Biosimilars Market

Biosimilars Market Size (2022 to 2027)

As per our research report, the global biosimilars market size was worth USD 6.26 billion in 2022. This figure is forecasted to grow at a remarkable compound annual growth rate (CAGR) of 39.39% and reach USD 32.93 billion by 2027. 

Some of the key insights from the report:

• Based on product type, the recombinant non-glycosylated protein segment covered the significant share of the global Biosimilars market in 2021.
• Based on Technology, the recombinant DNA technology segment is predicted to grow at the highest CAGR during the forecast period.
• The North American Biosimilars market dominated globally in 2021 and is expected to be worth USD 10.91 billion by 2027.
• The Asia pacific Biosimilars market is projected to grow at the highest CAGR of  41.92% during the forecast period.

According to WHO, A biosimilar is a biological product similar to the already licensed reference biotherapeutic product similar to quality, safety, and efficacy. It is the same as the generic drug but contains a biological entity. According to the FDA, FDA-approved biosimilars have been compared to FDA-approved biosimilars, known as the reference product. Reference and biosimilar products are large and generally complex molecules produced by living organisms that are carefully monitored to ensure consistent quality. Biosimilars are copies of drugs similar to biological drugs that have already been authorized (biological reference medicine) and are similar but not identical. The Indian Guidelines define "similar biologics" as a biological product/drug produced by genetic engineering techniques and claimed to be "similar" in terms of safety, efficacy, and quality to the reference biologics authorized by the Drug Controller General of India (DCGI) for safe use in India. The main reason for the development of biosimilar drugs is the patent protection expiry for many biological medicines.

MARKET DRIVERS:

The cost-effectiveness of biosimilars and the increasing prevalence of chronic diseases drive the global biosimilars market growth.

Adalimumab (Humira) for rheumatoid arthritis and trastuzumab (Herceptin) for breast cancer are commonly used biologics. According to WHO, chronic disorders such as Diabetes prevalence have increased faster in low-and middle-income countries than in high-income countries. In 2016, an estimated 1.6 million deaths were directly due to diabetes. Another 2.2 million deaths were due to high blood glucose levels in 2012. Asthma was estimated that more than 339 million people worldwide in 2016. Cancer is the second leading cause of death globally, responsible for an estimated 9.6 million deaths in 2018. Cancer Globally causes about 1 in 6 deaths.

Increasing manufacturing by biopharmaceutical companies globally is another significant contribution to the global biosimilars market growth.

Approximately 100 biopharmaceutical companies are actively involved in developing, developing, producing, and marketing biosimilar therapeutic products in India. Rising government initiatives and FDA approval are further expected to fuel the biosimilars market's growth rate. The FDA was given the authority to approve biosimilars, including interchangeable ones, to maintain the biosimilar product's safety, efficacy, and quality.

Furthermore, biosimilars regulations are critical for ensuring the viability and balance between original and biosimilar drugs. Factors such as the rising demand for prescription drugs, especially high-priced patented drugs, contribute to the rising demand for pharmaceutical drugs. In addition, many current biological products, such as Erbitux, Avastin, and Orencia, will expire their patents, opening many innovator firms and generic vendors to provide services suited explicitly to biosimilars. The demand to cut healthcare spending, the patent expiration of numerous blockbuster products and a growing number of biosimilar drug approvals by the FDA are expected to drive biosimilars market growth. In addition, the launch of new biosimilars, strategic innovations by industry players such as alliances and collaborations, favorable research funding situation, and drug development pressure on pharmaceuticals due to impending patent expiry contribute to the market's rise.

MARKET RESTRAINTS:

Patient safety and medical efficacy are projected to hamper market growth during the assessment period. On the other hand, the high cost of comparison drugs limits the market growth by increasing the financial pressure on patients and reimbursement service providers. These high prices result from a lack of economies of scale owing to reduced demand. Furthermore, biosimilar costs are not as low as generics due to the complex biological production processes for individual biosimilars. The most expensive biologics may cost USD 50,000 a year or more. In addition, biological drugs are more complex to manufacture than generic drugs. Because it's not as easy to make a biosimilar drug as it is to make a generic version of a brand-name drug because most of the drugs are made from chemicals and have a known structure. Those mentioned above are some of the factors restraining the growth of the biosimilars market.

Impact of COVID-19 on the global biosimilars market:

The impact of COVID-19 on the Biosimilars market may be significant and has posed a major challenge to pharmaceutical companies focusing on biosimilar development. The reduced FDA approval of non-COVID therapists during the current pandemic is expected to delay product approvals and launches, hindering market growth. Also, as most clinical trials have been postponed to combat COVID-19 and minimize infection among participants, most pipeline products show a slow pace of research and development activities.

Also, due to lockdown and travel restrictions across the globe, there is a shortage of supply chains and raw materials that would impact biosimilar production. Thus, due to the factors mentioned above, COVID-19 significantly impacts the market under study. Furthermore, in the coming decade, there would be an increase in the patent expiry of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovative companies and generic manufacturers to offer services tailored specifically to biosimilars. Also, factors such as the cost-effective nature of biosimilars, increasing acceptance and acceptance by various stakeholders in need of diversification of Technology and business models, and the growing prevalence of chronic diseases are expected to drive the global biosimilars market.

REPORT COVERAGE:

The global biosimilars market research report has been 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

The Recombinant non-glycosylated protein product type holds a significant share of the global biosimilars market based on the product type. Globally, an increase in the development rate of insulin and growth hormone products is boosting market growth. In addition, the market for biosimilars is expected to grow in response to rising cancer incidences. During the forecast period, the Recombinant Glycosylated Protein segment is expected to proliferate. Due to patent expiration, biological drugs such as erythropoietin and monoclonal antibodies are predicted to develop this category.

Biosimilars Market - By Technology:

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

Based on Technology, recombinant DNA technology is the most lucrative segment among all. It is estimated to register a healthy growth rate during the forecast period and is responsible for developing biosimilar drugs such as human growth hormones, insulin, and erythropoietin. In addition, the bio-ability similar to curing diseases quickly and effectively is enhanced by advanced Technology.

During the projected period, monoclonal antibody technology is expected to rise at a 30.0 percent CAGR. The number of monoclonal antibodies used for cancer and autoimmune disorders have resulted in the rapid development of monoclonal antibody technology's, propelling the market forward.

Biosimilars Market - By Disease:

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

Based on the disease, oncology disease dominated the market. Owing to the increased availability of lower-cost biosimilar drugs to treat cancer, the Oncology market leads with the largest share of the global biosimilars market. In addition, factors such as drug clearance for various categories of medications in this section are leading. One of the major factors driving the growth of this oncology disease sector is the many oncology drugs available in the cancer care market.

On the other hand, a blood disorder is anticipated to witness significant growth during the forecast period. With delivering earnings, the blood disorders segment is likely to develop. Common diseases such as anemia and hemophilia and promising outcomes from ongoing clinical trials are some factors driving the market growth.

Biosimilars Market - By Region:

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

In 2020, North America held the largest share of the global biosimilars market. It is due to the acceptance of the advanced technologies coming into the market in this region. In addition, introducing various drugs and products that receive approval from the FDA is expanding the market growth in this region.

Europe region, followed by North America, is influencing the market growth during the period due to the increase in constructional activities on healthcare centers for proper patient care.

The Asia-Pacific biosimilars market has been the quickest region in recent and upcoming years. The area will hit the industry with a CAGR value during the period. The growing annual income of a person per annum in developing countries is accelerating the growth of the biosimilars market.

The Latin American Biosimilars Market size is predicted to grow from USD 1.21 billion in 2021 and is estimated at a CAGR of 29.68%. The Latin American market is driven by factors including the increasing prevalence of chronic disorders like cancer and diabetes, complementing the growing demand for pharmaceutical drugs and exceedingly high-priced proprietary medicines.

The MEA Biosimilars Market is forecasted to grow from USD 2.17 billion by 2026 at a CAGR of 24.96% from 2021 to 2026. Rising demand to increase the number of research centers in developed countries elevates the market's growth rate in this region.

KEY MARKET PARTICIPANTS:

Some of the promising companies dominating the global biosimilars market profiled in the report are Sandoz International GmbH, Wockhardt Ltd, Hospira, Inc., Teva Pharmaceutical Industries Reddy's Laboratories, Biocon Limited, Mylan, Inc., Zydus Cadila, Celltrion Inc., Roche Diagnostics, and Cipla Ltd. Global industry players are engaging in corporate investments, partnerships, and mergers to maintain their market positions.

RECENT MARKET DEVELOPMENTS:

• The FDA approved Fujifilm Kyowa Kirin Biologics' adalimumab biosimilar Hulio in July 2020 for the subcutaneous treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.
• In April 2020, Pfizer planned to launch two additional biosimilars in the United States. Their commitment to developing biosimilars is extraordinary amid the COVID-19 pandemic, where the focus has turned to Coronavirus medicine and vaccine development.
• The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) both approved Fresenius Kabi's regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) in May 2020.