Biosimilars Market Outlook 2031
The Global Biosimilars market size was valued at USD 35 Billion in 2022 and is likely reach to USD 105.14 Billion by 2031, expanding at a CAGR of 13% during the forecast period, 2023-2031. The market growth is attributed to high increase in incidence of chronic diseases that include cancer, anemia, diabetes, and deficiency of growth hormones along with wide availability of cost-effective biosimilar drugs.
Biosimilars are drugs that are similar to the biologic drugs that are already approved. The approval of biosimilars is performed and done as per the standards of pharmaceutical quality. They possess the quality, efficacy, and safety that are identical or similar to biologic drugs. Approximately 14 million people were diagnosed with cancer and around 8.2 million deaths were registered due to cancer globally in 2012.
As the patents for pharmaceutical drugs are of high cost, the total healthcare cost also increases. Therefore, it is emphasized by governments of various countries to opt for the synthesis of cost-efficient drugs.
The US, which has the highest expenditure for healthcare, has recently emphasized to cut down the expenditures for healthcare. Not only the US, Japan and India also regulated the price for healthcare and reduced the budget for healthcare.
In order to maintain the effectiveness and the safety of the drugs, some guidelines have been imposed by several regulatory authorities. These regulatory authorities include U.S Food and Drug Administration (FDA), European Medicine Agency, and China Food and Drug Administration.
The outbreak of COVID-19 has a great impact on the global biosimilars market as the process of approval and launch of products are delayed due to the reduction in the approval of non-COVID-19 therapies by regulatory bodies.
The process of research and development has been also slowed down along with trials in order to reduce the spread of infection among the participants. The production of biosimilars is hindered as there is a shortage of raw materials and supply chain due to lockdown and restrictions imposed on travel across the world as per the COVID-19 guidelines to ensure safety.
Market Trends, Drivers, Restraints, and Opportunities
- High demand for biosimilar drugs as these drugs are cost-effective when compared to biologic drugs, which prove to be a key driving factor of the market.
- Increasing investment on continuous research and development activities for the development of the drugs is expected to fuel the growth of the market.
- Number of initiatives taken by governments across countries in order to reduce the expenditure of healthcare is anticipated to boost the growth of the market.
- Strict and binding rules & regulations enforced by regulatory bodies to develop and produce biosimilars are key challenges expected to restrain the market growth.
- Complex process of manufacturing biosimilars and need for a very high investment are key factors hindering the growth of the market.
Scope of Biosimilars Market Report
The report on the global biosimilars market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Biosimilars Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
Products (Recombinant Non-Glycosylated Proteins [Human Growth Hormones, Interferons, Granulocyte Colony-Stimulating Factor, and Insulin] and Recombinant Glycosylated Proteins [Follitropin, Monoclonal Antibodies, and Erythropoietin]) and Applications (Blood Disorder, Chronic & Autoimmune Disorder, Oncology, Growth Hormonal Deficiency, and Others)
Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast
Key Players Covered in the Report
Amgen Inc.; F. Hoffmann-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories Ltd.; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Samsung Bioepis; Biocon; and Mylan N.V.
Biosimilars Market Segment Insights
Recombinant glycosylated proteins segment to expand at an impressive CAGR
On the basis of products, the global biosimilars market is divided into recombinant non-glycosylated proteins and recombinant glycosylated proteins.
The recombinant non-glycosylated proteins segment is further divided into human growth hormones, interferons, granulocyte colony-stimulating factor, and insulin, while the recombinant glycosylated proteins segment is sub-divided into follitropin, monoclonal antibodies, and erythropoietin.
The recombinant non-glycosylated proteins segment held a major revenue share of the market in 2019 owing to increase in regulatory approvals and rise in prevalence of chronic diseases. Three new drugs named Terrosa (teriparatide biosimilar), Movymia, and Lusduna (insulin glargine biosimilar) were launched by the European Medicines Agency in November 2016.
As per the reports by the Centers for Disease Control and Prevention (CDC) published in 2016, 29 million individuals are suffering from diabetes in the U.S. and the reports by the Canadian Diabetes Association suggest that 5 million people are expected to be diagnosed with diabetes in Canada by 2025.
On the other hand, the recombinant glycosylated proteins segment is anticipated to expand at an impressive CAGR during the forecast period owing to patent cliff of biological products such as monoclonal antibodies and erythropoietin.
For example, the European Medicines Agency and the US FDA approved Roche’s Actemra/RoActemra (tocilizumab) in the year 2009 and 2010 respectively. The patents for these drugs expired in December 2015 for the US and April 2017 for Europe.
Biosimilars are high in demand in European countries such as France, the UK, and Germany as the market conditions are favorable and numerous biopharmaceuticals companies are present there with better regulatory frameworks as compared to other countries.
Blood disorder is expected to grow at a rapid pace
Based on applications, the market is segmented into blood disorder, chronic and autoimmune disorder, oncology, growth hormonal deficiency, and others. The market was dominated by the oncology segment in 2019 owing to an increase in the number of cancer cases including blood cancer, lung cancer, breast cancer, stomach cancer, and colorectal cancer.
According to a report by World Health Organizations, approximately 8.8 million were the victims of cancer in 2015, which makes it the second leading cause for healthcare deaths globally.
The major fact responsible for the high death rate in low to middle income countries is due to unavailability of advanced healthcare systems and high cost of drugs.
However, the blood disorder segment is expected to grow at a rapid pace over the forecast period owing to an increase in the incidence of blood clots, hemophilia, anemia, and other blood disorders and positive impact of ongoing trials for biosimilars.
In the market, countries such as India, China, and the UK held together a large share due to increasing tries to lower the expenditures for healthcare, governments’ supports, and others.
Biosimilars Market Regional Outlook
North America is anticipated to register a fast CAGR
In terms of regions, the global biosimilars market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. Europe held a major share of the market in terms of revenue in 2020 due to well-developed healthcare and favorable regulatory frameworks for biosimilars.
The presence of some major biopharmaceutical companies including GlaxoSmithKline, Sanofi, Novartis, Merck, and AstraZeneca in the region presents a key driving factor for the market growth.
Along with Europe, Asia Pacific is projected to account for a large market share in the coming years owing to an increase in the incidence of chronic diseases and an increase in demand for therapies that are cost-effective.
Countries such as South Korea, India, and China are primarily focusing on the development of products that are more effective and less expense at the same time.
However, the market in North America is anticipated to register a fast CAGR owing to an increase in efforts of developing advanced products made by manufacturers in both Canada and the US. The first biosimilar product, Zarxio (filgrastim-sndz), which was approved by the FDA in March 2015.
- Recombinant Non-Glycosylated Proteins
- Human Growth Hormones
- Granulocyte Colony-stimulating Factor
- Recombinant Glycosylated Proteins
- Monoclonal Antibodies
- Blood Disorder
- Chronic & Autoimmune Disorder
- Growth Hormonal Deficiency
- Asia Pacific
- North America
- Latin America
- Middle East & Africa
Key players competing in the global biosimilar market are Amgen Inc.; F. Hoffmann-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories Ltd.; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Samsung Bioepis; Biocon; and Mylan N.V.
Many of these players have adopted business strategies such as the development of new drugs, introducing new technology, merger, partnership, and production capacity expansion to increase their market position and expand their consumer base globally.
For example, a strategic partnership was established by Teva Pharmaceutical Industries Ltd. and Celltrion Healthcare in October 2016 in order to commercialize CT-P6 and CT-P10 in Canada and the US.