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市場調查報告書
商品編碼
1792655
2025 年至 2033 年結核病診斷市場規模、佔有率、趨勢及預測(按疾病分期、檢測類型、最終用戶和地區)Tuberculosis Diagnostics Market Size, Share, Trends and Forecast by Disease Stage, Test Type, End-User, and Region, 2025-2033 |
2024年,全球結核病診斷市場規模達26.1億美元。展望未來, IMARC Group預測,到2033年,市場規模將達到37.9億美元,2025-2033年期間的複合年成長率為4.01%。北美市場佔據主導地位,2024年市佔率超過35.7%。先進的醫療保健、強力的政府支持、高度的認知度以及技術創新是推動結核病診斷市場佔有率成長的一些因素。
市場成長主要受全球結核病患者病率上升的驅動,尤其是在發展中地區。分子檢測和核酸擴增檢測等診斷技術的進步提高了結核病檢測的準確性、速度和靈敏度,從而刺激了對創新診斷解決方案的需求。此外,為了控制結核病的傳播,人們越來越重視早期快速診斷,這促使人們採用自動化系統和數位平台來更快地獲得診斷結果。政府措施以及非政府組織和世界衛生組織等全球衛生組織的支持,正在增加對結核病控制項目的資金投入,進一步推動結核病診斷市場的成長。人們對結核病認知的不斷提高、對更高效診斷工具的需求以及對整合醫療解決方案的推動,都促進了結核病診斷市場的擴張。
在美國,結核病診斷的最新進展著重於自動化檢測流程以提高效率。經FDA批准的新平台正在提高實驗室通量,提供更快、更準確的結果,並支持全球控制潛伏性結核病的努力。這些創新在簡化工作流程的同時,確保了診斷程序的精準性。例如,2025年4月,Revvity公司獲得FDA批准,其Auto-Pure 2400平台整合了T-SPOT.TB檢測,以實現潛伏性結核病診斷的自動化和增強。此核准的解決方案能夠提高實驗室通量並提供準確的結果,助力全球結核病控制工作。
結核病基因體定序技術進步助力診斷
結核分枝桿菌分離株基因組定序的最新進展顯著促進了結核病診斷市場的發展。該計劃旨在加速抗藥性分析,從而實現更快、更準確的診斷方法。透過識別基因標記,定序工作可以改善臨床決策,並制定更個人化的治療策略。基因組定序在結核病監測中的廣泛應用將有助於更深入地了解結核病的區域變異和抗藥性模式。這些分子層面的洞察有望改進診斷工具,從而更快地檢測結核病並更有效地管理結核病。基因組定序的持續發展將徹底改變結核病診斷方法,支持改善治療效果並實現全球消除結核病的目標。例如,截至2025年3月,印度已完成10,000個結核分枝桿菌分離株的基因組定序,這是「Dare2eraD結核病」計畫的一部分,旨在提前實現世界衛生組織的2030年目標,消除結核病。這項突破將增強結核病診斷,加速抗藥性分析,並改善治療效果。該計劃由 DBT、CSIR 和 ICMR 牽頭,將對超過 32,000 個分離株進行測序,徹底改變結核病監測和臨床決策。
耐多藥結核病日益受到關注,推動診斷創新
多重抗藥性結核病 (MDR-TB) 和耐利福平結核病 (RR-TB) 的盛行率不斷上升,對結核病診斷市場前景產生了重大影響。由於這些抗藥性菌株繼續在全球範圍內造成大量死亡,迫切需要先進的診斷解決方案來快速準確地識別這些感染。多重抗藥性結核病對異煙肼和利福平等主要抗菌藥物的治療具有抵抗力,這項挑戰凸顯了快速抗藥性檢測和分析的重要性。這種對抗藥性菌株的早期和精確識別的需求推動了對更複雜的診斷工具的需求,例如分子和基因組檢測,這些工具可以檢測抗藥性模式並指導治療策略。抗藥性結核病菌株的增加正在推動更好、更快的診斷方法的開發,以改善治療效果並降低死亡率。根據世界衛生組織統計,多重抗藥性結核病(MDR-TB)和耐利福平結核病(RR-TB)在2023年全球造成約15萬人死亡。多重抗藥性結核病是由對異煙肼和利福平具有抗藥性的細菌引起的,而異煙肼和利福平被認為是治療結核病最有效的抗菌藥物之一。
全國消除結核病運動推動診斷需求
印度國家結核病消除計畫 (NTEP) 在全國範圍內啟動了結核病消除運動,這對結核病診斷行業產生了重大影響。該計劃涵蓋全國眾多地區,旨在透過廣泛的篩檢工作加強結核病的發現和治療。這項大規模運動增加了對能夠有效識別潛伏性和活動性結核病病例的快速準確診斷工具的需求。由於該計劃專注於早期診斷和減少結核病傳播,對分子檢測和快速檢測方法等先進診斷解決方案的需求也在增加。結核病診斷市場預測表明,檢測基礎設施的擴展和對及時干預的重視將進一步推動創新結核病診斷技術的應用,最終有助於改善結核病控制並加快治療反應。例如,2024 年 12 月,印度國家結核病消除計畫 (NTEP) 啟動了為期 100 天的結核病消除運動,涵蓋 33 個邦和聯邦屬地的 347 個地區。
The global tuberculosis diagnostics market size was valued at USD 2.61 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 3.79 Billion by 2033, exhibiting a CAGR of 4.01% during 2025-2033. North America dominated the market, holding a significant market share of over 35.7% in 2024. Advanced healthcare, strong government support, high awareness, and technological innovation are some of the drivers contributing to the tuberculosis diagnostics market share.
