한글목차

CT-388의 주요 성장 촉진요인

1. 시장 점유율 확대 및 신규 환자 확보

• CT-388은 아직 임상 개발 단계에 있기 때문에 상업적 의미의 시장 점유율을 확보하지는 못했지만, 초기 데이터는 큰 가능성을 시사하고 있습니다.
• 신규 환자 투여는 임상 II/III상 시험 결과와 규제 당국의 승인에 따라 달라질 수 있지만, 초기 임상 Ib상 시험(비만인 건강한 성인)의 결과는 설득력 있는 유효성을 보여주어 처방 의사들의 강한 관심을 불러일으킬 것으로 보입니다.
• Roche는 CT-388을 주요 GLP-1/GLP-1/GIP 작용제에 대한 미래의 경쟁자로 만들기 위해 적극적인 개발, 의사 및 과학자들의 인식 제고, 비만/대사성 질환 포트폴리오의 확장을 추구하고 있습니다.

2. 주요 적응증 확대

• 비만/과체중 : 개발 중인 1차 적응증으로, CT-388은 비만 성인 환자를 대상으로 한 임상 Ib상 시험에서 강력한 체중 감소 효과를 입증했습니다.
• 제2형 당뇨병 : 비만+제2형 당뇨병 환자를 대상으로 CT-388의 추가 코호트 및 시험군이 평가되고 있습니다. 초기 데이터에 따르면, 포도당 항상성 개선과 당뇨병 예비군 정상화를 시사하고 있습니다.
• 심대사 위험의 동반질환(체중 관련 동반질환) : 동반질환(당뇨병, 고혈압, 고지혈증, 이상지질혈증 등)을 가진 환자를 대상으로 CT-388이 과체중과 대사 위험성을 가진 환자에게도 효과가 있는지를 검증하는 시험입니다.
• 파이프라인 개발 : CT-388은 GLP-1과 GIP 수용체에서 B-알레스틴 결합을 최소화한 '편향된 신호전달'이라는 설계상의 특징을 가지고 있어, 효과의 지속성을 향상시키고 수용체 탈감작을 억제하며 내약성을 개선할 수 있는 가능성이 있습니다. 향후 임상(Phase IIb/III)에서 고용량, 장기 투여를 통해 그 프로파일을 더욱 명확히 할 수 있을 것으로 예상됩니다.

3. 지리적 확장

• CT-388은 전 세계적으로 개발되고 있으며, Roche/Genentech는 북미, 유럽 및 그 이상의 다양한 집단(T2D 유무에 관계없이)을 대상으로 여러 임상시험(Phase Ib 시험, Phase II 용량 설정 시험)을 진행하고 있습니다.
• 다른 비만/T2D 치료제와 마찬가지로, 규제 당국의 승인과 가격 책정/환급이 이루어지면 신흥 시장(아시아태평양, 라틴아메리카 등)이 장기적으로 중요한 성장 지역이 될 것으로 예상됩니다. (초기 시험 데이터를 제외한 지역별 시험 데이터는 아직 공개되지 않았습니다.)
• Roche는 세계 상용화를 지원하기 위해 생산능력을 인수하거나 확장하고, (Carmot Therapeutics 인수에 이어) 비만/대사성 질환 포트폴리오를 구축하고 있습니다.

4. 신규 적응증 승인(규제 상황/기대)

• 2024년 중반 현재, CT-388은 비만 환자를 대상으로 한 양호한 임상 1상 시험을 완료하고, 제2형 당뇨병을 동반하지 않은 과체중/비만 환자를 대상으로 한 임상 2상/임상 2b상 시험으로 넘어가고 있습니다. 아직 약사 승인은 받지 못했습니다.
• 향후 예정된 허가 신청에서는 우선 비만증이 대상이며, 그 다음에는 제2형 당뇨병 또는 대사성 질환을 가진 집단이 대상이 될 것으로 보입니다. 그 시기는 Phase II/III 시험 결과에 따라 달라질 수 있습니다.
• CT-388이 비만과 제2형 당뇨병 모두에서 승인되면 Roche의 대사질환 치료제 포트폴리오를 다양화하고 기존 GLP-1/GIP 치료제를 대체할 수 있는 경쟁력 있는 치료제를 제공하게 될 것입니다.

