Pune, Feb. 28, 2023 (GLOBE NEWSWIRE) -- According to Market.us, the global biosimilars market accounted for USD 9.5 billion in 2022 and is projected to reach USD 34.4 billion by 2032, exhibiting a CAGR of 14.1% in the forecast period (2023-2032). Market growth has been positively affected by the rapid upgradation of existing pharmacies and their expansion to increase market penetration.
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Key Takeaway:
- By product type, the monoclonal antibodies segment dominated the market in 2022 because of increasing incidences of cancer, rheumatoid arthritis, multiple sclerosis, and cardiovascular diseases.
- By application, the oncology segment dominates the market as the number of cancer patients is on the rise.
- In 2022, Europe dominated the market with the highest revenue share of 33.8%.
- Asia-Pacific is expected to grow at the highest CAGR between 2023-2032 due to the rapid growth in the pharmaceutical industry in the region.
The rising incidences of chronic diseases and increased demand for biosimilars because of their cost-effectiveness are mainly driving market growth. Global market growth is also driven by regulatory approvals and other regulations that favor biosimilar adoption in various countries. This market will be constrained by the complexity of manufacturing biosimilars as well as resistance from reference biologic producers.
Factors affecting the growth of the biosimilars industry?
Several factors can affect the growth of the biosimilars industry. Some of these factors include:
- Increasing geriatric population: The Increasing geriatric population increases the possibility of disorders which helps the market positively.
- Rising chronic diseases: The increasing incidences of chronic diseases like cancer, rheumatoid arthritis, multiple sclerosis, and cardiovascular diseases, etc., are affecting the market's growth positively.
- Unhealthy habits: Long working hours, improper diet, and insufficient sleep are responsible for decreasing immunity and creating more disease possibilities, which helps the market grow.
- Research and Development: The major players are focusing on the R&D and development of drugs fueling the market's growth positively.
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Top Trends in Global Biosimilars Market
There are new opportunities in the market because 83% of global sales are made by the top 25 biologics. Biosimilars introduced to the market are highly effective and powerful, taking advantage of expiring patents. Due to the rising incidence of chronic diseases such as cancer and rheumatoid, the drugs will be more popular in the market. They are cost-effective too. For example, it is seen that Amgen drug Neulasta, used to treat neutropenia, is more costly than US$ 10,000 per ml, while its biosimilar Ziextenzo is less expensive at US$ 6,500 per ml, which represents 37% savings.
Problems can arise from manufacturing variations that are identical to the reference product. Regulators may require preclinical or clinical evidence to show that manufacturing did not affect product safety and effectiveness. Biosimilar producers must compete with other biosimilar producers, the original biologic producer, and the generic drug manufacturer. As new biosimilar products are introduced to the market, the initial biologic company will be able to launch reformulated pharmaceuticals as well as second-generation treatments. In addition, they will be able to compete with the original biologic business. Biosimilar is still perceived by physicians as undesirable, which can have an impact on their prescriptions. Biosimilars are also restricted due to patent extensions and lower prices than generic drugs.
Market Growth
The market for insulin biosimilars is growing due to an increase in diabetes incidence. Patients with diabetes can choose to have biosimilar insulin analogs, which is a cost-effective solution. The biosimilars market is also growing due to recent product approvals from respective authorities. The market will grow due to favorable government policies, new product launches, and regulatory approvals.
Regional Analysis
Europe is expected to continue its dominance over the forecast period. The emergence of market leaders, strong product pipelines, and rising product approvals positively influences the market growth. North America will experience a promising CAGR over the next few years. Market growth in this region is being driven by factors such as the rapid adoption of the biosimilar, rising cases of cancer, numerous market players, and large investments in the research & development of biosimilars.
