Biosimilars Market

Biosimilars Market Size (2023 to 2028)

As per our research report, the global biosimilars market size was worth USD 8.72 billion in 2023. This figure is forecasted to grow at a remarkable compound annual growth rate (CAGR) of 39.39% and reach USD 45.91 billion by 2028. 

Biosimilars Market Share Insights:

• Based on product type, the recombinant non-glycosylated protein segment accounted for the major share of the global biosimilars market in 2022.
• Based on technology, the recombinant DNA technology segment held the leading share of the worldwide market in 2022.
• North America had the major share of the global market in 2022.
• The APAC region captured the leading share of the worldwide market in 2021 and is expected to grow at the highest CAGR during the forecast period among all regions.

Biosimilars were introduced in the early 1990s and are unlike generic drugs. Around 59 in the United Kingdom and 19 biosimilar products in the United States have received approval from the FDA by April 2019. Currently, over 1040 biosimilars are operating in the biopharma R&D pipeline. Drug-related authorities such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada monitor biosimilar products' quality and safety. In addition, they have their guidance of requirements for demonstration. According to the Biologics Price Competition and Innovation (BPCI) Act - FDA 351(k) is the pathway for the approval of biosimilars. But the first approval happened in 2015 for Sandoz Zarxio in the United States. On Jan 2018, the Food and Drug Administration in the United States introduced a Biosimilar Action Plan (BAP), which promotes and protects public health services.

Impact of COVID-19 on the biosimilars market:

The COVID-19 pandemic has shown a severe negative impact on the global biosimilars market and offered new opportunities to market participants. The global biosimilars market has been growing steadily over the last few years and the recent COVID-19 pandemic has caused disruptions in the global supply chains and regulatory processes that affected the production and availability of biosimilars and eventually resulted negatively in the growth of the biosimilars market. To curb the impact of the COVID-19 pandemic, several governments worldwide have imposed restrictions such as travel bans and borders closure and these have impacted the availability of raw materials required to produce biosimilars. Such factors resulted in the shortage of certain biosimilar drugs and delays in production activities and impacted the market growth negatively. On the other hand, the COVID-19 pandemic has boosted the demand for biosimilar drugs. There is increased pressure on the healthcare systems and the need to reduce healthcare costs and affordable alternatives to biological drugs had been growing continuously this has created a greater need for biosimilars that can provide the same benefits at a lower cost and offer opportunities to the market participants of biosimilars.

MARKET DRIVERS:

The cost-effective nature of biosimilars majorly drives global biosimilars market growth.

Compared to biologics and various government cost-saving initiatives, the low cost of biosimilars is a significant factor fuelling the biosimilars market growth. Several factors, such as patent expiration of biological drugs and low-price cost-saving initiatives by the governments, are also fuelling the growth of the biosimilars market. Furthermore, the rise in the scale of pharmaceutical companies and the growing prevalence of improving the quality of drugs are promoting the market’s growth rate. In addition, increasing focus on introducing medications with the latest technology and the growing number of new-entry level biosimilar manufacturers are also accelerating.

Patents of several drugs have expired, and many drugs expect to lose patent protection in the upcoming years, which is expected to favor the biosimilars market growth. In addition, the growing acceptance and adoption by various stakeholders, the need for diversity in technology and business models, and the growing commonness of chronic diseases propel the market growth.

Furthermore, the emergence of advanced technologies and the launch of innovative techniques in manufacturing drugs, and the increasing demand for proper diabetic health management treatment are a few of the other significant areas offering scope for the biosimilars market to excel further. In addition, the rise in awareness over the availability of various products and increasing initiatives by the government through campaigns in undeveloped countries is significantly helping the market to achieve new heights in the biosimilars market growth.

