Marché des tests de toxicologie in vitro en Amérique du Nord – Tendances et prévisions du secteur jusqu’en 2030

Analyse et taille du marché des tests de toxicologie in vitro en Amérique du Nord

Le marché nord-américain des tests de toxicologie in vitro est fragmenté par nature, car il se compose de nombreux acteurs nord-américains tels que Thermo Fisher Scientific Inc. (États-Unis), Labcorp Drug Development (États-Unis), Merck KGaA (Allemagne), Charles River Laboratories (États-Unis) et Bio-Rad Laboratories, Inc. (États-Unis), entre autres. La présence de ces entreprises génère des prix compétitifs pour les produits de tests de toxicologie in vitro dans toute la région. En raison de la présence de ces acteurs aux niveaux régional et international, les fournisseurs et les fabricants proposent des produits avec des spécifications et des caractéristiques différentes pour tous les budgets. La demande croissante de produits de tests de toxicologie in vitro stimule la croissance du marché. En outre, les industries pharmaceutiques et médicales en pleine croissance devraient stimuler la croissance du marché.

Data Bridge Market Research analyse que le marché nord-américain des tests de toxicologie in vitro devrait atteindre 11 902,69 millions USD d'ici 2030, à un TCAC de 14,0 % au cours de la période de prévision. Le segment des produits et services représente le segment le plus important du marché en raison de la demande croissante de produits de test de toxicité chez les patients. Ce rapport de marché couvre également en profondeur l'analyse des prix, l'analyse des brevets et les avancées technologiques.

Market Definition

In-vitro toxicology testing involves testing chemicals, drugs, and other substances to assess their potential toxicity using in-vitro (non-animal) testing methods. In-vitro toxicology testing involves using cells, tissues, or cellular components outside their natural environment to evaluate substances' safety and potential hazards. The market encompasses a wide range of in-vitro tests and assays that assess various aspects of toxicity, including but not limited to cytotoxicity, genotoxicity, carcinogenicity, organ toxicity, reproductive toxicity, and environmental toxicity. These tests are conducted on cell cultures, tissue models, or other in-vitro systems to mimic the response of biological systems to potential toxicants.

North America In-Vitro Toxicology Testing Market Dynamics

This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:

Drivers

Increasing Demand for Toxicology Testing Products

The main activity of the pharmaceutical industry is quality management. Drugs must be sold as formulations that are sterile, therapeutically active, reliable, and predictable in their performance. New and improved medicinal agents are being developed at an accelerated speed. At the same time, more exact and sophisticated analytical methods are being developed for their evaluation. Due to the rising incidence of chronic diseases and the emergence of the COVID-19 pandemic, the demand for drugs and medical devices has proportionally increased. The demand for toxicology testing further gets escalated with the increased demand for the products of biotechnology and pharmaceutical industries,

A toxicology study is a crucial part of drug development used to characterize the toxicity profile of a drug by identifying its impact on organ structure/ functionality. The study provides critical information and knowledge that is used by regulatory agencies, among others to prevent or reduce the likelihood that a disease or other negative health outcome would occur. The Food and Drug Administration has issued several guidance documents for industry such as safety testing of drug metabolites, in-vitro metabolism and transporter-mediated drug-drug interaction studies, and clinical drug interactions studies.

Rapidly Growing Pharmaceutical and Medical Device Industries

Many revolutionary trends and advances have been witnessed by the pharmaceutical and medical device industries that have dramatically improved the medicines available to patients. It was possible to witness the effect of artificial intelligence and big data on the diagnosis and treatment of diseases.

Combined with their potential to remedy previously untreatable diseases, the effectiveness and protection of biopharmaceutical drugs help pharmaceutical companies to succeed. An opportunity for sustained healthy growth supports the existing biologics-development pipeline. Since 1995, the number of biotech patents applied has increased by 25% annually. More than 1,500 biomolecules are presently undergoing clinical trials, and the biologics success rate has so far been more than double that of small-molecule drugs, with 13% of biopharmaceuticals entering the phase I testing phase going on to launch.

