Latest news with #IVIG
Yahoo
6 days ago
- Health
- Yahoo
‘They won't help me': Sickest patient face insurance denials despite policy fixes
In 2023, Sheldon Ekirch was diagnosed with small fiber neuropathy, which makes her limbs and muscles feel as if they're on fire. Specialists recommended a series of infusions to ease her pain, but her insurer refused to pay for the expensive treatment, which it says is 'not considered medically necessary.' (Ryan M. Kelly for KFF Health News) HENRICO, Virginia — Sheldon Ekirch spends a lot of time on hold with her health insurance company. Sometimes, as the minutes tick by and her frustration mounts, Ekirch, 30, opens a meditation app on her phone. It was recommended by her psychologist to help with the depression associated with a stressful and painful medical disorder. In 2023, Ekirch was diagnosed with small fiber neuropathy, a condition that makes her limbs and muscles feel as if they're on fire. Now she takes more than a dozen prescriptions to manage chronic pain and other symptoms, including insomnia. 'I don't feel like I am the person I was a year-and-a-half ago,' said Ekirch, who was on the cusp of launching her law career, before getting sick. 'Like, my body isn't my own.' Ekirch said specialists have suggested that a series of infusions made from blood plasma called intravenous immunoglobulin — IVIG, for short — could ease, or potentially eradicate, her near-constant pain. But Ekirch's insurance company has repeatedly denied coverage for the treatment, according to documents provided by the patient. Patients with Ekirch's condition don't always respond to IVIG, but she said she deserves to try it, even though it could cost more than $100,000. 'I'm paying a lot of money for health insurance,' said Ekirch, who pays more than $600 a month in premiums. 'I don't understand why they won't help me, why my life means so little to them.' For patient advocates and health economists, cases like Ekirch's illustrate why prior authorization has become such a chronic pain point for patients and doctors. For 50 years, insurers have employed prior authorization, they say, to reduce wasteful health care spending, prevent unnecessary treatment, and guard against potential harm. The practice differs by insurance company and plan, but the rules often require patients or their doctors to request permission from the patient's health insurance company before proceeding with a drug, treatment, or medical procedure. The insurance industry provides little information about how often prior authorization is used. Transparency requirements established by the federal government to shed light on the use of prior authorization by private insurers haven't been broadly enforced, said Justin Lo, a senior researcher for the Program on Patient and Consumer Protections at KFF, a health information nonprofit that includes KFF Health News. Yet it's widely acknowledged that prior authorization tends to disproportionately impact some of the sickest people who need the most expensive care. And despite bipartisan support to reform the system, as well as recent attempts by health insurance companies to ease the burden for patients and doctors, some tactics have met skepticism. Some insurers' efforts to improve prior authorization practices aren't as helpful as they would seem, said Judson Ivy, CEO of Ensemble Health Partners, a revenue cycle management company. 'When you really dive deep,' he said, these improvements don't seem to touch the services and procedures, such as CT scans, that get caught up in prior authorization so frequently. 'When we started looking into it,' he said, 'it was almost a PR stunt.' When Arman Shahriar's father was diagnosed with follicular lymphoma in 2023, his father's oncologist ordered a whole-body PET scan to determine the cancer's stage. The scan was denied by a company called EviCore by Evernorth, a Cigna subsidiary that makes prior authorization decisions. Shahriar, an internal medicine resident, said he spent hours on the phone with his father's insurer, arguing that the latest medical guidelines supported the scan. The imaging request was eventually approved. But his father's scan was delayed several weeks — and multiple appointments were scheduled, then canceled during the time-consuming process — while the family feared the cancer would continue to spread. EviCore by Evernorth spokesperson Madeline Ziomek wrote in an emailed statement that incomplete clinical information provided by physicians is a leading cause of such denials. The company is 'actively developing new ways to make the submission process simpler and faster for physicians,' Ziomek said. In the meantime, Shahriar, who often struggles to navigate prior authorization for his patients, accused the confusing system of 'artificially creating problems in people's lives' at the wrong time. 'If families with physicians are struggling through this, how do other people navigate it? And the short answer is, they can't,' said Shahriar, who wrote about his father's case in an essay published last year by JAMA Oncology. 'We're kind of reaching a tipping point where we're realizing, collectively, something needs to be done.' The fatal shooting of UnitedHealthcare CEO Brian Thompson on a New York City sidewalk in December prompted an outpouring of grief among those who knew him, but it also became a platform for public outrage about the methods insurance companies use to deny treatment. An Emerson College poll conducted in mid-December found 41% of 18- to 29-year-olds thought the actions of Thompson's killer were at least somewhat acceptable. In a NORC survey from the University of Chicago conducted in December, two-thirds of respondents indicated that insurance company profits, and their denials for health care coverage, contributed 'a great deal/moderate amount' to the killing. Instagram accounts established in support of Luigi Mangione, the 26-year-old Maryland suspect accused of murder and terrorism, have attracted thousands of followers. 