Rho(d) immune globulin (human) - Biologic Drug Details

Summary for rho(d) immune globulin (human)

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for rho(d) immune globulin (human)

Recent Clinical Trials for rho(d) immune globulin (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1
Assistance Publique - Hôpitaux de Paris	Phase 3
Chang Gung Memorial Hospital	Phase 2

See all rho(d) immune globulin (human) clinical trials

Pharmacology for rho(d) immune globulin (human)

Mechanism of Action	Endogenous Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Immunoglobulins

Note on Biologic Patents

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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. General 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 rho(d) immune globulin (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Rho(D) Immune Globulin (Human)

Introduction to Rho(D) Immune Globulin

Rho(D) immune globulin, also known as RhIg, is a biologic drug used to prevent the formation of Rh antibodies in Rh-negative individuals, particularly during pregnancy or after exposure to Rh-positive blood. This medication is crucial in preventing hemolytic disease of the newborn (HDN) and other complications associated with Rh incompatibility.

Market Size and Growth Projections

The global human Rho D immune globulin market is anticipated to experience significant growth. By 2033, the market is projected to reach USD 1.5 billion, growing at a Compound Annual Growth Rate (CAGR) of 6.3% during the forecast period from 2021 to 2033[1].

Key Drivers of Market Growth

Increasing Prevalence of Rh Incompatibility

The rising prevalence of Rh incompatibility, especially in developing countries, is a major driver for the market. Rh incompatibility occurs when an Rh-negative woman carries an Rh-positive fetus, leading to potential complications such as HDN in future pregnancies. The global prevalence of Rh negativity varies from 3% to 25%, with higher rates in Caucasian populations[1].

Advancements in Delivery Systems

The development of novel delivery systems, including subcutaneous and intranasal formulations, is enhancing patient convenience and compliance. These advancements are expected to drive market growth by offering more flexible and user-friendly administration options[1].

Rising Adoption of Prophylactic Treatment

The increasing adoption of prophylactic treatment regimens, which involve administering Rho(D) immune globulin at specific intervals during pregnancy, is creating new growth opportunities. This preventive approach is becoming more widespread due to its efficacy in preventing Rh sensitization[1].

Market Segmentation

By Mode of Administration

Intramuscular injections currently hold the largest market share due to their well-established efficacy, safety profile, and ease of administration. However, subcutaneous and intranasal formulations are gaining traction and are expected to grow significantly in the coming years[1].

By End User

Hospitals are the primary end users, followed by prenatal clinics and obstetric practices. Home healthcare settings, although currently a smaller segment, are expected to grow as subcutaneous formulations become more prevalent and self-administration trends increase[1].

Geographical Analysis

North America

North America dominates the market, driven by the high prevalence of Rh incompatibility, well-established healthcare infrastructure, and favorable reimbursement policies. The United States is the largest market in this region, with major pharmaceutical companies and a strong emphasis on prenatal care[1].

Europe

Europe is the second-largest market, with significant contributions from countries like Germany, France, and the United Kingdom. The region's mature healthcare system and high awareness about prenatal care support market growth[1].

Asia-Pacific

The Asia-Pacific region is expected to witness the highest growth rate during the forecast period. Countries like China, India, and Japan are driving this growth due to large population bases, increasing awareness about prenatal care, and improving access to healthcare services[1].

Economic and Cost Considerations

Cost Savings Through Optimized Administration

Cost analyses suggest that withholding Rho(D) immune globulin administration at early stages of pregnancy (less than 12 weeks) could result in significant cost savings. For instance, if the sensitization rate is below 3%, health care payers in the United States could save up to $5.5 million per 100,000 pregnancies[2].

Impact of Shortages

Currently, there is a shortage of Rho(D) immune globulin due to increased demand and manufacturing deviations. This shortage is expected to affect the market, with suppliers like Kedrion Biopharma anticipating reduced product availability throughout 2024. Despite these challenges, manufacturers are working to expedite their return to full production capacity[4].

Technological and Regulatory Landscape

Innovations in Immunoglobulin Production

Advancements in immunoglobulin production technologies are enhancing the efficacy and safety of Rho(D) immune globulin. The exploration of novel formulations and delivery systems, such as subcutaneous implants or intranasal delivery, may provide new growth opportunities for market players[1].

Regulatory Updates

The FDA's announcement of shortages highlights the need for transparent communication and proactive resolution from manufacturers. Regulatory bodies are closely monitoring the supply chain to ensure that the demand for Rho(D) immune globulin is met without compromising patient safety[4].

Financial Trajectory

The global immunoglobulin market, which includes Rho(D) immune globulin, is expected to grow significantly. The overall immunoglobulin market was valued at USD 13.36 billion in 2023 and is projected to reach around USD 28.70 billion by 2034, growing at a CAGR of 7.2% from 2024 to 2034[3].

Challenges and Opportunities

High Cost and Limited Reimbursement

One of the challenges facing the market is the high cost of Rho(D) immune globulin and limited reimbursement policies in certain regions. However, the growing demand in emerging economies and expanding access to prenatal care services are expected to drive market growth[1].

Increasing Adoption in Emerging Markets

The growing number of pregnancies in developing countries, coupled with increasing awareness about prenatal care, presents significant opportunities for market growth. The Asia-Pacific region, in particular, is expected to witness rapid expansion due to these factors[1].

Key Takeaways

• The global human Rho D immune globulin market is projected to reach USD 1.5 billion by 2033, driven by increasing prevalence of Rh incompatibility and advancements in delivery systems.
• Intramuscular injections currently dominate the market, but subcutaneous and intranasal formulations are gaining traction.
• North America and Europe are significant markets, with the Asia-Pacific region expected to show the highest growth rate.
• Cost analyses suggest potential savings by optimizing administration timing.
• The market faces challenges such as shortages and high costs but is driven by growing demand in emerging economies.

FAQs

Q: What is the primary use of Rho(D) immune globulin?

A: Rho(D) immune globulin is primarily used to prevent the formation of Rh antibodies in Rh-negative individuals, particularly during pregnancy or after exposure to Rh-positive blood.

Q: What are the key drivers of the Rho(D) immune globulin market?

A: The key drivers include the increasing prevalence of Rh incompatibility, advancements in delivery systems, and the rising adoption of prophylactic treatment regimens.

Q: Which region is expected to witness the highest growth rate in the Rho(D) immune globulin market?

A: The Asia-Pacific region is expected to witness the highest growth rate due to its large population base, increasing awareness about prenatal care, and improving access to healthcare services.

Q: What are the current challenges facing the Rho(D) immune globulin market?

A: The market is currently facing challenges such as shortages due to increased demand and manufacturing deviations, as well as high costs and limited reimbursement policies in certain regions.

Q: How is the global immunoglobulin market expected to grow?

A: The global immunoglobulin market, which includes Rho(D) immune globulin, is expected to grow from USD 13.36 billion in 2023 to around USD 28.70 billion by 2034, at a CAGR of 7.2% from 2024 to 2034.

Sources

1. Data Horizzon Research: "Human Rho D Immune Globulin Market Size, Share, Growth, Trends..."
2. PubMed: "Economic analysis of foregoing Rh immunoglobulin for bleeding in pregnancy"
3. BioSpace: "Immunoglobulin Market Size to Worth around USD 28.70 Bn by 2034"
4. AABB.org: "FDA Announces Shortages of Rho(D) Immune Globulin"

Last updated: 2024-12-20