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Cell and Gene Therapy Market - Global Industry, Analysis, Size, Share, Growth, Trends, and Forecasts 2023-2030

Cell and gene therapies are amongst the most complex and advanced medical treatments under development and are revolutionizing approaches to treating a wide range of diseases that currently have very poor or no effective intervention. Cells, each of which contains full genetic information, are the building blocks for complex life. Genes carry information in the form of DNA which, not only determines physical characteristics but also governs the day-to-day functioning of the body’s biological processes and ultimately maintains health. A genetic disorder or disease occurs when a segment of DNA is damaged, missing, duplicated, or substituted, causing the body to function unexpectedly. This can be seen in conditions like Cancer where a dividing cell mutates and develops a genetic abnormality, that causes it to begin to reproduce rapidly developing into a tumor. Other clinical conditions associated with genetic disorders are often described as rare and complex diseases. This disease caused o genetic level so they treated it with gene therapy and cell therapies.

Cell therapy uses cultivated cells that have been genetically modified to address a specific genetic condition. Cells cultivated under carefully controlled conditions are introduced to the patient and contain vital genetic information to introduce the required therapeutic effect. Cells can be acquired from an individual patient whose cells are processed and re-administered into the patient, known as autologous cell therapy. In some instances, cells may have been adapted from donor cells. this is known as allogeneic cell therapy. Gene therapy is a new-age treatment, it works by changing a patient’s DNA on a cellular level either with treatments inside the body or outside the body. Many of these treatments use therapeutic viruses which are engineered to introduce changes in a patient’s cells. These new medicines treat genetic diseases at the source by affecting changes in their tissue, cells, or DNA with the potential to be effective only once.

Global Cell & Gene Therapy Market – Competitive Landscape

On November 1, 2023, AstraZeneca signed a joint research collaboration agreement with Cellectis to develop up to ten cell and gene therapy candidates. As part of the agreement, Cellectis will receive a USD 25 million upfront payment and an initial equity investment of USD 80 million. On July 5, 2023, LabCorp partnered with Forge Biologics for gene therapies. On May 10, 2023, Cathay Health backed Ascend Gene and Cell Therapies launches with over USD 130 million in funding. On January 9, 2023, Sanguine Bioscience partnered with Broadoak Capital partners to accelerate the launch of new products and services in support of the cell & gene therapy market.

Some of the Key Players in the Global Cell and gene Therapy Market Include –

  • Novartis AG
  • Bluebird, Inc.
  • Gilead Sciences
  • Thermo Fisher Scientific
  • Catalent Inc.
  • Lonza
  • Merck KGaA
  • Miltenyi Biotech
  • Samsung Biologics
  • Takara Bio Inc.

Global Cell & Gene Therapy Market – Growth Drivers

The rising prevalence of genetic disorders and rare diseases globally is a significant driver for the growth of the cell and gene therapy market. These therapies offer targeted and personalized treatment options for patients with specific genetic conditions. According to the World Health Organization genetic disorders and congenital abnormalities occur in about 2%-5% of all live births, account for up to 30% of pediatric hospital admissions, and cause about 50% of childhood deaths in industrialized countries. Ongoing advancements in genomic research, including the identification of genetic targets and understanding of disease mechanisms, provide a strong foundation for the development of novel cell and gene therapies, driving innovation in the market. The demographic shift towards an aging population contributes to the increased prevalence of age-related diseases. Cell and gene therapies present opportunities for addressing degenerative conditions associated with aging, driving market growth. Continuous progress in gene editing technologies, such as CRISPR-Cas9, TALENs, and zinc-finger nucleases, accelerate the development of precise and efficient cell and gene therapies and efficient cell and gene therapies fostering market expansion. Supportive regulatory frameworks and expedited approval processes from agencies like the U.S. FDA and EMA facilitate the development and commercialization of cell and gene therapies. This regulatory support acts as a catalyst for market growth. Growing investments from pharmaceutical companies, biotech firms, and government organizations in cell and gene therapy research and development contribute to the expansion of the market by fostering innovation and accelerating product pipelines. The broader shift in healthcare towards personalized medicine aligns with the principles of cell and gene therapy, offering tailored treatments based on individual genetic profiles. This trend propels the market forward as personalized approaches gain prominence.

