Gene Vector Market Size, Share, By Vector Type, Therapeutic Area, Application, End-User, and Region - Trends, Analysis, and Forecast till 2035

• The gene vector market size will expand to USD 2497.4 Million by 2035.
• The market was valued at reached USD 927.2 million in 2024.
• The market demonstrates an annual growth rate of 11.5%.

Gene vectors are essential tools in molecular biology, serving as vehicles to transfer genetic material into host cells. The target market growth is driven by the increasing demand for advanced genetic therapies particularly in treating genetic disorders, cancers and infectious diseases.    

For instance, in October 2024, Roche plans to employ Dyno Therapeutics’ engineered adeno-associated virus (AAV) capsid platform to develop next-generation AAV vectors for gene therapies targeting unspecified neurological diseases, through a collaboration that could generate more than USD 1 billion for Dyno. Roche will use Dyno Therapeutics' modified adeno-associated virus (AAV) capsid platform to create next-generation AAV vectors for gene therapies targeting unidentified neurological illnesses, in a relationship that could be worth more than $1 billion for Dyno.  

Key Takeaways:

• North America held the largest share of the market in 2024 due to a strong biopharmaceutical industry, substantial investments in research and development and the presence of numerous centers focused on advanced gene therapies across the region.
• Asia Pacific is expected to be the fastest-growing market during the forecast period as it is driven by an increase in manufacturing capabilities for gene therapies and vaccines, along with substantial investments in healthcare infrastructure and research initiatives in the region.
• By vector type, the viral vectors is expected to account for the largest share of the gene vector market in the upcoming years as they are extensively utilized in biotechnology and gene therapy for delivering specific genes or genetic material into cells.

Key Drivers of Target Market:

Rising Prevalence of Genetic Disorders is Expected to Boost Market Growth

The increasing incidence of genetic disorders, such as sickle cell disease and cystic fibrosis is boosting the demand for gene vectors, which is used in therapeutic applications to modify or replace defective genes.   

• For instance, In September 2024, Italian startup Aptadir Therapeutics launched with $1.6 million to bring a new class of investigational drugs to the clinic. The Milan-based startup is focused on correcting a chemical process known as DNA methylation to treat diseases that arise from its malfunction. DNA methylation occurs when methyl groups attach to DNA, influencing how genes work. However, when this process goes into overdrive referred to as hyper methylation it can lead to diseases, such as cancer and certain genetic disorders.

Advancements in Gene Therapy Technologies is expected to Speeding up Market Expansion

Rapid advances in gene editing technologies, specifically CRISPR/Cas9 and the creation of more efficient gene delivery systems are boosting the effectiveness of gene vectors, driving the gene vector market growth.   

• For instance, in June 2023, American Gene Technologies, a clinical-stage biotechnology company based in Rockville, Maryland, is launching a new company Addimmune to continue to develop gene and cell therapy technologies to cure HIV. Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial.  

Restraints:

Regulatory Approval Challenges Hampers the Target Market Growth

Gene therapies often involve intricate biological systems and require careful selection of delivery vehicles or vectors. The complexity of these products makes it difficult to establish a standardized regulatory pathway as there is no one-size-fits-all approach for clinical programs.

• Counterbalance Statements: While the complexity of gene therapy products presents regulatory challenges, it also drives innovation in regulatory frameworks. As more products enter the market the regulatory agencies are likely to develop clearer and more tailored guidelines, which can streamline the approval process over time.

Opportunities & Market Trends:

Growing Demand for Stem Cell Therapy to Provide Growth Opportunities in the Future

• The growing interest in stem cell therapies presents a big opportunity for retroviral vectors which are required for introducing therapeutic genes into stem cells and improving their ability to cure various diseases.  
• For instance, in July 2024, Bioserve India is excited to announce the launch of its advanced stem cell products in India. These new products from REPROCELL aims to support innovation in scientific research and drug development, supporting advancements in regenerative medicine and therapeutic discovery in Indian Market. Within the stem cell market, numerous industries are engaged in critical activities such as research and development manufacturing, and distribution of stem cell therapy products.

The gene vector market is classified into vector type, therapeutic area, application, end-user, and region.

Vector Type:

Gene vector market by vector type is categorized into viral vectors, non-viral vectors, exosomes, and others. The viral vectors segment is expected to dominate over the forecast period as the modular nature of this segment enable easy scaling up or down making them suitable for a wide range of applications from small residential units to large industrial systems. 

• For instance, in May 2024, Charles River Laboratories International, Inc. announced the launch of its reference materials for adeno associated virus (AAV) and lentiviral vector (LVV) portfolio, designed to streamline Cell and Gene Therapy (CGT) research and development as it scales to Good Manufacturing Practice- (GMP) quality. The additional reference materials add to the Company’s extensive portfolio of plasmid and viral vector contract development and manufacturing organization (CDMO) offerings.

Therapeutic Area:

Based on therapeutic area, the gene vector market is segmented into neurology, oncology, hepatology, genetic disorders, infectious diseases, and others. The oncology segment dominates the focused market share as this segment is anticipated to continue being a lucrative market due to the ongoing advancements in gene therapy technologies and a growing focus on personalized medicine for cancer patients.

Application:

On the basis of application, the gene vector market is segmented into gene therapy, cell therapy, vaccine development, and others. The gene therapy segment is expected to dominate the market over the forecast period due to the increasing demand for advanced therapies and substantial investments in the development and commercialization of gene therapies.