The market is primarily driven by the increasing global prevalence of TB, especially in developing regions. Advances in diagnostic technologies, such as molecular and nucleic acid amplification tests, have improved accuracy, speed, and sensitivity in detecting TB, which has boosted demand for innovative diagnostic solutions. Additionally, the rising emphasis on early and rapid diagnosis to control the spread of TB has led to the adoption of automated systems and digital platforms for faster results. Government initiatives, along with support from NGOs and global health organizations like the WHO, are increasing funding for TB control programs, further driving tuberculosis diagnostics market growth. Growing awareness about TB, the need for more efficient diagnostic tools, and the push for integrated healthcare solutions have all contributed to the expansion of the TB diagnostics market.
In the United States, recent advancements in tuberculosis diagnostics focus on automating testing processes to increase efficiency. New FDA-approved platforms are improving lab throughput, delivering faster and more accurate results, and supporting global efforts to control latent tuberculosis. These innovations are streamlining workflows while ensuring precision in diagnostic procedures. For instance, in April 2025, Revvity secured FDA approval for its Auto-Pure 2400 platform integrated with the T-SPOT.TB test to automate and enhance latent tuberculosis diagnostics. The approved solution enables higher lab throughput with accurate results, aiding global tuberculosis control efforts.
Advancements in TB Genome Sequencing for Enhanced Diagnostics
Recent advancements in genome sequencing of Mycobacterium tuberculosis isolates are significantly enhancing the tuberculosis diagnostics market. This initiative aims to accelerate resistance profiling, enabling faster and more accurate diagnostic methods. By identifying genetic markers, the sequencing efforts improve clinical decision-making and allow for more personalized treatment strategies. The expanded use of genome sequencing in TB surveillance will provide a deeper understanding of regional TB variations and drug resistance patterns. These molecular insights are expected to refine diagnostic tools, enabling quicker detection and more effective management of TB. The ongoing developments in genome sequencing are set to revolutionize TB diagnostics, supporting efforts to improve treatment outcomes and meet global TB elimination targets. For example, as of March 2025, India has completed genome sequencing of 10,000 Mycobacterium tuberculosis isolates as part of the Dare2eraD TB program, aiming to eliminate tuberculosis ahead of the WHO's 2030 targets. This breakthrough will enhance TB diagnostics, speed up resistance profiling, and improve treatment outcomes. The initiative, led by DBT, CSIR, and ICMR, is set to sequence over 32,000 isolates, revolutionizing TB surveillance and clinical decision-making.
Rising Concern of Multidrug-Resistant TB Driving Diagnostic Innovation
The increasing prevalence of multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant tuberculosis (RR-TB) is significantly impacting the tuberculosis diagnostics market outlook. As these drug-resistant strains continue to cause a high number of global deaths, there is an urgent need for advanced diagnostic solutions to identify these infections quickly and accurately. The challenge posed by MDR-TB, which resists treatment with key antimicrobial drugs like isoniazid and rifampicin, highlights the importance of rapid resistance detection and profiling. This need for early and precise identification of resistant strains is driving demand for more sophisticated diagnostic tools, such as molecular and genomic testing, that can detect resistance patterns and guide treatment strategies. The rise of resistant TB strains is pushing the development of better, faster diagnostic methods to improve treatment outcomes and reduce mortality rates. According to WHO, multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant tuberculosis (RR-TB) caused an estimated 150,000 deaths globally in 2023. MDR tuberculosis is caused by bacteria that are resistant to isoniazid and rifampicin, which are considered to be among the most potent antimicrobial drugs for TB.
