United States Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Global Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market reached US$55.7 billion in 2023 and is expected to reach US$140.9 billion by 2031, growing at a CAGR of 12.3% during the forecast period 2024-2031, according to DataM Intelligence report.

Key Development:

United States: Recent Industry Developments

✅ In July 2025, Takeda Pharmaceutical Company Limited received U.S. FDA approval for GAMMAGARD LIQUID ERC [Immune Globulin Infusion (Human)] with ≤2 μg/mL IgA in a 10 % solution, indicated for patients aged two and older with primary immunodeficiency marking a shift away from the older lyophilized (freeze‐dried) format.

✅ In June 2024, Biotest AG (part of Grifols S.A.) obtained U.S. FDA approval for Yimmugo® [Immune Globulin Intravenous (Human) next‐generation solution], for primary immunodeficiency in adults, enhancing IVIG therapy options.

✅ In January 2024, the FDA approved HYQVIA as a maintenance therapy in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), broadening the immunoglobulin‐therapy portfolio for neuromuscular disorders.

✅ In April 2023, Takeda expanded the U.S. label for HYQVIA® [Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase] to include children aged 2-16 with primary immunodeficiency, offering once‐monthly subcutaneous dosing flexibility.

Japan: Recent Industry Developments

✅ In September 2025, regulatory commentary in Japan noted that new IVIG approvals may leverage indication extrapolation based on quality comparability and prior approval experience-potentially accelerating launch of new immunoglobulin formats.

✅ In December 2024, Takeda's HYQVIA [Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase] was approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan for patients with agammaglobulinemia or hypogammaglobulinemia-making it the first facilitated subcutaneous immunoglobulin product in the country.

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Key Players:

=> Takeda Pharmaceutical Company Limited, CSL Behring, Grifols, S.A, Kedrion Biopharma, Octapharma AG, Biotest AG, Hualan Biological Engineering Inc, Shanghai RAAS Blood Products Co., Ltd, Beijing Tiantan Biological Products Co., Ltd, Sinopharm Group Co., Ltd among others.

Growth Forecast Projected:

The Global Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Type: IgG*, IgA, IgM

➥ By Indication: Primary Immunodeficiency Diseases*, Secondary Immunoglobulin Deficiency Diseases, Immune Mediated Thrombocytopenia, Others

➥ By Distribution Channel: Hospital Pharmacies*, Retail Pharmacies, Online Pharmacies

Regional Analysis for Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market?

A: In 2023, the Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market was valued at US$55.7 billion , reflecting its strong industry presence.

Q2: How large is the Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market expected to be by 2031?

A: By 2031, industry forecasts suggest the Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market will grow to around US$140.9 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 12.3% during the forecast period from 2024 to 2031.

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