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 used by regulatory agencies, among others, to prevent or reduce the likelihood of a disease or other negative health outcomes. The Food and Drug Administration has issued several guidance documents for industry, such as safety testing of drug metabolites, in-vitro metabolism, transporter-mediated drug-drug interaction, and clinical drug interaction studies.
In April 2020, as per an article published in NCBI, toxicity testing has been evolving for the last 20 years, due to increasing concern regarding the sustainability of toxicology methodologies.
Moreover, the stringent government regulations for the approval of drugs and medical devices. There is a need for sterile medical products for patient safety along with safeguarding pharmaceutical and medical device companies from product recall is further escalating the demand for the market. Therefore, increasing demand for toxicology testing products in the pharmaceutical and biotechnology industry acts as a driver for the growth of the market.
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Data Bridge Market Research analyses that the North America In-Vitro Toxicology Testing Market is expected to grow at a CAGR of 14.0% in the forecast period of 2023 to 2030 and is expected to reach USD 11,902.69 million by 2030. The rapidly growing pharmaceutical and medical device industries are projected to propel the growth of the market.
Key Findings of the Study
Rapidly Growing Pharmaceutical and Medical Device Industry
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 pharmaceutical industry relies on in-vitro toxicology testing to assess the safety and potential risks of drug candidates during the early stages of discovery and development. In-vitro testing allows researchers to evaluate the effects of substances on cells, tissues, and organs, providing valuable information on toxicity profiles, drug interactions, and potential side effects. The need for accurate and reliable toxicity assessments drives the demand for in-vitro toxicology testing in the pharmaceutical industry.
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.
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2023 to 2030
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Base Year
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2022
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Historic Years
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2021 (Customizable to 2015 - 2020)
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Quantitative Units
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Revenue in USD Million
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Segments Covered
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Product and Service (Consumables, Services, Assays, Equipment’s, and Software), Toxicology End Point 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, and Other Toxicity Endpoints & Tests), Technology (Cell Culture Technologies, High-Throughput Technologies, Molecular Imaging, and OMICS Technology), Method (Cellular Assays, Biochemical Assays, Ex-Vivo Models, and In Silico Models), Industry (Pharmaceutical & Biopharmaceutical Companies, Diagnostics, Food, Chemicals, Cosmetics & Household Products), Distribution Channel (Direct Tender, Retail Sales, and Others)
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Countries Covered
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U.S., Canada and Mexico
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Market Players Covered
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Thermo Fisher Scientific Inc.(U.S.), Labcorp Drug Development (U.S.), Merck KGaA (Germany), Charles River Laboratories (U.S.), Lonza (Switzerland), Bio-Rad Laboratories, Inc. (U.S.), Catalent, Inc (U.S.), SGS Société Générale de Surveillance SA (Switzerland), QIAGEN (Germany), Intertek Group plc. (U.K.), Eurofins Scientific (Luxembourg), Promega Corporation (U.S.), Aragen Life Sciences Ltd. (India), Cyprotex Plc. (U.K.), Shanghai Medicilon Inc. (China), Creative Biolabs (U.S.), BioIVT (U.S.), AAT Bioquest, Inc. (U.S.), Gentronix (U.K.), IONTOX (U.S.), InSphero (U.S.), MB Research Laboratories (U.S.), Creative Bioarray (U.S.), and Preferred Cell Systems (U.S.)
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Data Points Covered in the Report
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
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Segment Analysis
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.
- Based on product and service, the North America in-vitro toxicology testing market is segmented into consumables, services, assays, equipments, and software.
In 2023, the consumables segment is expected to dominate the North America in-vitro toxicology testing market
In 2023, the consumables segment is expected to dominate the market with a market share of 33.41% due to its increasing demand among the population.
- 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. In 2023, the ADME (absorption, distribution, metabolism, & excretion) testing segment is expected to dominate the market with a market share of 21.15%.
- Based on technology, the market is segmented into cell culture technologies, high-throughput technologies, molecular imaging, and OMICS technology.
In 2023, the cell culture technologies segment is expected to dominate the North America in-vitro toxicology testing market
In 2023, the cell culture technology segment is expected to dominate the market with a market share of 34.57% due to rising technological advancements.
- Based on method, the market is segmented into cellular assays, biochemical assays, ex-vivo models, and in silico models. In 2023, the cellular assays segment is expected to dominate the market with a market share of 37.58%.
- Based on industry the market is segmented into pharmaceutical & biopharmaceutical companies, diagnostics, food, chemicals, and cosmetics & household products. In 2023, the pharmaceutical and biopharmaceutical companies segment is expected to dominate the market with a market share of 32.81%.
- Based on distribution channel, the market is segmented into direct tender, retail sales, and others. In 2023, the direct tender segment is expected to dominate the market with a market share of 48.87%.
Major Players
Data Bridge Market Research analyzes Thermo Fisher Scientific Inc. (U.S.), Labcorp Drug Development (U.S.), Merck KGaA (Germany), and Charles River Laboratories (U.S.), Bio-Rad Laboratories, Inc. (U.S.), as the major market players in the North America in-vitro toxicology testing market.
Market 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.
Regional Analysis
Geographically, the countries covered in the North America in-vitro toxicology testing market are, U.S., Canada, and Mexico.
As per Data Bridge Market Research analysis:
The U.S. is expected to dominate and be the fastest-growing country in North America in-vitro toxicology testing market
The U.S. is expected to dominate in the North America in-vitro toxicology testing market owing to the higher level of investments by various manufacturers and increasing demand for in-vitro toxicology testing in the country. The U.S. is estimated to be the fastest growing country in North America in-vitro toxicology testing market due to the growing adoption of advanced technology and launch of new products in this region.
For more detailed information about the North America in-vitro toxicology testing market report, click here – https://www.databridgemarketresearch.com/pt/reports/north-america-vitro-toxicology-testing-market
