Biotech API Market Size, Share, Trends & Competitive Analysis By Type of Product (Synthetic APIs, Biotech APIs); By Source (Microbial Fermentation, Plant Extracts, Animal Sources, Genetically Modified Organisms); By Therapeutic Area (Oncology, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Neurological Disorders, Respiratory Disorders, Others); By Manufacturing Process; By Application; By Regions, and Industry Forecast, Global Report 2023-2030

The global Biotech API Market size was valued at USD 65.30 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 7.2% during the forecast period, reaching a value of USD 109.26 billion by 2030.

Biotech API Market research report by Future Data Stats, offers a comprehensive view of the market's historical data from 2017 to 2021, capturing trends, growth patterns, and key drivers. It establishes 2021 as the base year, analyzing the market landscape, consumer behavior, competition, and regulations. Additionally, the report presents a well-researched forecast period from 2022 to 2030, leveraging data analysis techniques to project the market's growth trajectory, emerging opportunities, and anticipated challenges.

MARKET OVERVIEW:

Biotech API, also known as Biopharmaceutical Active Pharmaceutical Ingredient, refers to the active substance or molecule derived from biological sources that is used as a key ingredient in the production of biopharmaceutical drugs. Unlike traditional chemical-based APIs, biotech APIs are produced through biological processes such as fermentation, bioprocessing, or recombinant DNA technology. These APIs play a crucial role in the development and manufacturing of various therapeutic products, including biologics, biosimilars, and other advanced medicines. Biotech APIs offer numerous advantages, such as high specificity, potency, and reduced side effects, making them an essential component in the rapidly growing biopharmaceutical industry.

Biotech APIs are complex and often large molecules, including proteins, peptides, nucleic acids, and monoclonal antibodies. They are produced using living organisms like bacteria, yeast, or mammalian cells, or through genetically modified organisms (GMOs). The production process involves various steps, including cell culture, purification, and formulation, to obtain a highly pure and active API. These APIs serve as the therapeutic agent in biopharmaceutical drugs and are crucial for their efficacy and targeted action in treating diseases such as cancer, autoimmune disorders, and genetic disorders. The biotech API market continues to expand as the demand for innovative and personalized medicines grows, driving advancements in biotechnology and pharmaceutical research and development.

MARKET DYNAMICS:

One of the key drivers is the increasing demand for biopharmaceutical drugs. Biotech APIs are essential components in the production of biologics and biosimilars, which have gained significant popularity due to their high efficacy and targeted therapeutic effects. The rising prevalence of chronic diseases, such as cancer, autoimmune disorders, and metabolic diseases, fuels the demand for innovative biopharmaceutical treatments, thereby propelling the growth of the Biotech API market. Additionally, advancements in biotechnology and genetic engineering techniques have facilitated the production of complex biotech APIs, opening new avenues for drug development and expanding the market.

However, the Biotech API market also faces certain restraints and challenges. One of the primary restraints is the high cost associated with research, development, and manufacturing of biotech APIs. The complex production process, stringent regulatory requirements, and expensive infrastructure contribute to the overall cost burden. Moreover, the risk of product failure and the need for substantial investments in clinical trials and quality control pose challenges to market growth. Additionally, the strict regulatory landscape surrounding biotech APIs, including compliance with safety and efficacy standards, can impede market expansion.

Despite these challenges, the Biotech API market presents promising opportunities. The increasing focus on personalized medicine and targeted therapies offers significant growth prospects for biotech APIs. Technological advancements, such as next-generation sequencing and gene editing, provide opportunities for the development of novel biotech APIs with enhanced specificity and efficacy. Furthermore, collaborations and partnerships between pharmaceutical companies, biotech firms, and research institutions are fostering innovation and accelerating the development of new APIs. The growing investment in biopharmaceutical research and development, particularly in emerging markets, also opens up untapped opportunities for market expansion. Overall, the Biotech API market holds immense potential for growth and transformation in the coming years.

BIOTECH API MARKET SEGMENTAL ANALYSIS

BY TYPE OF PRODUCT:

The market encompasses two primary types of products: synthetic APIs and biotech APIs. Synthetic APIs are chemically synthesized active pharmaceutical ingredients, widely used in the pharmaceutical industry for the production of conventional drugs. These synthetic compounds offer advantages such as standardized production processes, cost-effectiveness, and well-established regulatory frameworks, contributing to their dominance in the market. On the other hand, biotech APIs are derived from biological sources and manufactured using biotechnological processes, including microbial fermentation or genetic engineering. Biotech APIs have gained significant traction in recent years due to their high specificity, potency, and reduced side effects compared to conventional drugs.

The increasing demand for biopharmaceuticals and the growing focus on personalized medicine are driving the demand for biotech APIs, propelling their market growth. Factors such as advancements in biotechnology, rising prevalence of chronic diseases, and increasing investments in research and development further contribute to the dominance of biotech APIs in the Biotech API market.

BY SOURCE:

The market is influenced by four primary sources: microbial fermentation, plant extracts, animal sources, and genetically modified organisms (GMOs). Microbial fermentation involves using microorganisms like bacteria or yeast to produce APIs. It is a widely adopted source due to its scalability, cost-effectiveness, and ability to produce complex molecules. Plant extracts are another significant source, utilizing natural compounds derived from plants for API production. This source gains prominence due to the abundance of plant-based resources and their potential for therapeutic benefits. Animal sources, such as enzymes or antibodies derived from animals, contribute to the market as well. They offer unique properties and can be crucial for specific drug formulations.

Additionally, GMOs play a dominant role in API production by modifying organisms to express desired characteristics for enhanced yield and productivity. The utilization of GMOs enables the production of complex and valuable APIs. The dominance of these sources in the Biotech API market is driven by factors like accessibility, cost-effectiveness, scalability, and the potential to obtain high-quality APIs with specific attributes required for various therapeutic applications.

BY THERAPEUTIC AREA:

The market is influenced by a range of therapeutic areas, including oncology, cardiovascular disorders, infectious diseases, metabolic disorders, neurological disorders, respiratory disorders, and others. Oncology stands out as a dominant therapeutic area due to the increasing prevalence of cancer and the growing demand for targeted therapies. Biotech APIs play a crucial role in developing innovative treatments for various types of cancer. Cardiovascular disorders, such as heart disease and hypertension, also contribute significantly to the market as biotech APIs are utilized to develop drugs that address these conditions. Furthermore, infectious diseases, including viral and bacterial infections, present a dominant segment in the market as biotech APIs are vital in the development of vaccines and antiviral therapies.

Metabolic disorders, such as diabetes and obesity, drive the demand for biotech APIs for the development of personalized treatments. Additionally, neurological disorders, respiratory disorders, and other therapeutic areas offer substantial growth opportunities as the understanding of these diseases improves, leading to the development of targeted biopharmaceutical solutions. The dominant factors shaping the Biotech API market in these therapeutic areas include the prevalence of diseases, unmet medical needs, advancements in biotechnology, and the focus on personalized medicine to cater to specific patient populations.

BY MANUFACTURING PROCESS:

The market is influenced by two primary manufacturing processes: in-house manufacturing and contract manufacturing organizations (CMOs). In-house manufacturing refers to the production of APIs conducted within the facilities of pharmaceutical companies themselves. This approach provides companies with greater control over the entire manufacturing process, including quality assurance and regulatory compliance. In-house manufacturing allows for efficient coordination between API production and the formulation of final drug products, leading to streamlined operations. On the other hand, CMOs offer specialized manufacturing services to pharmaceutical companies, outsourcing the API production process.

CMOs provide expertise, infrastructure, and flexibility, enabling companies to focus on core competencies such as drug formulation and marketing. The dominant factors shaping the Biotech API market in terms of manufacturing processes include the company's strategic priorities, cost considerations, technical expertise required, capacity requirements, and the need for flexibility in production. The choice between in-house manufacturing and CMOs is influenced by these factors, determining the dominant approach within the market.

BY APPLICATION:

The market is influenced by four primary application segments: generic drugs, branded drugs, biosimilars, and biologics. Generic drugs play a significant role in the market due to their cost-effectiveness and wide availability. Biotech APIs are utilized in the production of generic drugs to offer affordable alternatives to their branded counterparts. Branded drugs, on the other hand, contribute to the market as biotech APIs are utilized in their development, providing innovative treatments with unique formulations and delivery systems. Biosimilars, which are highly similar to existing biologic drugs, rely on biotech APIs for their production.

The growing demand for biosimilars as more biologic drugs go off-patent drives the market growth in this segment. Biologics, including monoclonal antibodies, vaccines, and cell therapies, represent a dominant and rapidly expanding segment in the market. Biotech APIs are essential in the development of biologics, offering targeted and personalized treatments for various diseases. The dominant factors shaping the Biotech API market in terms of applications include patent expiration, cost considerations, regulatory approvals, market competition, therapeutic advancements, and the increasing focus on personalized medicine and targeted therapies. These factors drive the demand for biotech APIs across the different application segments.

REGIONAL ANALYSIS:

North America holds a dominant position in the market due to the presence of a well-established biopharmaceutical industry, advanced healthcare infrastructure, and a strong focus on research and development. Europe also plays a significant role in the market, driven by robust regulatory frameworks, a high demand for biotech-based drugs, and favorable government initiatives supporting biopharmaceutical innovation. Asia Pacific is a rapidly growing region in the Biotech API market, attributed to the rising healthcare expenditure, increasing investments in biotechnology and pharmaceutical sectors, and a large patient population base. Latin America exhibits growth potential with a growing pharmaceutical industry and increasing adoption of biotech-based drugs.

The Middle East and Africa region are also witnessing growth, driven by advancements in healthcare infrastructure, rising awareness about biopharmaceuticals, and government initiatives promoting research and development. The regional analysis of the Biotech API market provides insights into the market dynamics, regulatory landscape, competitive scenario, and growth opportunities specific to each region, helping stakeholders make informed decisions and capitalize on the dominant factors influencing the market within each geographical area.

COVID-19 IMPACT:

The COVID-19 pandemic has had a significant impact on the Biotech API market. The global healthcare industry faced numerous challenges due to the pandemic, including disruptions in supply chains, manufacturing operations, and clinical trials. The Biotech API market experienced both positive and negative effects as a result of the pandemic. On the positive side, the urgent need for vaccines, therapeutics, and diagnostics to combat the virus led to a surge in demand for biotech APIs. Pharmaceutical companies and biotech firms ramped up their production capabilities to develop COVID-19 vaccines and treatments, leading to increased investments in research and development of biotech APIs.

However, the pandemic also brought about disruptions in the supply of raw materials, transportation, and regulatory processes, impacting the overall manufacturing and distribution of biotech APIs. Lockdown measures and restrictions affected clinical trials, causing delays and hindering the progress of new biotech API-based drugs. Despite the challenges, the Biotech API market demonstrated resilience and adaptability during the pandemic, with a renewed focus on innovation, collaboration, and strengthening healthcare infrastructure.

INDUSTRY ANALYSIS:

Mergers & Acquisitions

• In March 2023, Asahi Kasei acquired Cambrex, a provider of active pharmaceutical ingredients (APIs).
• In February 2023, Lonza acquired Patheon, a provider of contract development and manufacturing services (CDMO).
• In January 2023, Jubilant Life Sciences acquired Piramal Life Sciences, a provider of APIs and formulations.

Product New Launches

• In September 2022, Samsung BioLogics launched its new API manufacturing facility in South Korea.
• In June 2022, Catalent launched its new API manufacturing facility in the United States.
• In April 2022, WuXi AppTec launched its new API manufacturing facility in China.

KEY MARKET PLAYERS:

• Lonza Group Ltd.
• Pfizer Inc.
• Merck & Co., Inc.
• Novartis AG
• Johnson & Johnson
• Roche Holding AG
• Sanofi SA
• AstraZeneca PLC
• Eli Lilly and Company
• Bristol-Myers Squibb Company
• GlaxoSmithKline plc
• Teva Pharmaceutical Industries Ltd.
• Boehringer Ingelheim International GmbH
• Amgen Inc.
• AbbVie Inc.
• Gilead Sciences, Inc.
• Biogen Inc.
• Celgene Corporation
• Takeda Pharmaceutical Company Limited
• Bayer AG
• Genentech, Inc.
• Cipla Ltd.
• Dr. Reddy's Laboratories Ltd.
• Mylan N.V.
• Lupin Limited