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전두측두엽 치매 : 시장 인사이트, 역학 및 시장 예측(2036년)

Frontotemporal Dementia - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 178 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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전두측두엽 치매(FTD)에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 2025년 주요 시장(미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본)의 FTD 시장 규모는 약 1억 2,000만 달러인 것으로 나타났습니다.
  • FTD는 실행 기능, 행동, 언어에 진행성 기능 장애를 일으키는 신경인지 질환입니다.
  • 전두측두엽 치매(FTD)는 전두측두형 장애라고도 불리며, 드문 질환으로 다른 치매에 비해 젊은 연령대에서 발병하는 경향이 있습니다. 전두측두엽 치매 환자의 약 60%는 45-64세입니다.
  • 증상은 행동이나 정서적 불안정에서부터 의사소통 및 운동 기능 장애에 이르기까지 매우 다양합니다. FTD의 가족력이 있는 사람의 경우 발병 위험이 높으며, 증례의 약 15-40%가 유전자 변이와 관련이 있습니다. 그러나 대부분의 경우 근본적인 원인은 여전히 밝혀지지 않았습니다.
  • 행동형 전두측두엽 치매(bvFTD)는 조기에 인격이나 행동의 변화를 일으키는 반면, 원발성 진행성 실어증(PPA)은 주로 언어 능력을 손상시키지만, 둘 다 보통 중년에 발병합니다.
  • FTD의 유병률을 살펴보면, 돌연변이와 관련된 사례(40%)에 비해 돌연변이가 없는 사례(60%)의 비율이 더 높은데, 이는 FTD 사례의 대부분이 산발성임을 나타내지만, 유전적 요인도 여전히 중요한 역할을 하고 있습니다.
  • FTD 진단에는 다른 질환과 중복되는 다양한 증상, 특이적인 바이오마커의 부재, 그리고 종합적인 임상 평가의 필요성이라는 과제가 있습니다. FTD의 증상은 정신 질환이나 다른 치매와 유사한 경우가 많아 오진이 빈번하게 발생하며, 정확하고 신속한 진단이 어려워지고 있습니다.
  • 현재, FTD를 치료하거나 진행을 지연시키거나 회복시키기 위한 FDA 승인 질환 수정 요법은 존재하지 않습니다. 시중에서 판매되는 치료법은 흥분, 충동성, 우울증 등의 행동 증상에 대한 적응증 외 사용을 통한 대증 요법으로 엄격히 제한되어 있습니다.
  • 현재 FTD의 치료는 주로 항우울제나 항정신병약 등의 약물을 이용한 대증요법이 중심이며, 관리 측면에서는 삶의 질(QOL)을 향상시키기 위한 언어 치료, 행동 중재, 간병인 지원 등의 지지요법에 중점을 두고 있습니다.
  • FTD에는 질환 수정 요법의 부재, 질환 기전에 대한 이해 부족, 조기 진단의 어려움 등 중요한 미충족 의료 수요가 존재합니다. 이러한 요구 사항은 표적 치료법 개발, 바이오마커 기반 진단의 발전, 그리고 환자 치료 개선을 위한 기회를 제공하고 있습니다.

전두측두엽 치매(FTD) 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 FTD 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하는 한편, 세계 각 지역의 시장 규모에 대한 상세한 평가와 성장률 전망(과거 데이터 및 2022-2036년 전망)을 제시하고 있습니다. 본 보고서는 전두측두엽 치매(FTD) 분야의 주요 미충족 요구 사항을 부각시키고, 경쟁 구도와 임상 환경을 분석함으로써 고부가가치의 성장 기회를 도출하며, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

전두측두엽 치매(FTD) 시장을 주도하는 주요 요인

FTD 유병률의 증가

FTD의 전반적인 유병률은 특히 중년층에서 증가하고 있으며, 이것이 시장 성장의 주요 촉진요인이 되고 있습니다. 미국에서는 2025년에 약 13만 300건의 FTD 진단 사례가 확인되었으며, 인식 제고, 진단 기술의 발전, 그리고 고령화의 진행에 따라 2036년까지 그 수가 더욱 증가할 것으로 예상됩니다.

유전자 치료 분야의 기회 확대

유전자 치료는 프로그라눌린이나 C9orf72와 같은 근본적인 유전자 변이를 표적으로 삼아 교정함으로써, 장기적인 질병 경과를 변화시킬 가능성을 지니고 있어 FTD 치료에 유망한 기회를 제공하고 있습니다. 최신 연구에서는 근본적인 원인을 해결하기 위한 유전자 치환, 안티센스 올리고뉴클레오티드 및 기타 정밀 의료 접근법의 가능성이 강조되고 있으며, 이는 혁신적인 치료법 개발을 위한 큰 기회를 마련하고 있습니다.

