Biotechnology

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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.”

  • Tufts Center for the Study of Drug Development

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:

  • Erbitux (cetuximab) - February 2016
  • Rituxan (rituximab) - September 2016
  • Herceptin (trastuzumab) - June 2019
  • Avastin (bevacizumab) - July 2019
  • Aranesp (darbepoetin alfa) - May 2024
  • Enbrel (etanercept) - November 2028

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.

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Biotechnology Published Insights

Coherent Market Insights

Regenerative Medicine (Bone and Joint) Market, by Technology (Stem Cell, Biomaterial, and Tissue Engineering), by Application (Bone Graft Substitutes, Osteoarticular Diseases, Allogeneic Bones, Autogenic Bones, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027

Published Date : Feb 2021

Regenerative medicines are medical products or active pharmaceutical ingredients that have the ability to cure organs and tissues organs damaged by various factors such as aging, trauma, and can also be used to provide stability of health in congenital disorders such ... Read more

Coherent Market Insights

Cervical Cancer Vaccines Market, By Product Type (Cervarix, Gardasil, and Gardasil 9), By Distribution Channel (Hospitals, Clinics, and Government Entities), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Trends, and Forecast 2018 - 2026

Published Date : Jul 2019

Cervical Cancer Vaccines Market – Insights Cervical cancer is currently the leading cause of cancer mortality among women worldwide. According to World Health Organization 2018, around 90% of deaths fro... Read more

Coherent Market Insights

Custom Recombinant Protein Production Services Market, By Expression System (Mammalian, Bacteria, Insect, Yeast, and Others), By End User (Research Institutes, Biotechnology and  Pharmaceutical Companies, Contract Research Organizations and Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2021 - 2028

Published Date : Sep 2021

Recombinant proteins have a wide range of applications in biotechnology, research, and medicine. Custom recombinant protein production is one of the efficient techniques used in life sciences sector that play a major role in advanced healthcare. Proteins are manipulat... Read more

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