GPCR 표적 치료제 시장은 향후 수년간 크게 성장할 것으로 예측됩니다. 이는 암으로 진단되는 환자 수 증가, GPCR 표적 치료제에 대한 인지도의 향상, 각사가 임상시험 중이나 승인 신청 중의 GPCR 표적 치료제 증가 등에 기인합니다.
GPCR 표적 치료제 시장 전망은 ZAVZPRET, POTELIGEO, AIMOVIG, VYEPTI와 같은 성공적인 의약품으로 유망합니다. Kyowa Hakko Kirin이 개발하여 POTELGEO로 개발되고 있는 Mogamulizumab은 CCR4 수용체를 표적으로 하여 CCR4 양성의 성인 T세포 백혈병, 말초성 T세포 림프종, 피부 T세포 림프종 치료에 효과적임이 증명되었습니다. Amgen과 Novartis가 개발한 AIMOVIG(erenumab)는 CGRP 수용체를 표적으로 하여 편두통, 혈관수축, 화끈거림, 안정협심증에 사용되고 있으며, GPCR 표적치료제의 특이성과 유효성을 나타내고 있습니다. VYEPTI는 FDA가 승인한 편두통 예방을 위한 링거 치료제입니다.
Volagidemab과 Leronlimab, GPC-100, GSBR-1290과 같은 새로운 치료제는이 시장의 확대 가능성을 돋보이게 합니다. 항글루카곤 수용체 항체인 Volagidemab은 글루카곤 수용체 신호전달을 차단함으로써 저혈당을 촉진하는 것으로, I형과 II형의 당뇨병을 대상으로 2상 시험 중입니다. Leronlimab은 CCR5 수용체를 표적으로 하는 바이러스 침입 억제제로 HIV, 비알코올성 지방간염(NASH), HIV-NASH, 고형암을 대상으로 2단계 개발 중입니다. 이러한 진보는 다양한 질병에서 GPCR 표적 약물의 큰 치료 가능성과 시장 기회를 보여줍니다.
본 보고서에서는 GPCR 표적 치료제의 주요 7개 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)에 대한 조사 분석을 실시하고, 각 지역 시장 규모, 현재의 치료법, 암메트니즈, 신약 등의 정보를 제공합니다.
DelveInsight's "GPCR-Targeting therapies - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the GPCR-targeting therapies, historical and competitive landscape as well as the GPCR-targeting therapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The GPCR-targeting therapies market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM GPCR-targeting therapies market size from 2020 to 2034. The report also covers current GPCR-targeting therapies treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
GPCR-Targeting Therapies Understanding
GPCR-Targeting Therapies Overview
G protein-coupled receptors (GPCRs) are important classes of cell surface receptors involved in multiple physiological functions. Aberrant expression, upregulation, and mutation of GPCR signaling pathways are frequent in many types of cancers, promoting hyperproliferation, angiogenesis, and metastasis. GPCRs are classified into several types based on their sequence and function: the main classes in humans are Class A (Rhodopsin-like), Class B (Secretin and Adhesion), Class C (Metabotropic glutamate/pheromone), and Class F (Frizzled/TAS2), with additional classes D (fungal mating pheromone receptors) and E (cyclic AMP receptors) found in other organisms. Class A is the largest group, including most hormone, neurotransmitter, and sensory receptors, while Class B is divided into secretin and adhesion subfamilies, Class C includes glutamate and GABA receptors, and Class F covers frizzled and smoothened receptors involved in Wnt signaling. This classification reflects the structural diversity and wide-ranging functions of GPCRs in health and disease.
Currently, GPCR-targeting therapies are approved for treating conditions such as PTCL, migraine, CTCL, and their types such as sezary syndrome (SS) and mycosis fungoides. They are also being developed for Nonalcoholic Steatohepatitis (NASH), HIV-NASH, solid tumors, and both Type I and Type II diabetes mellitus.
The GPCR-targeting therapies epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indication for GPCR-targeting therapies, total eligible patient pool for GPCR-Targeting therapies in selected indication, total treated cases in selected indication for GPCR-targeting therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the GPCR-targeting therapies reports encloses a detailed analysis of GPCR-targeting therapies-marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the GPCR-targeting therapies' 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
ZAVZPRET (zavegepant): Pfizer
ZAVZPRET is a novel, small-molecule CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults. ZAVZPRET blocks the CGRP receptor, which is implicated in migraine pathophysiology by mediating neurogenic inflammation and vasodilation. ZAVZPRET is formulated as a nasal spray, enabling rapid absorption through the nasal mucosa and direct entry into the bloodstream, bypassing gastrointestinal absorption and first-pass metabolism.
POTELIGEO (mogamulizumab-kpkc): Kyowa Hakko Kirin
POTELIGEO is a humanized monoclonal antibody developed by Kyowa Kirin that targets chemokine receptor 4 (CCR4), a protein frequently expressed on certain cancerous T-cells. By binding to CCR4, POTELIGEO attracts immune cells to destroy these malignant cells, enhancing the body's immune response against the cancer.
