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市場調查報告書
商品編碼
1797896
全球泛自閉症障礙診斷市場:預測至 2032 年—按類型、診斷方法、服務、年齡層、分銷管道、最終用戶和地區進行分析Autism Spectrum Disorder Diagnostics Market Forecasts to 2032 - Global Analysis By Type, Diagnostic Method, Service, Age Group, Distribution Channel, End User and By Geography |
根據 Stratistics MRC 的數據,全球泛自閉症障礙診斷市場預計在 2025 年達到 299.9 億美元,預計到 2032 年將達到 566.1 億美元,預測期內的複合年成長率為 9.5%。
自閉症頻譜(ASD) 的診斷需要經過全面的評估,包括發展篩檢和深入評估,由心理學家、神經科和發育小兒科等專家進行。診斷過程的目標是識別限制性和重複性行為、興趣和活動的模式,以及社交溝通和互動方面的持續挑戰。這些症狀應該從幼兒時期就已存在,儘管它們可能在社交需求超出個人能力之前不會完全被察覺。臨床醫生會使用標準化測量方法,例如自閉症診斷觀察量表和自閉症診斷訪談修訂版,並結合來自父母、教育工作者和看護者的回饋。
根據美國疾病管制與美國中心自閉症和發展障礙監測 (ADDM) 網路的數據,2022 年,每 31 名 8 歲兒童中就有 1 名(約 3.2%)被診斷為泛自閉症障礙(ASD)。
提高對自閉症的認知和盛行率
推動診斷市場發展的關鍵因素之一是全球泛自閉症障礙診斷數量的不斷成長。這一成長源於篩檢程序的改進、診斷標準的拓寬、社會和臨床認知的提升,以及實際病例數的增加。社區組織、醫療保健系統和學校對早期徵兆識別能力的提高,也促進了轉診評估的增加。此外,儘管自閉症譜系障礙(ASD)過去相對容易被誤解,但如今許多國家已將自閉症譜系障礙篩檢作為兒童發展計畫的一部分,從而顯著擴展了診斷服務和工具的市場。
訓練有素的專業人員短缺和服務缺口
診斷自閉症譜系障礙 (ASD) 面臨的最大挑戰之一是缺乏熟練的專家,例如發育小兒科、兒童心理學家、神經科和語言病理學家。診斷過程需要大量的培訓和跨學科合作,而這在新興國家和農村地區尤其匱乏。因此,家庭往往需要等待數月甚至數年,導致診斷和早期療育服務延遲。都市區通常擁有更多的資源和專家,這導致獲得醫療服務的機會有顯著差異。診斷速度和品質的地區差異,加上專業知識分佈不均,限制了整體市場的成長。
基因和生物標記研究進展
持續進行的自閉症生物學病因研究發現了一些頗具前景的基因標記、神經影像模式和生化指標,這些指標有可能徹底改變自閉症的診斷方法。基於生物標記的檢測提供了可擴展、早期且客觀的篩檢技術,或許可以補充甚至超越行為評估。隨著對自閉症病因的科學認知不斷進步,診斷技術將得到改進,從而能夠識別不同的自閉症亞型,從而實現更專業的干涉方法。這將提高診斷的準確性和可靠性,並為自閉症治療的個人化醫療策略鋪平道路。
資料隱私和道德問題
許多新的診斷技術,尤其是那些使用人工智慧、行動應用程式和遠端保健平台的技術,都需要收集敏感的個人和行為數據,這些數據通常來自兒童。這些技術引發了嚴重的隱私、知情同意和資料保護問題,尤其是在美國《健康保險互通性與課責法案》(HIPAA)和歐盟《一般資料保護規則》(GDPR)等法律嚴格的司法管轄區。違反保密規定、濫用非醫療資料以及資料所有權不明確可能會損害公眾信任,並阻礙新診斷技術的採用。未能實施強而有力的安全措施和開放隱私權政策的公司不僅可能面臨聲譽受損的風險,還可能面臨法律後果。
新冠疫情泛自閉症障礙(ASD) 診斷市場產生了多方面的影響。最初,封鎖、診所關閉以及對面對面評估的限制導致服務中斷,導致全球範圍內的診斷延誤和漫長的等待時間。安全隱患和專家就診管道受限導致許多家庭延遲診斷,尤其是在醫療資源匱乏的農村地區。然而,這場危機也推動了基於人工智慧的評估、篩檢工具和虛擬行為觀察的進步,以及遠距遠端醫療和遠距離診斷解決方案的快速普及。最終,雖然短期收益受到影響,但疫情透過將遠距離診斷納入標準診療,提高了特定人群的可近性,並在市場中創造了新的成長機會,引發了長期變革。
行為評估部分預計將成為預測期內最大的部分
