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市場調查報告書
商品編碼
1423588
到 2030 年腫瘤伴同性診斷市場預測:按產品、技術、適應症、最終用戶和地區進行的全球分析Oncology Companion Diagnostic Market Forecasts to 2030 - Global Analysis By Product (Instrument, Consumables and Software), Technology, Indication, End User and By Geography |
根據 Stratistics MRC 的數據,2023 年全球腫瘤伴同性診斷市場規模將達到 35 億美元,預計到 2030 年將達到 94 億美元,預測期內複合年成長率為 14.9%。
腫瘤學中的伴同性診斷是指專門設計用於幫助癌症患者選擇最合適的治療方法或治療策略的診斷方法和測試。透過識別患者腫瘤中的特定生物標記、基因突變和分子特徵,這些測試可以幫助醫療專業人員為個別患者量身定做治療計劃。這些診斷發現了預測患者對特定治療的潛在反應的生物標記。
根據美國癌症協會2022年1月預測,到年終,美國將總合新增190萬癌症病例。此外,患有慢性病的人是美國最常使用伴同性診斷的人,推動了市場的成長。
越來越重視標靶治療和免疫治療
標靶治療和免疫療法通常需要特定的生物標記或基因指紋來進行最佳患者選擇。伴同性診斷對於識別這些預測生物標記至關重要,以便根據患者的分子特徵選擇最佳治療藥物。伴同性診斷有助於將有效的標靶治療和免疫療法更快推向市場。經過驗證的診斷的可用性可透過增加監管機構和醫療保健專業人員對其功效的信心來支持這些治療方法的商業性成功。
開發成本高且報銷有限
由於伴同性診斷的開發成本較高,診斷公司可能會選擇不進行研發。這可能導致缺乏創造力並延遲新的和增強的癌症診斷的發展。由於成本問題,醫療保健系統或付款人可能不願意為伴同性診斷提供資金,這可能會延遲測試的採用。因此,臨床採用可能會被推遲,進一步阻礙市場成長。
能夠縮短臨床試驗時間
有效伴同性更有可能對特定藥物產生反應的患者群體的伴隨診斷可以簡化臨床試驗。將具有特定生物標記或基因譜的患者涵蓋其中有助於更快地在臨床試驗中證明療效,從而有可能縮短開發新藥的時間。補充診斷使臨床試驗能夠更準確地識別和參與最有可能從正在研究的治療中受益的人。因此,密集的患者招募可以減少完成實驗所需的時間和資源,進一步加快受試者招募速度,並為預測期內的市場成長創造廣泛的機會。
監管挑戰和嚴格的核准流程
由於嚴格的監管標準,伴同性診斷通常需要更長的開發時間和更高的開發成本。獲得監管部門的批准需要進行廣泛的臨床前和臨床驗證研究,從而導致更長的開發時間和更高的成本。不同腫瘤類型或病患小組之間生物標記表達的差異可能會對驗證和解釋過程提出挑戰,這可能導致缺乏監管核准。
COVID-19 的影響
醫療保健和其他醫療機構已重新分配人員和設備,以適應 COVID-19 患者的增加。非緊急患者和相關診斷測試的積壓是由於腫瘤學優先事項的轉變,過去將重點放在緊急或嚴重的癌症病例。隨著衛生保健系統適應流行病的障礙,癌症的篩檢、診斷和治療逐漸得到改善。繼續努力解決延期病例和診斷測試的積壓問題,有助於腫瘤伴同性診斷市場的復甦。
次世代定序儀(NGS)領域預計在預測期內規模最大
由於次世代定序對患者腫瘤 DNA、RNA 和其他遺傳資料的全面探索,下一代次世代定序(NGS) 領域預計將出現良好的成長。與傳統的單基因測試相比,它透過同時識別與癌症相關的多個基因突變、改變和生物標記來提供更完整的情況。在選擇合格的患者進行評估新標靶治療和免疫療法的臨床試驗時,基於次世代定序儀的伴同性診斷至關重要且受市場驅動。
預計白血病領域在預測期內的複合年成長率最高。
由於白血病是一種影響骨髓和血液的惡性,因此預計白血病領域在預測期內將出現最高的複合年成長率。白血病是腫瘤伴同性診斷市場的主要部分之一,因為它是一種影響骨髓和血液的惡性。在尋找合格的患者進行測試新型免疫療法、標靶治療或白血病聯合治療的臨床試驗時,伴同性發揮重要作用。伴同性診斷支持創新治療方法和治療方法的創建和評估。
預計北美在預測期內將佔據最大的市場佔有率。這是因為來自美國癌症研究所 (NCI) 等組織的資金加速了精準治療的市場開拓,並對當地市場產生了積極影響。 NCI 的小型企業技術轉移 (STTR) 和小型企業創新研究 (SBIR) 計劃致力於增強和創建用於癌症診斷、預防和治療的尖端工具和解決方案。此外,在加拿大舉行的許多會議旨在提高人們對伴隨診斷發展和趨勢的認知,進一步支持了這種擴張。
由於各種惡性的盛行率不斷增加以及對準確和客製化診斷設備的需求不斷成長,預計亞太地區在預測期內將呈現最高的複合年成長率。使用伴同性診斷識別生物標記有助於為特定患者量身定做治療計劃。患者和醫療保健提供者對伴同性診斷和個人化治療的好處的了解不斷增加,導致其採用率不斷提高。此外,亞太國家不斷上漲的醫療成本也促進了先進診斷技術的取得。
According to Stratistics MRC, the Global Oncology Companion Diagnostic Market is accounted for $3.5 billion in 2023 and is expected to reach $9.4 billion by 2030 growing at a CAGR of 14.9% during the forecast period. Companion diagnostics in oncology refers to diagnostic methods or tests that are intended specially to help cancer patients choose the best therapy or course of treatment. By identifying certain biomarkers, genetic mutations, or molecular features in a patient's tumour, these tests assist medical professionals in customizing treatment plans for individual patients. These diagnostics find biomarkers that predict a patient's potential response to a certain treatment.