'The past several weeks have further challenged us to even more intensely listen to the public narrative about our industry,' Cigna Group CEO David Cordani said during an earnings call on Jan. 30. Cigna is focused on 'making prior authorizations faster and simpler,' he added. The first Trump administration and the Biden administration put forth policies designed to improve prior authorization for some patients by mandating that insurers set up electronic systems and shortening the time companies may take to issue decisions, among other fixes. Hundreds of House Democrats and Republicans signed on to co-sponsor a bill last year that would establish new prior authorization rules for Medicare Advantage plans. In January, Republican congressman Jefferson Van Drew of New Jersey introduced a federal bill to abolish the use of prior authorization altogether. Meanwhile, many states have passed legislation to regulate the use of prior authorization. Some laws require insurers to publish data about prior authorization denials with the intention of making a confusing system more transparent. Reform bills are under consideration by state legislatures in Hawaii and elsewhere. A bill in Virginia approved by the governor March 18 takes effect July 1. Other states, including Texas, have established 'gold card' programs that ease prior authorization requirements for some physicians by allowing doctors with a track record of approvals to bypass the rules. No one from AHIP, an insurance industry lobbying group formerly known as America's Health Insurance Plans, was available to be interviewed on the record about proposed prior authorization legislation for this article. But changes wouldn't guarantee that the most vulnerable patients would be spared from future insurance denials or the complex appeals process set up by insurers. Some doctors and advocates for patients are skeptical that prior authorization can be fixed as long as insurers are accountable to shareholders. Kindyl Boyer, director of advocacy for the nonprofit Infusion Access Foundation, remains hopeful the system can be improved but likened some efforts to playing 'Whac-A-Mole.' Ultimately, insurance companies are 'going to find a different way to make more money,' she said. During the summer of 2023, Ekirch was working full time and preparing to take the bar exam when she noticed numbness and tingling in her arms and legs. Eventually, she started experiencing a burning sensation throughout her body. That fall, a Richmond-area neurologist said her symptoms were consistent with small fiber neuropathy, and, in early 2024, a rheumatologist recommended IVIG to ease her pain. Since then, other specialists, including neurologists at the University of Virginia and Virginia Commonwealth University, have said she may benefit from the same treatment. There's no guarantee it will work. A randomized controlled trial published in 2021 found pain levels in patients who received IVIG weren't significantly different from the placebo group, while an older study found patients responded 'remarkably well.' 'It's hard because I look at my peers from law school and high school — they're having families, excelling in their career, living their life. And most days I am just struggling, just to get out of bed,' said Ekirch, frustrated that Anthem continues to deny her claim. In a prepared statement, Kersha Cartwright, a spokesperson for Anthem's parent company, Elevance Health, said Ekirch's request for IVIG treatment was denied 'because it did not meet the established medical criteria for effectiveness in treating small fiber neuropathy.' On Feb. 17, her treatment was denied by Anthem for the final time. Ekirch said her patient advocate, a nurse who works for Anthem, suggested she reach out to the drug manufacturer about patient charity programs. 'This is absolutely crazy,' Ekirch said. 'This is someone from Anthem telling me to plead with a pharmacy company to give me this drug when Anthem should be covering it.' Her only hope now lies with the Virginia State Corporation Commission Bureau of Insurance, a state agency that resolves prior authorization disputes between patients and health insurance companies. She found out through a Facebook group for patients with small fiber neuropathy that the Bureau of Insurance has overturned an IVIG denial before. In late March, Ekirch was anxiously waiting to hear the agency's decision about her case. 'I don't want to get my hopes up too much, though,' she said. 'I feel like this entire process, I've been let down by it.' KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism.
Associated Press
12-05-2025
- Health
- Associated Press
Invivyd Announces New Pipeline Discovery Program Focused on Monoclonal Antibody Treatment for Measles
WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has initiated a discovery program for a measles monoclonal antibody (mAb). Multiple healthcare providers (HCPs) who are treating active measles and monitoring contacts and outbreaks have inquired directly to Invivyd about the possibility of accessing such a medicine, as there are no currently approved therapies for measles or for post-exposure prophylaxis. Measles monoclonal neutralizing antibody discovery efforts would join current Invivyd discovery programs for next-generation COVID-19, respiratory syncytial virus (RSV), and influenza mAbs designed to treat acute infection or provide a high-quality alternative to vaccination. There are currently no anti-viral treatments for measles. Clinicians have limited options for treatment of individuals sick with measles including high-dose Vitamin A, which is useful to support recovery from measles infections among children who are Vitamin A deficient, and human donor-derived pooled plasma immune globulin (IG) administered via IV (IVIG) to treat active phase measles. Both therapies have limitations for treatment, in addition to not being approved, well-characterized clinical tools: Vitamin A can be hepatotoxic, and IVIG is a non-uniform, polyclonal collection of antibodies collected and pooled from many donors and is poorly suited for widespread use. Standard measles vaccines confer excellent, long-lasting protection from disease and are the most important tools to prevent measles