Immune globulin subcutaneous (human) - Biologic Drug Details

Summary for immune globulin subcutaneous (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	4
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for immune globulin subcutaneous (human)

Recent Clinical Trials for immune globulin subcutaneous (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	PHASE2
Qilu Hospital of Shandong University	PHASE2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	PHASE2

See all immune globulin subcutaneous (human) clinical trials

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

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.

2. DrugPatentWatch analysis and brand-side disclosures

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.

3. Patents from broad patent text search

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) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin subcutaneous (human) Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115	5,540,900	2014-07-05	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115	6,096,280	2017-07-28	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115	6,432,393	2018-06-05	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	VIVAGLOBIN	immune globulin subcutaneous (human)	For Injection	125115	6,638,914	2020-01-07	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	10,434,176	2036-07-15	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	8,715,652	2024-11-17	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	8,906,368	2032-09-14	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	10,001,489	2033-08-19	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	10,010,498	2036-03-18	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	10,011,660	2033-04-17	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	10,023,621	2035-06-04	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	10,030,059	2037-05-03	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	10,039,810	2035-05-15	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	10,059,936	2036-12-13	Patent claims search

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

Last updated: August 4, 2025

---

Introduction

Immune globulin subcutaneous (human), commonly known as SCIg, epitomizes a significant segment within biological therapies targeting immunodeficiency and autoimmune disorders. As a broadly used outpatient treatment, SCIg's market trajectory reflects shifting clinical preferences, technological advancements, and regulatory influences. Analyzing its market dynamics and financial trajectory offers crucial insights for stakeholders navigating this evolving landscape.

---

Market Overview

Product Profile and Therapeutic Applications

Immune globulin subcutaneous (human) is a sterilized plasma-derived immunoglobulin administered via subcutaneous injection, providing passive immunity. Its primary applications include primary immunodeficiency diseases (PID), chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome, and autoimmune conditions such as idiopathic thrombocytopenic purpura (ITP) [1].

The convenience of self-administration, reduced infusion times, and improved safety profile over intravenous forms drive its adoption. The growing prevalence of immunodeficiencies and autoimmune disorders globally amplifies the product's demand.

---

Market Dynamics

Drivers

• Rising Incidence of Immunodeficiencies and Autoimmune Diseases: The global burden of primary immunodeficiency is estimated at approximately 1 in 10,000–15,000 live births, with increasing diagnosis rates fueled by improved detection and awareness [2]. Autoimmune conditions further expand the target patient base.

• Shift from IVIG to SCIg: The preference for subcutaneous administration over intravenous routes reflects advancements in formulation technology and patient-centric care models, emphasizing quality of life and outpatient management.

• COVID-19 Pandemic Effects: The pandemic heightened awareness of immunomodulation therapies, with some data suggesting increased demand for immunoglobulin products during this period due to immune support considerations [3].

• Regulatory Support and Approvals: Favorable regulatory pathways and expanded indications catalyze product acceptance and commercialization.

Challenges

• Supply Chain Constraints: The plasma-derived nature of immune globulin depends on plasma collection, limiting manufacturing scalability amidst rising demand. Disruptions like the COVID-19 pandemic exacerbated shortages.

• Pricing and Reimbursement Pressures: Increasing scrutiny over drug pricing affects profitability, especially in cost-conscious healthcare environments.

• Competitive Landscape: Numerous players, including market incumbents and biosimilar entrants, intensify price competition and market share dynamics.

• Patient Adherence and Preference: While self-injection is advantageous, factors such as needle phobia or injection site reactions can influence adherence.

---

Competitive Landscape

Major pharmaceutical companies dominate SCIg production. Shire (now part of Takeda), CSL Behring, and Octapharma have significant market shares, driven by extensive portfolios and global distribution networks. Recent entrants and biosimilars introduce price competitiveness and novel delivery systems, prompting incumbent companies to innovate further.

Innovations and Pipeline Developments

Efforts focus on:

• Enhanced formulations reducing infusion volumes.
• Donor plasma diversification strategies to secure supply.
• Auto-injector devices improving patient ease of use.
• Extended half-life formulations to reduce injection frequency.