According to the American Cancer Society, in January 2022, a total of 1.9 million new cancer cases from cancer are expected to occur in the United States by the end of 2022. Moreover, people with chronic conditions are the most frequent users of companion diagnostics in the United States; they drive the market's growth.
Growing emphasis on targeted therapies and immunotherapies
For the best patient selection, targeted treatments and immunotherapies frequently need for certain biomarkers or genetic fingerprints. In order to match patients with the most appropriate medicines based on their molecular profile, companion diagnostics are essential in the identification of these predictive biomarkers. Complementary diagnostics help effective targeted treatments and immunotherapies reach the market more quickly. The availability of validated diagnostics helps these therapies succeed commercially by boosting the trust of regulators and healthcare professionals in their effectiveness.
High development costs and limited reimbursement
Diagnostic firms may choose not to engage in research and development due to the high development costs involved with companion diagnostics. This can result in a lack of creativity and slow development of fresh, enhanced oncology diagnostic tests. Healthcare systems or payers may be reluctant to fund companion diagnostics owing to cost concerns, which might result in a delayed uptake of the tests. Their incorporation into clinical practice may be delayed as a result and further hamper the growth of the market.
Its ability to reduce clinical trial timelines
Clinical trials can be streamlined by oncology companion diagnostics that effectively identify patient populations likely to react to a certain drug. Trials can prove efficacy faster by including patients with certain biomarkers or genetic profiles, which might shorten the time it takes to create new drugs. Complementary diagnostics enable clinical trials to more accurately identify and enlist people who will most likely benefit from the investigated treatment. Thus, the time and resources required to complete the experiment are decreased as a result of the focused patient recruiting, which speeds up enrolment further creating wide range of opportunities for the growth of the market during the forecast period.
