Antibody Mediated Rejection Market

DelveInsight's "Antibody-Mediated Rejection (AMR) - Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the Antibody-Mediated Rejection, historical and forecasted epidemiology as well as the Antibody-Mediated Rejection market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

 

The Antibody-Mediated Rejection market report provides current treatment practices, emerging drugs, Antibody-Mediated Rejection market share of the individual therapies, current and forecasted Antibody-Mediated Rejection market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current Antibody-Mediated Rejection treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

Study Period: 2019-2032

Antibody-Mediated Rejection (AMR) Understanding and Treatment Algorithm

The DelveInsight’s Antibody-Mediated Rejection market report gives a thorough understanding of the disease. Antibody‐mediated rejection (AMR) is a significant complication following organ transplantation that contributes to short‐ and long‐term injury in transplant recipients. Despite desensitization protocols, up to one‐third of highly sensitized recipients may develop acute AMR following transplantation. AMR is also of significant concern in non-sensitized individuals, as de novo DSAs can develop early or late after transplantation.

 

The phenotype of AMR ranges from hyperacute rejection, acute AMR, and chronic AMR. AMR diagnosis depends on typical histological lesions, C4d staining, and serum DSA detection. C4d, a protein from the classical complement activation cascade that remains attached to the site of complement activation, is regarded as a diagnostic marker for AMR. The introduction of C4d as a marker of AMR aroused an ever-increasing interest in recognizing mechanisms of allograft rejection. AMR episodes occurring at different periods seem to be different clinical sub-entities. Early AMR is usually correlated with sensitization, pre-existing alloantibodies, and rapid graft dysfunction and is usually easy to be controlled; while late AMR is mostly correlated with withdrawal or reduction of immunosuppressants and noncompliance with immunosuppressive therapy, whereas late AMR has little response to antirejection strategies and thus correlate with poor graft outcomes.

 

The diagnosis of AMR—as defined by the modified Banff 97 and recently revised in the Banff 2019 classification—requires three cardinal features, including (a) functional evidence of allograft dysfunction, (b) morphological evidence of acute tissue injury, and evidence of Ab-dependent activation of the classical pathway of the complement system (i.e., C4d deposition in the peritubular capillaries), and detection of circulating DRSA. This report covers five major organ transplants where AMR is defined, namely Kidney, Lung, Liver, Heart, and Pancreas.

 

Treatment

The existing literature on the treatment of AMR is characterized by marked heterogeneity concerning the definition of AMR as well as the applied treatment protocols. The primary aims of therapeutic approaches to antibody-mediated rejection are to remove circulating donor-specific anti-HLA antibodies and block their effects, reduce their production, or both. Although no therapeutics have received FDA approval for the treatment of antibody-mediated rejection, the mainstays of contemporary therapy are plasma exchange and intravenous immune globulin, used with immunotherapies.

 

The goal of AMR treatment is to reduce the inflammation in the allograft, eliminate the factors that cause inflammation, and effectively prevent antibody formation without jeopardizing the normal immune responses that protect patients from serious infections.Treatment of AMR includes majorly immunosuppressive medications, plasmapheresis or plasma exchange (PLEX), and IVIG, complement inhibitor, because the complement system has attracted increasing attention as an important contributor to AMR. It includes the anti-CD20 monoclonal antibody, proteasome inhibitor, and IL-6 inhibitor. Sometimes surgical splenectomy, splenic embolization, and splenic radiation are used as a salvage procedure for severe early AMR.

Epidemiology

The Antibody-Mediated Rejection epidemiology section provides insights about historical and current Antibody-Mediated Rejection patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

 

Key Findings

In the year 2021, the total cases of Antibody-Mediated Rejection were 5,102 in the 7MM which are expected to grow during the study period, i.e., 2019–2032.

