You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 17, 2025

Immune globulin intravenous (human) - Biologic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


Summary for immune globulin intravenous (human)
Tradenames:8
High Confidence Patents:0
Applicants:8
BLAs:10
Suppliers: see list7
Recent Clinical Trials: See clinical trials for immune globulin intravenous (human)
Recent Clinical Trials for immune globulin intravenous (human)

Identify potential brand extensions & biosimilar entrants

SponsorPhase
The Affiliated Hospital of Putian UniversityPhase 4
Nanping First Hospital Affiliated to Fujian Medical UniversityPhase 4
The Second Hospital of Anhui Medical UniversityPhase 4

See all immune globulin intravenous (human) clinical trials

Pharmacology for immune globulin intravenous (human)
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 intravenous (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin intravenous (human) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for immune globulin intravenous (human) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Immune Globulin Intravenous (Human)

Last updated: July 7, 2025

Introduction

Immune Globulin Intravenous (Human), or IGIV, stands as a cornerstone in treating immune deficiencies, autoimmune disorders, and infectious diseases. This biologic drug, derived from human plasma, delivers essential antibodies to bolster the immune system. As demand surges amid rising autoimmune conditions and an aging global population, IGIV's market dynamics and financial path offer critical insights for stakeholders. This analysis delves into current trends, competitive forces, and revenue projections, equipping business professionals with actionable data to navigate this lucrative sector.

What is Immune Globulin Intravenous (Human)?

IGIV represents a purified form of immunoglobulin G antibodies, administered intravenously to patients with conditions like primary immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, and Kawasaki disease. Its efficacy stems from neutralizing pathogens and modulating immune responses, making it indispensable in both therapeutic and prophylactic settings. The drug's production involves complex plasma fractionation processes, which demand stringent regulatory oversight to ensure safety and efficacy.

In 2023, the IGIV market reached approximately $12.5 billion globally, driven by increasing disease prevalence and expanded clinical applications. Major manufacturers, including CSL Behring and Grifols, dominate supply chains, but production constraints—such as plasma shortages—continue to influence availability and pricing.

Market Dynamics of IGIV

The IGIV market operates in a high-stakes environment shaped by supply-demand imbalances, regulatory hurdles, and competitive pressures. This sector has witnessed steady growth, with a compound annual growth rate (CAGR) of 7.5% from 2018 to 2023, according to industry reports.

Supply and Demand Trends

Demand for IGIV escalates as healthcare systems address a growing patient base. In the U.S. alone, over 250,000 individuals rely on IGIV for primary immunodeficiencies, while global figures approach 500,000 cases. Factors like the COVID-19 pandemic amplified usage, with off-label applications for severe infections boosting consumption by 15% in 2021.

On the supply side, plasma donations remain the bottleneck. Leading suppliers, such as Takeda Pharmaceutical, source from regulated donor networks, but geopolitical disruptions and raw material costs have driven shortages. For instance, Europe faced a 10% supply deficit in 2022, pushing prices upward by 8-12% annually.

Key Players and Competition

The IGIV landscape features a concentrated group of players, with CSL Behring holding a 30% market share, followed by Grifols at 25%, and Takeda at 20%. These companies leverage vertical integration, from plasma collection to final product distribution, to maintain dominance.

Emerging competitors, including Bio Products Laboratory and Kedrion Biopharma, introduce biosimilars that challenge pricing structures. In 2023, the entry of a Grifols biosimilar reduced average selling prices by 5% in select markets, intensifying competition. Strategic alliances, like Takeda's partnership with a Chinese distributor, expand geographic reach, particularly in Asia-Pacific regions where demand grows at a 9% CAGR.

Regulatory and Pricing Environment

Stringent regulations from bodies like the FDA and EMA govern IGIV production, mandating rigorous testing for viral safety and potency. Recent approvals, such as the FDA's nod for a new IGIV formulation in 2022, have eased some barriers but increased compliance costs by 15% for manufacturers.

Pricing dynamics reflect this complexity. In the U.S., IGIV costs average $50-100 per gram, varying by indication and payer negotiations. Reimbursement policies, such as those under Medicare, cap expenditures but also incentivize generic alternatives, potentially capping market growth at 6% annually through 2028.

Challenges and Opportunities

Market challenges include supply chain vulnerabilities and rising costs of goods sold, which climbed 20% in 2023 due to inflation. Environmental factors, like climate-driven disruptions in plasma sourcing, add uncertainty.