MARKET RESTRAINTS:

The stringent regulatory environment for biosimilars is majorly hampering the market growth. Limited therapeutic areas of biosimilars act as an impediment to the growth of the biosimilars market. Currently, biosimilars are only available for diseases such as cancer, autoimmune diseases, and diabetes. Compared to generic drugs, biosimilars have complex and lengthy regulatory processes for approvals due to the complexity involved in the manufacturing of the biosimilars and this can result in growing costs and delays that can discourage the market participants from investing significant amounts in the innovation of biosimilars. Unfavorable reimbursement policies for biosimilars are further hindering the market growth. Poor acceptance from physicians and patients for biosimilars due to concerns about the safety and efficacy of biosimilars is limiting the adoption of biosimilars and inhibiting the market’s growth rate. The scarcity of people with the technical expertise to handle the equipment used for manufacturing biosimilars is showcasing a negative impact on the biosimilars market growth. Lack of awareness among healthcare providers, patients, and payers regarding the benefits and safety of biosimilars and intellectual property issues are further notable obstacles to the growth of the global biosimilars market.

REPORT COVERAGE:

The global biosimilar market is segmented and sub-segmented into product type, technology, disease, and end-user.

Biosimilars Market - By Product Type:

• Protein
• Insulin
• Human Growth Hormones
• Granulocyte Colony-stimulating Factor (G-CSF)
• Interferons
• Recombinant Glycosylated Proteins
• Erythropoietin
• Monoclonal Antibodies
• Follitropin
• Recombinant Peptides
• Glucagon

Based on the product type, the recombinant non-glycosylated protein segment accounted for the major share of the global biosimilar market in 2022 and is expected to register a healthy CAGR in the coming years. The segment's growth can be attributed to the growing production rate of insulin and growth hormone drugs globally. In addition, the growing prevalence of cancer is favoring segmental growth. Therefore, the Recombinant Glycosylated Proteins segment will likely witness a high CAGR value during the forecast period. Furthermore, the patent expiration of biological drugs such as erythropoietin and monoclonal antibodies is expected for the growth of this segment during the forecast period.

Biosimilars Market - By Technology:

• Mass Spectroscopy
• Chromatography
• Monoclonal Antibody Technology
• Recombinant DNA Technology
• Nuclear Magnetic resonance (NMR) technology
• Electrophoresis
• Bioassay

Based on technology, the recombinant DNA technology segment is estimated to lead the biosimilars market during the forecast period. Biosimilar products such as human growth hormones, insulin, and erythropoietin are manufactured using this segment. The advanced technologies help intensify the biosimilar's ability to treat diseases instantly and efficiently.

Biosimilars Market - By Disease:

• Oncology Diseases
• Blood Disorders
• Growth hormone deficiencies
• Chronic and autoimmune diseases
• Others

Based on disease, the oncology segment led the market and held a significant share of the global biosimilars market in 2022 and is anticipated to continue dominating the market during the forecast period owing to the increase in obtaining less-cost bio-similar drugs for the treatment of cancer. Furthermore, this segment is leading due to the factors like the approval for different types of drugs, and the massive number of oncology products in the stream of cancer treatment is one of the significant factors that make this oncology disease segment proliferate.

On the other hand, the blood disorders segment is likely to grow at a healthy CAGR during the forecast period. Diseases such as anemia and hemophilia and the positive results of ongoing clinical trials contribute to segmental growth.

Biosimilars Market - By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa

In 2021, the North American biosimilars market held the largest share of the worldwide market, and the region's domination is likely to continue during the forecast period. The growing acceptance of advanced technologies primarily drives regional market growth. In addition, introducing various drugs and products that receive approval from the FDA is expanding the market growth in this region. The U.S. occupied the major share of the North American market in 2021, followed by Canada. The U.S. biosimilars market growth is primarily driven by the growing patient population, increasing healthcare spending and a well-established regulatory environment. The Canadian market is predicted to witness a notable CAGR during the forecast period due to the increasing patient population suffering from chronic diseases and rising demand for cost-effective treatment options.

The Asia-Pacific biosimilars market is one of the potential regions worldwide and is estimated to grow at the fastest CAGR during the forecast period. In developing countries, the growing disposable income is accelerating the biosimilars market growth in APAC. The rising aging population and the increasing population suffering from cancer, diabetes and autoimmune diseases are propelling the APAC clinical nutrition market growth. Increasing demand for cost-effective treatment options in developing countries such as India, China and Japan is fuelling the growth rate of the APAC market. Countries such as South Korea and Japan are expected to showcase a notable CAGR during the forecast period due to the favorable regulatory environment for biosimilars and increasing number of biosimilar launches in these countries.

