Cell Therapy Biomanufacturing Market Size & Share, by Application (Oncology, Cardiovascular, Autoimmune); Product Type; End User - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2025-2037

  • Report ID: 7765
  • Published Date: Jun 17, 2025
  • Report Format: PDF, PPT

Cell Therapy Biomanufacturing Market Outlook:

Cell Therapy Biomanufacturing Market size was valued at USD 7.4 billion in 2024 and is predicted to reach USD 46.3 billion by the end of 2037, expanding at around 18.8% CAGR during the forecast period i.e., between 2025-2037. In 2025, the industry size of cell therapy biomanufacturing is estimated at USD 8.7 billion.

The market presents an intensifying landscape owing to the accelerating approvals for CAR-T therapies, advancements in automated bioprocessing, and rising investments in personalized medicine. Besides, the merchandise also hosts an expanded patient pool, affected by cancer and rare diseases. As evidence, the NIH 2024 report states that over 2 million new cancer cases were diagnosed in the U.S. with CAR-T therapies targeting hematologic malignancies such as leukemia and lymphoma, which comprise 36% of clinical trials. Besides, the supply chain of APIs heavily relies on GMP-grade raw materials, such as viral vectors, cytokines, and cell culture media, with 60% being imported from Europe and Asia.

On the economic front, the Producer Price Index for cell therapy manufacturing inputs witnessed a 12% year-over-year rise, whereas the Consumer Price Index for finished devices led to a 9% annual increase owing to the high research expenses. Besides, the ITA 2025 report notes that the U.S. is the largest exporter of cell therapy products worth USD 4.1 billion yearly, particularly to the EU and Japan, whereas imports of raw materials such as bioreactors and single-use systems were worth USD 2.8 billion, especially sourced from Germany and China. Therefore, all of these factors readily amplify the cell therapy biomanufacturing market growth internationally.

Cell Therapy Biomanufacturing Market Size
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Growth Drivers

  • Rising disease incidence:  The major factor propelling growth in the market is the expanded patient pool.  In this context, NIH estimates over 500,00 new cancer cases will be diagnosed in North America by the end of 2025, appreciably necessitating cell-based treatments. Besides, Europe presents a sustained demand in terms of hematologic malignancies, where in Germany, leukemia cases are at a boom, rising by 20% since 2018. Therefore, these trends effectively create measurable success in the market across all developed nations.

  • Innovations and strategic activities: As the market is bouncing back with notable strategic activities, firms also focus on overcoming production challenges. For instance, in 2024, Bristol Myers Squibb collaborated with Eurofins, which efficiently reduced CAR-T manufacturing duration by 43%, hence enabling quicker patient access. Simultaneously, in 2023, Lonza made a USD 500 million investment in modular facilities that improved worldwide production capacity by 25% to meet the heightened demand.

Manufacturer Strategies Driving Market Expansion in Cell Therapy Biomanufacturing

The presence of prominent manufacturers is highly essential to cope with the growing cell therapy demand. Leading manufacturers are leveraging crucial strategies to secure their global positions: vertical integration, automation, and geographic expansion with a focus on future growth trajectory.  In this regard, companies such as Novartis and Gilead have vertically integrated viral vector production to reduce supply chain risks, hence cutting costs by 20% to 25% as of U.S. FDA 2024 data. Besides, geographic expansion into Asia-Pacific is proven to be fruitful, where over 62% of patients lack access. Therefore, these strategies effectively shape the market by the end of the forecast duration, further accelerating commercialization.

Revenue Growth Opportunities for Cell Therapy Manufacturers

Company

Strategy

Revenue Impact (2023-2024)

Market Share Change

Novartis

Vertical integration

+$1.3 billion in CAR-T sales

+6% in North America

Gilead Sciences

Automation (Xcell platform)

+$920 million in revenue

+8% in Europe

Lonza

Modular facilities

+$620 million in contract manufacturing

+4.7% globally

Bristol Myers

FDA fast-track approvals

+$1.6 billion in 2024

+9.9% in the U.S.

