Global antibody-mediated rejection market - 2024-2031

Global antibody-mediated rejection market - 2024-2031

The global antibody-mediated rejection (AMR) market reached US$YY million in 2023 and is expected to reach US$YY million by 2031, growing at a CAGR ofYY% during the forecast period 2024-2031.

Antibody-mediated rejection (AMR) refers to all allograft rejections caused by antibodies that target donor-specific HLA molecules, blood group antigen (ABO)-isoagglutinin, or endothelial cell antigens. AMR can result in damage to the transplanted organ, such as a kidney, and can cause various symptoms depending on the organ involved, such as difficulty breathing, cough, and fever.

A significant concern after a person receives an organ transplant from a donor is antibody-mediated rejection (AMR)—a process by which antibodies in the recipient can cause their immune systems to reject and damage the donor organ.

One-third of organ transplants are failed due to transplant rejection. Although acute transplant rejection responds fairly reasonably to steroids, chronic rejection (which is predominantly mediated by antibodies) has no adequate therapy.

The improvement of long-term allograft survival is still hampered by antibody-mediated rejection (AMR), which is still a primary cause of kidney transplant failure despite advancements in immunosuppressive medicine. Together with the creation of new treatment options, there have been notable developments recently in our knowledge of the pathophysiological mechanism underlying AMR.

AMR has also been detected early because of the establishment of surveillance techniques that use donor-derived cell-free DNA and gene profile testing. Many clinical trials are now being conducted, providing many chances to enhance kidney transplant patient outcomes.

Market Dynamics: Drivers

Increasing Organ Transplants Conducted

The global market growth for antibody-mediated rejection is expected to increase due to the rise in the number of organ transplants conducted. For instance, according to preliminary data from the United Network for Organ Sharing (UNOS), over 42,887 organ transplants were conducted in the United States in 2022, which is an increase of 3.7% over 2021 and a new annual record.

In addition, the Global Observatory on Donation and Transplantation reported that over 144,302 organs were transplanted in 2021, indicating an 11.3% increase over 2020, with 16 transplants per hour in 2021. However, it's worth noting that there were only 38,156 actual deceased organ donors in 2021.

Antibody-mediated rejection (ABMR) in organ transplantation has been recognized as the main cause of graft rejection. The binding of donor-specific HLA antibody (DSA) and A/B blood type antibody on graft endothelial cells causes complement-dependent tissue damage.

For instance, in November 2022, Kings College London researchers successfully modeled. The discovery may allow scientists to investigate new mechanisms and test treatment strategies for transplant rejection outside of the human body antibody-mediated transplant rejection in human kidneys.

Also in April 2024, Mayo Clinic is committed to enhancing patient care for transplant recipients by exploring novel approaches, given its status as the biggest organ transplant provider in the US. Our enthusiasm for our new partnership with the Terasaki Institute for Biomedical Innovation stems from this.

Moreover, the increase in awareness, technological advancements, and increasing research activities with investments and funding are among the additional factors boosting the global market growth during the forecast period.

Restraints

Factors such as the high drug development costs, treatment side effects, and stringent regulatory authorities authorizing the new drug treatments are expected to hamper the market.



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Segment Analysis

The antibody-mediated rejection (AMR) market is segmented based on treatment, route of administration, distribution channel and region.

The biologics segment accounted for approximately 34.8% of the antibody-mediated rejection (AMR) market share

The biologics segment is expected to hold the largest market share over the forecast period. The increasing research activities for developing biologics treatments for antibody-mediated rejection are expected to boost the segment's growth in the global market. For instance, HI-Bio's Felzartamab is currently in development for the treatment of late antibody-mediated renal allograft rejection, IgA nephropathy (IgAN), membranous nephropathy (anti-PLA2R antibody-positive membranous nephropathy), and refractory/relapsed multiple myeloma.

The company found that the decline in autoantibody levels occurred regardless of initial aPLA2R levels. Patients in the trial also reported decreases in proteinuria, a protein in the urine that, in high levels, can be indicative of poor kidney function.

Furthermore, according to clinicaltrials.gov, there are currently two phase 2 and two phase 3 clinical trials recruiting, while two phase II and one phase III trials are currently active assessing the effectiveness and safety of monoclonal antibody nominees for antibody-mediated rejections.

Human Immunology Biosciences revealed that felzartamab, an antibiotic designed for the prevention of antibody-induced organ transplant rejection, had been given Orphan Drug Designation by the US FDA in March 2024.

