Toxicology Services Global Market - Forecast To 2028
The toxicity testing is essential for generating information about a substance’s toxic properties, which helps in the evaluation of adverse health and environmental risks posed by these substances. The federal agencies have made mandatory to conduct toxicity testing for various industries such as pharmaceutical, medical devices, cosmetic, agrochemical, industrial chemical, food for the approval of novel products and launch into the market. The agencies use information from toxicity testing to establish acceptable concentrations of environmental agents in drinking water, to register and re-register pesticides and chemicals, food additives, cosmetics, to approve and initiate the clinical evaluation of investigational pharma or biopharma products, to set permissible exposure limits for workers, to establish tolerances for pesticide residues on food, and ultimately to protect public health and the environment. These toxicology studies are performed using in-vitro, in-vivo and in-silico methodologies to examine specific adverse events or specific endpoints such as acute toxicity, chronic toxicity, dermal toxicity, genotoxicity, ocular toxicity, carcinogenicity, developmental & reproductive toxicity, neural toxicity, cardiotoxocity, hepatoxicity, immunotoxicity and ecotoxicity
According to IQ4I analysis, the toxicology services global market is expected to grow at a mid single digit CAGR from 2021 to 2028. The factors such as mandatory toxicology testing requirements for various industries like pharma, medical device, cosmetic, chemical and food for their product approvals or registration, the increasing trend of outsourcing, increase in pharma R&D expenditure are driving the toxicology services market. Whereas, the emergence of advanced technology likes 3D-model, ex-vivo, organ-on-a-chip and in-silico tools, increasing in the utilization of nano-materials and regulatory changes to enhance safety profiles of agents will provide immense growth opportunities for the toxicology services market. However, increasing focus towards drug repurposing, lack of skilled personnel, high cost and long duration of the tests and stringent government regulations towards animal studies are expected to hamper the market growth.
The toxicology services global market is categorized into various market segments based on the study methods, industry, end-points and geography. Based on the study methods, the toxicology market is categorized into in-vivo, in-vitro and in-silico. Among these, in-vitro toxicology services segment accounted for the highest revenue in 2021 and is expected to grow at a mid single digit CAGR from 2021 to 2028. The factors such as strategic focus towards the incorporation of 3Rs, Replacement, Reduction and Refinement into legislation guidelines and practice of animal experiments applicable for safety assessments/toxicity evaluations for chemicals, pesticides, cosmetics and pharmaceuticals (For instance, U.S. EPA recently signed a memo to significantly reduce mammalian testing with the goal of completely eliminating it by 2035 and ban of animal testing in cosmetic industries in Europe and several countries) and increasing scientific and technological advancements in cell isolation technologies, cell imaging technologies, stem cell culture, 3D-printing, microfluidic & nanofluidic technologies results in the development of physiologically relevant in vitro model systems such as 3D cell culture model, ex-vivo and organ-on-a chip assays for toxicology studies and adoption of these novel in-vitro models by the service providers is accelerating uptake of in vitro methods and drives in-vitro toxicology services market. The in-vitro toxicology services global market is sub-segmented into cellular and biochemical assays, ex-vivo and 3D-model and organ on a chip. Among these cellular and biochemical assays is accounted for the highest revenue in 2021 and is expected to grow at a mid single digit CAGR from 2021 to 2028 due to increasing utilization of cell-based assays and biochemical assays due to its simple and cost-effective operation compared to complex animal model studies, availability of various types of cell-lines for early discovery toxicology studies and increasing adoption of advanced cell imaging technologies like fluorescence live-cell imaging and non-labelled imaging in cell-based assays to advance toxicology studies by the service providers. For instance, Evotec offers cell-based cytotoxicity panel assays by utilizing advanced high content screening systems such as Cellomics ArrayScan VTI’s and Cellomics ToxInsight which has automated fluorescence imaging to simultaneously analyze multi-parametric indicators of cellular toxicity. The 3D-model and Organ-on-a-chips are expected to grow at a high single digit CAGR from 2021 to 2028 due to increasing focus towards the development and adoption of advanced 3D models and organ on a chip for toxicity studies by the regulatory bodies and service providers. For instance, 3D models such as Epiderm, CORROSITEX, EpiSkin, SkinEthic RHE, epics have been regulatory validated for Skin corrosion and Skin irritation tests.