National TB Elimination Campaign Boosting Diagnostic Demand
The launch of a nationwide TB elimination campaign under India's National TB Elimination Programme (NTEP) is significantly impacting the tuberculosis diagnostics industry. The initiative, covering numerous districts across the country, aims to enhance TB detection and treatment through widespread screening efforts. This large-scale campaign increases the demand for rapid and accurate diagnostic tools that can identify both latent and active TB cases efficiently. As the program focuses on early diagnosis and reducing TB transmission, the need for advanced diagnostic solutions, such as molecular and rapid testing methods, has risen. Tuberculosis diagnostics market forecast suggests that the expansion of testing infrastructure and focus on timely intervention will further drive the adoption of innovative TB diagnostics technologies, ultimately contributing to improved TB control and faster treatment response. For instance, in December 2024, a 100-Day TB Elimination Campaign was launched under the National TB Elimination Programme (NTEP) in India, spanning across spanning 347 districts across 33 states and union territories.
Latent TB refers to individuals who have the bacteria in their body but are not showing symptoms, and while they are not contagious, they have a higher risk of developing active TB later. As awareness about the potential progression from latent to active TB increases, there is a growing demand for diagnostic tools that can detect latent infections early. This push for early detection through screening programs, especially in high-risk populations, is fueling the market's growth. Active TB, characterized by symptoms and infectiousness, requires immediate detection and treatment to curb its spread. With the global rise in TB cases, there is a significant demand for rapid diagnostic solutions, such as molecular tests, PCR-based diagnostics, and culture methods, that can quickly and accurately identify active infections. These advancements in TB diagnostics are supporting the market's expansion.
Nucleic acid testing led the market in 2024 due to its ability to provide rapid, accurate, and highly sensitive results. NAT, including polymerase chain reaction (PCR) and other molecular tests, allows for the detection of Mycobacterium tuberculosis DNA in patient samples, making it particularly effective for diagnosing both latent and active TB infections. The speed and precision of NAT reduce diagnostic delays, improving treatment outcomes and limiting the spread of TB. As the demand for quicker, more reliable diagnostic solutions grows, particularly in high-burden regions, NAT continues to gain traction. Furthermore, the ability to detect drug-resistant TB strains through NAT is increasingly crucial, driving further adoption and market growth in efforts to control TB more effectively.
Diagnostics and research laboratories led the market in 2024, holding around 53.2% of the market. These laboratories are central to the development and implementation of advanced diagnostic technologies, such as molecular tests, PCR, and culture-based methods. They provide critical infrastructure for accurate TB detection, offering a variety of testing services for both latent and active TB. With increasing research efforts to develop more efficient, faster, and cost-effective diagnostic tools, these laboratories are at the forefront of innovation in the TB diagnostics market. Additionally, as the demand for accurate and timely diagnosis grows, particularly in TB-endemic regions, the expansion of diagnostics and research laboratories to meet these needs is driving market growth. The continuous advancements and high demand for testing solutions in these settings support the overall market expansion.
In 2024, North America accounted for the largest market share of over 35.7%, owing to its advanced healthcare infrastructure, which ensures widespread access to high-quality diagnostic tools and services. The region benefits from strong government support, with initiatives like the Centers for Disease Control and Prevention (CDC) working toward improving TB detection, treatment, and prevention. Increased awareness of TB and its risks among the population, coupled with substantial investment in healthcare research and development, contributes to the market's growth. Additionally, the presence of leading diagnostic companies and technological innovations, such as molecular diagnostics and automated systems, further enhances TB detection accuracy and speed. These factors combined position North America as a major player in the global TB diagnostics market.