Competitive Landscape
Binocit, abseamed, and epoetin-hexal are the major players in this market. Factory gate is the market's value, which refers to the value of goods sold by the creator or manufacturer of the goods to any entity (including downstream producers and wholesalers) or directly to customers. This market also includes related services that are sold to the producers of the goods. Due to the presence of many local businesses, the market is somewhat fragmented. These market players are looking to expand their market share by investing, acquisitions, mergers, and acquisitions. Companies spend money to develop better products. Companies also place great importance on pricing. Different strategies, such as mergers, acquisitions, and government policies, facilitate market growth as well as open up lucrative opportunities for market players.
Mojor Key Market Players of Biosimilars Market
- Novartis AG
- Amgen Inc.
- Pfizer Inc.
- Viatris Inc.
- Eli Lilly and Company
- Synthon Pharmaceuticals Inc.
- Teva Pharmaceutical Industries Ltd.
- LG Chem Life Sciences Innovation Center, Inc.
- Celltrion Healthcare
- Biocon Biologics Ltd.
- Coherus Biosciences, Inc.
- Bio-Thera Solutions
- Intas Pharmaceuticals Ltd.
- F. Hoffmann-La Roche Ltd.
- Samsung Bioepis Co.
- Merck Serono
- Biogen Idec Inc.
- Genentech, Inc.
- Other Key Players
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Scope of the Report
| Report Attribute | Details |
| Market Value (2022) | USD 9.5 Billion |
| Market Size (2032) | USD 34.4 billion |
| CAGR (from 2023 to 2032) | 14.1% |
| Europe Revenue Share | 33.8% |
| Historic Period | 2016 to 2022 |
| Base Year | 2022 |
| Forecast Year | 2023 to 2032 |
Market Drivers
Biological drugs are the result of cutting-edge research. These discoveries could open the door to new treatments that offer more options for patients. The development of personalized treatments has been possible due to a better understanding of the disease's genetic and molecular bases. Recombinant proteins, for example, aid the immune system in identifying foreign molecules and binding them. Due to the drop in productivity in small-molecule therapeutic R&D, biologics will continue expanding rapidly.
Due to the rising prevalence of chronic diseases such as asthma, arthritis, cancer, and other conditions, biosimilars will continue to gain popularity. Biosimilars are increasingly being used to treat chronic conditions caused by unhealthy habits such as poor eating habits, long working hours, and restricted physical activity. They can increase the immune system's response to cancer cells and help the immune system eliminate them. According to a United Nations report, 70% of global deaths from chronic diseases are expected by 2030. The burden of chronic diseases worldwide is expected to increase to 60%. As a result, biosimilars are expected to be in demand.
Market Restraints
Because primary care physicians and specialists are not aware of the biosimilar, the market for biosimilars isn't growing to its full potential. Biosimilars are cell-line-based and offer the same efficacy and safety as biologics. The chances of prescribing biosimilars to patients can be reduced if there is not enough information. This can impact the market negatively. PwC's Health Research Institute found that 55% of 442 doctors were unfamiliar with biosimilars, and 35% were reluctant to prescribe them due to concerns about follow-on biologics. A lack of knowledge by primary care physicians regarding biosimilars is limiting the market growth.
Generic drugs are often 40% to 50% less expensive than branded and biologics pharmaceuticals. Biosimilars are 15% to 20% cheaper than biologics. This is due to high development and clinical testing costs, as well as high investments in resources. Generic drugs require less modification which makes them more affordable and easier to manufacture. Generic drugs can be developed at the cost of approximately US$ 2-3 million. Biosimilars can be more costly. According to Springer Link's 2021 report, it costs US$ 100 million to US$ 200 million to develop and approve a biosimilar. This is significantly more than the cost of developing generic drugs, which can run from US$1 million to US$ 6 million. The development of biosimilars can take between five and nine years, while the development process for generic drugs takes around two years. Both investors and manufacturers will be disappointed by the length of this time. This will likely slow down the market's growth for the forecast period. Due to these factors and limited information on efficiency, the US market is seeing a slower growth rate.
