India Cell and Gene Therapy Market Size, Share, Trends and Forecasts 2031

Key Findings

• The India Cell and Gene Therapy Market is expanding rapidly due to breakthroughs in regenerative medicine, personalized therapies, and advanced genetic engineering technologies.
• Increasing approvals of CAR-T therapies, gene replacement therapies, and stem-cell–based treatments are transforming clinical outcomes across oncology, rare diseases, and chronic conditions.
• Advancements in viral vectors, CRISPR gene editing, and next-generation delivery platforms are accelerating development pipelines in India.
• Growing investments from biotechnology firms, venture capital groups, and government research programs are strengthening infrastructure for cell and gene therapy innovation.
• Rising prevalence of cancer, genetic disorders, and degenerative diseases is fueling demand for targeted and curative treatment modalities.
• Expansion of GMP-certified manufacturing facilities, bioprocessing technologies, and automated cell therapy platforms is improving scalability and commercial viability.
• Integration of AI-driven drug discovery, bioinformatics, and multi-omic analysis is enhancing precision, safety, and therapeutic predictability.
• Public–private partnerships are promoting clinical trial expansion, talent development, and cross-border collaboration in India.

India Cell and Gene Therapy Market Size and Forecast

The India Cell and Gene Therapy Market is projected to grow from USD 22.8 billion in 2025 to USD 67.4 billion by 2031, at a CAGR of 19.8%. Growth is driven by rising demand for personalized medicine, expansion of clinical trials for rare genetic diseases, and increasing success of high-profile therapies such as CAR-T cell treatments for hematologic cancers. Gene therapies targeting inherited disorders such as spinal muscular atrophy (SMA), hemophilia, and retinal dystrophies are gaining regulatory acceptance. Investment in manufacturing capacity, such as viral vector production and automated cell expansion systems, is accelerating commercialization. As healthcare systems evolve to support highly specialized therapies, market penetration is expected to rise significantly across India.

Introduction

Cell and gene therapies represent the forefront of biomedical innovation, offering curative potential for diseases previously considered untreatable. Cell therapy involves modifying or transplanting living cells to repair damaged tissues or modulate immune responses, while gene therapy introduces, removes, or edits genes to correct disease-causing mutations. In India, these therapies are transforming treatment paradigms for cancer, rare diseases, neurological disorders, and organ failure. The market includes CAR-T cell therapies, iPSC-derived treatments, hematopoietic stem cell transplants, in vivo and ex vivo gene therapies, and gene editing platforms. Rapid advancements in genomic sequencing, viral delivery systems, and immuno-oncology research continue to expand therapeutic possibilities.

Future Outlook

By 2031, the India Cell and Gene Therapy Market will shift toward scalable, automated, and precision-engineered therapeutic solutions. Genome editing technologies such as CRISPR-Cas9, base editing, and prime editing will play central roles in correcting inherited diseases with unprecedented accuracy. Manufacturing innovations such as closed-system bioprocessing, real-time quality analytics, and decentralized production will reduce costs and improve access. Expansion of allogeneic “off-the-shelf” CAR-T therapies will address limitations of autologous production. Regulatory frameworks will evolve to streamline clinical approvals while ensuring safety and long-term monitoring. India will emerge as a major hub for cell and gene therapy research, backed by strong academic institutions, biotech accelerators, and investment programs.

India Cell and Gene Therapy Market Trends

• Growing Adoption of CAR-T Cell Therapies and Next-Generation Immunotherapies
  CAR-T therapies targeting CD19, BCMA, and other tumor-associated antigens are showing exceptional clinical success in treating leukemias and lymphomas. In India, adoption is rising as hospitals establish specialized CAR-T treatment centers and expand apheresis capabilities. Next-generation CAR-T platforms feature enhanced persistence, reduced toxicity, and multi-target constructs to improve outcomes. Research on allogeneic, off-the-shelf CAR-T therapies is progressing rapidly, aiming to overcome manufacturing delays and reduce costs. This trend marks a shift toward personalized, immune-driven oncology solutions with transformative potential.

