Market Snapshot

Market Overview

Market Overview

The COVID-19 pandemic has had a profound impact on both the global economy and public health. Throughout this challenging period, various sectors, including the pharmaceutical industry, have displayed remarkable resilience and collaboration. Notable instances of cross-stakeholder cooperation among academia, industry, and government have emerged, encompassing endeavors such as drug re-purposing initiatives, antibody discovery programs, vaccine research and development, and clinical trial enrolments, particularly for COVID-19 patients.

Key Developments in the Biosimilar Space

One noteworthy milestone in the biosimilar sector occurred in March 2020 when Samsung Bioepis announced the approval of a 420mg multi-dose vial of its Herceptin biosimilar, Ontruzant. This cost-effective product not only reduces waste but also received FDA approval in 2019 in its 150 mg single-dose form.

In the same month, Celltrion and Teva introduced their trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), to the US market. Herzuma, approved in Canada as well, offers treatment options for breast and gastric cancer patients.

Segmentation by Product Class

Biosimilars hold the promise of enhancing patient access to vital treatments while concurrently reducing healthcare costs. However, their development poses significant challenges due to the intricate nature of biologic drugs, which exhibit molecular complexity and sensitivity to manufacturing and handling variations.

One area poised for substantial growth in the biosimilars market is the development of biosimilars for complex monoclonal antibodies (mAbs). Complex mAbs are among the best-selling biologics and are used in the treatment of various conditions, including cancer and autoimmune disorders like rheumatoid arthritis. This growth is driven by the approaching expiration of patents for several top-selling biologics.

As pharmaceutical companies increasingly enter the rapidly expanding mAb biosimilars market, competition for these biosimilars is expected to intensify. This trend reflects the industry's commitment to meeting the rising demand for these critical therapies.

Segmentation by Geography

Biosimilar trends in developed and emerging markets share similarities, except for the United States. Developed markets like Europe, the United States, and Japan lead in biosimilar presence and development. The growth in these markets is driven by incentives from physicians and insurance providers, encouraging the adoption of cost-effective biosimilars.

In contrast, emerging markets have a nascent biosimilar landscape due to limited access for patients and a preference for lower-cost therapies among physicians. Treatment rates for flagship biologics remain low in emerging markets compared to developed ones, hindering biosimilar adoption. However, most emerging markets are poised for significant growth, thanks to streamlined approval processes compared to developing nations.

As healthcare systems evolve and regulations improve, emerging markets are expected to bridge the gap, offering affordable biosimilars to a broader patient base. This trend indicates a promising future for biosimilars, aligning with global efforts to make vital biologic treatments more accessible and cost-effective worldwide.

Competitive Landscape

Company Share Analysis of Biosimilar Market, %
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Market Segmentation

Company Performance

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Table of Contents

Table of Contents

1. Research Methodology and Scope

2. Market Overview

        2.1 Approved Biosimilar Products

        2.2 Biosimilars Products in Pipeline

        2.3 Key Market Developments

        3.1 Approved and Pipeline Analysis of Biosimilar Products by Major Companies

3. Market Dynamics

        3.1 Drivers

        3.2 Restraints

4. Industry Regulations

5. Competitive Landscape

6. Key Biosimilars Products in Development

        6.1 Biosimilar Adalimumab

        6.2 Biosimilar Bevacizumab

        6.3 Cetuximab Biosimilars

        6.4 Biosimilar Infliximab

        6.5 Biosimilar ranibizumab

        6.6 Biosimilar Rituximab

        6.7 Biosimilar Trastuzumab

        6.8 Biosimilar Etanercept

        6.9 Biosimilar Insulin Lispro

        6.10 Biosimilar Insulin Glargine

        6.11 Biosimilar Pegfilgrastim

        6.12 Biosimilar Teriparatide

7. Biosimilar Market Analysis by Product Class

        7.1 Monoclonal Antibodies

        7.2 Recombinant Hormones

        7.3 Immunomodulators

        7.4 Anti-inflammatory Agents

        7.5 Others

8. Biosimilar Market Analysis by Applications

        8.1 Blood Disorders

        8.2 Growth Hormonal Disorders

        8.3 Chronic and Autoimmune Disorders

        8.4 Oncology

        8.5 Others

9. Biosimilars Market by Region

        9.1 North America

                 9.1.1 United States

                 9.1.2 Canada

                 9.1.3 Mexico

        9.2 Europe

                 9.2.1 United Kingdom

                 9.2.2 Spain

                 9.2.3 Italy

                 9.2.4 Germany

                 9.2.5 Rest of Europe

        9.3 Asia-Pacific

                 9.3.1 China

                 9.3.2 India

                 9.3.3 Japan

                 9.3.4 Australia

                 9.3.5 South Korea

                 9.3.6 Rest of Asia-Pacific

        9.4 South America

                 9.4.1 Brazil

                 9.4.2 Rest of South America

        9.5 Middle East and Africa

10. Company Profiles

        10.1 Pfizer

        10.2 Eli Lily and Company

        10.3 Cellitron Healthcare

        10.4 Mylan

        10.5 Coherus BioSciences

        10.6 Teva Pharmaceuticals

        10.7 Sandoz

        10.8 Biogen

        10.9 Samsung Bioepis

        10.10 Amgen

11. Appendix

Major Players

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