Autoimmune Hepatitis Diagnosis and Treatment Market Size to Reach USD 19.15 Bn by 2032

The global autoimmune hepatitis diagnosis and treatment market size was valued at USD 14.03 billion in 2023 and is expected to reach around USD 19.15 billion by 2032, growing at a CAGR of 3.3% between 2023 and 2032.


Ottawa, March 28, 2024 (GLOBE NEWSWIRE) -- The global autoimmune hepatitis diagnosis and treatment market size is calculated at USD 14.33 billion in 2024 and is projected to hit around USD 18.13 billion by 2031, a study published by Towards Healthcare a sister firm of Precedence Research.

Report Highlights:

  • Early detection offers promise of saving lives 
  • Liver transplant gives a new life to patients
  • Disease recurrence within 5 years of liver transplantation boosts market growth

A World Health Organization study found that implementing vaccination, diagnostics, medication, and education could prevent 4.5 million early deaths in low- and middle-income countries by 2030. The global hepatitis strategy aims for a 90% reduction in new infections and a 65% decrease in fatalities between 2016 and 2030, supported by all WHO members.

Autoimmune hepatitis is a chronic liver disease that occurs when the body's immune system mistakenly attacks healthy liver cells, causing inflammation and damage. It's unclear why this happens, but genetic factors, environmental triggers, and an overactive immune response are believed to play a role.

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Symptoms of autoimmune hepatitis can vary widely and include fatigue, jaundice, abdominal discomfort or pain, nausea, loss of appetite, dark urine, joint pain, and unexplained weight loss. Some people may not have any symptoms, especially in the early stages of the disease.

Early diagnosis and appropriate treatment are crucial for several reasons. AIH can progress over time and lead to severe complications such as cirrhosis (scarring of the liver), liver failure, and even liver cancer if left untreated. Early detection allows for prompt initiation of treatment, which can help slow down or stop the progression of the disease, reduce inflammation, and prevent further liver damage.

Non-Invasive Imaging Technique

  • In 2023, a study in Hepatology International talked about how FibroScan and elastography are becoming more critical for diagnosing and tracking autoimmune hepatitis. Other research showed they work well compared to liver biopsy.
  • In 2022, a review in Ultrasound in Medicine & Biology found that FibroScan was good at checking liver fibrosis in autoimmune hepatitis patients, even in the early stages.

Diagnosis of autoimmune hepatitis typically involves a combination of medical history review, physical examination, and blood tests to check liver function and detect specific antibodies associated with autoimmune hepatitis. Imaging studies such as ultrasound or MRI to assess liver damage, and sometimes a liver biopsy to confirm the diagnosis and determine the extent of liver inflammation and scarring.

Treatment for autoimmune hepatitis usually involves medications to suppress the immune system and reduce inflammation. These may include corticosteroids like prednisone and other immunosuppressants such as azathioprine or mycophenolate mofetil. Treatment aims to achieve remission, where liver inflammation is under control and liver function returns to normal or near-normal levels.

It's essential for individuals with autoimmune hepatitis to follow their treatment plan carefully and regularly monitor their liver function with blood tests. They may also need ongoing medical care and regular follow-up appointments with a hepatologist (liver specialist) or gastroenterologist to ensure the disease remains under control and to address any complications or side effects of treatment.

Early diagnosis and appropriate treatment prevent complications, slow disease progression, and improve long-term outcomes. If you or someone you know experiences symptoms suggestive of liver problems, seeking medical attention promptly for evaluation and management is essential.

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Increasing Prevalence of Autoimmune Hepatitis

The increasing incidence of autoimmune hepatitis worldwide is a significant driver of growth in the diagnosis and treatment market. This trend can be attributed to several factors. There has been a considerable improvement in awareness about autoimmune hepatitis among healthcare providers and the general public. This heightened awareness has led to more individuals seeking medical attention for symptoms suggestive of liver problems, leading to more diagnoses.

For instance,

  • Autoimmune hepatitis affects more females than males, with a ratio of 3.6 to 1. Exact epidemiological data is lacking, so the true incidence and prevalence in the United States are unknown. However, it's estimated that 100,000 to 200,000 individuals are affected each year. Given the increasing prevalence of liver diseases, it's crucial to provide appropriate treatment for autoimmune hepatitis.

Advancements in medical technology have revolutionized the diagnostic process for autoimmune hepatitis. New and improved diagnostic tools and techniques have been developed, allowing for more accurate and efficient disease detection. For example, blood tests can detect specific antibodies associated with autoimmune hepatitis, while imaging techniques like MRI and ultrasound can assess liver damage more precisely.