Global Cell & Gene Therapy Market– Restraints

One of the primary restraints facing the global cell and gene therapy market is the high cost associated with the development, manufacturing, and administration of these therapies. The price is USD 3.5 million per treatment, making the therapy, called Hemgenix the most expensive drug in the world. Affordability remains a significant barrier to widespread adoption. The intricate and resource-intensive manufacturing processes involved in producing cell and gene therapies contribute to challenges in scalability, production efficiency, and cost-effectiveness, hindering large-scale accessibility. Inconsistent or limited reimbursement policies for cell and gene therapies pose a significant obstacle. The lack of a comprehensive reimbursement framework may deter healthcare providers and limit patient access to these innovative treatments. Limited long-term safety data for some cell and gene therapies raises concern among regulatory bodies, healthcare professionals, and patients. Addressing and establishing the long-term safety profile of these therapies is crucial for gaining wider acceptance. Despite regulatory support, navigating complex regulatory landscapes and obtaining approvals for novel cell and gene therapies can be time-consuming and challenging. Stringent regulatory requirements may slow down the market’s growth. Ethical considerations related to gene editing and genetic modifications, along with potential social and cultural concerns may lead to public resistance and impact the acceptance of cell and gene therapies. Insufficient long-term clinical data on the efficacy and safety of certain cell and gene therapies create uncertainty among healthcare professionals and regulators, influencing the cautious adoption of these treatments.

Global Cell & Gene Therapy Market – Opportunities

The global cell and gene therapy market presents opportunities for expansion into diverse therapeutic areas, into diverse therapeutic areas, including oncology, rare genetic disease, cardiovascular disorders, and autoimmune conditions, providing a broad scope for addressing unmet medical needs. The shift towards personalized medicine opens up avenues for cell and gene therapies, allowing tailored treatments based on individual patient profiles. This trend aligns with the growing emphasis on precision medicine and targeted therapeutic approaches. Increasing patient advocacy and awareness initiatives contribute to a better understanding of cell and gene therapies, potentially leading to higher patient acceptance and demand for innovative treatment options.

Global Cell & Gene Therapy Market – Geographical Insight

The market for global cell and gene therapy is segmented into regions such as North America, Latin America, Europe, Asia-Pacific, the Middle East & Africa. North America is the largest market for cell and gene therapy due to robust research infrastructure, supportive regulatory frameworks, and a high level of investment in biotechnology. Europe is a significant player in the cell and gene therapy sector, with countries like the United Kingdom, Germany, and Switzerland actively contributing to research and development efforts. Regulatory approvals from the European Medicines Agency further strengthen the market in this region. The Asia-Pacific region is witnessing substantial growth in the cell and gene therapy market. Countries like China and Japan are making notable strides, driven by advancements in healthcare infrastructure, increasing R&D activities, and a growing emphasis on personalized medicine.

Global Cell & Gene Therapy Market – Key Development

  • On October 10, 2023, OrganBio unveiled a new division for vaccine and cell and gene therapy clinical trials.
  • On August 8, 2023, Bluebird touts Zynteglo, Skysona launched progress as FDA decision on sickle cell therapy nears.
  • On June 20, 2023, Laurus to launch gene therapy assets in India.
  • On June 12, 2023, FDA braces for looming boom in cell and gene therapy submissions.
  • On February 8, 2023, Vertex teases launched plans for the first CRISPR gene editing therapy ahead of the FDA decision.
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Research Methodology: Aspects

Market research is a crucial tool for organizations aiming to navigate the dynamic landscape of customer preferences, business trends, and competitive landscapes. At Cognizance Market Research, acknowledging the importance of robust research methodologies is vital to delivering actionable insights to our clientele. The significance of such methodologies lies in their capability to offer clarity in complexity, guiding strategic management with realistic evidence rather than speculation. Our clientele seek insights that excel superficial observations, reaching deep into the details of consumer behaviours, market dynamics, and evolving opportunities. These insights serve as the basis upon which businesses craft tailored approaches, optimize product offerings, and gain a competitive edge in an ever-growing marketplace.