 

The disease epidemiology covered in the report provides historical as well as forecasted Antibody-Mediated Rejection epidemiology ,segmented as Transplant Incident cases and Total cases of Antibody-Mediated Rejection in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country Wise- Antibody-Mediated Rejection (AMR) Epidemiology

The epidemiology segment also provides the Antibody-Mediated Rejection epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Antibody-Mediated Rejection (AMR) Drug Chapters

The drug chapter segment of the Antibody-Mediated Rejection report encloses the detailed analysis of Antibody-Mediated Rejection marketed drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Antibody-Mediated Rejection 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.

 

Emerging Drugs

The report provides the details of the emerging therapies under the late and mid-stage of development for Antibody-Mediated Rejection treatment.

Antibody-Mediated Rejection (AMR) Market Outlook

The Antibody-Mediated Rejection market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Antibody-Mediated Rejection market trends by analyzing the impact of current therapies on the market, unmet needs, drivers, barriers, and demand for better technology.

 

This segment gives a thorough detail of Antibody-Mediated Rejection market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

 

According to DelveInsight, the Antibody-Mediated Rejection market in 7MM is expected to witness a major change in the study period 2019-2032.

 

Key Findings

The Antibody-Mediated Rejection market size in the 7MM is expected to change during the study period 2019–2032. The therapeutic market of Antibody-Mediated Rejection in the seven major markets is expected to increase during the study period (2019–2032). In 2021, the total market size of Antibody-Mediated Rejection was USD 88.32 million which is expected to rise during the study period (2019–2032).

 

The United States Market Outlook

The total market size of Antibody-Mediated Rejection in the United States accounted for USD 65.58 million in 2021 which is expected to rise during the study period (2019–2032).

 

EU-5 Countries: Market Outlook

In EU5, the total market size of Antibody-Mediated Rejection was USD 20.50 million in 2021, which is expected to rise during the study period (2019–2032).

 

Japan Market Outlook

In Japan, the total market size of Antibody-Mediated Rejection was USD 2.24 million in 2021, which is expected to rise during the study period (2019–2032).

Antibody-Mediated Rejection (AMR) Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Antibody-Mediated Rejection market or expected to get launched in the market during the study period 2019-2032. The analysis covers Antibody-Mediated Rejection market uptake by drugs; patient uptake by therapies; and sales of each drug.

 

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Antibody-Mediated Rejection (AMR) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Antibody-Mediated Rejection key players involved in developing targeted therapeutics.

 

Pipeline Development Activities

The report covers detailed information on collaborations, acquisition, and merger, licensing patent details, and other information for Antibody-Mediated Rejection emerging therapies.

Reimbursement Scenario in Antibody-Mediated Rejection (AMR)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs ' opinions working in the Antibody-Mediated Rejection domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Antibody-Mediated Rejection market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitively and Market Intelligence analysis of the Antibody-Mediated Rejection Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

  • The report covers the descriptive overview of Antibody-Mediated Rejection, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies
  • Comprehensive insight has been provided into the Antibody-Mediated Rejection epidemiology and treatment in the 7MM
  • Additionally, an all-inclusive account of both the current and emerging therapies for Antibody-Mediated Rejection are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
  • A detailed review of the Antibody-Mediated Rejection market; historical and forecasted is included in the report, covering drug outreach in the 7MM
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Antibody-Mediated Rejection market.

Report Highlights

  • In the coming years, the Antibody-Mediated Rejection market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Antibody-Mediated Rejection R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • Major players are involved in developing therapies for Antibody-Mediated Rejection. The launch of emerging therapies will significantly impact the Antibody-Mediated Rejection market.
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Antibody-Mediated Rejection.
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Antibody-Mediated Rejection (AMR) Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Antibody-Mediated Rejection Pipeline Analysis
  • Antibody-Mediated Rejection Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

Antibody-Mediated Rejection (AMR) Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage
  • Antibody-Mediated Rejection Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

Antibody-Mediated Rejection (AMR) Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers

Key Questions

Market Insights:

  • What was the Antibody-Mediated Rejection drug class share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the Antibody-Mediated Rejection total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
  • What are the key findings of the market across 7MM and which country will have the largest Antibody-Mediated Rejection market size during the forecast period (2019-2032)?
  • At what CAGR, the Antibody-Mediated Rejection market is expected to grow by 7MM during the forecast period (2019-2032)?
  • What would be the Antibody-Mediated Rejection market outlook across the 7MM during the forecast period (2019-2032)?
  • What would be the Antibody-Mediated Rejection market growth till 2032, and what will be the resultant market Size in the year 2032?
  • How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

 

Epidemiology Insights:

  • What are the disease risk, burden, and regional/ethnic differences of Antibody-Mediated Rejection?
  • What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What is the historical Antibody-Mediated Rejection patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What would be the forecasted patient pool of Antibody-Mediated Rejection in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • Where will be the growth opportunities in the 7MM concerning the patient population about Antibody-Mediated Rejection?
  • Out of all 7MM countries, which country would have the highest population of Antibody-Mediated Rejection during the forecast period (2019-2032)?
  • At what CAGR the patient population is expected to grow by 7MM during the forecast period (2019-2032)?

 

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

  • What are the current options for the Antibody-Mediated Rejection treatment in addition to the approved therapies?
  • What are the current treatment guidelines for the treatment of Antibody-Mediated Rejection in the USA, Europe, and Japan?
  • What are the Antibody-Mediated Rejection marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
  • How many companies are developing therapies for the treatment of Antibody-Mediated Rejection?
  • How many therapies are in-development by each company for Antibody-Mediated Rejection treatment?
  • How many are emerging therapies in mid-stage, and late stage of development for Antibody-Mediated Rejection treatment?
  • What are the key collaborations (Industry - Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Antibody-Mediated Rejection therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Antibody-Mediated Rejection and their status?
  • What are the current challenges faced in drug development?
  • What are the key designations that have been granted for the emerging therapies for Antibody-Mediated Rejection?
  • What are the global historical and forecasted markets of Antibody-Mediated Rejection?

Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the Antibody-Mediated Rejection market
  • To understand the future market competition in the Antibody-Mediated Rejection market and Insightful review of the key market drivers and barriers
  • Organize sales and marketing efforts by identifying the best opportunities for Antibody-Mediated Rejection in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
  • Organize sales and marketing efforts by identifying the best opportunities for the Antibody-Mediated Rejection market
  • To understand the future market competition in the Antibody-Mediated Rejection market

1. Key Insights

2. Report Introduction

3. Antibody-Mediated Rejection (AMR) Market Overview at a Glance

3.1. Market Share (%) Distribution of AMR in 2019

3.2. Market Share (%) Distribution of AMR in 2032

4. Executive Summary of Antibody-Mediated Rejection (AMR)

4.1. Key Events

5. Epidemiology and Market Methodology

6. Disease Background and Overview

6.1. Introduction

6.2. Types of Antibody-Mediated Rejection

6.3. Pathogenesis of Antibody-mediated Rejection

6.4. Risk Factors and Causes of Antibody-mediated Rejection

6.5. Complications

6.6. Clinical features of Antibody-mediated Rejection

7. Diagnosis and Differential diagnosis of Antibody-Mediated Rejection

7.1. The Banff Classification

7.2. T cell-mediated rejection (TCMR)

7.3. The International Society for Heart and Lung Transplantation Recommendations for Monitoring for Antibody-Mediated Rejection