infection but have important limitations in post-exposure prophylaxis and are increasingly underutilized by sizeable populations in America due to restricted healthcare access or religious or personal views on the use of vaccines in general. Recent research published in the Journal of the American Medical Association (JAMA) estimates the potential health effects of declining vaccine uptake and highlights the enormous health consequences to Americans associated with the reestablishment of previously eradicated pathogens such as measles. Acute measles infection involves clinical features of varying severity, including fevers, pneumonia, encephalitis, and high-risk of secondary bacterial infections, with one in four infections leading to hospitalization and one in every 1,000 causing death. The virus deletes immunological memory, creating an immunological amnesia that enhances risk of disease against all infections for years. One in a few thousand cases will cause a 100% fatal deterioration of brain tissue called subacute sclerosing panencephalitis approximately 7-10 years after infection. 'Despite effective vaccines, measles outbreaks are increasing globally, including in the U.S. where our elimination status is at risk. With over 20 million unvaccinated Americans in the U.S., and hundreds of millions globally, the burden of measles is high and poised to get worse. There is a huge need for effective treatments,' commented Dr. Michael Mina, MD, PhD, an infectious disease and vaccination expert, previously Professor of Epidemiology and Immunology at Harvard University School of Public Health. 'A monoclonal antibody is a particularly attractive therapeutic option for many reasons: antibodies against measles can be highly neutralizing and thus able to rapidly stop infection; they can avoid toxicities and drug-drug interactions that accompany small molecule approaches; and, finally, monoclonal antibodies can serve as a critical prophylaxis tool for at-risk populations. In addition to treating acute infection, pre- and post-exposure prophylaxis may be especially important for children too young to be vaccinated, the immune compromised who cannot be vaccinated, and the elderly, whose immune protection may have waned, and as prophylaxis for people who are otherwise unvaccinated during measles outbreaks.' 'A measles monoclonal antibody may be an increasingly important therapeutic option in the coming years. Invivyd's core strategy is to use best-in-class pharmaceutical monoclonal antibodies to lower the burden of viral infectious diseases,' commented Marc Elia, Chairman of the Invivyd Board of Directors. 'Measles (rubeola) is an important potential therapeutic target and an excellent fit with our integrated capabilities in antibody discovery, development, and commercialization. Our goal is to discover and develop a safe, convenient, highly effective mAb against measles with a best-in-class profile that can be easily adopted in contemporary clinical practice. We will look forward to updating on our progress later this year.' About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit to learn more. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'anticipates,' 'believes,' 'could,' 'expects,' 'estimates,' 'intends,' 'potential,' 'predicts,' 'projects,' and 'future' or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the company's discovery programs; the company's goal to identify a preclinical monoclonal antibody candidate targeting measles, and the timing thereof; beliefs about the limitations of existing measles vaccines and therapies, the potential health effects of declining measles vaccine uptake, and the need for effective measles treatments; expectations regarding the potential benefits of a measles monoclonal antibody; Invivyd's strategy to use best-in-class pharmaceutical monoclonal antibodies to lower the burden of viral infectious diseases, and its goal to discover and develop a safe, convenient, highly effective, monoclonal antibody against measles with a best-in-class profile that can be easily adopted in contemporary clinical practice; the company's devotion to delivering protection from serious viral infectious diseases; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company's forward-looking statements and you should not place undue reliance on the company's forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress and results of the company's discovery, preclinical and clinical development activities; whether the company's discovery efforts will result in a preclinical monoclonal antibody candidate targeting measles, and the timing thereof, and whether or not any preclinical candidate identified is determined to be suitable for clinical development; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the predictability of clinical success of the company's product candidates based on neutralizing activity in nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; the company's reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company's product candidates; changes in the regulatory environment; changes in expected or existing competition; the complexities of manufacturing monoclonal antibodies; whether Invivyd is able to use best-in-class pharmaceutical monoclonal antibodies to lower the burden of viral infectious diseases; macroeconomic and political uncertainties; the company's ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading 'Risk Factors' in the company's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC), and in the company's other filings with the SEC, and in its future reports to be filed with the SEC and available at Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Media Relations (781) 208-1747 [email protected] Investor Relations (781) 208-1747 [email protected]
Yahoo
12-05-2025
- Health
- Yahoo
Invivyd Announces New Pipeline Discovery Program Focused on Monoclonal Antibody Treatment for Measles
