‘IgG4-Related Disease-Market Insights, Epidemiology, and Market Forecast--2028’ report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology as well as the market trends of IgG4-Related Disease in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
The report provides the current treatment practices, emerging drugs, market share of the individual therapies, the current and forecasted market size of IgG4-Related Disease from 2017 to 2028 segmented by seven major markets. The report also covers current treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate best of the opportunities and assess the underlying potential of the market.
Geography Covered
IgG4-Related Disease - Disease Understanding and Treatment Algorithm
IgG4-related disease (IgG4-RD) is a systemic fibroinflammatory disease characterized by dense infiltration of IgG4-positive plasma cells in the affected tissue(s) with or without elevated plasma levels of IgG4. It is a chronic-fibroinflammatory disorder affecting a wide range of organs. Elevation of serum IgG4 concentrations and abundant infiltration of IgG4-expressing plasma cells are key diagnostic features of this autoimmune disease. Although common organ involvement of IgG4-RD includes the salivary glands, pancreas, and bile duct, hepatic involvement is less well established. IgG4RD may be present in a certain proportion of patients with a wide variety of diseases, including Mikulicz’s disease, autoimmune pancreatitis, hypophysitis, Riedel thyroiditis, interstitial pneumonitis, interstitial nephritis, prostatitis, lymphadenopathy, retroperitoneal fibrosis, inflammatory aortic aneurysm, and inflammatory pseudotumor.
The diagnostic workup of IgG4-RD is complex and usually requires a combination of clinical examination, imaging, histological, and serological analyses. However, no finding alone is specific for IgG4-RD. Therefore, its diagnosis requires careful interpretation of examination results in context with the patient’s clinical appearance as well as the exclusion of a broad variety of differential diagnoses.
The IgG4-Related Disease market report gives the thorough understanding of the IgG4-Related Disease by including details, such as disease introduction, immunoglobulins, clinical manifestations, pathophysiological mechanisms, symptoms, clinical Features of Organ system involvement, pathophysiology, the pathogenesis of IgG4-related disease and diagnosis. It also provides treatment algorithms and treatment guidelines for IgG4-Related Disease in the US, Europe, and Japan.
IgG4-Related Disease Epidemiology
According to the American College of Rheumatology, IgG4 related disease tends to affect middle-aged to elderly individuals. Unlike many autoimmune diseases, IgG4-RD tends to affect males more often than females. Some patients have levels of IgG4 in their blood that are 20 or 30 times higher than the upper limit of normal. In a significant minority of patients, however, the serum IgG4 concentration is normal. The organs that are often involved in IgG4-RD include meninges, orbits, lacrimal glands, major salivary glands, thyroid gland, lungs, aorta, kidneys, pancreas, and bile ducts.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology scenario of IgG4-Related Disease in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom) and Japan from 2017 to 2028 for the following aspects:
As per a study conducted by Gervasio et al. titled “IgG4-related Orbital Inflammation” stated that the incidence of IgG4-ROD had been reported between 5% and 20% among inflammatory orbital lesions. It was also the lacrimal gland being the most commonly involved site in IgG4-ROD, i.e., approximately 62–88%. Other common sites included the trigeminal nerve, i.e., approximately 9.5–39%, extraocular muscles 19–25%, orbital fat 28.6–40%, eyelid 12% and the nasolacrimal duct system 1.5–9.5. While, less commonly, IgG4-ROD may affect the sclera. Also, IgG4-RD, particularly AIP, tends to occur more often in older males compared to females associated with salivary gland lesions and a higher serum IgG4 level.
According to a study conducted by Yamamoto et al. titled “Mechanisms and assessment of IgG4-related disease: lessons for the rheumatologist” stated that the number of patients with IgG4-related disease was estimated to be about 8000 in Japan, including around 4300 patients with IgG4-related dacryoadenitis and sialadenitis and 2700 patients with type 1 AIP. In addition, the average age of disease onset was in the seventh decade of life, with the gender ratio showing a predisposition of IgG4-related disease in men.
IgG4-Related Disease Drug Chapters
This segment of the IgG4-Related Disease report encloses the detailed analysis of late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
To meet the increasing demand for the treatment of IgG4-Related Disease, companies have shifted their focus toward the development of targeted therapies. Expected launch of potential therapies may increase the market size in the coming years, assisted by an increase in the prevalent population of IgG4-Related Disease and awareness of the disease. The overall dynamics of IgG4-Related Disease market is anticipated to change in the coming years owing to the expected launch of emerging therapies of the major key players, such as Xencor and Bristol-Myer Squibb will significantly increase the market during the forecast period (2019–2028).
