Pregabalin Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Pregabalin Market is segmented By Product (Capsules, Oral solutions, Tablets, Others), By Application (Neuropathic Pain, Epilepsy, Anxiety Disorder, Others), By End User (Pharmaceutical Companies, Research Institutes, Others (Hospitals and Clinics)), and By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Pregabalin Market Size

The Global Pregabalin Market size was valued US$ YY billion in 2022 and is estimated to reach US$ YY billion by 2031, growing at high CAGR during the forecast period (2024-2031). 

Pregabalin is an anti-convulsive medication used to treat epilepsy, fibromyalgia, neuropathic pain, fibromyalgia, and other generalized anxiety disorders. Its mode of action involves a decrease in pain signals sent by the damaged nerves in the body.

Pregabalin Market Scope

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Pregabalin Market Dynamics

The pregabalin market growth is driven by the rising prevalence of epilepsy, neuropathic pain, and other related disorders globally. In addition, the increasing geriatric population, coupled with the increasing prevalence of diabetes, neuropathic pain, fibromyalgia, and others.

The growing prevalence of epilepsy, neuropathic pain, and other related disorders globally, is expected to drive the global pregabalin market growth

Epilepsy is a chronic non-communicable disease of the brain that affects people of all ages. According to the recent updates by the World Health Organization (WHO), 2019, there are an estimated 50 million people worldwide with Epilepsy, of whom up to 75% live in resource-poor countries with little or no access to treatment or medical services, and the average incidence of Epilepsy each year in the U.S is estimated about 150,000 or 48 for every 100,000 people. It was found that in the United States, the number of males and females with Epilepsy was 1,477,323 and 1,331,276, respectively, in 2017. Moreover, about 80% of people with Epilepsy live in middle- and low-income countries.

The FDA approval of generic versions coupled with adverse effects of pregabalin is likely to hamper the market growth

In 2018, Pfizer completed its patent expiry of Lyrica (pregabalin), and in July 2019, InvaGen Pharmaceuticals Inc. (Ciplas wholly owned step-down subsidiary) received final approval for the generic version of Pfizer Lyrica, which is anticipated to decrease the market revenue.

On the contrary, side effects related to pregabalin include chest pain, cold sweats, cool, pale skin, cough-producing mucus, difficult or labored breathing, muscle aches, twitching or jerking, or weakness, noisy breathing, seizures are expected to hinder the market growth.

COVID-19 Impact Analysis

Currently, big pharma giants are more seeking collaborations and approvals to develop a vaccine in the market space, to prevent the spread of COVID-19 as soon as possible. The main focus of pharma firms on the vaccines and treatment of COVID 19 is to impact the other drug manufacturing and supply.

The outbreak also impacted generic manufacturers, supplying most of the market volume due to supply chain issues. This is expected to decline the production rates. However, this can also drive up the prices of drugs in the short term. Moreover, the innovator drug manufacturers are likely to fill the supply gap leading to a relatively lower impact on the market as a whole.

Pregabalin Market Segment Analysis

The neuropathic pain segment is expected to hold largest share in this market segment

Neuropathic pain often refers to burning or shooting pain. The damage of nerves usually causes it. Pregabalin is used to reduce neuropathic pain by blocking the pain signals. The increasing neuropathic pain and growing risk factors such as diabetes and HIV are anticipated to fuel the market growth. For instance, as per the International Diabetes Federation, an estimated 9.3% adult population was affected by diabetes in 2019, and the number is estimated to reach almost 11% by 2045. Moreover, as per the National Institute of Health 2019 article, globally, diabetic polyneuropathy (DPN) has a lifetime prevalence of nearly 50%, and it is the most common diabetic complication and around 20 to 30% of patients with DPN suffer from neuropathic pain.

The Capsule segment is expected to hold largest share in this market segment

Pregabalin capsules are expected to hold the largest share of the segment over the forecast period. It is taken by mouth. Pregabalin oral capsule is used to treat neuropathic pain and fibromyalgia. It’s also used to treat partial-onset seizures when taken with other seizure drugs. When the capsule is treated with an aqueous solution, water enters the capsule by osmosis, and the contents get absorbed due to the breakage of the shell. For instance, in December 2017, Zydus Pharmaceuticals (USA) Inc received tentative approval from the US health regulator to market pregabalin capsules used to manage certain kinds of seizures, nerve pain and fibromyalgia.

The Pharmaceutical companies segment is expected to hold largest share in this market segment

Pharmaceutical companies hold the largest share of the pregabalin market segment.  On January 21, 2019, the US Food and Drug Administration (FDA) has approved nine generic versions of Pfizer’s nerve pain drug Lyrica (pregabalin), the first generics approved for the medication. For instance, in May 2020, Neuraxpharm launched the generic version of Lyrica in the United Kingdom.

Increased cases of diseases like epilepsy have resulted in demand for their effective treatment, particularly in the form of pregabalin. Novel medications have been developed by various pharmaceutical companies and regulate neuropathic pain caused by diabetic peripheral neuropathy. Furthermore, they can also manage symptoms of postherpetic neuralgia, fibromyalgia and neuropathic pain related to spinal cord injury.

Global Pregabalin Market Geographical Share

North America region holds the largest market share of global pregabalin market

North America is expected to have significant market growth over the forecast period. This growth is due to the growing prevalence of chronic diseases, well-established healthcare infrastructure, and the high adoption of advanced technologies and government initiatives to mandate the maintenance of health records. The Medscape Diabetic neuropathy article estimated that about 47% of patients with diabetes have some peripheral neuropathy case. Neuropathy is estimated to be present in 7.5% of patients at the time of diabetes diagnosis. More than half of cases are distal symmetric polyneuropathy.

As per the Centers for Disease Control and Prevention (CDC), around 3.4 million people in the United States live with seizures, including 470,000 children. Moreover, four out of 10 people with epilepsy continue to experience uncontrolled seizures despite all available treatments, while many more experience less than optimal seizure control.

Pregabalin Market Companies and Competitive Landscape

The global pregabalin market is moderately competitive with presence of local as well as global companies.  Some of the key players which are contributing to the growth of the market include Pfizer Inc., Mylan N.V., Teva Pharmaceuticals, Cipla Limited, and Medley Pharmaceuticals Limited, Torrent Pharmaceuticals Ltd, Lupin Limited, Zydus Cadila Healthcare Ltd, Sanofi, Genesis Biotec Inc, Chongqing Succeway Pharmaceutical Co., Ltd.'s, Xian tianguangyuan biotech co, Hebei yingong new material tech, Cangzhou Wanyou New Material Tech, Xi'an Kono chem co., Ltd. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the market globally. For instance, In December 2020, Sawai has launched Japan’s first generic version of Lyrica pregabalin brand.

Pregabalin Market Key Companies to Watch

Pfizer Inc. 

Overview: Pfizer Inc. (Pfizer), incorporated on June 2, 1942, is a research-based global biopharmaceutical company. The Company is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio includes medicines and vaccines. The Company manages its commercial operations through two business segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). IH focuses on developing and commercializing medicines and vaccines that improve patients' lives. IH therapeutic areas include internal medicine, vaccines, oncology, inflammation and immunology and rare diseases. EH includes legacy brands, branded generics, generic sterile injectable products, and biosimilars and infusion systems. EH also includes a research and development (R&D) organization, as well as its contract manufacturing business. The Company sold its products in over 125 countries.

Product Portfolio: The Company’s portfolio comprised of include internal medicine, vaccines, oncology, inflammation and immunology and rare diseases and others.

Key Development: In October 2017, U.S. FDA approved Lyrica® CR (Pregabalin) extended-release tablets CV.

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