For instance,

  • In 2020, shear wave elastography (SWE) will be a method that measures how stiff liver tissue is, which can show if there's scarring (fibrosis). It's getting more popular because it's non-invasive, affordable, and easy to move around. There are new versions like 2D SWE, which gives a color map of liver stiffness for a better look, and Quantitative SWE (QSWE), which uses set rules to measure and improve accuracy no matter what ultrasound machine or person is doing.

As a result of these advancements, healthcare providers are better equipped to diagnose autoimmune hepatitis early in its course. Early diagnosis is crucial because it enables prompt initiation of treatment, which can help prevent further liver damage and improve long-term outcomes for patients. Timely treatment reduces the risk of complications such as cirrhosis, liver failure, and liver cancer associated with untreated autoimmune hepatitis.

For instance,

  • In November 2022, Gilead Sciences, Inc. received Food and Drug Administration approval for Vemlidy tablets to treat chronic hepatitis B in children 12 and older.
  • In April 2022, Gilead Sciences, Inc.'s Veklury received Food and Drug Administration approval for pediatric patients with COVID-19, helping to reduce the risk of hospitalization or death.
  • In April 2022, Antios Therapeutics, Inc. was granted a patent for their innovative therapy, ATI-2173, to treat the hepatitis B virus, enhancing their range of treatments.
  • In January 2022, the Food and Drug Administration approved Lupin's Tenofovir alafenamide tablets for treating chronic hepatitis B viral infection.

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The increasing incidence of autoimmune hepatitis underscores the importance of ongoing efforts to raise awareness about the disease and enhance diagnostic capabilities. By improving awareness among healthcare providers and the public and investing in developing advanced diagnostic tools, we can ensure that more cases of autoimmune hepatitis are detected early and that affected individuals receive timely and effective treatment, ultimately improving patient outcomes.

Early Detection Offers the Promise of Saving Lives

Advancements in diagnostic technologies have vastly improved how doctors detect autoimmune hepatitis. For instance, blood tests can now spot specific antibodies linked to this condition, giving doctors a clearer picture. Also, imaging methods like MRI and ultrasound help doctors see inside the body more clearly. These improvements make it easier and faster for doctors to diagnose autoimmune hepatitis accurately.

For instance,

  • In 2021, a study in Alimentary Pharmacology & Therapeutics discussed a new liver function test called the "ALT index" that could identify liver damage earlier than regular tests.
  • In 2022, another study in Clinical Chemistry identified a protein marker called "glycoprotein asialoorosomucoid-3" that could assist in the early detection of liver injuries.

This is important because doctors can start treatment sooner when they can identify the disease early. Early treatment can prevent further damage to the liver and improve the patient's chances of recovery. Because of these technological advancements, doctors have more reliable tools to catch autoimmune hepatitis in its early stages, which is crucial for better patient outcomes. As a result, healthcare providers are keen to adopt these advanced diagnostic tools, driving the growth of the diagnostic market.

Liver Transplant Gives a New Life to Patient

A liver transplant is increasingly in demand as a treatment option for autoimmune hepatitis, a condition where the body's immune system attacks the liver. When other treatments fail to control the disease or if severe liver damage occurs, a liver transplant may be necessary. Globally, thousands of liver transplant surgeries are performed each year to treat various liver diseases, including autoimmune hepatitis. These surgeries involve replacing a diseased liver with a healthy liver from a deceased or living donor.

  • In 2021, 9,236 liver transplant surgeries were performed in the United States, a 3.7% increase from 2020. With the increasing role of transplant anesthesiologists, more research is being conducted to enhance patient treatment. Advancements in organ preservation technology now allow for the potential preservation of marginal organs for transplant or improving the quality of organs for transplantation.

The number of liver transplant surgeries performed worldwide varies from year to year and by region, but it's estimated to be tens of thousands annually. Factors such as advancements in surgical techniques, organ donation practices, and post-transplant care have contributed to the increasing success rates of liver transplants.

A liver transplant remains a life-saving treatment option for many patients with end-stage liver disease, including those with autoimmune hepatitis. It offers a chance for improved quality of life and long-term survival. Continued efforts to raise awareness about organ donation, improve transplant techniques, and expand access to transplantation services are crucial to meet the growing demand for liver transplants globally.

Impact of Limited Awareness

Limited awareness of autoimmune hepatitis poses significant challenges for both patients and healthcare providers. For individuals experiencing symptoms of autoimmune hepatitis, such as fatigue, jaundice, abdominal discomfort, and unexplained weight loss, a lack of knowledge about the disease may lead to hesitation in seeking medical attention. They may attribute their symptoms to other causes or not recognize the seriousness of their condition, resulting in delayed diagnosis and treatment initiation.

