Visiongain has published a new report entitled Biological Safety Testing Market Report 2024-2034: Forecasts by Products (Consumables, Instruments, Services & Others), by Application (Cellular & Gene Therapy, Monoclonal Antibodies (mAbs), Vaccines & Therapeutics, Blood-based Therapy & Others), by Tests (Endotoxin Tests, Mycoplasma Tests, Sterility Tests, Residual Host Contamination Detection Tests, Bioburden Tests, Virus Safety Tests, Others) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies.
The global Biological Safety Testing market is estimated at US$3,907.2 million in 2024 and is projected to grow at a CAGR of 12.6% during the forecast period 2024-2034.
Rising Safety Standards in Drug Development Propel Demand for Biological Safety Testing
The escalating emphasis on safety in drug development and commercialization is significantly amplifying the demand for biological safety testing. As pharmaceutical and biotechnological innovations surge, ensuring the safety and efficacy of new drugs becomes paramount. Regulatory agencies worldwide, including the FDA and EMA, have stringent safety guidelines that necessitate thorough biological safety assessments before any drug can reach the market. Biological safety testing encompasses a variety of critical evaluations, such as sterility testing, endotoxin testing, and cell line authentication. These tests are essential to confirm that biological products are free from contaminants and comply with safety standards. With the advent of advanced biologics, biosimilars, and personalized medicine, the complexity and specificity of safety testing have intensified.
Moreover, the rise in biopharmaceutical products, including vaccines and gene therapies, has further underscored the need for meticulous biological safety testing. Companies are increasingly investing in sophisticated testing technologies and partnering with specialized contract research organizations to meet these rigorous requirements. This growing focus on safety not only ensures the protection of public health but also enhances the credibility and marketability of pharmaceutical products. Consequently, the biological safety testing market is witnessing robust growth, driven by the industry's unwavering commitment to safety and regulatory compliance.
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How will this Report Benefit you?
Visiongain’s 299-page report provides 99 tables and 177 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the Biological Safety Testing market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Biological Safety Testing. Get financial analysis of the overall market and different segments including product, application, tests, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing Biological Safety Testing market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.
What are the Current Market Drivers?
Biotech R&D Investment Surge Propels Demand for Advanced Biological Safety Testing Solutions
The increasing investment in biotech R&D is poised to serve as a pivotal market driver for biological safety testing, fuelled by promising trends in artificial intelligence (AI) adoption within the biopharmaceutical sector. Throughout 2020 and 2021, the market witnessed an optimistic surge in AI integration within biopharmaceutical research and development, with projections indicating sustained growth in the coming years. Notably, the AI in healthcare market, a significant component of the biopharmaceutical sector, is anticipated to experience positive growth, as illustrated by projections and regional performance indicators. The United States, a major player in the global AI biopharma market, exhibited robust revenue growth across all regions in 2021, with some areas experiencing double-digit expansion. Similarly, the European biotech market showcased positive growth trends during the same period.
Furthermore, according to the Organisation for Economic Co-operation and Development (OECD) the escalating investment in biotechnology, with spending witnessing notable growth in 2020 compared to 2019 across major countries. This growth is attributed to increased awareness and the growing need for digital advancements in the healthcare sector.
The COVID-19 pandemic has played a significant role in driving the demand for AI adoption within the pharmaceutical industry. The crisis underscored the importance of AI-based health applications and digital tools, highlighting the need for enhanced scrutiny of AI's relationship with patients and medical staff, focusing on human and emotional needs. Additionally, the pandemic accentuated the importance of general data access and the application of AI for disease outcome prediction, further driving the demand for AI in biopharma.
As investment in biotech R&D continues to expand, spurred by advancements in AI technology and the evolving landscape of the biopharmaceutical industry, the demand for robust biological safety testing solutions is expected to surge. Organizations will prioritize ensuring the safety, quality, and efficacy of their biopharmaceutical products, driving the adoption of sophisticated testing methodologies and fostering innovation within the biological safety testing market.
Rise of Monoclonal Antibodies and Biosimilars in Therapeutics
Monoclonal antibodies (mAbs) and biosimilars represent a dynamic and rapidly expanding segment within the pharmaceutical industry. With advancements in biotechnology and genetic engineering, there has been a surge in the development of mAbs targeting various diseases, including cancer, autoimmune disorders, and infectious diseases. These therapeutic proteins offer targeted treatment options with potentially fewer side effects compared to traditional therapies.
Furthermore, the emergence of biosimilars, which are highly similar versions of approved biologic medicines, has garnered significant attention in recent years. Biosimilars offer the promise of increased access to biologic therapies at lower costs, driving competition in the market and potentially reducing healthcare expenditures. As patents for original biologics expire, the market for biosimilars is expected to witness substantial growth, further fuelling developments in this area.
The increasing developments of mAbs and biosimilars present both opportunities and challenges in biological safety testing. While these therapies hold immense potential for improving patient outcomes, ensuring their safety and efficacy remains paramount. Rigorous biological safety testing is essential to evaluate the purity, potency, and safety profile of mAbs and biosimilars, addressing concerns related to immunogenicity, stability, and product comparability.
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Where are the Market Opportunities?