• Advancements in Gene Editing Technologies Including CRISPR, TALENs, and Base Editing
  Gene editing is revolutionizing genetic disease treatment by enabling precise DNA modifications. CRISPR-Cas9 remains the most widely adopted technology due to its simplicity, efficiency, and versatility. Base editing and prime editing offer even greater accuracy with reduced off-target effects. Research institutions in India are leveraging these tools to develop therapies for hemoglobinopathies, metabolic disorders, and neuromuscular diseases. Improved delivery systems such as lipid nanoparticles and engineered viral vectors are accelerating translation into clinical applications. This trend underscores the rapid evolution of precision genetic engineering.

• Expansion of Viral Vector Manufacturing and Advanced Bioprocessing
  Viral vectors such as AAV, lentivirus, and adenovirus are essential for gene therapy delivery. Demand for high-quality vectors is increasing dramatically as more therapies enter clinical trials. Manufacturers in India are investing heavily in GMP-certified vector production facilities, automated purification systems, and scalable bioreactors. Advances in upstream and downstream processing are improving yields and reducing production costs. This trend is essential for supporting commercialization of gene therapies at population scale.

• Rise of Allogeneic and Off-the-Shelf Cell Therapies
  Allogeneic therapies derived from donor cells or engineered cell lines offer advantages in scalability, cost, and treatment accessibility. In India, companies are developing universal CAR-T cells, NK cell therapies, and stem-cell–derived treatments that eliminate the need for patient-specific manufacturing. Gene editing tools help reduce immunogenicity, enabling wider applicability. This trend signifies the market’s transition from bespoke therapies toward mass-produced regenerative medicines.

• Integration of AI, Multi-Omics, and Computational Biology in Therapy Development
  AI algorithms and multi-omic platforms including genomics, transcriptomics, and proteomics are accelerating drug discovery and identifying precise therapeutic targets. Computational biology helps predict gene-editing outcomes, optimize vector design, and model immune responses. Companies in India are leveraging these advanced tools to improve therapy safety profiles and reduce R&D timelines. This trend drives greater innovation efficiency and pipeline diversification.

Market Growth Drivers

• Rising Prevalence of Cancer, Genetic Disorders, and Degenerative Diseases
  Increasing rates of leukemia, lymphoma, muscular dystrophies, retinal disorders, and metabolic diseases are driving strong demand for curative therapies. Cell and gene therapies offer treatment options for patients unresponsive to conventional therapies. As disease burden grows, healthcare providers in India are prioritizing advanced biologic and genetic treatments. This driver is central to sustained long-term market expansion.

• Strong R&D Investment and Expanding Clinical Trial Activity
  Biotechnology companies, government research agencies, and academic institutions in India are significantly increasing funding for gene therapy pipelines. Clinical trials targeting rare genetic diseases, solid tumors, and inherited blood disorders are expanding. Accelerated regulatory pathways and orphan drug incentives encourage innovation. These investments strengthen the scientific environment needed for breakthrough therapies.

• Advances in Bioprocessing, Manufacturing Automation, and Gene Delivery Platforms
  High-efficiency bioreactors, modular production suites, and automated cell-processing systems are reducing cost and improving quality. Innovations in viral vector engineering and non-viral delivery systems strengthen clinical feasibility. Improved manufacturing reliability supports commercialization of high-value therapies. These technological advancements serve as a major growth catalyst.

• Rising Acceptance of Personalized and Precision Medicine
  Cell and gene therapies embody the principles of personalized medicine by targeting root causes rather than symptoms. Physicians and patients in India increasingly recognize the value of therapies designed to correct genetic abnormalities or modulate immune responses. Personalized treatment strategies improve outcomes, reduce relapse rates, and enhance long-term quality of life. This acceptance supports higher adoption of advanced therapies.

• Government Initiatives and Supportive Regulatory Policies
  Public health agencies in India are establishing gene therapy guidelines, funding translational research, and expanding treatment access programs. Incentives for rare disease therapies and tax benefits for biotech manufacturers further support market development. Regulatory reforms aimed at simplifying clinical approvals also accelerate product introduction.

Challenges in the Market

• Extremely High Treatment Costs Limiting Patient Access
  Cell and gene therapies are among the most expensive medical treatments globally, with some therapies costing hundreds of thousands to millions of dollars per patient. These high prices result from complex manufacturing, specialized facilities, and lengthy clinical development processes. Many healthcare systems in India face reimbursement challenges and budget constraints, making it difficult for patients to access these therapies. Limited insurance coverage exacerbates financial barriers. As a result, widespread adoption is restricted despite strong clinical demand. Addressing affordability remains one of the most pressing challenges in the market.

