Forum Exchange POXEL – 01/12/2023 22:12:49 – DT2 market growth driven by new GLP-1RAs

Type 2 Diabetes (T2D) is a crowded and competitive landscape with many generic and biosimilar drugs entering the market, and market growth is primarily driven by growing populations in nine key markets (9MM: US, France, Germany, Italy, Spain, UK). , Japan, China and India). As of 2019, major successful franchises such as Victoza in glucagon-like peptide-1 (GLP-1), Januvia in dipeptidyl peptidase-4 (DPP-4I) inhibitors, and Lantus in the market are experiencing market share erosion. to the mix of new therapies coming out of the pipeline and generics and biosimilars that are rapidly entering the market. In particular, Victoza’s market share is eroding due to continued growth of Lilly’s once-weekly GLP-1 Trulicity (dulaglutide) and the rapid growth of Novo Nordisk’s Ozempic (semaglutide) and Rybelsus (oral semaglutide). Januvia’s attrition comes as its patent expires in 2022 and physician preference for sodium-glucose-glucose transporter-2 (SGLT-2I) inhibitor therapies such as Farxiga (dapagliflozin) and Jardiance (empagliflozin) due to their ability to improve glycemic control is related. treatment of cardiorenal comorbidities.

Many of the current treatments are often considered by physicians to be suboptimal to meet patient needs, and challenges remain such as improving patient compliance, safety profile, and acceptance that account for T2D comorbidities. Most treatments entering the market are either “me-too” treatments or generics, offering little or no difference to their authors, and thus these unmet needs remain unmet. Addressing these unmet needs can be identified in the drug development pipeline, the most significant breakthrough therapy recently launched on the market, Eli Lilly’s GLP-1 receptor agonist (GLP-1RA)/polypeptide receptor agonist gastric inhibitor (GIP), Mounjaro (tirzepatide), immediately in the USA, five European countries (5EU: France, Germany, Italy,

The figure below summarizes the unmet needs and opportunities in T2D.

GlobalData expects the DT2 market to see significant growth from 2019 to 2029, with 9MM sales totaling $45.9 billion in 2019, rising to $136.2 billion in 2029, with sales growing at a compound annual growth rate (CAGR) of almost doubled to 11.5%. Many drugs are in development, primarily me and biosimilar therapies, a significant number of which are developed by national pharmaceutical companies in the emerging markets of India and China for their fast-growing markets. Therapies likely to drive significant market growth include semaglutide GLP-1RA (Ozempic) with a CAGR of 29.3% and oral semaglutide (Rybelsus) with a CAGR of 112% due to significant market growth with initiation of therapy. in 9MM. throughout the forecast period. In addition,

In particular, significant developments, label renewals and biosimilar launches in all major classes are driving their growth. In the GLP-1RA space, the launch of once-weekly subcutaneous Ozempic and oral Rybelsus in 2020 were particularly game-changing and demonstrated cardiovascular benefits, reduced risk of major adverse cardiovascular events (MACE), and benefits for weight loss demonstrated. treatment of obesity. In the current GLP-1 market, there is significant competition for clinical data for weight loss in patients with and without T2D, and semaglutide has demonstrated its importance in this area. However, Eli Lilly’s recently launched GLP-1/GIP dual agonist therapy Mounjaro demonstrated superior clinical data versus semaglutide in weight loss, as well as improved glycemic control, potential cardiovascular benefits, and improvement in blood triglycerides. While Mounjaro’s sales growth is expected to continue beyond 2029, it is expected to compete for significant market share with semaglutide, along with Lilly’s Trulicity (dulaglutide), which is expected to reach $10.2 billion in 2029 sales.

The DPP-4I market is experiencing an overall decline in major brands, with sitagliptin (Januvia), the former market-leading T2D therapy, experiencing significant market decline with its patent expiring in 2027 and the development of sitagliptin generics. India. market. However, several me-to DPP-4I therapies have been launched in the Chinese market, resulting in steady growth for the DPP-4I market (9MM CAGR 0.3%, China CAGR 0.39%), but likely continued erosion. Januvia is a brand name for conventional treatments such as Onglyza and Tradjenta.