India's Rise: A New Frontier in Biological Safety Testing
India emerges as a key player in the global biological safety testing market, driven by its robust pharmaceutical industry and strategic investments in cutting-edge laboratory infrastructure. With India ranked third worldwide in pharmaceutical production by volume and holding a significant share in the global supply of generic medicines, the country is poised to capitalize on its position as a leading provider of pharmaceutical products.
According to the Economic Survey 2022-23, India's pharmaceutical sector ranks fourteenth globally in terms of value, underscoring its substantial contribution to the global healthcare market. Notably, India boasts the largest share in vaccine manufacturing, accounting for 60% of the market. This dominance in vaccine production positions India as a pivotal player in addressing global health challenges, including infectious diseases and pandemics.
In January 2023, Eurofins Scientific, a prominent player in the biological safety testing industry, announced its investment in establishing an advanced laboratory campus in Genome Valley, Hyderabad. This strategic move reflects the growing recognition of India's potential as a hub for pharmaceutical research and development. The newly acquired assets encompass state-of-the-art facilities tailored to meet the needs of both global pharmaceutical clients and domestic biotech firms.
The cutting-edge laboratories in Genome Valley cover an expansive area exceeding 90,000 square feet and offer a comprehensive range of services. These include synthetic organic chemistry, analytical research and development (R&D), bioanalytical services for large and small molecules, in-vivo pharmacology, safety toxicology, and formulation R&D. The establishment of such advanced facilities underscores India's commitment to fostering innovation and driving advancements in pharmaceutical research and safety testing.
With its growing capabilities in biological safety testing and investment in state-of-the-art infrastructure, India is well-positioned to play a significant role in shaping the future of the global pharmaceutical industry. As the demand for safe and effective pharmaceuticals continues to rise worldwide, India's emergence as a key market in biological safety testing is poised to accelerate, offering immense opportunities for growth and innovation in the sector.
Digital Tech and AI to Transform the Biological Safety Testing Market
The convergence of digital technology and AI in biological safety testing heralds a transformative era of opportunity within the global market. By investing in IT platforms and AI, companies not only bolster speed, connectivity, and responsiveness but also stimulate innovation and foster market growth. Advanced IT platforms streamline biological safety testing processes, slashing time-to-market for biopharmaceutical products. Automated workflows and real-time data analysis empower swift decision-making, enabling companies to capitalize on emerging opportunities.
Robust IT infrastructure facilitates seamless collaboration among geographically dispersed teams and stakeholders. Cloud-based solutions enable secure data sharing and access, fostering knowledge exchange and collective progress. Personalized dashboards and mobile applications enhance client engagement, providing real-time insights and actionable intelligence. Proactive client engagement cultivates long-term relationships, setting companies apart in a competitive landscape.
Moreover, investment in AI augments biological safety testing by unlocking new opportunities for insights-driven decision-making and precision medicine. AI-powered analytics enhance predictive capabilities, enabling proactive risk management and driving positive health outcomes.
In April 2024, Merck introduced the ground-breaking Aptegra™ CHO genetic stability assay, leveraging whole genome sequencing and bioinformatics to expedite biosafety testing. This digital solution revolutionizes biosafety testing, enhancing efficiency and accuracy in analysis. Additionally, Merck's unveiling of AIDDISON™ in December showcases the company's commitment to innovation. This AI-driven platform merges generative design with predictive synthesis planning, facilitating the rapid identification of promising candidates and mitigating late-stage failures.
The adoption of digital technology and AI in biological safety testing creates vast opportunities for market growth and advancement. By harnessing the power of technology, companies drive innovation, optimize efficiency, and position themselves for sustained success in an evolving industry landscape.
Competitive Landscape
The major players operating in the Biological Safety Testing market are Almac Group, Charles River Laboratories, Clean Cells, Creative Biogene, Eurofins Scientific, F. Hoffmann-La Roche Ltd., Laboratory Corporation of America, Lonza Group, Merck KGaA, Sartorius AG, SGS Société Générale de Surveillance SA, Thermo Fisher Scientific Inc., and Wuxi Apptec. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.
Recent Developments
- On 20th March 2024, Merck KGaA is allocating over US$319 million towards establishing a new Bioprocessing Production Center in Daejeon, South Korea. This new facility represents the largest investment by Merck's Life Science business sector in the Asia-Pacific region to date, underscoring the company’s dedication to enhancing its capabilities in this rapidly developing area.
- On 27th February 2024, Eurofins CDMO Alphora has revealed the inauguration of a fresh pilot-scale biologics development facility spanning 3,300 square feet in Mississauga, Canada. The capabilities of this pilot biologics facility encompass analytical services, upstream and downstream development, process design and gap analysis, process scale-up, bioassays, and cGMP quality documentation.
- On 13th February 2024, Thermo Fisher Scientific Inc.'s PPD clinical research division is enhancing its array of services at its good manufacturing practices (GMP) laboratory in Middleton, Wisconsin, by introducing mycoplasma and supplementary biosafety testing capabilities. This new offering, provided by the analytical testing service within the clinical research division, guarantees the absence of contaminants in biopharmaceutical products, thereby assisting clients in delivering safe medications to patients.
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To find more Visiongain research reports on the Pharma sector, click on the following links:
- Biosimilars and Follow-On Biologics Market Report 2024-2034
- Clinical Trial Packaging and Labelling Market Report 2024-2034
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