Biosimilar Testing and Development Services Market to Grow with a CAGR of 12.34% through 2030
The advancements
in analytical characterization techniques and the growing collaborations
between biopharmaceutical companies, is expected to drive the Global Biosimilar
Testing and Development Services Market growth in the forecast period, 2026-2030
According to
TechSci Research report, “Biosimilar Testing and Development Services Market
– Global Industry Size, Share, Trends, Competition Forecast &
Opportunities, 2030F”, the Global Biosimilar Testing and Development
Services Market stood at USD
3.68 Billion in 2024 and is expected to reach USD 7.41 Billion by
2030 with a CAGR of 12.34% during the forecast period. The Global Biosimilar
Testing and Development 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.
With growing awareness about biosimilars and their cost advantages, healthcare
systems are prioritizing their adoption, strengthening the demand for
comprehensive testing solutions.
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. The emphasis on biosimilar lifecycle management and
post-marketing surveillance is reinforcing the importance of advanced
analytical testing, ensuring sustained market growth.
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 and
development services market is poised for continued expansion.
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"Global Biosimilar Testing and Development Services Market”
The Global Biosimilar
Testing and Development 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 and Development 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. This expansion has driven the demand for comprehensive biosimilar
testing services, including analytical characterization, comparability studies,
immunogenicity assessments, and pharmacokinetic (PK) evaluations, to ensure
safety and efficacy. Additionally, regulatory agencies are increasingly
supporting biosimilar interchangeability, particularly for autoimmune
biologics, further accelerating adoption and necessitating extensive testing to
meet approval standards. The growing acceptance of biosimilars among healthcare
providers and payers, coupled with increasing investments in biosimilar
research, is fueling the expansion of this segment.
Based
on the Region, Asia-Pacific emerged as the fastest growing region in the Global
Biosimilar Testing and Development Services Market during the forecast period. This is due
to the increasing adoption of biosimilars, a favorable regulatory landscape,
and the rapid expansion of biopharmaceutical manufacturing capabilities.
Countries such as China, India, South Korea, and Japan are heavily investing in
biosimilar research and development, supported by government initiatives to
promote affordable healthcare solutions. The region is witnessing a surge in
biosimilar approvals, driven by rising healthcare expenditures, a growing
patient population, and the increasing burden of chronic diseases such as
cancer, autoimmune disorders, and diabetes. Regulatory agencies in
Asia-Pacific, such as China’s NMPA and India’s CDSCO, have streamlined
biosimilar approval pathways, reducing development timelines and fostering
market growth. Additionally, the presence of leading contract research
organizations (CROs) and contract development and manufacturing organizations
(CDMOs) offering cost-effective biosimilar testing services has attracted
global pharmaceutical companies to outsource testing activities to
Asia-Pacific. The increasing adoption of advanced analytical technologies,
growing partnerships between multinational and local biosimilar manufacturers,
and the expansion of biopharmaceutical production facilities further drive the
region’s rapid growth. As a result, Asia-Pacific is poised to be the
fastest-growing region in the biosimilar testing and development services
market during the forecast period.
Major
companies operating in Global Biosimilar Testing and Development 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.
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“The Global Biosimilar Testing and
Development 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 and
Development 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 and Development 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 and Development Services Market.
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