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Market Overview

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The global biosimilar contract manufacturing market surpassed USD 2.26 billion in 2021 and is projected to reach USD 5.56 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 16.19% from 2021 to 2027. Over 2 billion people worldwide lack access to affordable life-saving medications, putting their lives at risk. Making essential drugs more accessible and affordable can improve the quality of life for patients and reduce health inequality. While biologic drugs are at the forefront of medical advancements, their high cost constitutes a significant portion of public and private drug expenses. In contrast, biosimilars offer an equally effective treatment at a more affordable price, presenting a more sustainable solution. Consequently, the biosimilar market is experiencing substantial growth across all regions globally. Since 2015, the biosimilars market has grown at a CAGR of over 50%, and it is poised for even greater expansion due to several favorable factors. The increasing acceptance of biosimilars in treating autoimmune diseases, cancer, and blood disorders, combined with their lower cost compared to branded biologics, are major drivers of this market growth.

The rising demand for biosimilars, the increasing number of approved biosimilars, and the robust pipeline have also contributed to the growing demand for outsourcing biosimilar manufacturing. As a result, many pharmaceutical and biotech companies are outsourcing their biosimilar research and development (R&D) and manufacturing to contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), driving the growth of the biosimilar contract manufacturing market. Outsourcing biosimilar manufacturing allows pharma/biotech companies to enter the market early, free up resources and manufacturing facilities, focus on core businesses, and minimize drug costs. Consequently, the CMO industry has witnessed remarkable growth in the past decade and is expected to continue its upward trajectory in the future. CMOs are no longer simply a one-time manufacturing option but have become integral to the supply chains of pharma/biotech companies.

Initially, major pharmaceutical companies played a significant role in the growth of the biopharma contract manufacturing market. However, contributions from biotechnology and life sciences companies have also increased in recent years, especially with the high global demand for biologics, including biosimilars. With the entry of numerous biotech companies, there will be a greater demand for contract manufacturing services in biologics, including the biosimilar market. Outsourcing manufacturing allows biotech firms to introduce products to the market without investing in building or upgrading their manufacturing facilities. As the cost of biosimilars must be significantly lower than that of branded biologics, outsourcing manufacturing activities makes economic sense for drug developers. Therefore, CMOs are witnessing healthy growth in their biosimilar contract manufacturing business.

The demand for contract manufacturing services is gaining momentum due to increased investments by major pharmaceutical companies in the research and development of various biologics and biosimilars. Moreover, the significant advantage of reduced investment for developing and manufacturing drugs through contract manufacturing is expected to drive the adoption of these services by pharma/biotech companies in the coming years. Leading CMOs are expanding their manufacturing capacities to maintain a strong position in the biosimilar contract manufacturing market. For example, Catalent Pharma Solutions completed a USD 5.5 million expansion program at its manufacturing site in Philadelphia, Pennsylvania, in April 2018, providing additional clinical packaging and storage capacity.

Although North America and Europe have accounted for the highest volume of global biosimilar sales, major Asian markets, Southeast Asia, Latin America, and Australasia are expected to experience higher volume growth rates in the next decade. The first biosimilar approved by the US Food and Drug Administration (FDA) was Sandoz’s Zarxio in 2015. However, there was a decline in the number of biosimilars approved in the US in 2020 compared to previous years. In China, on the other hand, there has been a significant increase in biosimilar approvals from 2018 to 2021. Regulatory changes and the biosimilar pipeline are expected to drive the growth of the biosimilar industry. With the rising number of inflammatory and autoimmune diseases, the demand for biosimilars will continue to grow. This demand is further fueled by the patent expirations of blockbuster biologic drugs that are significantly more expensive than biosimilars. Consequently, there is an increasing need to outsource the manufacturing of biosimilars, contributing to the growth of the biosimilar contract manufacturing market.

Between 2020 and 2025, the exclusivity of the first 17 blockbuster drugs with annual peak sales reaching USD 60 billion is set to expire, paving the way for numerous biosimilars to enter the market. Biosimilars are gaining traction across various specialties and distribution channels in which they have recently been introduced. The biologics market, which encompasses the treatment of cancers, diabetes, and autoimmune diseases, accounts for over 60% of the overall biologics market and continues to grow in cost. To address the limitations posed by the high prices of biologics and their impact on healthcare budgets, biosimilars are being introduced after the patents and exclusivity periods of originator biologics expire. By 2018, biologicals with annual sales exceeding USD 68 billion lost patent protection. A 20% discount could save up to USD 14 billion, while discounts of 30% or 40% could save USD 20 billion or USD 27 billion, respectively. As several biologic patents are set to expire in various countries by 2025, this presents an opportunity to develop new biosimilars. Europe, in particular, offers significant opportunities for exploration in the biosimilar contract manufacturing market.

Biosimilars are driving the expansion of the global biopharmaceutical industry, leading to the introduction of many new products, players, and production facilities. Consequently, the number of approved and investigational biosimilars is on the rise, intensifying competition among biosimilars and their reference products in the coming years. Many developers are focusing on biosimilars of the same reference products, resulting in a growing pipeline of biosimilars. In 2019, biosimilars experienced sustained growth with an average yearly growth rate of 20%. This growth has further increased to an average of 27% per year over the past five and a half years.

