的人口將超過60歲,到2050年,這一數字預計將達到21億。這些人口結構的變化促使人們需要擴展和改進診斷服務,從而推動對更先進的診斷設備和檢測解決方案的需求。伴隨診斷使醫療專業人員能夠根據特定的基因譜量身定做治療方案,從而改善治療效果並降低副作用風險。這種向個人化醫療的轉變對於滿足老齡化社會複雜的醫療需求至關重要。
策略夥伴關係與合作
診斷公司與製藥公司之間的夥伴關係促進了診斷工具與創新治療方法的結合,確保合適的患者獲得最有效的治療。透過整合藥物研發和診斷技術的洞見,這些合作加速了伴隨診斷的開發,簡化了監管核准流程,並改善了個人化醫療服務的可及性。隨著精準醫療需求的成長,這些合作對於透過開發全面的端到端解決方案來擴大市場覆蓋範圍至關重要,這些解決方案能夠加速標靶治療的研發。例如,2024年,BD(貝克頓·迪金森公司)和Quest Diagnostics宣佈建立全球合作夥伴關係,共同開發基於流式細胞技術的癌症及其他疾病伴隨診斷。該合作旨在為製藥業提供從探索性檢測組合開發到FDA核准的診斷試劑盒的端到端解決方案,其目標是推進個人化醫療並改善臨床療效。
加強診斷藥物核准的監管流程
診斷藥物核准監管流程的進步和改進是市場成長的關鍵促進因素。監管機構認知到伴隨診斷在實現精準醫療中發揮的關鍵作用,並正在簡化核准流程。更短的審查週期和更清晰的伴隨診斷測試開發與核准框架,正推動監管格局朝著更加有利於該領域創新的方向發展。這些改進不僅加速了新型診斷技術的進步,也為投資伴隨診斷的公司提供了更清晰的市場准入途徑。此外,隨著監管機構認知到這些評估在確保新治療方法有效性方面的重要性,伴隨診斷公司的發展機會也不斷增加。
The global companion diagnostics market size reached USD 8.5 Billion in 2025. Looking forward, IMARC Group expects the market to reach USD 24.0 Billion by 2034, exhibiting a growth rate (CAGR) of 11.86% during 2026-2034.North America leads the market attributed to its advanced healthcare infrastructure, high adoption of personalized medicine, and strong regulatory support. The region also benefits from significant investments in research operations and a growing number of biotechnology and pharmaceutical companies. The rising incidences of cancer, the increasing demand for personalized medicine, and continuous technological advancements, including next-generation sequencing (NGS), are some of the primary factors driving the market growth.
Personalized medicine, which customizes therapies according to a person's genetic profile, is a critical factor propelling the companion diagnostics market demand. Matching particular treatments to a patient's distinct genetic profile necessitates accurate diagnostic tools, resulting in a greater need for companion diagnostics that assist in directing therapeutic choices for improved results and reduced side effects. Apart from this, improvements in diagnostic technologies, particularly in molecular diagnostics and next-generation sequencing (NGS), are notably enhancing the precision and dependability of companion diagnostics. These advancements enable the detection of genetic mutations and biomarkers with improved accuracy, thus increasing the effectiveness of therapies and driving the need for companion diagnostics in medical environments. Furthermore, healthcare investments are increasingly focused on precision medicine, which involves using diagnostic tests to tailor treatments. As more healthcare systems adopt targeted therapies and personalized treatment regimens, there is a higher demand for companion diagnostics, particularly in oncology, where tailored therapies are crucial.
Advancements in Gene Therapy and Rare Disease Diagnostics
With the growing use of gene therapies for genetic disorders, there is an increase in the demand for diagnostic tools that guarantee the safe and efficient use of these therapies. Companion diagnostics play a crucial role in determining which patients qualify for gene therapy, especially in rare genetic disorders where treatment effectiveness significantly relies on specific biomarkers. These diagnostics assist in identifying existing antibodies or genetic elements that may influence therapy effectiveness, guaranteeing that patients get the most suitable treatment. This critical role is actively being addressed by key players in the diagnostic and pharmaceutical industries, who are developing and gaining regulatory approvals for advanced companion diagnostic assays to facilitate the safe and effective administration of gene therapies. In 2024, Labcorp received FDA approval for its nAbCyte(TM) Anti-AAVRh74var HB-FE Assay, a companion diagnostic for Pfizer's gene therapy BEQVEZ(TM) (fidanacogene elaparvovec-dzkt) to treat hemophilia B. The test identified preexisting anti-AAVRh74var antibodies in patients, ensuring safe and effective gene therapy treatment. This approval marked a breakthrough in gene therapy diagnostics for rare genetic disorders.
Integration of AI in Diagnostics
Tools powered by AI improve the speed, accuracy, and efficiency of diagnostic tests by examining extensive datasets, such as genetic and clinical data, to pinpoint biomarkers with unmatched precision. AI algorithms can aid in forecasting patient reactions to particular therapies, allowing for more tailored treatment strategies. In oncology and various complex conditions, AI enhances the process of selecting patients for clinical trials, guaranteeing that only those with the highest potential to benefit from the treatment are included. This technological progress is further solidified by strategic collaborations between companies, integrating AI-powered solutions to refine diagnostic processes and accelerate clinical trial advancements. In 2024, ABION and Deep Bio signed an MOU in Seoul, South Korea to collaborate on AI-driven companion diagnostics and cancer clinical trials. The partnership integrated Deep Bio's AI-powered pathology tools into ABION's drug pipeline to enhance precision in patient selection and accelerate trial efficiency. This supported ABION's ongoing combination trials in lung cancer therapy.
