Biosimilar Contract Manufacturing Market Analysis

Global Biosimilar Contract Manufacturing Market Overview

The Biosimilar Contract Manufacturing Market Size was valued at USD 5.5 Billion in 2022 and is projected to grow from USD 6.5 Billion in 2023 to USD 26.1 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 18.90% during the forecast period (2023 - 2032). The growing use of biosimilars in the treatment of illnesses like cancer, autoimmune conditions, blood disorders, and others, as well as their lower cost when compared to biologics, are the key market drivers enhancing the market growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Biosimilar Contract Manufacturing Market Trends

• The increasing popularity of biosimilars in treating diseases, such as cancer, autoimmune diseases, blood disorders, and others is driving the market growth

One of the main drivers of the market is the rising use of biosimilars in the treatment of diseases like cancer, autoimmune disorders, blood disorders, and others, as well as their lower cost when compared to biologics. Several biosimilars were authorised to treat COVID-19 during the pandemic. For instance, the COVID-19 treatment biosimilar Tocilizumab from Hetero Healthcare was approved by India's Drug Controller General in September 2021. Such approvals are probably going to increase the adoption of biosimilars in developing nations and hence expand the market in those nations in the upcoming years. The industry's expansion is largely related to the approaching patent expiration of popular biologics. According to IQVIA, biologic proprietary medications such Chantix, Forteo, Truvada, Ciprodex, and Afinitor were no longer available in the United States as of 2020. The growing need for low-cost, highly effective drugs and the rising number of biologics whose patents are about to expire are both contributing to the industry's expected growth. Diseases like cancer, autoimmune disorders, blood problems, and neurological disorders are becoming more commonplace.

According to Cancer Tomorrow, more cancer cases are anticipated in the upcoming years. Over 19.3 million instances of cancer were reported in 2020, according to Cancer Tomorrow's predictions, and this number is projected to increase to 30.2 million by 2040. The market for cancer biosimilars is anticipated to increase as cancer incidence rises. The industry is anticipated to benefit from this. The pipeline of biosimilar medications has improved recently as a result of the rising need for affordable and highly effective therapies. For instance, according to the Biosimilars/Biobetters Pipeline Directory, the pipeline for biosimilars will increase by 108% between 2013 and 2020.

The expansion of the biosimilar pipeline is anticipated to increase manufacturing demand and, as a result, to foster industry growth. The majority of medications approved during the COVID-19 pandemic were intended to treat COVID-19. But it had no bearing on whether or not biosimilar medicines were approved. The European Medicines Agency, for instance, approved nine biosimilar medications in 2020 and seven biosimilar medications in 2021. The regulatory clearance of biosimilars is projected to increase demand for them in manufacturing, which will encourage growth. Thus, driving the Biosimilar Contract Manufacturing market revenue.

Biosimilar Contract Manufacturing Market Segment Insights

Biosimilar Contract Manufacturing Product Insights

The Market segments of Biosimilar Contract Manufacturing, based on Product, includes recombinant non-glycosylated proteins and recombinant glycosylated proteins. Recombinant non-glycosylated proteins segment dominated the global market in 2022. Granulocyte Colony-Stimulating Factors (G-CSFs), insulin, interferon, and human growth hormone are examples of recombinant non-glycosylated proteins. Hematopoietic cells are the primary target of G-CSF, a growth factor that occurs naturally. Patients are administered this biosimilar following myelosuppressive chemotherapy. G-CSF usage among chemotherapy-treated cancer patients has improved over time. Another popular recombinant non-glycosylated protein is insulin.

Biosimilar Contract Manufacturing Production Technology Insights

The Biosimilar Contract Manufacturing Market segmentation, based on Production Technology, includes mammalian and non-mammalian. Mammalian segment dominated the market of Biosimilar Contract Manufacturing in 2022. This is as a result of the significant advantage of creating mammalian proteins with the proper post-translational modifications that offer a native structure when using mammalian cells for protein expression. About 70.0% of the protein therapies have been created from mammalian cells, such as Chinese Hamster Ovary (CHO) cell lines, which have been among the most popular.

Biosimilar Contract Manufacturing Application Insights

The Market segmentation of Biosimilar Contract Manufacturing, based on Application, includes oncology, blood disorders, growth hormonal deficiency, chronic & autoimmune disorders, rheumatoid arthritis, and others. Oncology segment dominated the global market in 2022. The high incidence of cancer, including liver, colon, lung, stomach, breast, and blood cancers, is to blame for this. The WHO lists cancer as one of the leading causes of death in the globe. In 2020, it caused 10 million deaths. The quest for low-cost therapeutic pharmaceuticals with excellent efficacy is being driven by the high expense of cancer medications and treatments. This is boosting the market's expansion by raising the need for biosimilar cancer medications.