Regulatory challenges and stringent approval processes
Complying with strict regulatory criteria frequently results in longer development times and higher development costs for companion diagnostics. The necessity of conducting extensive preclinical and clinical validation studies in order to obtain regulatory clearance results in longer development times and higher costs. The presence of variability in biomarker expression among distinct tumour types or patient groups might provide challenges to the validation and interpretation process, which may result in regulatory approvals being denied.
Covid-19 Impact
Hospitals and other healthcare institutions reallocated personnel and equipment in order to handle the increase in COVID-19 patients. A backlog of non-urgent patients and accompanying diagnostic tests resulted from priorities shifting in oncology departments, which were centered on urgent or critical cancer cases. Cancer screenings, diagnoses, and treatments have gradually improved as healthcare systems have adjusted to the obstacles presented by the epidemic. Ongoing initiatives to clear the backlog of postponed cases and diagnostic testing have contributed to the market recovery for cancer companion diagnostics.
The next-generation sequencing (NGS) segment is expected to be the largest during the forecast period
The next-generation sequencing (NGS) segment is estimated to have a lucrative growth, because of comprehensive study of a patient's tumor DNA, RNA, and other genetic data which is made possible by next-generation sequencing. Comparing it to conventional single-gene testing, it allows for the simultaneous identification of several genetic mutations, changes, and biomarkers linked to cancer, yielding a more complete picture. When it comes to selecting patients who are qualified for clinical trials evaluating new targeted treatments or immunotherapies, next-generation sequencing -based companion diagnostics are essential thus propelling the market.
The leukemia segment is expected to have the highest CAGR during the forecast period
The leukemia segment is anticipated to witness the highest CAGR growth during the forecast period, as leukemia is a malignancy that affects the bone marrow and blood. It is one of the major segments of the oncology companion diagnostic market. As soon as it comes to finding qualified individuals for clinical trials testing novel immunotherapies, targeted therapies, or combination treatments for leukemia, companion diagnostics play a crucial role. They aid in the creation and assessment of innovative therapies and therapeutic approaches.
North America is projected to hold the largest market share during the forecast period owing funding from organizations like the National Cancer Institute (NCI) would hasten the development of precision therapies and have a favorable impact on the regional market. The NCI's Small Business Technology Transfer (STTR) and Small Business Innovation Research (SBIR) programs work to enhance and create cutting-edge tools and solutions for cancer diagnosis, prevention, and treatment. Furthermore, a number of conferences held in Canada to raise awareness of the developments and trends in CDx serve as an additional boost to this expansion.
Asia-Pacific is projected to have the highest CAGR over the forecast period, owing to growing incidence of different malignancies has increased need for accurate and customized diagnostic instruments. The identification of biomarkers using companion diagnostics facilitates the customization of treatment plans for specific patients. Adoption has expanded as a result of patients' and healthcare professionals' growing understanding of the advantages of companion diagnostics and tailored treatment. Furthermore, access to sophisticated diagnostic technologies has been made easier by the growing cost of healthcare in a number of Asia Pacific nations.
Key players in the market
Some of the key players profiled in the Oncology Companion Diagnostic Market include Roche Ltd., F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Inc., Illumina, Inc., Agilent Technologies, Inc., Abbott, Invivoscribe, Inc., bioMerieux SA, Myriad Genetics, Inc., ARUP Laboratories, QIAGEN N.V., Agendia N.V, Biogenex Laboratories, Inc., GE Healthcare, Life Technologies Corporation, Ventana Medical Systems, Inc., Labcorp Drug Development, Leica Biosystems, MolecularMD Corporation and Dako, Inc.
In December 2023, Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, including three clinical stage assets with best-in-class potential in obesity and diabetes.
In November 2023, Roche launches automated serology hepatitis E virus tests, including a test to detect acute HEV infections, recommended in the new WHO 2023 Essential Diagnostics List. The tests complete Roche's panel used for the differential diagnosis of acute viral hepatitis caused by the hepatitis A, B, C and E viruses.
In November 2023, Thermo Fisher Scientific & Flagship Pioneering Expand Ongoing Strategic Partnership to Jointly Create New Platform Companies with First-in-Class Enabling Technologies for Life Sciences.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.