Gene Therapy Market – DataM Intelligence

Market Overview:

Gene therapy is the cutting-edge therapy employed for cancer, chronic disease, infectious disorder, and blood conditions. Gene therapy interests the partial or complete substitute of defective genes in a patient’s body with healthy ones for treatment or prevention of disease growth. Gene therapy is of two types depending upon the site of the target gene on a chromosome including somatic gene therapy & germline gene therapy.

Market Size Growth Rate:

According to the DataM market research report, the global gene therapy market size is valued at USD 7.4 billion in 2022, it is expected to reach USD 29.2 billion by 2030, with growth at a CAGR of 19.4% over the forecast period 2023-2030. North America is estimated to contribute 38.6% to the growth of the global market over the forecast period.

The fundamental factors that drive the gene therapy market growth includes an upsurge in the preponderance of chronic conditions like cancer, rare disease genetic conditions, and others globally. Further, rise in government support, increase in product approvals, growing research investments and activities, and increasing market developments such as expansion, mergers, and acquisitions among others.

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Market Drivers:

The growing cases of chronic disorders such as cancer, hematological diseases, and rare genetic disorders drive the global gene therapy market in the forecast period. For instance, according to the National Center for Health Statistics, in 2022, over 1,918,030 fresh cancer cases and more than 609,360 cancer-associated deaths were estimated to transpire in the United States only, including around 350 deaths daily because of lung cancer, the top reason of cancer death.

Moreover, according to the Breast Cancer Organization, approximately 13% i.e., one out of eight women in the U.S. are expected to grow invasive breast cancer in their lifetime. The same source in 2022, estimated that more than 287,850 new cases of invasive breast cancer expected to be diagnosed in women in the U.S., along with 51,400 new cases of non-invasive (in situ) breast cancer. Similarly, the according to the U.S. Centers for Disease Control and Prevention (CDC) in August 2022, over 33,000 individuals in the U.S. were with hemophilia.

Market Restraints:

The high cost of gene therapies is estimated to hamper the global gene therapy market growth in the forecast period. For instance, according to the Institute for Clinical and Economic Review (ICER) indicates the moderate cost of gene therapy is between $1 million and $2 million per dose. Likewise, according to the same source cell therapy prices vary more widely relying on the application and the type of product, the intermediate cost per treatment is $1 million. 

Also, in November 2022, the Food and Drug Administration (FDA) authorized the globe’s first gene therapy for hemophilia B, Hemgenix (etranacogene dezaparvovec). Hemgenix has a list price of $3.5 million per use. Further, the U.K.’s National Institute for Health and Care Excellence (NICE) has published a draft recommendation suggesting that England’s National Health Service (NHS) should not cover the gene therapy Hemgenix (etranacogene dezaparvovec) for adults with hemophilia B.

Market Opportunities:

The increasing research funding to develop novel gene therapies for distinct chronic disorders is expected to present the global gene therapy market with prospective growth opportunities in forthcoming years. For instance, in March 2022, the National Heart Lung, and Blood Institute funded USD 12 million to an Indiana University School of Medicine investigator. The funding is for analysing significant compositions in a gene therapy technique for securer and potentially curative therapies for haemophilia.

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COVID-19 Impact Analysis:

Coronavirus 2019 (COVID-19) has induced substantial disturbance to the cell and gene therapy (CGT) market, which has historically encountered significant intricacies in the collection of materials, and manufacturing and transportation-related operations. As decision-makers redirected their preferences to COVID-19-associated cases, the pre-existing problems in market clearance and cost and reimbursement of CGTs were intensified. However, it is pressing to notice that some CGT developers adapted and are continuing to adapt their endeavours toward the design of promising COVID-19-related therapeutics and vaccines. Manufacturing strength, telemedicine, innovative payment mechanisms, digitalization, and value-based pricing are expected to be increasingly harnessed to secure that market access to CGTs is not harshly disrupted.

Russia-Ukraine War Impact Analysis:

The continued turmoil in Ukraine has pushed clinical trial supporters to suspend many clinical investigations including for gene and cell therapies in the interest of rescuing clinical investigation enlistees and healthcare professionals associated, negatively impacting the global gene therapy market. For instance, according to the U.S. Food and Drug Administration’s clinical trial database, there are more than 250 operational clinical investigations with research locations based in Ukraine. The unfortunate reality is that the violence and mass exile happening across Ukraine are expected to hold lasting implications for the gene therapy market.

Recent Developments in the Industry:

1. In February 2022, Sarepta Therapeutics (US) formed a collaboration to utilize GenEdit’s NanoGalaxy platform and Sarepta’s gene editing technology to design gene editing therapeutics for the treatment of neuromuscular diseases. 
2. In May 2022, Novartis AG (Switzerland) obtained FDA authorization for KYMRIAH for adult individuals with relapsed or refractory follicular lymphoma after two or more additional lines of systemic treatment. 
3. In May 2022, the FDA authorized the drug, Evrysdi an SMN-enhancing therapy that works by targeting the SMN2 gene for newborns under two months old with spinal muscular atrophy.
4. In August 2022, the US FDA authorized Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy indicated for the treatment of adult and pediatric individuals with beta-thalassemia who need regular red blood cell transfusions.

Market Segmentation:

As per the research analysis, the global gene therapy market is segmented by Therapy Type (Somatic Gene Therapy, Germline Therapy), by Application (Cardiology, Neurology, Infectious Diseases, Inherited Diseases, Oncology and Others), by End-user (Hospitals, Specialty Clinics, Research Institutes, and Others).