Conversely, opportunities arise from expanding indications. Clinical trials, such as those exploring IGIV for Alzheimer's disease, could unlock a $2 billion market segment by 2030. Digital innovations in supply chain management, adopted by firms like Grifols, promise to mitigate shortages and enhance efficiency.

Financial Trajectory of IGIV

IGIV's financial performance reflects robust revenue growth tempered by high operational costs and patent expirations. From 2018 to 2023, global revenues surged from $9 billion to $12.5 billion, propelled by volume increases and premium pricing.

Revenue Trends and Profitability

Top players report strong financials. CSL Behring's IGIV segment generated $4.5 billion in revenue in 2023, up 12% year-over-year, with net margins at 18%. Grifols achieved $3.2 billion in sales, though profitability dipped to 15% amid supply issues.

Profitability hinges on economies of scale. Larger firms benefit from integrated operations, reducing per-unit costs by 10-15%. However, biosimilar threats erode margins; Takeda's recent earnings showed a 5% decline in IGIV profits due to competitive pricing.

Research and Development Investments

R&D spending remains critical, totaling $1.5 billion across major players in 2023. Investments target next-generation formulations, such as subcutaneous IGIV variants, which offer convenience and could capture 20% of the market by 2026.

Patent landscapes influence financial strategies. Key patents for IGIV products, like CSL's core technology expiring in 2025, open doors to biosimilars. Companies counter this with lifecycle management, filing extensions that preserve revenue streams.

Future Projections and Risks

Projections forecast the IGIV market to reach $18 billion by 2030, with a CAGR of 6-8%. This growth stems from demographic shifts, including a 20% rise in elderly populations prone to immune disorders.

Financial risks include regulatory delays and economic downturns. A potential recession could cut demand by 5-10%, while currency fluctuations impact export revenues for firms like Takeda. Mergers, such as Grifols' acquisition of a rival in 2023, signal consolidation to bolster financial resilience.

Despite these, strategic investments in emerging markets—where revenues could double by 2028—position IGIV as a high-return asset for pharmaceutical portfolios.

Conclusion

The IGIV market's evolution underscores a balance of opportunity and challenge, with dynamic forces shaping its financial future. Stakeholders must monitor supply trends, competitive entries, and regulatory shifts to capitalize on growth while mitigating risks.

Key Takeaways

  • IGIV demand continues to rise, driven by increasing immune-related diseases and an aging population, projecting market expansion to $18 billion by 2030.
  • Key players like CSL Behring and Grifols maintain dominance through vertical integration, though biosimilars pose pricing pressures.
  • Financial growth is strong but vulnerable, with revenues up 12% in 2023, yet patent expirations and supply shortages threaten margins.
  • R&D investments are pivotal, focusing on new indications and formulations to sustain profitability amid regulatory scrutiny.
  • Strategic adaptations, such as mergers and market expansions, will define long-term trajectories for IGIV stakeholders.

FAQs

  1. What factors primarily drive the growth of the IGIV market?
    The IGIV market grows due to rising incidences of autoimmune diseases and expanded therapeutic uses, with global demand increasing by 7.5% annually from new patient populations and off-label applications.

  2. How do patent expirations affect IGIV's financial trajectory?
    Patent expirations, such as those occurring in 2025 for major formulations, introduce biosimilars that lower prices and erode revenues, potentially reducing profit margins by 5-10% for original manufacturers.

  3. What role do regulatory bodies play in IGIV pricing?
    Agencies like the FDA enforce strict safety standards, which influence pricing by requiring costly compliance, often resulting in higher per-unit costs that are passed on through payer negotiations.

  4. How might economic factors impact IGIV investments?
    Economic downturns could decrease healthcare spending, reducing IGIV demand by up to 10%, while inflation raises production costs, making strategic investments in efficient supply chains essential.

  5. What opportunities exist for new entrants in the IGIV sector?
    New entrants can target underserved markets, like Asia-Pacific, with cost-effective biosimilars, potentially capturing 15-20% market share by innovating in formulation and distribution.

Sources

  1. Grand View Research. "Immune Globulin Intravenous Market Size, Share & Trends Analysis Report by 2030." Accessed via industry reports on plasma-derived therapies.
  2. CSL Behring Annual Report 2023. Financial data on revenue and R&D investments.
  3. FDA Regulatory Updates 2022-2023. Information on IGIV approvals and safety guidelines.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.