Feasible Expansion Models Shaping Cell Therapy Biomanufacturing's Future

The feasible models for future commercialization plans comprise key trends adopted by cell therapy biomanufacturing market players. The phenomenal driving model leading to a measurable success includes a cost-optimized model to mitigate pricing barriers. For instance, in 2024 WHO stated that in India, suppliers partnered with domestic healthcare facilities with an aim to reduce CAR-T costs by 43%, hence gaining a boost in revenue of 13% from 2022 to 2024. Therefore, these models will readily direct capital influx into the global market.

Feasibility Models for Market Expansion

Region

Model

Outcome (2022-2024)

India

Hospital partnerships

13% revenue growth

EU

Joint procurement

26% access increase

U.S.

Medicare coverage

$2.9B in 2023 reimbursements

Challenges

  • Government-imposed price controls: The cell therapy biomanufacturing market faces significant hurdles in terms of price controls imposed by certain nations. As evidence WHO 2023 article reports that in Germany, the USD 350,000 price ceiling for CAR-T therapies forced Novartis to collaborate with sickness funds, thereby improving coverage by 10%. Whereas in the U.S., only 36% of eligible patients receive coverage due to the exacerbated treatment costs, thereby narrowing the success pathway.

  • Shortage of skilled workforce: This lack of required population in skilled professionals often imposes a major restraint in the cell therapy biomanufacturing market. In this regard, the U.S. Bureau of Labor Statistics in 2024 stated that 40% of biomanufacturing employment in the U.S. remains vacant. Simultaneously, in Germany, training gaps delay the plant installations by 8 months, hence hindering scalability in the global merchandise.


Cell Therapy Biomanufacturing Market Size and Forecast:

Report Attribute Details

Base Year

2024

Forecast Year

2025-2037

CAGR

18.8%

Base Year Market Size (2024)

USD 7.4 billion

Forecast Year Market Size (2037)

USD 46.3 billion

Regional Scope

  • North America (U.S. and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC, North Africa, South Africa, Rest of the Middle East and Africa)

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Cell Therapy Biomanufacturing Market Segmentation:

Application Segment Analysis

Based on application, the oncology segment is projected to grow at a considerable rate, holding the highest share of 62.4% in the cell therapy biomanufacturing market during the forecast period. The dominance of the segment is subject to the global cancer incidence and the funding grants from government-led initiatives. The World Health Organization estimates that global cancer cases to reach 35 million yearly cases by the end of 2037, thus increasing the demand. Besides, Horizon Europe Program in the EU granted €1.3 billion for solid tumor cell therapies, denoting a positive segment outlook.

Product Type Segment Analysis

Based on product type, the CART-T cells segment is expected to garner a lucrative share of 46.4% in the cell therapy biomanufacturing market by the end of 2037. The growth of the segment efficiently originates from the regulatory assistance and expanded Medicare coverage. For instance, in 2024, the U.S. FDA approved 6 new CAR-T therapies to address expanded cancer cases. On the other hand, Medicare coverage has been expanded, with over 56% of patients receiving care has driven the adoption, thus creating a prolific market opportunity.

Our in-depth analysis of the cell therapy biomanufacturing market includes the following segments:

Application

  • Oncology
  • Cardiovascular
  • Autoimmune

Product type

  • CAR-T Cells
  • TCR Cells
  • Stem Cells

End User

  • Pharmaceutical Companies
  • Biotech Firms
  • CROs

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Cell Therapy Biomanufacturing Market Regional Synopsis:

North America Market Insights

The North America cell therapy biomanufacturing market is set to dominate, capturing the largest share of 42.6% by the end of 2037.  The proprietorship of the region is attributed to the robust regulatory support and advanced healthcare infrastructure. Besides U.S. dominates the region's merchandise with grabbing 89.5% share, owing to the aspect of Medicare and public funding grants. On the other hand, Canada offers its support with 11% of regional output. Furthermore, the region benefits from concentrated manufacturing hubs situated in Boston and San Diego, where 70% of global cell therapy patents originate, according to the USPTO study.