Multiple HCPs have requested from Invivyd a monoclonal antibody (mAb) for treatment of active measles infection and post-exposure prophylaxis to reduce the consequence of outbreaks. Such a medicine could accelerate the pathway to functional eradication of measles Measles (rubeola) virus appears to offer an attractive target for best-in-class monoclonal antibody discovery and development utilizing Invivyd technology More than 20 million Americans are unvaccinated against measles; U.S. is at risk for losing functional elimination as vaccination rates decline Goal is to identify a preclinical measles mAb candidate in 2025; company anticipates providing a progress update by end of year WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has initiated a discovery program for a measles monoclonal antibody (mAb). Multiple healthcare providers (HCPs) who are treating active measles and monitoring contacts and outbreaks have inquired directly to Invivyd about the possibility of accessing such a medicine, as there are no currently approved therapies for measles or for post-exposure prophylaxis. Measles monoclonal neutralizing antibody discovery efforts would join current Invivyd discovery programs for next-generation COVID-19, respiratory syncytial virus (RSV), and influenza mAbs designed to treat acute infection or provide a high-quality alternative to vaccination. There are currently no anti-viral treatments for measles. Clinicians have limited options for treatment of individuals sick with measles including high-dose Vitamin A, which is useful to support recovery from measles infections among children who are Vitamin A deficient, and human donor-derived pooled plasma immune globulin (IG) administered via IV (IVIG) to treat active phase measles. Both therapies have limitations for treatment, in addition to not being approved, well-characterized clinical tools: Vitamin A can be hepatotoxic, and IVIG is a non-uniform, polyclonal collection of antibodies collected and pooled from many donors and is poorly suited for widespread use. Standard measles vaccines confer excellent, long-lasting protection from disease and are the most important tools to prevent measles infection but have important limitations in post-exposure prophylaxis and are increasingly underutilized by sizeable populations in America due to restricted healthcare access or religious or personal views on the use of vaccines in general. Recent research published in the Journal of the American Medical Association (JAMA) estimates the potential health effects of declining vaccine uptake and highlights the enormous health consequences to Americans associated with the reestablishment of previously eradicated pathogens such as measles. Acute measles infection involves clinical features of varying severity, including fevers, pneumonia, encephalitis, and high-risk of secondary bacterial infections, with one in four infections leading to hospitalization and one in every 1,000 causing death. The virus deletes immunological memory, creating an immunological amnesia that enhances risk of disease against all infections for years. One in a few thousand cases will cause a 100% fatal deterioration of brain tissue called subacute sclerosing panencephalitis approximately 7-10 years after infection. 'Despite effective vaccines, measles outbreaks are increasing globally, including in the U.S. where our elimination status is at risk. With over 20 million unvaccinated Americans in the U.S., and hundreds of millions globally, the burden of measles is high and poised to get worse. There is a huge need for effective treatments,' commented Dr. Michael Mina, MD, PhD, an infectious disease and vaccination expert, previously Professor of Epidemiology and Immunology at Harvard University School of Public Health. 'A monoclonal antibody is a particularly attractive therapeutic option for many reasons: antibodies against measles can be highly neutralizing and thus able to rapidly stop infection; they can avoid toxicities and drug-drug interactions that accompany small molecule approaches; and, finally, monoclonal antibodies can serve as a critical prophylaxis tool for at-risk populations. In addition to treating acute infection, pre- and post-exposure prophylaxis may be especially important for children too young to be vaccinated, the immune compromised who cannot be vaccinated, and the elderly, whose immune protection may have waned, and as prophylaxis for people who are otherwise unvaccinated during measles outbreaks.' 'A measles monoclonal antibody may be an increasingly important therapeutic option in the coming years. Invivyd's core strategy is to use best-in-class pharmaceutical monoclonal antibodies to lower the burden of viral infectious diseases,' commented Marc Elia, Chairman of the Invivyd Board of Directors. 'Measles (rubeola) is an important potential therapeutic target and an excellent fit with our integrated capabilities in antibody discovery, development, and commercialization. Our goal is to discover and develop a safe, convenient, highly effective mAb against measles with a best-in-class profile that can be easily adopted in contemporary clinical practice. We will look forward to updating on our progress later this year.' About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit to learn more. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'anticipates,' 'believes,' 'could,' 'expects,' 'estimates,' 'intends,' 'potential,' 'predicts,' 'projects,' and 'future' or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the company's discovery programs; the company's goal to identify a preclinical monoclonal antibody candidate targeting measles, and the timing thereof; beliefs about the limitations of existing measles vaccines and therapies, the potential health effects of declining measles vaccine uptake, and the need for effective measles treatments; expectations regarding the potential benefits of a measles monoclonal antibody; Invivyd's strategy to use best-in-class pharmaceutical monoclonal antibodies to lower the burden of viral infectious diseases, and its goal to discover and develop a safe, convenient, highly effective, monoclonal antibody against measles with a best-in-class profile that can be easily adopted in contemporary clinical practice; the company's devotion to delivering protection from serious viral