The increasing demand for Biologics driving the global API market

Biologics are therapeutic entities composed of sugars, proteins, or nucleic acids and manufactured from natural sources such as human, animal, or microorganisms. Biologics can also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (transplantation), cell therapies, and gene therapies. These biologics such as proteins, genes and others which are engineered by nature or prepared synthetically play a major role either through inhibiting certain protein receptors (in cell signaling pathway) present on the surface of the cells, controlling the production of vital proteins, or activating or suppressing the immune system components and thereby delivering highly targeted and effective treatment for various types of life-threatening chronic diseases in the field of gastroenterology, neurology, oncology, inherited genetic disorders, diabetes, and rheumatology which do not attain remission through conventional treatments. Biologics are typically given either subcutaneously (with a needle through the skin) or intravenously (through an IV tube).
According to IQ4I analysis, the global biologics API is expected to grow at a double-digit CAGR from 2020 to 2027 to reach $120,980.9 million by 2027. The Biotech API includes monoclonal antibodies, recombinant proteins, vaccines, cell and gene therapy products. Among biotech API, monoclonal antibodies accounted for the major market share in 2020 and the vaccines segment is projected to be the fastest-growing segment with a low teen CAGR from 2020 to 2027.
Monoclonal antibodies are laboratory-engineered molecules by using unique B-cells fused to an immortal hybridoma cell line so that large quantities of identical antibodies can be generated. An emerging trend in the monoclonal antibody segment is antibody-drug conjugates that are anticancer drugs under the new class of biopharmaceutical drugs. As these ADCs are highly effective for the treatment of cancer many biopharmaceutical companies are involved in research to examine the potential effects in therapeutic application areas such as autoimmune diseases. The recent development of Bispecific antibodies (BsAbs) or multi-specific antibodies offers attractive new opportunities for the design of novel protein therapeutics. Most bispecific antibodies are designed to recruit cytotoxic effector cells of the immune system to target pathogenic cells.
According to the WHO, the global vaccination rate is nearly 85%, demonstrating a high clinical demand for vaccines. The great hope in the control of infectious diseases is always a vaccine. Vaccines have always sounded the sign of relief from morbidity and mortality for societies. They have played an important role in the reduction of communicable diseases from the second half of the 20th century. In 2020, WHO called COVID-19 a pandemic, and in this context most of the pharmaceutical manufacturing companies have strategized for the development of COVID-19 vaccine to keep their leading position in the market and there were many acquisitions and collaborations for the research and development of COVID-19 vaccines. For instance, in April 2020, Sanofi S.A. (France) and GlaxoSmithKline plc (U.K.) collaborated to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology and GSK will contribute its proven pandemic adjuvant technology to the collaboration. Sanofi is investing $200 million to expand a vaccine manufacturing site in Val de Reuil, France. The expansion further strengthens Sanofi’s position as one of the world’s leading seasonal flu vaccine providers.
At forefront of various medicines, the development of stem cell and gene therapies in the drug market is an emerging trend, since there is a demand for personalized medicine for several diseases. The diseases can be extremely complex and their cure requires a combination of treatments with different mechanisms. New emerging techniques like CRISPR will improve gene therapy technologies in the coming years. CRISPR/Cas9 offers the advantage of being more cost-effective but will require significant fine-tuning to avoid or limit previously observed off-target mutagenesis. In some genetic disorders where a mutation causes an excess of the encoded protein, such as in hereditary transthyretin amyloidosis or Huntington’s disease (HD), gene therapy can be used to “silence,” or suppress the resultant gain-of-function using RNA interference (RNAi). Also, the current gene therapies are focused more on single gene mutation and leukemia conditions.
