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


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.


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 Rhu Albumin Market

Published Date : Jun 2022

A biopharmaceutical is a medicinal product that is derived from biological sources such as animals, humans, and microorganisms using biotechnology. They are manufactured using stem cells, mammalian cells, etc., through tissue culture methods. ... View more

Coherent Market Insights Middle East And Asia Pacific Cell And Gene Therapy Market

Published Date : Mar 2022

Cell therapy is the administration of living cells in patients for the treatment of a disease such as oncology, Immunology and others. The source of a cell can be autologous or allogeneic, which can be derived from stem cells such as bone marrow. Stem cells therapy is... View more

Coherent Market Insights Covid 19 Sample Collection Kits Market

Published Date : Mar 2022

Coronavirus disease is a contagious disease caused by severe acute respiratory syndrome (SARS-CoV-2). COVID-19 sample collection kits are the kits that consist of reagents and consumables for facilitating the detection and diagnosis of SARS-Cov2 infection from nasal, ... View more

Coherent Market Insights Blood Based Biomarker Market

Published Date : Feb 2022

The term biomarker, or biological marker, refers to a broad range of measures that capture what is happening in a cell or organism at a given moment. Blood-based biomarkers can be effective in formulating new diagnostic and treatment proposals. Blood-based biomarkers ... View more

Coherent Market Insights Middle East And Asia Pacific Biotechnology Market

Published Date : Feb 2022

Biotechnology is a broad field that deals with the use of living organisms to create products that are beneficial to long-term development. It uses cellular and molecular processes to create products and technologies that may improve human life on Earth. It has a numb... View more

Coherent Market Insights Vaccines Market

Published Date : Feb 2022

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Coherent Market Insights Mr Vaccines Market

Published Date : Feb 2022

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Coherent Market Insights Uk Cell And Gene Therapy Research Challenges Market

Published Date : Jan 2022

Cell therapy can be defined as the transfer of new cells into a patient’s body to repair or replace damaged tissue or cells to treat a disease. The introduced cells can be from patient’s own body or from the donor. Different types of cells can be utilized ... View more

Coherent Market Insights Small Scale Bioreactors Market

Published Date : Dec 2021

Bioreactors are processing vessels used for providing effective environment for enzymes or cells during biochemical processing which involves biological active substances and microorganisms. The bioreactor processes are aerobic or anaerobic. There are various types of... View more

Coherent Market Insights Covid 19 Rapid Diagnostic Test Market

Published Date : Dec 2021

A rapid diagnostic test of a sample of a person helps to detect the presence of viral proteins (antigens) related to the COVID-19 virus. This ensures an accurate and a speedy diagnosis, and its usage is Centers for Disease Control and Prevention CDC-app... View more

Coherent Market Insights T Cell Lymphoma Market

Published Date : Dec 2021

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Coherent Market Insights Ataxia Market

Published Date : Oct 2021

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Coherent Market Insights Bovine Serum Albumin Market

Published Date : Sep 2021

Bovine serum albumin (BSA) is protein derived from cows. Bovine serum albumin has negative charge, which binds salts, water, fatty acid, vitamins, and hormones and carries these attached materials between tissues and cells. BSA offers features such as sensitivity, com... View more

Coherent Market Insights Covid 19 Nasal Swab Test Market

Published Date : Sep 2021

COVID-19 infection is caused by SARS-CoV-2, which is a highly transmissible and life-threatening strain of coronavirus. Nasal swab is a method used for collecting clinical test samples of nasal secretions. Nasal swabs can be used for analysis of number of infectious d... View more

Coherent Market Insights Latin America Insulin Vials Market

Published Date : Aug 2021

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Coherent Market Insights Histology And Cytology Market

Published Date : Aug 2021

Cytology refers to the microscopic examination of both plant and animal cell samples with regards to their structure, chemical composition, and function. The examination of cells can be carried out through various methods such as scraping the tissue surface, collectio... View more

Coherent Market Insights Plant Phenotyping Market

Published Date : Aug 2021

Phenotype refers to the physical characteristics of an organism that can be observed and measured. Interactions between alleles of an organism gives rise to different combinations of phenotypes such as morphology, biochemical properties, etc. Gregor Mendel, also known... View more

Coherent Market Insights Antifreeze Proteins Market

Published Date : Aug 2021

Antifreeze proteins are peptides or polypeptides produced by certain organisms that lower the freezing point of water to prevent crystallization in the frozen state. This allows organisms to survive at a temperature below zero degree Celsius without any freezing damag... View more

Coherent Market Insights Genomic Biomarker Market

Published Date : Aug 2021

Genomic biomarkers are either DNA or RNA characteristics that are associated with a physiological process, immunological process or therapeutic response. A genomic biomarker reveals the expression, function, and regulation of a gene. DNA characteristics that act as ge... View more

Coherent Market Insights Blood And Blood Components Market

Published Date : Aug 2021

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