중증근무력증 - 시장 인사이트, 역학 및 시장 예측(-2034년)
Myasthenia Gravis - Market Insight, Epidemiology And Market Forecast - 2034
상품코드 : 1544151
리서치사 : DelveInsight
발행일 : 2024년 08월
페이지 정보 : 영문 287 Pages
 라이선스 & 가격 (부가세 별도)
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한글목차

주요 7개국의 중증근무력증 시장 규모는 2023년 약 49억 5,000만 달러에 달했습니다. 예측 기간 동안 상당한 성장이 예상됩니다. 주요 7개국 중 미국이 2023년 약 76%로 가장 큰 시장 점유율을 차지했으며, EU 4개국과 영국이 2023년 약 8억 9,300만 달러의 시장을 차지했으며, 이는 상당한 CAGR로 증가할 것으로 예상됩니다. 유럽 국가 중 독일은 2023년 가장 큰 시장 점유율을 차지했으며 영국, 프랑스, 이탈리아가 그 뒤를 이었습니다. 스페인은 같은 해 시장 점유율이 가장 낮습니다.

중증근무력증 치료제 전체 시장 규모는 니포칼리맙, 바토클라맙, 데스카르테스-08과 같은 새롭고 효과적인 치료제의 등장으로 예측 기간 동안 성장할 것으로 예상됩니다.

근이영양증 협회에 따르면 중증근무력증은 면역계가 신체 조직을 공격하는 자가면역질환입니다. 중증근무력증은 신경과 근육의 결합, 즉 신경근접합부(neuromuscular junction)를 공격하여 신경과 근육의 결합을 방해합니다.

중증근무력증에서 가장 흔한 자가항체 표적은 니코틴성 아세틸콜린 수용체(ACHR)이며, 그 다음으로 근육특이적 키나아제(MuSK)와 지단백질 수용체 관련 단백질 4(LRP4)가 있습니다. 중증근무력증은 특정 근육군을 포함한 무통성, 가변성, 피로성 근력 저하를 나타냅니다. 가장 전형적인 초기 증상은 비대칭 눈꺼풀 처짐과 양안 복시를 동반한 안근 약화입니다.

중증근무력증의 임상 진단은 근전도 검사, 약리학 검사 및 혈청 Ab 측정에 의해 확정됩니다. 근전도 검사에서 양성인 경우 NMT의 시냅스 후 장애, 콜린 에스테라제 억제제(ChE-Is)에 대한 임상 반응은 중증근무력증 진단을 뒷받침하고, 특정 Abs의 검출은 중증근무력증을 확정하고 Ab 관련 하위 그룹을 식별합니다. 표준 분석에서 ACHR과 MuSK가 검출되지 않는 환자에서는 근전도 검사를 통한 확인이 중요합니다.

현재 치료법은 확립되어 있지 않습니다. 사용 가능한 치료법은 증상을 조절할 수 있으며, 많은 경우 비교적 높은 삶의 질을 유지할 수 있습니다.

중증근무력증의 주요 치료법으로는 콜린에스테라아제 효소 억제제, 면역억제제 및 생물학적 요법이 일반적으로 사용됩니다. 이러한 표준 치료로 증상이 호전되지 않거나 빠른 증상 완화가 필요한 경우, 혈장 요법이나 면역글로불린 정맥주사 요법이 사용되기도 합니다. 이러한 치료는 근위축성 근위축증의 위기 상황에서 특히 유용합니다.

이 보고서는 주요 7개국 중증근무력증 시장을 조사하여 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 의료 미충족 수요 등을 제공합니다.