7.4. Antibody Panels and Clinical Indicators for Pathological Diagnosis of Cardiac AMR

7.5. Biomarkers

8. Treatment of Antibody-mediated Rejection

8.1. Algorithm for treatment of Kidney rejection

8.2. Algorithm for diagnosis and treatment of pancreas rejection

8.3. Algorithm for AMR in Heart Transplantation

9. Epidemiology and Patient Population

9.1. Key Findings

9.2. Assumptions and Rationale

9.3. Epidemiology Scenario in the 7MM

9.3.1. Transplant Incidence Cases in the 7MM

9.3.2. Total Cases of Antibody-Mediated Rejection (AMR) in the 7MM

9.4. Epidemiology Scenario in the United States

9.4.1. Transplant Incidence Cases in the United States

9.4.2. Antibody-Mediated Rejection Cases in the United States

9.5. Epidemiology Scenario in EU-5 Countries

9.5.1. Transplant Incidence Cases in EU-5

9.5.2. Antibody-Mediated Rejection Cases in EU-5

9.6. Epidemiology Scenario in Japan

9.6.1. Transplant Incidence Cases in Japan

9.6.2. Antibody-Mediated Rejection Cases in Japan

10. Patient Journey

11. Key Endpoints in Antibody-mediated Rejection Clinical Trials

12. Emerging Therapies

12.1. Key Cross Competition

12.2. Clazakizumab: CSL Behring

12.2.1. Product Description

12.2.2. Other Developmental Activities

12.2.3. Clinical Developmental Activities

12.2.4. Safety and Efficacy

12.2.5. Analyst’s Views

12.3. Imlifidase: Hansa Biopharma

12.3.1. Product Description

12.3.2. Other Developmental Activities

12.3.3. Clinical Developmental Activities

12.3.4. Safety and Efficacy

12.3.5. Analyst’s Views

12.4. BIVV020: Sanofi

12.4.1. Product Description

12.4.2. Clinical Developmental Activities

12.4.3. Analyst’s Views

12.5. FCR001: Talaris Therapeutics

12.5.1. Product Description

12.5.2. Other Developmental Activities

12.5.3. Clinical Developmental Activities

12.5.4. Safety and Efficacy

12.5.5. Analyst’s Views

12.6. Dazodalibep (VIB4920): Horizon Therapeutics

12.6.1. Product Description

12.6.2. Other Developmental Activities

12.6.3. Clinical Developmental Activities

12.6.4. Analyst’s Views

13. Conjoint Analysis

14. Antibody Mediated Rejection (AMR): 7 Major Market Analysis

14.1. Key Findings

14.2. Market Outlook

14.3. 7MM Market Size

14.3.1. Market Size of Antibody-Mediated Rejection in the 7MM

14.3.2. Market Size of Antibody-Mediated Rejection by Therapies in the 7MM

14.4. Market Size in the United States

14.4.1. Total Market Size of Antibody-Mediated Rejection (AMR) in the United States

14.4.2. Market Size of Antibody-Mediated Rejection (AMR) by Therapies in the United States

14.5. Market Size in the EU-5

14.5.1. Total Market size Total Market Size of Antibody-Mediated Rejection (AMR) in EU-5

14.5.2. Market Size of Antibody-Mediated Rejection (AMR) by Therapies in EU-5

14.6. Japan Market Size

14.6.1. Total Market Size of Antibody-Mediated Rejection (AMR)

14.6.2. Market size by Therapies

15. Market Access and Reimbursement

16. KOL Views

17. Market Drivers

18. Market Barriers

19. SWOT Analysis

20. Unmet needs

21. Appendix

21.1. Bibliography

21.2. Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

List of Table

Table 1: Summary of Antibody Mediated Rejection (AMR), Market, Epidemiology, and Key Events (2019–2032)

Table 2: T cell-mediated rejection

Table 3: ISHLT Recommendations for Monitoring for AMR

Table 4: Antibody Panels and Clinical Indicators for Pathological Diagnosis of Cardiac AMR

Table 5: Non-HLA DSA Biomarker for AMR

Table 6: Transplant Incidence Cases in the 7MM (2019–2032)

Table 7: Total Cases of Antibody-Mediated Rejection (AMR) in the 7MM (2019–2032)

Table 8: Transplant Incidence Cases in the US (2019–2032)

Table 9: Antibody-Mediated Rejection Cases in the United States (2019–2032)

Table 10: Transplant Incidence Cases in EU-5 (2019–2032)