• For instance, in December 2024, Genethon and Hansa Biopharma have initiated a phase 2 clinical trial evaluating Hansa’s immunoglobulin G (IgG) antibody cleaving enzyme therapy imlifidase (marketed in Europe under the name Idefirix) as a pretreatment for Genethon’s GNT-0003, an investigational adeno-associated virus serotype 8 (AAV8) vector-based gene therapy intended to treat severe Crigler–Najjar syndrome.

End-User:

By end-user, the gene vector market is segmented into research institutes, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), and other end-users. The contract development and manufacturing organizations (CDMOs) segment dominates the focused market share owing to the increasing demand for gene vectors due to rising investments in gene therapy development and research initiatives.

Region:

Geographically, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America: This region is expected to dominate the target market share as government initiatives such as the Orphan Drugs Act, encourages research into rare diseases which fuels the demand for gene vectors.

• For instance, in November 2024, The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency.

Asia Pacific: This is the largest and fastest-growing region in target market as the there is a growing need for effective treatments for chronic diseases, genetic disorders and cancers, which drives the demand for focused market in this region

Gene Vector Market Report Scope:

Segmentation:

By Vector Type:

• Viral Vectors
• Non-Viral Vectors
• Exosomes
• Others

By Therapeutic Area:

• Neurology
• Oncology
• Hepatology
• Genetic Disorders
• Infectious Diseases
• Others

By Application:

• Gene Therapy
• Cell Therapy
• Vaccine Development
• Others

By End User:

• Research Institutes
• Contract Research Organizations (CROs)
• Contract Development and Manufacturing Organizations (CDMOs)
• Other End Users

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Russia
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Indonesia
  • Malaysia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating in the gene vector market include Thermo Fisher Scientific, Merck KGaA, Lonza Group, and among others. The gene vector market has an extensive range of players, including major biotechnology companies, contract development and manufacturing organisations (CDMOs) and young startups. Strategic actions such as alliances, mergers and acquisitions, and constant developments in gene vector technologies all boosts this environment.

For instance, in October 2024, SK pharmteco announced a multi-year manufacturing agreement wherein SK pharmteco will be the preferred manufacturing partner for Aavigen’s lead gene therapy product AVG-101 for the treatment of heart failure. AaviGen’s proprietary heart-specific adeno-associated viral vector technology enables the development of therapies that target and reverse the underlying molecular causes of heart muscle dysfunction.

List of Key Players in the Market:

• Thermo Fisher Scientific Inc.
• Merck KGaA
• SK pharmteco Inc.
• Lonza Group
• Catalent
• Cobra Biologics
• Genezen Laboratories
• RegenxBio
• Charles River Laboratories
• Fujifilm Diosynth Biotechnologies
• Kaneka Eurogentec SA
• uniQure NV
• Alnylam Pharmaceuticals
• Amgen
• Bluebird Bio
• Novartis

• In December 2024, The Medical Research Council (MRC), part of UKRI, is launching its first two Centres of Research Excellence (CoRE), which will develop transformative new advanced therapeutics for currently untreatable diseases. Oxford is leading one of these Centres and co-leading the other. Together, these international collaborations will receive up to £50 million each over 14 years.
• In May 2024, SK pharmteco, a global contract development, manufacturing, and analytical testing organization serving the pharmaceutical and cell & gene therapy industry, announced the upcoming launch of Lentiviral Vector (LVV) Analytical Services, a comprehensive suite of analytical testing solutions specifically designed for LVV and cell therapy programs.
• In March 2024, Global genomics solutions provider Integrated DNA Technologies (IDT) is expanding its gene synthesis offerings with a new custom vector onboarding tool. The easy-to-use solution is designed for researchers who want to skip in-house cloning steps and move quickly into functional studies with 100% sequence-verified clonal DNA. By using IDT’s new gene synthesis custom vector onboarding tool, researchers can submit their vector sequence via IDT’s website without having to contact a sales representative, eliminating unnecessary back-and-forth emails.
• In March 2024, Polyplus part of Sartorius, a distinguished upstream solutions provider for biologic and cell and gene therapy production and a part of the Sartorius group, has announced the introduction of pPLUS AAV-RC2, a groundbreaking RepCap plasmid tailored for the production of adeno-associated virus vector 2 (AAV2). This launch is a significant addition to Polyplus’s portfolio, aligning with the company’s strategic direction to become a leading provider of critical raw materials for AAV production.
• In October 2023, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced the launch of the Viral Vectors NIIMBL-led program. The program will be focused on developing available, economically viable manufacturing processes and analytical platforms for adeno-associated virus (AAV) gene therapy vectors. NIIMBL hopes the program will provide access to high-quality viral vectors without cost or speed limitations.
• In April 2023, Yposkesi, SK pharmteco’s clinical and commercial viral vector manufacturing arm for cell and gene therapies, today announces the launch of LentiSure™, an optimized Lentiviral (LV) Vector manufacturing platform for increasing lentivirus production efficiency and robustness. Lentivirus or LV vectors are used to produce cell-based immuno-oncology therapies.

Analyst View of Gene Vector market:

The gene vector market presents a dynamic landscape filled with opportunities driven by technological advancements, increasing healthcare demands, and supportive regulatory environments. Further, it is expected that constant evolution in this sector as new therapies emerge and existing technologies are refined in coming years.

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