預計行為評估領域將在預測期內佔據最大的市場佔有率。這些測試是診斷自閉症譜系障礙 (ASD) 的基礎,因為它們專注於仔細觀察患者的社交互動、溝通技巧和重複行為——所有這些都是自閉症的關鍵指標。為了進行全面評估,世界各地的臨床醫生經常使用標準化工具,例如自閉症診斷觀察量表 (ADOS) 和自閉症診斷訪談修訂版 (ADI-R),並經常結合看護者的意見。這些工具因其非侵入性、價格實惠且適用於廣泛年齡層而廣受歡迎。此外,行為評估與教育和醫療保健系統緊密結合,使其易於用於早期篩檢和早期療育。
預計數位評估工具領域在預測期內將實現最高複合年成長率
預計數位評估工具領域將在預測期內實現最高成長率。這得益於基於雲端和人工智慧的App平台的快速普及,這些平台能夠實現對自閉症相關行為的遠端、可擴展和早期篩檢。這些工具價格實惠,並且能快速洞察,非常適合診所、學校和家庭使用。智慧型手機普及率的提高、數位素養的提高以及遠端醫療,進一步推動了這些工具的普及。此外,數位評估工具正在徹底改變自閉症譜系障礙(ASD)的診斷方式,憑藉其即時數據分析、與醫療保健系統的互通性以及方便用戶使用介面的優勢,鞏固了其作為全球成長最快市場的地位。
預計北美將在預測期內佔據最大的市場佔有率,這得益於標準化診斷方法的廣泛應用、較高的認知度以及先進的醫療基礎設施。該地區受益於ASD評估和干涉的保險覆蓋範圍擴大,以及強力的政府和非營利項目鼓勵早期篩檢。其市場主導地位因能夠接觸到頂級診斷公司、高素質臨床專業人員以及基因檢測和基於人工智慧的篩檢工具等最尖端科技而得到進一步加強。此外,北美是全球ASD診斷的中心,這歸因於多種因素,包括自閉症盛行率的不斷上升、大量的研究資金以及醫療保健組織和學術機構之間的強力夥伴關係。
預計亞太地區將在預測期內實現最高的複合年成長率,這得益於政府早期篩檢和早期療育項目的增加、醫療基礎設施的改善以及自閉症意識的不斷提升。農村和半都市區醫療服務可近性的改善正在擴大患者群體,而中國、印度和日本等國家的快速經濟成長也推動了對診斷技術的投資增加。遠端醫療服務和數位評估工具的日益普及,使得診斷更便宜、方便。此外,國際診斷公司與本地醫療服務提供者之間的合作、盛行率的上升以及教育普及率的活性化也推動了該地區市場的成長。
According to Stratistics MRC, the Global Autism Spectrum Disorder Diagnostics Market is accounted for $29.99 billion in 2025 and is expected to reach $56.61 billion by 2032 growing at a CAGR of 9.5% during the forecast period. Autism Spectrum Disorder (ASD) is diagnosed through a comprehensive evaluation that typically involves developmental screening and a detailed assessment by specialists such as psychologists, neurologists, or developmental pediatricians. The goal of the diagnostic process is to find limited, repetitive patterns of behavior, interests, or activities as well as ongoing challenges with social communication and interaction. Although these symptoms may not be completely noticeable until social demands surpass the person's capacity, they must be present from an early age. Together with feedback from parents, educators, and caregivers, clinicians utilize standardized instruments such as the Autism Diagnostic Observation Schedule and the Autism Diagnostic Interview-Revised.