infectious diseases; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company's forward-looking statements and you should not place undue reliance on the company's forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress and results of the company's discovery, preclinical and clinical development activities; whether the company's discovery efforts will result in a preclinical monoclonal antibody candidate targeting measles, and the timing thereof, and whether or not any preclinical candidate identified is determined to be suitable for clinical development; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the predictability of clinical success of the company's product candidates based on neutralizing activity in nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; the company's reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company's product candidates; changes in the regulatory environment; changes in expected or existing competition; the complexities of manufacturing monoclonal antibodies; whether Invivyd is able to use best-in-class pharmaceutical monoclonal antibodies to lower the burden of viral infectious diseases; macroeconomic and political uncertainties; the company's ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading 'Risk Factors' in the company's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC), and in the company's other filings with the SEC, and in its future reports to be filed with the SEC and available at Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Media Relations(781) 208-1747media@ Investor Relations(781) 208-1747investors@ in to access your portfolio
Malaysian Reserve
05-05-2025
- Business
- Malaysian Reserve
Intravenous Immunoglobulin (IVIG) Market Forecast to Surge During the Forecast Period (2025-2034) with Rising Demand for Autoimmune and Immunodeficiency Treatments
The intravenous immunoglobulin (IVIG) market is experiencing significant growth due to the rising prevalence of autoimmune diseases, immune deficiencies, and neurological disorders. Advancements in biotechnology and an increased focus on personalized medicine are driving innovation in IVIG therapies. LAS VEGAS, May 5, 2025 /PRNewswire/ — DelveInsight's IVIG Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging IVIG therapy, market share of individual therapies, and current and forecasted IVIG market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the IVIG Market Report As per DelveInsight's analysis, the total market size of IVIG in the 7MM is expected to surge significantly by 2034. In 2024, BIVIGAM generated a revenue of approximately USD 50 million in the United States. In 2024, chronic inflammatory demyelinating polyneuropathy affected approximately 21K patients in the United States. Key companies in the market include ADMA Biologics, Grifols Therapeutics, OCTAPHARMA, Takeda Pharmaceuticals, Kedrion Biopharma, LFB Biopharmaceuticals, Biotest, Japan Blood Products Organization, KM Biologics, Teijin, Nihon Pharmaceutical, GC Biopharma, CSL Behring, Pfizer, Evolve Biologics, and others. Some of the promising IVIG therapies include ASCENIV, BIVIGAM, GAMUNEX-C, OCTAGAM 5% & 10%, GAMMAGARD LIQUID; S/D (immune globulin infusion; Intravenous [human]), GAMMAPLEX 5% & 10%, IQYMUNE, INTRATECT, VENOGLOBULIN, KENKETSU VENILON, Kenketu GLOVENIN-I, YIMMUGO, ALYGLO, PRIVIGEN, PANZYGA, TAK-880, and others. In September 2024, GC Biopharma USA, Inc. announced the launch and distribution of its IG product ALYGLO (IVIG), the company's first 10% IVIG therapy for the treatment of adult patients aged 17 years and older with PI. Discover which therapies are expected to grab the IVIG market share @ Intravenous Immunoglobulin Market Report IVIG Market Dynamics The intravenous immunoglobulin market has seen significant growth over the last few years, driven by a combination of factors, including the increasing incidence of autoimmune and inflammatory disorders, the rising prevalence of immunodeficiencies, and advancements in the development of IVIG therapies. IVIG is used in a variety of indications, from autoimmune diseases like rheumatoid arthritis and lupus to primary and secondary immunodeficiencies. As the global demand for these therapies increases, so does the complexity of the supply chain, with manufacturers needing to ensure that they can meet the growing need for human plasma, a key raw material for IVIG production. One of the biggest challenges in the IVIG market is the supply and demand imbalance of human plasma. Plasma collection is a time-intensive process, and the cost of obtaining plasma continues to rise, affecting the overall cost of IVIG production. This leads to fluctuating prices for IVIG, making it a significant concern for both healthcare providers and patients. Additionally, the rising demand for IVIG is outpacing the capacity of plasma donation centers, further exacerbating the supply issue. On the other hand, technological advancements in manufacturing processes, such as the development of more efficient purification techniques, have the potential to improve production yields and reduce costs. The growing interest in alternative sources of immunoglobulins, such as recombinant immunoglobulins and synthetic antibodies, also adds a layer of competition to the traditional IVIG market. However, these alternatives are still in the early stages of adoption, with IVIG maintaining its dominant position due to its proven safety and efficacy profile. Finally, regulatory and reimbursement policies play a critical role in shaping the IVIG market dynamics. Stringent regulations related to product safety, as well as reimbursement frameworks that vary from region to region, impact market access. Ongoing clinical research into new indications for IVIG, as well as efforts to improve patient outcomes, will be key drivers in shaping the market landscape in the coming years. IVIG Treatment Market Multiple VIG products have been approved in the U.S., each tailored to specific clinical needs. These include BIVIGAM, CARIMUNE, FLEBOGAMMA, GAMMAGARD S/D (a low IgA formulation), GAMMAGARD Liquid, GAMMAKED, GAMMAPLEX, GAMUNEX, OCTAGAM, and