North America In-Vitro Toxicology Testing Market – Industry Trends and Forecast to 2030

North America In-Vitro Toxicology Testing Market Analysis and Size

The North America in-vitro toxicology testing market is fragmented in nature, as it consists of many North America players such as Thermo Fisher Scientific Inc. (U.S.), Labcorp Drug Development (U.S.), Merck KGaA (Germany), Charles River Laboratories (U.S.), and Bio-Rad Laboratories, Inc. (U.S.) among others. The presence of these companies produces competitive prices for in-vitro toxicology testing products across the region. Due to the presence of these players at regional and international levels, suppliers and manufacturers offer products with different specifications and characteristics in all budgets. The rising demand for in-vitro toxicology testing products drives market growth. Additionally, the rapidly growing pharmaceutical and medical industries are expected to drive the market growth.

Data Bridge Market Research analyzes that the North America in-vitro toxicology testing market is expected to reach USD 11,902.69 million by 2030, at a CAGR of 14.0% during the forecast period. The product and service segment accounts for the largest segment in the market due to the increasing demand for toxicity testing products among patients. This market report also covers pricing analysis, patent analysis, and technological advancements in depth.

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

Based on industry, the market is segmented into pharmaceutical & biopharmaceutical companies, diagnostics, food, chemicals, cosmetics & household products.

Distribution Channel

• Direct Tender
• Retail Sales
• Others

Based on distribution channel, the market is segmented into direct tender, retail sales, and others.

North America In-Vitro Toxicology Testing Market Regional Analysis/Insights

North America in-vitro toxicology testing market is analysed and market size information is provided based on country, product and service, toxicology endpoint and test, technology, method, industry, and distribution channel.

The countries covered in this market report are U.S., Canada and Mexico.

The U.S. is expected to dominate in North America as there is a rising demand for in-vitro toxicology testing products. This share is attributable to the presence of key market players such as Labcorp Drug Development, Thermo Fisher Scientific Inc., Charles River Laboratories, Merck KGaA and Bio-Rad Laboratories, Inc. among others. Rising demand for toxicology testing and technological advancements are anticipated to fuel the market growth during the forecast period in this region.

The country section of the report also provides individual market-impacting factors and changes in market regulation that impact the current and future trends of the market. Data points like downstream and upstream value chain analysis, technical trends, porter's five forces analysis, and case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of North America brands and their challenges faced due to large or scarce competition from local and domestic brands, the impact of domestic tariffs, and trade routes are considered while providing forecast analysis of the country data.

Competitive Landscape and North America In-Vitro Toxicology Testing Market Share Analysis

North America in-vitro toxicology testing market competitive landscape provides details of the competitor. Details included are company overview, company financials, revenue generated, market potential, new market initiatives, regional presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, and application dominance. The above data points provided are only related to the companies' focus related to the market.

Some of the major market players operating in the North America in-vitro toxicology testing market are Thermo Fisher Scientific Inc., Labcorp Drug Development, Merck KGaA, and Charles River Laboratories, among others.

SKU-70249