Biological Drug API Manufacturing Services Market 2024 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2030

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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

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