POTELIGEO was first approved in Japan in 2012 for treating relapsed or refractory CCR4-positive adult T-cell leukemia (ATL). In 2014, its approval was expanded in Japan to include relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). The FDA approved POTELIGEO in 2018 for treating Mycosis Fungoides and Sezary Syndrome. It is also approved in Europe for these same conditions.
In June 2020, Kyowa Kirin announced the commercial availability of POTELIGEO in Germany for the treatment of adult patients with mycosis fungoides and Sezary syndrome who have received at least one prior systemic therapy.
AIMOVIG (erenumab-aooe): Novartis/Amgen
Erenumab is a fully human monoclonal antibody developed by Amgen and Novartis, which can specifically bind to CGRP receptors and is an antagonist that directly competes with CGRP ligands. CGRP ligands are small neuropeptides with potent vasodilating effects in the setting of chronic pain and migraine. When competing with CGRP, erenumab offers advantages over small molecule drugs in specificity and potency. The antibody is suitable for treating migraine, vasoconstriction, hot flashes, and stable angina pectoris. The monoclonal antibody was listed in the US and the EU in May and July 2018 respectively.
Emerging Drugs
Volagidemab: REMD Biotherapeutics
Volagidemab (REMD-477) is a human anti-glucagon receptor antibody developed by REMD Biotherapeutics against juvenile type I diabetes (T1D) and type II diabetes (T2D). It binds to the human GCGR and competitively blocks glucagon receptors (GCGR) signal transduction to increase liver glucose uptake, reduce liver glycogen decomposition and gluconeogenesis, and promote glycogen synthesis, to achieve the effect of hypoglycemia (CK060182). Up to March 2021, there were multiple experimental projects under development, of which, the research and development of type I and type II diabetes were in clinical stage II, the study on glucose intolerance was in clinical stage I and the study on metabolic disorders was in the preclinical stage (CK060183).
Leronlimab: CytoDyn
Leronlimab is a viral entry inhibitor, a class of HIV therapies that prevent the virus from entering and infecting healthy cells. Unlike Highly Active Antiretroviral Therapy (HAART), which targets the virus after it has entered the cell and begun replicating, Leronlimab acts earlier in the infection process. The importance of the CCR5 receptor in HIV is underscored by the natural resistance to HIV infection seen in individuals with a genetic mutation that prevents CCR5 expression. It is being developed for the treatment of Nonalcoholic Steatohepatitis (NASH), HIV-NASH, and solid tumors. Currently, it's in Phase II.
In April 2019, the Company entered into several agreements with Samsung, under which Samsung agreed to perform technology transfer, process validation, manufacturing, pre-approval inspection, and supply services for the commercial supply of leronlimab bulk drug substance.
The market for GPCR-Targeting therapies is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of GPCR-Targeting therapies, and the increasing number of GPCR-Targeting therapies that are under clinical trials and filed for approval by various companies.
The market outlook for GPCR-targeting therapies is promising, driven by successful drugs like ZAVZPRET, POTELIGEO, AIMOVIG, and VYEPTI. Mogamulizumab, developed by Kyowa Hakko Kirin and marketed as POTELIGEO, targets the CCR4 receptor and has proven effective in treating CCR4-positive adult T-cell leukemia, peripheral T-cell lymphoma, and cutaneous T-cell lymphomas. AIMOVIG (erenumab), developed by Amgen and Novartis, targets the CGRP receptor and is used for migraines, vasoconstriction, hot flashes, and stable angina pectoris, showcasing the specificity and potency of GPCR-targeting therapies. VYEPTI is the FDA-approved IV treatment for migraine prevention.
Emerging therapies like Volagidemab and Leronlimab, GPC-100, and GSBR-1290 highlight the expanding potential of this market. Volagidemab, an anti-glucagon receptor antibody, is in Phase II trials for Type I and Type II diabetes, promoting hypoglycemia by blocking glucagon receptor signaling. Leronlimab, a viral entry inhibitor in Phase II development, targets the CCR5 receptor and is being developed for HIV, Nonalcoholic Steatohepatitis (NASH), HIV-NASH, and solid tumors. These advancements underline the significant therapeutic potential and market opportunities for GPCR-targeting drugs across various conditions.
Several key players, including CytoDyn, REMD Biotherapeutics, Structure Therapeutics, GPCR Therapeutics, and others, are involved in developing drugs for GPCR-Targeting therapies for various indications such as NASH, Multiple Myeloma, Diabetes, and others. Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of GPCR-Targeting therapies and define their role in the therapy of cancer.
This section focuses on the uptake rate of potential approved and emerging GPCR-Targeting therapies expected to be launched in the market during 2024-2034.
GPCR-Targeting Therapies Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
The presence of numerous drugs under different stages is expected to generate immense opportunity for GPCR-Targeting therapies market growth over the forecasted period.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for GPCR-Targeting therapies.
KOL Views
To keep up with current and future market trends, we take Industry Experts' 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 GPCR-Targeting therapies' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.
DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins Sidney Kimmel Cancer Center and others.
Their opinion helps understand and validate current and emerging therapy treatment patterns or GPCR-Targeting therapies 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 analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
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.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
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 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
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, the Children's 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 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.
The abstract list is not exhaustive, will be provided in the final report