Human immunoglobulin or immunoglobulin for intravenous injection (IVIG) is a therapeutic preparation of concentrated antibodies (immunoglobulins) derived from human blood plasma. IVIG formulations contain purified immunoglobulin G antibodies intended for use as replacement therapy for immunodeficient patients or as immunotherapy for certain autoimmune or inflammatory conditions. IVIG therapy provides patients with a broad range of normal antibody specificities which can neutralize or prevent the harmful effects of certain toxins or agents.
The global human immunoglobulin (pH4) for intravenous injection market is estimated to be valued at US$ 2,055.76 Mn in 2023 and is expected to exhibit a CAGR of 16% over the forecast period 2023 to 2030.
Market Dynamics:
The rapid growth of the global human immunoglobulin (pH4) for intravenous injection market is primarily attributed to the increasing prevalence of various immunodeficiency diseases globally. According to estimates by the World Health Organization (WHO), there are over 350 million people affected by some form of primary or secondary immunodeficiency worldwide. The rising cases of diseases such as chronic inflammatory demyelinating polyneuropathy (CIDP), hypogammaglobulinemia, human immunodeficiency virus (HIV), and multiple sclerosis are consequently fueling the demand for IVIG therapy for efficient management of symptoms. Furthermore, ongoing research and clinical trials focused on evaluating the effectiveness of IVIG therapy in treating various autoimmune conditions such as Guillain-Barré syndrome and muscle weakness disorders are also propelling the market growth.
SWOT Analysis
Strength:
- Human Immunoglobulin (pH4) has been approved for various therapeutic areas such as immunodeficiency diseases, transplantation, and neurology. This wide range of treatment options is a major strength.
- The recombinant production process allows for a reliable supply and consistent purity and safety profile. This ensures treatment continuity for patients.
- Leading manufacturers have established production facilities around the world to ensure global supply security.
Weakness:
- Manufacturing intravenous immunoglobulin involves a complex multi-step process making it relatively expensive compared to other treatment options.
- The intravenous route of administration requires hospital visits or clinical settings, which poses accessibility challenges for some patients.
Opportunity:
- Expanding approvals in new therapeutic areas such as hematology-oncology and infectious diseases can unlock a sizable untapped market potential.
- In emerging markets, increasing healthcare spending and awareness about immunodeficiency conditions presents an opportunity for market growth.
- Technology advances may enable subcutaneous or intramuscular administration in the future, reducing costs and expanding the target patient pool.
Threats:
- Biosimilar competition can capture market share as patents on flagship brands expire.
- Stringent regulatory requirements worldwide add to product development and commercialization timelines and costs.
- COVID-19 posed supply challenges but the long-term impact remains uncertain.
Key Takeaways
The global Human Immunoglobulin (pH4) for Intravenous Injection Market is expected to witness high growth. The market was valued at $2,055.76 Mn in 2023 and is forecast to reach $5,456.45 Mn by 2030, expanding at a CAGR of 16%.
Regional analysis: North America currently dominates the market with the highest revenue share of around 35% in 2023. This is attributed to favorable reimbursement policies and the large patient population affected by primary immunodeficiency diseases in the region. However, Asia Pacific is expected to emerge as the fastest growing regional market during the forecast period due to rising health awareness, improving access to healthcare facilities, and increasing per capita healthcare expenditure in countries such as China, India, and Japan.
Key players: Major players operating in the Human Immunoglobulin (pH4) for Intravenous Injection Market are Takeda Pharmaceutical Company Limited, CSL Behring, Grifols S.A., Kedrion S.p.A, Octapharma, Baxalta, and Biotest AG. Takeda currently holds the leading market share of around 20% owing to its flagship Hizentra brand used for treating various neurological and immunological disorders. CSL Behring follows in second position with a strong portfolio of products such as Privigen and Hizentra for primary immunodeficiency treatment and Rh0(D
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