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Report ID: HC0026
Pages: 185
Base Year: 2023
Format: PDF
Historical Date: 2019-2022
MARKET SCOPE:
The global cell and gene therapy biomanufacturing market is projected to grow significantly, registering a CAGR of 11.3% during the forecast period (2024 – 2032).
Cell and gene therapy biomanufacturing involves the creation of therapeutic products through the manipulation of cells or genes, addressing various diseases. In cell therapy, live and functional cells are administered to patients to restore, repair, or enhance damaged tissues or organs. Conversely, gene therapy focuses on altering genetic material within a patient’s cells to prevent or treat diseases. The biomanufacturing process for cell and gene therapies is intricate and highly regulated, intending to produce these advanced therapeutic products consistently and safely at a scale suitable for clinical and commercial applications. The initial step includes isolating cells from the patient or another source, followed by their expansion in a controlled culture environment. This cultivation phase aims to provide optimal conditions for cell growth while preserving the desired characteristics of the therapeutic cells. The overall objective is to adhere to rigorous quality control measures throughout the biomanufacturing process, ensuring the reliability, safety, and effectiveness of the final cell and gene therapies. The field of cell and gene therapy biomanufacturing continues to evolve, integrating advances in automation, process optimization, and standardization to enhance efficiency and scalability, bringing these innovative therapies closer to widespread clinical implementation.
MARKET OVERVIEW:
Driver: Increasing cancer diseases worldwide is expected to boost the market growth.
The increasing prevalence of cancer and other targeted diseases, coupled with rising research and development investments in pharmaceutical companies, is propelling the expansion of the market. A revised version of GLOBOCAN 2020 by the International Agency for Research on Cancer (IARC) indicates a global cancer burden of 19.3 million cases and 10 million cancer-related deaths in 2020. A recent study predicts that over the next five years, more than 50 million people will be diagnosed with cancer. Factors such as aging populations and socioeconomic risk factors are significant contributors to the rising incidence of cancer worldwide. Notably, breast cancer represents one in every four cancers diagnosed in women globally, surpassing lung cancer as the most commonly diagnosed cancer worldwide, particularly prevalent in low- and middle-income nations.
Given the complexity of cancer, cell and gene therapy emerges as a promising field for cancer treatment. Various gene therapy treatment approaches, including immunotherapy, gene transfer, and oncolytic virotherapy, offer innovative solutions. As the incidence of cancer continues to rise, the reliance on gene therapy is expected to grow, thereby stimulating market growth. The evolving landscape of cancer treatment presents substantial opportunities for advancements in cell and gene therapies, positioning them as crucial players in addressing the complexities of cancer and improving patient outcomes.
Opportunities: Approval of cell and gene therapies by regulatory agencies is expected to pave the way for market growth in the upcoming years.
The approval of cell and gene therapies by regulatory agencies represents a pivotal milestone, unlocking lucrative opportunities for market players in the pharmaceutical and biotechnology sectors. This validation from regulatory bodies not only signifies the safety and efficacy of these innovative therapies but also opens the door to a rapidly expanding market. In response to the growing significance of cell and gene therapies, pharmaceutical and biotechnology companies are actively engaging in strategic collaborations. These collaborations are designed to expedite the research, development, and commercialization processes, ultimately leading to an enhanced market presence, increased revenue, and a larger market share.
Strategic collaborations within the industry involve partnerships between different stakeholders, such as pharmaceutical companies, biotech firms, research institutions, and sometimes regulatory bodies. These collaborations leverage the unique strengths and expertise of each participant, fostering a synergistic approach to advancing cell and gene therapies.
Furthermore, the combined efforts of multiple entities contribute to a more comprehensive understanding of the intricacies involved in cell and gene therapy development, paving the way for breakthrough innovations. Overall, the approval of cell and gene therapies and the subsequent strategic collaborations reflect a dynamic and collaborative ecosystem within the pharmaceutical and biotechnology industries. As these therapies continue to revolutionize medical treatment, the strategic partnerships forged today will play a crucial role in shaping the future landscape of regenerative medicine and personalized healthcare.