Given the lack of product protection for several commercially viable biosimilars and their approaching patent expiration, there are currently numerous biosimilars in the pipeline. The number of biosimilars in the pipeline, most of which are still in development and targeting popular reference products, has increased by over 50% annually over the past 18 months. This growth rate is also reflected in the number of biosimilars targeting less popular reference products. This trend of increasing biosimilars in development targeting the same reference products is expected to continue in the short term as existing biosimilar companies expand their portfolios and new developers enter the field.

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Market Segmentation

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The market is segmented based on various factors, including source, scale of operation, product, indication, and geography.

Segmentation by Source
Mammalian
Non-mammalian

Segmentation by Scale of Operation
Commercial
Research

Segmentation by Product
Finished Dosage Form (FDF
Active Pharmaceutical Ingredients (APIs)

Segmentation by Indication
Oncology
Blood Disorders
Inflammatory & Autoimmune Disorders
Others

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey, UAE

Biosimilars are produced and manufactured using cell lines from both mammals and non-mammals. Among these, mammalian cell lines dominate the global biosimilar contract manufacturing market, accounting for approximately 71% of the market share and experiencing rapid growth. The production of biosimilars, generation of manufacturing cell lines, and optimization of manufacturing scale-up require stringent control conditions and detailed analytics to ensure that the biosimilar composition profile meets the specifications of the originators. Mammalian cell recombinant expression is particularly useful in generating proteins for discovery research and biotherapeutic applications, as it enables the production of proteins that closely mimic properties in human patients.

The global non-mammalian biosimilar contract manufacturing market is growing at a compound annual growth rate (CAGR) of 15.54%. Non-mammalian products include biotherapeutics developed from microbial sources, which are commonly used for generating recombinant protein therapeutics. Currently, there are approximately 650 approved protein drugs globally, with around 400 of them derived from recombinant microbial technologies.

In terms of scale of operation, the global biosimilar contract manufacturing market is divided into commercial and research segments. In 2021, the commercial segment accounted for 85.73% of the global market share. The demand for developing novel biosimilars has been increasing, driven by the emergence of various chronic inflammatory conditions, cancers, autoimmune diseases, and other medical conditions.

Numerous biosimilars are currently in the pipeline, and researchers are working to ensure their reliable replication at a scale suitable for clinical trials and mass production. Contract manufacturing is gaining popularity due to the approaching commercial scale and entry of biosimilar drugs into the clinical pipeline. Larger biopharmaceutical companies, despite having well-established facilities meeting good manufacturing practice (GMP) standards, prefer to outsource manufacturing to reduce costs. Contract manufacturers utilize cell-culture and microbial technologies to provide manufacturing services on both clinical and commercial scales. Consequently, there is an increasing trend of contract manufacturing for biosimilars in various research activities, contributing to the growth of the research segment.

Contract manufacturing activities in the biosimilar industry can be broadly categorized into active pharmaceutical ingredients (APIs) manufacturing and finished dosage form (FDF) manufacturing. In 2021, FDF accounted for 52.88% of the global biosimilar contract manufacturing market. FDF refers to a drug product that has undergone all production steps, including manufacturing, testing, and approval, before being made available to the public. Achieving the FDF stage is crucial in the product life cycle and can only be accomplished if the manufacturing facilities of pharmaceutical companies or outsourced organizations meet high standards. Companies without standard manufacturing facilities for producing FDFs typically seek licensing for this purpose.

APIs contract manufacturing involves the development of drugs through contract manufacturing by outsourcing to other companies. The global APIs contract manufacturing market is expected to experience increased demand in the forecast period due to factors such as access to skilled labor with cost advantages, favorable government policies, and tax incentives. The global market for biosimilar contract manufacturing of active pharmaceutical ingredients was valued at USD 1.065 billion in 2021. Manufacturing APIs is a complex and specialized activity that requires integration of expertise in chemistry, biology, and engineering.

In terms of indication, the global biosimilar contract manufacturing market is segmented into oncology, blood disorders, inflammation & autoimmune disorders, and other indications. Among these, the oncology segment holds the largest share of 33.5%. The development of biosimilars is closely tied to therapeutic areas, disease prevalence, and treatment costs. Immunology and oncology are therapeutic areas that impose a significant financial burden on healthcare systems, thus creating a high demand for biosimilars. Most of the biosimilars approved by the FDA and EMA target inflammatory conditions, driven by the increasing prevalence and cost burden of chronic diseases. These biosimilars are highly productive and available at lower costs.

Europe dominates the global biosimilar contract manufacturing market, accounting for a significant share of 39.44% in 2021, and is projected to grow at a CAGR of 15.14% during the forecast period. The region benefits from a well-defined regulatory framework for biosimilars and an established biosimilar industry with leading companies like Lonza, Boehringer Ingelheim GmbH, Rentschler Biopharma SE, among others, contributing to the increasing demand for contract manufacturing. Germany, France, the UK, Italy, and Spain are the major countries driving the growth of the biosimilar contract manufacturing market in the region.