IgG4-Related Disease Market Outlook
IgG4-related disease (IgG4-RD) is a systemic fibro inflammatory disease characterized by dense infiltration of IgG4-positive plasma cells in the affected tissue(s) with or without elevated plasma levels of IgG4. Some patients with asymptomatic IgG4-RD can be watched without treatment, e.g., asymptomatic lymphadenopathy or mild submandibular gland enlargement. Special attention should be made to active IgG4-RD in the pancreas, biliary tree, aorta, mediastinum, kidneys, retroperitoneum, and mesentery as in those cases starting therapy is urgent that must be considered.
There are no specific drugs available that cure the disease completely as the pathophysiology of the IgG4-related disease is not clear and still under research and development. Currently, the market holds no approved therapies for patients with IgG4-related diseases. According to the recent guidelines published by “International Consensus Guidance Statement on the Management and Treatment of IgG4‐Related Disease,” which explained the criteria for determining the type of disease caused due to IgG4 levels and the treatment guidelines for the patients. The commonly used treatment options include Glucocorticoids, Immunomodulators, and Rituximab.
This segment gives a thorough detail of market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to the author, the market of IgG4-Related Disease in 7MM is expected to change from 2019 to 2028.
IgG4-Related Disease Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the market or will get launched in the market during the study period from 2017 to 2028. The analysis covers market uptake by drugs; patient uptake by therapies and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allowing the comparison of the drugs on the basis of market share and size will again be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Expected launch of therapies for IgG4-Related Disease such as XmAb5871 (Xencor) and Abatacept (Bristol-Myer Squibb) and other targeted therapies in the forecast period [2019–2028] will also create a positive impact on the IgG4-Related Disease market.
IgG4-Related Disease Report Insights
IgG4-Related Disease Report Key Strengths
IgG4-Related Disease Report Assessment
Key Benefits
The report provides the current treatment practices, emerging drugs, market share of the individual therapies, the current and forecasted market size of IgG4-Related Disease from 2017 to 2028 segmented by seven major markets. The report also covers current treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate best of the opportunities and assess the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
IgG4-Related Disease - Disease Understanding and Treatment Algorithm
IgG4-related disease (IgG4-RD) is a systemic fibroinflammatory disease characterized by dense infiltration of IgG4-positive plasma cells in the affected tissue(s) with or without elevated plasma levels of IgG4. It is a chronic-fibroinflammatory disorder affecting a wide range of organs. Elevation of serum IgG4 concentrations and abundant infiltration of IgG4-expressing plasma cells are key diagnostic features of this autoimmune disease. Although common organ involvement of IgG4-RD includes the salivary glands, pancreas, and bile duct, hepatic involvement is less well established. IgG4RD may be present in a certain proportion of patients with a wide variety of diseases, including Mikulicz’s disease, autoimmune pancreatitis, hypophysitis, Riedel thyroiditis, interstitial pneumonitis, interstitial nephritis, prostatitis, lymphadenopathy, retroperitoneal fibrosis, inflammatory aortic aneurysm, and inflammatory pseudotumor.
The diagnostic workup of IgG4-RD is complex and usually requires a combination of clinical examination, imaging, histological, and serological analyses. However, no finding alone is specific for IgG4-RD. Therefore, its diagnosis requires careful interpretation of examination results in context with the patient’s clinical appearance as well as the exclusion of a broad variety of differential diagnoses.
The IgG4-Related Disease market report gives the thorough understanding of the IgG4-Related Disease by including details, such as disease introduction, immunoglobulins, clinical manifestations, pathophysiological mechanisms, symptoms, clinical Features of Organ system involvement, pathophysiology, the pathogenesis of IgG4-related disease and diagnosis. It also provides treatment algorithms and treatment guidelines for IgG4-Related Disease in the US, Europe, and Japan.
IgG4-Related Disease Epidemiology
According to the American College of Rheumatology, IgG4 related disease tends to affect middle-aged to elderly individuals. Unlike many autoimmune diseases, IgG4-RD tends to affect males more often than females. Some patients have levels of IgG4 in their blood that are 20 or 30 times higher than the upper limit of normal. In a significant minority of patients, however, the serum IgG4 concentration is normal. The organs that are often involved in IgG4-RD include meninges, orbits, lacrimal glands, major salivary glands, thyroid gland, lungs, aorta, kidneys, pancreas, and bile ducts.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology scenario of IgG4-Related Disease in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom) and Japan from 2017 to 2028 for the following aspects:
- Prevalent Population of IgG4-Related Disease
- Diagnosed Prevalent Population of IgG4-Related Disease
- Gender-specific Prevalent Population of IgG4-RD
- Diagnosed Prevalent Population of Autoimmune Pancreatitis (AIP)
As per a study conducted by Gervasio et al. titled “IgG4-related Orbital Inflammation” stated that the incidence of IgG4-ROD had been reported between 5% and 20% among inflammatory orbital lesions. It was also the lacrimal gland being the most commonly involved site in IgG4-ROD, i.e., approximately 62–88%. Other common sites included the trigeminal nerve, i.e., approximately 9.5–39%, extraocular muscles 19–25%, orbital fat 28.6–40%, eyelid 12% and the nasolacrimal duct system 1.5–9.5. While, less commonly, IgG4-ROD may affect the sclera. Also, IgG4-RD, particularly AIP, tends to occur more often in older males compared to females associated with salivary gland lesions and a higher serum IgG4 level.
