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시장보고서
상품코드
2018980
만성 염증 탈수 초다발 신경병증(CIDP) : 시장 인사이트, 역학, 시장 예측(2036년)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
만성 염증 탈수 초다발 신경병증(CIDP) 시장의 주요 촉진제
CIDP 유병률 증가
12elveInsight의 추정에 따르면, 2023년 주요 7개 시장에서 만성 염증 탈수 초다발 신경병증(CIDP) 진단을 받은 환자 수는 약 4만 5,000명에 달했습니다. 이러한 환자 수는 2036년까지 더 늘어날 것으로 예측됩니다. 예측 기간 동안 CIDP 환자 수 증가는 진단 능력의 향상, 의료진의 인식 개선, 진단 기술의 발전에 기인하는 것으로 보입니다.
VYVDURA 승인
VYVDURA가 일본에서 CIDP 치료제로 승인된 것은 치료 환경의 큰 진전을 의미합니다. CIDP 치료제로 승인된 최초이자 유일한 신생아 Fc 수용체(FcRn) 억제제인 VYVDURA는 독자적인 작용기전과 집에서 자가 주사할 수 있는 편의성을 제공하며, ADHERE 연구와 실제 임상 데이터를 통해 입증된 강력한 효능과 안전성을 제공합니다. 데이터로 뒷받침되고 있습니다.
개발 중인 CIDP 치료제 출시 전망
현재 개발 중인 CIDP 치료제에는 riliprubart(SAR445088, Sanofi), nipocalimab(Johnson & Johnson Innovative Medicine), batoclimab(MVT-1401, Immunovant Sciences GmbH/HanAll Pharma/Roivant Sciences) 등이 있습니다.
만성 염증 탈수 초다발 신경병증(CIDP)은 희귀질환으로 분류되지만, 최근 들어 그 인지도가 높아지고 있습니다. 이는 주로 진단 기술의 향상, 의료진의 인식 향상, 질병에 대한 이해의 심화에 기인합니다. CIDP의 관리는 일반적으로 약물 치료와 지지요법의 조합으로 이루어지며, 주요 목적은 염증 억제, 면역 반응 조절, 운동 및 감각 기능 향상에 있습니다.
CIDP의 치료 환경은 약물요법과 지지요법을 결합한 다각적인 접근으로 발전하고 있습니다. 프레드니손이나 덱사메타손과 같은 코르티코스테로이드가 초기 치료제로 자주 사용됩니다. 이들은 관해 유도에 효과적이지만 골다공증, 체중 증가, 감염에 대한 감수성 증가 등 심각한 장기적 부작용의 위험이 높다는 단점이 있습니다. 이러한 부작용 때문에 스테로이드 보존제와의 병용요법이 필요한 경우가 많지만, 그 효과가 모든 사람에게 적용되는 것은 아닙니다.
만성 염증 탈수 초다발 신경병증(CIDP) 주요 7개국(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본) 시장을 조사 분석했으며, 각국 시장 규모와 예측, 각 치료법 시장 점유율, 현재 치료법, 미충족 수요 등에 대해 조사 분석하여 전해드립니다.
DelveInsight's "Chronic Inflammatory Demyelinating Polyneuropathy Market Insights, Epidemiology, and Market Forecast - 2036" report delivers an in-depth understanding of CIDP, historical and forecasted epidemiology, as well as the CIDP market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
The chronic inflammatory demyelinating polyneuropathy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM CIDP market size from 2022 to 2036. The Chronic Inflammatory Demyelinating Polyneuropathy market report also covers CIDP treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Key Factors Driving the Chronic Inflammatory Demyelinating Polyneuropathy Market
Rising Prevalence of CIDP
According to DelveInsight's estimates, in 2023, there were approximately 45K diagnosed prevalent cases of chronic inflammatory demyelinating polyneuropathy in the 7MM. These cases are further expected to increase by 2036. The rise in CIDP cases during the forecast period can be attributed to improved diagnostic capabilities, increased awareness among healthcare providers, and advancements in diagnostic technologies.