The frequency of information updates is a cornerstone of our commitment to providing timely, relevant, and accurate insights. Cognizance Market Research adheres to a rigorous schedule of data collection, analysis, and distribution to ensure that our reports reflect the most current market realities. This proactive approach enables our clients to stay ahead of the curve, capitalize on emerging trends, and mitigate risks associated with outdated information.

Our research process is characterized by meticulous attention to detail and methodological rigor. It begins with a comprehensive understanding of client objectives, industry dynamics, and research scope. Leveraging a combination of primary and secondary research methodologies, we gather data from diverse sources including surveys, interviews, industry reports, and proprietary databases. Rigorous data analysis techniques are then employed to derive meaningful insights, identify patterns, and uncover actionable recommendations. Throughout the process, we remain vigilant in upholding the highest standards of data integrity, ensuring that our findings are robust, reliable, and actionable.

Key phases involved in in our research process are mentioned below:


Understanding Clients’ Objectives:

Extensive Discussions and Consultations:

  • We initiate in-depth discussions and consultations with our clients to gain a comprehensive understanding of their objectives. This involves actively listening to their needs, concerns, and aspirations regarding the research project.
  • Through these interactions, we aim to uncover the underlying motivations driving their research requirements and the specific outcomes they hope to achieve.

Industry and Market Segment Analysis:

  • We invest time and effort in comprehensively understanding our clients’ industry and market segment. This involves conducting thorough research into market trends, competitive dynamics, regulatory frameworks, and emerging opportunities or threats.
  • By acquiring a deep understanding of the broader industry landscape, we can provide context-rich insights that resonate with our clients’ strategic objectives.

Target Audience Understanding:

  • We analyze our clients’ target audience demographics, behaviors, preferences, and needs to align our research efforts with their consumer-centric objectives. This entails segmenting the audience based on various criteria such as age, gender, income level, geographic location, and psychographic factors.
  • By understanding the nuances of the target audience, we can tailor our research methodologies to gather relevant data that illuminates consumer perceptions, attitudes, and purchase intent.


Identifying Challenges and Opportunities:

  • We proactively identify the challenges and opportunities facing our clients within their respective industries. This involves conducting SWOT (Strengths, Weaknesses, Opportunities, Threats) analyses and competitive benchmarking exercises.
  • By identifying potential obstacles and growth drivers, we can provide strategic recommendations that help our clients navigate complexities and capitalize on emerging opportunities effectively.

Grasping Specific Goals:

  • We delve into the intricacies of our clients’ objectives to gain clarity on the specific goals they aim to accomplish through the research. This entails understanding their desired outcomes, such as market expansion, product development, or competitive analysis.
  • By gaining a nuanced understanding of our clients’ goals, we can tailor our research approach to address their unique challenges and opportunities effectively.

Data Collection:


Primary Research Process:

  • Surveys: We design and administer surveys tailored to capture specific information relevant to our clients’ objectives. This may involve employing various survey methodologies, such as online, telephone, or face-to-face interviews, to reach target audiences effectively.
  • Interviews: We conduct structured or semi-structured interviews with key stakeholders, industry experts, or target consumers to gather in-depth insights and perspectives on relevant topics. These interviews allow us to probe deeper into specific issues and uncover valuable qualitative data.
  • Focus Groups: We organize focus group discussions with carefully selected participants to facilitate interactive discussions and gather collective opinions, attitudes, and preferences. This qualitative research method provides rich contextual insights into consumer behaviors and perceptions.
  • Observations: We conduct observational research by directly observing consumer behaviors, interactions, and experiences in real-world settings. This method enables us to gather objective data on consumer actions and reactions without relying on self-reported information.