전두측두엽 치매(FTD)의 이해와 치료 알고리즘

전두측두엽 치매(FTD)의 개요와 진단

FTD는 기억 장애, 추상적 사고 및 추론 능력 저하, 실행 기능 장애와 같은 지적 기능 상실을 특징으로 하는 신경퇴행성 질환이며, 그 증상은 일상생활에 지장을 줄 정도로 심각합니다. 임상 증상으로는 행동 변화, 식습관 변화, 공감 능력 상실, 무관심, 실행 기능 장애 등이 포함됩니다. 65세 미만 환자에서 두 번째로 흔한 치매 유형입니다.

전두측두엽 퇴행증을 유발하는 질환은 여러 가지가 있습니다. 그중에서도 특히 대표적인 것은 타우 단백질이 관련된 뇌 질환군과 TDP43이라 불리는 단백질이 관련된 뇌 질환군, 이 두 가지입니다.

전두측두엽 치매(FTD)의 진단

FTD는 다른 신경계 질환과 증상이 겹치기 때문에 진단 과정이 복잡합니다. FTD에 대한 단일하고 결정적인 검사 방법은 존재하지 않기 때문에 의료진은 여러 가지 진단 방법을 활용하고 있습니다. 임상 평가는 행동 및 인지 측면의 증상을 평가하는 데 있어 매우 중요한 역할을 하며, FTD를 다른 형태의 치매와 구별하는 데 도움이 됩니다. 또한, 유사한 증상을 유발할 가능성이 있는 간 질환이나 신장질환 등 다른 질환을 배제하기 위해 혈액 검사를 실시하는 경우가 많습니다. 또한, 신경심리학적 검사는 추론 능력이나 기억력을 평가하는 데 도움이 되며, FTD에 특유한 인지 기능 장애에 대한 추가적인 인사이트를 제공합니다. 뇌 영상 진단 기술 또한 진단에 있어 필수적입니다. 자기공명영상(MRI)은 전두엽 및 측두엽의 구조적 변화를 감지하는 데 도움이 되며, 플루오로데옥시글루코스 양전자 단층촬영(FDG-PET) 검사는 대사 저하 부위를 파악하는 데 유용하며, 이는 신경퇴행을 시사할 수 있습니다.

전두측두엽 치매(FTD)의 치료

현재 병태를 변화시키는 치료법은 승인되지 않았기 때문에 FTD의 치료는 주로 대증요법으로 이루어집니다. 행동이나 정서적 증상을 관리하기 위해 항우울제나 항정신병약 등의 약물이 일반적으로 사용됩니다. 언어청각치료는 특히 원발성 진행성 실어증의 경우, 의사소통에 어려움을 겪는 환자들을 돕는 데 기여합니다. 행동 중재 및 작업 치료를 포함한 지지요법은 일상생활 기능을 유지하는 데 중요한 역할을 합니다. 또한, 환자의 전반적인 삶의 질(QOL)을 향상시키기 위해서는 간병인에 대한 지원과 상담도 필수적입니다.

전두측두엽 치매(FTD)의 역학

전두측두엽 치매(FTD)의 역학 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight의 분석에 따르면, 주요 7개국에서 FTD로 진단받은 환자 수는 2025년에 약 13만 300명으로 추정되며, 예측 기간(2026-2036년) 동안 상당한 연평균 성장률(CAGR)을 기록하며 증가할 것으로 전망됩니다.
  • FTD는 전체 치매 사례의 10-20%를 차지하는 것으로 추정됩니다.
  • G7 국가에서 FTD 사례 중 비율이 가장 높았던 것은 bvFTD였으며, 반면 사례 수가 가장 적었던 것은 언어형 FTD(원발성 진행성 실어증)였습니다.
  • EU4 및 영국에서는 독일과 이탈리아에서 감소 추세가 관찰되고 있으며, 이들 국가에서는 예측 기간(2026-2036년) 동안 FTD로 진단받은 유병 사례 수가 감소할 것으로 예상됩니다.
  • 2025년, 미국에서는 C9orf72(약 40%) 유전자 특이적 FTD로 진단된 유병 사례가 가장 많았으며, 그 다음으로 GRN(프로그라눌린) 유전자 특이적 변이와 관련된 사례가 기록되었습니다.