The prosperity and growth of these industries proportionally increase the demand for toxicity testing for the quality control of the products developed by them. Therefore, the rapidly growing pharmaceutical and medical device industries act as a driver for the growth of the market.

Opportunity

 Growing Adoption of Quality Check Products to Prevent Product Recalls

Medical devices, drugs, and biologics are playing an increasingly important role in today's healthcare delivery. However, ongoing quality concerns with drugs and related recalls raise possible health hazards to the use of these drugs on patients. One of the major reasons for product recall in the pharmaceutical companies is the toxicity profile of their drugs and other products which could pose serious health complications among the patients who consume them. There has been detailed reporting of the potentially devastating effects of toxicity on humans. It is common for toxins to trigger permanent side effects at sufficient concentrations throughout the bloodstream and even death in extreme cases.

In-process controls to track the existence of toxicity must include the aseptic production of compounded products. Therefore, in the pharmaceutical and biomedical industries, effective and efficient monitoring for the existence of toxicity is important. All injectable or implantable products labelled as pyrogen-free or sterile must undergo toxicology testing before being released. This avoids toxicity in patients and makes it easy to comply with regulatory and cGMP guidelines. Hence, the growing adoption of quality check products to prevent product recalls acts as an opportunity for the growth of the market.

Restraint / Challenge

High Cost Associated with In-Vitro Toxicology Testing and Products

Automated toxicity testing systems are equipped with the latest technology and advanced features. They have wide functionalities and features. The automated AST gives efficient and accurate detection of toxicity. However, the high cost of these devices is likely to impact the market.

The high cost of capital investment is the biggest restraint for the market. The development of new products demands deep research and clinical studies. The technological innovations in toxicity testing have led to early detection but it requires a high amount of capital investment because of its latest and improved technology.

Thus, the advancement comprises of automated antimicrobial susceptibility testing (AST) system) Microdilution, rapid automated instrument methods, MIC strip tests, genotypic methods, disk diffusion method, e-tests, and POCT-compatible technologies, all these advanced features make the device costly. This may act as a restraining factor for the in-vitro toxicology testing market.

Recent Developments

• In June 2023, Lonza, a North America manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, announced it has acquired Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage technology platform for the development of ADCs. This will help the company to expand its North America presence.
• In May 2023, Labcorp Drug Development and BML announced the expansion of clinical laboratory testing capabilities in Japan. This will help the company to strengthen its product portfolio in this region.
• In December 2022, Merck KGaA a leading science and technology company, today announced a research collaboration and commercial license agreement with Mersana Therapeutics, Inc., Cambridge, Massachusetts, USA to discover novel antibody-drug conjugates (ADCs) leveraging Mersana’s proprietary Immunosynthen STING-agonist ADC platform, directed against up to two targets.
• In October 2022, Thermo Fisher Scientific Inc. announced that it is going to expand its laboratory operations in Highland Heights, Kentucky, helping customers deliver life-changing medicines to patients. The current facility, which includes central lab and biomarker operations, provides biopharma customers with high-quality laboratory services to accelerate drug development. This helped company to expand its clinical diagnostics business across various regions in the world and helped to increase the North America presence in the market.
• In December 2021, Aragen Life Sciences Ltd. acquired Intox Pvt. Ltd. to strengthen its safety assessment platform which has helped the company establish its presence.

North America In-Vitro Toxicology Testing Market Scope

The North America in-vitro toxicology testing market is segmented into six notable segments such as product and service, toxicology endpoint and test, technology, method, industry, and distribution channel. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Product and Service

• Consumables
• Services
• Assays
• Equipments
• Software

Based on product and service, the market is segmented into consumables, services, assays, equipments, and software.

