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市場調査レポート
商品コード
1792655
結核診断市場:市場規模・シェア・動向・予測、病期別、検査の種類別、エンドユーザー別、地域別(2025~2033年)Tuberculosis Diagnostics Market Size, Share, Trends and Forecast by Disease Stage, Test Type, End-User, and Region, 2025-2033 |
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結核診断市場:市場規模・シェア・動向・予測、病期別、検査の種類別、エンドユーザー別、地域別(2025~2033年) |
出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 140 Pages
納期: 2~3営業日
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世界の結核診断の市場規模は2024年に26億1,000万米ドルとなりました。今後、IMARC Groupは、2033年には37億9,000万米ドルに達し、2025~2033年のCAGRは4.01%になると予測しています。北米が市場を独占し、2024年には35.7%以上の大きな市場シェアを占める。先進医療、政府の強力な支援、高い認知度、技術革新などが、結核診断市場シェアに貢献している市場促進要因の一部です。
市場は主に、特に新興国市場における結核の世界の有病率の増加が牽引しています。分子検査や核酸増幅検査などの診断技術の進歩により、結核の検出精度、スピード、感度が向上し、革新的な診断ソリューションに対する需要が高まっています。さらに、結核の蔓延を抑制するために早期かつ迅速な診断が重視されるようになったことで、より迅速な結果を得るための自動化システムやデジタルプラットフォームの導入が進んでいます。NGOやWHOのような世界の保健機関からの支援に加え、政府のイニシアチブが結核対策プログラムへの資金を増加させており、結核診断市場の成長をさらに後押ししています。結核に対する意識の高まり、より効率的な診断ツールの必要性、統合された医療ソリューションの推進などが、結核診断市場の拡大に寄与しています。
米国では、最近の結核診断の進歩は、効率性を高めるための検査プロセスの自動化に焦点を当てています。FDAが承認した新しいプラットフォームは、ラボのスループットを向上させ、より迅速で正確な結果を提供し、潜在性結核の制圧に向けた世界の取り組みを支援しています。これらの技術革新は、診断手順の精度を確保しながら、ワークフローを合理化しています。例えば、2025年4月、レヴィティはT-SPOT.TB検査と統合されたAuto-Pure 2400プラットフォームについて、潜伏結核診断を自動化し強化するためのFDA承認を取得しました。この承認されたソリューションにより、正確な結果とともにラボのスループットが向上し、世界の結核対策に貢献します。
診断強化のための結核ゲノムシークエンシングの進歩
結核菌分離株のゲノム配列決定における最近の進歩は、結核診断市場を大幅に強化しています。このイニシアチブは耐性プロファイリングを加速し、より迅速で正確な診断法を可能にすることを目的としています。遺伝子マーカーを特定することで、シークエンシングの取り組みは臨床上の意思決定を改善し、より個別化された治療戦略を可能にします。結核サーベイランスにおけるゲノムシークエンシングの利用拡大により、結核の地域変異や薬剤耐性パターンに対する理解が深まります。このような分子レベルでの洞察により、診断ツールが改良され、結核の迅速な発見とより効果的な管理が可能になると期待されています。現在進行中のゲノムシークエンシングの開発は、結核診断に革命をもたらし、治療成績を向上させ、世界の結核撲滅目標を達成するための努力を支援します。例えば、2025年3月現在、インドはDare2eraD結核プログラムの一環として、10,000株の結核菌のゲノム配列決定を完了しており、WHOの2030年目標よりも早く結核を撲滅することを目指しています。この画期的な研究により、結核診断が強化され、耐性菌プロファイリングが迅速化され、治療成績が改善されます。DBT、CSIR、ICMRが主導するこのイニシアチブでは、32,000株以上の分離株の塩基配列を決定し、結核サーベイランスと臨床的意思決定に革命を起こす予定です。
多剤耐性結核への懸念の高まりが診断技術革新を促進
多剤耐性結核(MDR-TB)とリファンピシン耐性結核(RR-TB)の増加は、結核診断市場の見通しに大きな影響を与えています。これらの薬剤耐性結核菌は世界的に多数の死者を出し続けているため、これらの感染症を迅速かつ正確に特定する高度な診断ソリューションが急務となっています。イソニアジドやリファンピシンのような主要な抗菌薬による治療に抵抗するMDR-TBがもたらす課題は、迅速な耐性検出とプロファイリングの重要性を浮き彫りにしています。このような耐性株の早期かつ正確な同定の必要性から、耐性パターンを検出し、治療戦略を導くことができる分子検査やゲノム検査など、より高度な診断ツールに対する需要が高まっています。耐性結核菌の増加は、治療成績を改善し死亡率を低下させるために、より優れた、より迅速な診断方法の開発を後押ししています。WHOによると、多剤耐性結核(MDR-TB)とリファンピシン耐性結核(RR-TB)は、2023年に世界で推定15万人の死亡を引き起こします。MDR結核は、結核に対する最も強力な抗菌薬のひとつとされるイソニアジドとリファンピシンに耐性を持つ細菌によって引き起こされます。
全国的な結核撲滅キャンペーンが診断需要を後押し
インドの国家結核撲滅プログラム(NTEP)の下での全国的な結核撲滅キャンペーンの開始は、結核診断業界に大きな影響を与えています。全国多数の地区を対象とするこのイニシアチブは、広範なスクリーニング活動を通じて結核の発見と治療を強化することを目的としています。この大規模なキャンペーンにより、潜在性結核と活動性結核の両方を効率的に特定できる迅速で正確な診断ツールの需要が高まっています。このプログラムでは早期診断と結核感染の減少に重点が置かれているため、分子検査法や迅速検査法などの高度な診断ソリューションに対するニーズが高まっています。結核診断の市場予測によれば、検査インフラの拡大とタイムリーな介入への注力により、革新的な結核診断技術の採用がさらに促進され、最終的には結核対策の改善と治療対応の迅速化に寄与することが示唆されています。例えば、2024年12月、インドでは国家結核撲滅プログラム(NTEP)のもと、33州および連邦直轄領の347地区にまたがる100日間結核撲滅キャンペーンが開始されました。
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.