The global market value of the biological drug API manufacturing services market was valued at USD 350.2 billion in 2022, and a
CAGR of 9.5% is expected during the forecast period. The revolution in drug development
in the expanding field of biotechnology is driving the growth of the market
significantly. The growing importance of generics and technological
advancements in API manufacturing are the key factors driving growth in the
biological drug API manufacturing service market, and the increasing
penetration of counterfeit drugs is driving growth in the market.
Increasing
growth in the precision medicine market is driving the demand for biological
drug API manufacturing services significantly. The rising incidence of various
diseases is driving the market's growth significantly.

Impact of
Covid-19
COVID-19 had a mixed impact on the biological drug API
manufacturing market. COVID-19 brought economic uncertainty, due to which
people were only bothered about the essential things needed for survival. The
pandemic brought a challenge for the medical industry to meet the demand
generated due to work-force challenges, and increased demand for healthcare
resources has led to delays and fluctuations in the market. The pandemic has
also highlighted the importance of biopharmaceuticals, driving investment in
the sector and accelerating research and development efforts.
Growth Drivers
The increasing prevalence of chronic diseases, rising
demand for personalized medicines, advancements in biotechnology, and the
demand for personalized medicines, along with the expanding pipeline of
biopharmaceutical products, are driving growth in the market. A growing aging
population and the focus on innovative therapeutic approaches contribute to the
market’s expansion.
The push for cost-effective and efficient manufacturing
processes, coupled with the rising popularity of biological drugs, is further
propelling the growth of the market. The increasing number of chronic disease
patients worldwide is significantly impacting the growth of the market.
Increasing growth in the biotechnology market is significantly driving demand
for drug efficacy.
Segmentation
By Type
·
Innovative API
·
Generic API
By Potency
·
Traditional API
·
HPAPI
Biotech APIs by
Product
·
Monoclonal
Antibodies
·
Hormones and
Growth Factors
·
Cytokines
·
Fusion Protein
·
Therapeutic
Enzymes
·
Recombinant
Vaccines
·
Blood Factors
By Type of Drug
·
Over-the
counter Drug
·
Prescription
Drug
By Therapeutic
Applications
·
Oncology
·
Communicable
Diseases
·
Diabetes
·
Cardiovascular
Diseases
·
Pain Management
·
Respiratory
Diseases
·
Other
Therapeutic Applications
Regional
Outlook
·
Asia Pacific
·
North America
·
Latin America
·
Europe
·
Middle East and
Africa
Biological Drug
API Manufacturing Services Market by Type
On the basis of the type, the Biological Drug API
Manufacturing Services Market is segmented into Innovative API and Generic API.
Innovative APIs are associated with novel, patented biological drugs. They are
developed by pharmaceutical companies through extensive research and clinical
trials. Manufacturing services for innovative APIs require advanced technology
and adherence to strict quality standards.
Generic APIs, on the other hand, are
replicas of existing, off-patent, innovative drugs. Once the patent protection
for a particular innovative drug expires, other companies do produce generic
versions. Generic API manufacturing services involve replicating the biologics
active ingredient, ensuring bioequivalence. Cost-effectiveness is a key demand
factor for generic APIs.

Biological Drug
API Manufacturing Services Market by Therapeutic Application
On the basis of therapeutic application, the biological
drug API manufacturing services market is segmented into oncology, communicable
disease, diabetes, cardiovascular diseases, pain management, respiratory system
diseases, and other therapeutic applications. Cardiovascular diseases are the
leading segment due to increasing prevalence of cardiac cases. The biological drug API services market is
diverse, catering to various therapeutic applications, of which oncology is the
second leading segment due to the increasing number of cancer patients
worldwide due to an imbalanced lifestyle.
The growing emphasis on personalized
and targeted therapies is driving growth in the region. The advancements in
biotechnology and the rise of biologics in cancer treatment contribute to the
prominence of oncology in the biological drug API manufacturing service market.
Biologics targeting autoimmune diseases, such as rheumatoid arthritis or psoriasis,
drive demand for specialized manufacturing services. Biopharmaceuticals
treating respiratory conditions, like asthma or chronic obstructive pulmonary
diseases, contribute to the market’s diversity.
Biopharmaceuticals targeting
cardiovascular conditions, like monoclonal antibodies for lipid management,
showcase the market’s expansion into diverse therapeutic areas. Biologics for
diabetes management, including insulin and related therapies, are integral to
the portfolio of biological drug API manufacturing services. Biological drugs
for infectious diseases, such as vaccines or anti-viral treatments, play a
crucial role in addressing global health challenges. The increasing number of
cases of cardiovascular diseases is driving growth in the market.
Regional
Outlook
On the basis of the regions, the biological drug API
manufacturing services market is segmented into 5 parts: Asia Pacific, North
America, Europe, Latin America, and the Middle East and Africa. North America,
followed by Europe, is dominating the market and is expected to dominate during
the forecast period due to increasing demand for generic drugs, rising demand
for biologics and specialty drugs, and technological advancements in the
manufacturing processes of API. Due to the presence of leading market players
like Pfizer, the market is witnessing immense growth opportunities in the
future.
Europe, including countries like Germany, England, Russia, Belgium, and
Sweden, is witnessing significant growth in the market due to advanced healthcare
infrastructure, cost-effective manufacturing, and a skilled workforce. The
presence of key market players like Novartis and Sanofi is driving growth in
the European market. The growing aging population worldwide is driving the
demand for biological drug APIs. Emerging markets like India and China are
witnessing significant growth in the market due to the regulatory environment,
infrastructure, increasing population, and rising prevalence of chronic disease
in the region. Lower production costs in this region are driving the growth of
the market significantly.
Countries like China and India play a crucial role
with their established pharmaceutical industries. Collaboration with global
pharmaceutical companies further enhances the region’s position, making Asia
Pacific a key player in the biological drug API manufacturing services market.
The increasing number of oncology and cardiovascular disease patients is
driving the growth of the market. The increasing prevalence of diabetes is
another reason behind the significant growth in the market. Irregular
lifestyles and obesity are the main causes of these diseases. The increasing
number of acute and chronic disease patients is driving the growth of the
market significantly.

Key Players
·
Lonza Group
·
Boehringer Ingelheim
·
Samsung
Biologics
·
Wuxi Biologics
·
Thermo Fisher
Scientific
·
Pfizer
·
AstraZeneca
·
Mankind
·
Cipla
·
DSM Biologics
·
Other Players
Specifications |
Descriptions |
No Specifications |