United States Tuberculosis Diagnostics Market Analysis
In 2024, the United States accounted for 88.7% of the market share in North America. The United States is witnessing increased tuberculosis diagnostics adoption due to the rising prevalence of multi-drug resistant (MDR) tuberculosis. For instance, during 2023, at the time of initial diagnosis, 589 (8.5%) tuberculosis cases in the United States were found to have resistance to at least isoniazid, including 100 (1.4%) cases of multidrug-resistant tuberculosis (MDR TB). The growing burden of MDR strains is compelling healthcare providers to implement more robust and early-stage diagnostic solutions. Enhanced government support, coupled with an expanding network of diagnostic laboratories, is contributing to the prioritization of efficient tuberculosis detection. The focus on MDR tuberculosis is prompting strategic investments in molecular and culture-based diagnostics. In addition, public health campaigns are raising awareness, leading to increased screening rates across high-risk populations. Technological advancements and ongoing clinical research for rapid MDR identification further accelerate the demand for accurate tuberculosis diagnostics.
Asia Pacific Tuberculosis Diagnostics Market Analysis
Asia Pacific is experiencing growing tuberculosis diagnostics adoption driven by expanding diagnostics facilities across the region. For instance, industry experts estimate that, as of February 2025, there are around 3,00,000 labs across India, and this number is growing. With national healthcare systems scaling their capabilities, there is greater access to modern diagnostic tools, enabling early identification and management of tuberculosis cases. The proliferation of public-private partnerships is boosting diagnostic infrastructure in both urban and rural areas. Government initiatives to strengthen infectious disease detection are encouraging hospitals and clinics to adopt updated tuberculosis diagnostics. Expanding laboratory networks, integration of automated testing systems, and capacity building for healthcare professionals are key contributors to this trend. In addition, rising health awareness among populations and improved patient outreach have enhanced participation in tuberculosis screening programs. The increase in diagnostic facilities supports timely intervention and reduces transmission risks, underscoring the importance of structured healthcare delivery in tuberculosis management across Asia Pacific.
Europe Tuberculosis Diagnostics Market Analysis
Europe is seeing heightened tuberculosis diagnostics adoption influenced by the rising geriatric population. In the WHO European Region, in 2023, more than 172,000 individuals with new and relapsed tuberculosis were reported, reflecting numbers similar to those seen in 2022. As older adults are more susceptible to infectious diseases due to weakened immunity, tuberculosis screening and diagnostic measures are becoming essential in elderly care. Healthcare systems are incorporating tuberculosis testing into routine evaluations for seniors, particularly in long-term care settings. With aging populations concentrated in urban centers, diagnostic services are being tailored to accommodate this demographic. Innovations in non-invasive testing and mobile diagnostic units are facilitating access for older patients. The growing burden of age-related comorbidities increases the demand for precise and early detection tools. Policymakers are integrating tuberculosis diagnostics into geriatric health strategies, emphasizing preventative care.
Latin America Tuberculosis Diagnostics Market Analysis
Latin America is witnessing increased tuberculosis diagnostics adoption due to the expansion of healthcare facilities and privatization. The Brazilian Federation of Hospitals (FBH) and the National Confederation of Health (CNSaude) report that 62% of Brazil's 7,191 hospitals are privately owned. The region is investing in modern medical infrastructure, resulting in enhanced diagnostic capabilities. Privatized healthcare models are introducing competitive, patient-centric services that prioritize accurate tuberculosis detection. New diagnostic centers and private clinics are improving access and efficiency in early-stage tuberculosis testing.
Middle East and Africa Tuberculosis Diagnostics Market Analysis
The Middle East and Africa are recording growth in tuberculosis diagnostics adoption driven by increasing healthcare expenditure. For instance, in 2021, the overall prevalence of latent tuberculosis infection (LTBI) in the MENA region was determined to be 41.78%. In gender-specific subgroup analyses, the LTBI prevalence was 33.12% in males and 32.65% in females. The government and private sectors are investing heavily in healthcare infrastructure, leading to greater availability of diagnostic tools. Rising financial commitment is enabling the procurement of advanced equipment and training of professionals in tuberculosis testing.
The tuberculosis diagnostics market is witnessing significant advancements through various avenues, including product launches, partnerships, funding, government initiatives, and research and development. Companies are focusing on introducing innovative diagnostic tools, while collaborations between organizations aim to enhance treatment and diagnostic capabilities. Increased funding is being directed toward the development of advanced diagnostics, particularly for drug-resistant strains. Government initiatives, such as national programs and free diagnostics, are crucial for broadening access to care. Research efforts are geared toward improving and standardizing diagnostic technologies. Currently, government initiatives and partnerships are the most common practices, reflecting a collaborative approach to tackling tuberculosis through better diagnostic solutions.