Biosimilars Market Size & Share, by Product Type (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins, Recombinant Peptides); Technology (Bioassay Technology, Recombinant DNA Technology, Monoclonal Antibody Technology); Application (Hematology, Oncology, Autoimmune Diseases) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2023-2033

Global Biosimilars Market Definition

Biosimilars are pharmaceuticals that are structurally and functionally identical to biological treatments, and they are safe and effective treatment options for a wide range of illnesses. Biosimilars, are not exact replicas of the original product despite are quite close regardless. They are produced utilizing various cell types, fermentation environments, and purification techniques. Owing to this, biosimilars differ slightly from the original product in terms of structure and content. The safety and effectiveness of the biosimilars are unaffected by these variations.

Before they are permitted for sale, biosimilars must pass stringent testing and clinical studies that show their interchangeability and resemblance with the reference product. They are also carefully examined for safety and effectiveness after receiving approval. In addition to arthritis and renal issues, biosimilars can treat cancer, and chronic bowel and skin diseases such as psoriasis, IBS, and colitis. Drugs such as these provide patients with greater accessibility to life-saving drugs at a potentially lower cost. In addition, since biosimilars are very similar to their reference biologics, they require much less research and development.

Global Biosimilars Market: Key Insights

Global Biosimilars Market Size, Forecast, and Trend Highlights Over 2023 - 2033

The global biosimilars market is estimated to garner a revenue of ~USD 209.0 billion by the end of 2033 by growing at a CAGR of ~23.0 % over the forecast period, i.e., 2023 – 2033. Further, the market generated a revenue of ~USD 18.0 billion in the year 2022. The growth of the market can primarily be attributed to the growing spending on biologics worldwide. Moreover, biologics are medications generated from live organisms that are used to treat a variety of ailments, including cancer, autoimmune disorders, and inflammations. They are often more expensive than ordinary small-molecule medications and can consume a sizable percentage of healthcare spending. It was found that, in Europe, biologics represented almost 34% of medicine spending at list prices, comprising small molecules, biologics, and biosimilar competitors.

 Biosimilars help increase access to healthcare for many as it is responsible for the reduction in the healthcare costs associated with the use of biologics. Since biosimilar drugs are a very similar copies of their reference biologics, they require much less research and development for equal efficacy and safety than their reference biologics. The recent approvals of biosimilar drugs are expected to reduce the spending on biologics, resulting in the demand for biosimilars among healthcare service providers, which in turn, is expected to create massive revenue generation opportunities for the key players operating in the global biosimilars market during the forecast period. It is estimated that biosimilars are expected to reduce direct spending on biologic drugs in the United States by ~USD 54 billion from 2017 to 2026, or around 3% of the total estimated biologic spending over the same period.

Global Biosimilars Market: Growth Drivers and Challenges

Growth Drivers

• Upsurge in the Approval Rates of Biosimilars – which now many other countries are involved in, as biosimilars are safe and effective medications for treating many illnesses and chronic conditions. The surge in the approval of these drugs worldwide is expected to drive the global biosimilar market in the forecasted period. For instance, it was found that 9 new biosimilars were approved in the European Union in 2020 and ~7 were approved in 2021.

• Growing Number of Cancer Cases – One of the biggest causes of mortality in the world is cancer, and it is predicted that there will be an increase in the number of new cancer cases. The rise in cancer incidence is driving up demand for biological medications, which are frequently used in cancer therapy. It was found that there were approximately 19 million new cancer cases registered worldwide in 2020.

• Rising Prevalence of Crohn’s disease – The global market for biosimilars is expanding owing to the increased frequency of Crohn's disease. Inflammation of the digestive system is brought on by the inflammatory bowel disorder (IBD) known as Crohn's disease. Although the precise etiology of Crohn's disease is unknown, and it is thought to be the result of a confluence of the immune system, environmental, and genetic variables. As per the data, in North America and Western Europe, ~100 to 300 per 100,000 people suffer from Crohn’s disease every year.

• Increasing Number of People Suffering from Kidney Disease – End-stage renal disease (ESRD), which necessitates dialysis or a kidney transplant, can develop from kidney disease. Moreover, Erythropoiesis-stimulating agents (ESAs), among other biologic medications, are frequently used to treat anemia in ESRD patients. The high cost of these medications, however, makes biosimilars a desirable substitute for both patients and healthcare professionals. It was estimated that worldwide over 850 million people were suffering from some form of kidney disease in 2021.

• Rising Cases of Arthritis – Inflammation in the joints is a typical symptom of arthritis, which affects millions of people worldwide. An autoimmune condition called rheumatoid arthritis (RA) damages and inflames the joints, resulting in pain and incapacity. Therefore, the escalating ratio of RA is boosting the requirement of rheumatoid arthritis treatment, which in turn estimated to drive the demand for biological medications. It is observed that in 2021 about 350 million people had arthritis globally.

Challenges

• Increasing Competition in the Market - There is intense competition in the market for both biosimilar manufacturers and originator biologic manufacturers. When new biosimilar products enter the market, the originator manufacturer may use a variety of strategies to compete with the competition, such as competitive pricing, launching second-generation products, reformulations, and improved dosing measures. Hence, such a factor is projected to impede market growth in the coming years.
• Manufacturing Process Concerns for Biosimilar Agents
• The difficulty of Generating an Exact Copy of Biosimilars and Biologics

Global Biosimilars Market Segmentation

The global biosimilars market is segmented and analyzed for demand and supply by product type segment into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. Amongst these segments, the recombinant non-glycosylated proteins segment garnered the highest market share in the year 2022, backed by the growing concern of rising incidences of diabetes along with the surge in the spread of diabetes worldwide. Furthermore, recombinant non-glycosylated proteins are used for the treatment of the diabetes, and it is predicted to boost the growth of the segment in the market. For instance, it was estimated that ~1.5 million deaths were directly caused by diabetes worldwide, it was the 9th leading cause of death in 2019.

The global biosimilars market is also segmented and analyzed for demand and supply by application into hematology, oncology, and autoimmune diseases. Amongst these segments, the oncology segment garnered the highest market share owing to the rising number of cancer cases across the globe. Moreover, biosimilars have been created and approved to deliver efficient results in breast cancer treatment, colorectal cancer treatment, and other solid tumor treatments. Chemotherapy and other cancer therapies are combined with biosimilars to increase cancer patients' chances of survival and quality of life, and it is expected to increase the segment’s growth in the market. For instance, about 18 million people were suffering from cancer globally in 2020.

Our in-depth analysis of the global biosimilars market includes the following segments:

Global Biosimilars Market Regional Synopsis

The Europe biosimilars market, amongst the market in all the other regions, is projected to hold the largest market share by the end of 2033. The growth of the market can be attributed majorly to the presence of a strong healthcare network in the region, and the growing number of hospitals and diseases. As per the reported data, nearly 10 percent of the total population in the United States were suffering from diabetes in the year 2021. Moreover, the rising awareness of biosimilars amongst the healthcare service providers, along with the surge in prescribing biosimilars, is further anticipated to drive the growth of the market in the region. Furthermore, the volume of biosimilar prescribing has generated high savings from biosimilar competition, and it is projected to drive the market’s growth in the region.

Top Featured Companies Dominating the Global Biosimilars Market

• Biocon Limited

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• SWOT Analysis

• Amgen Inc.
• Novartis AG
• Intas Pharmaceuticals Ltd.
• BioXpress Therapeutics SA
• Genor Biopharma Co. Ltd
• Allergan plc (AbbVie Inc.)
• Coherus BioSciences, Inc.
• Pfizer Inc.
• Reliance Life Sciences Private Limited