Biologics Safety Testing Market Share, Size, Trends, Industry Analysis Report, By Product & Service (Consumable, Instrument, Services); By Application; By Test Type; By Region; Segment Forecast, 2023-2032
- Published Date:Mar-2023
- Pages: 116
- Format: PDF
- Report ID: PM3097
- Base Year: 2022
- Historical Data: 2019-2021
Report Summary
The global biologics safety testing market was valued at USD 3,715.99 million in 2022 and is anticipated to grow at a CAGR of 12.41% during the forecast period. The need for biologics, which drives the expansion of the global market, is driven by the rising prevalence of chronic illnesses and the rising desire for tailored medications. Additionally, strict regulatory requirements for the approval and marketing of biologics, especially in developed regions, are driving the growth of the global market. The existence of several institutions like the FDA and CDC for medication approval and testing significantly impacts the market.
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Drugs, vaccines, therapies, stem or tissue cells, and other blood-derived products are all subjected to biological safety assessment. Testing guarantees contaminant-free goods. Additionally, the expansion of biopharmaceutical product pipelines will hasten market expansion. The market for biologics safety testing is growing due to the expanding trend of contract research organizations (CROs) outsourcing biologics testing. Without requiring the sponsor to hire full-time employees, CROs offer the technical support, knowledge, and execution experience needed to complete clinical trials safely and effectively.
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Industry Dynamics
Growth Driver
Technological advancements in the field of biologics vaccine such as mRNA vaccines and recombinant protein-based vaccines and the development of new and advanced instruments for biologics testing are leading to biologics safety testing market expansion. The increasing investment in research and development in the pharmaceutical and biotechnology industries has led to the development of new biologics and increased demand for biologics safety testing. For instance, in November 2022, BioNTech announced that it is developing an mRNA facility in Singapore. The state-of-the-art mRNA manufacturing facility will be built as part of BioNTech's expanding pipeline of mRNA-based vaccinations and therapeutics and will increase capacity for possible clinical trials and the commercial supply of our mRNA vaccines.
Report Segmentation
The market is segmented based on test type, product & services, application, and region.
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By Test Type |
By Product & Services |
By Application |
By Region |
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Instrument segment is expected to grow at a high CAGR in 2022
The instrument segment is expected to grow at a considerable CAGR in 2022. Due to rising cases and diagnoses of chronic diseases, biological drugs are a preferred mode of treatment, increasing the need for kits and reagents used in biologics safety testing. Additionally, increasing technological advancement in the research of biological drugs and their development has increased the demand for sophisticated and specialized kits and reagents.
For instance, in February 2023, Revive Therapeutics plans to develop an MDMA microneedle patch along with its list of lined-up projects. The project is in partnership with PharmaTher for the development of several clinical applications, including assessing the effectiveness of PharmaTher's brand-new microneedle patch ("MN-Patch") delivery method for delivering 3,4-Methylenedioxymethamphetamine ("MDMA").
The instrument segment is expected to grow substantially during the forecast period. The demand for the instrument sector in the global market is driven by the rising need for high-throughput testing, which can be accomplished with automated instruments. Additionally, advanced instruments are required with the advancement in biologics testing technology.
Vaccine Development segment is anticipated to exhibit high CAGR in 2022
The vaccine development and manufacturing segment had the largest market share in 2022. The increasing global demand for vaccines due to the COVID-19 pandemic, the rising investment in research and development of biologics vaccines, and the growing prevalence of other infectious diseases are driving the growth of the biologics vaccine development segment.
In February 2023, Daiichi Sankyo announced it was building a mRNA vaccine plant in Kitamoto. The company has recently applied for its mRNA Covid-19 vaccine DS-5670 and is now setting up the way to manufacture the vaccine in Japan.
Rising vaccination programs and increasing corporate investments in vaccine development drive the demand for this segment. The expanding alliances and partnerships between biotechnology, pharmaceutical, and academic organizations for developing biologic vaccines also drive the expansion of the biologics vaccine development market.