According to data from the U.S. Centers for Disease Control and Prevention's Autism and Developmental Disabilities Monitoring (ADDM) Network, about 1 in 31 eight-year-old children-approximately 3.2%-were identified with Autism Spectrum Disorder (ASD) in 2022.
Growing awareness and prevalence of ASD
One of the main factors propelling the diagnostics market is the increase in diagnoses of autism spectrum disorder worldwide. This growth is a result of improved screening procedures, expanded diagnostic criteria, and increased public and clinical awareness in addition to an actual rise in cases. More referrals for evaluation result from improved early sign recognition by community organizations, healthcare systems, and schools. Furthermore, the market for diagnostic services and tools has grown dramatically as ASD is now actively screened for as part of child development programs in many countries, having previously been a relatively misunderstood condition.
Shortage of trained specialists and service disparities
One of the most important issues in diagnosing ASD is the lack of skilled specialists, such as developmental pediatricians, child psychologists, neurologists, and speech-language pathologists. The diagnostic process necessitates extensive training and interdisciplinary collaboration, but there is a shortage of these specialists, particularly in developing countries and rural areas. Families are consequently frequently faced with lengthy waiting lists, which can last for months or even years. This causes a delay in diagnosis and early intervention services. Because urban areas typically have more resources and specialists, there are glaring differences in the availability of care. Regional disparities in the promptness and quality of diagnosis are exacerbated by the unequal distribution of expertise, which restricts the growth of the entire market.
Developments in genetic and biomarker research
Promising genetic markers, neuroimaging patterns, and biochemical indicators that have been found through ongoing research into the biological causes of autism have the potential to completely transform diagnostics. Tests based on biomarkers may offer scalable, early, and objective screening techniques that supplement or even outperform behavioral evaluations. Diagnostic techniques can be improved to identify distinct subtypes of autism as scientific knowledge of the etiology of ASD grows, allowing for more specialized intervention approaches. This improves diagnosis precision and dependability while also paving the way for personalized medicine strategies in the treatment of ASD.
Concerns about data privacy and ethics
The gathering of sensitive personal and behavioral data, frequently from children, is necessary for many new diagnostic technologies, especially those that use AI, mobile apps, and telehealth platforms. Particularly in areas with stringent laws like the US Health Insurance Portability and Accountability Act (HIPAA) or the EU's General Data Protection Regulation (GDPR), this presents serious questions regarding privacy, consent, and data protection. Confidentiality violations, non-medical data misuse, or ambiguous data ownership could erode public confidence and discourage the use of novel diagnostic techniques. Businesses that neglect to put strong security measures and open privacy policies in place risk legal repercussions as well as harm to their reputation.
The COVID-19 pandemic had a mixed effect on the market for diagnostics for autism spectrum disorder (ASD). At first, lockdowns, clinic closures, and limitations on in-person evaluations caused service disruptions, which resulted in delayed diagnoses and long waiting lists globally. Due to safety concerns or limited access to specialists, many families delayed assessments, especially in underserved and rural areas. But the crisis also spurred advancements in AI-based evaluations, digital screening tools, and virtual behavioural observations, as well as a faster uptake of telehealth and remote diagnostic solutions. The pandemic eventually sparked long-term changes by incorporating remote diagnostics into standard practice, improving accessibility for certain populations, and creating new growth opportunities for the market, even though short-term revenues suffered.