There is significant commercial activity in the SGLT-2I market with label updates for major blockbuster treatments for heart failure (HF) and now T2DM patients with chronic kidney disease (IRC). Farxiga successfully obtained label updates for these two cardiorenal comorbidities of T2DM following positive trial results for Dapa-HF, Dapa-CKD and DECLARE-TIMI 58 and Invokana for heart failure T2DM and diabetic kidney disease. Jardiance (empagliflozin) received similar label updates for T2D with HF and CKD following the EMPA-REG trials and is competing strongly with Farxiga for successful long-term market dominance in the SGLT market -2I. However, Invokana is expected to continue to lose market share (9MM CAGR decline forecast at 14.6%).

The SGLT-2I space is rapidly gaining market share over DPP-4I and other non-insulin diabetes treatments, as multiple clinical data over the past few years have demonstrated that they treat T2D comorbidities. This addresses a major unmet need and is novel to the class, as physicians were previously weary of SGLT-2I due to concerns about its safety profile. Competition has also increased in the SGLT-2I market in India and China, with several generics in the Indian market and several me-too therapies recently launched in China, such as Ruigin (henagliflozin) and phase III janagliflozin (XZP -5965). as well as oral triple therapy SGLT-1/SGLT-2/DPP-4I, THDBH-100.

In the insulin market, there are several changes in treatments that dominate market share, with successful franchises such as Eli Lilly’s Humalog (insulin lispro) and Sanofi’s Lantus (insulin glargine) seeing sales decline significantly over 2019-29. This is directly related to the emergence of biosimilar/interchangeable insulins such as Sanofi’s Admelog (insulin lispro), Lilly’s Basaglar (insulin glargine), and Mylan.Semglee’s insulin (long-acting insulin glargine). In addition, Novo Nordisk’s insulin portfolio has a wide market application, including Fiasp (ultra-rapid insulin aspart), Tresiba (insulin degludec) and the combinations Xultophy (insulin degludec + GLP-1RA) and Ryzodeg (insulin degludec + aspart). Market uptake for combination therapies remains strong, as evidenced by Xultophy (CAGR 9.1%) and Ryzodeg (CAGR 16.9%), as well as Sanofi’s Soliqua (insulin glargine + lixisenatide, CAGR 28.5%). This is due to the innovative mechanisms and advantages of combination therapy in terms of increasing its effectiveness, improving patient compliance and eliminating the complications of multiple daily injections. In addition, other drivers of the insulin market include the release of weekly basal insulins,

New classes are also emerging in the T2D market, with Lilly’s first-in-class therapeutic retatrutide, a new Phase II pipeline agent for the GLP-1RA/GIP/glucagon (GR) receptor class of triple agonists. A new class, Glimins, consists of Poxel’s first-line oral therapy imeglimin, currently marketed in Japan but in Phase II in the EU and US, and a new class of glucokinase activator (GK) PF-04937319 in phase II. in China and will likely be the second therapy launched in this class after dorzagliatin is launched in 2022. All of these new treatments address major unmet needs in the T2DM therapeutic space, with retatrutide treating additional comorbidities, particularly obesity, and imeglimin, which has a completely novel mechanism, useful for patients with poor response to traditional oral antidiabetic therapies. PF-04937319 offers some improvements in safety and tolerability that traditional first-line therapies, thiazolidinediones (TZDs) and sulfonylureas (SUs), fail to provide. There are other promising treatments, such as an oral insulin (insulin tregopil) that may dominate the Indian insulin market, and Oramed’s ORMD-0801, an oral insulin in phase III in the US. large share of the insulin market. US insulin market to 2029.

In addition to these late-stage pipeline agents, multiple biosimilar/interchangeable insulins and I- DPP-4I and SGLT-2I therapies are likely to enter the Indian and Chinese markets between 2019 and 2029. This will lead to erosion of key blockbuster insulins and a long-term decline in branded therapies produced by major players in the T2D space, particularly in emerging markets. The launch of Lilly’s dual agonist Mounjaro and its GLP-1 Trulicity (dulaglutide), Novo Nordisk’s semaglutide therapies (Ozempic and Rybelsus), GLP-1 classes and GLP-1/GIP, and significant future launches. GLP/GIP/GR class,

In addition, some treatments with patent expirations between 2019 and 2029 will lead to the development of generics and biosimilars, opening the way to new classes of agents that could gain more market share if they can address unmet needs. We hope that doctors and patients will be arrested. Most of these agents in the pipeline will compete for market share and will increasingly be prescribed in combination across classes for patients with increasingly complex T2D co-morbidities.

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