市場調查報告書
商品編碼
1462644
到 2030 年免疫腫瘤檢測市場預測:按產品、適應症、技術、應用和地區進行的全球分析Immuno Oncology Assay Market Forecasts to 2030 - Global Analysis By Product, Indication, Technology, Application and By Geography |
根據 Stratistics MRC 的數據,2023 年全球免疫腫瘤檢測市場規模為 50.4 億美元,預計在預測期內年複合成長率為 12.8%,到 2030 年將達到 117.1 億美元。
免疫腫瘤學檢測市場是指醫療保健行業內的一個部門,專注於利用人體免疫系統支持癌症研究和治療的檢測方法的開發和商業化。這些檢測方法在藥物開發中發揮重要作用,能夠評估新型免疫腫瘤治療方法,幫助研究人員識別有前景的候選藥物並評估其療效和安全性。
根據 ECIS 的數據,2040 年歐洲癌症患者人數預計將達到 336 萬人,而 2025 年將達到 294 萬人。
人們對免疫療法的興趣日益濃厚
免疫療法已成為一種有前途的癌症治療方法,它利用人體的免疫系統有效對抗腫瘤。傳統的癌症治療經常遇到抗藥性,並可能產生嚴重的副作用,因此免疫療法很有吸引力,因為它的副作用較少,並且有望產生有針對性的持久反應。免疫腫瘤學檢測對於免疫療法藥物的開發和評估至關重要,使研究人員和臨床醫生能夠評估其療效、安全性和作用機制。
開發成本高
免疫腫瘤學檢測法的研發過程包括廣泛的驗證研究、檢測法通訊協定最佳化和臨床驗證研究,以確保準確性、重現性和法律規章。此類活動需要大量的財務投資,包括設備、試劑、人員和監管備案。對於資源有限的小型企業來說,高昂的初始成本和漫長的開發時間可能會阻礙它們進入市場並與較大的現有企業進行有效競爭。
技術進步
多重檢測、次世代定序(NGS) 和高通量篩檢等技術創新使研究人員能夠以更高的效率和精度同時分析多個參數,從而徹底改變了免疫腫瘤學領域。多重檢測可測量單一樣本中的多種分析物,從而全面了解免疫系統與癌細胞之間複雜的相互作用。 NGS 技術為基因組和轉錄組分析提供了前所未有的機會,有助於識別新型生物標記和治療標靶。
來自替代技術的競爭
液態切片和診斷成像方法等替代技術具有非侵入性、即時監測和全面分子分析等獨特優勢。這些替代技術有可能為癌症進展、治療效果和患者結果提供有價值的見解,並且在許多情況下補充甚至超越免疫腫瘤學測試的能力。因此,研究人員和臨床醫生可能會選擇這些替代方法,特別是在免疫腫瘤學檢測受到樣本可用性、檢測複雜性或成本限制的情況下。
最初,疫情爆發擾亂了供應鏈、實驗室業務和臨床試驗,導致檢測開發、驗證和商業化延遲。對非必要醫療程序和實驗室活動的限制也阻礙了免疫腫瘤學研究的實施以及檢測技術在臨床實踐中的採用。此外,醫療保健資源和資金被用於對抗 COVID-19,從而轉移了對免疫腫瘤學研究和開發的注意力和投資。然而,隨著大流行的進展,免疫學和感染疾病研究的重要性被認知,可能引發對免疫腫瘤學檢測的興趣和投資。
預計消耗品領域在預測期內將是最大的
在預測期內,消耗品領域佔據了市場的最大佔有率,因為它在支持免疫腫瘤檢測的操作和擴充性發揮著至關重要的作用。在癌症發生率上升和免疫療法普及的推動下,對免疫腫瘤檢測的需求持續成長,對耗材的需求也相應成長。此外,檢測開發的創新通常依賴於旨在提高檢測靈敏度、特異性和通量的專用耗材。這創造了免疫腫瘤檢測市場對耗材的持續需求。
流式細胞技術領域預計在預測期內年複合成長率最高
由於流式細胞技術儀在分析免疫細胞群及其在腫瘤微環境中的相互作用方面的多功能性和精確性,預計在預測期內將出現最高的年複合成長率。在單細胞層面同時測量多個參數的能力為了解免疫細胞表現型、活化狀態和功能反應提供了寶貴的見解。此外,流式細胞技術可以評估免疫查核點表達和細胞激素的產生,有助於評估免疫治療效果和患者分層。
在估計期間,亞太地區佔據最大佔有率。隨著人口快速成長、人口老化和生活方式的改變,亞太國家的癌症發病率和死亡率正在迅速上升。都市化、菸草消費、污染和飲食習慣等因素導致該地區癌症發生率增加。因此,醫療基礎設施的改善、診斷服務的獲取以及對癌症篩檢計劃的認知的提高正在導致癌症患者的早期發現和診斷。
預計歐洲地區在預測期內將實現盈利成長。歐洲藥品管理局 (EMA) 和歐盟委員會等歐洲監管機構建立的嚴格法規結構確保了臨床研究和患者治療中使用的免疫腫瘤檢測的安全性、有效性和品質。歐洲法規環境強調透明度、基於證據的決策和道德考慮,這有助於在相關人員之間建立對免疫腫瘤學檢測的信任和信心。因此,監管合規性將透過促進及時進入市場、促進創新以及加速在整個歐洲採用精準醫學和個人化癌症治療的免疫腫瘤學測試來推動市場成長。
According to Stratistics MRC, the Global Immuno Oncology Assay Market is accounted for $5.04 billion in 2023 and is expected to reach $11.71 billion by 2030 growing at a CAGR of 12.8% during the forecast period. The Immuno Oncology Assay Market refers to the sector within the healthcare industry focused on developing and commercializing assays that aid in the study and treatment of cancer by harnessing the body's immune system. These assays play a pivotal role in drug development by enabling the evaluation of novel immuno-oncology therapies, helping researchers identify promising candidates and assess their efficacy and safety profiles.
