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Cell Gene Therapy Market

ID: MRFR/HC/20603-CR
200 Pages
Rahul Gotadki
July 2025

Cell and Gene Therapy Market Research Report By Therapy Type (Cell Therapy, Gene Therapy, Combination Therapy), By Application (Oncology, Genetic Disorders, Cardiovascular Diseases, Infectious Diseases), By End Use (Hospital, Research Institutions, Pharmaceutical Companies, Biotechnology Companies) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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Cell Gene Therapy Market Summary

As per MRFR analysis, the Cell and Gene Therapy Market was estimated at 15.01 USD Billion in 2024. The Cell and Gene Therapy industry is projected to grow from 17.73 USD Billion in 2025 to 93.76 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 18.12 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Cell and Gene Therapy Market is poised for substantial growth driven by technological advancements and increasing demand for personalized medicine.

  • North America remains the largest market for cell and gene therapies, driven by robust healthcare infrastructure and investment.
  • Asia-Pacific is emerging as the fastest-growing region, fueled by increasing healthcare expenditure and a rising patient population.
  • Cell therapy continues to dominate the market, while gene therapy is rapidly gaining traction as the fastest-growing segment.
  • Key market drivers include the rising prevalence of genetic disorders and advancements in gene editing technologies, which are shaping the future of therapeutic options.

Market Size & Forecast

2024 Market Size 15.01 (USD Billion)
2035 Market Size 93.76 (USD Billion)
CAGR (2025 - 2035) 18.12%

Major Players

Novartis (CH), Gilead Sciences (US), Bristol-Myers Squibb (US), Amgen (US), Spark Therapeutics (US), Bluebird Bio (US), Regeneron Pharmaceuticals (US), Sangamo Therapeutics (US), Celyad Oncology (BE)

Cell Gene Therapy Market Trends

The Cell and Gene Therapy Market is currently experiencing a transformative phase characterized by rapid advancements in technology and an increasing understanding of genetic diseases. This sector appears to be gaining momentum as researchers and companies explore innovative therapeutic approaches that target the underlying causes of various conditions. The integration of cutting-edge techniques, such as CRISPR and viral vector delivery systems, seems to enhance the efficacy of treatments, potentially leading to improved patient outcomes. Furthermore, the collaboration between academic institutions and industry players indicates a concerted effort to accelerate the development of novel therapies, which may reshape the landscape of healthcare in the coming years. In addition, regulatory bodies are adapting to the evolving nature of this market, suggesting a more streamlined approval process for new therapies. This shift could facilitate faster access to groundbreaking treatments for patients in need. As the Cell and Gene Therapy Market continues to expand, it is likely that investment in research and development will intensify, fostering a competitive environment that encourages innovation. The future of this market appears promising, with the potential to address previously untreatable diseases and improve the quality of life for countless individuals.

Technological Advancements

The Cell and Gene Therapy Market is witnessing remarkable technological progress, particularly in gene editing and delivery methods. Innovations such as CRISPR technology and advanced viral vectors are enhancing the precision and effectiveness of therapies, allowing for targeted interventions that were previously unattainable.

Regulatory Evolution

Regulatory frameworks are evolving to keep pace with the rapid advancements in the Cell and Gene Therapy Market. Authorities are increasingly focused on creating pathways that expedite the approval of novel therapies, which may lead to quicker patient access to innovative treatments.

Collaborative Research Initiatives

There is a growing trend of collaboration between academic institutions and biotechnology firms within the Cell and Gene Therapy Market. These partnerships are fostering an environment of shared knowledge and resources, which could accelerate the development of new therapies and enhance overall market growth.

Cell Gene Therapy Market Drivers

Rising Prevalence of Genetic Disorders

The increasing incidence of genetic disorders is a primary driver for the Cell and Gene Therapy Market. As more individuals are diagnosed with conditions such as hemophilia, cystic fibrosis, and muscular dystrophy, the demand for innovative therapies rises. According to recent estimates, approximately 1 in 1,500 individuals are affected by rare genetic disorders, highlighting a substantial patient population in need of effective treatments. This growing prevalence necessitates the development of targeted gene therapies, which aim to address the underlying genetic causes of these diseases. Consequently, pharmaceutical companies are investing heavily in research and development to create novel gene therapies, thereby propelling the Cell and Gene Therapy Market forward.

Growing Demand for Personalized Medicine

The shift towards personalized medicine is significantly influencing the Cell and Gene Therapy Market. Patients increasingly seek treatments tailored to their unique genetic profiles, which enhances therapeutic efficacy and minimizes adverse effects. This trend is supported by advancements in genomic sequencing technologies, which allow for comprehensive genetic analysis. As a result, the market for personalized therapies is expected to grow substantially, with projections indicating a value of USD 2 trillion by 2030. The emphasis on individualized treatment plans drives the development of gene therapies that can be customized to meet specific patient needs, thereby fostering innovation within the Cell and Gene Therapy Market.