목차

제1장 중요한 인사이트

제2장 보고서 소개

제3장 중증근무력증 시장 개요

제4장 역학과 시장 예측 조사 방법

제5장 주요 요약

제6장 주요 사건

제7장 질환 배경과 개요

제8장 역학과 환자 인구

제9장 환자 동향

제10장 출시 약제

제11장 신흥 치료제

제11장 새로운 치료법

제12장 중증근무력증 : 시장 분석

제13장 주요 오피니언 리더의 견해

제14장 SWOT 분석

제15장 미충족 수요

제16장 시장 접근과 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

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영문 목차

영문목차

Key Highlights:

DelveInsight's "Myasthenia Gravis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the myasthenia gravis, historical and forecasted epidemiology and the Myasthenia Gravis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The myasthenia gravis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Myasthenia Gravis market size from 2020 to 2034. The report also covers current Myasthenia Gravis treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered:

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Myasthenia Gravis Overview

According to the Muscular Dystrophy Association, myasthenia gravis is an autoimmune disease when the immune system attacks the body's tissues. In myasthenia gravis, that attack interrupts the connection between nerve and muscle-the neuromuscular junction.

The most common target of pathogenic autoantibodies in myasthenia gravis is the nicotinic acetylcholine receptor (AChR), followed by a muscle-specific kinase (MuSK) and lipoprotein receptor-related protein 4 (LRP4). Myasthenia gravis presents with painless, fluctuating, fatigable weakness involving specific muscle groups. The most typical initial presentation includes ocular weakness with asymmetric ptosis and binocular diplopia, while the less common presentation includes early or isolated oropharyngeal or limb weakness.

Myasthenia Gravis Diagnosis

The clinical diagnosis of Myasthenia gravis is confirmed by electromyography (EMG) studies, pharmacologic testing, and serum Ab assay. Positive results on EMG confirm a postsynaptic defect of the NMT, the clinical response to cholinesterase inhibitors (ChE-Is) supports myasthenia gravis diagnosis, and detection of specific Abs confirms myasthenia gravis and identifies Ab-related subgroups. EMG confirmation is crucial in patients with neither AChR nor MuSK Abs on the standard assay.

Myasthenia Gravis Treatment

Currently, there is no known cure. Available treatments can control symptoms and often allow you to have a relatively high quality of life.

The primary approach for managing myasthenia gravis typically includes the use of cholinesterase enzyme inhibitors, immunosuppressive medications, and biological therapies. In cases where symptoms do not respond well to these standard treatments or when there is a need for quick symptom relief, options such as plasmapheresis or intravenous immunoglobulins may be employed. These interventions are particularly useful during myasthenic crises.

Several emerging treatments for myasthenia gravis are currently in the process of development. These encompass Fc receptor antagonists, Anti C5, Interleukin-6 receptor antagonists, T lymphocyte replacements, and other options.

Myasthenia Gravis Epidemiology

As the market is derived using the patient-based model, the Myasthenia Gravis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Myasthenia Gravis, Gender-specific Diagnosed Prevalent cases of Myasthenia Gravis, Age-specific Diagnosed Prevalent cases of Myasthenia Gravis, Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA classification, Diagnosed Prevalent Cases of Generalized Myasthenia Gravis by Antibody Serology in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034. As per DelveInsight's estimations, the total diagnosed prevalent cases of Myasthenia Gravis in the 7MM were approximately 287 thousand cases in 2023 and are projected to increase during the forecast period.

Myasthenia Gravis Drug Chapters

The drug chapter segment of the Myasthenia gravis report encloses a detailed analysis of myasthenia gravis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands myasthenia gravis clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

SOLIRIS (eculizumab): Alexion, AstraZeneca Rare Disease

SOLIRIS is a first-in-class complement inhibitor that works by inhibiting the terminal part of the complement cascade, a part of the immune system that, when activated in an uncontrolled manner, plays a role in ultrarare severe disorders like anti-acetylcholine receptor (AchR) antibody-positive myasthenia gravis. The drug is designed to have an IV infusion route of administration.

VYVGART (efgartigimod alfa-fcab): Argenx

VYVGART (efgartigimod alfa-fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with gMG who are anti-acetylcholine receptor (AChR) antibody-positive and in Japan for the treatment of adults with gMG who do not have a sufficient response to steroids or nonsteroidal immunosuppressive therapies (ISTs). VYVGART has IV infusion route of administration.