The toxicology services global market based on the industry is categorized into pharmaceutical, medical devices, cosmetics, chemicals and others. Among the industries, Pharmaceutical accounted for the highest revenue in 2021 and is expected to grow at a mid single digit CAGR from 2021 to 2028 due to mandatory toxicology studies required for the new drug to enter into the market and increasing pharma R&D expenditure with a focus on the development of new drugs (For instance, the global pharmaceutical R&D spending is $179.4 billion in 2020 with an increase of 6.8% from 2018), increasing development of novel drugs (For instance, FDA has approved 229 new drugs in the 2001-2010 decade. This comparatively small figure has increased to 309 new drugs and an average of 38 per year from 2011 to 2018. In 2020, FDA has approved 53 NMEs) and increased the trend of pharma outsourcing. For instance, According to IQ4I analysis, there are 50 GLP-certified facilities in India. In that xx laboratories are having the capability to conduct toxicology studies. Among xx laboratories, xx% or xx of facilities provide toxicology services. In that, 24 facilities are offering toxicology services to pharmaceuticals. Medical devices are expected to grow at a high single digit CAGR from 2021 to 2028 due to increasing focus on development of innovative medical devices (For instance, In 2020, NMPA approved a total of 9,849 medical device initial registrations, registration renewals and registration of changes, increased by 16.3% compared with 2019). The pharmaceutical segment is further sub-segmented into drug discovery and developmental toxicology. Among these, drug developmental toxicology is accounted for the highest revenue in 2021 and is expected to grow at a mid single digit CAGR from 2021 to 2028 due to increasing focus towards the development of novel drugs with increasing demand for preclinical toxicology studies. Drug discovery toxicology is expected to grow at a mid single digit CAGR from 2021 to 2028. The factors such as increasing focus towards the adoption of an early fail strategy to weed out molecules that might have a high risk-to-benefit ratio (For instance, it is estimated that around 50% of investigational compounds fail during the development phase of clinical trials) and increased trend of drug discovery outsourcing has fuelled demand for investigative discovery toxicology services.
Based on toxicology endpoints, the toxicology global market is segmented into acute toxicity, chronic toxicity, dermal toxicology, ocular toxicology, safety pharmacology, reproductive and developmental toxicology, genotoxicity, carcinogenicity, neurotoxicity, ecotoxicology and others. Among these, acute toxicology services are accounted for the highest revenue of in 2021 and are expected to grow at a mid single digit CAGR from 2021 to 2028 due to the mandatory requirement to conduct acute toxicology studies for the approval or registration of new drugs, medical devices, cosmetics, chemical and food additives in the market. Developmental & Reproductive toxicology services are expected to grow high single digit CAGR from 2021 to 2028. The factors such as lack of development and reproductive toxicology data for most commonly used substances will increase the demand for their services. For instance, U.S. studies have shown that almost 93% of the chemical additives which are added to food lack reproductive or developmental toxicity data.
The toxicology services global market based on geography is segmented into North America, Europe, Asia-Pacific and the Rest of the world (RoW). North America accounted for the largest revenue in 2021 and is expected to grow at a mid single digit CAGR from 2021 to 2028. The factors such as increasing R&D expenditure, mandatory toxicology studies required for a new drug, chemical, food additive, agrochemical and medical device to enter into the market, increase in the development of new drugs, increase in the development of novel medical devices (FDA approved 40 innovative medical devices through its premarket approval process in 2020, a 25% increase from 32 in 2019) and increasing adoption of advanced technologies and novel in-vitro and in-silico models to expand the services capabilities by the toxicity service providers are driving the toxicology services market in the region.