Figure 1: Biosimilar Contract Manufacturing Market, by Application, 2022 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Biosimilar Contract Manufacturing Regional Insights

By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. Europe Biosimilar Contract Manufacturing market dominated this market in 2022 (45.80%). The presence of important biopharmaceutical contract development and manufacturing companies like Lonza, Boehringer Ingelheim GmbH, Rentschler Biopharma SE, and Element Materials Technology as well as a clearly defined regulatory environment for biosimilars are to thank for this. The regional market has also grown as a result of a robust healthcare infrastructure and an increase in product releases. Further, the German market of Biosimilar Contract Manufacturing held the largest market share, and the U.K market of Biosimilar Contract Manufacturing was the fastest growing market in the European region

Further, the major countries studied in the market report are The US, Canada, German, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: BIOSIMILAR CONTRACT MANUFACTURING MARKET SHARE BY REGION 2022 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

The North America Biosimilar Contract Manufacturing Market accounted for the healthy market share in 2022. The widespread use of biosimilar medications in the area is being facilitated by the recent high number of biosimilar drug approvals, which is also fostering the region's development. Further, the U.S. market of Biosimilar Contract Manufacturing held the largest market share, and the Canada market of Biosimilar Contract Manufacturing was the fastest growing market in the North America region.

The Asia Pacific Biosimilar Contract Manufacturing market is expected to register significant growth from 2023 to 2032. The main drivers of the region's growth are the high prevalence of chronic diseases and the expanding desire for less priced therapeutic items. Another significant aspect that is projected to contribute significantly to the region's growth is the growing emphasis on contract projects in nations like China, India, and South Korea. In Asia Pacific, the incidence of non-communicable diseases like cancer, diabetes, and autoimmune disorders has also increased due to rapid urbanisation, the expanding geriatric population, and lifestyle changes. This is boosting the region's need for affordable therapies and fostering regional growth. Moreover, China’s market of Biosimilar Contract Manufacturing held the largest market share and the Indian market of Biosimilar Contract Manufacturing was the fastest growing market in the Asia-Pacific region.

Biosimilar Contract Manufacturing Key Market Players & Competitive Insights

Leading market players are investing heavily in research and development in order to expand their product lines, which will help the market of Biosimilar Contract Manufacturing, grow even more. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, Biosimilar Contract Manufacturing industry must offer cost-effective items.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global Biosimilar Contract Manufacturing industry to benefit clients and increase the market sector. In recent years, the Biosimilar Contract Manufacturing industry has offered some of the most significant advantages to medicine. Major players in the Biosimilar Contract Manufacturing market, including 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., and Almac Group, are attempting to increase market demand by investing in research and development Applications.

A contract development and manufacturing organisation (CDMO), Recipharm AB (Recipharm) provides services in manufacturing, development, and technology. In addition to clinical trial materials like APIs and other medications, the company's manufacturing capabilities include contract manufacturing of pharmaceuticals including semi-solids, oral liquids, solid dosages, and sterile items. Customers are helped by Recipharm's technology and development services from the first product concept to the licenced commercial pharmaceutical product. It comprises, among other things, services like the provision of raw materials and the development of formulations.

The company Baxter International Inc. (Baxter) offers a variety of medical supplies. Dialysis for both acute and chronic illnesses, sterile intravenous solutions, generic injectable medications, parenteral nutrition therapies, infusion systems and devices, inhaled anaesthetics, and surgical hemostat and sealant products are among the company's product and service offerings. Hospitals, rehabilitation facilities, kidney dialysis clinics, nursing homes, and patients' homes all use the company's products. Baxter distributes its goods through a network of independent distributors, medication wholesalers, specialty pharmacies, and other providers of alternate sites in addition to its own direct sales staff.

Key Companies in the market of Biosimilar Contract Manufacturing include

• 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

Biosimilar Contract Manufacturing Industry Developments

September 2022 Ropidoxuridine, the company's principal clinical sensitizer drug candidate, will be manufactured by Shuttle Pharmaceuticals Holdings Inc. in accordance with a contract with TCG GreenChem, Inc. This drug will be used in the formulation of a drug product that will be tested in clinical studies of Ropidoxuridine and RT of malignancies.

Biosimilar Contract Manufacturing Market Segmentation

Biosimilar Contract Manufacturing Product Outlook

• Recombinant Non-glycosylated Proteins


• Recombinant Glycosylated Proteins

Biosimilar Contract Manufacturing Production Technology Outlook

• Mammalian


• Non-Mammalian

Biosimilar Contract Manufacturing Application Outlook

• Oncology


• Blood Disorders


• Growth Hormonal Deficiency


• Chronic & Autoimmune Disorders


• Rheumatoid Arthritis


• Others

Biosimilar Contract Manufacturing Regional Outlook

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  North America

  
  
  
  
  • US
  
  
  • Canada
  
  
  
  


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  Europe

  
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


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  Asia-Pacific

  
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


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  Rest of the World

  
  
  
  
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    Middle East

    
    
  
  
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    Africa

    
    
  
  
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    Latin America