Increased Healthcare Investments
Investments in healthcare is a key factor influencing the market as worldwide healthcare systems aim to enhance treatment results and lower expenses. Governments, private investors, and healthcare organizations are focusing on personalized and precision medicine, which directly entails the utilization of companion diagnostics. By pinpointing the most effective therapies, companion diagnostics can minimize the trial-and-error method frequently encountered in traditional treatments, resulting in a more efficient allocation of healthcare resources. Moreover, the growing focus on value-based healthcare, linking reimbursement to patient results instead of care volume, corresponds effectively with the function of companion diagnostics in enhancing treatment precision. The cost-efficiency of targeted treatments facilitated by companion diagnostics further reinforces their incorporation into global healthcare systems. With rising economic pressures on healthcare systems, investments in tools that enhance efficient and effective care, like companion diagnostics, are strengthening the market growth.
Rising Aging Population
With the growing geriatric population, there is a rise in the prevalence of chronic and age-related illnesses, such as cancer, heart diseases, and neurological conditions. Older adults frequently need more tailored therapies, which can yield the best outcomes when customized to their genetic profile. The World Health Organization (WHO) states that by 2030, one out of every six individuals worldwide will be 60 years or older, and this figure is expected to climb to 2.1 billion by 2050. This demographic change necessitates increased and enhanced diagnostic services, driving the demand for superior diagnostic instruments and testing solutions. Companion diagnostics allow healthcare professionals to customize treatments according to specific genetic profiles, enhancing treatment results and lowering the likelihood of negative reactions. This movement towards individualized healthcare is crucial for addressing the intricate requirements of aging populations.
Strategic Partnerships and Collaborations
Partnerships and collaborations between diagnostic companies and pharmaceutical firms facilitate the combination of diagnostic tools with innovative therapies, guaranteeing that suitable patients obtain the most efficient treatments. Through the integration of knowledge in drug development and diagnostic technologies, these collaborations expedite the creation of companion diagnostics, simplify the regulatory approval process, and improve the accessibility of personalized healthcare options. With the increase in demand for precision medicine, these collaborations are vital for broadening the market offerings by developing all-encompassing, end-to-end solutions that facilitate the creation of targeted treatments. For example, in 2024, BD (Becton, Dickinson and Company) and Quest Diagnostics announced a global partnership to created flow cytometry-based companion diagnostics for cancer and other diseases. The partnership aimed to offer an end-to-end solution for the pharmaceutical industry, ranging from exploratory panel development to FDA-approved diagnostic kits. The goal was to advance personalized healthcare and improve clinical outcomes.
Enhancing Regulatory Pathways for Diagnostic Approval
The advancement and improvement of regulatory processes for diagnostic approval are a crucial factor impelling the market growth. Regulatory agencies are simplifying the approval pathways for companion diagnostics, acknowledging their vital contribution to facilitating precision medicine. With quicker review periods and explicit frameworks for the creation and authorization of companion diagnostics tests, the regulatory landscape is becoming increasingly supportive of innovation in this area. These enhancements not only promote the advancement of novel diagnostic technologies but also offer more defined routes to market access for firms investing in companion diagnostics. In addition, as regulators recognize the significance of these assessments in guaranteeing the efficacy of novel treatments, they are generating more chances for companion diagnostics companies to prosper.
The publisher provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2026-2034. Our report has categorized the market based on product & service, technology, indication, and end user.
Assays, kits and reagents hold the largest market share
Assays, kits, and reagents play important roles in identifying patients who are most likely to benefit from a particular therapeutic product. These diagnostic tools aid in determining the absence or presence of specific biomarkers, protein expressions, genetic mutations, etc., linked to the potential side effects and effectiveness of targeted therapies. This, in turn, is propelling the market growth in this segment.
Polymerase chain reaction (PCR) exhibits a clear dominance in the market
The growth in this segmentation is bolstered by the easy availability of polymerase chain reaction (PCR) kits and reagents used for companion diagnostics. Moreover, their widespread applications in detecting gene mutations with low or limited allele frequencies are contributing to their dominance in the global market.
Cancer currently accounts for the majority of the total market share
The widespread incidence of cancer is propelling the usage of companion diagnostics, thereby fueling the market growth in this segmentation. According to the American Cancer Society, in January 2022, 1.9 million cancer cases were recorded in the U.S. Consequently, continuous product launches and approvals by government bodies are positively influencing the companion diagnostics market growth in this segmentation. For example, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which assisted in identifying patients with early breast cancer (EBC). Besides this, according to the Lung Cancer Research Foundation, in the United States estimated 236,740 individuals were diagnosed with lung cancer in 2022, thereby propelling the need for lung cancer companion diagnostics.
Pharmaceutical & biopharmaceutical companies hold the largest market share
The rising adoption of companion diagnostics by pharmaceutical & biopharmaceutical companies in drug development is one of the primary factors propelling the market growth in this segmentation. Moreover, the inflating popularity of companion diagnostics biomarkers is also acting as another significant growth-inducing factor.
North America leads the market, accounting for the largest companion diagnostics market share
The market research 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 accounted for the largest market share.
North America currently dominates the global market, with the United States emerging as a major contributor. Strategic collaborations among biopharmaceutical companies and companion diagnostic manufacturers are primarily augmenting the regional market. For example, QIAGEN and Denovo Biopharma partnered to develop a companion diagnostic test for the treatment of diffuse large B-Cell Lymphoma (DLBCL). Furthermore, the increasing drug approvals by governing authorities, such as the United States Food and Drug Administration (US FDA), are projected to bolster the companion diagnostics market in North America over the forecasted period.
The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include: