According to Vision Research Reports, the global biosimilar contract manufacturing market was valued at USD 5.5 billion in 2021 and it is predicted to surpass around USD 25.9 billion by 2030 with a CAGR of 18.79% from 2022 to 2030.
According to Vision Research Reports, the global biosimilar contract manufacturing market was valued at USD 5.5 billion in 2021 and it is predicted to surpass around USD 25.9 billion by 2030 with a CAGR of 18.79% from 2022 to 2030.
Report Highlights
- The recombinant non-glycosylated proteins segment held the largest share of more than 55.2% of the overall revenue in 2021.
- The mammalian segment accounted for the largest revenue share of more than 71.6% in 2021. The segment is expected to witness a significant CAGR during the forecast period.
- The oncology segment is expected to grow at the fastest CAGR of 19.84% during the forecast.
- The Europe region dominated the global industry in 2021 and accounted for the largest share of more than 47.08%.
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Growing demand for low-cost therapeutics and the increasing prevalence of diseases, such as cancer, autoimmune disorders, blood disorders, and other diseases are the major factors driving the industry. In recent years, the approvals for biosimilar drugs have increased. For instance, in August 2022, the U.S. FDA approved Coherus’ drug Cimerli as an interchangeable biosimilar for Lucentis.
This biosimilar is used in treating ophthalmology conditions, such as Diabetic Macular Edema (DME), Macular Edema following Retinal Vein Occlusion (RVO), Neovascular (wet) Age-Related Macular Degeneration (AMD) Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV). A growing number of biosimilar approvals are expected to profit the industry post-pandemic. There has been a rise in the number of biologics losing patents. For instance, biologics, such as Humira, Eylea, Keytruda, Stelara, Revlimid, and Eliquis, are expected to lose patents by 2030. The growing number of biologics losing patents is expected to promote the demand for biosimilars, thus promoting industry growth.
A significant number of small- and medium-sized biopharmaceutical companies lack infrastructure for manufacturing biosimilars. Furthermore, big pharmaceutical companies try to focus on their core competencies, such as research and marketing, owing to which they outsource manufacturing services. Such factors are further expected to promote industry growth to a great extent. Cancer is one of the major causes of death worldwide. The estimates of Cancer Tomorrow state that cancer is expected to affect 30.2 million people by 2040. The rising burden of the disease and the high cost of drugs are expected to promote the demand for low-cost biosimilars. This is likely to improve the manufacturing of cancer biosimilar in the post-pandemic period.
Scope of The Report
| Report Coverage | Details |
| Market Size in 2021 | USD 5.5 billion |
| Revenue Forecast by 2030 | USD 25.9 billion |
| Growth rate from 2022 to 2030 | CAGR of 18.79% |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segmentation | Product, production technology, application, region |
| Companies Covered | Boehringer Ingelheim GmbH; Lonza; Catalent Inc.; Biocon; IQVIA Inc.; AGC Biologics.; Samsung Biologics.; WuXi Biologics.; Element Materials Technology; Rentschler Biopharma SE; Avid Bioservice, Inc.; Alcami Corporation, Inc.; Fujifilm Kyowa Kirin Biologics Co., Ltd.; Thermo Fisher Scientific Inc.; Almac Group |
Product Insights
The recombinant non-glycosylated proteins segment held the largest share of more than 55.2% of the overall revenue in 2021. Recombinant non-glycosylated proteins consist of Granulocyte Colony-Stimulating Factors (G-CSFs), insulin, interferon, and human growth hormone. G-CSF is a naturally occurring growth factor that targets hematopoietic cells. This biosimilar is given to patients after myelosuppressive chemotherapy. Over the years, the use of G-CSF has improved among cancer patients receiving chemotherapy. Insulin is another widely used recombinant non-glycosylated protein.
The rising incidence of diabetes and the availability of biosimilars at lower costs than branded insulins are expected to improve the adoption of insulin biosimilars and thus is expected to promote the segment’s growth. The recombinant non-glycosylated proteins segment is expected to grow at the fastest CAGR during the forecast period. The increase in demand for monoclonal antibodies is one of the major factors expected to boost segment growth. Furthermore, recombinant glycosylated protein biosimilars are used for the treatment of blood disorders, cancers, and infectious diseases. This segment is expected to witness the fastest growth rate from 2022 to 2030, given the increasing incidence of cancer cases around the world and recombinant glycosylated protein biosimilars being an effective treatment against them.