Asia-Pacific is expected to grow at a high single digit CAGR from 2021 to 2028. The factors such as growing pharma and biopharma industries with development of innovative drugs into the market (For instance, in 2020, the Pharmaceuticals and Medical Devices Agency (PDMA) approved 123 new drug products in Japan and NMPA approved total of 46 locally developed new drugs including 28 chemical drugs and 18 biological products), mandatory regulatory toxicology studies needed for approval of new drugs, medical device, agrochemical into the market, increasing number of agrichemical registrations (For instance, in China, As of June, 2020, 474 new pesticide registrations were granted in China, this registration number increased by 378% comparing to 2019), increasing government investment towards the pharma and biopharma industries (For instance, in June 2021, Indian Government spending additional $26,578.3 million for the pharmaceutical PLI scheme in 13 key sectors such as active pharmaceutical ingredients, drug intermediaries and key starting materials over five years) are driving toxicology services in the region. Further, changing regulations to ensure safety profiles of pesticides will boost the demand for toxicology services in the region's future. For instance, in Japan, every registered pesticide shall be subject to periodic re-evaluation every 15 years with the same data requirements for new registration at the time of re-evaluation, and application for re-evaluation will start to be accepted in 2021.
There is an increasing focus towards the adoption of replace, reduce and refinement strategies in toxicity studies. The adoption of predictive models (in-vitro and in-silico) will enable compounds to be deselected earlier in development, thereby limiting the need for animal testing. Thus, industries are focusing on employing an integrated approach of in-vitro, in-silico and in-vivo methods to characterize a particular chemical or molecular entity. For instance, in drug discovery front-loading of predictive assays (in-vitro and in-silico) will improve the quality of candidate drugs, decrease toxicological/preclinical attrition, and reduce the number of animals used in nonclinical safety assessment. As these predictive models are getting more importantance, there is an increasing focus on the advancements of these methods to modify the toxicity testing approach.
The development of relevant microphysiological based 3D model (oragnoid or spheroid) assays for front-loading toxicity assessments of pharmaceuticals, cosmetics, materials, industrial chemicals and food additives will reduce the number of animals testing in preclinical testing. Also, the development of different scaffold techniques and 3D printing further advanced the field of 3D-cell-based assays. 3D-bioprinting is a cutting-edge technology used to fabricate 3D models in-vitro that holds tremendous promise in toxicity testing. Some CROs are adopting 3D model in toxicity studies to advance their offerings. For instance, Charles River laboratories are working with Epithelix and MatTek (3D-Model supplier) to develop EpiAirway and MucilAir models for inhalation toxicology.
Similarly, there is also substantial interest in recent years towards the adoption of microfluidic based organ on chip-based assays in toxicology studies. These innovative devices provide insights into normal human organ function and disease pathophysiology, as well as more accurately predict the safety in humans. Therefore, they are likely to become useful additions to traditional preclinical cell culture methods and in vivo animal studies in the near term, and in some cases replacements for them in the longer term. The development of single organ on chips such as Liver on a chip, Kidney on a chip, Intestine on-chip, Skin On a chip, Brain On a chip, Heart on a Chip will particularly assist in organ-targeted toxicity studies. For instance, the development of quad-culture human Liver-Chip can be used to predict toxicity at clinically relevant drug concentrations and investigate diverse mechanisms of DILI, enabling researchers to de-risk drug candidates before the clinic. The focus on the development of multi-organ on-chip or human on-chip by integrating several artificial organs via recirculation fluidic flow will create highly functional and robust systems to enable a more accurate model for toxicity testing. Some of the companies are launching organ-on-chip-based services for toxicity studies to advance the testing approach. For instance, in October 2020, CN Bio launched Drug Metabolism and Safety Toxicity Testing Services using the company’s Liver-on-Chip technology to generate predictive and human-relevant data, improving the translatability from discovery to the clinic, and accelerating new drugs to market. The regulatory bodies are also showing great interest to validate organ on chips for toxicity studies. For instance, FDA has entered a multi-year research and development agreement with Emulate Inc in 2017 to test the company’s liver-chip in toxicity studies. After the successful completion of these studies, in October 2020, FDA again collaborated with emulate to use a range of Organ-Chips from Emulate to study the safety, efficacy, and mechanisms of drugs regulated by the FDA.
