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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Pemphigus vulgaris is an autoimmune disorder in which painful blisters are formed on the mucus membrane and skin. The disorder is rare and affects mouth, nose, throat, lungs, eyes, and sometimes genitals. The disorder is caused when the body produces antibodies against self-cells, although the exact cause and mechanism is unknown. Formation of Immunoglobulin G (IgG) antibodies against self desmosomal adhesion proteins, present on epidermal keratinocytes, results in blister formation. Its diagnosis involves biopsy (tissue sampling), blood tests for pemphigus specific antibodies, and endoscopy. The treatment involves administration of immunosuppressant drugs and corticosteroids.

Pemphigus Vulgaris Treatment Market Drivers

New drug approvals is expected to drive the global pemphigus vulgaris treatment market growth over the forecast period. For instance, in June 2018, the U.S. Food and Drug Administration (FDA) approved the use of Rituximab for the treatment of pemphigus vulgaris. Rituximab is a humanized anti-cd20 monoclonal antibody and acts to reduce the number of skin lesions. The drug acts by targeting cd20 antigen, expressed on cells of B cell lineage and kills B cells. Rituximab acts by inhibiting cell proliferation and inducing cell apoptosis. Rituximab has minimal immunogenicity and can be reused.

Moreover, active research and development by key manufacturers is expected to have positive impact on the global pemphigus vulgaris treatment market growth. For instance, F. Hoffmann-La Roche AG, in collaboration with Genentech, Inc., is conducting a Phase-3 clinical trial (estimated study completion by November 2019) to check the efficacy and safety of drug rituximab as compared to Mycophenolate Mofetil. Rituximab is a U.S.FDA approved drug for the treatment of pemphigus vulgaris and Mycophenolate Mofetil is a drug which, according to National Centre for Biotechnology Information (NCBI), is found to be an effective adjuvant that increases the immunosuppressive effect.

Moreover, Principia Biopharma, a U.S.-based late stage biopharmaceutical company, is conducting Phase-3 clinical trial (estimated study completion by December 2019) for PRN1008 drug, which is a covalent inhibitor of BTK (Bruton’s tyrosine kinase), in pemphigus vulgaris patients. Treatment with PRN1008 was found to inhibit the B cell activation and antibody mediated immune cell activation. These factors are expected to support the global pemphigus vulgaris treatment market growth over the forecast period.

Pemphigus Vulgaris Treatment Market Regional Analysis

Government agencies are indulged in research and development of new drugs for pemphigus vulgaris treatment. For instance, National Institute of Allergy and Infectious Diseases (NIAID), an agency of the U.S. Department of Health and Human Services (HHS), is conducting a Phase 1 trial to check use of Polyclonal T regulatory cells in treatment of pemphigus vulgaris. The study started in September 2017, and is estimated to be completed by September 2020. Therefore, active research and development by key players in the region is expected to support North America pemphigus vulgaris treatment market growth over the forecast period.

Argenx SE, a Netherlands-based biopharmaceutical company, is conducting Phase-2 clinical trial (estimated study completion by August 2019) to check the efficacy of ARGX-113 in treatment of pemphigus vulgaris. ARGX-113 is an antibody Fc fragment (crystallizable fragment), which acts against neonatal Fc Receptor, involved in IgG half-life prolonging pathway and ultimately leading to persistence of autoantibodies, thus mediating the removal of autoantibodies from the system. Therefore, increasing number of clinical trials to develop new therapies for pemphigus vulgaris is expected to fuel the Europe pemphigus vulgaris treatment market growth over the forecast period.

According to National Organization for Rare Disorders (NORD), a U.S.-based non-profit organization, pemphigus vulgaris is more prevalent in Europe and the U.S. compared to other regions of the world. Owing to this, people in these regions are expected to be greatly affected by new drug discoveries and also contribute more to the overall expenditure for pemphigus vulgaris treatment in the near future. This in turn is expected to fuel global pemphigus vulgaris treatment market growth over the forecast period.

Pemphigus Vulgaris Treatment Market Restraints

According to the U.S. National Library of Medicine, in rare cases, use of nonsteroidal anti-inflammatory drugs is a cause of pemphigus vulgaris. This restricts the use of anti-inflammatory agents in the pemphigus, which is characterized by blisters containing inflammatory mediators. Moreover, Rituximab, the only U.S. FDA approved drug used for treatment of pemphigus vulgaris, has side effects such as joint or muscle pain, anemia, kidney problems, muscle spasms, and in rare cases allergic reactions. Such side effects are expected to restrain the global pemphigus vulgaris treatment market growth over the forecast period.

Pemphigus Vulgaris Treatment Market Key Players

Some of the key players operating in the global pemphigus vulgaris treatment market include, Principia Biopharma, Argenx SE, Alexion Inc., Genentech, Inc., Novartis International AG, GlaxoSmithKline plc. Vifor Pharma Management Ltd., and F. Hoffmann-La Roche AG

Pemphigus Vulgaris Treatment Market Taxonomy

The global pemphigus vulgaris treatment market is segmented on the basis of drugs route of administration, distribution channel, and region. 

By Drugs

  • Azathioprine
  • Rituximab
  • Cyclophosphamide
  • Cyclosporine
  • Pipeline drugs
    • PRN1008
  • Others

By Route of Administration

  • Oral
  • Injectable

By Distribution Channel

  • Hospital pharmacies
  • Retail pharmacies
  • Online pharmacies

By Region

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

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users