전두측두엽 치매(FTD) 시장의 전망

FTD는 다양한 임상 증상과 근본적인 병태를 지닌 이질적인 신경퇴행성 질환군으로, 주로 타우 단백질 또는 TDP-43 단백질의 응집이 관련되어 있습니다. 현재 승인된 질병 경과 조절 요법이나 근치 요법은 없으며, 치료는 여전히 주로 대증 요법에 그치고 있습니다. 행동 및 정신 증상의 관리에는 SSRI, 항우울제, 항정신병약 등의 약물 치료 외에도 비약물적 치료(행동 치료, 언어 치료, 작업 치료)가 주를 이룹니다. 특히, 콜린에스테라제 억제제나 NMDA 수용체 길항제는 그 효능이 제한적이거나 일관성이 부족하며, 일부 환자의 경우 증상을 악화시킬 가능성이 있습니다.

후기 임상시험의 실패나 개발 프로그램의 중단에서 알 수 있듯이, FTD 치료제 개발은 여전히 큰 과제에 직면해 있습니다. 예를 들어, 알렉터(Alector)사의 라토지네맙(AL001)은 3상 임상시험에서 주요 평가 지표를 달성하지 못해 개발이 중단되었습니다. 또한, 프레베일 테라퓨틱스(Preveil Therapeutics)의 유전자 치료 프로그램 'PR006'도 중단되었으며, 이로 인해 이 분야의 높은 개발 실패 위험과 임상적 성공의 어려움이 여실히 드러나고 있습니다.

이러한 좌절에도 불구하고, 파이프라인은 활발하게 전개되고 진화를 거듭하고 있으며, 정밀 의학 및 유전자 기반 접근법에 중점을 두고 있습니다. 안티센스 올리고뉴클레오티드, 단일클론 항체, 신경염증을 표적으로 하는 치료법 등 새로운 전략에 더해, 유전학 및 바이오마커 개발의 진보로 인해 FTD의 질병 수정 치료에 대한 미래의 가능성이 계속해서 확대되고 있습니다.

전반적으로, 동종 최초의 치료법 등장, 진단 기법의 개선, 그리고 이 질환에 대한 인식 제고가 2022년부터 2036년까지 주요 7개국 규모의 FTD 시장을 꾸준한 성장으로 이끌 것으로 예상됩니다.

  • 추산에 따르면, FTD의 시장 규모가 가장 컸던 곳은 미국으로, 2025년에는 약 8,000만 달러에 달할 것으로 예상됩니다.
  • 미국은 2025년 주요 7개국(G7)의 전두측두엽 치매 시장 규모 중 약 70%를 차지하며, 다른 주요 시장인 EU4 국가(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본과 비교해 가장 큰 시장 규모를 보였습니다.
  • FTD 시장은 연구가 대증요법에서 표적 치료 및 유전자 치료로 전환됨에 따라 변화하고 있으며, 임상에서 높은 실패율이나 후기 개발 단계에서의 개발 중단과 같은 과제가 지속되고 있음에도 불구하고, 안티센스 올리고뉴클레오티드나 신경염증을 표적으로 하는 약물 등 정밀 의료 접근법에 대한 관심이 높아지고 있습니다.
  • PBFT02나 DNL593과 같은 초기 단계의 후보 약물 및 기타 신흥 치료법의 등장으로 인해, 예측 기간 동안 FTD 치료 분야에서의 경쟁이 심화될 것으로 예상됩니다.
  • 유전자 치료 : PBFT02(Passage Bio) 및 AVB-101(AviadoBio) 등의 후보 약물은 AAV(아데노연관바이러스) 기반 전달 시스템을 이용하여 프로그란린 유전자의 치환을 실현하고 있으며, 유전적으로 확인된 FTD 환자 집단에서 장기적인 질병 경과 수정을 위한 유망한 접근법으로 주목받고 있습니다.
  • 단백질 대체 요법 : DNL593(Denali Therapeutics사)은 재조합 프로그라린 단백질 요법으로 설계되었으며, 정맥 주사를 통해 투여됩니다. 이는 FTD-GRN 환자의 단백질 농도 저하를 회복시키고, 질환의 병태를 개선하는 것을 목적으로 합니다.
  • 표적 지향형 저분자 화합물 : 경구용 소트릴린 억제제인 VES001(Vesper Bio)은 세포 내 수송 경로의 조절을 통해 프로그란린 수치를 증가시키는 방식으로 작용하며, FTD에 대한 경구용 기전 기반 치료법의 가능성을 부각시키고 있습니다.

