Biosimilars Market by Types (Human growth hormone, Erythropoietin, Monoclonal antibodies, Insulin, Interferon, Granulocyte-Colony Stimulating Factor, Peptide) and Application (Blood disorders, Oncology diseases, Growth hormone deficiencies) - Global Opportunity Analysis and Industry Forecast, 2021-2028

Biosimilars Market

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.

Market Size

According to Business Intelligence Insights "Biosimilar market expected to grow from USD 16.5 Billion in 2021 to USD 46.8 Billion by 2026, at a CAGR of +23% during the forecast period of 2021 to 2028.

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.

Lockdown and travel restrictions have severely impacted overall businesses in China, India, Spain, Germany, the U.S., and many parts across the globe. Partial or complete lockdown and social distancing norms had to be imposed in manufacturing plants, R&D centers, and across other business units as well. Labor shortage, logistics, and transportation restrictions have severely affected supply chains leading to Production loss resulting in a sales decline. A similar decline in the biosimilars market was observed during the first half of the year 2020. The market is expected to recover in the fourth quarter of 2020. 

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.

However, market growth may be impeded due to factors such as complexities in manufacturing, Biosimilar development is a time-consuming and expensive procedure that necessitates large financial inputs, technological competence, clinical trial experience, scientific standards, and quality assurance methods. Biosimilar manufacturers, unlike generic drug developers, must invest in clinical trials and post-approval safety monitoring systems that are comparable to those of the original innovators. technological innovations and growing adoption of biosimilar products are expected to offer lucrative growth opportunities in the coming years for biosimilars.

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).

In terms of Application, Hematology segment hold the largest market share in the year 2021. According to the Biosimilars Council, biosimilars are priced 10% to 35% lesser than branded biological medicines, and a sum of USD 250 billion could be saved through application of biosimilars in the next decade.

Biosimilars Market Segmentation Analysis

By Product

• Monoclonal Antibodies
  • Infliximab
  • Trastuzumab
  • Rituximab
  • Adalimumab
  • Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
• Insulin
• Granulocyte Colony-Stimulating Factor
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Enoxaparin Sodium
• Glucagon
• Calcitonin

By Indication

 

• Oncology
• Inflammatory & Autoimmune Disorders
• Chronic Diseases
• Blood Disorders
• Growth Hormone Deficiency
• Infectious Diseases
• Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)

Key Players

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)

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.

Europe is the largest regional market for biosimilars. Increasing cancer and diabetes prevalence and  constant adoption of newer technologies are major attributing factors for growth of the market in the Europe region. The market in the region is primarily  led by countries like UK and Germany. Every year, roughly 375,000 new cancer cases are diagnosed in the United Kingdom, or around 1,000 every day. Every year, more than 182,000 new cancer cases in women are diagnosed in the United Kingdom. Every year, roughly 193,000 new cancer cases in men are diagnosed in the United Kingdom. 

Asia Pacific is estimated to grow at the fastest CAGR in the coming years. Asia pacific hold the largest market share and captured more than 30% of the global biosimilar market. Growing healthcare spending, increased awareness among researchers to develop in-house technologies to reduce cost, and economic development in emerging countries like India and China is expected to drive growth in this region. In the Union Budget 2021 India announced it will invest USD 30.70 billion in healthcare infrastructure.

Strategic Developments

• January 05, 2022: Amneal Acquires Saol Therapeutics’ Baclofen Franchise -  Amneal's commercial institutional and speciality portfolio in neurology will be expanded as a result of the acquisition, as well as commercial infrastructure in preparation for its debut into the biosimilar institutional market.

Table

Report Attributes	Details
Market Size Value in 2021	USD 16.5 Billion
Market Size Value in 2026	USD 46.8 Billion
Growth Rate	+23%
Base Year	2021
Forecast Period	2022-2027
Historical Data	2017-2020
Forecast Units	(USD Billion)
Countries Covered	North America: U.S and Canada Europe: Germany, France, Italy, U.K, Spain, Russia, Rest of Europe APAC: China, Japan, South Korea, India, Australia, South East Asia, Rest of Asia Pacific Latin America: Brazil, Mexico Middle East And Africa: Saudi Arab, South Africa, UAE
Segments Covered	By Types and Application and Region.
Competitive landscape	Leading companies, Competitive strategies and Consumer engagement scope
Customization is available	If our report does not contain the information you require, you can contact our experts to have segments created for you. Please contact us at sales@businessintelligence-insights.com if you have any questions.

 

Frequently Asked Questions (FAQ):