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U.S. Biosimilars Market Size, Share and Industry Analysis By Drug Class (Filgrastim & Pegfilgrastim, Monoclonal Antibodies, Others), By Disease Indication (Cancer, Autoimmune Diseases, Others) By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy) and Regional Forecast, 2019 - 2026

Region : United States | Format: PDF | Report ID: FBI100990



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A major portion of the treatment cost is captured by the cost of pharmaceutical drugs. The high cost of pharmaceutical drugs possesses an obstruction in making healthcare accessible to all. Biosimilars, which are an identical copy of the branded reference products are thus, an effective way to address the demands of the unmet population, as they provide a cost-effective alternative. Strong support from the U.S. government has also encouraged the adoption of biosimilars in the healthcare sectors. In addition, the increased market opportunity for biosimilars in the U.S. have encouraged huge R&D investments and new product launch, which has further geared up the competition in the U.S. biosimilars market. For example, in November 2018, the FDA granted approval to Truxima, the first biosimilar of Rituxan (rituximab), developed by Celltrion Inc. thus, providing an effective alternative treatment drug for B-cell non-Hodgkin’s lymphoma. 

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"Increased Research for Development of Biosimilars, to Drive the Market"

Many pharmaceutical companies are now focusing on the development of biosimilars of branded products. This has led to significant R&D investment and increased research activities, which are anticipated to be the primary factors contributing to the U.S. biosimilars market growth. In addition, increasing preference for biosimilars as they are cost-effective, rising prevalence of chronic diseases, and increased government efforts for the to provide affordable healthcare, patent expiry, and potential pipeline candidates are expected to fuel the demand for the U.S. market. 

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Based on disease indication, the U.S. biosimilars market segments include cancer, autoimmune diseases, and others. The autoimmune diseases segment accounted for a share of 72.7% in 2018 and is estimated to dominate the U.S. market throughout the forecast period. Increased prevalence of the autoimmune diseases, limited drug options, and higher adoption of biosimilars are the factors attributed to the growth of autoimmune diseases segment during the forecast period, and ultimately boosting in this market. According to the Centers of Disease Control and Prevention, by 2040, 26% of U.S. adults which accounts for 78 million people are estimated to have doctor-diagnosed arthritis, further augmenting the demand of biosimilars for treating arthritis in the U.S. On the other hand, cancer segment is anticipated to register a remarkable biosimilars market growth in the U.S. during the projected period owing to the high cost of treatment, significant R&D investments, increasing prevalence and adoption of sedentary lifestyles. Based on drug class, the U.S. market segment include filgrastim & pegfilgrastim, monoclonal antibodies, and others. The monoclonal antibodies segment accounted for maximum U.S. biosimilars market share in 2018, mainly due to the increased use of monoclonal antibodies in the treatment of cancer, increased research and clinical study, and large scale production. In terms of distribution channel, the U.S. market segments include hospital pharmacy, retail pharmacy, and online pharmacy. 

Key Market Players

"Novartis AG, Pfizer Inc., Amgen Inc. to Account for More Than Half of the Market Share in Terms of Revenue"

Novartis AG is estimated to remain in a leading position in the U.S. biosimilars market owing to the increased sale of Zarxio and Erelzi. The share of Pfizer Inc. in the U.S. market is expected to increase owing to the recent FDA approval for TRAZIMERA and NIVESTYM, and robust pipeline products. Other players operating in the market are Merck & Co., Coherus BioSciences, Inc., AbbVie Inc., F. Hoffmann-La Roche Ltd., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Celltrion Inc., and others. 

List of Companies Profiled

  • Novartis AG

  • Merck & Co.

  • Coherus BioSciences, Inc.

  • AbbVie Inc.

  • Pfizer Inc.

  • Hoffmann-La Roche Ltd.

  • Eli Lilly and Company

  • Teva Pharmaceutical Industries Ltd.

  • Celltrion Inc.

  • Amgen Inc.

