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Spain Biosimilar Contract Manufacturing Market

ID: MRFR/Pharma/50117-HCR
200 Pages
Garvit Vyas
February 2026

Spain Biosimilar Contract Manufacturing Market Research Report By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins), By Production Technology (Mammalian, Non-Mammalian) and By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic & Autoimmune Disorders, Rheumatoid Arthritis, Others) - Growth & Industry Forecast 2025 To 2035

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Spain Biosimilar Contract Manufacturing Market Summary

As per Market Research Future analysis, the Spain Biosimilar Contract Manufacturing Market size was estimated at 270.5 USD Million in 2024. The Biosimilar Contract-manufacturing market is projected to grow from 321.6 USD Million in 2025 to 1815.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 18.8% during the forecast period 2025 - 2035

Key Market Trends & Highlights

The Spain biosimilar contract-manufacturing market is poised for growth driven by various factors.

  • The market is experiencing a rising demand for cost-effective therapies, particularly in the oncology and autoimmune segments.
  • Regulatory support and streamlined processes are facilitating faster market entry for biosimilars, enhancing competition.
  • Technological advancements in manufacturing are improving production efficiency and product quality, contributing to market expansion.
  • Key drivers include increasing healthcare expenditure and government initiatives for biosimilar adoption, which are likely to bolster market growth.

Market Size & Forecast

2024 Market Size 270.5 (USD Million)
2035 Market Size 1815.0 (USD Million)
CAGR (2025 - 2035) 18.89%

Major Players

Samsung Biologics (KR), Lonza Group (CH), Boehringer Ingelheim (DE), Fujifilm Diosynth Biotechnologies (JP), Catalent (US), Wuxi Biologics (CN), Rentschler Biopharma (DE), KBI Biopharma (US), Amgen (US)

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Spain Biosimilar Contract Manufacturing Market Trends

The Spain Biosimilar Contract Manufacturing Market is experiencing notable growth, driven by increasing demand for cost-effective alternatives to biologic therapies. In Spain, the regulatory environment is becoming more favorable, encouraging the development and production of biosimilars. This shift is largely influenced by the need to manage healthcare costs while ensuring patient access to essential medications. As a result, pharmaceutical companies are increasingly seeking partnerships with contract manufacturers to leverage their expertise and capabilities in biosimilar production. Moreover, advancements in biomanufacturing technologies are enhancing the efficiency and scalability of biosimilar production processes. Spanish manufacturers are investing in state-of-the-art facilities and adopting innovative techniques to meet the rising demand. This trend is likely to continue as the market matures, with a focus on quality assurance and compliance with stringent regulatory standards. The collaboration between local manufacturers and international firms is also expected to foster knowledge transfer and innovation, further propelling the biosimilar contract-manufacturing market in Spain.

Rising Demand for Cost-Effective Therapies

The increasing pressure on healthcare budgets is driving the demand for biosimilars as affordable alternatives to expensive biologic drugs. This trend is particularly evident in Spain, where healthcare providers are actively seeking ways to reduce costs while maintaining high standards of patient care.

Regulatory Support and Streamlined Processes

The Spanish government is enhancing its regulatory framework to facilitate the approval and commercialization of biosimilars. This supportive environment is likely to encourage more companies to enter the biosimilar contract-manufacturing market, fostering competition and innovation.

Technological Advancements in Manufacturing

Innovations in biomanufacturing technologies are transforming the production landscape for biosimilars. Spanish contract manufacturers are adopting cutting-edge techniques to improve efficiency, reduce production costs, and ensure compliance with regulatory requirements.