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Production Technology Insights
Based on production technologies, the global industry has been further segmented into mammalian and non-mammalian. The mammalian segment accounted for the largest revenue share of more than 71.6% in 2021. The segment is expected to witness a significant CAGR during the forecast period. This is due to the fact that using mammalian cells for protein expression has the major benefit of producing mammalian proteins with the correct post-translational modifications that provide a native structure. Mammalian cells like Chinese Hamster Ovary (CHO) cell lines have been among the most preferred and about 70.0% of the protein therapeutics have been developed from CHO cells.
The non-mammalian segment also gained a significant share in 2021. Non-mammalian products include biotherapeutics developed for microbial sources. Microbial systems are commonly used to generate recombinant protein therapeutics. To date, approximately 650 protein drugs have been approved worldwide, with approximately 400 derived from microbial recombinant technologies. Furthermore, microbial products are used in the production of cytokines, hormones, enzymes, and MABs. These factors are assisting the segment’s growth.
Application Insights
The oncology segment is expected to grow at the fastest CAGR of 19.84% during the forecast. This is due to the high prevalence of cancer, including liver, colorectal, lung, stomach, breast, and blood cancers. According to the WHO, cancer is one of the major causes of death worldwide. 10 million deaths occurred in 2020 due to it. The high cost of cancer drugs and treatment is driving the demand for low-cost therapeutic drugs that are highly effective. This is increasing the demand for biosimilar drugs for cancer, which is promoting the growth of the segment. The chronic and autoimmune disorders segment accounted for the largest share in 2021.
The most commonly occurring autoimmune disorders that can be treated by biosimilars are polyarticular spondylitis, plaque psoriasis, Crohn’s disease, and arthritis. Such conditions are commonly treated with biologics, such as adalimumab and etanercept, making them the most preferred therapy for autoimmune disorders. Boehringer Ingelheim, Momenta Pharmaceuticals, Pfizer, Sandoz, Zydus Cadila, and many other major pharmaceutical companies have been granted licenses and approvals for developing biosimilar versions of adalimumab. The high burden of these diseases is expected to promote the demand for biosimilars, thus boosting the segment growth.
Regional Insights
The Europe region dominated the global industry in 2021 and accounted for the largest share of more than 47.08% of the overall revenue due to a well-defined regulatory framework for biosimilars and the presence of significant biopharmaceutical contract development and manufacturing organizations like Lonza, Boehringer Ingelheim GmbH, Rentschler Biopharma SE, and Element Materials Technology. In addition, strong healthcare infrastructure and an increase in product introductions have contributed to the expansion of the regional market.
The high number of approvals of biosimilar drugs in recent years is further contributing to the adoption of biosimilars in the region and thus is promoting the growth of the region. In Asia Pacific region is expected to witness the fastest CAGR over the forecast period. The growing demand for less expensive therapeutic products and the high prevalence of chronic diseases are the key factors contributing to the region’s growth. Increasing focus on contract developments in countries including China, India, and South Korea is another major factor anticipated to drive the region’s growth. Rapid urbanization, the growing geriatric population, and lifestyle changes in Asia Pacific have also led to an increase in the incidence of non-communicable diseases, such as cancer, diabetes, and auto-immune disorders. This is fueling the demand for cost-effective treatments in the region, thus promoting regional growth.
Key Players
- Boehringer Ingelheim Biopharmaceuticals GmbH
- Lonza
- Catalent, Inc.
- Biocon
- IQVIA Inc.
- AGC Biologics
- Samsung Biologics
- WuXi Biologics
- Element Materials Technology
- Rentschler Biopharma SE
- Avid Bioservices, Inc.
- Alcami Corporation, Inc.
- Fujifilm Kyowa Kirin Biologics Co., Ltd.
- Thermo Fisher Scientific Inc.
- Almac Group
Market Segmentation
- By Product Outlook
- Recombinant Non-glycosylated Proteins
- Recombinant Glycosylated Proteins
- By Production Technology Outlook
- Mammalian
- Non-Mammalian
- By Application Outlook
- Oncology
- Blood Disorders
- Growth Hormonal Deficiency
- Chronic & Autoimmune Disorders
- Rheumatoid Arthritis
- Others
- By Regional Outlook
- North America
-
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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