PRIVIGEN. PRIVIGEN is distinguished as one of the rare IVIG therapies approved in all major markets—the US, EU5, and Japan—demonstrating widespread clinical acceptance and strong regulatory endorsement for the treatment of immune deficiencies and autoimmune diseases. In recent years, a global shortage of immunoglobulin has become a pressing concern, with Japan notably affected since 2019. The steep increase in demand has necessitated urgent imports. Two major factors driving this demand are the approval of IVIG for halting the progression of chronic inflammatory demyelinating polyneuropathy (CIDP) and the emergence of more concentrated IVIG formulations. However, scaling up IVIG production and use poses significant challenges. Chief among them is maintaining a consistent plasma donor supply, a task made even harder during the pandemic due to widespread shutdowns of blood collection facilities. Additionally, IVIG must be administered by trained healthcare professionals in clinical settings, which places added strain on both patients and the healthcare infrastructure. Learn more about the approved IVIG therapies @ IVIG Drugs Key Emerging IVIG Therapies and Companies Several companies—such as Grifols Therapeutics, ADMA Biologics, Takeda, LFB Biopharmaceuticals, OCTAPHARMA, Pfizer, CSL Behring, Biotest AG, and GC Biopharma—are actively involved in the development and commercialization of intravenous immunoglobulin therapies, with many already having approved products established in the market. TAK-880, developed by Takeda, is a low IgA-IgG intravenous immunoglobulin formulation under investigation for treating primary immunodeficiency diseases, especially in patients with IgA hypersensitivity. It is currently undergoing regulatory filing with the FDA and EU for approval in this indication. The anticipated launch of these emerging therapies are poised to transform the IVIG market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the IVIG market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about IVIG clinical trials, visit @ IVIG Therapies IVIG Overview Intravenous Immunoglobulin (IVIG) is a blood product derived from the pooled plasma of thousands of healthy donors, containing a broad spectrum of immunoglobulin G (IgG) antibodies. It is primarily used to treat patients with immune deficiencies, autoimmune diseases, and certain inflammatory conditions. In individuals with primary immunodeficiency disorders, IVIG helps provide the necessary antibodies their bodies cannot produce, thereby preventing recurrent infections. Additionally, IVIG plays a vital role in immune modulation, dampening harmful autoimmune responses in diseases like Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenic purpura (ITP). The mechanism of IVIG is complex and multifaceted, involving suppression of pathogenic autoantibodies, modulation of Fc receptors on immune cells, and alteration of cytokine production. Its clinical utility continues to expand, with ongoing research investigating its role in treating conditions like myasthenia gravis, systemic lupus erythematosus, and certain neurological disorders. While generally considered safe, IVIG can cause side effects such as headaches, infusion reactions, and, rarely, thromboembolic events or renal dysfunction, necessitating careful patient selection and monitoring. As a critical therapeutic option in immunology and neurology, IVIG remains a cornerstone for managing diverse immune-mediated disorders. IVIG Epidemiology Segmentation Primary immunodeficiency diseases had an estimated prevalence of around 38K cases across the EU4 and the UK in 2023. The IVIG market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Selected Indications Total Target Patient Pool by Indications Total Treated Patients by Indications IVIG Report Metrics Details Study Period 2020–2034 IVIG Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key IVIG Companies ADMA Biologics, Grifols Therapeutics, OCTAPHARMA, Takeda Pharmaceuticals, Kedrion Biopharma, LFB Biopharmaceuticals, Biotest, Japan Blood Products Organization, KM Biologics, Teijin, Nihon Pharmaceutical, GC Biopharma, CSL Behring, Pfizer, Evolve Biologics, and others Key IVIG Therapies ASCENIV, BIVIGAM, GAMUNEX-C, OCTAGAM 5% & 10%, GAMMAGARD LIQUID; S/D (immune globulin infusion; Intravenous [human]), GAMMAPLEX 5% & 10%, IQYMUNE, INTRATECT, VENOGLOBULIN, KENKETSU VENILON, Kenketu GLOVENIN-I, YIMMUGO, ALYGLO, PRIVIGEN, PANZYGA, TAK-880, and others Scope of the IVIG Market Report IVIG Therapeutic Assessment: IVIG current marketed and emerging therapies IVIG Market Dynamics: Conjoint Analysis of Emerging IVIG Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, IVIG Market Access and Reimbursement Discover more about IVIG therapies in development @ IVIG Clinical Trials Table of Contents 1 Key Insights 2 Report Introduction 3 IVIG Market Overview at a Glance in the 7MM 3.1 Market Share (%) Distribution by Therapies in 2024 3.2 Market Share (%) Distribution by Therapies in 2034 4 Epidemiology and Market Forecast Methodology 5 Executive Summary of IVIG 6 Key Events 7 IVIG Background and Overview 7.1 Introduction 7.2 Mechanism of Action 7.3 Potential of IVIG 7.4 Adverse Reactions to IVIG Therapy 7.4.1 Mild to Moderate Immediate Reactions 7.4.2 Serious Immediate Reactions 7.4.3 Delayed Reactions 7.4.4 Preventive Measures and Risk Mitigation 7.4.5 Risks and Drawbacks 7.5 Current and Emerging IVIG Therapies 7.6 IVIG in Different Indications 7.6.1 Immune-Mediated Polyneuropathies 7.6.1.1 Guillain-Barré Syndrome (GBS) 7.6.1.2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) 7.6.1.3 Multifocal Motor Neuropathy (MMN) 7.6.1.4 Small Fiber Neuropathy (SFN) 7.6.1.5 Myasthenia Gravis 7.6.1.6 Lambert-Eaton Myasthenic Syndrome (LEMS) 7.6.1.7 Stiff-Person Syndrome (SPS) 7.6.1.8 Autoimmune Encephalitis and Autoimmune Epilepsy 7.6.1.9 Neuromyelitis Optica Spectrum Disorder (NMOSD) and MOG Antibody-Associated Disease (MOGAD) 7.6.1.10 Secondary Immunodeficiency Diseases (SIDD) 7.6.2 Systemic Immune-Mediated Conditions 7.6.2.1 Systemic Vasculitis Syndromes 7.6.2.2 Systemic Lupus Erythematosus (SLE) 7.6.2.3 Systemic