---

Financial Trajectory

Market Size and Growth Rates

The global immune globulin market, inclusive of intravenous (IVIG) and subcutaneous forms, was valued at approximately USD 9 billion in 2021 and is projected to grow at a CAGR of 7-9% through 2030 [4].

Specifically, the SCIg segment is witnessing robust growth, driven by its advantages and expanding indications, with valuations exceeding USD 1.5 billion in 2021.

Revenue Sources and Profitability

• Revenue Drivers: Increase in patient numbers, higher dosing regimens, and expanded indications contribute markedly.
• Profit Margins: Typically high due to the specialized nature, but margins are increasingly impacted by raw material costs, manufacturing complexity, and price pressures.

Geographical Trends

North America leads with the highest market penetration, driven by established healthcare infrastructure. Europe follows, with regional regulatory differences influencing market penetration. Emerging markets such as Asia-Pacific display high growth potential due to rising healthcare expenditure and awareness.

---

Regulatory and Policy Impact

Regulatory frameworks, such as the U.S. FDA's fast-track designations and EMA approvals, accelerate product lifecycle, while reimbursement policies influence market access. Policies favoring outpatient-based therapies and patient-centric models bolster SCIg adoption.

---

Future Outlook

• Market Expansion: Anticipated growth in autoimmune disorders and secondary immunodeficiencies will sustain demand.
• Technological Innovation: Novel delivery devices and formulations promise higher adherence and improved patient experiences, facilitating market expansion.
• Supply Chain Optimization: Digital and manufacturing innovations aiming to secure plasma supply chains will mitigate shortages.
• Competitive Dynamics: Biosimilar entrants and manufacturing alliances could alter pricing and market share distributions.

The confluence of technological advances, expanding indications, and market demand supports a positive financial trajectory, provided manufacturing and supply-demand challenges are effectively managed.

---

Key Takeaways

1. Growing Global Demand: The incidence of immunodeficiency and autoimmune diseases, combined with a shift from IVIG to SCIg, underpins a lucrative, expanding market.

2. Innovation Is Critical: Advancements in formulations, auto-injector devices, and supply chain management will influence competitive positioning and profitability.

3. Supply Chain as a Bottleneck: Plasma collection limitations underscore supply constraints, necessitating strategic collaborations and technological optimization.

4. Pricing and Reimbursement Dynamics: Stakeholders must navigate evolving policy environments that influence profitability margins.

5. Regional Variations Matter: North America leads, but emerging markets present significant growth opportunities, contingent on regulatory and infrastructural developments.

---

FAQs

1. What factors are driving the increasing adoption of subcutaneous immunoglobulin over intravenous formulations?
The ease of self-administration, fewer infusion-related adverse events, reduced healthcare resource utilization, and improved patient quality of life are primary drivers enhancing SCIg adoption.

2. How do supply constraints impact the financial outlook for immune globulin subcutaneous products?
Supply limitations can restrict sales growth, elevate prices, and induce revenue volatility. Over-reliance on plasma pools necessitates strategic supply chain diversification and innovation.

3. What role do biosimilars play in the future of immune globulin market dynamics?
Biosimilars introduce price competition, potentially reducing costs and expanding access. Their success depends on regulatory pathways, patent expiry, and manufacturing capability.

4. How has the COVID-19 pandemic affected the market trajectory for SCIg?
The pandemic increased awareness of immune support therapies, temporarily strained supply chains, and shifted healthcare utilization patterns toward outpatient and self-administered treatments.

5. What are the key regulatory trends influencing the growth of SCIg products?
Regulatory agencies facilitate accelerated approvals for new indications, streamline manufacturing standards, and support innovations in delivery technology, all of which promote market growth.

---

References

[1] GlobalData. (2022). Immunoglobulin Market Analysis.
[2] Rees, A. et al. (2020). Global Prevalence Data of Primary Immunodeficiency. Journal of Immunology.
[3] Smith, J. (2021). Impact of COVID-19 on Plasma and Immunoglobulin Supply Chains. Healthcare Business Today.
[4] MarketWatch. (2022). Immunoglobulin Market Size & Forecast.