Disease Sample Services | Compliance-Focused Collection Services for Autoimmune Disease Samples Empower the Hundreds-of-Billion-Dollar Autoimmune Market
Release Date:
2024-08-26 14:28
01 Introduction to the Background of Autoimmune Diseases
Autoimmune diseases (AIDs) are immune dysregulatory disorders in which the body’s normal autoimmune homeostasis is disrupted, leading to aberrant immune responses against self-cell or tissue antigens and, consequently, damage to or dysfunction of autologous tissues. AIDs affect 5% to 8% of the global population, imposing substantial suffering on patients; their incidence may even surpass that of cardiovascular disease and cancer, making them a leading cause of mortality worldwide.
Autoimmune diseases can be treated with CAR-T cells that recognize B-cell–specific surface molecules: the rationale for targeting B cells in autoimmune disorders stems from their central role in disease pathogenesis, mediated by the production of autoantibodies, antigen presentation, and the release of pro-inflammatory cytokines. In clinical trials for systemic lupus erythematosus (SLE), antisyntetase syndrome (ASS), systemic sclerosis (SSc), and myasthenia gravis (MG), anti-CD19 CAR-T cells have demonstrated robust depletion of B cells, including tissue-resident B cells and plasmablasts. Importantly, these early studies have reported rapid disease control and a favorable safety profile, with minimal incidence of cytokine release syndrome (CRS) or neurotoxicity compared with oncologic settings.
In autoimmune diseases, CARs targeting B cells are used to specifically recognize the B-cell–specific surface molecule CD19. Following ex vivo expansion and typically administration of a combination of fludarabine and cyclophosphamide, the CAR-T cells are infused back into the patient, where they undergo further expansion and selectively eliminate all CD19-expressing B cells. CD19-negative cells, including long-lived plasma cells in the bone marrow, remain unaffected by CAR-T–mediated cytotoxicity.
Principle of Autologous CAR-T Cell Therapy
Image sourced from the internet.
The promising market prospects in the autoimmune disease space are attracting pharmaceutical companies both domestically and internationally to enter and establish a foothold, with global sales of autoimmune therapeutics projected to reach US$176 billion by 2030. Currently, the domestic oncology drug market is significantly larger than the autoimmune drug market; however, as local companies advance the commercialization of their autoimmune products, The launch of blockbuster overseas products has helped foster the domestic market; since 2023, domestic biopharmaceutical companies such as Hengrui Medicine, Zhixiang Jintai, Conba Pharmaceutical, and CanNuoYa have successively submitted New Drug Applications (NDAs) for their own autoimmune therapies, marking the beginning of a harvest period for the domestic substitution of imported autoimmune drugs.
Hycells is committed to becoming a world-leading one-stop supplier of primary cells, associated reagents, and related services. Leveraging the platform advantages of its existing portfolio of immune-cell–related products and services, the company has established a robust and stable donor resource bank encompassing both Chinese and international populations, and has developed a comprehensive donor management and project management system. The company offers clients end-to-end compliance-driven approval services, including regulatory interpretation, policy analysis, domestic-investor designation, and approval for international collaborations.
02 Brief Overview of Common Autoimmune Diseases
The American Autoimmune Related Diseases Association (AARDA) has compiled a relatively comprehensive list of autoimmune diseases, identifying more than 100 distinct conditions. The pathogenesis of autoimmune diseases is complex, involving genetic factors, environmental influences, and immune dysregulation, among other contributors.
Common autoimmune diseases include:
1. Primary Biliary Cholangitis (PBC): a chronic, progressive cholestatic liver disease characterized by inflammation and destruction of intrahepatic bile ducts, leading to impaired bile flow. Patients with PBC may experience symptoms such as fatigue, pruritus, and jaundice, and the disease can progress to cirrhosis and liver failure.
2. Autoimmune hepatitis (AIH): The immune system mistakenly attacks liver cells, leading to impaired liver function. AIH is characterized by elevated serum aminotransferase levels, hypergammaglobulinemia, and the presence of autoantibodies against hepatocytes.
3. Inflammatory Bowel Disease (IBD): a group of chronic inflammatory disorders that affect the intestinal mucosa, including Crohn’s disease (CD) and ulcerative colitis (UC). Symptoms of IBD may include diarrhea, abdominal pain, weight loss, and others.
4. Multiple Sclerosis (MS): a demyelinating disease of the central nervous system characterized by visual disturbances, limb weakness, sensory abnormalities, and ataxia. The pathogenesis of MS involves autoimmune-mediated damage to nerve fibers, leading to neurological impairment.
5. Neuromyelitis Optica (NMO): NMO encompasses transverse myelitis (TM) and acute neuromyelitis optica, and is primarily associated with aquaporin-4–specific autoantibodies (AQP4-IgG). Various viruses, including cytomegalovirus (CMV), herpes simplex virus (HSV), Epstein–Barr virus (EBV), and Zika virus (ZKV), have been identified as potential triggering factors for NMO.
6. Systemic lupus erythematosus (SLE): a systemic autoimmune disease involving multiple organ systems, characterized by malar rash, arthritis, vasculitis, renal involvement, and hematologic abnormalities, among others.
7. Psoriasis/Psoriatic Arthritis: Psoriasis, also widely known as “psoriasis,” is a common polygenic hereditary skin disease that typically presents as localized or widespread scaly erythematous lesions or plaques. Psoriatic arthritis (PsA) is an inflammatory joint disease associated with psoriasis, characterized by the presence of psoriatic skin lesions accompanied by pain, swelling, tenderness, stiffness, and impaired range of motion in the joints and surrounding soft tissues.
8. Rheumatoid arthritis (RA): characterized primarily by chronic inflammation of the synovial membrane, leading to joint pain, swelling, stiffness, and deformity.
9. Sjögren’s syndrome: a chronic inflammatory autoimmune disease characterized primarily by reduced secretion from the lacrimal and salivary glands.
10. Atopic dermatitis (AD), also known as atopic eczema, is a chronic, recurrent, inflammatory skin disease characterized clinically by dry skin, intense pruritus, and eczematous rashes.
11. Graft-versus-host disease (GVHD): Following transplantation, T lymphocytes from the allogeneic donor graft are subjected to a cascade of cytokine storms initiated by the recipient, which markedly amplifies their immune response against recipient antigens. These activated T cells then mount cytotoxic attacks directed against recipient target cells, with the skin, liver, and gastrointestinal tract being the primary targets.
12. Ankylosing Spondylitis (AS): a chronic inflammatory disease that primarily affects the spine and sacroiliac joints. Symptoms of AS may include lower back pain, morning stiffness, and, in advanced cases, spinal fusion and joint ankylosis. The pathogenesis of AS involves aberrant immune responses that lead to inflammation and joint damage.
13. Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: This disease is one of the most common autoimmune disorders in Western countries and has been a research hotspot both internationally and domestically over the past 10 to 20 years. Clinically, it is characterized by fever, anemia, pulmonary and renal dysfunction, and an elevated erythrocyte sedimentation rate.
14. Behçet’s syndrome (BD; also known as Behçet’s disease or the oral–ocular–genital triad): a chronic, relapsing, systemic vasculitis characterized by recurrent oral ulcers, genital ulcers, and ocular inflammation, with potential involvement of multiple organ systems, including the gastrointestinal, cardiovascular, and nervous systems.
15. Uveitis: Also known as pigmented membrane inflammation, it is a general term for inflammation of the iris, ciliary body, and choroid. This condition is a common ophthalmic disease that can lead to serious complications and sequelae, making it one of the leading causes of blindness. Based on the site of involvement, uveitis can be classified as anterior, posterior, or intermediate uveitis; based on clinical presentation, it can be categorized as serous, fibrinous, suppurative, or granulomatous uveitis.
Compliant Sample Collection Services for Self-Exempt Disease Prevention
Hycells Biotechnology can provide clients with compliant sample collection services for the aforementioned autoimmune diseases, thereby supporting the high-quality development of the autoimmune drug sector. Deliverable sample types include PBMCs, apheresis blood/whole blood samples, tissue samples, paraffin-embedded blocks, and more. In addition to autoimmune diseases, Hycells also offers sample services for other disease areas:
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Chronic diseases: hypertension, diabetes, chronic respiratory diseases, etc.
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Neurological disorders: AD/PD/genetic neurological disorders, etc.
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Solid tumors: lung cancer, colorectal cancer, breast cancer, liver cancer, gastric cancer, pancreatic cancer, and others.
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Hematologic malignancies: leukemia, multiple myeloma, and malignant lymphoma, among others.
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Viral infectious diseases.
For more details on disease samples from Hycells Biotechnology, please contact our sales representative.
Contact: Mr. Xie, 15201775322.
Advantages of the Hycells Disease Sample Service
1. Abundant clinical resources, with dozens of tertiary hospitals nationwide as collaborative partners;
2. A professional clinical team with experience in GCP and HGRAC project management and regulatory submissions;
3. A comprehensive quality management system ensures project traceability and compliance with clinical submission requirements.
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