Biologics are the biological drug product that is produced from living organism or contain components of living organisms. Biologic drugs include a wide variety of products derived from humans, animals, or microorganisms by using biotechnology. Types of biologics include vaccines, blood components, cells, allergens, genes, tissues, and recombinant proteins. Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control the production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologics are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biological intracellular and cellular actions.
Biologic drugs are used for the treatment of numerous diseases and conditions and are the most advanced therapies available. Some biologic drugs are used for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune disease. Available biologics have revolutionized cancer treatment, delayed or reversed the course of immune-related conditions, changed the lives of people with rare diseases, and offered hope for many patients who previously had no effective treatment options for their condition. The production of biologics involves advanced techniques like genetic engineering, cell culture, and recombinant DNA technology. Typically, these processes utilize living cells, such as bacteria, yeast, or mammalian cells, to produce the desired therapeutic proteins. The intricate nature of biologics often results in a higher degree of specificity, reducing side effects compared to conventional drugs. Monoclonal antibodies, a prominent type of biologic, exemplify this precision by selectivity binding to specific molecules involved in disease processes.
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Global Biologics Market – Competitive Landscape
On October 15, 2023, Syngene International to invested about USD 100 million annually in research and biologics. On July 20, 2023, Tillotts Pharma and TVM Capital Life Science announced the formation of Mage Biologics to develop innovative oral antibody therapy for ulcerative colitis. On April 14, 2023, Samsung Biologics invested in a Swiss ADC firm. On April 25, 2023, Serum Life Sciences to pump an additional USD 150 million in Biocon Biologics. On September 13, 2022, Novartis earmarks USD 300 million to expand biologic manufacturing operations. On October 21, 2021, Flerie invested AB Leads USD 52 million acquisition of a Swedish Biopharma facility.
Some of the Key Players in the Global Biologics Market Include –
- Novartis AG
- Pfizer Inc
- Dickinson & Company
- Smith’s Medicals
- Roche Diagnostics
- AstraZeneca
- Bayer AG
- GSK
- Merck & Co
- Eli Lilly
Global Biologics Market – Growth Drivers
The rising incidence of chronic diseases, including cancer, autoimmune disorders, and diabetes is a major growth driver for the global biologic market as these therapies offer targeted and effective treatment options. According to the National Center for Biotechnology Information (NCBI), autoimmune diseases affect 1 in 10 individuals. According to the World Health Organization, about 422 million people worldwide have diabetes. Ongoing advancements in biotechnology, such as gene editing, recombinant DNA technology, and protein engineering, drive innovation in the development of biologics, enhancing their therapeutic potential. The aging global population contributes to the growth of the biologics market, as older individuals often require advanced and targeted therapies provided by biologics drugs for various age-related conditions. Growing investments in research and development by pharmaceutical companies and biotech firms fuel the discovery and development of new biologics, contributing to market expansion. Increasing awareness among patients about the benefits of biologics, coupled with growing demand for personalized and targeted therapies, is driving the adoption of biologic treatments globally. Expanding applications of biologics in oncology, including monoclonal antibodies and immunotherapies are significant growth drivers, offering promising treatment options for various cancers. The increasing acceptance and development of biosimilars create opportunities for market growth by providing more affordable alternatives to original biological drugs and expanding patient access.
Global Biologics Market – Restraints
The global biologics market faces the restraint of high development costs, including research, clinical trials, and manufacturing expenses, which can limit the entry of smaller companies and hinder innovation. According to the National Center for Biotechnology Information (NCBI), the cost of research and development of new drugs ranges from USD 314 million to 2.8 billion. The intricate nature of biologic manufacturing processes poses a challenge, leading to longer production timelines and potential supply chain vulnerabilities, impacting the overall efficiency of the biologics market. Biologics often have a limited patent lifespan, exposing them to competition from biosimilars upon expiration, leading to potential revenue erosion for original manufacturers. Biologics often require specific storage and transportation conditions, such as low temperatures, posing logistical challenges and increasing the risk of product spoilage or degradation. Immunogenicity, the potential for biologics to trigger immune responses, can be a restraint, impacting both safety and efficacy and necessitating careful monitoring and management. Biologics face competition from traditional small-molecule drugs, especially in certain therapeutic areas, where oral medications may offer cost advantages and easier administration. Monitoring and ensuring the long-term safety of biologics post-market approval pose challenges, particularly for rare or delayed adverse effects that may not have been apparent during clinical trials.
Global Biologics Market – Opportunities
The global biologics market presents opportunities for the development of innovative and targeted therapies, addressing unmet medical needs across various disease areas, such as oncology, autoimmune disorders, and infectious diseases. The increasing demand for cost-effective alternatives to biologics has created opportunities in the biosimilars segment, fostering competition and expanding patient access to biologic therapies. Advancements in biologics allow for personalized medicine approaches, tailoring treatments to individual patient profiles, which can improve efficacy and minimize adverse effects. Ongoing technological advancements in bioprocessing, genetic engineering, and analytical techniques create opportunities for the development of more efficient and cost-effective biologic manufacturing processes.
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Global Biologics Market – Geographical Insight
The market for global biologics is segmented into regions such as North America, Latin America, Europe, Asia-Pacific, the Middle East & Africa. North America is the largest market for biologics market due to the robust biopharmaceutical industry and favorable regulatory environment. Europe plays a significant role in the biologics market with countries like Switzerland and Germany hosting prominent biotech firms and contributing to research and development. Asia, particularly China and India, has emerged as a key player in the biologics market, with a growing emphasis on biopharmaceutical research, development, and manufacturing capabilities.
Global Biologics Market – Key Development
- On October 19, 2023, WuXi Biologics launched a new bioprocessing platform.
- On September 28, 2023, Merck received priority review from the FDA for a new biologics license application for Sotatercept, an Activin Signaling inhibitor to treat adults with pulmonary arterial hypertension.
- On August 23, 2023, CVS Health launched a company to produce cheaper biosimilar versions of expensive biotechnology products.
- On May 16, 2023, AGC Biologics Launched BravoAAV™ and ProntoLVV™ platforms offering flexible and accelerated vector development and manufacturing for cell and gene therapy programs.