On the healthcare provider side, limited awareness can manifest in various ways. Some primary care physicians and general practitioners may not be familiar with the signs and symptoms of autoimmune hepatitis, leading to misdiagnosis or missed diagnosis altogether. Even if autoimmune hepatitis is considered, healthcare providers may lack knowledge about appropriate diagnostic tests and treatment options, further contributing to delays in patient care.

Delayed diagnosis and treatment of autoimmune hepatitis can have serious consequences. Without timely intervention, the disease may progress unchecked, leading to irreversible liver damage, cirrhosis, liver failure, and even death. Additionally, untreated autoimmune hepatitis can increase the risk of complications such as hepatocellular carcinoma (liver cancer).

Educating both the public and healthcare providers about autoimmune hepatitis is crucial to improving outcomes for affected individuals. Public awareness campaigns help raise recognition of the signs and symptoms of the disease, encouraging individuals to seek medical attention promptly. Healthcare provider education programs can ensure that clinicians are knowledgeable about autoimmune hepatitis, enabling timely diagnosis and appropriate management.

Increasing awareness can lead to improved access to specialized care, including hepatology and gastroenterology services, where patients can receive comprehensive evaluation and treatment from experts in liver diseases. By addressing the issue of limited awareness, we can reduce the burden of autoimmune hepatitis and improve outcomes for patients worldwide.

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Geographical Landscape

North America's leadership in the autoimmune hepatitis diagnosis and treatment market is due to significant investments in research and development and the presence of key industry players. Organizations play a crucial role by providing patients with information about diagnostic methods such as endoscopy, CT scan, and biopsy.

For instance,

  • Non-alcoholic fatty liver disease affected over 7 million people in 2020, while liver cancer is the fastest-growing and deadliest form of cancer in Canada, according to the Canadian Liver Foundation's 2021 report.

These factors contribute to the high demand for early diagnosis tools for liver diseases in North America, fueling market growth in the region. The geographical landscape of autoimmune hepatitis in Europe encompasses various regions with differing prevalence rates and healthcare infrastructures.

For instance,

  • In 2021, according to the GOV. estimates that there were 10,501 early deaths from liver disease in England, with a rate of 21.2 per 100,000 people under 75. This is higher than the 10,127 deaths in 2020. The increase of 374 deaths from 2020 to 2021 adds to the previous increase of 909 deaths from 2019 to 2020.

Countries across Europe may have varying levels of awareness, access to diagnostic tools, and treatment options for autoimmune hepatitis. Genetic predisposition, environmental influences, and healthcare policies can contribute to differences in the distribution and management of autoimmune hepatitis across European regions.

In the autoimmune hepatitis market, Asia Pacific is the dominant region. Factors such as the increasing geriatric population and growing awareness about regular health check-ups are driving the growth of this region's liver disease diagnostics market. Additionally, the regulatory approval of advanced technologies that can be integrated with imaging systems is expected to boost regional growth further.

Competitive Landscape

The competitive landscape of the autoimmune hepatitis diagnostics and treatment market is dynamic and driven by continuous innovation, research, and development efforts to address the unmet needs of patients with autoimmune hepatitis. Collaboration among industry players, healthcare providers, and regulatory authorities plays a crucial role in driving advancements and improving standards of care for individuals affected by this condition.

Recent Development

  • In January 2022, the Food and Drug Administration approved Lupin's Tenofovir alafenamide tablets for treating chronic hepatitis B viral infection.
  • In June 2022, Echosens and Novo Nordisk joined forces to use more accessible tests to diagnose a liver condition called NASH without invasive procedures. They aim to increase the number of NASH diagnoses by four times by 2025, especially for those with more severe cases.

Market Players

  • Abbott
  • Siemens Healthcare Private Limited
  • Beckman Coulter
  • Roche Diagnostics
  • Pfizer Inc
  • GE Healthcare
  • Philips Healthcare
  • Cadila Pharmaceuticals
  • Bristol Myers Squibb Company
  • Merck & Co., Inc.

Market Segment

By Type

  • Type 1
  • Type 2

By Diagnosis

  • Blood Tests
    • Liver Tests
    • Antibody Tests
    • Other Blood Tests
  • Liver Biopsy
  • Imaging Tests
    • Ultrasound
    • CT
    • MRI

By Treatment Type

  • Medications
    • Glucocorticoids
    • Immunosuppressants
  • Surgery
  • Liver Transplant
  • Other Treatments

By Geography

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

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