  • Other prominent players

Report Coverage

Biosimilars refers to the medical biologic product that is similar to another medical biologics product called as the reference product. Biosimilars possesses equal similarity with the reference product in terms of purity, safety, efficacy, and potency. But it may differ in clinically inactive components used. Though biosimilars are identical to the reference product; approval of biosimilars requires positive clinical study to prove its safety and efficacy in the treatment of concerned disease or condition. Biosimilars offer a cost-effective alternative to highly-priced branded drugs, which has become the primary reason for increased demand for biosimilars in the pharmaceutical and healthcare sector. The higher adoption of biosimilars for the treatment of diseases and reduced healthcare cost have also triggered drugs manufacturers to conduct research and launch new biosimilars in the market. Increased FDA approvals for biosimilars, increased research, patent expiry, and potential pipeline candidates are expected to positively impact the demand for biosimilars in the U.S.

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The U.S. biosimilars market report provides qualitative and quantitative insights on industry trends and a detailed analysis of market size and growth rate for all possible segments in the market. The market is segmented by drug class, by disease indication, and by distribution channel. On the basis of the drug class, the U.S. biosimilars market segments include filgrastim & pegfilgrastim, monoclonal antibodies, and others. Based on disease indication, this market segments include cancer, autoimmune diseases, and others. The autoimmune diseases segment is further divided into arthritis, psoriasis, neutropenia, and others. Various distribution channels covered under the report are hospital pharmacy, retail pharmacy, and online pharmacy. 

Along with this, the report on U.S. market analysis includes market dynamics and competitive landscape. Various key insights provided in the report are the prevalence of key diseases associate with the scope for key countries, new product launch, pipeline analysis, patent snapshot of biologics, the regulatory scenario in key countries, reimbursement scenario for key countries, recent industry developments such as mergers & acquisitions, and key industry trends.




By Drug Class

  • Filgrastim & Pegfilgrastim

  • Monoclonal Antibodies

  • Others

By Disease Indication

  • Cancer

  • Autoimmune Diseases

    • Arthritis

    • Psoriasis

    • Neutropenia

    • Others

  • Others

By Distribution Channel

  • Hospital Pharmacy

  • Retail Pharmacy

  • Online Pharmacy


Key Industry Developments

  • In April 2019, Samsung Bioepis received FDA approval for ETICOVO, a biosimilar of Etanercept for the treatment of rheumatoid arthritis.

  • In March 2019, Pfizer received FDA approval for TRAZIMERA, a biosimilar of Trastuzumab for treating patients with breast cancer and gastroesophageal junction adenocarcinoma.

  • In July 2018, Pfizer received FDA approval for NIVESTYM, a biosimilar of Filgrastim for indications equal to that of reference product.

  • In November 2018, the FDA granted approval to Truxima, biosimilar of rituximab developed by Celltrion Inc. for the treatment of B-cell non-Hodgkin’s lymphoma.

Frequently Asked Questions

Fortune Business Insights says that the U.S. market was valued at USD 436.1 Million in 2018 and is projected to reach USD 17,696.0 Million by 2026.

In 2018, the market was valued at USD 436.1 Million.

Growing at a CAGR of 54.7%, the market will exhibit steady growth in the forecast period (2019-2026)

Autoimmune diseases segment is expected to be the leading segment in this market during the forecast period.

Extensive R&D in biosimilars, increased prevalence of chronic disorders and anticipated product launches will drive the growth of the U.S. market.

Novartis AG, Pfizer Inc., Amgen Inc. are the top players in the market.

New and anticipated biosimilars launches, increasing prevalence of chronic disorders, extensive R&D initiatives in biosimilars and cost effectiveness of biosimilars would drive the adoption.

Adoption of newer biosimilars, new indications for biosimilars, and new and anticipated launches of products, advances in R&D leading to significant improvement of biosimilars and increasing prevalence of chronic disorders, and cost effectiveness of biosimilars are the hyper-market trends of the U.S. market.

U.S. Biosimilars Market Size, Share and Global Industry Trend Forecast till 2026
  • Jul, 2019
  • 2018
  • 2015-2017
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