The European biosimilar market is predicted to showcase a promising CAGR due to increased construction activities in healthcare centers to provide proper patient care. The UK, Germany and France held a major share of the European market in 2021 and the trend is expected to continue throughout the forecast period. The expiration of patents for several biologic drugs, and the support of regulatory authorities for the development and approval of biosimilars are primarily boosting the European market growth. The rising adoption of biosimilars by healthcare providers and patients owing to their cost-effectiveness and efficacy biosimilars is further promoting the growth of the European market.

The Latin American biosimilars market is projected to hold a considerable share of the worldwide market in the coming years. Factors such as increasing healthcare spending and growing number of initiatives by Latin American countries are favoring the Latin American biosimilars market growth. Countries such as Brazil and Mexico captured a major share of the Latin American market in 2021.

The MEA biosimilars market is anticipated to grow at a moderate CAGR during the forecast period.

KEY MARKET PLAYERS:

Sandoz International GmbH, Wockhardt Ltd, Hospira, Inc., Teva Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories, Biocon Limited, Mylan, Inc., Zydus Cadila, Celltrion Inc., Roche Diagnostics and Cipla Ltd are some of the notable players in the Latin American biosimilars market.

RECENT HAPPENINGS IN THIS MARKET:

• In May 2020, Dr. Reddy Laboratories received approval for ELYXYB by FDA, which is for patients with migraine in adults with or without aura and is the most successful migraine treatment.
• In March 2020, Teva pharmaceuticals and Celltrion joined and launched the fourth biosimilar trastuzumab of Herzuma. This bio-similar is available in the form of an injection commonly used by patients with breast cancer.
• In February 2020, Dr.Reddy’s laboratories acquired Wockhardt assets. Dr. Reddy’s stated that the deal would include treatments like respiratory, neurology, pain, and vaccines. This acquisition will help the company to increase its business across domestic countries.
• In December 2019, Mylan and Biocon companies introduced a new drug called Ovigri, a biosimilar to Herceptin. The FDA approved it for the patients to provide dosage and flexible treatment for those with breast cancer and stomach cancer like gastric or gastroesophageal. It is available in two types of dosages 420 mg multi-dose and 150mg single use.
• In November 2019, Teva pharmaceuticals and Celltrion, both companies, united and announced the TRUXIMA injection for patients with non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukaemia (CLL) in adults.
• In November 2019, Sandoz received FDA approval for its new drug related to its oncology care biosimilar Ziextenzo TM. This drug reduces the occurrence of febrile neutropenia, the most significant adverse effect of chemotherapy which is one of the cancer treatments.
• In July 2019, Cipla and Alvotech partnered and introduced a new AVTO2 biosimilar to HUMIRA. This drug treats autoimmune diseases like Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, and so on.
• In July 2019, Celltrion and Nan Fung integrated to confirm Vcell Healthcare Limited to develop and market bio-similar in China. This bio-similar had approval from the US FDA and EMA, where these products were Celltrion CT-P13 and CT-P10.
• In June 2019, the FDA approved Amgen’s Knajinti, the 5th bio-similar for Roche’s Herceptin (trastuzumab) and the 20th bio-similar.
• In May 2018, Pfizer received approval from the FDA for RETACRIT, a biosimilar for Epogen and Procrit. It is the first biosimilar approved in the U.S. This Retacrit is used for patients with anemia and decreases red blood cell transfusion with growing access to low-cost alternative treatment.
• In January 2018, Biocon joined Swiss pharma Sandoz to develop and manufacture multiple bio-similar patients with immunology and oncology. This partnership aims to boost the ability to end bio-similar and share the cost and profit.
• In January 2018, Dr. Reddy’s laboratories partnered with Turkish to develop and commercialize three bio-similar products based on the drug substance and product.
• In February 2016, Sandoz obtained Pfizer’s bio-similar Infliximab to widen its portfolio of bio-similar. Infliximab is a tumor necrosis factor-alpha that treats autoimmune diseases, including psoriasis and arthritis.
• In January 2016, Mylan publicly stated that it would integrate with Momenta to develop six bio-similar products. This integration is to develop bio-similar products and release them into the market.
• In February 2015, Pfizer stated that it would obtain Hospira for $17 billion to increase and confirm the drug business to develop sterile injectables within Pfizer’s pharma industry.