Advancements in Gene Editing Technologies

Technological innovations in gene editing, particularly CRISPR and TALEN, are revolutionizing the Cell and Gene Therapy Market. These advancements enable precise modifications to DNA, facilitating the development of therapies that can effectively target and correct genetic mutations. The market for gene editing is projected to reach USD 10 billion by 2026, indicating a robust growth trajectory. As researchers continue to explore the potential of these technologies, the ability to create tailored therapies for various genetic disorders becomes increasingly feasible. This not only enhances the efficacy of treatments but also expands the scope of applications within the Cell and Gene Therapy Market, attracting significant investment and interest from stakeholders.

Increased Investment in Biopharmaceuticals

The surge in investment within the biopharmaceutical sector is a crucial driver for the Cell and Gene Therapy Market. Venture capital funding and public-private partnerships are on the rise, with investments exceeding USD 20 billion in recent years. This influx of capital is primarily directed towards the development of innovative therapies that address unmet medical needs. As companies strive to bring novel gene and cell therapies to market, the financial backing allows for extensive research, clinical trials, and regulatory compliance. This trend not only accelerates the pace of innovation but also enhances the overall growth potential of the Cell and Gene Therapy Market, as more therapies become available to patients.

Regulatory Support for Innovative Therapies

Regulatory bodies are increasingly supportive of the development and approval of innovative therapies, which serves as a significant driver for the Cell and Gene Therapy Market. Initiatives aimed at expediting the approval process for breakthrough therapies have been implemented, allowing for faster access to life-saving treatments. For instance, the FDA's accelerated approval pathway has facilitated the introduction of several gene therapies in recent years. This regulatory environment encourages pharmaceutical companies to invest in research and development, knowing that there is a streamlined process for bringing their products to market. As a result, the Cell and Gene Therapy Market is likely to experience accelerated growth, as more therapies gain regulatory approval and become available to patients.

Market Segment Insights

By Type: Cell Therapy (Largest) vs. Gene Therapy (Fastest-Growing)

In the Cell and Gene Therapy Market, the distribution of market share among various segment types reveals that Cell Therapy holds a substantial portion due to its established presence and proven efficacy in treating a variety of conditions. Gene Therapy, on the other hand, while smaller in market share, is gaining traction as innovative technologies emerge, offering new avenues for treating genetic disorders. As a result, Combination Therapy also begins to carve out its niche, appealing to segments of the market seeking integrated treatment methodologies. Growth trends in this segment are influenced by several factors, including an increasing prevalence of genetic disorders, advancements in technology, and a heightened emphasis on personalized medicine. Cell Therapy remains bolstered by ongoing clinical trials and regulatory approvals, reflecting its status as a mainstay in therapeutic approaches. Conversely, Gene Therapy is poised for rapid growth, driven by novel therapeutic platforms and increased investment in research and development. Combination Therapy shows potential as it may provide synergistic benefits, but it is still maturing in the market landscape.

Cell Therapy (Dominant) vs. Combination Therapy (Emerging)

Cell Therapy is a dominant player in the Cell and Gene Therapy Market, characterized by established methodologies and a robust clinical foundation. This segment primarily involves the use of living cells to treat diseases, including various cancers and genetic disorders. As therapies continue to demonstrate success in clinical settings, Cell Therapy enjoys a strong market position supported by multiple approved products. In contrast, Combination Therapy, while emerging, seeks to leverage the strengths of different therapeutic approaches, integrating Cell and Gene Therapies for enhanced efficacy. Though still developing, it aims to address complex diseases through innovative strategies, which could lead to transformative results in patient outcomes. The growing acceptance of Combination Therapy indicates potential for significant expansion as it garners interest from both researchers and practitioners.

By Application: Oncology (Largest) vs. Genetic Disorders (Fastest-Growing)

In the Cell and Gene Therapy Market, the application segments of Oncology, Genetic Disorders, Cardiovascular Diseases, and Infectious Diseases exhibit varied market shares. Oncology stands out as the largest segment, driven by the increasing prevalence of cancer worldwide and the advancements in gene therapies specifically targeting tumor cells. On the other hand, Genetic Disorders are gaining traction rapidly due to rising awareness and diagnostic improvements, making it the fastest-growing segment. Both segments benefit significantly from favorable regulatory frameworks.

Oncology: Dominant vs. Genetic Disorders: Emerging

Oncology is the dominant application area within the Cell and Gene Therapy Market, characterized by innovative therapies that address complex tumors. This segment leads the market due to extensive research, high investment levels, and increasing demand for personalized medicine. Conversely, Genetic Disorders represent an emerging area with significant growth potential. Driven by improved genetic understanding and innovations in CRISPR technology, this segment is expanding its reach. Increased patient advocacy and healthcare initiatives are fueling its growth, reflecting a shift toward early interventions and tailored treatment options for genetic conditions.

