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.View less

Biotechnology Published Insights

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Published Date : Jan 2022

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Published Date : Dec 2021

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Published Date : Dec 2021

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Published Date : Dec 2021

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Published Date : Oct 2021

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Covid 19 Nasal Swab Test Market

Published Date : Sep 2021

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Latin America Insulin Vials Market

Published Date : Aug 2021

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Published Date : Aug 2021

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Genomic Biomarker Market

Published Date : Aug 2021

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Published Date : Aug 2021

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Gene Panel Market

Published Date : Jul 2021

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Orthopedic Regenerative Medicine Market

Published Date : Feb 2021

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Published Date : Nov 2020

Plant-based biologics are biologic drugs that are manufactured by using plant molecular farming. They are also known as plant-made biologics (PMB). The applications and advantages of plant-based biologics have stretched beyond the traditional boundaries of vaccines an... View more

Genomics And Proteomics Reagents Research Kits And Analytical Instrumentation Market

Published Date : Aug 2020

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Europe Allogeneic Human Chondrocyte Market

Published Date : Aug 2020

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Transcriptomics Technologies Market

Published Date : Jul 2020

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Viral Vectors And Plasmid Dna Manufacturing Market

Published Date : Mar 2020

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Dengue Vaccines Market

Published Date : Jan 2020

Dengue fever is a mosquito-borne viral infection causing a severe flu-like illness. Dengue vaccine is only recommended in those who have previously had dengue fever. It is given as three injections over a year. Dengue is most likely to affect individual’s tropic... View more

Biotechnology Published Insights

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