Endotoxin segment dominated the market in 2022
The endotoxin test segment accounted for the largest market share globally. The demand for endotoxin testing in medical devices is rising, and some pharmaceutical companies are emphasizing quality assurance and legal compliance, fueling the market growth. In December 2022, the Endosafe Nexus 200 was introduced by Charles River Laboratories, broadening its selection of endotoxin tests. The Nexus 200 is the latest iteration of Charles River's completely robotic, data integrity-compliant instrument. Endosafe Limulus Amebocyte Lysate (LAL) cartridge technology is used to perform complicated serial dilutions for water, in-process, and final product testing.
The Mycoplasma test segment registered the highest growth rate over the study period. Mycoplasma identification and eradication are crucial for biologics created for clinical investigations and approved products for human use. The bioburden segment is expected to grow at a high CAGR during the forecast period. During the projected period, factors, including growing safety concerns about biologics vaccines and increased product recalls because of microbial contamination, are anticipated to propel market expansion.
North America region is expected to dominate the market growth in 2022
North America region is expected to dominate the market in 2022. The region is expanding with the FDA's presence, the thriving healthcare markets in the US and Canada, significant investments in biotechnology, rising support for cancer research, and the creation of novel biologics, vaccines, and medications. The presence of significant pharmaceutical and biotechnology firms and academic institutions in the region is also aiding the development of the market.
In February 2023, The US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) of Sandoz, a company pioneer in off-patent drugs for the planned biosimilar denosumab. The biosimilar plays a significant role in the management of osteoporosis, the possible prevention of fractures caused by osteoporosis, and the treatment of bone cancer.
The Asia-Pacific region is anticipated to expand throughout the projection period at a high CAGR. Due to the rising prevalence of chronic diseases and the increasing demand for personalized medicines, the growing demand for biologics is driving the growth of the Asia-Pacific market. Additionally, with cheap labor and abundant resources, the market is set to grow in this region.
Competitive Insight
Some of the major players operating in the global market include Avance Biosciences, Charles River Laboratories, Thermo Fisher Scientific, Merck, Creative Biogene, Eurofins Scientific, Lonza Group, Maravai LifeSciences, WuXi AppTec, Pace Analytical Services & Eurofins Scientific.
Recent Developments
- In January 2023, Avania was engaged by Bone Biologics, a marketer of orthobiologics products for spine fusion markets, as the contract research organization (CRO) for the company's pilot clinical study with NB1. In patients with degenerative disc disease undergoing Transforaminal Lumbar Interbody Fusion (TLIF), the trial will assess the efficacy and safety of Bone Biologic's new NB1.
- In December 2022, Asahi Kasei Medical acquired Bionova Scientific, a US Biologics CDMO. Recombinant protein treatments are the area of expertise for Bionova. Bionova offers top-notch equipment and a highly technical crew capable of meeting customer demands. It has a strong track record with complicated next-generation antibody therapeutics, such as antibody-drug conjugates (ADCs) and bispecific antibodies.
Biologics Safety Testing Market Report Scope
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Report Attributes |
Details |
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Market size value in 2023 |
USD 4,169.72 million |
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Revenue forecast in 2032 |
USD 11,949.49 million |
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CAGR |
12.41% from 2023– 2032 |
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Base year |
2022 |
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Historical data |
2019– 2021 |
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Forecast period |
2023- 2032 |
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Quantitative units |
Revenue in USD million and CAGR from 2023 to 2032 |
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Segments covered |
By Product & Service, By Test Type, By Application, By Region |
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Regional scope |
North America, Europe, Asia Pacific, Latin America; Middle East & Africa |
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Key companies |
Avance Biosciences, Charles River Laboratories, Thermo Fisher Scientific, Merck KGaA, Creative Biogene, Eurofins Scientific, Lonza Group AG, Maravai LifeSciences, WuXi AppTec, Pace Analytical Services Inc. and Eurofins Scientific |
FAQ's
The biologics safety testing market report covering key segments are test type, product & services, application, and region.
Biologics Safety Testing Market Size Worth $11,949.49 Million By 2032.
The global biologics safety testing market anticipated to grow at a CAGR of 12.4% during the forecast period.
North America is leading the global market.
Key driving factors in biologics safety testing market are development of new and advanced instruments for biologics testing.
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