By End Use: Pharmaceutical Companies (Largest) vs. Research Institutions (Fastest-Growing)

In the Cell and Gene Therapy Market, the market share distribution reveals that Pharmaceutical Companies dominate the sector, leveraging their extensive resources and established infrastructure. They play a crucial role in developing and commercializing therapies, greatly influencing market trends and patient access to innovative treatments. On the other hand, Research Institutions represent the fastest-growing segment, driven by increased investments in gene and cell research, leading to substantial advancements in therapeutic technologies. Their role in clinical trials and collaborations with pharmaceutical entities further boosts their market presence.

Research Institutions (Dominant) vs. Biotechnology Companies (Emerging)

The dynamics within the Cell and Gene Therapy Market showcase Research Institutions as a dominant segment due to their pivotal role in innovation and development of therapies. They contribute significantly to foundational research and clinical trials, aided by their collaborations with larger pharmaceutical firms. In contrast, Biotechnology Companies reflect an emerging segment characterized by their agility and focus on niche therapies. While they face challenges in scaling operations, their emphasis on groundbreaking treatments positions them uniquely within the market, tapping into unmet medical needs and personalized medicine.

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Regional Insights

The Cell and Gene Therapy Market shows a robust growth trajectory within its regional segmentation. In 2024, North America is projected to hold a substantial market value of 4.5 USD Billion, expected to surge to 16.0 USD billion by 2035, reflecting its majority holding in the sector due to advanced healthcare systems and substantial Research and Development investments.

Europe follows with a valuation of 3.0 USD Billion in 2024, anticipated to grow to 10.5 USD billion by 2035, driven by strong regulatory frameworks and increased funding for biotechnological innovations.Meanwhile, South America is relatively smaller, valued at 0.5 USD Billion in 2024; however, its growth potential to 2.0 USD billion by 2035 cannot be overlooked, as it seeks to enhance its healthcare infrastructure. The Asia Pacific region, a rising player, recorded a value of 1.5 USD billion in 2024, projected to reach 6.5 USD billion by 2035, propelled by increasing patient populations and demand for advanced therapies.

Lastly, the Middle East and Africa exhibit a market value of 0.97 USD billion in 2024, with growth to 2.0 USD billion by 2035, indicating growing interest in gene therapy.

Collectively, these regions reflect varied dynamics, with North America and Europe being the dominant forces in the Cell and Gene Therapy Market, fueled by significant investments, while other regions create opportunities for market growth and innovation.

Cell and Gene Therapy Market Regional Insights

Source: Primary Research, Secondary Research, Market Research Future Database, and Analyst Review

Cell Gene Therapy Market Regional Image

Key Players and Competitive Insights

The Cell and Gene Therapy Market is a rapidly evolving sector driven by significant advancements in biotechnological innovations and the increasing prevalence of genetic disorders. The competitive landscape of this market is marked by a diverse range of companies that are leveraging cutting-edge research and development to deliver transformative therapies designed to target the root causes of diseases.

The landscape is characterized by strategic collaborations, mergers, and acquisitions that aim to enhance the product pipelines and expand the therapeutic reach of established and emerging players. As the demand for personalized medicine grows, the competition intensifies, pushing companies to continuously innovate and improve their offerings to achieve a competitive edge.Novartis stands out in the Cell and Gene Therapy Market with its strong commitment to research and development, leading to groundbreaking gene therapies that cater to various serious conditions.

The company has established a solid market presence bolstered by its extensive portfolio and strategic collaborations that enhance its capabilities in gene therapy development.

Novartis is recognized for its strength in navigating regulatory pathways to bring therapies to market efficiently, making it a formidable competitor in the field. With a strong emphasis on clinical trials and partnerships with research institutions, the company has positioned itself as a leader in the global landscape of cell and gene therapy, continuously striving to meet unmet medical needs through innovative solutions.Regeneron Pharmaceuticals is another key player in the Cell and Gene Therapy Market, known for its pioneering approach and robust product pipeline.

The company is engaged in several significant research initiatives that target individual genetic mutations and diseases, enhancing its market presence through the development of advanced therapies. Regeneron's strengths lie in its sophisticated technologies and proprietary platforms that facilitate rapid innovation.

The company has effectively expanded its capabilities through strategic mergers and acquisitions, positioning itself strongly in the global market. With a focus on presenting cutting-edge solutions, Regeneron's commitment to offering high-quality products further cements its reputation as a competitive force in cell and gene therapy solutions worldwide.