The purpose of the FDA's Orphan Drug Designation program is to provide support in the growth of treatments for rare medical conditions affecting less than 200,000 Americans.

Geographical Analysis

North America accounted for approximately 42.4% of the antibody-mediated rejection (AMR) market share

North America region is expected to hold the largest market share over the forecast period. Owing to the increasing research activities to reduce transplant rejection in North America is expected to boost the regional market growth dominating the global market during the forecast period.

For instance, Northwestern University scientists have designed the first electronic device for continually observing the health of transplanted organs in real time, positioned directly on a transplanted kidney, the ultrathin, soft implant can notice temperature anomalies associated with inflammation and other body reactions that occur with transplant rejection.

Moreover, seeking to enhance organ transplant survival rates, internationally recognized investigators in immunology and bioengineering at the Icahn School of Medicine at Mount Sinai have obtained $15.1 million from the National Institute of Allergy and Infectious Diseases (NIAID) to conduct a novel, five-year multi-center investigation schedule that intends study trained immunity the innate immune system’s capability to recognize infections and other insults as a mark for averting organ transplant rejection.

The ability to personalize management for a given kidney transplant recipient and identify treatments that will improve their long-term outcome remains a critical unmet need. Earlier identification of AMR with noninvasive biomarkers and prediction models to assess the individual risk of graft failure should be considered. Enrolling patients with AMR in clinical trials to assess novel therapeutic agents is highly encouraged.

As per Penn Medicine News in December 2023, the shortage of kidneys became one of the public health problems in the U.S. Approximately 90,000 individuals in the U.S. waiting for a kidney transplant. In addition, 4,000 people die every year due to the lack of kidney transplantation.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the antibody-mediated rejection (AMR) market. Several studies indicated that postrenal transplant patients have an elevated danger of intricacies with COVID-19 infection owing to their immunocompromised status and corresponding comorbidities.

These caused a reduction in the treatment demand also owing to the restrictions posed by the pandemic many transplant surgeries were either postponed or canceled which also caused a reduction in treatment demand for antibody-mediated rejection negatively impacting the global market during the forecast period.

The COVID-19 pandemic hampered the production, dispersion, and manufacturing of pharmaceuticals worldwide. Furthermore, owing to social distancing, footfall in clinics and medical institutions has dropped by more than 70% throughout this pandemic, resulting in a reduction in the volume of surgical operations, clinical trials, activities for research and development, and other pursuits, all of which have hampered market growth in the historical period.

Market Segmentation

By Treatment
• Corticosteroids
• Biologics
• Immunosuppressants
• Plasmapheresis
• Others

By Route of Administration
• Injectable
• Oral
• Others

By Distribution Channel
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the antibody-mediated rejection market include CSL Behring, Hansa Biopharma, Novartis AG, Talaris Therapeutics, Amgen Inc., Bristol-Myers Squibb, Eli Lilly and Company, Inc., Sanofi S.A., Teva Pharmaceuticals Industries Ltd, Ltd. and Biogen among others.

Key Developments

 On May 9, 2024, Researchers at MIT, Brigham and Women's Hospital, and Harvard Medical School developed a potential new treatment for alopecia areata, an autoimmune disorder that causes hair loss and affects people of all ages, including children.

 On August 10, 2023, the PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, was granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States.

 On November 28, 2022, Hansa Biopharma announced positive topline data from the imlifidase phase 2 study in antibody-mediated rejection (AMR) episodes post-kidney transplantation.

 On March 16, 2022, the trial's Independent Data Monitoring Committee recommended that the evaluation of Jardiance (empagliflozin) in grownups with chronic kidney disease (CKD) be halted early.

 On February 1, 2021, Horizon Therapeutics acquired the AstraZeneca spinout Viela Bio for $3 billion. The confiscation is expected to provide Horizon a grip on clinical-phase autoimmune and inflammatory disorder drug nominees, R&D capacities, and an authorized monoclonal antibody.

Why Purchase the Report?
• To visualize the antibody medicated rejection market segmentation based on treatment, route of administration, distribution channel, and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of antibody-mediated rejection (AMR)’ market level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Treatment mapping is available in excel consisting of key treatments of all the major players.

The antibody-mediated rejection (AMR) market report would provide approximately 62 tables, 54 figures, and 182 Pages.

Target Audience 2024
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies