Chronic Hepatitis B – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Chronic Hepatitis B Market Outlook

Thelansis’s “Chronic Hepatitis B Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Chronic Hepatitis B treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Chronic Hepatitis B Overview

Chronic Hepatitis B (CHB) infection is characterized by the presence of Hepatitis B surface antigen (HBsAg) in the serum for at least six months. The markers HBeAg and HBV DNA, assessed using polymerase chain reaction (PCR) assays, serve as indicators of viral replication and infectivity, whereas HBsAg signifies the presence of hepatitis B viral infection. Severe complications associated with chronic infection encompass cirrhosis, liver failure, hepatocellular carcinoma, and mortality. In a minority of cases, HBV DNA can be detected in the serum without concurrent HBeAg presence. This phenomenon is attributed to the "pre-core" mutant, which impedes the production and release of the "e" antigen, despite ongoing HBV DNA replication and is associated with progressive liver disease. The risk of progressing to chronic hepatitis B following acute HBV infection varies with age; approximately 90% of infants progress to chronic conditions, while less than 5% of adults develop chronic illnesses. Transmission of HBV at a period of five years or younger can lead to significant long-term complications such as chronic hepatitis, cirrhosis, or hepatocellular carcinoma (HCC). Presently, two distinct therapeutic approaches have gained approval for treating CHB patients. These strategies include Interferon-alpha (IFN-α) or Pegylated-Interferon-alpha (Peg-IFN-α) and direct-acting antiviral medications, including nucleoside analogs such as lamivudine (LAM), telbivudine (LdT), and entecavir (ETV), as well as nucleotide analogs such as adefovir dipivoxil (ADV) and tenofovir disoproxil fumarate (TDF).

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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