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Last Updated: May 23, 2025

Immune globulin subcutaneous, human-klhw - Biologic Drug Details


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Summary for immune globulin subcutaneous, human-klhw
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Pharmacology for immune globulin subcutaneous, human-klhw
Mechanism of ActionAntigen Neutralization
Physiological EffectPassively Acquired Immunity
Established Pharmacologic ClassHuman Immunoglobulin G
Chemical StructureImmunoglobulins
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for immune globulin subcutaneous, human-klhw Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin subcutaneous, human-klhw Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for immune globulin subcutaneous, human-klhw Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Immune Globulin Subcutaneous, Human-klhw

Introduction to Subcutaneous Immunoglobulin (SCIG)

Subcutaneous immunoglobulin (SCIG) is a method of administering immunoglobulin therapy where the medication is delivered under the skin, rather than into a vein. This approach allows for slower absorption, reducing the risk of side effects compared to intravenous administration. SCIG is primarily used to treat various immune deficiencies, providing a convenient and effective way to boost the immune system[4].

Market Size and Growth

The subcutaneous immunoglobulin market has experienced robust growth in recent years. As of 2023, the market size was valued at $11.19 billion, and it is expected to grow to $12.72 billion in 2024 at a compound annual growth rate (CAGR) of 13.7%. By 2028, the market is projected to reach $21.38 billion with a CAGR of 13.9%[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the SCIG market:

  • Increased Prevalence of Immunodeficiency Disorders: The rising number of patients with primary and secondary immunodeficiency disorders is a significant driver. These conditions necessitate regular immunoglobulin infusions to reinforce the immune system[1][3].
  • Patient Preference for Home-Based Care: There is a growing preference among patients for home-based care, which SCIG facilitates through its convenient self-administration method[1][3].
  • Enhanced Therapeutic Efficacy: Advances in drug delivery systems and formulations have improved the therapeutic efficacy of SCIG, making it a more attractive treatment option[1][4].
  • Growing Awareness and Diagnosis Rates: Increased awareness and improved diagnostic techniques have led to higher diagnosis rates of immunodeficiency disorders, contributing to market growth[1][4].
  • Favorable Reimbursement Policies: Expanding reimbursement policies have made SCIG more accessible to patients, further driving market growth[1][4].

Applications and End-Uses

SCIG is used across various applications and end-uses:

  • Primary Immunodeficiency Disorders: SCIG is indicated for the treatment of primary humoral immunodeficiency (PI) in patients two years of age and older[2][5].
  • Autoimmune Diseases: It is also used to treat autoimmune diseases by providing antibodies to help strengthen the weakened immune system[1][4].
  • Neurological Disorders: The market is expanding into neurological disorders, with SCIG being used to treat conditions such as multiple sclerosis and other neuroinflammatory diseases[1][4].
  • End-Uses: SCIG is administered in clinics, hospitals, and homecare settings, with homecare being a particularly growing segment due to patient preference and convenience[1][3].

Geographical Insights

  • North America: This region dominated the global SCIG market in 2023, driven by rising healthcare expenditure and increasing prevalence of immunodeficiency disorders[3][4].
  • Asia-Pacific: This region is expected to be the fastest-growing in the forecast period, driven by increasing healthcare access and rising awareness of immunodeficiency disorders[3][4].

Major Players and Innovations

Key players in the SCIG market include Grifols S.A., Bio Product Laboratory, Biotest AG, CSL Behring, and Laboratoire français du Fractionnement et des Biotechnologies. These companies are innovating in several areas:

  • XEMBIFY 20%: Grifols launched XEMBIFY, a 20% subcutaneous immunoglobulin therapy, which is a ready-to-use formulation that simplifies the treatment process and increases patient convenience. It is stable at room temperature for up to 24 months, eliminating the need for refrigeration during storage and transportation[1][5].
  • Subcutaneous Human-klhw: Major companies are developing subcutaneous human-klhw formulations, which contain human immune globulins (Ig) to strengthen the immune system. These formulations are designed for subcutaneous administration and are particularly useful for treating primary immunodeficiency diseases[1][4].

Challenges and Limitations

Despite the growth, the SCIG market faces several challenges:

  • High Cost of Treatment: The high cost of SCIG products and administration equipment is a significant barrier to widespread adoption. Affordability concerns limit patient access, especially in regions with insufficient insurance coverage[3].
  • Regulatory and Reimbursement Issues: The market is also influenced by regulatory approvals and reimbursement policies, which can affect the accessibility of SCIG treatments[3].

Future Trends and Innovations

The SCIG market is expected to continue its strong growth trajectory, driven by several trends and innovations:

  • Advancements in Drug Delivery Systems: Innovations in drug delivery systems are enhancing the efficacy and convenience of SCIG treatments[1][4].
  • Increasing Demand for Home Infusion Therapies: The preference for home-based care is driving the demand for SCIG, which allows for self-administration at home[1][3].
  • Developments in Antibody Therapy: Expanding applications in neurology and dermatology, along with advancements in antibody therapy, are further propelling the market[1][4].
  • Innovations in Formulations: Continuous innovations in formulations, such as the development of subcutaneous human-klhw, are improving treatment outcomes and patient convenience[1][4].

Patient-Centric Approach

A patient-centric approach is a key driver of the SCIG market's growth. The convenience of subcutaneous administration allows for self-administration at home, enhancing flexibility and treatment adherence. This shift aligns with patient preferences, creating a more user-friendly treatment landscape[3].

Key Takeaways

  • The SCIG market is experiencing rapid growth driven by increased prevalence of immunodeficiency disorders, patient preference for home-based care, and advancements in drug delivery systems.
  • Major players are innovating with new formulations like XEMBIFY 20% and subcutaneous human-klhw.
  • The market faces challenges such as high treatment costs and regulatory issues but is expected to continue growing due to favorable trends and innovations.
  • A patient-centric approach is crucial in driving market growth and satisfaction.

FAQs

1. What is Subcutaneous Immunoglobulin (SCIG)? SCIG is a method of administering immunoglobulin therapy where the medication is delivered under the skin, rather than into a vein, to treat various immune deficiencies.

2. What are the key drivers of the SCIG market growth? Key drivers include the increased prevalence of immunodeficiency disorders, patient preference for home-based care, enhanced therapeutic efficacy, growing awareness and diagnosis rates, and favorable reimbursement policies.

3. Which region dominates the global SCIG market? North America dominated the global SCIG market in 2023, but the Asia-Pacific region is expected to be the fastest-growing in the forecast period.

4. What are the major innovations in SCIG formulations? Major innovations include the development of XEMBIFY 20% and subcutaneous human-klhw formulations, which offer improved convenience, efficacy, and patient comfort.

5. What are the challenges facing the SCIG market? The high cost of treatment and regulatory/reimbursement issues are significant challenges limiting the widespread adoption of SCIG treatments.

Cited Sources:

  1. The Business Research Company, "Subcutaneous Immunoglobulin (SCIG) Global Market Report 2024"
  2. Medicaid, "Immune Globulin Subcutaneous, Human – klhw 20% Solution ... "
  3. Polaris Market Research, "Subcutaneous Immunoglobulin Market Size, Global Report, 2024"
  4. EIN Presswire, "Global Subcutaneous Immunoglobulin (SCIG) Market Size, Share And Growth Analysis For 2024-2033"
  5. Grifols, "Grifols launches XEMBIFY ® (immune globulin subcutaneous human-klhw) 20%, a new Primary Immunodeficiency treatment"
Last updated: 2024-12-22

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