Spain Biosimilar Contract Manufacturing Market Drivers

Increasing Healthcare Expenditure

The rising healthcare expenditure in Spain is a pivotal driver for the biosimilar contract-manufacturing market. As the Spanish government allocates more funds towards healthcare, the demand for affordable treatment options intensifies. In 2025, healthcare spending is projected to reach approximately €200 billion, reflecting a growth of around 5% from previous years. This increase in budget allows for the integration of biosimilars into treatment protocols, thereby enhancing patient access to essential medications. The biosimilar contract-manufacturing market stands to benefit significantly as pharmaceutical companies seek to leverage cost-effective production methods to meet this growing demand. Consequently, the market is likely to witness a surge in partnerships between biosimilar developers and contract manufacturers, aiming to optimize production efficiency and reduce costs.

Aging Population and Chronic Diseases

Spain's demographic shift towards an aging population is a crucial factor influencing the biosimilar contract-manufacturing market. With an increasing number of individuals aged 65 and above, the prevalence of chronic diseases such as diabetes and arthritis is on the rise. By 2025, it is estimated that over 20% of the Spanish population will be over 65, leading to a heightened demand for biologic therapies. This demographic trend compels healthcare providers to explore biosimilars as a viable alternative to expensive biologics, thereby driving the need for contract manufacturing services. The biosimilar contract-manufacturing market is expected to expand as pharmaceutical companies aim to develop and produce biosimilars that cater to this growing patient demographic, ensuring that effective treatments are accessible and affordable.

Rising Focus on Personalized Medicine

The growing emphasis on personalized medicine in Spain is emerging as a notable driver for the biosimilar contract-manufacturing market. As healthcare shifts towards tailored treatment approaches, the demand for biologics and their biosimilars is expected to rise. Personalized medicine aims to optimize therapeutic efficacy by considering individual patient characteristics, which may lead to increased utilization of biosimilars as alternatives to traditional biologics. In 2025, the market for personalized medicine in Spain is projected to grow by approximately 10%, indicating a shift in treatment paradigms. This trend encourages contract manufacturers to adapt their capabilities to meet the specific needs of biosimilar developers, thereby enhancing their service offerings and fostering innovation within the biosimilar contract-manufacturing market.

Government Initiatives for Biosimilar Adoption

The Spanish government has implemented various initiatives to promote the adoption of biosimilars, which serves as a significant driver for the biosimilar contract-manufacturing market. Policies aimed at encouraging the use of biosimilars include financial incentives for healthcare providers and educational programs to raise awareness among patients and physicians. In 2025, the government is expected to allocate an additional €50 million towards these initiatives, further stimulating market growth. By fostering an environment conducive to biosimilar utilization, the government is likely to enhance competition among manufacturers, leading to lower prices and increased availability of biosimilars. This proactive approach not only benefits patients but also creates opportunities for contract manufacturers to engage with biosimilar developers, thereby expanding their market presence.

Competitive Landscape and Market Entry Strategies

The competitive landscape within the biosimilar contract-manufacturing market is evolving, driven by the entry of new players and strategic collaborations. As established pharmaceutical companies seek to expand their portfolios, they are increasingly partnering with contract manufacturers to leverage their expertise in biosimilar production. In 2025, the number of contract manufacturing organizations (CMOs) specializing in biosimilars is expected to increase by 15%, reflecting a growing recognition of the market's potential. This influx of new entrants may lead to intensified competition, prompting existing players to innovate and enhance their service offerings. Consequently, the biosimilar contract-manufacturing market is likely to experience dynamic shifts as companies adopt various market entry strategies to secure their positions and capitalize on emerging opportunities.

Market Segment Insights

By Product: Recombinant Glycosylated Proteins (Largest) vs. Recombinant Non-glycosylated Proteins (Fastest-Growing)

In the Spain biosimilar contract-manufacturing market, the recombinant glycosylated proteins segment holds the largest share, reflecting the growing demand for these complex biologics. This type of protein is primarily used in therapies for various diseases, enhancing its market position as healthcare providers increasingly prefer glycosylated options for their efficacy and compatibility. Conversely, recombinant non-glycosylated proteins are emerging rapidly as they cater to specific therapeutic needs, particularly in oncology, where their simplified structure allows for faster production times and reduced costs. The growth trends in this segment are driven by advancements in bioprocessing technologies and an increased focus on personalized medicine. The regulatory landscape is also evolving, facilitating quicker approvals for biosimilar products. With the rise in chronic diseases and the need for cost-effective therapeutic solutions, the recombinant non-glycosylated proteins are witnessing significant investments, thus establishing themselves as a fast-growing segment in the Spain biosimilar contract-manufacturing market.

