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.
Plasmid DNA is becoming increasingly important in clinical research for gene therapy and genetic vaccine applications. Good manufacturing practice (GMP)-grade plasmid DNA is required for direct gene transfer into humans. The same is true if the drug material contains ... View more
COVID-19 sample collection kits are used for diagnosis and detecting SARS-CoV2 virus infection. The collection kits include vital reagents provided for collecting samples and delivering them to the laboratory where the testing services will be performed on such sample... View more
The IPV are very safe. At the site of injection pain or mild redness may occur. To preventfrom Poliomyelitis, which affects children under age of 5. This infection can turn into irreversible paralysis and can also cause death. There are two types of vaccines used: an ... View more
A biomarker (short for biological marker) is an objective measure that captures what is happening in a cell or an organism at a given moment. Biomarkers can serve as early warning systems for health. A blood-based biomarker (biological marker in the patient’s bl... View more
Biotechnology is biology-based technology that uses cellular and bimolecular processes to create technologies and products that improve the human lives and the health of the planet. Microorganisms' biological processes have been used for over 6,000 years to produce fo... View more
The measles and rubella (MR) vaccine, which protects against measles and rubella, is recommended by the Centers for Disease Control and Prevention (CDC). MR vaccine should be given to children in two doses, the first at 12 to 15 months of age and the second at 4 to 6 ... View more
Vaccines help to strengthen the immune system and protect it from dangerous, life-threatening diseases such as hepatitis, polio, tuberculosis, and others. Vaccines help the body to fight against path... View more
Gene therapy can be described as the transfer of genetic material mostly in a vector or carrier while cell therapy includes the transfer of cells with the applicable function into the patient’s body. In the broader sense, gene therapy involves introduction, with... View more
Regenerative medicines can be defined as ways for regrowing, replacing injured cells, organs, or tissues, with medication covering the production of artificial organs, tissue engineering, and therapeutic stem cells, as well as the production of artificial organs. Rege... View more
Bioreactors are bioprocessing devices that are used for biochemical processing that involves biological active substances and micro-organisms. This bioprocessing can be aerobic or anaerobic. The various type of bioreactors are designed as cylindrical structures and co... View more
T-cell lymphoma is a type of blood cancer which arises from unregulated growth and multiplication of T-cell lymphocytes present in the immune system of the human body. T-cell lymphoma is of two major types: peripheral T-cell lymphoma and T-cell lymphoblastic lymphoma.... View more
Ataxia is a group of degenerative disorders associated with the cerebellum in the brain, which is responsible for regulating balance and coordination of the body. Ataxia does not have a cure and only its symptoms such as weakness, difficulty in movement and others can... View more
Bovine serum albumin (BSA or "Fraction V") is a serum albumin protein, which is extracted from blood plasma of cows. BSA is available in various forms such as powder or liquid for use in immunology, biochemistry and imm... View more
COVID-19 (Coronavirus Disease) is caused by the novel coronavirus SARS-CoV-2, which is a RNA virus. Few of the common symptoms of COVID-19 include fever, dry cough, fatigue, and body ache. COVID-19 disease can be transmitted from one person to another by the inhalatio... View more
Insulin is a peptide hormone required in the body for normal carbohydrate, protein, and fat metabolism. Insulin is produced in the pancreas by the beta cells in specialized areas of pancreas called islets of Langerhans. Insulin promotes glucose uptake in the body cell... View more
Cytology can be defined as the microscopic study of cell sample, which can be collected from any part of the body such as lungs, vagina, kidney, and others to assess the presence of irregular growth or lumps on the body surface. Cytology can also be used to assess abn... View more
Neurological biomarkers are detectable substances majorly found in the cerebrospinal (CSF) fluid when there has been some damage to the brain. These biomarkers help in early diagnosis of neurological disorders, drug development, and for developing personalized medicin... View more
Plant phenotyping refers to a set of methods and tools used to measure plant characteristics or phenotypes such as height, color, etc. Phenotypes are affected by environmental factors and interactions between genes. The knowledge of phenotypic characteristics of a pla... View more