Secondary Research Process:

  • Literature Review: We conduct comprehensive literature reviews to identify existing studies, academic articles, and industry reports relevant to the research topic. This helps us gain insights into previous research findings, theoretical frameworks, and best practices.
  • Industry Reports: We analyze industry reports published by reputable trade associations (whitepapers, research studies, etc.), and government agencies (U.S. Census Bureau, Bureau of Labor Statistics, and Securities and Exchange Commission etc.) to obtain macro-level insights into market trends, competitive landscapes, and industry dynamics.
  • Government Publications: We review government publications, such as economic reports, regulatory documents, and statistical databases, to gather relevant data on demographics, market size, consumer spending patterns, and regulatory frameworks.
  • Online Databases: We leverage online databases, such as industry portals, and academic repositories (PubMed Central (PMC), ScienceDirect, SSRN (Social Science Research Network), Directory of Open Access Journals (DOAJ), NCBI, etc.), to access a wide range of secondary data sources, including market statistics, financial data, and industry analyses.



Data Analysis:

The data analysis phase serves as a critical juncture where raw data is transformed into actionable insights that inform strategic decision-making. Through the utilization of analytical methods such as statistical analysis and qualitative techniques like thematic coding, we uncover patterns, correlations, and trends within the data. By ensuring the integrity and validity of our findings, we strive to provide clients with accurate and reliable insights that accurately reflect the realities of the market landscape.


Transformation of Raw Data:

  • Upon collecting the necessary data, we transition into the data analysis phase, where raw data is processed and transformed into actionable insights. This involves organizing, cleaning, and structuring the data to prepare it for analysis.

Utilization of Analytical Methods:

  • Depending on the research objectives, we employ a diverse range of analytical methods to extract meaningful insights from the data. These methods include statistical analysis, trend analysis, regression analysis, and qualitative coding.

Statistical Analysis:

  • Statistical tools are instrumental in uncovering patterns, correlations, and trends within the data. By applying statistical techniques such as descriptive statistics, hypothesis testing, and multivariate analysis, we can discern relationships and derive valuable insights.

Qualitative Analysis Techniques:

  • In addition to quantitative analysis, we leverage qualitative analysis techniques to gain deeper insights from qualitative data sources such as interviews or open-ended survey responses. One such technique is thematic coding, which involves systematically categorizing and interpreting themes or patterns within qualitative data.

Integrity and Validity Maintenance:

  • Throughout the analysis process, we maintain a steadfast commitment to upholding the integrity and validity of our findings. This entails rigorous adherence to established methodologies, transparency in data handling, and thorough validation of analytical outcomes.

Data Validation:

The final phase of our research methodology is data validation, which is essential for ensuring the reliability and credibility of our findings. Validation involves scrutinizing the collected data to identify any inconsistencies, errors, or biases that may have crept in during the research process. We employ various validation techniques, including cross-referencing data from multiple sources, conducting validity checks on survey instruments, and seeking feedback from independent experts or peer reviewers. Additionally, we leverage internal quality assurance protocols to verify the accuracy and integrity of our analysis. By subjecting our findings to rigorous validation procedures, we instill confidence in our clients that the insights they receive are robust, reliable, and trustworthy.


Importance of Data Validation:

  • Data validation is the final phase of the research methodology, crucial for ensuring the reliability and credibility of the findings. It involves a systematic process of reviewing and verifying the collected data to detect any inconsistencies, errors, or biases.

Scrutiny of Collected Data:

  • The validation process begins with a thorough scrutiny of the collected data to identify any discrepancies or anomalies. This entails comparing data points, checking for outliers, and verifying the accuracy of data entries against the original sources.

Validation Techniques:

  • Various validation techniques are employed to ensure the accuracy and integrity of the data. These include cross-referencing data from multiple sources to corroborate findings, conducting validity checks on survey instruments to assess the reliability of responses, and seeking feedback from independent experts or peer reviewers to validate the interpretation of results.

Internal Quality Assurance Protocols:

  • In addition to external validation measures, internal quality assurance protocols are implemented to further validate the accuracy of the analysis. This may involve conducting internal audits, peer reviews, or data validation checks to ensure that the research process adheres to established standards and guidelines.
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