Recombinant Glycosylated Proteins (Dominant) vs. Recombinant Non-glycosylated Proteins (Emerging)

Recombinant glycosylated proteins serve as the dominant segment in the Spain biosimilar contract-manufacturing market, favored for their structural complexity and proven effectiveness in treatment protocols. Their ability to mimic natural proteins in human biology ensures high therapeutic value, which has become essential in the management of various health conditions. In contrast, recombinant non-glycosylated proteins are emerging as an alternative due to their simpler molecular structures, allowing manufacturers to streamline production processes. This makes them particularly attractive for developing cost-effective solutions in the competitive landscape, especially in oncology and other specialty areas. As both segments evolve, they cater to distinct yet overlapping needs within the market.

By Production Technology: Mammalian (Largest) vs. Non-Mammalian (Fastest-Growing)

In the Spain biosimilar contract-manufacturing market, the distribution of production technology reveals that mammalian systems hold the largest share, catering to the majority of biopharmaceutical needs due to their ability to produce complex proteins. On the other hand, non-mammalian technologies are gaining traction, capturing a significant niche, particularly in rapid production cycles and consistency. Growth trends indicate a shift towards non-mammalian platforms, driven by advancements in genetic engineering and increasing demand for cost-effective production methods. Non-mammalian technologies, while still emerging, offer innovative solutions for companies looking to expedite their manufacturing processes, making them an attractive option in the competitive landscape of biosimilars. The market is witnessing a dynamic shift, with both segments contributing uniquely to the evolving biosimilar ecosystem.

Technology: Mammalian (Dominant) vs. Non-Mammalian (Emerging)

Mammalian production technology remains the dominant force in the biosimilar contract-manufacturing market, known for its superior ability to produce biologics that require post-translational modifications. This method leverages the intricate cellular machinery of mammalian cells to ensure biological activity and efficacy, making it a preferred choice for many biopharmaceutical manufacturers. Conversely, non-mammalian technologies, including yeast and bacterial systems, are emerging as viable alternatives, offering advantages such as shorter production times and lower operational costs. These emerging technologies appeal to manufacturers seeking to enhance flexibility and responsiveness to market demands, positioning them for rapid growth as the industry continues to evolve toward more efficient and scalable production methods.

By Application: Oncology (Largest) vs. Chronic & Autoimmune Disorders (Fastest-Growing)

In the Spain biosimilar contract-manufacturing market, the application segment is prominently led by Oncology, which holds the largest market share due to the increasing prevalence of cancer and the growing acceptance of biosimilars among healthcare providers. Blood Disorders and Growth Hormonal Deficiency also contribute significantly, but at a smaller scale. Chronic & Autoimmune Disorders are showing an upward trend, indicating a rising demand in this area, driven by expanding patient populations and awareness regarding treatment options. Growth trends in this segment are influenced by various factors, including advancements in biosimilar development and increasing healthcare expenditure. The rising incidence of chronic diseases along with favorable regulatory environments boosts the adoption of biosimilars in these therapeutic areas. Notably, the Chronic & Autoimmune Disorders segment is emerging as a significant player, reflecting changing treatment paradigms and a shift towards personalized medicine, catering to patient-specific needs.

