The biotech industry includes bio-pharma, bio-services, bio-agri, bio-industrials and bioinformatics. Biopharma is a rapidly growing segment that accounts for a dominant share in this sector. Advancements in biotechnology have enabled researchers to evaluate and identify target biomarkers/cell receptors to develop targeted and personalized therapies. Scientific research and technological advancements have resulted in the emergence of various personalized medicines that are undergoing research. According to research conducted by the Personalized Medicine Coalition, 42% of all compounds and 73% of oncology compounds in the pipeline possess the potential to be personalized medicine. Moreover, according to this study, it is expected that companies will increase their investment in R&D of personalized medicines by 1/3rd over the following five years. The study found that over 20% of drugs approved in 2014 were personalized medicines.
The biotechnology sector has witnessed some disruptive innovations such as gene and cell therapies, immunotherapy, and antibody drug conjugates. Advancement in stem cell therapy is resulting in effective treatment therapies for chronic conditions, organ growth and repair and disease prevention.
Key Challenges
Biotech products have extensive application in oncology and autoimmune disease treatment. However, the cost of these drugs is high owing to extensive research and trials that need to be carried out for the same. Therefore, there is constant pressure to reduce price and increase accessibility, especially in emerging economies. In the U.S., companies are facing reimbursement issues with respect to biopharmaceutical products. Besides, there are regulatory and scientific challenges faced by the sector. Scientific research for new molecules and targeted therapies is capital intensive and challenging owing to growing concern for safety of the drug.
Also, there is lack of awareness about personalized medicine among most healthcare providers, which may hamper its adoption. Clinical adoption of biotechnology products is essential for its success. However, it significant scientific evidence and backing is required to ensure its safety.
“Translating genomic discoveries into personalized medicines entails overcoming substantial scientific, regulatory, and economic challenges, including identifying validated biomarkers, as well as developing personalized therapeutics and clinically relevant diagnostic tests.”
Opportunities
The biopharmaceutical sector offers vast lucrative growth opportunities. High efficacy and safety of biopharmaceutical products has led to a growth in their demand, Furthermore, consumers are willing to pay high prices for biopharmaceutical products compared to other conventional products. Biopharmaceutical brands have set new standards for blockbuster drugs by recording an annual average sale of over US$ 2bn. Drugs such as Humira have generated sales revenue of over US$ 10bn.
Governments in emerging economies are endorsing biosimilars as cost-effective alternatives to biotech products, which is expected to create significant growth opportunities for manufacturers of generic drugs. Therefore, cost-effectiveness and high quality are prime parameters that need to be considered while developing biosimilars. Recent and upcoming biologic patent expirations include the following:
Companies such as Teva Pharmaceuticals, Hospira, Sandoz, and Amgen are focusing on development of biosimilars and vaccines as preventive measures in addition to treatment. For instance, in 2015, Zarxio TM became the first biosimilar to be approved in the U.S. market. The EMA approved Mosquirix, a malaria vaccine, in the same year. Extensive research is currently underway to develop a dengue vaccine, which could be another breakthrough pharmaceutical product in the near future.
Conclusion
The increasing research in the biotechnology sector is expected to result in higher number of biopharmaceutical products seeking FDA approvals. Biopharmaceuticals are positioned to be promising treatment solutions that would improve patient outcomes and help with reduction of the cost of drug development.
Global Cell Culture Media for Vaccine Market – A Novel Approach in Disease Management Cell culture media for vaccine plays a major role in advanced healthcare, as it regulates the cell cycle. It is the ... View more
Tissue Banking Market – Insights Tissue banking is the method of harvesting, processing, storage, and distribution of transplantable human tissues. Tissues retrieved from human body are used to repair o... View more
Clustered regularly interspaced short palindromic repeats (CRISPR) technology is a simple yet powerful nucleic acid-targeting editing tool for genome. It allows researchers to easily alter DNA sequences and modify gene function. It has potential applications, which in... View more
Plasmid DNA (pDNA) plays a major role in modern healthcare. Plasmid DNA can be used directly as a therapeutic agent such as in gene therapy or generation of vaccine antigens or indirectly for a range of research applications. These applications include the use of pDNA... View more
U.S. Non-oncology Biopharmaceuticals Market- Insights Biologics can be defined as molecules derived from living cells such as microorganisms, plants or animal cells and used in the treatment, diagnosis or pre... View more
Immune checkpoint inhibitors are a part of immuno-oncology therapies, which involves use of patients’ immune system to fight against cancer. Immuno-oncology uses novel immunotherapies such as immune checkpoint inhibitors that boost the immune system of patients.... View more
Typhoid fever, also simply called as typhoid is a bacterial infection caused by Salmonella typhi, also known as Salmonella enterica serotype Typhi. The typhoid fever is usually caused due to ingestion of contaminated food or water. Typhoid vaccines prevents typhoid fe... View more
Cytogenetics is a technology that studies the structure and function of a cell (chromosome) and gene abnormalities in a disease. Molecular cytogenetics is a combination of molecular biology and cytogenetics. Statistics:... View more
Global Cell and Gene Therapy Market – Rich Product Pipeline Cell and gene therapy plays a major role in modern healthcare, as they provide concepts and techniques that can be used in gene regulation, ce... View more
tPA tissue plasminogen activator is produced by using recombinant technology techniques known as recombinant tissue plasminogen activator (rtPA). Specific rtPAs are tenecteplase, alteplase, and reteplase. These enzymes are used in clinical treatment of thrombotic stro... View more
Stem Cell Cartilage Regeneration Market – Insights Increasing adoption of minimally invasive surgery procedures is expected to drive growth of stem cell cartilage regeneration market. Stem cell therap... View more
Rising demand for human biologics cannot be fulfilled by currently used mammalian cell culture production platforms, as these platforms are highly expensive and have limited scalability. However, recent developments in plant expression vectors, downstream processing, ... View more
Protein Expression Systems Market – Insights Protein expression has become an important laboratory technology in biochemistry, molecular biology, and protein research as well as other scientific researc... View more
Gene Therapy for Rare Disease Market - Insights Gene therapy involves insertion of genetic material into cells of the patients to provide new function or to restore missing or inappropriate functioning ... View more
Pneumococcal Vaccines Market Insights Pneumococcal vaccine is used to prevent infection caused by streptococcus pneumoniae bacteria. There are two types of pneumococcal vaccines: pneumococcal conjugate vaccin... View more
Micro-needles are new form of dose delivery systems, which can easily overcome various problems associated with the conventional formulations. Microneedle device consists of needles of micron size, which are arranged on a small dermal patch. The main principle of micr... View more
Tissue engineering is an interdisciplinary field addressed to develop functional three-dimensional tissues combining cells, scaffolds, and bioactive molecules. This field involves scientific areas such as cell biology, chemistry, material science, molecular biology, m... View more
Plant serves as an important source to produce cost-effective vaccine derivatives. Plant-based production of vaccine helps to reduce economic burden of infectious disease in emerging economies, owing to its large-scale production and cost-efficiency. Various clinical ... View more
Contact Us