Although there is more attention towards advancing in-vitro methodologies, animal toxicity studies are still is the mainstay of testing. So there is an increasing focus towards the refinement of animal studies by adopting transgenic animal models. For instance, Big Blue Transgenic Rodent Mutation Assay was developed to measure in vivo mutagenesis in somatic and germ cell tissues in genotoxicity studies. Companies are expanding their toxicity services providing capabilities by acquiring advanced models. For instance, in June 2021, Gentronix acquired Big Blue transgenic mutation assay models from Merck to expand its genetic toxicology capabilities. Apart from transgenic models, also there is increasing focus towards the utilization of Zebrafish as animal models in toxicity studies due to some exceptional set of characteristics features like small size (easy to breed and inexpensive to maintain), very high reproducibility, and quick development (embryos develop rapidly; embryogenesis is complete five days after fertilization), transparency of the embryo (embryo is transparent, morphological structures and internal organs, including brain, eyes, heart, liver, and kidney can be easily visualized using light microscopy, without the need for surgery. Organ-specific and overall developmental toxicity can be assessed visually or quantified using dyes).
The toxicology services market is fragmented, the top 5 players occupy XX% of the market share and the remaining XX% of the market is occupied by other players. Companies are adopting various organic and inorganic strategies to expand their market in a competitive market. To gain market share, companies are constantly focusing on adapting innovative methods in toxicity studies. For instance, Charles River Laboratories has advanced transgenic models such as Tg.rasH2 mouse for genotoxic/non-genotoxic compounds, p53 +/- mouse for known genotoxic compounds and Tg.AC mouse for dermal drugs to advance carcinogenicity testing approach. Some of the companies have adopted inorganic strategies to expand the service offerings. For instance, in July 2021, Inotiv, Inc acquired assets from MilliporeSigma’s BioReliance portfolio to accelerate the start-up of genetic toxicology business. Some of the companies are expanding their toxicology laboratory capacities to meet the growing demand of services. For instance, in March 2020, Sinclair Research, opened its 20,000-square-foot toxicology laboratory to support GLP nonclinical toxicology research studies to meet the growing demand from pharmaceutical customers for outsourced drug development services. Also, some of the toxicology services providers are collaborating with other CRO to provide end to end drug discovery and development services. For instance, in September 2020, European Research Biology Center (ERBC) a toxicology service company is collaborating with Oncodesign, Cynbiose, Aepodia and PharmaLex a.r.c. to provide full-service offering ranging from hit findings, preclinical research and regulatory developments to first-in-man trials for the biotech and pharma industries. This established network helps to provide greater added value services to clients worldwide. Along with this, some of the consortium of vertically integrated corporate research entities is adding toxicology services capabilities to provide end to end preclinical services. For instance, in August 2020, Genesis Biotechnology Group acquired Comparative Biosciences, Inc. (CBI) to add GLP toxicology and safety pharmacology to significantly enhance capabilities for providing IND enabling studies in toxicology and safety pharmacology to better serve our industry partners.
The key players in the Toxicology services global market include Charles River Laboratories International (U.S.), CMIC Holdings Co., Ltd (Japan), Evotec SE (Germany), Eurofins Scientific S.E. (Luxemburg), Inotiv, Inc. (U.S.), North American Science Associates, LLC (U.S.), Laboratory Corporation of America Holdings (U.S.), ITR Laboratories Canada Inc. (Canada), Pharmaron Beijing Co. Ltd. (China), SGS SA (Switzerland) and Wuxi Apptec (China).