Sclerosis (SSc) 7.6.2.4 Inflammatory Myopathies 7.6.3 Hematological Disorders 7.6.3.1 Immimmune Thrombocytopenia (ITP) 7.6.3.2 Immune Thrombocytopenia (ITP) 7.6.3.3 Pediatric ITP 7.6.4 Pediatric Autoimmune Diseases 7.6.4.1 Kawasaki Disease 7.6.4.2 Giant Cell Hepatitis with Autoimmune Hemolytic Anemia (GCH with AIHA) 7.6.4.3 Fetal and Neonatal Autoimmune and Alloimmune Thrombocytopenia (FNAIT) 7.6.4.4 Gestational Alloimmune Liver Disease (GALD) 7.6.5 Dermatology 7.6.5.1 Bullous Autoimmune Dermatoses 7.6.5.2 Stevens-Johnson Syndrome (SJS) 7.6.6 SARS-CoV-2 Infection 7.6.6.1 Autoimmune Diseases Induced by SARS-CoV-2 Infection 7.6.6.2 Long COVID 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Total diagnosed prevalent cases of selected indications across 7MM 8.3 Total Target Patient Pool by indications across 7MM 8.4 Total Treated Patients by Indications in the 7MM 9 Marketed Therapies 9.1 Key cross 9.2 ASCENIV (immune globulin intravenous, human–slra): ADMA Biologics 9.2.1 Product Description 9.2.2 Regulatory Milestones 9.2.3 Other Developmental Activities 9.2.4 Clinical Development 9.2.5 Safety and Efficacy 9.3 BIVIGAM (Immune Globulin Intravenous (Human), 10%): ADMA Biologics 9.3.1 Product Description 9.3.2 Regulatory Milestones 9.3.3 Safety and Efficacy 9.4 GAMUNEX-C (immune globulin injection (Human), 10%): Grifols Therapeutics 9.4.1 Product Description 9.4.2 Regulatory Milestones 9.4.3 Safety and Efficacy 9.5 OCTAGAM 5% & 10%: OCTAPHARMA 9.5.1 Product Description 9.5.2 Regulatory Milestones 9.5.3 Other Developmental Activities 9.5.4 Clinical Development 9.5.5 Safety and Efficacy 9.6 GAMMAGARD LIQUID; S/D (immune globulin infusion; Intravenous [human]): Takeda Pharmaceuticals 9.6.1 Product Description 9.6.2 Regulatory Milestones 9.6.3 Safety and Efficacy 9.7 GAMMAPLEX 5% & 10% (Immune Globulin Intravenous (Human), 10%): Kedrion Biopharma 9.7.1 Product Description 9.7.2 Regulatory Milestones 9.7.3 Safety and Efficacy 9.8 IQYMUNE: LFB Biopharmaceuticals 9.8.1 Product Description 9.8.2 Regulatory Milestones 9.9 INTRATECT: Biotest/Grifols 9.9.1 Product Description 9.9.2 Regulatory Milestones 9.9.3 Other Developmental Activities 9.10 VENOGLOBULIN: Japan Blood Products Organization 9.10.1 Product Description 9.10.2 Regulatory Milestones 9.10.3 Other Developmental Activities 9.10.4 Safety and Efficacy 9.11 KENKETSU VENILON: KM Biologics/ Teijin 9.11.1 Product Description 9.11.2 Regulatory Milestones 9.11.3 Other Developmental Activities 9.11.4 Safety and Efficacy 9.12 Kenketu GLOVENIN-I: Nihon Pharmaceutical/ Takeda 9.12.1 Product Description 9.12.2 Regulatory Milestones 9.12.3 Other Developmental Activities 9.12.4 Safety and Efficacy 9.13 YIMMUGO: Biotest AG 9.13.1 Product Description 9.13.2 Regulatory Milestones 9.13.3 Other Developmental Activities 9.13.4 Clinical Development 9.13.5 Safety and Efficacy 9.14 ALYGLO: GC Biopharma 9.14.1 Product Description 9.14.2 Regulatory Milestones 9.14.3 Other Developmental Activities 9.14.4 Clinical Development 9.14.5 Safety and Efficacy 9.15 PRIVIGEN: CSL Behring 9.15.1 Product Description 9.15.2 Regulatory milestones 9.15.3 Other Developmental Activities 9.15.4 Clinical Development 9.15.5 Safety and Efficacy 9.16 PANZYGA: Pfizer/Octapharma 9.16.1 Product Description 9.16.2 Regulatory Milestones 9.16.3 Other Developmental Activities 9.16.4 Clinical Development 9.16.5 Safety and Efficacy 10 Emerging Therapies 10.1 Key Cross Competition 10.2 TAK-880 : Takeda 10.2.1 Product Description 10.2.2 Other Developmental Activities 10.2.3 Analyst View 11 IVIG: 7 Major Market Analysis 11.1 Key Findings 11.2 Market Outlook 11.3 Key Market Forecast Assumptions 11.4 Market Size of IVIG in the 7MM 11.5 The United States 11.5.1 Total Market Size of IVIG in the United States 11.5.2 Market Size of IVIG by Products in the United States 11.6 EU4 and the UK 11.6.1 Total Market Size of IVIG in EU4 and the UK 11.6.2 Market Size of IVIG by Products in EU4 and the UK 11.7 1.5 Japan 11.7.1 Total Market Size of IVIG in Japan 11.7.2 Market Size of IVIG by Products in Japan 12 KOL Views 13 SWOT Analysis 14 Unmet Needs 15 Market Access and Reimbursement 15.1 United States 15.1.1 Centre for Medicare and Medicaid Services (CMS) 15.2 EU4 and the UK 15.2.1 Germany 15.2.2 France 15.2.3 Italy 15.2.4 Spain 15.2.5 United Kingdom 15.3 Japan 15.3.1 MHLW 15.4 Market Access and Reimbursement in IVIG 15.4.1 ASCENIV 15.4.2 BIVIGAM 15.4.3 PANZYGA 15.4.4 PRIVIGEN 15.4.5 ALYGLO 15.4.6 IQYMUNE 16 Appendix 16.1 Bibliography 16.2 Report Methodology 17 DelveInsight Capabilities 18 Disclaimer Related Reports Immune Thrombocytopenia Market Immune Thrombocytopenia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key immune thrombocytopenia companies, including Rigel Pharmaceuticals, Kissei Pharmaceutical, Sobi (Dova Pharmaceuticals), Asahi Kasei Pharma, Amgen, Argenx, Grifols (Biotest), Zenyaku Kogyo, Chugai Pharmaceutical, Novartis, Principia Biopharma, GC Pharma, UCB Biopharma, Takeda (Millennium Pharmaceuticals), Pfizer, Genosco, Oscotec, Vertex, Alpine Immune Sciences, Sanofi, Bioverativ company, among others. Guillain-Barre Syndrome Market Guillain-Barre Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Guillain-Barre syndrome companies, including Annexon, Hansa Biopharma, among others. Chronic Inflammatory Demyelinating Polyradiculoneuropathy Market Chronic Inflammatory Demyelinating Polyradiculoneuropathy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CIDP companies, including Sanofi, Novartis, Eli Lilly, Celgene, AbbVie, Takeda Pharmaceuticals, among others. Kawasaki Disease Market Kawasaki Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Kawasaki disease companies, including Ampio Pharmaceuticals, Anviron, Reven Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:
Forbes
23-04-2025
- Health
- Forbes
Treating Autoimmune Diseases: Four New Technologies To Watch
