Oncology Enabling Development of Improved Biologic Products

Advancements in oncology settings are improving patient quality of life. Due to effective biosimilars, healthcare providers are able to receive better outcomes in several cancer patients who can opt for convenient treatments such as a painless injections rather than receiving a lengthy chemotherapy session. Patent expiry of biologic drugs for the treatment of cancer are creating a scope for incremental opportunities. As such, oncology indication segment of the biosimilars market is estimated to reach a value of ~US$ 21.1 Bn by the end of 2027.

Since the oncology segment is likely to witness aggressive growth during the forecast period, companies in the biosimilars market are increasing efforts to introduce improved formulations of biologic products. Apart from biosimilars, companies are increasing the production of epoetins and filgrastims for the treatment of chemotherapy-induced neutropenia. Healthcare companies are also developing biosimilars to Rituximab, since the novel drug is FDA-approved. Biologic drugs similar to Rituximab are creating incremental opportunities for companies, as these drugs are being increasingly used in the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

biosimilars market infographic

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Innovations in mAbs Increase Cancer Treatment Options

Innovations in monoclonal antibodies (mAbs) are expected in the biosimilars market landscape in the near future. Healthcare companies are increasing their efficacy in hybridoma-based technology to develop improved mAbs with the help of genetic engineering. Monoclonal antibodies are a key source of revenue in the recombinant glycosylated proteins segment. As such, among product types, the recombinant glycosylated proteins segment of the biosimilars market is estimated to reach a value of ~US$ 23.5 Bn by 2027. Hence, manufacturers are aiming at the integration of humanized mAbs based on grafting the murine complementary regions into the human immune globulin backdone.

Monoclonal antibodies are being pervasively used for the treatment of cancer, diabetes, and autoimmune diseases. Manufacturers in China are facing fierce competition to gain approvals for biosimilar mAbs. For instance, in December 2019, Shanghai Henlius Biotech - a producer of advanced mAb products, announced the approval of China’s first-of-its-kind Rituximab biosimilar HLX01 for the treatment of non-Hodgkin’s lymphoma.

Companies Seek Approval for Orphan Biosimilars

Companies in the biosimilars market are tapping into opportunities in orphan biosimilars. Biosimilars are gaining popularity as affordable treatment options for patients in need of biologics. Due to the high prevalence of rare diseases, companies have a renewed purpose to steer innovation in biosimilars. Thus, manufacturers are increasing efforts to fulfill unmet needs of patients with rare diseases by increasing the availability of low-cost biosimilars.

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Development of new orphan biosimilars is in the pipeline for most healthcare companies. They are increasing efforts to gain approvals on new biologic products. For instance, Amgen - a U.S. multinational biopharmaceutical company, revealed that the company has gained approval for its biosimilar medicine, which is a version of Johnson and Johnson/MRK’s Remicade (infliximab).

Manufacturers in the biosimilars market are commercializing orphan biosimilars for the treatment of rare blood diseases involving blood clotting and impaired bone marrow function. Hence, companies are increasingly focusing on the development of biosimilars for blood disorders, since the segment is anticipated for exponential growth during the forecast period.

Low-cost Biosimilar Insulin in Offing

The global biosimilars market is largely consolidated with five major players accounting to more than ~50% of the market share. This poses as a challenge for emerging players to gain prominence in the biosimilars market. Moreover, unfavorable regulatory landscape as suggested by the FDA in the U.S. poses as a challenge for drug manufacturers.

Currently, the biosimilars market in North America is projected for exponential growth during the forecast period. The U.S. being one the most developed economies in North America is faced with several restraints in the current developmental programs for protein products, including insulin, due to stringent and time-constrained regulatory norms imposed by the FDA. Hence, manufacturers in the biosimilars market are increasing R&D activities to produce affordable biological products before the 2020 deadline issued by the FDA.

Insulin is an important recombinant non-glycosylated protein that is creating incremental opportunities for companies in biosimilars market, due to high prevalence of diabetic patients.

biosimilars market segmentation

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Analysts’ Viewpoint

The biosimilars market is expected to expand at a high CAGR of ~23% during the forecast period. Manufacturers are gaining business stability by increasingly innovating in biosimilars catering to cancer patients and are driving down costs of medicines.

One of the biggest barriers in the growth of orphan biosimilars is the long clinical development pathway due to evidence requirements for rare disease drugs. Hence, manufacturers are focusing on analytical similarity with originators to develop approval-worthy biosimilars. Companies should invest in developing economies of Asia Pacific such as India, since the country is an emerging hub for biologics and biosimilars. India’s biopharma sector is aiming to emulate the global standard in generic drugs and is increasing efforts to improve access to affordable biosimilar products.

Biosimilars Market: Overview

  • The global biosimilars market was valued at ~US$ 8 Bn in 2018 and is projected to expand at a high CAGR from 2019 to 2027. The growth of the market can be attributed to various factors, including significant product pipeline, focus of market players on expanding their presence in emerging markets, rise in prevalence of non-communicable diseases, cost savings offered by biosimilars, patent expiries of major biologics, and increase in adoption rate of biosimilars.
  • Biosimilars can be defined as a biologic medical product, which is considered to be similar to already approved biologic. These biosimilars are approved based on their efficacy, quality, safety, and the same standards of pharmaceutical quality that apply to all biologic medicines.
  • Biosimilars are the copy versions of biologics, which have reached the end of patent protection. The patent expiries of major biologics are expected to contribute to the growth of the biosimilars market. As a result of increasing approvals and sales of biosimilars, biologics, which had a steady or growing demand, witnessed a strong decline in their sales.
  • The global burden of chronic diseases has been increasing globally. Aging population and changing societal behavior are the key factors contributing to the increase in prevalence of chronic diseases. Major chronic diseases include diabetes, hypertension, stroke, respiratory diseases, oral diseases, obesity, arthritis, and cancer.
  • The approvals of biosimilars have been increasing globally, owing to changing regulations and increasing pressure on the healthcare system to facilitate treatment to all patients. Biosimilars or copy biologics are being increasingly adopted by physicians, authorities, and patients, owing to much-needed improvements to access therapeutically-viable treatments for various diseases. 

Biosimilars Market: Segmentation

  • The global biosimilars market has been segmented based on product, indication, and region
  • In terms of product, the biosimilars market has been categorized into recombinant glycosylated proteins, recombinant non-glycosylated proteins, and recombinant peptides. Recombinant glycosylated proteins segment has been further divided into monoclonal antibodies, erythropoietin, and others. The recombinant non-glycosylated proteins segment has been sub-segmented into insulin, granulocyte colony stimulating factor, recombinant human growth factor, and interferons.
  • Based on indication, the biosimilars market has been divided into chronic diseases, oncology, autoimmune diseases, infectious diseases, blood disorders, growth hormone deficiency, and others. The oncology segment dominated the market in 2018. It is anticipated to remain dominant during the forecast period, owing to increase in prevalence of cancer and significant pipeline of biosimilars focused on the treatment of cancers. 

Biosimilars Market: Regional Segmentation

  • In terms of region, the global biosimilars market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
  • Europe dominated the global biosimilars market in 2018, and is likely to remain dominant during the forecast period. Europe is considered the global pioneer in the biosimilars market with the first approved biosimilar in 2006. This region accounts for over 70% of the global biosimilar spending, as it is the most developed biosimilar market. In addition, Europe has over 60 approved biosimilars currently, contributing significantly to the growth of the biosimilars market in the region.
  • The global biosimilars market in Asia Pacific is anticipated to expand at a high CAGR during the forecast period. The robust growth of the market in the region can be attributed to increase in manufacturing of biosimilars in India and Korea. In addition, there are over 300 biosimilars under development in Asia, which would help Asia position itself as the center for global biosimilars manufacturing and adoption. 

Biosimilars Market: Major Players

  • Key players operating in the global biosimilars market include
    • Pfizer, Inc.
    • Intas Pharmaceuticals Ltd.
    • Biocon
    • Dr. Reddy’s Laboratories Ltd.
    • Teva Pharmaceutical Industries Ltd.
    • Sandoz International GmbH (A Novartis Division)
    • Celltrion Inc.
    • Amgen, Inc.
    • STADA Arzneimittel AG
    • Apotex Inc. (Apobiologix)
  • These players are focused on adopting organic growth strategies to strengthen their product portfolio. These companies have adopted strategies such as collaborations, investment in research & development, strengthening their biosimilars pipeline, and product launches in order to stay competitive in the biosimilars market.

Biosimilars Market - Scope of the Report

TMR’S report on the global biosimilars market studies the past as well as current growth trends and opportunities to gain valuable insights of the same indicators for the said market during the forecast period of 2019 to 2027. The report provides the overall market revenue of the global biosimilars market for the period 2017–2027, considering 2018 as the base year and 2027 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the global biosimilars market for the forecast period.

The report has been prepared after an extensive research. Primary research involves bulk of research efforts, wherein analysts carried out interviews with industry leaders and opinion makers. Extensive secondary research involves referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global biosimilars market.

Secondary research also includes Internet sources, statistical data from government agencies, websites, and trade associations. Analysts have also employed a combination of the top-down and bottom-up approaches to study various phenomena in the global biosimilars market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments and sub-segments included in the scope of the study. Additionally, the report sheds light on the changing competitive dynamics in the global biosimilars market. These indices serve as valuable tools for existing market players as well as for entities interested in participating in the global biosimilars market. The next section of the global biosimilars report highlights the USPs, which include regulatory scenarios for biosimilars globally, Biosimilars pipeline analysis, and potential product launches in the global biosimilars market.

The report delves into the competitive landscape of the global biosimilars market. Key players operating in the global biosimilars market have been identified, and each one of these has been profiled for their distinguishing business attributes. Company overview, financial standings, recent developments, and SWOT are some of the attributes of players profiled in the global biosimilars market report.

Key Questions Answered in Biosimilars Market Report

  • What is the sales/revenue generated by biosimilar products across all regions during the forecast period?
  • What are the key trends in the biosimilars market?
  • What are the major drivers, restraints, and opportunities in the market?
  • In which region is the biosimilars market set to expand at the fastest CAGR during the forecast period?
  • Which segment will have the highest revenue globally in 2027 and which product segment will expand at the fastest CAGR during the forecast period?

Biosimilars Market - Research Objectives and Research Approach

The comprehensive report on the global biosimilars market begins with an overview of the said market, followed by the scope and objectives of the study. Following this, the report provides detailed explanation of the objectives of this study and healthcare compliances laid down by accredited agencies in the purview of research in the biosimilars market. It is followed by market introduction, market dynamics, and an overview of the biosimilars market, which includes TMR analysis of market drivers, restraints, and trends affecting the growth of the market. Furthermore, Y-o-Y analysis with elaborate insights has been provided to understand the Y-o-Y trends of the biosimilars market. The next section of the biosimilars report highlights the USPs, which include regulatory scenarios for biosimilars globally, biosimilars pipeline analysis, and key product launches in the global market.

For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section further divided into small sections. The entire report comprises an exhaustive collection of graphs and tables that are appropriately interspersed in the entire compilation. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of the market shares of key segments in the past and at the end of the forecast period.

Revenue generated by key biosimilars market manufacturers have been mapped to ascertain the size of the global biosimilars market in terms of value. The forecast presented here assesses the total revenue generated in the biosimilars market. In order to provide an accurate forecast, we initiated by sizing up the current biosimilars market with the help of the parent market.

The report analyzes the biosimilars market in terms of product, indication, and region. Key segments under each criteria have been studied at length, and the market share for each of these at the end of 2027 has been provided. These valuable insights would help market stakeholders in making informed business decisions for investments in the biosimilars market.

Biosimilars Market - Segmentation

Product

Recombinant Glycosylated Proteins

  • Monoclonal Antibodies
  • Erythropoietin
  • Others

Recombinant Non-glycosylated Proteins

  • Insulin
  • Granulocyte Colony Stimulating Factor
  • Recombinant Human Growth Factor
  • Interferons

Recombinant Peptides

Indication

Chronic Diseases

Oncology

Autoimmune Diseases

Infectious Diseases

Blood Disorders

Growth Hormone Deficiency

Others

Region

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

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