Toxicology Endpoint and Test

• ADME (Absorption, Distribution, Metabolism, & Excretion) Testing
• Cytotoxicity Testing
• Genotoxicity Testing
• Dermal Toxicity Testing
• Ocular Toxicity Testing
• Organ Toxicity Testing
• Skin Irritation, Corrosion, & Sensitization Testing
• Phototoxicity Testing
• Other Toxicity Endpoints & Tests

Based on toxicology endpoint and test, the market is segmented into ADME (absorption, distribution, metabolism, & excretion) testing, cytotoxicity testing, genotoxicity testing, dermal toxicity testing, ocular toxicity testing, organ toxicity testing, skin irritation, corrosion, & sensitization testing, phototoxicity testing, and other toxicity endpoints & tests.

Technology

• Cell Culture Technologies
• High-Throughput Technologies
• Molecular Imaging
• OMICS Technology

Based on technology, the market is segmented into cell culture technologies, high-throughput technologies, molecular imaging, and OMICS technology.

Method

• Cellular Assays
• Biochemical Assays
• Ex-Vivo Models
• In Silico Models

Based on method, the market is segmented into cellular assays, biochemical assays, ex-vivo models, and in silico models.

Industry

• Pharmaceutical & Biopharmaceutical Companies
• Diagnostics
• Food
• Chemicals
• Cosmetics & Household Products

En fonction de l'industrie, le marché est segmenté en sociétés pharmaceutiques et biopharmaceutiques, diagnostics, aliments, produits chimiques, cosmétiques et produits ménagers.

Canal de distribution

• Appel d'offres direct
• Ventes au détail
• Autres

En fonction du canal de distribution, le marché est segmenté en appels d'offres directs, ventes au détail et autres.

Analyse/perspectives régionales du marché des tests de toxicologie in vitro en Amérique du Nord

Le marché des tests de toxicologie in vitro en Amérique du Nord est analysé et des informations sur la taille du marché sont fournies en fonction du pays, du produit et du service, du point final et du test de toxicologie, de la technologie, de la méthode, de l'industrie et du canal de distribution.

Les pays couverts dans ce rapport de marché sont les États-Unis, le Canada et le Mexique.

Les États-Unis devraient dominer l'Amérique du Nord en raison de la demande croissante de produits de tests toxicologiques in vitro. Cette part est attribuable à la présence d'acteurs clés du marché tels que Labcorp Drug Development, Thermo Fisher Scientific Inc., Charles River Laboratories, Merck KGaA et Bio-Rad Laboratories, Inc., entre autres. La demande croissante de tests toxicologiques et les avancées technologiques devraient alimenter la croissance du marché au cours de la période de prévision dans cette région.

La section par pays du rapport fournit également des facteurs individuels ayant un impact sur le marché et des changements dans la réglementation du marché qui ont un impact sur les tendances actuelles et futures du marché. Des points de données tels que l'analyse de la chaîne de valeur en aval et en amont, les tendances techniques, l'analyse des cinq forces de Porter et les études de cas sont quelques-uns des indicateurs utilisés pour prévoir le scénario de marché pour chaque pays. En outre, la présence et la disponibilité des marques nord-américaines et les défis auxquels elles sont confrontées en raison de la concurrence importante ou rare des marques locales et nationales, l'impact des tarifs nationaux et les routes commerciales sont pris en compte lors de l'analyse prévisionnelle des données nationales.

Analyse du paysage concurrentiel et des parts de marché des tests de toxicologie in vitro en Amérique du Nord

Le paysage concurrentiel du marché des tests de toxicologie in vitro en Amérique du Nord fournit des détails sur le concurrent. Les détails inclus sont la présentation de l'entreprise, les finances de l'entreprise, les revenus générés, le potentiel du marché, les nouvelles initiatives du marché, la présence régionale, les sites et installations de production, les capacités de production, les forces et les faiblesses de l'entreprise, le lancement du produit, la largeur et l'étendue du produit et la domination des applications. Les points de données ci-dessus fournis ne concernent que l'orientation des entreprises par rapport au marché.

Certains des principaux acteurs du marché opérant sur le marché des tests de toxicologie in vitro en Amérique du Nord sont Thermo Fisher Scientific Inc., Labcorp Drug Development, Merck KGaA et Charles River Laboratories, entre autres.

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