Oncology (Dominant) vs. Chronic & Autoimmune Disorders (Emerging)

Oncology, as the dominant segment in the Spain biosimilar contract-manufacturing market, is characterized by an extensive range of biosimilar products designed to treat various types of cancer. Its dominance stems from the urgent need for cost-effective treatments in a high-burden disease area, which has led to increased investments in research and development. Conversely, Chronic & Autoimmune Disorders represent an emerging opportunity, with a growing array of biosimilars targeting diseases such as rheumatoid arthritis and multiple sclerosis. The shift towards biosimilars in this segment is propelled by the need for affordable alternatives to expensive biologics, improved patient access to therapies, and a supportive regulatory landscape that incentivizes biosimilar innovation.

Get more detailed insights about Spain Biosimilar Contract Manufacturing Market

Key Players and Competitive Insights

The biosimilar contract-manufacturing market in Spain is characterized by a dynamic competitive landscape, driven by increasing demand for cost-effective biologics and the growing acceptance of biosimilars among healthcare providers. Key players such as Samsung Biologics (KR), Lonza Group (CH), and Boehringer Ingelheim (DE) are strategically positioned to leverage their extensive manufacturing capabilities and technological expertise. Samsung Biologics (KR) focuses on expanding its global footprint through strategic partnerships and investments in advanced manufacturing technologies, while Lonza Group (CH) emphasizes innovation in bioprocessing to enhance production efficiency. Boehringer Ingelheim (DE) is actively pursuing collaborations to strengthen its biosimilar portfolio, indicating a trend towards cooperative strategies that enhance competitive positioning.The market structure appears moderately fragmented, with several players vying for market share. Key business tactics include localizing manufacturing to reduce costs and optimize supply chains, which is particularly relevant in the context of increasing regulatory scrutiny and the need for rapid market entry. The collective influence of these major players shapes a competitive environment where agility and responsiveness to market demands are paramount.

In September Fujifilm Diosynth Biotechnologies (JP) announced the expansion of its manufacturing facility in Spain, aimed at increasing production capacity for biosimilars. This strategic move is likely to enhance its ability to meet the rising demand for biosimilars in Europe, positioning the company as a key player in the region. The expansion reflects a broader trend of companies investing in local manufacturing capabilities to ensure supply chain resilience and compliance with regional regulations.

In October Catalent (US) entered into a partnership with a leading European biopharmaceutical company to co-develop a new biosimilar product. This collaboration underscores Catalent's commitment to innovation and its strategic focus on enhancing its service offerings in the biosimilar space. By aligning with established biopharmaceutical firms, Catalent is likely to strengthen its market position and expand its portfolio, which may lead to increased competitiveness in the evolving landscape.

In November Wuxi Biologics (CN) launched a new digital platform aimed at streamlining the biosimilar development process. This initiative is indicative of the growing trend towards digitalization within the industry, as companies seek to leverage technology to enhance operational efficiency and reduce time-to-market. The integration of digital solutions may provide Wuxi Biologics (CN) with a competitive edge, allowing for more agile responses to client needs and market changes.

As of November current competitive trends in the biosimilar contract-manufacturing market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence (AI) in manufacturing processes. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise to drive innovation. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological advancements, supply chain reliability, and innovative product offerings, reflecting the industry's response to changing market dynamics.

Key Companies in the Spain Biosimilar Contract Manufacturing Market include

Industry Developments

In recent months, the Spain Biosimilar Contract Manufacturing Market has witnessed significant developments. Biocon announced the successful launch of its critical biosimilar product in Europe, contributing to its growing portfolio in the Spanish market as of August 2023. Sandoz continues to expand its capabilities by investing in new manufacturing facilities, enhancing its competitive edge within Spain.

Meanwhile, Merck KGaA has made strides in developing innovative biosimilars, particularly in oncology, reflecting the increasing demand for affordable treatment options in the region. Additionally, a noteworthy acquisition recently occurred with Fresenius Kabi acquiring a local manufacturing facility to bolster its production capacity in Spain in July 2023.