전반적으로, 유전자 및 단백질 대체 요법이 초기 단계의 혁신을 주도하고 있는 반면, 저분자 화합물은 확장성이 높고 침습성이 낮은 치료 옵션을 제공하고 있으며, 임상 및 개발상의 과제가 지속되고 있음에도 불구하고, 이러한 요소들이 결합되어 다양화되고 지속적으로 진화하는 FTD 치료 환경을 형성하고 있습니다.

자주 묻는 질문

  • 전두측두엽 치매(FTD) 시장 규모는 어떻게 예측되나요?
  • 전두측두엽 치매(FTD)의 유병률은 어떻게 변화하고 있나요?
  • 전두측두엽 치매(FTD) 치료에 사용되는 약물은 무엇인가요?
  • 전두측두엽 치매(FTD)의 진단 과정에서 어떤 어려움이 있나요?
  • 전두측두엽 치매(FTD) 치료의 주요 미충족 요구 사항은 무엇인가요?
  • 전두측두엽 치매(FTD) 시장의 성장 요인은 무엇인가요?

목차

제1장 주요 인사이트

제2장 소개

제3장 주요 요약

제4장 주요 사건

제5장 역학 및 시장 예측 조사 방법

제6장 전두측두엽 치매 : 시장 개요

제7장 전두측두엽 치매 : 질환 배경과 개요

제8장 전두측두엽 치매 : 치료 가이드라인

제9장 전두측두엽 치매 : 역학 및 환자 인구

제10장 전두측두엽 치매 : 환자 경과

제11장 신흥 치료제

제12장 전두측두엽 치매 : 주요 7개국 분석

제13장 전두측두엽 치매 : 미충족 수요

제14장 전두측두엽 치매 : SWOT 분석

제15장 전두측두엽 치매 : KOL의 견해

제16장 전두측두엽 치매 : 시장 진입 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM 26.07.20

Frontotemporal Dementia (FTD) Insights and Trends

  • According to DelveInsight's analysis, FTD market size was found to be ~USD 120 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • FTD is a neurocognitive condition causing progressive dysfunction in executive functioning, behavior, and language.
  • FTD, sometimes called frontotemporal disorders, is rare and tends to occur at a younger age than other dementias. About 60% of people with frontotemporal dementia are 45-64 years old.
  • Symptoms can differ significantly, ranging from behavioral and emotional disturbances to difficulties with communication and motor function. Risk is higher in individuals with a family history of FTD, with approximately 15-40% of cases associated with genetic mutations. However, in most cases, the underlying cause remains unknown.
  • Behavioral variant Frontotemporal Dementia (bvFTD) causes early personality and behavioral changes, while Primary Progressive Aphasia (PPA) primarily impairs language abilities, both typically presenting in midlife.
  • The diagnosed prevalence of FTD shows a higher proportion of non-mutated cases (60%) compared to mutation-associated cases (40%), indicating that most FTD cases are sporadic, though a substantial genetic component remains significant.
  • Diagnosing FTD presents challenges due to its varied symptoms that overlap with other conditions, lack of specific biomarkers, and the need for comprehensive clinical assessments. Misdiagnosis is common, as FTD symptoms can mimic psychiatric disorders or other dementias, complicating accurate and timely identification.
  • There are currently no FDA-approved, disease-modifying therapies to cure, slow, or reverse FTD. Market approved options are limited strictly to off-label symptomatic management of behaviors like agitation, impulsivity, and depression
  • Current treatment of FTD is mainly symptomatic, using medications like antidepressants and antipsychotics, while management focuses on supportive care such as speech therapy, behavioral interventions, and caregiver support to improve quality of life.
  • FTD faces key unmet needs, including the lack of disease-modifying therapies, poor understanding of disease mechanisms, and challenges in early diagnosis. These gaps present opportunities for developing targeted treatments, advancing biomarker-based diagnosis, and improving patient care.

DelveInsight's 'Frontotemporal Dementia (FTD) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the FTD, historical and forecasted epidemiology, as well as the FTD market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Frontotemporal Dementia (FTD) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates FTD patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in Frontotemporal Dementia (FTD) and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Frontotemporal Dementia (FTD) Market

Rising FTD Prevalence

The overall prevalence of FTD is increasing, particularly among middle-aged adults, making it a key driver of market growth. In the US, there were ~130,300 diagnosed prevalent cases of FTD in 2025, which are expected to rise further by 2036 due to improved awareness, diagnosis, and an aging population.

Rising Opportunities in Gene Therapy

Gene therapy offers a promising opportunity in FTD by enabling targeted correction of underlying genetic mutations, such as progranulin and C9orf72, with the potential for long-term disease modification. Emerging research highlights the potential of gene replacement, antisense oligonucleotides, and other precision approaches to address root causes, creating significant opportunities for innovative therapeutic development.

