The global industry was valued at US$
38.9 Bn in 2022 and is expected to register a CAGR of 7.1%
from 2023 to 2031.
WILMINGTON, Del., July 29, 2024 /PRNewswire/ -- Biomanufacturing
has the potential to manufacture many of the drugs we use today,
particularly biologics and biosimilars. Active Pharmaceutical
Ingredients (APIs) play an essential role in manufacturing
biologically active substances. They serve as the active core of
various drugs, including the nearly 20,000 drugs approved by the
FDA.
Extensive use of biologically active substances in the
development of innovative and effective pharmaceutical drugs is
contributing to the global biotech API manufacturing services
market size, which is expected to register a CAGR of
7.1% from 2023 to 2031 to surpass US$
73.0 Bn by 2031, according to Transparency Market
Research (TMR), a leading global market research
firm.
Demand for biologics, biosimilars, and other biopharmaceuticals
is growing at a rapid pace as they offer high efficacy and few side
effects. Moreover, existing treatment archetypes are evolving and
becoming more sophisticated all the time. Such a landscape requires
a significant transformation in R&D, technology, and
operations.
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Biotech API manufacturing services are playing a major role in
this transformation by enabling the development of advanced
pharmaceutical products and innovative treatment options. These
products include complex proteins, enzymes, hormones, and other
important biologically active substances.
TMR's recent Biotech API Manufacturing Services Market
Report offers in-depth insights into the drivers and
restraints of the market. It also highlights various
opportunities and challenges in the industry and the
post-COVID-19 market scenario.
Biotech API Manufacturing Services Market Key
Insights
- North America dominated the
market share in 2022
- Asia Pacific is estimated to
record rapid growth during the forecast period
- Based on the scale of operation, the large-scale segment
accounted for the largest share in 2022
Global Biotech API Manufacturing Services Market
Trends
- Contract Manufacturing is the New Growth Stimulant
Emerging economies in many regions have positioned themselves as
the go-to hub for biotech API manufacturing. India and China offer potential growth opportunities for
players operating in the market.
International pharmaceutical companies are looking to reduce
production costs by gaining access to these growing markets. They
are engaged in technology transfer to emerging economies to benefit
their R&D outsourcing. These initiatives bolstered the supply
of various biopharmaceutical products and essential vaccines
worldwide.
A lucrative R&D outscoring sector incentivizes several
regional companies to expand their API portfolio. These companies
are supplying APIs to major U.S.-based companies involved in the
manufacture of orphan drugs, addiction treatment, and obesity
medications.
In July 2024, Rusan Pharma
Private Limited was granted Good Manufacturing Practice (GMP)
approval by the FDA. The approval for the company's API
manufacturing facility in Gujarat, India, marks a critical step in its expansion
into the North America API market.
- Fermentation Infrastructure Gaining Traction in
Small-Molecule API Synthesis
Small molecule APIs have broadened their use beyond drugs in
medicines and are making their way to pesticides in farming. Their
low molecular weight offers some distinct advantages as
therapeutics.
Most drugs manufactured from small molecule APIs can be
administered orally and they can pass through cell membranes to
reach intracellular targets. In novel cancer therapeutics, small
molecules can be used as anticancer drugs that inhibit certain
proteins in cancer cells. High prevalence of cancer has led to
significant investment in biological and analytical advances in the
biotech API manufacturing services market landscape.
Biological and analytical advances enable modern fermentation
processes to develop safe and effective next-generation drugs.
These benefits have prompted stakeholders in the overall API
manufacturing sector to provide high-quality fermentation
manufacturing services. This is attracting drug manufacturers to
leverage fermentation sites, thereby boosting the biotech API
manufacturing services market expansion.
In March 2024, Antheia, an API
manufacturer, partnered with Olon Group, a developer and
manufacturer of APIs for CDMO and generic markets, to leverage
Olon's vast fermentation infrastructure to manufacture Antheia's
early products.
Biotech API Manufacturing Services Market Report
Scope:
Report
Coverage
|
Details
|
Forecast
Period
|
2023-2031
|
Base
Year
|
2020-2022
|
Size in 2022
|
US$ 38.9 Bn
|
Forecast (Value) in
2031
|
US$ 73 Bn
|
Growth Rate
(CAGR)
|
7.1 %
|
No. of
Pages
|
105
Pages
|
Segments
covered
|
By Service Type, By
Scale of Operations, By Region
|
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Biotech API Manufacturing Services Market Regional
Insights
The global market was valued at US$
38.9 Bn in 2022. North
America was the leading contributor to the market value in
2023. The region is expected to maintain its dominance during the
forecast period.
Asia Pacific is the
fastest-growing market for biotech API manufacturing
services. The region is benefitting from the availability
of low-cost labor and international pharma companies seeking to
reduce production costs.
- R&D Next-generation Diabetes Treatment Positioning
North America at the Top
Many individuals find it difficult to maintain a healthy
lifestyle in our modern world. This has led to a high prevalence of
lifestyle diseases, especially in North
America and many developed economies.
Prevalence of type 2 diabetes mellitus is predicted to increase
dramatically in the region in the near future. To counteract the
resulting impact on morbidity and mortality, stakeholders in the
pharma sector in North America are
developing next-generation diabetes treatment solutions.
Synthetic medicine API manufacturing is likely to play a major
role in North America's efforts
toward effective diabetes drugs. This has prompted many companies,
including Eli Lilly and Novo Nordisk, to boost their synthetic
medicine API manufacturing capabilities.
Eli Lilly, in May
2024, announced plans to invest an
additional US$ 5.3 Bn to build a
massive manufacturing complex, 30 miles away in Lebanon, Indiana. The expenditure is expected
to boost API production for Indianapolis-based drugmaker's injected
tirzepatide products Mounjaro, for type 2 diabetes, and Zepbound,
for obesity. With this investment, Eli Lilly aims to catch up with
the diabetes drug market leader Novo Nordisk and also expand its
biotech API manufacturing services market share.
Leading Players in Biotech API Manufacturing Services
Industry
Lonza Group Ltd., WuXi AppTec Co., Ltd., Boehringer Ingelheim
Biopharmaceuticals GmbH (Boehringer Ingelheim International GmbH),
CordenPharma International, Sterling Pharma Solutions, AbbVie,
Inc., Hikal Ltd., Almac Group, FUJIFILM Diosynth Biotechnologies,
Abzena Ltd., Regis Technologies, Inc., Rentschler Biopharma SE, and
Catalent, Inc. are the prominent players in the market.
Key Strategies by Biotech API Manufacturing Services Market
Players
- Leveraging Advancements in High-Potency
API
High prevalence of cancer worldwide has led to significant
hustle in the field of oncology, creating a need for high-potency
APIs. To better serve this growing need, Contract Development and
Manufacturing Organizations (CDMOs) in developing countries are
leveraging recent advancements in technology related to
High-Potency API (HPAPI) manufacturing to expand their capacity to
serve the diverse needs of customers.
For instance, in January 2023,
Sai Life Sciences, an India-based
CDMO, started a new HPAPI manufacturing facility at its
Bidar Campus in the Karnataka state of India. With this facility, the company seeks
to expand its expertise across HPAPI development and
manufacturing.
Biotech API Manufacturing Services Market
Segmentation
Service Type
- API Process Development & Manufacturing
- Analytical Testing & Quality Control
- Regulatory Support Scale-up & Commercial Manufacturing
Scale of Operation
- Small-scale
- Mid-scale
- Large-scale
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