Approval of VYVDURA
The approval of VYVDURA in Japan for the treatment of CIDP marks a significant advancement in the therapeutic landscape. VYVDURA, the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP, offers a unique mechanism of action and a highly convenient at-home self-injection option, supported by robust efficacy and safety data from the ADHERE trial and real-world evidence.
Expected Launch of Emerging CIDP Therapies
Some of the CIDP drugs in the pipeline include riliprubart ([SAR445088], Sanofi), nipocalimab (Johnson & Johnson Innovative Medicine), batoclimab ([IMVT-1401], Immunovant Sciences GmbH/HanAll Pharma/Roivant Sciences), and others.
Chronic Inflammatory Demyelinating Polyneuropathy Treatment Market
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) overview
Chronic inflammatory demyelinating polyneuropathy is a rare neurological disorder characterized by inflammation and damage to the protective covering of nerves, known as the myelin sheath. This damage disrupts the communication between nerves and muscles, leading to progressive weakness and impaired sensory function.
CIDP is clinically classified into typical and atypical forms. The typical form, the most common, involves symmetrical polyneuropathy, where both proximal and distal muscles are equally affected, leading to widespread weakness and sensory deficits. Symptoms usually progress gradually, but severity varies among patients, impacting walking, fine motor skills, and daily activities.
Atypical CIDP includes variants like Multifocal Acquired Demyelinating Sensory and Motor Neuropathy (MADSAM), or asymmetric CIDP, where nerve damage is localized rather than symmetrical. Another variant, Distal Acquired Demyelinating Symmetric Neuropathy (DADS), affects the lower limbs and progresses more slowly. CIDP may also affect only motor or sensory nerves.
The prognosis of CIDP largely depends on early diagnosis and timely treatment. Many patients respond positively to immunomodulatory therapies, resulting in significant improvement or even remission. However, some cases may become resistant to treatment, resulting in ongoing disability. A small number of patients may experience severe, progressive disease despite receiving therapy.
Chronic Inflammatory Demyelinating Polyneuropathy diagnosis
CIDP diagnosis involves clinical evaluation for symptoms like muscle weakness and sensory loss, along with nerve conduction studies (NCS) to detect slowed conduction. Cerebrospinal fluid (CSF) analysis may reveal elevated protein levels. Electromyography helps exclude other conditions, while imaging techniques, including MRI and ultrasound, support diagnosis and differentiate CIDP.
Chronic Inflammatory Demyelinating Polyneuropathy treatment
CIDP is a condition causing progressive nerve damage due to immune-mediated inflammation. Treatments include corticosteroids, IVIg, plasmapheresis, immunosuppressive agents, and experimental autologous stem cell transplantation. While corticosteroids improve symptoms, they have long-term side effects. IVIg is effective and well-tolerated, often leading to remission. Plasma exchange offers short-term relief, and immunosuppressants are used for resistant cases. Stem cell therapy is experimental but promising.
As the market is derived using a patient-based model, the CIDP epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Diagnosed Prevalent Cases of CIDP, Gender-specific Diagnosed Prevalent Cases of CIDP, Age-specific Diagnosed Prevalent Cases of CIDP, Clinical Subtype-specific Diagnosed Prevalent Cases of CIDP, and Refractory Cases of CIDP in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2022 to 2036.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recent Developments
The drug chapter segment of the CIDP market report encloses a detailed analysis of CIDP-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the CIDP clinical trial details, expressive pharmacological action, agreements and collaborations and approval, advantages and disadvantages of each included drug, and the latest news and press releases.
Marketed Chronic Inflammatory Demyelinating Polyneuropathy Drugs
HYQVIA (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase): Takeda
HYQVIA is an immunostimulant combining human immunoglobulin (IG 10%) with recombinant human hyaluronidase, enabling SC for easier administration. This treatment offers a convenient alternative to IVIg by allowing larger-volume, less frequent SC due to enhanced absorption. HYQVIA modulates the immune system to reduce autoimmune damage to the nerves in CIDP. In January 2024, the US FDA approved HYQVIA for the maintenance treatment of CIDP in adults. The European Commission also approved it for the same purpose, and the UK's MHRA granted approval in March 2024. Takeda filed for approval in Japan in August 2024.