Emerging FTD Competitive Landscape

Some of the FTD drugs in clinical trials include PBFT02, DNL593, VES001, AVB-101, TPN-101, and others.

Frontotemporal Dementia (FTD) Understanding and Treatment Algorithm

Frontotemporal Dementia (FTD) Overview and Diagnosis

FTD is a neurodegenerative disorder characterized by loss of intellectual functions, such as memory problems, impaired abstract thinking, reasoning, and executive function that are severe enough to hamper activities of daily living. The clinical manifestations include behaviour changes, dietary changes, loss of empathy, apathy, and executive function. It is the second most common form of dementia in individuals under 65 years of age.

There are a number of different diseases that cause frontotemporal degeneration. The two most prominent are a group of brain disorders involving the protein tau and a group of brain disorders involving the protein called TDP43.

Frontotemporal Dementia (FTD) Diagnosis

FTD is a complex process due to its symptom overlap with other neurological conditions. Since there is no single definitive test for FTD, healthcare professionals rely on multiple diagnostic approaches. Clinical evaluation plays a crucial role in assessing behavioural and cognitive symptoms, helping to differentiate FTD from other forms of dementia. Blood tests are often conducted to rule out other medical conditions such as liver or kidney disease that might cause similar symptoms. Neuropsychological testing further aids in evaluating reasoning and memory skills, offering additional insight into cognitive impairments specific to FTD. Brain imaging techniques are also fundamental in diagnosis; magnetic resonance imaging (MRI) helps detect structural changes in the frontal and temporal lobes, while fluorodeoxyglucose positron emission tomography (FDG-PET) scans identify areas of decreased metabolism, which can indicate neurodegeneration.

Frontotemporal Dementia (FTD) Treatment

FTD treatment is primarily symptomatic, as no disease-modifying therapies are currently approved. Medications such as antidepressants and antipsychotics are commonly used to manage behavioral and emotional symptoms. Speech and language therapy can help patients with communication difficulties, particularly in primary progressive aphasia. Supportive care, including behavioral interventions and occupational therapy, plays a key role in maintaining daily functioning. Caregiver support and counseling are also essential to improve overall patient quality of life.

Frontotemporal Dementia (FTD) Unmet Needs

The section "unmet needs of Frontotemporal Dementia (FTD)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. No disease-modifying therapies or cure available

2. Challenges in early and accurate diagnosis

3. Lack of reliable biomarkers for disease progression

4. High clinical and genetic heterogeneity limiting targeted treatment development

5. Frequent Phase III failures and product discontinuations, reflecting challenges in achieving clinical efficacy in FTD, and others.....

Comprehensive unmet needs insights in frontotemporal dementia (FTD) and their strategic implications are provided in the full report.

Frontotemporal Dementia (FTD) Epidemiology

Key Findings from Frontotemporal Dementia (FTD) Epidemiological Analysis and Forecast

  • According to DelveInsight's analysis, the total diagnosed prevalent cases of FTD in 7MM were found to be ~130,300 in 2025 and are estimated to rise with a significant CAGR throughout the forecast period (2026-2036).
  • FTD represents an estimated 10-20% of all dementia cases.
  • The highest proportion of FTD cases were observed in the bvFTD in the 7MM, while the least cases were found in language variant FTD (primary progressive aphasia).
  • In EU4 and the UK, a decreasing trend in observed for Germany and Italy, where the diagnosed prevalent cases of FTD are expected to decrease throughout the forecast period (2026-2036).
  • In 2025, the US recorded the highest number of diagnosed prevalent cases of C9orf72 (~40%) gene-specific FTD, followed by cases associated with the GRN (Progranulin) gene-specific mutation.

Frontotemporal Dementia (FTD) Drug Chapters & Competitive Analysis

The FTD drug chapter provides a detailed, market-focused review of current treatment and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the FTD treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the FTD therapeutics market.

Frontotemporal Dementia (FTD) Pipeline Analysis

PBFT02: Passage Bio

PBFT02 developed by Passage Bio is a gene therapy that utilizes an AAV1 viral vector to deliver a modified DNA encoding the granulin (GRN) gene to a patient's cells. The company has an active IND from the FDA and approved CTAs in multiple countries, it is currently being evaluated in Phase I/II clinical trials for treating FTD and mutations in the progranulin gene. The company received positive regulatory feedback on the clinical pathway to treat FTD-C9orf72 with PBFT02 in the ongoing upliFT-D trial. Passage Bio reported dosing of the first FTD-C9orf72 patient with Dose 2 PBFT02 in Cohort 4 of the upliFT-D study, with initial safety data to be reviewed by the Independent Data Monitoring Committee (IDMC) before proceeding with parallel enrollment of additional patients.