According to the ECIS, the European cancer burden is expected to reach 3.36 million new cases by 2040, compared to 2.94 million patients in 2025.
Growing interest in immunotherapy
Immunotherapy has emerged as a promising approach for cancer treatment, leveraging the body's immune system to combat tumors effectively. As traditional cancer treatments often encounter resistance and can have severe side effects, the appeal of immunotherapy lies in its potential for targeted and durable responses with fewer adverse effects. Immuno-oncology assays are integral to the development and evaluation of immunotherapeutic agents, allowing researchers and clinicians to assess their efficacy, safety, and mechanism of action.
High development costs
The research and development (R&D) process for immuno-oncology assays involves extensive validation studies, optimization of assay protocols, and clinical validation trials to ensure accuracy, reproducibility, and regulatory compliance. These activities require substantial financial investment, including expenditures on equipment, reagents, personnel, and regulatory submissions. For smaller companies with limited resources, the high upfront costs and long development timelines can be prohibitive, preventing them from entering the market or competing effectively with larger established players.
Technological advancements
Innovations such as multiplex assays, next-generation sequencing (NGS), and high-throughput screening are revolutionizing the field of immuno-oncology by enabling researchers to analyze multiple parameters simultaneously with greater efficiency and precision. Multiplex assays allow the measurement of multiple analytes in a single sample, providing comprehensive insights into the complex interactions between the immune system and cancer cells. NGS technologies offer unprecedented opportunities for genomic and transcriptomic profiling, facilitating the identification of novel biomarkers and therapeutic targets.
Competition from alternative technologies
Alternative technologies such as liquid biopsy assays or imaging modalities offer distinct advantages, such as non-invasiveness, real-time monitoring, and comprehensive molecular profiling. These alternatives may provide valuable insights into cancer progression, treatment response, and patient outcomes, often in ways that complement or surpass the capabilities of immuno-oncology assays. As a result, researchers and clinicians may opt for these alternative approaches, particularly in settings where immuno-oncology assays may be limited by sample availability, assay complexity, or cost.
