Industry Background:
Biosafety is an important mechanism that ensures the wellbeing of laboratory workers. Biosafety also includes the remainder of the medical facilities (including other hospital personnel and patients), the population, and research staff and patients. Work with identified and characterised strains of viable microorganisms that are not known to cause disease in healthy adult humans. Nonpathogenic or mildly dangerous agents, such as regularly isolated bacteria and fungi, as well as higher-risk pathogens, such as Mycobacterium tuberculosis and viral hemorrhagic fever agents, can be included in these microorganisms. Various classification schemata have been established to categorise the threats posed by these microorganisms to patients. Biologics Safety Testing provides a wide variety of clinical and industrial substance evaluations. Biologics Safety Testing ensures a product's safety, purity, and potency when adhering to customer manufacturing schedules and streamlining procedures to have industry-leading turnaround times.This growth is primarily driven by Demand for Biopharmaceuticals and Technical Progress in High Throughput Process Development.
Globally, a noticeable market trend is evident Rising Implementation of Quality by Design (QBD) Principles. Major Players, such as Charles River Laboratories International, Inc (United States), Merck KGaA (Germany), Lonza Group AG (Switzerland), SGS S.A. (Switzerland), Thermo Fisher Scientific Inc (United States), WuXi AppTec (China), Sartorius AG (Germany), Cytovance Biologics, Inc (Hepalink Inc.) (United States), Pace Analytical Services LLC (United States) and Toxikon Corporation (United States) etc have either set up their manufacturing facilities or are planning to start new provision in the dominated region in the upcoming years.
Key Developments in the Market:
On 20th November, 2020 – Ampersand Capital Partners (Leading Private Equity Firm), Signed a Merger Agreement of its Pacific Biomarkers Subsidiary with Neomed-Labs. This Merger is Intended to Establish Phase of Growth for The Now Combined Company and Provide Clinical Laboratory Testing for The Pharma, IVD, And Biotech Markets. and On 30th June, 2020 - Smiths Detection Announced its Agreement to Acquire PathSensors (Leading Bio-Technology Solutions and Environmental-Testing Company), The Acquisition Is Aimed to Expand Smiths Detection’s Sensing Capabilities Across the CBRNE (Chemical, Biological, Radiological, Nuclear and Explosive) Spectrum.
On 31st March, 2020 - Biolidics launched its ten-minute rapid test kits for COVID-19, the Launch is Followed by The Provisional Authorization from Singapore’s HAS. The First Batch of Biolidics’ Rapid Test Kits Is Expected to Be Available in April 2020.
Regulatory Insights:
United States, Code of Federal Regulations Title 21 “Sec. 610.20-610.21, General Biological Products Standards” - Modification of Any Particular Test Method, Manufacturing Process or The Conditions Under Which It Is Conducted as Required in This Part or In the Additional Standards for Specific Biological Products in Parts Is Permitted Only under the Approval Conditions.
Market Drivers
- Demand for Biopharmaceuticals
- Technical Progress in High Throughput Process Development
Market Trend
- Rising Implementation of Quality by Design (QBD) Principles
Restraints
Opportunities
Low Penetration in Emerging Regions Particularly Asia and Growing Healthcare Infrastructure
Challenges
Lack of Trained Professionals
AMA Research follow a focused and realistic research framework that provides the ability to study the crucial market dynamics in several regions across the world. Moreover, an in-depth assessment is mostly conducted by our analysts on geographical regions to provide clients and businesses the opportunity to dominate in niche markets and expand in emerging markets across the globe. This market research study also showcase the spontaneously changing Players landscape impacting the growth of the market. Furthermore, our market researchers extensively analyse the products and services offered by multiple players competing to increase their market share and presence.
Customization in the Report
AMA Research features not only specific market forecasts, but also include significant value-added commentary on:
- Market Trends
- Technological Trends and Innovations
- Market Maturity Indicators
- Growth Drivers and Constraints
- New Entrants into the Market & Entry/Exit Barriers
- To Seize Powerful Market Opportunities
- Identify Key Business Segments, Market Proposition & Gap Analysis
Against this Challenging Backdrop, Biologics Safety Testing Study Sheds Light on
— The Biologics Safety Testing Market status quo and key characteristics. To end this, Analyst at AMA organize and took survey of the Biologics Safety Testing industry Players. The resultant snapshot serves as a basis for understanding why and how the industry can be expected to change.
— Where Biologics Safety Testing industry is heading and what are the top priorities. Insights are drawn from financial analysis, the survey and interviews with key executives and industry experts.
— How every company in this diverse set of Players can best navigate the emerging competition landscape and follow a strategy that helps them position to hold value they currently claim, or capture the new addressable opportunity.