5. 강력한 수량 모멘텀(시험 주도, 시장 주도)

• 임상 Ib상(24주) 시험에서 위약대조군 대비 약 18.8%의 체중 감소를 보였으며, 이 기간 동안 5% 이상, 10% 이상, 15% 이상, 20% 이상 체중 감소를 달성한 환자가 큰 비중을 차지했습니다.
• 당뇨병 기저질환자에서 CT-388은 24주 후 치료받은 모든 환자에서 혈당 수치를 정상화했습니다. 이는 제2형 당뇨병 예방 및 대사 건강 측면에서 유망한 결과입니다.
• 현재까지 안전성/내약성은 인크 레틴 계열과 일치하는 것으로 보입니다 : 주로 경증에서 중등도의 소화기 계통의 부작용으로 초기 시험에서 큰 안전성 신호는 발견되지 않았습니다. 이는 좋은 순응도(adherence)의 가능성을 뒷받침합니다.

CT-388의 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본) 시장을 조사 분석했으며, 매출 예측, 작용기전(MoA), 용법·용량, 연구개발(R&D)에 관한 정보를 전해드립니다.

목차

제1장 보고서 소개

제2장 비만, 2형 당뇨병 등의 잠재적 적응증에서 CT-388 개요

• 제품 상세
• CT-388 임상 개발
  • CT-388 임상 연구
  • CT-388 임상시험 정보
  • 안전성과 유효성
• 기타 개발 활동
• 제품 프로파일

제3장 CT-388 경쟁 구도(출시된 치료법)

제4장 경쟁 구도(후기 단계의 새로운 CT-388 치료법)

제5장 CT-388 시장 평가

• 잠재적 적응증에 대한 CT-388 시장 전망
• 주요 7개 시장 분석
  • 주요 7개 시장의 잠재적 적응증에 대한 CT-388 시장 규모
• 시장 분석 : 국가별
  • 미국의 잠재적 적응증에 대한 CT-388 시장 규모
  • 독일의 잠재적 적응증에 대한 CT-388 시장 규모
  • 영국의 잠재적 적응증에 대한 CT-388 시장 규모

제6장 CT-388 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 보고서 구입 옵션

영문목차

Key Factors Driving CT-388 Growth

1. Market Share Gains and New Patient Starts

• CT-388 is still in clinical development, so it has not yet begun capturing market share in the commercial sense, but early data suggest strong potential.
• Anticipated new patient starts will depend on Phase II/III results and regulatory approvals; however, the early Phase Ib results (healthy adults with obesity) show compelling efficacy, likely to drive strong interest among prescribers.
• Roche is pursuing aggressive development, physician/scientific community visibility, and scaling its obesity / metabolic disorder portfolio to position CT-388 as a future competitor to leading GLP-1 / GLP-1/GIP agonists.

2. Expansion Across Key Indications

• Obesity / Overweight: The primary indication under development; CT-388 has shown strong weight loss in Phase Ib in obese adult patients.
• Type 2 Diabetes: An additional cohort and study arms are evaluating CT-388 in participants with obesity + T2D; early data suggest improvements in glucose homeostasis and normalization in pre-diabetes subgroups.
• Comorbid Cardiometabolic Risk ("weight-related comorbidities"): Studies include participants with comorbidities (e.g., pre-diabetes, hypertension, dyslipidemia) to test if CT-388 can deliver benefits in those with overweight plus metabolic risk.
• Pipeline Developments: The molecule has a design feature ("biased signaling" with minimal B-arrestin coupling at GLP-1 and GIP receptors) intended to improve durability of effect, reduce receptor desensitization, and potentially improve tolerability. Future studies (Phase IIb/III) will test higher doses / longer durations to further define its profile.

3. Geographic Expansion

• CT-388 is being developed globally; Roche / Genentech is conducting multiple trials (Phase Ib, Phase II dose-finding) in diverse populations (with and without T2D) which likely span N.America, Europe and potentially beyond.
• As with other obesity/T2D drugs, emerging markets (Asia-Pacific, Latin America, etc.) are expected to be important longer-term growth zones, assuming regulatory approvals and pricing/reimbursement align. (No public region-specific trial data yet beyond the early ones.)
• Roche is acquiring or scaling capacity, and building its obesity/metabolic disease portfolio (following its acquisition of Carmot Therapeutics), to support global commercialization.

