Biosimilar Testing Services Market to Grow with a CAGR of 12.04% through 2030
The advancements
in analytical characterization techniques and the growing collaborations
between biopharmaceutical companies, is expected to drive the Global Biosimilar
Testing Services Market growth in the forecast period, 2026-2030
According to
TechSci Research report, “Biosimilar Testing Services Market – Global
Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030F”,
the Global Biosimilar Testing Services Market stood at USD 1.53 Billion in
2024 and is expected to reach USD 3.03 Billion by 2030 with a CAGR of 12.04% during
the forecast period. The Global Biosimilar Testing Services Market is
witnessing rapid growth, driven by the escalating demand for high-quality,
cost-efficient alternatives to biologic therapies. The expiration of patents
for originator biologics is prompting pharmaceutical companies to invest in
biosimilar development, necessitating rigorous testing to establish safety,
efficacy, and comparability. Regulatory bodies worldwide are emphasizing robust
testing requirements, including structural characterization, bioassays, and
pharmacovigilance studies, to ensure biosimilar products meet stringent
approval standards. The increasing reliance on contract research organizations
(CROs) and specialized testing service providers is streamlining the complex
biosimilar development process.
Industry trends
are driving innovation and efficiency in biosimilar testing and development.
The incorporation of high-throughput screening, advanced spectroscopy, and
improved cell-based assays is enhancing the precision and reliability of
biosimilar characterization. Automation and digitalization are transforming
testing workflows, reducing human error, and increasing reproducibility in
analytical assessments. The market is also witnessing a surge in investments
aimed at improving bioanalytical capabilities, allowing companies to comply
with evolving regulatory guidelines. Emerging partnerships between biosimilar
manufacturers and testing firms are leading to the development of specialized
services such as glycan profiling, forced degradation studies, and in-depth
immunogenicity evaluations.
Growth
opportunities in the market are substantial, with ongoing efforts to refine
biosimilar testing protocols and enhance development efficiency. The adoption
of artificial intelligence and machine learning in biosimilar characterization
is unlocking new possibilities for predictive modeling and data interpretation,
reducing time-to-market for new biosimilars. Expanding regulatory harmonization
initiatives are simplifying approval pathways, fostering greater industry
participation. The rising demand for biosimilars in therapeutic areas such as
oncology, autoimmune diseases, and endocrinology is creating lucrative
opportunities for testing service providers. The emergence of personalized
medicine and targeted biologic therapies is encouraging the integration of
precision testing methodologies, ensuring biosimilar efficacy across diverse
patient populations. As governments and healthcare providers push for cost
savings without compromising treatment quality, the Biosimilar Testing Services
Market is poised for continued expansion.
Browse over XX
market data Figures spread through XX Pages and an in-depth TOC on
"Global Biosimilar Testing Services Market”
The Global Biosimilar
Testing Services Market is segmented into service type, molecule type,
therapeutic area, end user, regional distribution, and company.
Based on the Therapeutic
Area, Autoimmune Diseases emerged as the fastest growing segment in the Global Biosimilar
Testing Services Market during the forecast period. This is due to the increasing
prevalence of autoimmune disorders and the high-cost burden associated with
biologic therapies. Conditions such as rheumatoid arthritis, psoriasis,
inflammatory bowel disease (IBD), and ankylosing spondylitis require long-term
treatment with biologics, which are often expensive and create a significant
financial strain on healthcare systems and patients. The patent expirations of
blockbuster biologics such as adalimumab (Humira), infliximab (Remicade), and
etanercept (Enbrel) have opened opportunities for biosimilar manufacturers,
leading to a surge in biosimilar development and regulatory approvals.
Based
on the Region, Asia-Pacific emerged as the fastest growing region in the Global
Biosimilar Testing Services Market during
the forecast period. This is due to the expansion of biotechnology and academic
research institutions throughout the Asia-Pacific region, which has created a
strong foundation for innovation and knowledge transfer in biosimilar testing.
China, in particular, has invested heavily in life sciences infrastructure
through government-backed initiatives such as “Made in China 2025,” aiming to
reduce dependency on imported biologics by strengthening its biosimilar
capabilities. Meanwhile, in South Korea, public-private partnerships have
facilitated the establishment of advanced bio-clusters and GMP-compliant
laboratories, enabling the delivery of robust testing solutions across
biosimilar development pipelines. The region is also experiencing a rapid rise in
skilled scientific workforce and investments in bioinformatics and
high-throughput analytical platforms, which are critical for comprehensive
biosimilarity assessments. As a result, regional CROs and biosimilar
manufacturers are scaling up their infrastructure and services to meet global
standards, ensuring Asia-Pacific remains at the forefront of growth in the
biosimilar testing services market.
Major
companies operating in Global Biosimilar Testing Services Market are:
- Thermo
Fisher Scientific Inc.
- Charles
River Laboratories, Inc.
- SGS
S.A.
- Eurofins
Scientific Limited
- Intertek
Group plc
- Element
Materials Technology
- Pacific
BioLabs, Inc.
- Sartorius
AG
- WuXi
AppTec
- Syngene
International Ltd.
Download Free Sample Report
Customers can
also request for 10% free customization on this report
“The Global Biosimilar Testing Services
Market is expanding due to the increasing focus on interchangeability studies,
which play a crucial role in boosting physician and patient confidence in
biosimilars. Regulatory agencies are emphasizing real-world evidence (RWE) and
post-marketing surveillance to ensure long-term safety and efficacy, further
driving demand for specialized testing services. Additionally, rising
investments in contract research organizations (CROs) and contract development
and manufacturing organizations (CDMOs) are enabling cost-efficient biosimilar
development, allowing companies to meet stringent regulatory requirements
without heavy in-house infrastructure costs. These factors are accelerating
market growth and fostering wider biosimilar adoption.,” said Mr.
Karan Chechi, Research Director of TechSci Research, a research-based
management consulting firm.
“Biosimilar Testing
Services Market - Global Industry Size, Share, Trends, Opportunity, and
Forecast, Segmented By Service Type (Analytical Testing, Clinical Testing), By
Molecule Type (Monoclonal Antibodies, Recombinant Hormones, Insulin,
Interferons, Enzymes, Others), By Therapeutic Area (Oncology, Autoimmune
Diseases, Diabetes, Infectious Diseases, Neurology, Others), By End User
(Pharmaceutical & Biotechnology Companies, Contract Research Organizations,
Academic & Research Institutes, Others), By Region and Competition, 2020-2030F”,
has evaluated the future growth potential of Global Biosimilar Testing Services
Market and provides statistics & information on market size, structure and
future market growth. The report intends to provide cutting-edge market
intelligence and help decision makers take sound investment decisions. Besides,
the report also identifies and analyzes the emerging trends along with
essential drivers, challenges, and opportunities in Global Biosimilar Testing
Services Market.
Contact
TechSci
Research LLC
420
Lexington Avenue, Suite 300,
New York,
United States- 10170
Tel: +1-332-258-6602
Email: [email protected]
Website: www.techsciresearch.com