DNL593: Denali Therapeutics

DNL593 developed by Denali Therapeutics is an investigational, IV administered, brain-penetrant progranulin (PGRN) replacement therapy enabled by Denali's Protein Transport Vehicle (PTV) technology. PGRN is known to promote lysosomal function and have neurotrophic and anti-inflammatory effects. DNL593 uses a "brain shuttle" technology, aka PTV, to restore brain progranulin levels to facilitate the movement of intravenously administered protein across the blood-brain barrier into the central nervous system. Data from the ongoing Phase I/II study of DNL593 had demonstrated dose-dependent increases in CSF progranulin levels, consistent with robust brain delivery of DNL593, in healthy volunteers. Dosing for GRN-related FTD-GRN participants is ongoing.

Frontotemporal Dementia (FTD) Key Players, Market Leaders and Emerging Companies

  • Passage Bio
  • Denali Therapeutics
  • Vesper Bio
  • AviadoBio
  • Transposon Therapeutics
  • Alector, and others

Frontotemporal Dementia (FTD) Drug Updates

  • In April 2026, Denali Therapeutics announced that it had received notification from Takeda of its decision to terminate the collaboration agreement between the two companies to co-develop and co-commercialize DNL593.
  • As of April 2026, Denali Therapeutics announced that enrollment in the Phase I/II study of DNL593 in FTD-GRN has been completed with 40 participants, with biomarker and other study data expected by the end of 2026.
  • As per Passage Bio's 2026 annual report, the company plans to report updated interim safety and biomarker data from Dose 2 of the upliFT-D trial for PBFT02 in FTD-GRN patients and seek regulatory feedback on a registrational trial design in the first half of 2026.
  • In February 2026, Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly & Co., announced the discontinuation of the PR006 "PROCLAIM" drug development program for FTD with GRN variants due to a lack of compelling efficacy in the studied patient population. They remain committed to developing future programs to address the medical need of FTD interventions.
  • In November 2025, Vesper Bio announced a USD 2.5 million strategic investment from the Alzheimer's Drug Discovery Foundation (ADDF) and The Association for Frontotemporal Degeneration (AFTD) through their Treat FTD Fund.
  • In October 2025, Alector announced that its Phase III INFRONT-3 trial of latozinemab (AL001) for progranulin mutation related FTD failed to meet its primary clinical endpoint of slowing disease progression, despite showing biomarker improvement, leading to discontinuation of further studies.
  • In June 2025, Passage Bio, Inc. reported updated biomarker data from its ongoing Phase 1/2 upliFT-D trial evaluating PBFT02 for the treatment of FTD associated with GRN mutations, along with anticipated upcoming milestones.

Drug Class Insights

Frontotemporal Dementia (FTD) Market Outlook

FTD represents a heterogeneous group of neurodegenerative disorders with varied clinical presentations and underlying pathologies, primarily involving tau or TDP-43 protein aggregation. Currently, there is no approved disease-modifying therapy or cure, and treatment remains primarily symptomatic, focusing on non-pharmacological interventions (behavioral, speech, and occupational therapy) alongside medications such as SSRIs, antidepressants, and antipsychotics to manage behavioral and psychiatric symptoms. Notably, cholinesterase inhibitors and NMDA receptor antagonists have limited or inconsistent efficacy and may worsen symptoms in some patients.

FTD drug development continues to face significant challenges, as highlighted by late-stage clinical failures and program discontinuations. For instance, Alector's latozinemab (AL001) failed to meet primary endpoints in a Phase III trial, leading to discontinuation, while Prevail Therapeutics' PR006 gene therapy program has also been discontinued, underscoring the high attrition risk and difficulty in achieving clinical success in this space.

Despite these setbacks, the pipeline remains active and evolving, with a strong focus on precision medicine and gene-based approaches. Emerging strategies such as antisense oligonucleotides, monoclonal antibodies, and neuroinflammation-targeting therapies, along with advances in genetics and biomarker development, continue to offer future opportunities for disease-modifying treatments in FTD.

Overall, the launch of first-in-class therapies, improved diagnostic approaches, and increasing disease awareness are expected to drive steady growth in the 7MM FTD market from 2022-2036.