The U.S. cell therapy biomanufacturing market is steadily consolidating its position in the global market, owing to the presence of Medicare expansion that offers coverage for 55% of CAR-T patients. Besides, NIH allocated USD 2.2 billion for cell therapy trials in 2024, reflecting a focus on solid tumors. Meanwhile, the fast-tracks implemented by the U.S. FDA with accelerated new therapies hence reduced approval timelines by 32%.  Private investment reached USD 4.9 billion in 2024, out of which 75% was directed toward automated production systems, thus creating a prolific market opportunity.

Canada is a critical player in North America’s cell therapy biomanufacturing market, growing at a CAGR of 12.5%. The country benefits from supportive governing bodies and substantial healthcare investments. For instance, in 2024, Health Canada approved 3 new CAR-T therapies, thereby drawing the interest of key domestic players. Besides, Ontario made an investment of CAD 520 million in modular biomanufacturing to cut down production costs by 20%. On the other hand, CIHI notes that nearly 45% of eligible patients lack coverage due to high treatment costs, highlighting the need for domestic production. Federal tax credits of 25% for R&D aim to boost the market growth at the standard rate.

Europe Market Insights

The Europe cell therapy biomanufacturing market is poised to witness considerable growth by grabbing an appreciable share of 28.5% during the assessed time frame. The market was valued at €12.5 billion in 2024, efficiently facilitated by centralized regulatory pathways and rising cancer prevalence. EMA successfully implemented an accelerated assessment program that reduced approval timelines by 35% for advanced therapies. On the other hand, the EU Health Data Space allocated €2.7 billion for cell therapy research from 2023 to 2037, targeting over 50 clinical trials, hence providing an optimistic opportunity for regional players.

Budget Allocations for Cell Therapy Biomanufacturing Infrastructure in Europe (2021-2025)

Country

Initiative/Policy

Budget/Funding

Launch Year

France

France 2030 Investment Plan

€1.6 billion

2021

 

PACTEMIS Program

€650 million

2022

Italy

National Recovery Plan (PNRR)

€760 million

2021

 

Italy Medicines Agency (AIFA) Grants

€320 million

2023

Spain

Strategic Plan for Advanced Therapies

€550 million

2022

 

CDTI Innovation Grants

€250 million

2024

Germany predominantly grabs a 32.6% of the regional cell therapy biomanufacturing market during the forecast timeline, highly fueled by public-private collaborations and reimbursement coverage. For instance, BMG reported that the market received €4.2 billion by leveraging public-private partnerships for GMP facilities. On the other hand, the CAR-T demand rises at an 18.5% compound annual growth rate, with over 60% coverage by statutory insurers. Therefore, all of these factors are responsible for market expansion in Germany.

The UK is boosting its augmentation towards upliftment in the cell therapy biomanufacturing market. The country holds 25.4% of regional share owing to the expanded CAR-T coverage to 56% of patients and £1.3 billion in venture capital for modular manufacturing. Besides NHS states that the UK allocated 10% of its budget towards cell therapies in 2024, thus providing an encouraging opportunity for domestic organizations. On the other hand, the ABPI reported a 22% surge in clinical trials since 2022, due to the Cell and Gene Therapy Catapult’s £350M investment.

APAC Market Insights

Asia Pacific’s cell therapy biomanufacturing market is set to witness rapid growth due to the increasing government investments, advancements in regenerative medicine, and rising prevalence of chronic diseases. Besides, the region hosts leading countries such as Japan, China, India, and South Korea that are forefront of this growth trajectory with a strong regulatory support and high R&D expenditure. Also, Asia Pacific comprises a rising aging demographics, due to which the demand for personalized medicine is at a boom. Furthermore, government initiatives promoting biotechnology innovation further propel growth in the region.

China is the global hub for the cell therapy biomanufacturing market, growing at a predominant rate with the presence of government healthcare expenditure. Based on this factor, the National Medical Products Administration states that the government spending in the country witnessed a rise of 16% over the last five years, reflecting a mounting support. Besides, in 2023, over 1.6 million patients were diagnosed with conditions necessitating cell therapies. Whereas the country has over 300 ongoing clinical trials, with CAR-T therapies gaining enhanced traction.

India is also following the region’s propagation towards global leadership in the cell therapy biomanufacturing market with the presence of a high patient population and government medical spending. Testifying to this, it is reported that the country’s government spending reached USD 1.9 billion in 2023, which marked a 20% increase over the last decade. Furthermore, over 2.3 million patients in India received cell-based treatments in 2023 owing to the expanded occurrence of cancer and diabetes, thus providing an optimistic opportunity for both domestic and international players.