The increased therapeutic value of biotech API and the huge potential of the biologics global market have resulted in companies focusing on new partnerships and collaborations to expand their offerings. For example, in December 2020 AztraZenaca Plc (U.K.) and Alexion Pharmaceuticals, Inc. (U.S.) entered a definitive agreement for AztraZenaca Plc to acquire Alexion Pharmaceuticals, Inc. for $39.0 billion. This acquisition will boost AstraZeneca Plc’s rare-disease drug pipeline and capitalize on the biotech space in the U.S. In March 2020, Gilead Sciences, Inc., (U.S.) acquired Forty Seven, Inc. (U.S.) for $4.9 billion and the acquisition includes an antibody developed by Forty Seven Inc., to treat blood cancers that have shown promising results.
The novel biologics with the targeted therapy capabilities have revolutionized cancer treatment thereby increasing the survival rate of cancer patients. With the new biologic drugs, the five-year survival rate of breast cancer has increased from 75% to 90%, and the average 10-year survival rate is 83%. Some of the potential biologics used for the treatment of breast cancer are Pertuzumab, trastuzumab, Bevacizumab, and atezolizumab, and cetuximab, which are anti-EGFR (Epidermal growth factor) monoclonal antibodies inducing apoptosis in tumor cells, mepolizumab is an anti–IL-5 antibody approved for the treatment of severe eosinophilic asthma. Novel generations of biologics such as fusion proteins which is a combination of monoclonal antibodies and therapeutic proteins and multispecific antibodies for the treatment of various diseases are under the pre-clinical phase.
Increasing need for medications or drugs with the rise in incidence and prevalence of chronic diseases, various drug manufacturers have strategized for new drug approvals and research and development of biological drugs. For instance, in 2020, FDA approved 53 drugs, of which 65% were small molecules, 35% were biologics. Whereas during 2019, 48 novel drugs received FDA approval, out of which 25.0% were biologic drugs. The percent growth in biologics is 10.2% as compared to 2019 approvals, thus indicating the rise in the demand for biologics. In 2019, seven out of 10 blockbuster drugs were biologics outnumbering small molecule drugs. Some of the top-selling biologics in 2019 included Humira ($19.1 billion), Keytruda ($11.0 billion), Avastin ($7.28 billion) and Opdivo ($7.20 billion). The growth of the biologics market indirectly indicates the huge demand for services spanning all stages of biologic development starting from the preclinical stage to commercial manufacturing.
Biosimilars are biotherapeutic products that are similar to the commercialized reference biologic drugs in terms of efficacy, quality, safety, potency and purity. These slightly modified genres of original biologic drugs, with slight differences in their clinically active components, are emerging as an effective substitute for the highly expensive biotherapeutics. The growth of the biosimilar market is driven by the expiration of patents of various top-selling biologic drugs, need to substantially reduce healthcare expenditure by driving down the prices of biologics through competition, increasing regulatory approval of several biosimilars from the global patient pool for treating the highly prevalent chronic diseases with no effective conventional therapeutics till date. These biosimilars increase patient access to highly effective but expensive biotherapeutics by spurring stiff competition among the biopharmaceutical companies in the biologics market. In 2019, 10 biosimilars for various therapeutic areas like rheumatoid arthritis, psoriasis, blood disorders and cancers were approved by FDA. Due to the huge commercial potential of the biosimilar market, many biopharmaceutical companies are racing to develop and launch biosimilars for blockbuster drugs. In January 2020, Pfizer launched biosimilars of Roche’s Avastin, Herceptin and Rituxan at substantially reduced prices. Some of the top revenue-generating biologic drugs like Humira, Avastin and Herceptin have approximately 51, 57 and 60 biosimilar products in the pipeline across various stages of development respectively.
Biologics-based treatment as a new approach to disease management will continue to evolve due to their targeted and potential curative efficacy for various types of diseases will further boost the demand for biologics and thereby driving the growth of the global API market. 
Some of the prominent Biotech API players include Eli Lilly and Company (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Pfizer Inc. (U.S.), Biogen Inc (U.S.), Merck KGaA (Germany), AbbVie Inc. (U.S.), Novasep (France), WuXi Biologics (China), Catalent Inc. (U.S.), Samsung Biologics (South Korea), Lonza Group (Switzerland), Boehringer Ingelheim (Germany), Thermo Fisher (Patheon N.V., U.S.), and others.



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