  • According to the estimates, the largest market size of FTD was captured by the United States, i.e., ~USD 80 million in 2025.
  • The United States accounted for the highest market size of frontotemporal dementia approximately 70% of the total market size in 7MM in 2025, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
  • The FTD market is evolving as research shifts from symptomatic treatments to targeted and gene-based therapies, with growing focus on precision medicine approaches such as antisense oligonucleotides and neuroinflammation-targeting agents, despite ongoing challenges from high clinical failure rates and program discontinuations in late-stage development.
  • The entry of early-stage candidates such as PBFT02, DNL593, and other emerging therapies is expected to increase competitive intensity in the FTD treatment landscape over the forecast period.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Frontotemporal Dementia (FTD) (2022-2036 Forecast)

The FTD pipeline is increasingly focused on gene therapies, protein replacement strategies, and targeted small molecules, reflecting a shift toward precision medicine approaches aimed at addressing underlying genetic drivers such as GRN and C9orf72 mutations.

  • Gene therapies: Candidates such as PBFT02 (Passage Bio) and AVB-101 (AviadoBio) utilize AAV-based delivery systems to enable progranulin gene replacement, representing a promising approach for long-term disease modification in genetically defined FTD populations.
  • Protein replacement therapies: DNL593 (Denali Therapeutics) is designed as a recombinant progranulin protein therapy, administered via IV infusion, aiming to restore deficient protein levels and address disease pathology in FTD-GRN patients.
  • Targeted small molecules: VES001 (Vesper Bio), an oral sortilin inhibitor, works by increasing progranulin levels through modulation of intracellular trafficking pathways, highlighting the potential of oral, mechanism-driven therapies in FTD.

Overall, gene and protein replacement therapies dominate early-stage innovation, while small molecules offer scalable and less invasive treatment options, collectively shaping a diversified and evolving FTD therapeutic landscape, despite ongoing clinical and developmental challenges.

Frontotemporal Dementia (FTD) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the FTD market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The uptake of therapies in FTD during the forecast period (2026-2036) is expected to be gradual and heterogeneous, reflecting the complexity of the disease and the lack of established disease-modifying treatments. Adoption will be influenced by factors such as clinical efficacy, safety profile, cost, route of administration, and physician familiarity.

Emerging therapies are likely to see incremental uptake, particularly in well-defined patient subgroups, while overall market penetration may remain moderate in the near term due to clinical uncertainties and prior late-stage failures. However, as clinical evidence strengthens and novel therapies demonstrate meaningful benefits, uptake is expected to improve, supporting long-term market growth in FTD.

Market Access and Reimbursement of FTD

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Further details are provided in the final report....

Frontotemporal Dementia (FTD) Therapies Price Scenario & Trends

Pricing and analogue assessment of FTD therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Further details are provided in the final report....

Industry Experts and Physician Views for Frontotemporal Dementia (FTD)

To keep up with FTD market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the FTD emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in FTD, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the Johns Hopkins University, Berlin Institute of Health at Charite, UCLA School of Medicine, and others etc. were contacted. Their opinion helps understand and validate current and emerging FTD therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in FTD.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Frontotemporal Dementia (FTD), strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of Frontotemporal Dementia (FTD), explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the Frontotemporal Dementia (FTD) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM FTD market.

Report Insights

  • Frontotemporal Dementia (FTD) Patient Population Forecast
  • Frontotemporal Dementia (FTD) Therapeutics Market Size
  • Frontotemporal Dementia (FTD) Pipeline Analysis
  • Frontotemporal Dementia (FTD) Market Size and Trends
  • Frontotemporal Dementia (FTD) Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year forecast
  • Frontotemporal Dementia (FTD) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Frontotemporal Dementia (FTD) Treatment Addressable Market (TAM)
  • Frontotemporal Dementia (FTD) Competitive Landscape
  • Frontotemporal Dementia (FTD) Major Companies Insights
  • Frontotemporal Dementia (FTD) Price Trends and Analogue Assessment
  • Frontotemporal Dementia (FTD) Therapies Drug Adoption/Uptake
  • Frontotemporal Dementia (FTD) Therapies Peak Patient Share analysis

Report Assessment

  • Frontotemporal Dementia (FTD) Current Treatment Practices
  • Frontotemporal Dementia (FTD) Unmet Needs
  • Frontotemporal Dementia (FTD) Clinical Development Analysis
  • Frontotemporal Dementia (FTD) Emerging Drugs Product Profiles
  • Frontotemporal Dementia (FTD) Market Attractiveness
  • Frontotemporal Dementia (FTD) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Frontotemporal Dementia (FTD) market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of Frontotemporal Dementia (FTD)?
  • What are the disease risks, burdens, and unmet needs of Frontotemporal Dementia (FTD)? What will be the growth opportunities across the 7MM concerning the patient population with Frontotemporal Dementia (FTD)?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of Frontotemporal Dementia (FTD)? What are the current guidelines for treating Frontotemporal Dementia (FTD) in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Frontotemporal Dementia (FTD) market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow
  • 4.4. Key Conference Highlights