Key Companies in the Cell Gene Therapy Market market include

Industry Developments

The Cell and Gene Therapy Market has seen significant developments recently, particularly with companies like Novartis, Regeneron Pharmaceuticals, Gilead Sciences, Sangamo Therapeutics, Amgen, CRISPR Therapeutics, Spark Therapeutics, bluebird bio, Autolus Therapeutics, Roche, and Bristol Myers Squibb at the forefront.

In September 2023, Novartis reportedly pursued the acquisition of a clinical-stage gene therapy firm to strengthen its neurodegenerative disease portfolio, reflecting a trend toward consolidation in the sector.

Additionally, in March 2023, Gilead Sciences expanded its partnerships in gene therapy to target blood disorders, indicating a strategic focus on rare disease markets. Market valuations have risen significantly, fueled by increased R&D investments, particularly from companies like Amgen and Bristol Myers Squibb.

The regulatory environment continues to evolve, with agencies such as the FDA expediting approvals, enabling faster patient access to advanced therapies. Over the past two years, breakthroughs in CRISPR technology and personalized cell-based treatments have elevated global interest and underscored the transformative potential of these innovations.

Future Outlook

Cell Gene Therapy Market Future Outlook

The Cell and Gene Therapy Market is projected to grow at 18.12% CAGR from 2024 to 2035, driven by technological advancements, increasing investments, and rising prevalence of genetic disorders.

New opportunities lie in:

  • Development of personalized gene therapies for rare diseases.
  • Expansion of manufacturing capabilities for scalable production.
  • Strategic partnerships with biotech firms for innovative treatment solutions.

By 2035, the market is expected to be robust, driven by innovation and strategic collaborations.

Market Segmentation

Cell Gene Therapy Market Type Outlook

  • Cell Therapy
  • Gene Therapy
  • Combination Therapy

Cell Gene Therapy Market End Use Outlook

  • Hospital
  • Research Institutions
  • Pharmaceutical Companies
  • Biotechnology Companies

Cell Gene Therapy Market Application Outlook

  • Oncology
  • Genetic Disorders
  • Cardiovascular Diseases
  • Infectious Diseases

Report Scope

MARKET SIZE 2024 15.01(USD Billion)
MARKET SIZE 2025 17.73(USD Billion)
MARKET SIZE 2035 93.76(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR) 18.12% (2024 - 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 Billion
Key Companies Profiled Market analysis in progress
Segments Covered Market segmentation analysis in progress
Key Market Opportunities Advancements in personalized medicine drive growth in the Cell and Gene Therapy Market.
Key Market Dynamics Rising regulatory approvals and technological advancements drive innovation and competition in the Cell and Gene Therapy Market.
Countries Covered North America, Europe, APAC, South America, MEA

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FAQs

What is the projected market valuation for the Cell and Gene Therapy Market in 2035?

<p>The projected market valuation for the Cell and Gene Therapy Market in 2035 is 93.76 USD Billion.</p>

What was the market valuation of the Cell and Gene Therapy Market in 2024?

<p>The market valuation of the Cell and Gene Therapy Market in 2024 was 15.01 USD Billion.</p>

What is the expected CAGR for the Cell and Gene Therapy Market from 2025 to 2035?

<p>The expected CAGR for the Cell and Gene Therapy Market during the forecast period 2025 - 2035 is 18.12%.</p>

Which companies are considered key players in the Cell and Gene Therapy Market?

<p>Key players in the Cell and Gene Therapy Market include Novartis, Gilead Sciences, Bristol-Myers Squibb, Amgen, Spark Therapeutics, Bluebird Bio, Regeneron Pharmaceuticals, Sangamo Therapeutics, and Celyad Oncology.</p>

What are the main segments of the Cell and Gene Therapy Market?

<p>The main segments of the Cell and Gene Therapy Market include Type, Application, and End Use.</p>

How much is the Cell Therapy segment projected to grow by 2035?

<p>The Cell Therapy segment is projected to grow from 5.0 USD Billion in 2024 to 30.0 USD Billion by 2035.</p>

What is the projected value of the Gene Therapy segment in 2035?

<p>The Gene Therapy segment is projected to reach 45.0 USD Billion by 2035.</p>

Which application segment is expected to have the highest valuation by 2035?

<p>The Oncology application segment is expected to have the highest valuation, reaching 30.0 USD Billion by 2035.</p>

What is the projected market size for Biotechnology Companies in 2035?

<p>The projected market size for Biotechnology Companies in the Cell and Gene Therapy Market is 30.76 USD Billion by 2035.</p>

How does the market for Combination Therapy compare to other segments by 2035?

<p>The Combination Therapy segment is projected to grow from 3.01 USD Billion in 2024 to 18.76 USD Billion by 2035, indicating substantial growth.</p>

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