The behavioral assessments segment is expected to be the largest during the forecast period
The behavioral assessments segment is expected to account for the largest market share during the forecast period. These tests serve as the foundation for diagnosing ASD because they concentrate on closely observing a person's social interactions, communication abilities, and repetitive behaviors-all of which are key markers of autism. To ensure thorough evaluation, clinicians around the world frequently use standardized tools like the Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview-Revised (ADI-R), frequently in conjunction with caregiver input. They are very popular because of their non-invasiveness, affordability, and suitability for a range of age groups. Furthermore, behavioral assessments are easily accessible for early screening and intervention because they are intricately woven into the educational and healthcare systems.
The digital assessment tools segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the digital assessment tools segment is predicted to witness the highest growth rate, driven by the quick uptake of cloud-enabled, AI-powered, app-based platforms that allow for remote, scalable, and early screening of behaviors linked to autism. These tools are perfect for use in clinics, schools, and homes because they are affordable, accessible, and provide fast insights. Their adoption has been further accelerated by growing smart phone penetration, rising digital literacy, and the post-pandemic acceptance of telehealth. Moreover, digital assessment tools are revolutionizing ASD diagnostics and establishing themselves as the fastest-growing market in the world by combining real-time data analytics, interoperability with healthcare systems, and user-friendly interfaces.
During the forecast period, the North America region is expected to hold the largest market share, driven by widespread adoption of standardized diagnostic procedures, high awareness levels, and sophisticated healthcare infrastructure. The area benefits from substantial insurance coverage for ASD assessments and interventions, as well as robust governmental and nonprofit programs encouraging early screening. Its market dominance is further reinforced by the presence of top diagnostic companies, highly qualified clinical professionals, and access to cutting-edge technologies like genetic testing and AI-based screening tools. Additionally, North America is the world's leading center for ASD diagnostics due to a number of factors, including growing autism prevalence rates, substantial research funding, and solid partnerships between healthcare organizations and academic institutions.
Over the forecast period, the Asia-Pacific region is anticipated to exhibit the highest CAGR, driven by increased government programs for early screening and intervention, better healthcare infrastructure, and growing awareness of autism. While increasing access to healthcare in rural and semi-urban areas is expanding the patient base, rapid economic growth in nations like China, India, and Japan has resulted in increased investments in diagnostic technologies. Diagnostics are becoming more affordable and accessible due to the growing use of telehealth services and digital assessment tools. Furthermore, the accelerated market growth in this region is also being driven by partnerships between international diagnostic companies and regional healthcare providers, rising prevalence rates, and increased educational outreach.
Key players in the market
Some of the key players in Autism Spectrum Disorder Diagnostics Market include Agilent Technologies Inc., F. Hoffmann-La Roche Ltd., Abbott Laboratories, Cognoa Inc., Thermo Fisher Scientific Inc., Siemens Healthineers, Invitae Corporation, GE Healthcare, Illumina, Inc., GeneDx, PerkinElmer, Inc., Fulgent Genetics, Charles River Laboratories International, Inc., Myriad Genetics, Inc. and Cortica Inc.
In July 2025, Agilent Technologies Inc. announced the recent signing of a Memorandum of Understanding (MOU) with the Nanyang Environment & Water Research Institute, outlining their collaboration in advancing environmental and water research over the next three years. NEWRI is a leading research institute at Nanyang Technological University, Singapore, ranked 13th globally for Environmental Sciences by QS World University Ranking in 2025.
In March 2025, F. Hoffmann-LaRoche Ltd and Danish Zealand Pharma A/S have entered into a license agreement to co-develop and co-commercialise Zealand's Phase II long-acting amylin mimetic petrelintide in weight management of overweigt and obese people. Besides petrelintide monotherapy, Zealand will also help co-develop and co-commercialise drug combos such as petrelintide/CT-388, which Roche got in 2023 from the acquisition of Carmot Therapeutics, in the US and Europe.
In December 2024, Abbott Laboratories and DexCom that they have reached an agreement to settle all patent disputes between them related to continuous glucose monitoring devices. The agreement will dismiss all pending cases in courts and patent offices worldwide, along with a provision preventing legal action between the companies for patent and appearance disputes for the next 10 years.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.