COVID IMPACT:
The impact of the COVID-19 pandemic has been deeply felt across various facets of global society, and the realm of cell and gene therapy (CGT) has not been spared from its effects. The unprecedented scale and severity of the pandemic have triggered disturbances in social, economic, and political spheres worldwide. In this context, the CGT sector, which has traditionally grappled with inherent complexities in its supply chain, production processes, and logistical operations, now faces an added layer of disruption due to the challenges posed by the COVID-19 epidemic. The global CGT sector is intricately linked to a sophisticated and interdependent supply chain, relying on a range of materials such as specialized reagents, vectors, and other crucial components essential for the development of therapeutic interventions. The pandemic has given rise to disruptions in the production and distribution of these indispensable materials, subsequently impacting the timelines and progression of ongoing CGT projects. As the sector navigates these challenges, stakeholders are compelled to adapt swiftly, exploring alternative strategies for supply chain management, leveraging digital technologies for remote monitoring of trials, and seeking innovative solutions to ensure the continuous advancement of promising therapies despite the hurdles imposed by the pandemic.
SEGMENTATION ANALYSIS:
The consumable segment is anticipated to grow significantly during the forecast period.
In the 2022 consumables segment emerged as the primary focus within the product classification. This prevalence can be ascribed to various factors that shape the biomanufacturing landscape. In contrast to equipment, which generally boasts a shelf life of five to seven years, and software solutions that involve a one-time investment coupled with yearly maintenance costs, consumables serve as essential components required more frequently and in larger volumes for the production of cell and gene therapies. Consumables encompass a diverse array of materials, including specialized reagents, growth media, cell culture media, filtration systems, and other vital components pivotal for the biomanufacturing processes integral to cell and gene therapies. Owing to the recurrent and substantial demand for these consumables throughout the production cycle, their necessity tends to surpass that of equipment or software solutions.
The consumables segment plays a critical role in maintaining optimal conditions for cell growth, gene manipulation, and other crucial steps in the biomanufacturing process. The consistent and high-quality supply of consumables is imperative for the intricate protocols involved in cell and gene therapy production. Consequently, the dominance of the consumables segment underscores its significance within the biomanufacturing ecosystem, contributing substantially to the overall advancements and progress in the field of cell and gene therapy.
REGIONAL ANALYSIS:
The North American region is set to witness significant growth during the forecast period.
The North America market for cell and gene therapy biomanufacturing is poised to secure the leading market share in terms of revenue in the foreseeable future. This prominence is attributed to the region’s increasing engagement in gene and cell therapy research and product development, along with a substantial presence of contract development businesses. Additionally, domestic companies are expanding their manufacturing operations within the region.
COMPETITIVE ANALYSIS
The global cell and gene therapy biomanufacturing market is reasonably competitive with mergers, acquisitions, and product launches. See some of the major key players in the market.
Scope of the Report
** In – depth qualitative analysis will be provided in the final report subject to market
Primary and Secondary Research
In order to understand the market in detail we conduct primary and secondary research. We collect as much information as we can from the market experts through primary research. We contact the experts from both demand and supply side and conduct interviews to understand the actual market scenario. In secondary research, we study and gather the data from various secondary sources such as company annual reports, press releases, whitepapers, paid databases, journals, and many other online sources. With the help of the primary interviews, we validate the data collected from secondary sources and get a deep understanding on the subject matter. Post this our team uses statistical tools to analyses the data to arrive at a conclusion and draft it in presentable manner.
Market Size Estimations
Understanding and presenting the data collected is a crucial task. Market sizing is a critical part of the data analysis and this task is performed by using Top-down and bottom-up approaches. In this process, we place different data points, market information and industry trends at a suitable space. This placement helps us presume the estimated & forecast values for coming few years. We use several mathematical and statistical models to estimate the market sizes of different countries and segments. Each of this is further added up to outline the total market. These approaches are individually done on regional/country and segment level.
Data Triangulation
As we arrive at the total market sizes, the market is again broken down into segments and subsegments. This process is called as data triangulation and is implementable wherever applicable. This step not only helps us conclude the overall market engineering process, but also gives an assurance on accuracy of the data generated. The data is triangulated based on studying the market trends, various growth factors, and aspects of both demand and supply side.