Cell and Gene Therapy Market Research Report Information by Therapy Type (Cell Therapy and Gene Therapy), Application (Cancer, Neurological Disorders, Cardiovascular Disorders, Rare Diseases, Ophthalmology, Blood Disorders and Others), and Region (North America, Europe, Asia-Pacific, and Rest of the World)—Forecast till 2032

Global Cell and Gene Therapy Market Overview

The Cell and Gene Therapy Market size was valued at USD 12.83 billion in 2023 and is projected to grow from USD 15.01 billion in 2024 to USD 67.89 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 18.12% during the forecast period (2024 - 2032). The growing incidences of cancer and rare disorders and increasing approval for gene and cell therapy products are major factors driving the market growth.

Additionally, the growing investments in the field of cell and gene therapy will provide growth opportunities for the market in the future.

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Cell and Gene Therapy Market Trends

• Growing incidences of cancer and rare disorders

Increasing incidences of diseases such as cancer, cystic fibrosis, sickle cell anemia, and others, are burgeoning market growth. For instance, according to the International Agency for Research on Cancer, there were cancer cases of nearly 9,826,539 in Asia, 4,471,422 in Europe, 2,673 174 in Northern America, 1,551,060 in Latin America and the Caribbean, 1,185,216 in Africa, and 269 088 in Oceania cancer cases of both genders in 2022. Furthermore, India also reported increasing incidences of cancer, which is contributing to the growth of the Cell and Gene Therapy Market. As per the International Agency for Research on Cancer, in 2022, there were 192,020 breast cancer cases, 143,759 lip, oral cavity, 127,526 cervix uteri, 81,748 lung, 70,637 esophagus, 70,038 colorectum, and 727,588 cancer cases of others. These increased cases of cancer across India are increasing the demand for innovative drugs by healthcare providers and patients which leads to the frequent launches of drugs associated with cell and gene therapy. For instance, in April 2024, the Indian Institute of Technology (IIT) Bombay and Tata Memorial Centre launched gene-based therapy, namely NexCAR19 CAR T-cell therapy. This product is India’s first therapy that is affordable, accessible, and low-cost. CAR T-cell therapy is a huge achievement for India and for Indian cancer patients. Moreover, as per the American Lung Association, there were about 30,000 people with cystic fibrosis in the US and nearly 70,000 people worldwide in 2022. Also, in April 2024, the Centers for Disease Control and Prevention reported that nearly 6,000 babies born with Down syndrome in the United States. 

Thus, the increasing incidences of cancer and rare disorders across the globe and rising innovative product launches to treat these diseases are boosting the growth of the market.

 Increasing approval for gene and cell therapy products

Favorable regulatory authorities play an important role because these treatments are more widely accepted by healthcare professionals, patients, and regulatory bodies. Frequent approval increases the number of patients willing to consider these therapies. Furthermore, there are clear pathways for regulatory approval due to the increased use of cell and gene therapy.

In March 2024, Orchard Therapeutics launched Lenmeldy (atidarsagene autotemcel), previously named OTL-200, the first FDA-approved therapy for children affected by pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ), or early symptomatic early juvenile (ESEJ) forms of metachromatic leukodystrophy (MLD), collectively referred to as early-onset MLD.

In February 2024, U.S. Food and Drug Administration (FDA) has granted approval for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) to treat adult patients with relapsed or refractory multiple myeloma. These patients must have undergone at least one prior line of therapy, which included both a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide.

Cell and Gene Therapy Market Segment Insights

Cell and Gene Therapy, therapy type Insights

Based on therapy type, the global cell & gene therapy market has been segmented into cell therapy and gene therapy. The cell therapy segment held the largest market share in 2023 and gene therapy is the fastest-growing segment during the forecast period i.e., 2024 -2032.

Gene therapy segment is further segmented into Autologous and Allogenic. The autologous segment dominated the market in 2022. Additionally, it is anticipated that during the forecast period, this segment will increase more quickly. Due to the widespread use of CAR-T treatments and their successful outcomes in the treatment of various malignancies and genetic abnormalities, the market is expected to rise.

The gene therapy segment is further segmented into Ex-vivo and In-vivo. The in vivo therapy segment held the largest market share in 2023, owing to increase in the adoption of in vivo gene therapies globally. As vivo gene therapy can reach multiple sites or organs throughout the body, it allows for systemic treatment. This is especially beneficial for diseases that affect multiple organ systems or have systemic manifestations, allowing for a more comprehensive therapeutic approach.

FIGURE 2: CELL AND GENE THERAPY MARKET SIZE, BY THERAPY TYPE, 2023 & 2032 (USD BILLION)

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Cell and Gene Therapy Application Insights

Based on application, the global cell & gene therapy market has been segmented into Cancer, Neurological Disorders, Cardiovascular Disorders, Rare Diseases, Ophthalmology, Blood Disorders, and Others. The cancer segment held the largest market and is the fastest growing segment during the forecast period, owing to increase in prevalence of cancer, rise in development of gene and cell therapy drugs specific to oncology.  Advances in gene editing technologies such as CRISPER-CAS9, TALEN, and zinc finger nucleases, enable precise modifications of gene in immune cells to enhance their anti-cancer properties. These technologies can be used to knock out the genes that inhibit immune responses or to introduce genes that enhance cytotoxicity against cancer cells. For instance, in 2022, the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed.

However, the rare diseases segment is expected to grow at a significant CAGR during the forecast period, owing to rise in the prevalence of rare disease across the world. For instance, according to FDA in 2022, rare diseases affect 30 million people in the USA and many rare conditions are life-threatening and most do not have treatments.

