Peptide Therapeutics Market Analysis | CMI

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2. PEPTIDE THERAPEUTICS MARKET ANALYSIS • Peptide Therapeutics Market, By Type (Branded Peptide, Generic Peptide), By Application (Cancer, Cardiovascular Disease, Metabolic Disease, Respiratory Disease, Infectious Disease, Others), By Route of Administration (Oral Administration, Parenteral Administration, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East & Africa) - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027 • The global peptide therapeutics market is estimated to account for US$ 23,319.3 Mn in terms of value and is expected to reach US$ 57,166.5 Mn by the end of 2027.

3. Global Peptide Therapeutics Market: Drivers • Increasing prevalence of metabolic diseases and cardiovascular disorders (CVDs) is expected to boost growth of the global Peptide Therapeutics Market over the forecast period. For instance, according to American Heart Association’s Heart Disease and Stroke Statistics 2018, around 92.1 million adults in the U.S. are suffering from some form of CVD or the after-effects of stroke. • Moreover, increasing healthcare expenditure is also expected to aid in growth of the market. For instance, according to the Centers for Medicare & Medicaid Services (CMS), health spending in the U.S. is projected to grow at an average rate of 5.5% per year for 2018-27 and to reach nearly US$ 6.0 trillion by 2027.

4. Statistics: • North America region held dominant position in the global peptide therapeutics market in 2018, accounting for 42.1% share in terms of value, followed by Europe.

5. Global Peptide Therapeutics Market: Restraints • Poor chemical and physical stability and a short circulating plasma half-life of naturally occurring peptides are expected to hinder growth of the global peptide therapeutics market. • Moreover, presence of stringent safety regulations is also restraining the market growth. Pharmaceuticals products such as peptide therapeutics require better regulatory framework as these treat multiple pathological conditions; by 2020, the regulatory framework is expected to be better.

6. Global Peptide Therapeutics Market: Opportunities • R&D of new peptides is expected to offer lucrative growth opportunities for players in the market. For instance, in December 2019, CohBar, Inc. announced new preclinical data that confirmed the therapeutic potential of a novel CohBar peptide in a preclinical model of Idiopathic Pulmonary Fibrosis (IPF). • Moreover, R&D in microbiome research is also expected to boost growth of the peptide therapeutics market. In January 2020, researchers from The Chaim Sheba Medical Center, Israel, reported that high fructose consumption induced metabolic changes and dysbiosis in rats and that metabolic changes are probably independent of a specific microbiome profile. • Parenteral sub segment in the route of administration segment in global peptide therapeutics market was valued at US$ 16,416.8 Mn in 2018 and is expected to reach US$ 40,790.6 Mn by 2027 at a CAGR of 10.5% during the forecast period.

7. Market Trends/Key Takeaways • The market is witnessing increasing adoption of new platforms that develop next-generation protein or peptide therapeutics. For instance, in January 2020, Xenetic Biosciences, Inc. announced publication of the data from the completed Phase 1/2 clinical study of SHP656 ("PSA-recombinant Factor VIII", "PSA-rFVIII") in the journal Haemophilia. The study used Xenetic's PolyXen technology – a patent-protected platform technology for creating next-generation protein or peptide therapeutics. • The market is also witnessing increasing M&A activities. For instance, in January 2020, Almirall, S.A. acquired Bioniz Therapeutics Inc., a clinical stage biopharmaceutical company that develops first-in-class peptide treatments for immuno-inflammatory diseases.

8. Regulations U.S. • As per the FDC and PHS act of the U.S. FDA, CDER and CBER are responsible for certain part of therapeutic proteins • CDER now has regulatory role, which includes premarket review and continuing oversight of therapeutic peptides • 2012: As per FDA, ‘peptides are defined as any alpha amino acid polymer with specific defined sequence that is 40 amino acids or less in size’. • Since there are various peptide conjugate candidates that contain peptides in combination with small molecules, the regulatory aspect for peptide is still evolving • The FDA takes into account the history and manufacturing aspect of the candidate molecule to decide its regulatory pathway Example whether BLA would be submitted or NDA needs to be applied • All the non-clinical studies are carried out as per ICH-S6 guidelines

10. Global Peptide Therapeutics Market: Competitive Landscape • Major players operating in the global peptide therapeutics market include, AstraZeneca plc., Bachem Holding AG, CordenPharma International, Eli Lilly and Company, Ipsen S.A, Merck & Co., Inc., Novo Nordisk A/S, PolyPeptide Group, and Teva Pharmaceutical Industries Ltd.

11. Global Peptide Therapeutics Market: Key Developments • Major players in the market are focused on adopting collaboration strategies to expand their product portfolio. For instance, in October 2019, PolyPeptide Group collaborated with the Green Chemistry and Enabling Technologies Team of IBMM (Institut des Biomolécules Max Mousseron), for R&D greener solutions to produce synthetic peptides. • Major players in the market are also focused on adopting M&A strategies to expand their product portfolio. For instance, in July 2019, Xenetic Biosciences, Inc. completed acquisition of the novel CAR T (“Chimeric Antigen Receptor T Cell”) platform technology, called “XCART,” designed to use screening technique to identify peptide ligands that bind specifically to the unique B-cell receptor of malignant tumor cells.

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