North America holds the second-largest share in the global biosimilar contract manufacturing market. Factors contributing to its consistent market growth include the increasing prevalence of major chronic conditions such as inflammatory and autoimmune diseases (including cancers, blood disorders, etc.) and favorable regulatory policies and guidelines. The North American biosimilar contract manufacturing market was valued at USD 626.41 million in 2021. Biosimilars development in the region is strictly regulated, and only those presenting a comprehensive dossier demonstrating highly similar physicochemical, biological, and clinical performance are endorsed as biosimilars by regulatory agencies.

The Asia-Pacific (APAC) region is expected to witness the fastest growth in the global biosimilar contract manufacturing market during the forecast period. The region’s growing patient population with major inflammatory diseases and autoimmune disorders creates a greater need for biosimilars. APAC has the advantage of providing less expensive treatment due to the influx of medical travelers. Rapid urbanization, increased research and development expenditures, and rising outsourcing of biosimilar manufacturing will contribute to the continuous growth of the market in this region. In 2021, Latin America and the Middle East & Africa accounted for minimal shares in the biosimilar contract manufacturing market. These regions are expected to experience slow growth in the coming years as biosimilar manufacturers outsource their products to contract manufacturers. Additionally, regulations are being adjusted to facilitate the manufacture and registration of biosimilars, which will significantly expand the market in these regions.

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Competitive Landscape

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The global biosimilar contract manufacturing market is characterized by a concentration of key players such as Samsung Biologics, Lonza, and Boehringer Ingelheim GmbH. Additionally, there are emerging players including AbbVie, Inc., Catalent, Emergent BioSolutions, FUJIFILM Diosynth Biotechnologies, Merck KGaA, Pfizer CentreOne, and WuXi Biologics. The leading players in the market are focused on strategies such as acquisitions, partnerships, diversification of outsourcing services, and strengthening distribution networks to expand their market share. They are actively involved in expanding into new markets and serving the growing customer base, while also enhancing their production capabilities to attract end-users.

The presence of several emerging players has intensified competition among vendors in the biosimilar contract manufacturing market. The major vendors offering biosimilar contract manufacturing services are predominantly located in Europe, including both small and large companies. In North America and the Asia-Pacific region, there are fewer large players but several small and mid-sized vendors. Emerging economies like China, India, Brazil, and Mexico are expected to present significant growth opportunities for players in the biosimilar contract manufacturing market. Major vendors are becoming more proactive and diverse in their contract manufacturing services to meet the evolving demands of end-users due to increased competition and the emergence of multiple businesses.

Key companies profiled in this report include Lonza, Boehringer Ingelheim International GmbH, Catalent, FUJIFILM, Thermo Fischer Scientific, AbbVie, Abzena, AGC Biologic, Alcami, Almac Group, Avid Bioservices, Biocon, Element Materials Technology, Eurofins Scientific, Fresenius Kabi, Goodwin Biotechnology, Kemwell, mAbxience, Merck KGaA, Midas Pharma, Novartis AG, Pfizer, Rentschler Biopharma, Samsung Biologics, WuXi Biologics.

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Recent Industry Developments

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Celltrion and Lonza have announced a contract manufacturing agreement to produce a drug substance for Remsima, a biosimilar that has been approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of several autoimmune diseases, including Crohn’s disease and rheumatoid arthritis.

Novartis has entered into a contract manufacturing deal with Carisma Therapeutics, a company focused on developing a cell therapy platform. Carisma Therapeutics has developed CT-0508, a treatment targeting HER2-positive solid tumors.

In April 2021, Lonza, a leading global Contract Development and Manufacturing Organization (CDMO) in the biopharmaceutical industry, collaborated with Junshi Biosciences to accelerate the development and manufacturing of biologics. This collaboration utilizes Lonza’s GS Xceed Gene Expression System.

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Key Questions Answered

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What is the projected value of the biosimilar contract manufacturing market by 2027?

The global biosimilar contract manufacturing market, which was valued at USD 2.26 billion in 2021, is projected to reach USD 5.5 billion by 2027.

What is the growth rate of the global biosimilar contract manufacturing market?

The global biosimilar contract manufacturing market is expected to grow at a compound annual growth rate (CAGR) of over 16% from 2021 to 2027.

Who are the key players in the global biosimilar contract manufacturing market?

The key players in the biosimilar contract manufacturing market include Lonza, Catalent, Thermo Fischer Scientific, FUJIFILM, and Boehringer Ingelheim International GmbH.

What are the main factors driving the biosimilar contract manufacturing market?

The main driving factors in the global biosimilar contract manufacturing market are the increasing number of product launches and approvals of biosimilars, regulatory activities and policies that encourage the use of biosimilars, and the expiration of patents for blockbuster branded biologic drugs.

Which region dominates the global biosimilar contract manufacturing market?

Europe is the dominant region in the global biosimilar contract manufacturing market, with the largest share in 2021. The growing prevalence of chronic conditions such as autoimmune disorders, cancers, diabetes, and other inflammatory conditions contributes to the rising demand for biosimilars in Europe.