Immune globulin infusion (human), 10% with recombinant human hyaluronidase - Biologic Drug Details

Summary for immune globulin infusion (human), 10% with recombinant human hyaluronidase

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for immune globulin infusion (human), 10% with recombinant human hyaluronidase

Recent Clinical Trials for immune globulin infusion (human), 10% with recombinant human hyaluronidase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Baxalta now part of Shire	Phase 1
Baxalta Innovations GmbH, now part of Shire	Phase 1

See all immune globulin infusion (human), 10% with recombinant human hyaluronidase 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 infusion (human), 10% with recombinant human hyaluronidase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin infusion (human), 10% with recombinant human hyaluronidase 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
Takeda Pharmaceuticals U.s.a., Inc.	HYQVIA	immune globulin infusion (human), 10% with recombinant human hyaluronidase	Injection	125402		2024-03-05	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for immune globulin infusion (human), 10% with recombinant human hyaluronidase 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

International Patents for immune globulin infusion (human), 10% with recombinant human hyaluronidase

Country	Patent Number	Estimated Expiration
China	102943067
European Patent Office	1603541
Japan	2013031446

Supplementary Protection Certificates for immune globulin infusion (human), 10% with recombinant human hyaluronidase

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C20160022 00413	Estonia		PRODUCT NAME: RITUKSIMAB JS REKOMBINANTNE INIMESE HUEALURONIDAAS;REG NO/DATE: EU/1/98/067 26.03.2014
C20150034 00412	Estonia		PRODUCT NAME: TRASTUZUMAB JA REKOMBINANTNE INIMESE HUEALURONIDAAS;REG NO/DATE: EU/1/00/145 28.08.2013
2015C/044	Belgium		PRODUCT NAME: LA COMBINAISON DE TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/00/145/002 20130828

Market Dynamics and Financial Trajectory for the Biologic Drug: Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase

Last updated: August 9, 2025

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Introduction

The biologic drug combining immune globulin infusion (human), 10% concentration with recombinant human hyaluronidase represents a significant advancement in immunoglobulin therapy. This product enhances subcutaneous absorption by utilizing recombinant hyaluronidase to increase tissue permeability, offering improved convenience and patient compliance over traditional intravenous administration. As healthcare shifts toward personalized and minimally invasive treatments, understanding the market dynamics and financial prospects of this biologic is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

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Market Overview

The global immunoglobulin market has undergone exponential growth over the past decade, driven by expanding indications including primary immunodeficiency diseases (PID), chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenic purpura (ITP). The advent of formulations like human immune globulin 10% combined with recombinant hyaluronidase (rHuPH20) has further delineated the market by providing enhanced subcutaneous administration options, reducing dependence on infusion centers.

The rising prevalence of antibody deficiencies, especially in aging populations, and increased awareness of immunoglobulin therapies form the bedrock of steady demand. Additionally, the shift toward home-based treatments, enabled by recombinant hyaluronidase, supports sustainable growth trajectories.

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Market Drivers

1. Expanded Indications and Clinical Approvals
Regulatory authorities have approved immunoglobulin formulations with recombinant hyaluronidase for broader indications, including primary immunodeficiencies and off-label uses such as autoimmune diseases. This expansion taps into an already substantial patient base, fueling market growth.

2. Patient-Centric Treatment Modalities
Subcutaneous administration allows for outpatient and home-based therapies, improving patient quality of life and reducing healthcare costs. The incorporation of recombinant hyaluronidase significantly enhances absorption, enabling larger infusion volumes and reducing administration time (up to 20-fold faster in some cases), making this a preferred alternative for many patients.

3. Medical and Technological Advancements
Innovations in conjugation techniques and recombinant enzyme formulations have improved safety profiles and efficacy. The recombinant nature reduces the risk of pathogen transmission and immunogenicity associated with plasma-derived hyaluronidase.

4. Market Penetration and Competitive Landscape
Leading companies like CSL Behring, Grifols, and Takeda have introduced or are developing recombinant hyaluronidase-enhanced immunoglobulin products, intensifying competition and promoting market expansion. Patent protections and proprietary formulations also influence market dynamics.

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Market Challenges

1. High Manufacturing and R&D Costs
Producing recombinant enzymes and high-purity immunoglobulin involves complex bioprocessing, increasing costs. These costs are often transferred to end-users, influencing pricing strategies.

2. Regulatory Hurdles and Reimbursement Policies
Regulatory pathways for biosimilars and novel formulations require extensive clinical data. Variability in reimbursement policies worldwide can delay adoption, especially in markets with constrained healthcare budgets.

3. Market Competition and Patent Expirations
Patent cliff risks can lead to increased generic and biosimilar entries, potentially compressing pricing and margins.

4. Limited Awareness and Adoption in Emerging Markets
While developed economies rapidly adopt such innovations, emerging markets face awareness, distribution, and affordability barriers, constraining growth potential.

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Financial Trajectory and Revenue Projections

Current Valuation and Growth Estimates
The immunoglobulin market was valued at approximately USD 12-15 billion in 2022, with a compound annual growth rate (CAGR) of around 10% projected through 2030 (per Market Research Future [1]). The segment encompassing immunoglobulin plus recombinant hyaluronidase formulations is anticipated to grow at a slightly higher CAGR of 12-15%, due to technological advantages and expanding indications.