1. Based on application, the Oncology segment is estimated to contribute 34.3% to the growth of the global market over the forecast period (2023-2030). The increasing prevalence of cancer cases, growing awareness and increasing product approvals are expected to boost the segment growth throughout the forecast period. 
2. For instance, in August 2023, Genprex, Inc., a clinical-stage gene therapy corporation dedicated to designing life-changing therapies for individuals with cancer and diabetes, obtained the United States Food and Drug Administration (FDA) Orphan Drug Designation (ODD) to the corporation’s top drug nominee, REQORSA Immunogene Therapy (quratusugene ozeplasmid), indicated for the treatment of small cell lung cancer (SCLC).
3. Moreover, in December 2022, the US Food and Drug Administration authorized nadofaragene firadenovec-vncg (Adstiladrin), the first gene therapy to treat adults with bladder cancer. The adenovirus vector-based gene therapy is suggested for adults with high-threat non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors unresponsive to Bacillus Calmette-Guérin (BCG) treatment.
4. Further, the increasing investments from key market players in the cancer gene therapy also contributes to the market growth. For instance, in in May 2023, Laurus Labs invested in gene therapy tech, and expands its stake in lmmunoACT to 33.86%, ImmunoACT has a product line of Chimeric Antigen Receptor T cells (CAR-T cells) therapy assets under different design phases indicated for the therapy of multiple autoimmune disorders and oncology indications.

Geographical Classification:

The global gene therapy market is segmented into major countries, including North America, Europe, South America, Asia Pacific, and Middle East & Africa.

North America Gene Therapy Market:

With the increasing prevalence of chronic disease cases, growing investments from the government, and the presence of key market players holding most of the market share in this region, North America is expected to dominate the global gene therapy market. For instance, in May 2023, Muscular Dystrophy Association (MDA) launched the MDA Gene Therapy Support Network (GTx), ahead of a pending FDA authorization for the first gene therapy for Duchenne muscular dystrophy (DMD). The extended nationally recognized MDA Resource Center presents national head-to-head expert aid and suggestion for recently authorized gene therapy treatments for individuals living with neuromuscular diseases (NMDs).

Asia-Pacific Gene Therapy Market:

Increasing gene therapy market developments in Asia-Pacific are expected to boost the regional market growth during the forecast period. For instance, in August 2023, DotBio, a Singapore-based biopharma corporation with expertise in next-generation antibody therapeutics with a particular emphasis on multi-specific antibodies for immuno-oncology, secured a USD 5.6 million pre-Series A financing round. This oversubscribed round was directed by specialist life sciences investors Proxima Ventures, Gaorong Capital, and AIM-HI Accelerator Fund.

Europe Gene Therapy Market:

Increasing product approvals and rising government funding opportunities in Europe are boosting the European gene therapy Market Growth in the forecast period. For instance, the European Medicines Agency (EMA) has authorized over nineteen cell and gene therapy drugs. Also, four life sciences companies, ranging from medical diagnostics to medicines manufacturing will obtain funding under Life Sciences Innovative Manufacturing Fund (LSIMF), a £17 million in government funding supported by an additional private investment of £260 million.

Competitive Analysis:

There are numerous international, regional, and local suppliers in the global gene therapy industry. The competition in the global market is moderate. The vendors compete based on price, therapy type quality, and dependability. As a result, to prosper and survive in a competitive market, suppliers must provide cost-efficient and effective Therapy Types.

Major Companies:

Major companies working towards the market’s growth include Novartis AG, Gilead Sciences, CSL Behring LLC, Orchard Therapeutics, Bristol-Myers Squibb, Amgen, SiBiono Genentech, Shanghai Sunway Biotech Co, Spark Therapeutics, Inc. (Roche Holding AG) and Ferring B.V., among others.  

Related Reports

• Stem Cell Therapy Market
• Autologous Stem Cell and Non-Stem Cell Based Therapies Market
• Cell and Gene Therapy Manufacturing Services Market

Additional Benefits Post Purchase:

1) Unlimited Analyst support for a period of 1 year. 

2) Any query with regard to the scope offered will be addressed within 24- 48 hours.

3) An Excel sheet with market numbers will be provided separately.

The Full Report has the below insights: 

• The report offers a comprehensive evaluation of the market in terms of market value (US) and Y-o-Y Growth Rates (%). It does so via in-depth qualitative insights, historical data (2021-2022), and verifiable projections about market size during the forecast period (2023-2030).
• Visualize the composition of the global gene therapy market segmentation by therapy type, application, end user, and region, highlighting the key commercial assets and players. 
• By Therapy Type: Somatic Gene Therapy, and Germline Therapy.
• By Application: Cardiology, Neurology, Oncology, Infectious Diseases, Inherited Diseases, and Others.  
• By End User: Hospitals, Specialty Clinics, Research Institutes, and Others. 
• By Region: North America, South America, Europe, Asia Pacific, Middle East & Africa.
• Identify commercial opportunities in the global gene therapy market by analyzing trends and co-development deals.
• The report also covers data insights on various industry forces such as porter’s five forces analysis, supply chain analysis, pricing analysis, and regulatory analysis.
• Excel data sheet with thousands of data points of global gene therapy market-level 4/5 segmentation.
• PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study. 
• Product mapping in Excel for the key products of all major market players
• The report will provide access to approximately 61 market data tables, 64 figures, and close to 180 pages. 

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