According to a study conducted by Yamamoto et al. titled “Mechanisms and assessment of IgG4-related disease: lessons for the rheumatologist” stated that the number of patients with IgG4-related disease was estimated to be about 8000 in Japan, including around 4300 patients with IgG4-related dacryoadenitis and sialadenitis and 2700 patients with type 1 AIP. In addition, the average age of disease onset was in the seventh decade of life, with the gender ratio showing a predisposition of IgG4-related disease in men.
IgG4-Related Disease Drug Chapters
This segment of the IgG4-Related Disease report encloses the detailed analysis of late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
To meet the increasing demand for the treatment of IgG4-Related Disease, companies have shifted their focus toward the development of targeted therapies. Expected launch of potential therapies may increase the market size in the coming years, assisted by an increase in the prevalent population of IgG4-Related Disease and awareness of the disease. The overall dynamics of IgG4-Related Disease market is anticipated to change in the coming years owing to the expected launch of emerging therapies of the major key players, such as Xencor and Bristol-Myer Squibb will significantly increase the market during the forecast period (2019–2028).
IgG4-Related Disease Market Outlook
IgG4-related disease (IgG4-RD) is a systemic fibro inflammatory disease characterized by dense infiltration of IgG4-positive plasma cells in the affected tissue(s) with or without elevated plasma levels of IgG4. Some patients with asymptomatic IgG4-RD can be watched without treatment, e.g., asymptomatic lymphadenopathy or mild submandibular gland enlargement. Special attention should be made to active IgG4-RD in the pancreas, biliary tree, aorta, mediastinum, kidneys, retroperitoneum, and mesentery as in those cases starting therapy is urgent that must be considered.
There are no specific drugs available that cure the disease completely as the pathophysiology of the IgG4-related disease is not clear and still under research and development. Currently, the market holds no approved therapies for patients with IgG4-related diseases. According to the recent guidelines published by “International Consensus Guidance Statement on the Management and Treatment of IgG4‐Related Disease,” which explained the criteria for determining the type of disease caused due to IgG4 levels and the treatment guidelines for the patients. The commonly used treatment options include Glucocorticoids, Immunomodulators, and Rituximab.
This segment gives a thorough detail of market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to the author, the market of IgG4-Related Disease in 7MM is expected to change from 2019 to 2028.
IgG4-Related Disease Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the market or will get launched in the market during the study period from 2017 to 2028. The analysis covers market uptake by drugs; patient uptake by therapies and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allowing the comparison of the drugs on the basis of market share and size will again be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Expected launch of therapies for IgG4-Related Disease such as XmAb5871 (Xencor) and Abatacept (Bristol-Myer Squibb) and other targeted therapies in the forecast period [2019–2028] will also create a positive impact on the IgG4-Related Disease market.
IgG4-Related Disease Report Insights
- Patient Population
- Therapeutic Approaches
- Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
IgG4-Related Disease Report Key Strengths
- 10 Year Forecast
- 7MM Coverage
- Epidemiology Segmentation
- Drugs Uptake
- Highly Analyzed Market
- Key Cross Competition
IgG4-Related Disease Report Assessment
- Current Treatment Practices
- Unmet Needs
- Market Attractiveness
- Market Drivers and Barriers
Key Benefits
- This report will help to develop Business Strategies by understanding the trends shaping and driving the IgG4-Related Disease market.
- Organize sales and marketing efforts by identifying the best opportunities for IgG4-Related Disease market.
- To understand the future market competition in the IgG4-Related Disease market.
Table of Contents
1. Key Insights8. Unmet needs14. Market Drivers15. Market Barriers17. Capabilities18. Disclaimer19. About the Author
2. IgG4-Related Disease Market Overview at a Glance
3. Disease Background and Overview: IgG4-Related Disease
4. Epidemiology and Patient Population
5. Country Wise-Epidemiology of IgG4-Related Disease
6. Treatment
7. International Consensus Guidance Statement on the Management and Treatment of IgG4-Related Diseases
9. Emerging Drugs
10. IgG4-Related Disease: 7 Major Market Analysis
11. The United States Market Outlook
12. EU-5 Countries: Market Outlook
13. Japan: Market Outlook
16. Appendix
List of Tables
List of Figures
Companies Mentioned
A selection of companies mentioned in this report includes:
- Xencor
- Bristol-Myer Squibb