Table 11: Antibody-Mediated Rejection Cases in EU-5 (2019–2032)

Table 12: Transplant Incidence Cases in Japan (2019–2032)

Table 13: Antibody-Mediated Rejection Cases in Japan (2019–2032)

Table 14: Key-cross competition - Emerging drugs

Table 15: Clazakizumab, Clinical Trial Description, 2022

Table 16: Imlifidase, Clinical Trial Description, 2022

Table 17: BIVV020, Clinical Trial Description, 2022

Table 18: FCR001, Clinical Trial Description, 2022

Table 19: Dazodalibep (VIB4920), Clinical Trial Description, 2022

Table 20: 7MM Market Size of Antibody-Mediated Rejection in USD Million (2019–2032)

Table 21: 7MM Market Size of Antibody-Mediated Rejection by Therapies in USD Million (2019–2032)

Table 22: Market Size of Antibody-Mediated Rejection (AMR) in the United States, in USD Million (2019–2032)

Table 23: Market Size of Antibody-Mediated Rejection by Therapies in the United States, in USD Million (2019–2032)

Table 24: Market Size of Antibody-Mediated Rejection (AMR) in EU-5, in USD Million (2019–2032)

Table 25: Total Market Size of Antibody-Mediated Rejection (AMR) by Therapies in EU-5, in USD Million (2019–2032)

Table 26: Total Market Size of Antibody-Mediated Rejection (AMR) in Japan, in USD Million (2019–2032)

Table 27: Market Size of Antibody-Mediated Rejection by Therapies in Japan, in USD Million (2019–2032)

List of Figures

Figure 1: Epidemiology and Market Methodology

Figure 2: Activation of the Classical Complement Pathway in AMR in Renal Transplant Recipients

Figure 3: Diagnosis of Acute Antibody-mediated Rejection

Figure 4: Algorithm for Treatment of Presumed and Biopsy-proven Acute Kidney Allograft Rejection

Figure 5: Diagnosis and Treatment of Pancreas Rejection

Figure 6: Algorithm for AMR in Heart Transplantation

Figure 7: Transplant Incidence Cases in the 7MM (2019–2032)

Figure 8: Total Cases of Antibody-Mediated Rejection (AMR) in the 7MM (2019–2032)

Figure 9: Transplant Incidence Cases in the US (2019–2032)

Figure 10: Antibody-Mediated Rejection Cases in the United States (2019–2032)

Figure 11: Transplant Incidence Cases in EU-5 (2019–2032)

Figure 12: Antibody-Mediated Rejection Cases in EU-5 (2019–2032)

Figure 13: Transplant Incidence Cases in Japan (2019–2032)

Figure 14: Antibody-Mediated Rejection Cases in Japan (2019–2032)

Figure 15: Mechanism of Action

Figure 16: Market Size of Antibody-Mediated Rejection in the 7MM, USD Million (2019–2032)

Figure 17: 7MM Market Size of Antibody-Mediated Rejection by Therapies in USD Million (2019–2032)

Figure 18: Market Size of Antibody-Mediated Rejection (AMR) in the United States, USD Million (2019–2032)

Figure 19: Market Size of Antibody-Mediated Rejection (AMR) by Therapies in the United States, in USD Million (2019–2032)

Figure 20: Total Market Size of Antibody-Mediated Rejection in EU-5, USD Million (2019–2032)

Figure 21: Total Market Size of Antibody-Mediated Rejection (AMR) by Therapies in EU-5, in USD Million (2019–2032)

Figure 22: Total Market Size of Antibody-Mediated Rejection (AMR) in Japan, in USD Million (2019–2032)

Figure 23: Total Market Size of Antibody-Mediated Rejection by Therapies in Japan, in USD Million (2019–2032)

Figure 24: Market Drivers

Figure 25: Market Barriers

Figure 26: Unmet Needs

CSL Behring
Hansa Biopharma
Sanofi
Talaris Therapeutics
Horizon Therapeutics

 

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