As the market value of biosimilars in Spain is projected to grow significantly, companies like Mylan and Stada Arzneimittel are also intensifying efforts to increase their market presence. The Spanish government's support for biotechnology through favorable regulations is fostering an environment ripe for market expansion, indicating a robust future for biosimilars in the healthcare sector. Major happenings include the rise of partnerships among key players in the last two years, focusing on enhancing Research and Development capabilities to meet market demand efficiently.

Future Outlook

Spain Biosimilar Contract Manufacturing Market Future Outlook

The Biosimilar Contract Manufacturing Market in Spain is poised for growth at an 18.89% CAGR from 2025 to 2035, driven by increasing demand for cost-effective biologics and regulatory support.

New opportunities lie in:

  • Expansion of manufacturing capabilities for complex biosimilars
  • Strategic partnerships with biotech firms for co-development
  • Investment in advanced bioprocessing technologies to enhance efficiency

By 2035, the market is expected to achieve substantial growth and innovation.

Market Segmentation

Spain Biosimilar Contract Manufacturing Market Product Outlook

  • Recombinant Non-glycosylated Proteins
  • Recombinant Glycosylated Proteins

Spain Biosimilar Contract Manufacturing Market Application Outlook

  • Oncology
  • Blood Disorders
  • Growth Hormonal Deficiency
  • Chronic & Autoimmune Disorders
  • Rheumatoid Arthritis
  • Others

Spain Biosimilar Contract Manufacturing Market Production Technology Outlook

  • Mammalian
  • Non-Mammalian

Report Scope

MARKET SIZE 2024 270.5(USD Million)
MARKET SIZE 2025 321.6(USD Million)
MARKET SIZE 2035 1815.0(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 18.89% (2025 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Samsung Biologics (KR), Lonza Group (CH), Boehringer Ingelheim (DE), Fujifilm Diosynth Biotechnologies (JP), Catalent (US), Wuxi Biologics (CN), Rentschler Biopharma (DE), KBI Biopharma (US), Amgen (US)
Segments Covered Product, Production Technology, Application
Key Market Opportunities Growing demand for cost-effective biosimilars drives expansion in biosimilar contract-manufacturing market.
Key Market Dynamics Rising demand for cost-effective biosimilars drives competitive contract-manufacturing partnerships in Spain's pharmaceutical sector.
Countries Covered Spain
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FAQs

What is the market size of the Spain Biosimilar Contract Manufacturing Market in 2024?

In 2024, the Spain Biosimilar Contract Manufacturing Market is expected to be valued at 193.25 USD Million.

What is the projected market size for the Spain Biosimilar Contract Manufacturing Market by 2035?

The market is projected to reach 1616.7 USD Million by 2035.

What is the expected CAGR for the Spain Biosimilar Contract Manufacturing Market from 2025 to 2035?

The expected CAGR for this market during the forecast period is 21.301%.

Which segment of products dominates the Spain Biosimilar Contract Manufacturing Market?

The market is divided into recombinant non-glycosylated proteins and recombinant glycosylated proteins.

What will be the market value of recombinant non-glycosylated proteins in 2035?

The market for recombinant non-glycosylated proteins is expected to reach 591.67 USD Million by 2035.

What is the forecasted market value for recombinant glycosylated proteins in 2024?

In 2024, the market for recombinant glycosylated proteins is anticipated to be valued at 122.0 USD Million.

What will be the market size for recombinant glycosylated proteins in 2035?

By 2035, the market for recombinant glycosylated proteins is projected to reach 1025.03 USD Million.

Who are the key players in the Spain Biosimilar Contract Manufacturing Market?

Major players in this market include Biocon, Sandoz, Merck KGaA, and Fresenius Kabi among others.

What are the growth drivers for the Spain Biosimilar Contract Manufacturing Market?

The growth of the market is driven by increasing demand for biosimilars and advancements in biotechnology.

What challenges does the Spain Biosimilar Contract Manufacturing Market currently face?

Challenges include regulatory hurdles and competition from innovative biologics in the pharmaceutical industry.

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