Scientists from Belgian biotech company etherna, who are working on inverse RNA vaccines for ... More multiple sclerosis and other autoimmune diseases. For decades, the only option available to patients suffering from debilitating autoimmune diseases, which attack the body's own tissues, has been to suppress the immune system with corticosteroids or anti-cytokine antibodies. But while these treatments can ease symptoms, they come with a hidden long-term cost. Dampening the immune system's normal function over many years makes patients more vulnerable to opportunistic infections and cancer, creating a significant need for more sophisticated alternatives. As a venture investor following emerging trends in public health, I've been particularly concerned by data indicating that these diseases are on the rise. According to the U.S. National Health Council, rates of autoimmunity are approaching epidemic levels, with most autoimmune diseases being diagnosed in growing numbers in recent decades. The causes are not fully understood, but they're thought to range from changing lifestyle factors such as dietary patterns and sleep deprivation, to increasing exposure to harmful environmental toxins or viruses. We need better therapies, and fortunately, there are a few emerging technologies which could change the treatment landscape. CAR T-cell therapy is best known as a form of cancer immunotherapy, but it could also be a way of eliminating autoreactive B cells, a category of immune cells which underpin many autoimmune diseases by producing autoantibodies which target the body's own cells and tissues, causing damage. Back in 2022, researchers at the University of Erlangen-Nuremberg in Germany showed that administering CAR T-cell therapy to five people with severe lupus could completely remove the aberrant B cells, sending all of the patients into remission. But CAR T-cell therapy is not easy to scale for thousands of patients. However, a company called Coding Bio is working on an approach which CEO and co-founder Simon Bornschein describes as a more 'off-the-shelf' solution, developing so-called immune engager molecules which can help trigger precision killing of the autoreactive B cells. 'A lot of companies are moving towards such immune engagers, as they can be manufactured at scale to address a large patient population,' says Bornschein. One of the main causes of autoimmune diseases are immunoglobulin G (IgG) autoantibodies. Many patients are thus treated with intensive and laborious infusions of intravenous immunoglobulin (IVIG) therapy. While IVIG can be effective, it is often difficult for patients to tolerate because it is administered in large doses, with infusion sessions of up to eight hours at a time. One of Leaps by Bayer's portfolio companies, Nuvig Therapeutics, is working on a more effective and convenient alternative. One of the reasons that IVIG works is because there is a crucial fraction of the IgGs present in IVIG that are sialylated. Sialylation, or the addition of a sugar group to the antibody, alters where these antibodies eventually bind, helping switch the immune environment back to a more anti-inflammatory state. Pamela Conley, co-founder and CSO at Nuvig, says that the company has identified a way to capture the anti-inflammatory activity of sialylated IgGs in a novel drug. The resulting molecule, named NVG-2089, has been found to be 10-20 times more potent than IVIG in preclinical studies and so can be administered in much lower doses. 'It means it can be a much shorter therapy, smaller volumes, and an easier infusion to tolerate because of the increased potency of our drug,' she says. Nuvig has since completed a Phase 1 study in healthy volunteers which showed NVG-2089 to be safe and well-tolerated and are now moving into a Phase 2 trial in patients with a neuro-autoimmune disease called chronic inflammatory demyelinating polyneuropathy. While normal RNA vaccines train the immune system to recognize and attack antigens associated with a virus or cancer cells, a growing number of companies have been considering a so-called 'inverse vaccine.' Because autoimmune diseases are caused by autoantibodies binding to autoantigens on the body's own cells, their concept is to use RNA to train the immune system to forget these autoantigens. This can be done through boosting the numbers of regulatory T cells, which suppress a particular immune response, linked to a particular autoantigen. Belgian-based biotech etherna is now collaborating with Hasselt University with the aim of using this concept to develop a mRNA-based treatment for multiple sclerosis and other autoimmune diseases. 'The benefit of amplifying disease-suppressing Tregs is the potential to restore self-tolerance to autoantigens, resulting in long-term therapeutic effects,' says Bernard Sagaert, CEO of etherna. Instead of changing the function of IgG antibodies, we could also just use enzymes to break them down into fragments, an approach known as antibody cleaving. This strategy is being pioneered by a Swedish biotech called Hansa Biopharma, which is running a series of clinical trials in various autoimmune conditions where disease progression is linked to IgG antibodies mistakenly launching inflammatory attacks on the body's organ systems. The company has developed two enzymes, imlifidase and HNSA-5487, which are capable of rapidly degrading IgG antibodies and inhibiting their activity. 'We believe that they have the potential to address unmet need in IgG-driven autoimmune diseases where faster acting treatment options are needed,' says Hitto Kaufmann, Hansa Biopharma's Chief R&D Officer. The company recently completed patient enrollment for a global Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease, a rare condition where the immune system mistakenly attacks the kidneys and the lungs. An intriguing Phase 2 trial of imlifidase in addition to IVIG treatment, showed positive results in patients with Guillain Barré Syndrome, helping them recover muscle strength and independent walking ability. As these emerging therapies develop, I'm cautiously optimistic that we're nearing some major breakthroughs in our decades-long quest to stop the body attacking its own tissues and organs, which will hopefully allow people diagnosed with these debilitating illnesses to live longer and better lives. Thank you to David Cox for additional research and reporting on this article.
