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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Tumor Necrosis Factor (TNF) inhibitors are class of medications used for the management of inflammatory arthritis. These target the TNF- alpha, a component of the immune system that is responsible for inflammation in the body. Currently, five inhibitors are available in the market namely, etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira), certolizumab (cimzia), and golimumab (simponi). These are prescribed only for autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and psoriasis.

Biosimilars for the already marketed drug have been approved by the U.S. Food and Drug Administration (U.S. FDA). For instance, etanercept (brand name – Enbrel) manufactured by Amgen Inc. has two biosimilars i.e. etanercept- szzs (erelzi) manufactured by Novartis AG and etanercept – ykro (eticovo) manufactured by Samsung Bioepis Co., Ltd. The advantage of using biosimilars is that they are cheaper as compared to the original medicine. Some of the manufacturers operating in the global tumor necrosis factor inhibitors drugs market are Novartis AG, Johnson & Johnson Services, Inc., and Merck & Co., and among others.

Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Drivers

Leading manufacturers are engaged in the development and manufacture of new products as well as biosimilars in the global tumor necrosis factor (TNF) inhibitor drugs market over the forecast period. This factor is expected to aid in growth of the market over the forecast period. For instance, Eticovo, a second biosimilar of Enbrel, manufactured by Samsung Bioepis Co., Ltd, was approved by the U.S. FDA in May 2019 and the cost of Eticovo is US$ 1,500 less than the branded medicine (Enbrel costs around US$ 5,000 for per month supply).

Moreover, the first biosimilar of Enbrel i.e. Erelzi, manufactured by Novartis AG, is available in the form of a sensoready pen with an inbuilt autoinjector, which is beneficial for patients suffering from arthritis and cannot work properly with their limbs. Renflexis (biosimilar of infliximab) was introduced in the U.S market by Merck & Co. in July 2018, at a list price of US$ 753.39 which represents a 35% discount to the current list price of Remicade, its reference product.

Increasing prevalence of autoimmune diseases around the globe is expected to foster the market growth of tumor necrosis factor (TNF) inhibitors drugs. For instance, according to Centers for Disease Control and Prevention (CDC), 2017, around 54.4 million people in the U.S. are suffering from some form of arthritis during (2013 – 2015).

Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Restraints

According to National Center for Biotechnology Information (NCBI), 2019, it has been observed that 50% of the population suffering from autoimmune diseases worldwide, discontinue the use of TNF inhibitors after one year of use as only 5-10% of the population showed positive response to TNF inhibitors while the remaining people show disease activity or severe side effects even after the treatment with TNF inhibitors. Moreover, availability of alternatives drugs that belong to a different class available in the market is also expected to hinder the market growth. For instance, Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) approval in 2017, for Xeljanz (tofacitinib), a Janus kinase inhibitor which is a small molecular drug for rheumatoid arthritis.

Some side effects caused by TNF inhibitors have been reported in the population, which include, increase in the risk of infections of the skin, soft tissues, and joints, and also increase in risk of cancer (non-melanoma skin cancers). These may also result in some other serious side effects, such as pneumonia, tuberculosis, sepsis, osteomyelitis, and progressive multifocal leukoencephalopathy. The above factors are expected to restrain the global tumor necrosis factor inhibitors drugs market growth over the forecast period.

Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Regional Analysis

North America is expected to hold the dominant position in the global tumor necrosis factor inhibitor drugs market over the forecast period, owing to increasing development and launches of new products in the region. For instance, under a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis Co., Ltd., Renflexis (biosimilar of Remicade (infliximab)) received the U.S. FDA approval in 2019 and was the first medicine to be available in the U.S. as a TNF inhibitor.

Moreover, Amgen Inc. also announced the U.S. FDA approval for avsola in 2019 (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab) in the U.S. Also, Celgene Corporation recently received the U.S. FDA approval for otezla (apremilast) in 2019, an oral PDE4 inhibitor for the treatment of adult patients with mucositis (mouth ulcers) associated with behçet’s disease, a rare disorder that causes blood vessel inflammation throughout the body. Otezla is the first drug to be approved for this use in the U.S., providing a treatment option for behçet’s disease, many of whom develop mouth ulcers as a result of the condition.

Increasing incidence of autoimmune diseases in the population is expected to be another factor supporting the growth of North America in the global tumor necrosis factor inhibitor drugs market. For instance, according to the Centers for Disease Control and Prevention (CDC), in 2017, around 54.4 million adults in the U.S. were suffering from arthritis, which equals about 25% of the total population while, around 1.3 million people, 294,000 people and 0.6 to 2.4 million people over 15 years of age in the U.S were suffering from rheumatoid arthritis, juvenile arthritis, and spondylarthritides, respectively.

According to the same source, by the year 2040, it is estimated that 78 million (26%) of the U.S. adults in the age range of 18 years or older are expected to have arthritis. Therefore increasing prevalence of autoimmune diseases in North America is expected to boost the tumor necrosis factor drugs inhibitor market growth over the forecast period.

Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Key Players

Some of the key players operating in the global tumor necrotic factor inhibitor drugs market are Amgen Inc., Novartis International AG, Johnson & Johnson Services, Inc, Merck & Co., Inc. d.b.a., AbbVie Inc., UCB S.A., Sanofi S. A, Bristol-Myers Squibb Company, Cadila Healthcare Ltd, and GlaxoSmithKline plc.

Market Taxonomy

By Drug Type

  • Etanercept
  • Infliximab
  • Adalimumab
  • Certolizumab
  • Golimumab

By Indication

  • Rheumatoid Arthritis
  • Juvenile Arthritis
  • Psoriatic Arthritis
  • Plaque Psoriasis
  • Ankylosing Spondylitis
  • Ulcerative Colitis
  • Crohn's Disease
  • Others

By Route of Administration

  • Subcutaneous Injection
  • Intravenous injection

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

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