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市場調查報告書
商品編碼
1800780
2025 年至 2033 年伴隨診斷市場報告(按產品與服務、技術(免疫組織化學、聚合酶鍊式反應、原位雜合技術、即時 PCR、基因定序等)、適應症、最終用戶和地區分類)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 2025-2033 |
2024年,全球伴隨診斷市場規模達76億美元。展望未來, IMARC Group預計到2033年,該市場規模將達到223億美元,2025-2033年期間的複合年成長率(CAGR)為12.11%。北美憑藉其先進的醫療基礎設施、個人化醫療的普及率以及強力的監管支持,引領市場發展。該地區還受益於對研究營運的大量投資以及越來越多的生物技術和製藥公司。癌症發生率的上升、對個人化醫療的需求的不斷成長以及包括新一代定序(NGS)在內的持續技術進步,是推動市場成長的一些主要因素。
個人化醫療是指根據個人基因圖譜客製化治療方案,這是推動伴隨診斷市場需求成長的關鍵因素。根據患者獨特的基因圖譜匹配特定治療方案需要精準的診斷工具,因此對伴隨診斷的需求日益成長,因為這種診斷工具有助於指導治療選擇,從而改善療效並減少副作用。此外,診斷技術的進步,尤其是分子診斷和新一代定序 (NGS) 的進步,顯著提高了伴隨診斷的精確度和可靠性。這些進步使得基因突變和生物標記的檢測更加精準,從而提高了治療的有效性,並推動了醫療環境中對伴隨診斷的需求。此外,醫療保健領域的投資也越來越側重於精準醫療,即利用診斷測試來客製化治療方案。隨著越來越多的醫療保健系統採用標靶治療和個人化治療方案,對伴隨診斷的需求也隨之增加,尤其是在腫瘤領域,因為客製化治療方案至關重要。
基因治療和罕見疾病診斷的進展
隨著基因療法在遺傳性疾病中的應用日益廣泛,對確保這些療法安全有效的診斷工具的需求也日益成長。伴隨診斷在確定哪些患者符合基因治療條件方面發揮著至關重要的作用,尤其是在罕見遺傳性疾病中,其治療效果很大程度上依賴於特定的生物標記。這些診斷有助於識別可能影響治療效果的現有抗體或遺傳因子,確保患者獲得最合適的治療。診斷和製藥行業的主要參與者正在積極發揮這一關鍵作用,他們正在開發並獲得監管部門批准的先進伴隨診斷檢測方法,以促進基因療法的安全有效應用。 2024年,Labcorp公司獲得FDA批准其nAbCyte™抗AAVRh74var HB-FE檢測試劑盒,這是輝瑞公司用於治療乙型血友病的基因療法BEQVEZ™(fidanacogene elaparvovec-dzkt)的伴隨診斷試劑盒。此檢測試劑盒可辨識患者體內預先存在的抗AAVRh74var抗體,確保基因治療的安全有效。此次批准標誌著罕見遺傳疾病基因治療診斷領域的突破。
人工智慧在診斷上的應用
人工智慧工具透過檢查大量資料集(例如基因和臨床資料)來提高診斷測試的速度、準確性和效率,從而以無與倫比的精度找出生物標記。人工智慧演算法可以幫助預測患者對特定療法的反應,從而製定更有針對性的治療策略。在腫瘤學和各種複雜情況下,人工智慧改善了臨床試驗患者的篩選流程,確保只納入最有可能從治療中受益的患者。公司之間的策略合作進一步鞏固了這項技術進步,它們整合了人工智慧解決方案來改善診斷流程並加速臨床試驗的進展。 2024 年,ABION 和 Deep Bio 在韓國首爾簽署了一份合作備忘錄,合作進行人工智慧驅動的伴隨診斷和癌症臨床試驗。此次合作將 Deep Bio 的人工智慧病理學工具整合到 ABION 的藥物管線中,以提高患者選擇的精確度並加快試驗效率。這為 ABION 正在進行的肺癌治療聯合試驗提供了支持。
增加醫療保健投資
由於全球醫療體系致力於提高治療效果並降低成本,醫療保健投資是影響市場的關鍵因素。政府、私人投資者和醫療機構正致力於個人化和精準醫療,這直接關係到伴隨診斷的應用。透過精準定位最有效的療法,伴隨診斷可以最大限度地減少傳統治療中常見的反覆試驗,從而更有效率地配置醫療資源。此外,人們日益重視基於價值的醫療保健,即將報銷與患者結果而非醫療量掛鉤,這與伴隨診斷在提高治療精準度方面的作用高度契合。伴隨診斷促進的標靶治療的成本效益進一步鞏固了其在全球醫療體系中的地位。隨著醫療體系面臨的經濟壓力不斷增加,對諸如伴隨診斷等能夠提升醫療效率和療效的工具的投資正在推動市場成長。
人口老化加劇
隨著老年人口的成長,癌症、心臟病和神經系統疾病等慢性疾病和與年齡相關的疾病的盛行率也在上升。老年人通常需要更個人化的治療方案,根據其基因特徵進行客製化治療才能獲得最佳療效。世界衛生組織 (WHO) 指出,到 2030 年,全球每六個人中就有一人年齡在 60 歲或以上,預計到 2050 年這一數字將攀升至 21 億人。這種人口結構變化需要增加和增強診斷服務,從而推動對卓越診斷儀器和檢測解決方案的需求。伴隨診斷使醫療保健專業人員能夠根據特定的基因特徵量身定做治療方案,從而提高治療效果並降低不良反應的可能性。這種個人化醫療保健趨勢對於滿足老齡化人口的複雜需求至關重要。
策略夥伴關係與合作
診斷公司與製藥公司之間的合作與夥伴關係促進了診斷工具與創新療法的結合,確保合適的患者獲得最有效的治療。透過整合藥物開發和診斷技術的知識,這些合作加快了伴隨診斷的開發,簡化了法規核准流程,並提高了個人化醫療選擇的可及性。隨著精準醫療需求的不斷成長,這些合作對於透過開發全面的端到端解決方案來拓寬市場供應至關重要,這些解決方案有助於促進標靶治療的開發。例如,2024年,BD(碧迪公司)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儀的癌症和其他疾病的伴隨診斷。該合作旨在為製藥業提供端到端解決方案,涵蓋從探索性檢測組開發到FDA批准的診斷試劑盒的各個環節。其目標是推進個人化醫療並改善臨床療效。
加強診斷核准的監理途徑
診斷核准監管流程的進步和改進是推動市場成長的關鍵因素。監管機構正在簡化伴隨診斷的核准流程,以認可其對精準醫療發展的重要貢獻。隨著審查週期的縮短以及伴隨診斷測試創建和授權的明確框架,監管環境對該領域的創新的支持日益增強。這些改進不僅促進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明確的市場准入途徑。此外,隨著監管機構認知到這些評估在確保新型療法療效方面的重要性,它們也為伴隨診斷公司創造了更多發展機會。
The global companion diagnostics market size reached USD 7.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.3 Billion by 2033, exhibiting a growth rate (CAGR) of 12.11% during 2025-2033. 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.
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: