As per the latest research by Business Intelligence Insights (BII), The Biosimilar market was valued at around USD 16.5 Billion in 2021 and is expected to reaching a valuation of up to around USD 46.8 Billion by 2026. The market will grow at a CAGR of +23% during the forecast period of 2021 to 2026.
A biosimilar is a biologic drug which is "similar" to innovator drug (known as a reference product) that has already been approved by the drug regulatory authorities around the world. Biosimilars are very similar to the reference product in terms of safety, purity, and potency, but clinically inactive components may differ slightly. The FDA may require manufacturers to do a clinical trial (or studies) sufficient to show safety, purity, or potency in one or more purposes for which the reference product is licensed and the biosimilar seeks licensure when approving biosimilars.
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Market Dynamics
Adoption of advanced technology and increasing prevalence of Chronic diseases such as cancer and diabetes adds to the growing demand for pharmaceutical treatments, particularly the high-priced patented drugs. FDA approved only three biosimilars in the first quarter of 2020 which was led the market towards less competition for manufacturers of biosimilars. For instance, On April 14, 2020, Pfizer Leads With 2 First Quarter Biosimilar Launches. The first quarter of 2020 saw 3 biosimilars brought to market in the United States, 2 of them from Pfizer, and no new approvals from the FDA. That compares with 1 launch and 2 approvals in the year-ago quarter.
Rapidly increasing chronic diseases like cancer, diabetes supplements are creating demand for biosimilars. For instance, as per the Food and Agriculture Organization of the United States, chronic diseases are expected to account for over three-quarters of all fatalities worldwide by 2020, with developing nations accounting for 71% of deaths due to ischemic heart disease (IHD), 75% of deaths due to stroke, and 70% of deaths due to diabetes. The number of persons with diabetes in the developing world will more than double, from 84 million in 1995 to 228 million in 2025.
Key Players Analysis
Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy’s Laboratories Ltd. (India), Amgen, Inc. (US), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius SE & Co. KGaA (Germany), STADA Arzneimittel AG (Germany), Boehringer Ingelheim (Germany), Gedeon Richter PLC (Hungary), Celltrion (South Korea), Samsung Biologics (South Korea), Coherus BioSciences (US), Biocon Limited (India), Viatris, Inc. (US), Amega Biotech (Argentina), Apotex, Inc. (Canada), Biocad (Russia), mAbxience (Spain), Probiomed S.A. De C.V. (Mexico), Fujifilm Kyowa Kirin Biologics Co., Ltd. (Japan), Intas Pharmaceuticals Ltd. (India), Thermex (UK), Reliance Life Sciences (India), Kashiv Biosciences (US).
Covid -19 Impact Analysis
The COVID-19 pandemic has impacted every aspect of life and business. It has emerged as a global pandemic that has affected almost all countries across the globe and disrupted various business functions around the world. A drastic change in sales channels across different industries is observed. Multiple industries are experiencing economic slowdown or decline as a result of the COVID-19 crisis. The Healthcare sector also experienced a multitude of challenges across supply chains, business and manufacturing operations. US, India, Italy, Spain, the UK, Brazil, Russia, and Germany are the most severely affected countries and have experienced a sharp rise in COVID-19 cases.
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Segmentation Insights
The global biosimilars market is segmented based on Product, Indication, and region. Based on product the market is segregated into monoclonal antibodies and subsegments (Infliximab, Trastuzumab, Rituximab, Adalimumab, Other monoclonal antibodies like bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab) and Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Recombinant, Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Enoxaparin Sodium, Glucagon, and Calcitonin. Based on Indication the market is segmented into Oncology, Inflammatory & Autoimmune Disorders, Chronic Diseases, Blood Disorders, Growth Hormone Deficiency, Infectious Diseases, and Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases).
Regional Insights
At the regional level, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America is dominating the biosimilars market this is due to the availability of advanced healthcare infrastructure, favorable research funding/grants by the government, high spending on technological innovations, presence of major market players, swift adoption of advanced technologies, and increasing prevalence of cancer and other chronic disorders. According to the American Cancer Society (ACS), around 1.8 million new instances of cancer will be diagnosed in the United States in 2020, and more than 16.9 million Americans have a history of cancer.
Cancer is the biggest cause of mortality and disease in the United States, and it not only has a huge impact on the health of patients and survivors, but it also has a huge financial impact. The U.S. is the major country-level market in the North American biosimilars market. The R&D Administration of the US government has pledged to invest USD 142.2 billion in federal R&D to achieve this critical goal. Artificial intelligence (AI), quantum information science (QIS), 5G/advanced communications, biotechnology, and advanced manufacturing are among the science and technology that the Administration is focusing on for 2021. Increasing collaboration activities by major players to expand existing portfolios and bring value to the current offering are major market growth driving factors.
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