5. Epidemiology and Market Forecast Methodology

6. Frontotemporal Dementia (FTD) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of FTD By Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of FTD By Therapies in the 7MM, in 2036

7. Disease Background and Overview of Frontotemporal Dementia (FTD)

  • 7.1. Introduction
  • 7.2. Types
  • 7.3. Symptoms
  • 7.4. Causes
  • 7.5. Pathophysiology
  • 7.6. Diagnosis
  • 7.7. Treatment

8. Treatment Guidelines of Frontotemporal Dementia (FTD)

  • 8.1. Guidelines American College of Physicians and the American Academy of Family Physicians
  • 8.2. The Association for Frontotemporal Dementia (AFTD)

9. Epidemiology and Patient Population of Frontotemporal Dementia (FTD)

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Total Diagnosed Prevalent Cases of FTD in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Diagnosed Prevalent Cases of FTD in the United States
    • 9.4.2. Type-specific Diagnosed Prevalent Cases of FTD in the United States
    • 9.4.3. Mutation-specific Diagnosed Prevalent Cases of FTD in the United States
    • 9.4.4. Gene-specific Diagnosed Prevalent Cases of FTD in the United States
  • 9.5. EU4 and the UK
    • 9.5.1. Total Diagnosed Prevalent Cases of FTD in EU4 and the UK
    • 9.5.2. Type-specific Diagnosed Prevalent Cases of FTD in EU4 and the UK
    • 9.5.3. Mutation-specific Diagnosed Prevalent Cases of FTD in EU4 and the UK
    • 9.5.4. Gene-specific Diagnosed Prevalent Cases of FTD in EU4 and the UK
  • 9.6. Japan
    • 9.6.1. Total Diagnosed Prevalent Cases of FTD in Japan
    • 9.6.2. Type-specific Diagnosed Prevalent Cases of FTD in Japan
    • 9.6.3. Mutation-specific Diagnosed Prevalent Cases of FTD in Japan
    • 9.6.4. Gene-specific Diagnosed Prevalent Cases of FTD in Japan

10. Patient Journey of Frontotemporal Dementia (FTD)

11. Emerging Drugs

  • 11.1. Emerging Competitive Landscape of Frontotemporal Dementia (FTD)
  • 11.2. DNL593: Denali Therapeutics
    • 11.2.1. Drug Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trials Information
    • 11.2.4. Analyst'a Views
  • 11.3. PBFT02: Passage Bio
    • 11.3.1. Drug Description
    • 11.3.2. Other Developmental Activity
    • 11.3.3. Clinical Development
      • 11.3.3.1. Clinical Trials Information
    • 11.3.4. Analyst'a Views
  • 11.4. VES001:Vesper Bio
    • 11.4.1. Drug Description
    • 11.4.2. Clinical Development
      • 11.4.2.1. Clinical Trial Information
    • 11.4.3. Safety and Efficacy
    • 11.4.4. Analyst'a Views

12. Frontotemporal Dementia (FTD): 7MM Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Frontotemporal Dementia (FTD)
  • 12.3. Key Market Forecast Assumptions
    • 12.3.1. Cost Assumptions
    • 12.3.2. Pricing Trends
    • 12.3.3. Analogue Assessment
    • 12.3.4. Launch Year and Therapy Uptakes
  • 12.4. Conjoint Analysis of Frontotemporal Dementia (FTD)
  • 12.5. Total Market Size of FTD in the 7MM
  • 12.6. Total Market Size of FTD by Therapies in the 7MM
  • 12.7. The United States
    • 12.7.1. Total Market Size of FTD in the United States
    • 12.7.2. Total Market Size of FTD by Therapies in the United States
  • 12.8. EU4 and the UK
    • 12.8.1. Total Market Size of FTD in EU4 and the UK
    • 12.8.2. Total Market Size of FTD by Therapies in EU4 and the UK
  • 12.9. Japan
    • 12.9.1. Total Market Size of FTD in Japan
    • 12.9.2. Total Market Size of FTD by Therapies in Japan

13. Unmet Needs of Frontotemporal Dementia (FTD)

14. SWOT Analysis of Frontotemporal Dementia (FTD)

15. KOL Views of Frontotemporal Dementia (FTD)

16. Market Access and Reimbursement of Frontotemporal Dementia (FTD)

  • 16.1. The United States
  • 16.2. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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