Emerging Drugs

Nipocalimab: Janssen Research & Development, LLC

Nipocalimab (M281) is a high affinity, fully human, aglycosylated, effectors IgG1 anti-FcRn monoclonal antibody. In patients with gMG, nipocalimab is expected to improve nerve-to-muscle signals and muscle function, thus alleviating the clinical signs and symptoms of gMG. The drug is currently being evaluated in a Phase III trial to assess the safety and efficacy of nipocalimab in patients with myasthenia gravis at multiple locations around the globe.

Batoclimab: Immunovant Sciences GmbH

Batoclimab is a novel, fully humanized mAB that inhibits neonatal Fc receptors by blocking FcRn-IgG interactions and accelerating the degradation of autoantibodies. The drug is currently being evaluated in a Phase III trial to assess the efficacy and safety of batoclimab as induction and maintenance therapy in adult participants with gMG.

DESCARTES-08: Cartesian Therapeutics

DESCARTES-08 is the first RNA CAR T-cell (rCAR-T) therapy for autoimmune diseases. DESCARTES-08 contains killer T-cells engineered to hunt down pathogenic plasma cells that secrete autoantibodies. Descartes-08 is a T-cell therapy custom-made from a patient's blood. Cartesian Therapeutics is enrolling patients with gMG in a Phase IIb randomized controlled trial (RCT).

Myasthenia Gravis Market Outlook

Myasthenia gravis has a diverse treatment classification associated with the disease landscape. The management of myasthenia gravis primarily revolves around the utilization of cholinesterase enzyme inhibitors, immunosuppressive agents, biological therapies, and thymectomy as needed.

Refractory treatment options (VYVGART [efgartigimod alfa-fcab]; SOLIRIS; ULTOMIRIS [Ravulizumab (genetical recombination)], Plasma exchange/IVIG, and other therapies) are major revenue generators in the current treatment landscape.

The market for myasthenia gravis is expected to experience positive growth with the approval of potential drugs like Nipocalimab, Batoclimab, Descartes-08, and others.

Myasthenia Gravis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Nipocalimab in the US is expected to be launched by 2025.

Further detailed analysis of emerging therapies drug uptake in the report...

Myasthenia Gravis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Myasthenia Gravis emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on myasthenia gravis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from University of California, UCSF Medical Center, San Francisco; Department of Neurology, University of Virginia, Charlottesville, Virginia, USA; Department of Neurology, Kamillus-Hospital, Asbach, Germany; Dipartimento di Neuroscienze, Universita Cattolica del Sacro Cuore, Rome, Italy; Department of Neurology, National Hospital Organization, Nagasaki Kawatana Medical Center, Nagasaki, Japan, and others.

Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or myasthenia gravis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, 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. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and 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.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, 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.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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.

Scope of the Report:

Myasthenia Gravis Report Insights

Myasthenia Gravis Report Key Strengths

Myasthenia Gravis Report Assessment

Key Questions:

Market Insights

Epidemiology Insights

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

Reasons to Buy:

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Myasthenia Gravis Epidemiology and Market Insight report for the 7MM covers the forecast period from 2023 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the myasthenia gravis market?

The myasthenia gravis market is quite robust. The major players are Janssen Research & Development, LLC; Immunovant Sciences GmbH; Cartesian Therapeutics, and others which are currently developing drugs for the treatment of myasthenia gravis.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the myasthenia gravis market?

The increase in diagnosed prevalent cases of myasthenia gravis and the launch of emerging therapies are attributed to be the key drivers for increasing myasthenia gravis market.

5. What is the expected impact of emerging therapies or advancements in myasthenia gravis treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the myasthenia gravis treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Myasthenia Gravis market.

Table of Contents

1. Key Insights

2. Report Introduction

3. Myasthenia Gravis Market Overview at a Glance

4. Epidemiology and Market Forecast Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

8. Epidemiology and Patient Population

9. Patient Journey

10. Marketed Therapies

11. Emerging Therapies

11. Emerging Therapies

12. Myasthenia Gravis: Market Analysis

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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