Revenue Drivers

• Increased per-patient dosing and higher treatment adherence rates.
• Market penetration into autoimmune and neurology segments.
• Geographical expansion in Asia-Pacific, Latin America, and Middle East/North Africa, driven by rising healthcare expenditure and immunoglobulin awareness.

Profitability and Cost Considerations
Margins are influenced by manufacturing efficiencies, economies of scale, and competitive pricing strategies. Early-stage products, often with high R&D costs, may experience lower margins, but mature products benefit from scaling and mature supply chains.

Future Growth Scenarios
Optimistic scenario: With regulatory approvals in multiple jurisdictions and broad indications, revenues could surpass USD 6-8 billion globally by 2030 for combined formulations. Baseline forecasts foresee an annual incremental revenue increase of USD 600 million to USD 1 billion, driven by rising patient numbers and improved administration modalities.

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Key Market Segments and Regional Outlook

North America
Dominant due to high healthcare expenditure, advanced healthcare infrastructure, and established reimbursement systems. The U.S., being the largest market, benefits from approvals by the FDA, with growth driven by expanded indications and home infusion services.

Europe
Largely mature, but sustained growth persists through new patient onboarding and ongoing innovation. Regulatory harmonization via EU agencies enhances market access.

Asia-Pacific
High growth potential, fueled by increasing healthcare investment, increased disease awareness, and local production capacity—particularly in China, Japan, and India.

Emerging Markets
Potential for rapid growth is tempered by affordability and distribution challenges. Strategic partnerships and regional manufacturing can catalyze expansion.

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Regulatory and Patent Landscape

The regulatory landscape for recombinant hyaluronidase-enhanced immunoglobulins is evolving, with approvals in North America and Europe shaping market entry strategies. Patent protections for recombinant enzymes and formulation patents are critical in maintaining competitive advantages; however, the patent expirations scheduled beyond 2025 might invite biosimilar competition.

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Strategic Opportunities

• Product Line Diversification: Integration with other immunomodulatory agents or sale through combination therapies.
• Geographic Expansion: Focus on emerging markets with strategic price points and local manufacturing.
• Partnerships and Licensing: Collaborations to accelerate R&D, regulatory approval, and distribution networks.
• Digital Health Integration: Utilization of telemedicine and remote monitoring to enhance patient adherence and treatment outcomes.

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Risks and Mitigation Strategies

• Regulatory Delays: Engage early with authorities and invest in robust clinical trials.
• Pricing Pressures: Develop differentiated value propositions emphasizing efficacy and convenience.
• Supply Chain Disruptions: Build resilient manufacturing and distribution logistics.
• Market Competition: Maintain innovation leadership through sustained R&D investment and patent positioning.

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Conclusion

The integration of recombinant human hyaluronidase into immune globulin therapies signals a transformative shift in the biologic treatment landscape. Market dynamics favor continued growth driven by technological innovation, expanded indications, and evolving healthcare paradigms emphasizing patient-centric care. Financially, the segment is poised for strong growth, with revenues potentially exceeding USD 8 billion globally by the end of the decade, contingent upon successful regulatory approvals, competitive positioning, and market adoption strategies.

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Key Takeaways

• The immunoglobulin market is expanding at a robust CAGR (~12-15%), with recombinant hyaluronidase-enhanced formulations at the forefront.
• Patient convenience, improved absorption, and broader indications underpin commercial success.
• Key regions include North America, Europe, and Asia-Pacific, with emerging markets presenting significant growth opportunities.
• High manufacturing costs and regulatory hurdles are challenges, mitigated by strategic R&D, partnerships, and local manufacturing.
• Patents and biosimilar competition influence long-term financial trajectories, underscoring the importance of continual innovation.

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FAQs

1. What advantages does recombinant human hyaluronidase provide in immune globulin therapy?
Recombinant hyaluronidase enhances tissue permeability, enabling larger volumes of subcutaneous immune globulin to be administered more quickly and with greater patient comfort, facilitating at-home treatment and reducing healthcare resource utilization.

2. How does the market outlook for this biologic compare to traditional immunoglobulin therapies?
Recombinant hyaluronidase formulations are expected to outpace traditional therapies due to superior convenience, broader indications, and increased patient preference, supporting higher growth rates and market share.

3. What are the primary barriers to market expansion in emerging economies?
Affordability, distribution logistics, regulatory awareness, and healthcare infrastructure limitations pose significant challenges in emerging markets, though local manufacturing and tiered pricing strategies can mitigate these issues.

4. Which companies are key players in this segment?
Major industry players include CSL Behring, Grifols, Takeda, and Shire (now part of Takeda), all of whom are developing or marketing recombinant enzyme-enhanced immunoglobulin products.

5. What regulatory considerations influence the commercialization of these biologics?
Regulatory agencies require extensive clinical data to assess safety, efficacy, and manufacturing quality, especially for biosimilar and recombinant enzyme-based formulations, which can impact time-to-market and reimbursement approval processes.

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References

[1] Market Research Future, "Immunoglobulin Market Analysis," 2022.