Initially, the outbreak led to disruptions in supply chains, laboratory operations, and clinical trials, causing delays in assay development, validation, and commercialization. Restrictions on non-essential medical procedures and laboratory activities also hindered the conduct of immuno-oncology research and the adoption of assay technologies in clinical settings. Furthermore, the redirection of healthcare resources and funding towards COVID-19 response efforts diverted attention and investment away from immuno-oncology research and development. However, as the pandemic progressed, there emerged a heightened recognition of the importance of immunology and infectious disease research, potentially stimulating interest and investment in immuno-oncology assays.
The consumables segment is expected to be the largest during the forecast period
Consumables segment dominated the largest share of the market during the forecast period due to its indispensable role in supporting the operation and scalability of immuno-oncology assays. As the demand for immuno-oncology assays continues to rise, fueled by increasing cancer prevalence and the growing adoption of immunotherapy, the need for consumables also escalates proportionally. Moreover, innovations in assay development often rely on specialized consumables designed to improve assay sensitivity, specificity, and throughput. This creates a continuous demand for consumables within the immuno-oncology assay market.
The flow cytometry segment is expected to have the highest CAGR during the forecast period
Flow Cytometry segment is expected to have the highest CAGR during the projection period due to its versatility and precision in analyzing immune cell populations and their interactions within the tumor microenvironment. This segment allows for the simultaneous measurement of multiple parameters at the single-cell level, providing valuable insights into immune cell phenotypes, activation states, and functional responses. Additionally, flow cytometry enables the assessment of immune checkpoint expression and cytokine production, facilitating the evaluation of immunotherapy efficacy and patient stratification.
Asia Pacific region commanded the largest share over the extrapolated period. With a rapidly expanding population, aging demographics, and changing lifestyles, countries across Asia Pacific are experiencing a surge in cancer incidence and mortality rates. Factors such as urbanization, tobacco consumption, pollution, and dietary habits contribute to the rising burden of cancer in the region. As a result, improvements in healthcare infrastructure, access to diagnostic services, and awareness of cancer screening programs are leading to earlier detection and diagnosis of cancer cases in the region thereby enhancing the market growth.
Europe region is poised to witness profitable growth throughout the estimation period. The stringent regulatory framework established by European regulatory bodies, such as the European Medicines Agency (EMA) and the European Commission, ensures the safety, efficacy, and quality of immuno-oncology assays used in clinical research and patient care. The European regulatory environment emphasizes transparency, evidence-based decision-making, and ethical considerations, which contribute to building trust and confidence in immuno-oncology assays among stakeholders. As a result, regulatory compliance serves as a catalyst for market growth by facilitating timely market entry, encouraging innovation, and promoting the adoption of immuno-oncology assays for precision medicine and personalized cancer care throughout the European region.
Key players in the market
Some of the key players in Immuno Oncology Assay market include Agilent Technologies, Inc, Bio-Rad Laboratories, Inc, Charles River Laboratories, Inc, F. Hoffmann-La Roche Ltd, Guardant Health, Inc, HTG Molecular Diagnostics, Inc, llumina, Inc, NanoString Technologies, Inc, Novartis International AG, Perkinelmer, Inc, Qiagen Nv, Sartorius AG, Sysmex Corporation and Thermo Fisher Scientific, Inc.
In January 2024, Thermo Fisher Scientific introduced Gibco(TM) Cell Therapy Systems (CTS(TM)) Cellmation(TM) Software, a new automation solution. It integrates workflows across Thermo Fisher Scientific cell therapy instruments and ensures cGMP compliance for innovators in breakthrough cell therapies.
In March 2023, Mimetas, a company that models human diseases, formed a strategic alliance with Astellas Pharma Inc., a multinational pharmaceutical corporation. The partnership entails using MIMETAS' exhaustive tumor models to assist the next generation of immuno-oncological therapies.
In February 2023, Agilent Technologies, Inc. revealed that their xCELLigence RTCA HT (real-time cell analysis high-throughput) platform is compatible with the BioTek BioSpa 8 Automated Incubator. This combination, developed in response to market demands, enables a higher level of workflow automation and provides novel functionality for developing label-free high-throughput potency assays for the immuno-oncology market and high-throughput viral cytopathic effects (CPE) assays for the vaccine market.