VYVGART HYTRULO (Efgartigimod Alfa and Hyaluronidase-Qvfc): Argenx
VYVGART HYTRULO is a coformulation of efgartigimod alfa and recombinant human hyaluronidase, designed to enhance SC absorption. It works by reducing autoantibodies implicated in CIDP through inhibition of the FcRn receptor. Approved by the US FDA in June 2024, it received orphan drug designation for CIDP in 2021. This therapy offers a convenient option for maintaining remission via SC administration.
GAMMAGARD LIQUID/KIOVIG (Immune Globulin Infusion [Human] 10% Solution): Takeda
GAMMAGARD LIQUID/KIOVIG is a ready-to-use IV formulation of IVIg derived from human plasma, offering a broad spectrum of antibodies. It works by modulating the immune system, reducing inflammation, and preventing further nerve damage in CIDP. Clinical studies have shown its effectiveness in improving muscle strength and functional ability, helping manage symptoms and maintain long-term stability. It was approved by the US FDA in January 2024 for adults with CIDP. In May 2019, KIOVIG was also approved in the EU for treating CIDP in adults, children, and adolescents (0-18 years).
Emerging CIDP Drugs
Riliprubart (SAR445088): Sanofi
Riliprubart (SAR445088) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. By blocking C1s, riliprubart has the potential to inhibit key inflammatory mechanisms that drive demyelination and axonal damage in CIDP. Riliprubart has convenient subcutaneous route of administration. Currently the drug is in Phase III stage of Clinical trial evaluation for the treatment of CIDP.
Batoclimab (HL161): Immunovant Sciences GmbH/HanAll Pharma/Roivant Sciences
Batoclimab is a human monoclonal antibody directed against the Neonatal Crystallizable Fragment Receptor (FcRn), with potential immunomodulating activity. Upon administration, batoclimab targets and binds to FcRn at the Immunoglobulin G (IgG) binding site, thereby preventing the interaction between FcRn and the serum protein IgG. By preventing FcRn/IgG binding, batoclimab blocks the FcRn-mediated rescue of IgG, enables IgG degradation and prevents IgG-mediated inflammation. IgG plays a key role in many autoimmune diseases and is an important factor in inflammatory processes. Immunovant reported topline results in March 2025 from its Phase IIb study of batoclimab in CIDP, showing meaningful improvements in disability scores during the initial 12-week period. Patients with deeper reductions in IgG levels demonstrated higher responder rates.
Chronic Inflammatory Demyelinating Polyneuropathy Drug Class Insights
Chronic inflammatory demyelinating polyneuropathy treatment primarily involves corticosteroids as the first-line therapy, often combined with immunosuppressants like methotrexate or azathioprine for patients who do not respond adequately. In cases of severe or resistant disease, IVIg may be beneficial, and biologics such as rituximab can be considered for some cases.
Emerging therapies include riliprubart (SAR445088), nipocalimab (JNJ-80202135), and batoclimab (HL161).
Riliprubart (SAR445088), is an investigational IgG4 humanized monoclonal antibody designed to selectively block activated C1s, a key component of the classical complement pathway in the innate immune system.
Nipocalimab (JNJ-80202135) is an investigational, high-affinity monoclonal antibody administered IV as an FcRn inhibitor. It is currently in Phase II/III clinical trials for CIDP.
Batoclimab (HL161) a subcutaneous anti-FcRn antibody. Batoclimab specifically inhibits FcRn, promoting the breakdown of IgG and reducing its levels in circulation. It is being developed collaboratively by Immunovant, with HanAll Biopharma leading efforts to expand its indications. It targets rare autoimmune diseases by reducing IgG levels.
Chronic inflammatory demyelinating polyneuropathy, though classified as a rare disease, has gained increasing recognition in recent years. This is largely due to improvements in diagnostic techniques, greater awareness among healthcare professionals, and a deeper understanding of the condition. Management of CIDP typically involves a combination of pharmacological therapies and supportive interventions, with the primary objectives to suppress inflammation, modulate immune responses, and improve motor and sensory function.