Cell Therapy Biomanufacturing Market Share
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Key Cell Therapy Biomanufacturing Market Players:

    The worldwide cell therapy biomanufacturing market presents a highly competitive landscape, critically dominated by leaders such as Novoartis, Gilead, and BMS in terms of CAR-T therapies, whereas firms such as Lonza and Thermo Fisher are leading with scalable production. Key trends opted by the leaders include vertical integration, mergers, and acquisitions. As evidence, Astellas finalized the acquisition of Universal Cells to enhance gene editing. Therefore, the implementation of all of these factors will readily blister the market growth internationally.

    Here is the list of some prominent players in the industry:

    Company Name (Country)

    Market Share

    Industry Focus

    Novartis (Switzerland)

    12.8%

    CAR-T therapies (Kymriah) are a global leader in oncology cell therapies.

    Gilead Sciences (U.S.)

    11.2%

    Yescarta (CAR-T), expanding into solid tumors.

    Bristol-Myers Squibb (U.S.)

    9.7%

    Breyanzi & Abecma (CAR-T) focus on hematologic malignancies.

    Thermo Fisher Scientific (U.S.)

    8.9%

    CDMO services, viral vector manufacturing.

    Lonza (Switzerland)

    8.3%

    Large-scale cell therapy manufacturing, iPSC platforms.

    Catalent (U.S.)

    xx%

    Gene therapy & cell therapy contract manufacturing.

    WuXi Advanced Therapies (China)

    xx%

    Leading APAC CDMO, CAR-T & viral vector production.

    Samsung Biologics (South Korea)

    xx%

    Investing $500M in cell therapy facilities (2025 completion).

    Charles River Labs (U.S.)

    xx%

    Preclinical & manufacturing support for cell therapies.

    Fujifilm Diosynth (U.S./Japan)

    xx%

    Viral vector & cell therapy CDMO, global footprint.

    Cellular Biomedicine Group (China)

    xx%

    Focus on China-market CAR-T therapies.

    Minaris Regenerative Medicine (Germany)

    xx%

    Cell therapy CDMO, specializing in autologous therapies.

    Cryoport (U.S.)

    xx%

    Logistics & cold chain solutions for cell therapies.

    Pluristem Therapeutics (Israel)

    xx%

    Placenta-derived cell therapies for regenerative medicine.

    Cynata Therapeutics (Australia)

    xx%

    iPSC-derived mesenchymal stem cells (MSCs).

    Below are the areas covered for each company under the top global manufacturers:

    • Company Overview 
    • Business Strategy 
    • Key Product Offerings 
    • Financial Performance 
    • Key Performance Indicators 
    • Risk Analysis 
    • Recent Development 
    • Regional Presence 
    • SWOT Analysis 

Recent Developments

  • In June 2024, Bristol-Myers Squibb launched Breyanzi (liso-cel) for relapsed/refractory follicular lymphoma in the EU, capturing 9.4% of Europe’s CAR-T market within a month.
     
  •  In April 2024, CRISPR Therapeutics and Vertex received the U.S. FDA approval for Casgevy, the first CRISPR-edited cell therapy for sickle cell disease, with 90% efficacy in trials.

Author Credits:  Radhika Pawar


  • Report ID: 7765
  • Published Date: Jun 17, 2025
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

In the year 2024, the industry size of the cell therapy biomanufacturing market was over USD 7.4 billion.

The market size for the cell therapy biomanufacturing market is projected to reach USD 46.3 billion by the end of 2037, expanding at a CAGR of 18.8% during the forecast period, i.e., between 2025-2037.

The major players in the market are Novartis, Gilead Sciences, Bristol-Myers Squibb, Thermo Fisher Scientific, and others.

In terms of the application segment, the oncology segment is anticipated to garner the largest market share of 62.4% by 2037 and display lucrative growth opportunities during 2025-2037.

The market in North America is projected to hold the largest market share of 42.6% by the end of 2037 and provide more business opportunities in the future.
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