Cell and Gene Therapy Regional Insight

By Region, the study segments the market into North America, Europe, Asia-Pacific, and Rest of the World.

Based on region, the global cell & gene therapy market has been segmented into North America, Europe, Asia-Pacific, and the Rest of the World. North America accounted for the largest market share of 42.68% in 2022 and is anticipated to reach approximately USD 27.01 billion by 2032 at a 17.38% CAGR during the forecast period, owing to rise in the prevalence of chronic disease, availably of reimbursements for the gene therapy and rise in healthcare expenditure and research development activities for gene therapy drugs across the region. In North America, US dominated the market with market share of 82.36%.

However, Asia-Pacific is projected to grow at the highest CAGR of 20.10% during the forecast period, owing to a sizable population base, heightened healthcare awareness, and a surge in cases of cancer. These factors collectively drive the demand for gene therapy in the region. Additionally, pharmaceutical market expansion, government initiatives, and a surge in research and development activities contribute to the region's accelerated growth. Furthermore, a rise in research activities as well as the well-established presence of domestic companies in the region are expected to provide notable opportunities for market growth. Asia-Pacific is further segmented into the China, India, Japan, South Korea, Australia, and Rest of Asia-Pacific. Japan dominated the market in Asia-Pacific region with market share 24.55%.

FIGURE 3: CELL AND GENE THERAPY MARKET SIZE, BY REGION, 2023 & 2032 (USD Billion)

Cell and Gene Therapy Key Market Players & Competitive Insights

The Cell and Gene Therapy Market is distinguished by the presence of numerous global, regional, and local players catering to Cell and Gene Therapy medications. Furthermore, the growing incidences of cancer and rare disorders and increasing approval for gene and cell therapy products is further driving the growth of Cell and Gene Therapy Market during the forecast period. The major players have adopted a strategy of obtaining regulatory approval from government agencies for their products and signing contracts and agreements to broaden their reach. For instance, in June 2023, The U.S. Food and Drug Administration (FDA) approved Sarepta Therapeutics' (US) ELEVIDYS (delandistrogene moxeparvovec-rokl) gene therapy to treat pediatric patients with ambulatory Duchenne muscular dystrophy (DMD) who are between the ages of 4 and 5 and have a verified mutation in the DMD gene.

The Cell and Gene Therapy Market is extremely competitive, with players competing, partnering, and investing heavily in research and development to gain a significant market share. The market is moderately fragmented with rising competition, increasing collaborative partnerships, and other strategic decisions to achieve operational efficiency.

Mergers and collaborations were also observed to expand the company's product portfolio, as well as introduce new cell and gene therapy medications. The growth of prominent industry players is dependent on various factors, such as market conditions, government support, and industry development. It is also projected that a rise in the investments for R&D will also boost the market's growth in the upcoming future.

Key Companies in the Cell and Gene Therapy Market include.

• Novartis AG (Switzerland)


• Bristol-Myers Squibb Company (US)


• Amgen Inc. (US)


• Aurion Biotech (US)


• Sarepta Therapeutics, Inc. (US)


• Ferring B.V. (Switzerland)


• Sibiono Genetech Co, Ltd., Shenzhen (Sibiono)


• Bluebird Bio, Inc. (US)


• Kite Pharmaceuticals, Inc. (US)


• Janssen Global Services (US)

Global Cell and Gene Therapy Industry Developments

April 2024: The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb's Abecma (idecabtagene vicleucel; ide-cel) therapy for adult patients. With this approval, patients who were previously on two lines of therapy and who experienced a relapse or became resistant to treatment after being exposed to these three primary classes of treatment (triple-class exposed) can now receive prescriptions for Abecma.

March 2024: The U.S. Food and Drug Administration (FDA) approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL). Breyanzi offers a tailored therapy option that is given as a single infusion to patients with SLL or CLL who have relapsed, are resistant, and have not previously undergone standard care. This treatment option results in significant and durable responses.

February 2024: Janssen Global Services (Belgium) received an approval from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for CARVYKTI to treat relapsed and refractory multiple myeloma (RRMM).

December 2023: Bluebird bio, Inc. (US) received an approval from US Food Drug and Administration for Lyfgenia representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. 

March 2023: Aurion Biotech Receives Approval from Japan’s PMDA for New Drug Application VyznovaTM for its novel cell therapy, VyznovaTM for the treatment of bullous keratopathy of the cornea. The launch of VyznovaTM in Japan marks several firsts for Aurion Biotech, regenerative medicine, and millions of underprivileged patients. Notably, it is the first time a cell therapy for corneal endothelial disease has been approved.

Cell and Gene Therapy Market Segmentation

Cell and Gene Therapy, Therapy type Outlook

• Cell Therapy
  
  
  
  • Autologous
  
  
  • Allogenic
  
  
  
  


• Gene Therapy
  
  
  
  • Ex-vivo
  
  
  • In-vivo
  
  
  
  

Cell and Gene Therapy Application Outlook

• Cancer


• Neurological Disorder


• Cardiovascular Disorder


• Rare Diseases


• Ophthalmology


• Blood Disorders


• Others

Cell and Gene Therapy Regional Outlook

North America

• US


• Canada

Europe

• Germany


• France


• UK


• Italy


• Spain


• Rest of Europe

Asia-Pacific

• China


• Japan


• India


• South Korea


• Australia


• Rest of Asia-Pacific

Rest of the World

• Middle East


• Africa