The treatment landscape for CIDP has advanced with a multi-faceted approach, combining medications, and supportive care. Corticosteroids, such as prednisone and dexamethasone, are often the initial treatment. While they are effective in inducing remission, they carry a high risk of significant long-term side effects, including osteoporosis, weight gain, and increased susceptibility to infections. These adverse effects often necessitate combination therapies with steroid-sparing agents, which may not be universally effective.
Plasma exchange has shown short-term efficacy in removing harmful autoantibodies and improving symptoms. However, it is an invasive procedure that requires highly specialized centers and trained personnel, limiting its accessibility, IVIg has become the gold standard due to its demonstrated efficacy in long-term disease control and symptom improvement. Despite this, IVIg is costly, time-consuming, and heavily reliant on donor plasma, raising concerns about its long-term availability.
Several Chronic Inflammatory Demyelinating Polyneuropathy drugs are currently approved and available for the treatment of CIDP, reflecting the focus on immune modulation therapies. Key options include PANZYGA, an immunoglobulin (human - ifas) co-developed by Pfizer and Octapharma, and PRIVIGEN, an immunoglobulin offered by CSL Behring. PRIVIGEN is a ready-to-use, room-temperature-stored, liquid IVIg stabilized with proline.
There is a significant need for new treatments for CIDP, as existing therapies often fall short of fully managing the condition. Innovative drug development could provide more effective options for patients. Several promising drugs are currently in the pipeline, including riliprubart (SAR445088), nipocalimab (JNJ-80202135), and batoclimab (HL161), among others.
This section focuses on the uptake rate of potential CIDP drugs expected to be launched in the market during 2022-2036.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Pipeline Development Activities
The Chronic Inflammatory Demyelinating Polyneuropathy market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key Chronic Inflammatory Demyelinating Polyneuropathy companies involved in developing targeted therapeutics.
Pipeline development activities
The CIDP treatment market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for CIDP.
KOL Views
To keep up with current Chronic Inflammatory Demyelinating Polyneuropathy market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on CIDP evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Minnesota, the US, University Hospital of Leicester, the US, Thomas Jefferson University, the US, University Hospital Cologne, Germany, Centre Hospitalier Universitaire (CHU) de Saint-Etienne, France, Universita degli Studi del Piemonte Orientale, Italy, Hospital de la Santa Creu i Sant Pau, Spain, University College London, the UK, Kindai University, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or CIDP market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
As per the KOLs from the US, it is becoming increasingly evident that a significant number of patients diagnosed with CIDP may actually have a different underlying condition, or in some cases, no neuropathy at all. Studies suggest that up to half of those diagnosed in the US may be misdiagnosed, highlighting the need for more accurate diagnostic practices.
As per the KOLs from Germany, early diagnosis, swift treatment initiation, and close monitoring of treatment response are crucial in preventing long-term disability in CIDP. Adopting a 'hit hard and early' approach to treatment is key to managing the disease effectively, as it can significantly improve outcomes and reduce the risk of permanent nerve damage. Early intervention ensures the best chance for recovery and helps minimize the impact of this debilitating condition.
As per the KOLs from Japan, CIDP is an immune-mediated disorder that causes gradual peripheral nerve damage over two months or more. CIDP requires careful diagnosis and management due to its slow progression, and understanding its epidemiology is crucial for improving treatment strategies and patient outcomes in the region.
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 emerging Chronic Inflammatory Demyelinating Polyneuropathy 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.
To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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.
Chronic Inflammatory Demyelinating Polyneuropathy Market Access and Reimbursement
Pfizer CIDP Warranty Program
Pfizer's Pledge Warranty Program provides financial support for eligible adult CIDP patients prescribed PANZYGA. The program offers a refund of out-of-pocket drug costs for up to the first four treatments if the treatment is discontinued by the patient's healthcare provider for clinical reasons. Aggregate and per-treatment refund limits apply. If a patient's commercial insurance or other payers covered part of the drug's cost, they may also receive a refund up to the program maximum, minus the patient's out-of-pocket expenses.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, 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 CIDP Market Report
Chronic inflammatory demyelinating polyneuropathy market report insights
Chronic Inflammatory Demyelinating Polyneuropathy market report key strengths
Chronic Inflammatory Demyelinating Polyneuropathy Market report assessment
Chronic Inflammatory Demyelinating Polyneuropathy Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies