Subcutaneous immunoglobulin (ScIg) simply means “Immunoglobulin (Ig) administration via the subcutaneous (s.c.) route” and is being used for various purposes more than in previous years. The basic advantage of this administration method is that no venous leakage occurs also has comparatively fewer side effects. This will give immunoglobulin replacement therapy new levels which will increase the convenience of patients and healthcare individuals. Different studies are available with data that support the use of s.c. administration of Previously untreated patients with primary immunodeficiency, and autoimmune neurological conditions.
ScIg is safe and well-accepted by patients. ScIg is made from blood plasma. It involves the processing of blood to destroy live bacteria present. Then addition of immunoglobulin was made using various methods tested for sterility and packaged for consumption. The market is growing type as the number of patients suffering from immunodeficiency disorders has increased due to various reasons including urbanization. This ScIg is adopted as a primary treatment in various immunodeficiency disorders, autoimmune disorders, and neurological conditions. With the manufacturing market, the packaging and storage market also increases as per ScIg requirements. administration of immunoglobulin subcutaneously (SCIG) is equally effective in preventing infections and has a lower incidence of serious adverse effects compared to IVIG. The tolerability and acceptability of SCIG has been demonstrated in numerous studies showing improvements in quality of life and a preference for subcutaneous immunoglobulin therapy in patients with antibody deficiencies.
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Global Subcutaneous immunoglobulin Market – Competitive Insight
In April 2023, CSL Behring biotechnology company received its authorization from the FDA for ‘Hizentra’ (20% 20g/100ml) infusion on chronic inflammatory demyelinating polyneuropathy.
In September 2023, Japan’s first ScIg for Agammaglobulinemia treatment was marketed under the name CUVITRUTM.
In January 2024, Grifols Australia Pty Ltd introduced Xembify 20% after (the NBA) National Blood Authority agreed on arrangements.
Some of the Key Players in the Global Subcutaneous immunoglobulin Market Include –
- Takeda
- Biotest AG
- Grifols
- Octapharma
- CSL Behring
- KEDRION Biopharma
- ADMA Biologics
- Hansa Biopharma
- Kamada Ltd.
- Bio Product Laboratory
- Johnson & Johnson
Global Subcutaneous immunoglobulin Market – Growth Drivers
Subcutaneous Immunoglobulin therapy is also recommended for Pediatric Patients aged 2 years and older with primary immunodeficiency (PI). This formulation has demonstrated efficacy which is proven with phase 3 pivotal and extension studies. Many factors determine the market conditions. Those include innovation of new techniques, and technologies for drug delivery systems i.e. with improved properties such as smaller particle size, increased permeability, increased solubility, efficacy, specific site targeting, stability, toxicity, and sustained delivery, and many more. An increase in awareness about diseases and their correct treatment their side effects clearing of doubts and superstition present in patients’ minds increases the use of subcutaneous immunoglobulin. The development of immunoglobulin products and improved efficacy.
Global Subcutaneous immunoglobulin Market – Restraints
The subcutaneous Immunoglobulin has various disadvantages which cause its market demand to reduce. Some include; immunoglobulins not to be given to patients with fever, which is suspected in pregnant women so contraindicated in pregnant women and breastfeeding women. To overcome this disadvantage immunization via vaccination is required which then increases the cost of treatment. Products marketed are vials of single use so once opened cannot be used again. Administration requires a nurse specialist, storage requirements are fridge is still cold, so keep your supply in the fridge. Other side effects include redness, swelling, and itching at the site. Out of all the mentioned restraints the main restraint is the cost of the treatment. Making it cost-effective is the biggest restraint in the growth of the market. The high cost required to manufacture the immunoglobulin, then makes it available in concentration suitable for subcutaneous administration. Affordability and reimbursement of the ScIg therapy to the patient hinders the adoption of this as primary therapy replacing already marketed access.
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Global Subcutaneous Immunoglobin Market – Opportunities
Overall, SCIg appears to be an option for improving tolerability and patient comfort and reducing the long-term costs of high-dose immunoglobulin treatment in patients with neurological disorders. However, it is important to demonstrate that SCIg is as efficacious as IVIg for each indication in long-term clinical studies. Rapid push ig infusion should be offered to patients and their parents as a convenient alternative to IVIG and CIG by programmable pump therapy.
Global Subcutaneous Immunoglobulin Market – Key Developments
- April 2024, With Vyvgart firing in myasthenia gravis argenx lays launch plans for next potential autoimmune approval.
- January, 2024, CSL Behring announces availability of Hizentra® immunoglobulin subcutaneous 10g prefilled syringe.