Market Opportunities
Increasing research and development activities are enabling market growth. The large investments in R&D made by biopharma and pharmaceutical companies are driving the market growth. They are focusing on research and development to drive the long-term growth of the market. They are looking to partner and collaborate with other companies in order to gain a competitive edge in the market and expand their product ranges. Biotechnology is experiencing significant growth.
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Report Segmentation of the Biosimilars Market
Product Type Insight
The monoclonal antibody was the dominant product on the market based on type. It accounted for the largest revenue share. It is expected that it will continue to be the dominant product in the market over the next few years. Monoclonal antibodies are used to treat cancer, rheumatoid arthritis, multiple sclerosis, cardiovascular disease, and other conditions. It can be used to target infected cells and treat cancer. The erythropoietin market is expected to experience a promising CAGR over the next few years. It is responsible for the production of RBC. It can be used to treat anemia and kidney-related conditions. It is expected that it will continue to grow over the forecast period.
Biosimilars are available at lower prices, and the cancer rate is rising. According to the International Agency for Research on Cancer, there were 10.3 million cancer deaths and approximately 19.3 million cancer cases in 2020. Breast cancer is on the rise in women, accounting for 11.7% of all new cases. Lung cancer accounted for 11.4% of all new cases, while colorectal (and colorectal) cancers accounted for 10.0%. Therefore, this market is seeing a boom in biosimilar treatments for cancer.
Application Insight
The most popular market for biosimilars was oncology, with the highest revenue share. It is expected that it will continue to dominate the market in the coming years. The Increasing Prevalence of cancer and the aging population are the main drivers of market growth. The increasing incidence of breast carcinoma is another driver of market growth. This segment is experiencing rapid growth due to the increasing demand for biosimilars for cancer treatment. Over the next few years, it is possible to expect a promising CAGR in hormonal deficiencies. This is due to an increasing number of children suffering from growth hormone deficiencies.
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Biosimilars Market Segmentation
By Product Type
- Monoclonal Antibodies
- Recombinant Hormones
- Immunomodulators
- Anti-inflammatory Agents
- Other Types
By Application
- Blood Disorders
- Growth Hormonal Deficiency
- Chronic and Autoimmune Disorders
- Oncology
- Other Applications
By Geography
- North America
- The US
- Canada
- Mexico
- Western Europe
- Germany
- France
- The UK
- Spain
- Italy
- Portugal
- Ireland
- Austria
- Switzerland
- Benelux
- Nordic
- Rest of Western Europe
- Eastern Europe
- Russia
- Poland
- The Czech Republic
- Greece
- Rest of Eastern Europe
- APAC
- China
- Japan
- South Korea
- India
- Australia & New Zealand
- Indonesia
- Malaysia
- Philippines
- Singapore
- Thailand
- Vietnam
- Rest of APAC
- Latin America
- Brazil
- Colombia
- Chile
- Argentina
- Costa Rica
- Rest of Latin America
- Middle East & Africa
- Algeria
- Egypt
- Israel
- Kuwait
- Nigeria
- Saudi Arabia
- South Africa
- Turkey
- United Arab Emirates
- Rest of MEA
Recent Development of the Biosimilars Market
- Biocon Ltd. (specifically Biocon Biologics) has formed a partnership to table SEMGLEE, the first interchangeable biosimilar insulin-glargine injection for diabetes treatment. The US FDA approved this biosimilar in July 2021.
- Novartis AG (Sandoz), in 2021, signed an agreement for China's Bio-Thera Solution to commercialize BAT1706 (i.e., Bevacizumab has been proposed in many countries as a biosimilar to the drug.
- The US FDA approved Coherus Biosciences Inc. for "YUSIMRY" in 2021. It is used to treat psoriatic, rheumatoid, and psoriatic joint pains, psoriasis and ankylosing and ankylosing, spondylitis and juvenile idiopathic conditions, Crohn's disease, and psoriatica.
- Viatris Inc. and Biocon Biologics announced Abevmy's launch in Canada in May, a drug that is a biosimilar to Avastin.
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