• Manufacturing Complexity, Capacity Constraints, and Scalability Issues
  Producing high-quality viral vectors, CAR-T cells, and gene-modified cells requires specialized equipment, GMP environments, and highly skilled personnel. Manufacturing processes are lengthy, intricate, and prone to variability. Many facilities in India struggle to meet demand due to limited capacity and supply chain bottlenecks. Ensuring scalability without compromising safety and efficacy is a major constraint. Manufacturing challenges delay therapy delivery, increase costs, and restrict treatment availability.

• Safety Risks, Immune Reactions, and Long-Term Monitoring Requirements
  Gene editing and cell modification carry risks such as insertional mutagenesis, off-target edits, cytokine storms, and immune rejection. Patients require long-term monitoring to detect delayed adverse events. Regulatory agencies mandate extensive follow-up studies, increasing development timelines and cost. Safety concerns also limit patient eligibility for certain therapies. Managing these risks requires continuous innovation in vector design, editing precision, and safety switches.

• Regulatory Complexity and Inconsistent Global Standards
  Cell and gene therapies face some of the most stringent regulatory requirements due to their irreversible and genetic nature. Approval processes differ across regions in India, creating compliance challenges for manufacturers. Regulatory uncertainties slow clinical trial approvals and increase risk for investors. Harmonizing global regulatory frameworks remains difficult, hindering efficient commercialization. Continued dialogue between regulators and industry is essential for progress.

• Limited Expertise and Workforce Shortages in Advanced Cell Engineering
  Cell and gene therapy development requires multidisciplinary expertise in genomics, molecular biology, immunology, and bioprocessing. India faces significant shortages of trained personnel, particularly in manufacturing, quality control, and clinical administration. Academic institutions are expanding programs but demand far outpaces supply. Workforce limitations delay commercialization and reduce the speed of innovation.

India Cell and Gene Therapy Market Segmentation

By Therapy Type

• Cell Therapy (CAR-T, MSCs, iPSCs, NK cell therapy)

• Gene Therapy (In vivo, Ex vivo, Gene Replacement, Gene Editing)

• Gene-Modified Cell Therapy

• RNA-Based Therapeutics

By Application

• Oncology

• Genetic Disorders

• Neurology

• Ophthalmology

• Hematology

• Cardiology

• Musculoskeletal Disorders

• Infectious Diseases

By Vector Type

• Adeno-Associated Virus (AAV)

• Lentiviral Vectors

• Adenoviral Vectors

• Retroviral Vectors

• Non-Viral Delivery Systems (LNPs, Electroporation, Nanoparticles)

By End-User

• Hospitals

• Specialty Treatment Centers

• Biotechnology Companies

• Academic and Research Institutes

• Contract Development & Manufacturing Organizations (CDMOs)

Leading Key Players

• Novartis AG

• Gilead Sciences (Kite Pharma)

• Bristol Myers Squibb

• Pfizer Inc.

• Bluebird Bio

• Spark Therapeutics

• CRISPR Therapeutics

• Editas Medicine

• RegenxBio

• Vertex Pharmaceuticals

Recent Developments

• Novartis AG expanded new CAR-T therapy access programs across India, improving treatment availability for hematologic cancers.

• Gilead Sciences advanced its next-generation CAR-T pipeline targeting solid tumors, strengthening its position in India.

• CRISPR Therapeutics announced promising results for gene-edited therapies treating sickle cell disease in India clinical centers.

• Spark Therapeutics partnered with regional health institutions in India to expand gene therapy research infrastructure.

• Vertex Pharmaceuticals launched clinical advancements in CRISPR-based therapies targeting genetic metabolic disorders in India.

This Market Report Will Answer the Following Questions

1. What is the projected market size and growth rate of the India Cell and Gene Therapy Market by 2031?

2. Which therapeutic innovations CAR-T, CRISPR, AAV delivery are driving market expansion?

3. What manufacturing and regulatory challenges limit commercialization in India?

4. How are advancements in bioprocessing, automation, and AI transforming therapy development?

5. Who are the major global and regional players leading innovation in the cell and gene therapy sector?