Biologics Safety Testing Market is projected to reach USD 6.8 billion by 2027 from USD 3.6 billion in 2022, at a CAGR of 13.3% during the forecast period according to a new report by MarketsandMarkets™. The growth of the global biologics safety testing market is driven by factors such as companies investing heavily in the development of biologics and biosimilars, strict regulatory concerns over growing cell culture contamination, and increased demand for various drugs, cell therapies, diagnostics, and active biological products.

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Biologics Safety Testing Market Scope:

Report Coverage

Details

Market Size

USD 6.8 billion by 2027

Growth Rate

13.3% of CAGR

Largest Market

North America

Market Dynamics

Drivers, Restraints, Opportunities & Challenges

Forecast Period

2022-2027

Forecast Units

Value (USD Billion)

Report Coverage

Revenue Forecast, Competitive Landscape, Growth Factors, and Trends

Segments Covered

Product & Service, Application, Test Type, End User, and Region

Geographies Covered

North America, Europe, APAC, LATAM and MEA

Report Highlights

Updated financial information / product portfolio of players

Key Market Opportunities

Increased outsourcing of biopharmaceutical activities to CROs

Key Market Drivers

Rising investment in biopharmaceutical R&D

The sterility tests segment accounted for the third largest share of the Biologics Safety Testing market in 2021.

Based on test type, the biologics safety testing market is segmented into residual host-cell proteins and DNA detection tests, endotoxin tests, sterility tests, mycoplasma tests, bioburden tests, and virus safety tests. In 2021, the sterility tests segment accounted for the third largest market share. Sterility testing applies to a wide range of biological medicinal products, including vaccines, blood products, biotechnology products, and cell & tissue products. Hence, its wide application and regulatory requirement are expected to drive the market growth for sterility tests in the coming years.

The cell and gene therapy development and manufacturing segment registered second highest growth rate in the Biologics safety testing market in 2021.

Based on application, the biologics safety testing market is segmented into monoclonal antibodies development and manufacturing, vaccines development and manufacturing, blood and blood products development and manufacturing, cellular and gene therapy products development and manufacturing, and other applications. In 2021, the cell and gene therapy development and manufacturing segment registered second highest growth rate. Factors such as rising investments in regenerative medicine research and the growing pipeline of regenerative medicine products are driving the growth of the cell and gene therapy market. Also, increasing adoption of cell & gene therapy products for sterility testing, mycoplasma testing, endotoxin testing, adventitious virus testing, and raw material testing is expected to drive the growth of this application segment.

The Asia Pacific region is the fastest growing region of the Biologics safety testing market in 2021.

The Asia Pacific market is projected to witness the highest growth rate during the forecast period. Rapid growth in outsourcing preclinical, clinical, and laboratory testing services to APAC countries is expected to drive market growth during the forecast period. Several companies are focusing on increasing their market shares and customer base in the region to capitalize on these opportunities in the Asia Pacific market.

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Biologics Safety Testing Market Dynamics:

Drivers:

  1. Growing development of biosimilars and biologics
  2. Growing concerns over cell culture contamination
  3. Rising investments in biopharmaceutical R&D

Restraints:

  1. Shortage of skilled professionals

Opportunities:

  1. Emerging markets
  2. Increasing outsourcing of biopharmaceutical activities to CROs

Challenges:

  1. High cost of biologics

Key Market Players:

Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), Labcorp (US) and Eurofins Scientific (Luxembourg). The key players in this market are focusing on strategic expansions, partnerships, and product & service launches to expand their presence in the market.

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About MarketsandMarkets™:

MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients.

The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines - TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.

Built on the 'GIVE Growth' principle, we work with several Forbes Global 2000 B2B companies - helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry.

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