4. New Indication Approvals (Regulatory Status / Expectations)

• As of mid-2024, CT-388 had completed positive Phase Ib data in obesity and is moving into Phase II / Phase IIb trials for overweight / obesity with and without type 2 diabetes. No regulatory approvals yet.
• Expected upcoming regulatory filings will likely target obesity first, then type-2 diabetes or metabolic risk populations. The timing depends on Phase II/III readouts.
• If approved in both obesity and T2D, CT-388 would diversify Roche's metabolic disease portfolio and provide a competitive alternative to existing GLP-1/GIP therapies.

5. Strong Volume Momentum (Trial- and Market-Driven)

• The Phase Ib trial (24 weeks) demonstrated ~18.8% placebo-adjusted weight loss, with strong proportions of patients achieving >5%, >10%, >15%, and even >20% weight loss over that period.
• In participants with pre-diabetes baseline, CT-388 normalized glycemia in all such treated patients after 24 weeks, which is promising from a type-2 prevention / metabolic health standpoint.
• Safety/tolerability so far appears consistent with the incretin class: mainly mild to moderate gastrointestinal side effects, no major safety signals in early trials. This supports good adherence potential.

6. Competitive Differentiation and Market Trends

• Dual GLP-1 / GIP agonism plus biased signaling: CT-388 distinguishes itself by dual receptor targeting and minimized B-arrestin recruitment, which may reduce receptor desensitization and enhance durability of effect. This is a key differentiator vs many current agents.
• Efficacy / weight-loss potential: The early 18.8% weight loss over 24 weeks is substantial and compares favorably to other injectable GLP-1 or GLP-1/GIP agonists in similar time frames. If maintained or improved in longer trials, CT-388 could be best-in-class in obesity.
• Safety / tolerability: Thus far, tolerability is acceptable; GI side effects are most common, no new/unexpected safety signals in early data. This is important in markets sensitive to side effects & dropout.
• Market trends that favor CT-388:

Strong unmet need in obesity and overweight, especially in comorbid populations.

Payer interest in treatments that deliver large weight loss, improve glycemic control, and possibly cardiometabolic risk.

Increasing emphasis on real-world evidence, long-term durability, and patient convenience.

• Risks and headwinds:

As a relatively new entrant, CT-388 will need to prove safety and tolerability in larger populations and over longer durations (e.g., 72+ weeks) to match benchmarks.

Regulatory, pricing & reimbursement challenges, particularly in uninsured/underinsured markets.

Competition is intense from established players (Novo Nordisk, Eli Lilly, etc.), both on efficacy and on brand recognition.

Manufacturing, supply chain, and cost implications for an injectable therapy (if it remains injectable) could affect access in some markets.

CT-388 Recent Developments

• In September 2025, Swiss drug maker Roche signaled its ambition to join Eli Lilly and Novo Nordisk at the top of the booming weight-loss market, as it advanced one of its experimental obesity drugs into a late-stage trial. Roche's decision to begin a Phase III trial of its experimental obesity drug CT-388 marks a major step in its push to break into the fast-growing obesity drug market that some analysts estimate will be worth USD 150 billion annually by the early 2030's.
• In May 2024, Genentech announced positive results from the Phase Ib clinical trial of CT-388, a dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes. The study found that a once-weekly subcutaneous injection of CT-388 over 24 weeks resulted in significant weight loss in healthy adults with obesity compared to placebo. The weight loss achieved with CT-388 was clinically meaningful, with a mean placebo-adjusted weight loss of 18.8% (p-value < 0.001). At week 24, 100% of CT-388 treated participants achieved a weight loss of >5%, 85% achieved >10%, 70% achieved >15%, and 45% achieved >20%. The treatment was well tolerated, with mild to moderate gastrointestinal-related adverse events being the most common, consistent with the incretin class of medicines that CT-388 belongs to.

"CT-388 Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of CT-388 for potential indications like Obesity and Type 2 diabetes mellitus in the 7MM. A detailed picture of CT-388's existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the CT-388 for potential indications. The CT-388 market report provides insights about CT-388's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current CT-388 performance, future market assessments inclusive of the CT-388 market forecast analysis for potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of CT-388 sales forecasts, along with factors driving its market.

CT-388 Drug Summary

CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes (T2D). CT-388 was designed to have potent activity on both the GLP-1 and GIP receptors but with minimal to no B-arrestin recruitment on either receptor. This biased signaling significantly minimizes receptor internalization and consequent desensitization, which is expected to lead to prolonged pharmacological activity. It is currently being studied for the patients suffering from overweight/obesity with and without T2D. The report provides CT-388's sales, growth barriers and drivers, post usage and approvals in multiple indications.

CT-388 is in the Phase II stage of clinical development for the treatment of patients with Obesity (NCT06525935) and Type 2 diabetes mellitus (NCT06628362).

Scope of the CT-388 Market Report

The report provides insights into:

• A comprehensive product overview including the CT-388 MoA, description, dosage and administration, research and development activities in potential indications like Obesity and Type 2 diabetes mellitus.
• Elaborated details on CT-388 regulatory milestones and other development activities have been provided in CT-388 market report.
• The report also highlights CT-388's cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
• The CT-388 market report also covers the patents information, generic entry and impact on cost cut.
• The CT-388 market report contains current and forecasted CT-388 sales for potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The CT-388 market report also features the SWOT analysis with analyst views for CT-388 in potential indications.

Methodology:

The CT-388 market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

CT-388 Analytical Perspective by DelveInsight

• In-depth CT-388 Market Assessment

This CT-388 sales market forecast report provides a detailed market assessment of CT-388 for potential indications like Obesity and Type 2 diabetes mellitus in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted CT-388 sales data uptil 2034.

• CT-388 Clinical Assessment

The CT-388 market report provides the clinical trials information of CT-388 for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

CT-388 Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

CT-388 Market Potential & Revenue Forecast

• Projected market size for the CT-388 and its key indications
• Estimated CT-388 sales potential (CT-388 peak sales forecasts)
• CT-388 Pricing strategies and reimbursement landscape

CT-388 Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• CT-388 Market positioning compared to existing treatments
• CT-388 Strengths & weaknesses relative to competitors

CT-388 Regulatory & Commercial Milestones

• CT-388 Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

CT-388 Clinical Differentiation

• CT-388 Efficacy & safety advantages over existing drugs
• CT-388 Unique selling points

CT-388 Market Report Highlights

• In the coming years, the CT-388 market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The CT-388 companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence CT-388's dominance.
• Other emerging products for Obesity and Type 2 diabetes mellitus are expected to give tough market competition to CT-388 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CT-388 in potential indications.
• Analyse CT-388 cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted CT-388 sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of CT-388 in potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of CT-388? How strong is CT-388's clinical and commercial performance?
• What is CT-388's clinical trial status in each individual indications such as Obesity and Type 2 diabetes mellitus and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the CT-388 Manufacturers?
• What are the key designations that have been granted to CT-388 for potential indications? How are they going to impact CT-388's penetration in various geographies?
• What is the current and forecasted CT-388 market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of CT-388 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to CT-388 for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is CT-388? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. CT-388 Overview in potential indications like Obesity and Type 2 diabetes mellitus

• 2.1. Product Detail
• 2.2. CT-388 Clinical Development
  • 2.2.1. CT-388 Clinical studies
  • 2.2.2. CT-388 Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. CT-388 Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging CT-388 Therapies)

5. CT-388 Market Assessment

• 5.1. CT-388 Market Outlook in potential indications
• 5.2. 7MM Analysis
  • 5.2.1. CT-388 Market Size in the 7MM for potential indications
• 5.3. Country-wise Market Analysis
  • 5.3.1. CT-388 Market Size in the United States for potential indications
  • 5.3.2. CT-388 Market Size in Germany for potential indications
  • 5.3.3. CT-388 Market Size in France for potential indications
  • 5.3.4. CT-388 Market Size in Italy for potential indications
  • 5.3.5. CT-388 Market Size in Spain for potential indications
  • 5.3.6. CT-388 Market Size in the United Kingdom for potential indications
  • 5.3.7. CT-388 Market Size in Japan for potential indications

6. CT-388 SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options